February 2011 Vol 4, No 1

FEBRUARY 2011

www.TheOncologyNurse.com

VOL 4, NO 1

CONFERENCE NEWS

CANCER CENTER PROFILE

Waukesha Memorial Hospital’s Regional Cancer Center Interdisciplinary Care Taken to the Next Level

By Dawn Lagrosa

APNs Can Improve Cancer Care for Diverse, Underserved Minorities

By Fran Lowry

ORLANDO—A master’s level oncology specialization program prepares nurses with the clinical, cultural sensitivity, and research skills they will need to deal with issues impacting underrepresented minorities. By educating nursing professionals such as advanced practice nurses (APNs)

in oncology about disparities in cancer care, government cancer care initiatives, and different cultural practices in symptom management, they will have a unique opportunity to transform the healthcare system and improve the quality of care that is delivered to patients who Continued on page 10

SURVIVORSHIP

Cancer in the Family Left to right: Kelli K. Pettit, MD, breast surgeon; James C. Jones, MD, radiation oncologist; Peter Johnson, MD, medical oncologist; Jennifer T. Bergin, MD, breast imaging radiologist; Christine Wynveen, MD, breast pathologist; and Michelle Willman, RN, BSN, OCN, CBCN, breast care coordinator

hat started as tumor board conferences a decade ago has grown into a true multidisciplinary team approach to comprehensive breast care. ProHealth Care’s Center for Breast Care at Waukesha Memorial Hospital’s Regional Cancer Center in Waukesha, Wisconsin, is an interdisciplinary breast cancer clinic where patients can see multiple specialists in one visit. With the opening of the clinic, the various specialists involved in patient care can talk to each other about a patient in real time, not replacing tumor board conferences, but taking patient care to the next level.

W

Continued on page 32

PATIENT COMMUNICATION

Communicating Bad News Requires Deep Empathy

By Laird Harrison

T

o help patients cope with terminal illness, healthcare providers must imagine themselves in the place of these patients, according to Tami Borneman, MSN, CNS, a research specialist at City of Hope Cancer Center in Duarte, California.

In a presentation at the sixth annual Oncology Congress, she coaxed her audience to pretend their own deaths were imminent. “I really want us to take in what it’s like to be a person receiving bad news,” she said.

Healthcare workers need such exercis-

Physical, Emotional Issues Present Challenges to Patients, Caregivers

By Daniel Denvir

C

ancer is a disease for the entire family to survive, whether in terms of emotional hurt or the provision of concrete physical care. And alongside partners, spouses, and friends, many survivors care for young children.

Kathryn E. Weaver, PhD, of Wake Forest University School of Medicine and her fellow researchers estimate that 1.58 million US cancer survivors live with minor children, totaling 2.85 million young people in all (Cancer. 2010; 116:4395-4401). Many other cancer survivors are themselves young children, leaving parents balancing complicated medical care decisions with a host of other family responsibilities. A number of papers and presentations at the Cancer Survivorship Research Con-

INSIDE COMPLIMENTARY CE

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Endocrine treatment and cardiovascular/thromboembolic disease risk

CONFERENCE NEWS

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American Society of Hematology BREAST CANCER

Submit your cases online today at

Long-term care needs often taxing for caregivers Although the diagnosis of cancer can be psychologically painful, it can also be a moment for personal growth and transformation. Research has shown that family caregivers can also experience such growth in the time after diagnosis—but what about over the long term? The University of Miami’s Youngmee Kim, PhD, and fellow researchers found that caregivers’ personal growth experiences may peak during the caregiving experience and the period immediately thereafter. The study included 381 caregivers, polled at approximately 2 years and again Continued on page 36

Continued on page 14

Fostering a Dialogue to Improve Patient Care & Outcomes

ference addressed the role of the family in cancer survivorship.

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Women shun mammography guidelines

www.myelomacases.com ©2011 Green Hill Healthcare Communications, LLC

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ONCOLOGY NURSE EXCELLENCE AWARD

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MULTIDISCIPLINARY TUMOR BOARD CASE STUDY . . . . . . . . . .

22

We present the finalists

Metastatic gastrointestinal stromal tumor NAVIGATION AND SURVIVORSHIP NEWS . . . . . . . . .

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Cancer-related chronic pain among survivors Disparities in care for elderly Latinos

Announcing the ďŹ rst and only monoclonal antibody indicated for use in HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer Indication Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

to drive outcomes in HER2+ metastatic gastric/GEJ cancer

Boxed WARNINGS Herceptin administration can result in sub-clinical and clinical cardiac failure.

The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy Evaluate cardiac function prior to and during treatment. Discontinue Herceptin for cardiomyopathy Herceptin can result in serious and fatal infusion reactions and pulmonary toxicity.

Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death

Herceptin plus chemotherapy* extended median overall survival (OS) in HER2+ metastatic gastric and GEJ cancer1 In the ToGA trial†: •

The final overall survival analysis demonstrated a 13.5-month median OS with Herceptin + chemotherapy (cisplatin and either capecitabine or 5-fluorouracil) vs an 11.0-month median OS with chemotherapy alone1

•

The updated overall survival analysis demonstrated a 13.1-month median OS with Herceptin + chemotherapy (cisplatin and either capecitabine or 5-fluorouracil) vs an 11.7-month median OS with chemotherapy alone1

•

Herceptin should be administered until disease progression or unacceptable toxicity in HER2+ metastatic gastric and GEJ cancer

†

Trastuzumab in gastric cancer.

Final Median Overall Survival Analysis1

13.5

Hazard Ratio = 0.73 95% CI: 0.60-0.91 P=0.0038

11.0 Updated Median Overall Survival Analysis1‡

13.1 Hazard Ratio = 0.80 95% CI: 0.67-0.97

11.7 0

3

6

9

12

15

Months Herceptin plus chemotherapy* (n=298) Chemotherapy alone* (n=296) *Chemotherapy was cisplatin and either capecitabine or 5-FU. ‡ The updated analysis was conducted one year after the final analysis. No P value was associated with the updated analysis in the Herceptin Prescribing Information because there was no preplanned statistical testing for OS after the final analysis.

Additional Important Safety Information Exacerbation of chemotherapy-induced neutropenia has also occurred Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy The most common adverse reactions associated with Herceptin were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia Please see brief summary of full Prescribing Information, including Boxed WARNINGS and additional important safety information, on the following pages.

Reference: 1. Herceptin Prescribing Information. Genentech, Inc. October 29, 2010.

©2010 Genentech USA, Inc.

So. San Francisco, CA

All rights reserved.

10581800

11/10

HERCEPTIN® (trastuzumab) Brief Summary For full Prescribing Information, see package insert.

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY Cardiomyopathy Herceptin administration can result in sub clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function. [see Warnings and Precautions and Dosage and Administration] Infusion Reactions; Pulmonary Toxicity Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity.

Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension.

Monitor patients until symptoms completely resolve.

Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautions] Embryo-Fetal Toxicity Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. [see Warnings and Precautions, Use in Specific Populations] INDICATIONS AND USAGE Adjuvant Breast Cancer Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies] breast cancer • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel • with docetaxel and carboplatin • as a single agent following multi-modality anthracycline based therapy. Metastatic Breast Cancer Herceptin is indicated: • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Metastatic Gastric Cancer Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Cardiomyopathy Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death [see Boxed Warning: Cardiomyopathy]. Herceptin can also cause asymptomatic decline in left ventricular ejection fraction (LVEF).

There is a 4−6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Herceptin as a single agent or in combination therapy compared with those not receiving Herceptin. The highest absolute incidence occurs when Herceptin is administered with an anthracycline.

Withhold Herceptin for * 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and * 10% absolute decrease in LVEF from pretreatment values [see Dosage and Administration]. The safety of continuation or resumption of Herceptin in patients with Herceptin-induced left ventricular cardiac dysfunction has not been studied. Cardiac Monitoring Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended: • Baseline LVEF measurement immediately prior to initiation of Herceptin • LVEF measurements every 3 months during and upon completion of Herceptin • Repeat LVEF measurement at 4 week intervals if Herceptin is withheld for significant left ventricular cardiac dysfunction [see Dosage and Administration] • LVEF measurements every 6 months for at least 2 years following completion of Herceptin as a component of adjuvant therapy.

In Study 1, 16% (136/844) of patients discontinued Herceptin due to clinical evidence of myocardial dysfunction or significant decline in LVEF. In Study 3, the number of patients who discontinued Herceptin due to cardiac toxicity was 2.6% (44/1678). In Study 4, a total of 2.9% (31/1056) patients in the TCH arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued Herceptin due to cardiac toxicity. Among 32 patients receiving adjuvant chemotherapy (Studies 1 and 2) who developed congestive heart failure, one patient died of cardiomyopathy and all other patients were receiving cardiac medication at last follow-up. Approximately half of the surviving patients had recovery to a normal LVEF (defined as * 50%) on continuing medical management at the time of last follow-up. Incidence of congestive heart failure is presented in Table 1. The safety of continuation or resumption of Herceptin in patients with Herceptin-induced left ventricular cardiac dysfunction has not been studied.

Table 1 Incidence of Congestive Heart Failure in Adjuvant Breast Cancer Studies Incidence of CHF Study Regimen Herceptin Control 1 & 2a ACbAPaclitaxel+ Herceptin 2% (32/1677) 0.4% (7/1600) 3 ChemoAHerceptin 2% (30/1678) 0.3% (5/1708) 4 ACbADocetaxel+ Herceptin 2% (20/1068) 0.3% (3/1050) 4 Docetaxel+Carbo+ Herceptin 0.4% (4/1056) 0.3% (3/1050) a b

Includes 1 patient with fatal cardiomyopathy.

Anthracycline (doxorubicin) and cyclophosphamide

Table 2 Incidence of Cardiac Dysfunctiona in Metastatic Breast Cancer Studies

Study 5 (AC)b 5 (paclitaxel) 6

Incidence NYHA I−IV NYHA III−IV Herceptin Control Herceptin Control

Event Cardiac Dysfunction 28% 7% 19% 3% Cardiac Dysfunction 11% 1% 4% 1% Cardiac Dysfunctionc 7% N/A 5% N/A a Congestive heart failure or significant asymptomatic decrease in LVEF. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide. c Includes 1 patient with fatal cardiomyopathy.

In Study 4, the incidence of NCI-CTC Grade 3/4 cardiac ischemia/infarction was higher in the Herceptin containing regimens: (AC-TH: 0.3% (3/1068) and TCH 0.2% (2/1056)) as compared to none in AC-T. Infusion Reactions Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. [see Adverse Reactions] In postmarketing reports, serious and fatal infusion reactions have been reported. Severe reactions which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction. Interrupt Herceptin infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered, which may include: epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen. Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions. There are no data regarding the most appropriate method of identification of patients who may safely be retreated with Herceptin after experiencing a severe infusion reaction. Prior to resumption of Herceptin infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. While some patients tolerated Herceptin infusions, others had recurrent severe infusion reactions despite pre-medications. Embryo-Fetal Toxicity Herceptin can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of Herceptin during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise women of the potential hazard to the fetus resulting from Herceptin exposure during pregnancy and provide contraception counseling to women of childbearing potential. [see Use in Specific Populations, Patient Counseling Information].

Pulmonary Toxicity Herceptin use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions [see Warnings and Precautions]. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity. Exacerbation of Chemotherapy-Induced Neutropenia In randomized, controlled clinical trials the per-patient incidences of NCI CTC Grade 3−4 neutropenia and of febrile neutropenia were higher in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received Herceptin and those who did not. [see Adverse Reactions] HER2 Testing Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy because these are the only patients studied and for whom benefit has been shown. Due to differences in tumor histopathology, use FDAapproved tests for the specific tumor type (breast or gastric/ gastroesophageal adenocarcinoma) to assess HER2 protein overexpression and HER2 gene amplification. Tests should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results. Several FDA-approved commercial assays are available to aid in the selection of breast cancer and metastatic gastric cancer patients for Herceptin therapy. Users should refer to the package inserts of specific assay kits for information on the Intended Use, and the validation and performance of each assay. Limitations in assay precision make it inadvisable to rely on a single method to rule out potential Herceptin benefit.

Treatment outcomes for adjuvant breast cancer (Studies 2 and 3) and for metastatic breast cancer (Study 5) as a function of IHC and FISH testing are provided in Tables 8 and 10. Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.

Study 7 demonstrated that gene amplification and protein overexpression were not as well correlated as with breast cancer. Treatment outcomes for metastatic gastric cancer (Study 7), based on HER2 gene amplification (FISH) and HER2 protein overexpression (IHC) test results are provided in Table 12. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Cardiomyopathy [see Warnings and Precautions] • Infusion reactions [see Warnings and

Precautions] • Embryo-fetal Toxicity [see Warnings and Precautions] • Pulmonary toxicity [see Warnings and Precautions] • Exacerbation of chemotherapy-induced neutropenia [see Warnings and Precautions] The most common adverse reactions in patients receiving Herceptin in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of Herceptin treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity [see Dosage and Administration]. In the metastatic gastric cancer setting, the most common adverse reactions (* 10%) that were increased (* 5% difference) in the Herceptin arm as compared to the chemotherapy alone arm were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. The most common adverse reactions which resulted in discontinuation of treatment on the Herceptin-containing arm in the absence of disease progression were infection, diarrhea, and febrile neutropenia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adjuvant Breast Cancer Studies The data below reflect exposure to Herceptin across three randomized, openlabel studies, Studies 1, 2, and 3, with (n= 3355) or without (n= 3308) trastuzumab in the adjuvant treatment of breast cancer. The data summarized in Table 3 below, from Study 3, reflect exposure to Herceptin in 1678 patients; the median treatment duration was 51 weeks and median number of infusions was 18. Among the 3386 patients enrolled in Study 3, the median age was 49 years (range: 21 to 80 years), 83% of patients were Caucasian, and 13% were Asian.

Table 3 Adverse Reactions for Study 3, All Gradesa : Adverse Reaction

1 Year Herceptin Observation (n= 1678) (n=1708)

Cardiac Hypertension 64 (4%) Dizziness 60 (4%) Ejection Fraction Decreased 58 (3.5%) Palpitations 48 (3%) Cardiac Arrhythmiasb 40 (3%) Cardiac Failure Congestive 30 (2%) Cardiac Failure 9 (0.5%) Cardiac Disorder 5 (0.3%) Ventricular Dysfunction 4 (0.2%) Respiratory Thoracic Mediastinal Disorders Cough 81 (5%) Influenza 70 (4%) Dyspnea 57 (3%) URI 46 (3%) Rhinitis 36 (2%) Pharyngolaryngeal Pain 32 (2%) Sinusitis 26 (2%) Epistaxis 25 (2%) Pulmonary Hypertension 4 (0.2%) Interstitial Pneumonitis 4 (0.2%) Gastrointestinal Disorders Diarrhea 123 (7%) Nausea 108 (6%) Vomiting 58 (3.5%) Constipation 33 (2%) Dyspepsia 30 (2%) Upper Abdominal Pain 29 (2%) Musculoskeletal & Connective Tissue Disorders Arthralgia 137 (8%) Back Pain 91 (5%) Myalgia 63 (4%) Bone Pain 49 (3%) Muscle Spasm 46 (3%) Nervous System Disorders Headache 162 (10%) Paraesthesia 29 (2%) Skin & Subcutaneous Tissue Disorders Rash 70 (4%) Nail Disorders 43 (2%) Pruritis 40 (2%) General Disorders Pyrexia 100 (6%) Edema Peripheral 79 (5%) Chills 85 (5%) Aesthenia 75 (4.5%) Influenza-like Illness 40 (2%) Sudden Death 1 (0.06%) Infections Nasopharyngitis 135 (8%) UTI 39 (3%) Immune System Disorders Hypersensitivity 10 (0.6%) Autoimmune Thyroiditis 4 (0.3%) a

35 (2%) 29 (2%) 11 (0.6%) 12 (0.7%) 17 (1%) 5 (0.3%) 4 (0.2%) 0 (0%) 0 (0%) 34 (2%) 9 (0.5%) 26 (2%) 20 (1%) 6 (0.4%) 8 (0.5%) 5 (0.3%) 1 (0.06%) 0 (0%) 0 (0%) 16 (1%) 19 (1%) 10 (0.6%) 17 (1%) 9 (0.5%) 15 (1%) 98 (6%) 58 (3%) 17 (1%) 26 (2%) 3 (0.2%) 49 (3%) 11 (0.6%) 10 (0.6%) 0 (0%) 10 (0.6%) 6 (0.4%) 37 (2%) 0 (0%) 30 (2%) 3 (0.2%) 0 (0%) 43 (3%) 13 (0.8%) 1 (0.06%) 0 (0%)

The incidence of Grade 3/4 adverse reactions was <1% in both arms for each listed term.

Higher level grouping term.

The data from Studies 1 and 2 were obtained from 3206 patients, of whom 1635 received Herceptin; the median treatment duration was 50 weeks. The median age was 49 years (range: 24−80); 84% of patients were White, 7% Black, 4% Hispanic, and 4% Asian. In Study 1, only Grade 3−5 adverse events, treatment-related Grade 2 events, and Grade 2−5 dyspnea were collected during and for up to 3 months following protocol-specified treatment. The following non-cardiac adverse reactions of Grade 2−5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: arthralgia (31% vs. 28%), fatigue (28% vs. 22%), infection (22% vs. 14%), hot flashes (17% vs. 15%), anemia (13% vs.

7%), dyspnea (12% vs. 4%), rash/desquamation (11% vs. 7%), neutropenia (7% vs. 5%), headache (6% vs. 4%), and insomnia (3.7% vs. 1.5%). The majority of these events were Grade b

2 in severity. In Study 2, data collection was limited to the following investigator-attributed treatment-related adverse reactions: NCI-CTC Grade 4 and 5 hematologic toxicities, Grade 3−5 non-hematologic toxicities, selected Grade 2−5 toxicities associated with taxanes (myalgia, arthralgias, nail changes, motor neuropathy, sensory neuropathy) and Grade 1−5 cardiac toxicities occurring during chemotherapy and/ or Herceptin treatment. The following non-cardiac adverse reactions of Grade 2−5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: arthralgia (11% vs. 8.4%), myalgia (10% vs. 8%), nail changes (9% vs. 7%), and dyspnea (2.5% vs. 0.1%). The majority of these events were Grade 2 in severity. Safety data from Study 4 reflect exposure to Herceptin as part of an adjuvant treatment regimen from 2124 patients receiving at least one dose of study treatment [AC-TH: n = 1068; TCH: n = 1056]. The overall median treatment duration was 54 weeks in both the AC-TH and TCH arms. The median number of infusions was 26 in the AC-TH arm and 30 in the TCH arm, including weekly infusions during the chemotherapy phase and every three week dosing in the monotherapy period. Among these patients, the median age was 49 years (range 22 to 74 years). In Study 4, the toxicity profile was similar to that reported in Studies 1, 2, and 3 with the exception of a low incidence of CHF in the TCH arm.

Metastatic Breast Cancer Studies The data below reflect exposure to Herceptin in one randomized, open-label study, Study 5, of chemotherapy with (n=235) or without (n=234) trastuzumab in patients with metastatic breast cancer, and one single-arm study (Study 6; n=222) in patients with metastatic breast cancer. Data in Table 4 are based on Studies 5 and 6.

Among the 464 patients treated in Study 5, the median age was 52 years (range: 25−77 years). Eighty-nine percent were White, 5% Black, 1% Asian and 5% other racial/ethnic groups.

All patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for * 6 months and * 12 months were 58% and 9%, respectively. Among the 352 patients treated in single agent studies (213 patients from Study 6), the median age was 50 years (range 28−86 years), 86% were White, 3% were Black, 3% were Asian, and 8% in other racial/ethnic groups. Most of the patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for * 6 months and * 12 months were 31% and 16%, respectively.

Table 4 Per-Patient Incidence of Adverse Reactions Occurring in * 5% of Patients in Uncontrolled Studies or at Increased Incidence in the Herceptin Arm (Studies 5 and 6) Herceptin Single + Paclitaxel Herceptin ACb Agenta Paclitaxel Alone + ACb Alone n = 352 n = 91 n = 95 n = 143 n = 135 Body as a Whole Pain 47% 61% 62% 57% 42% Asthenia 42% 62% 57% 54% 55% Fever 36% 49% 23% 56% 34% Chills 32% 41% 4% 35% 11% Headache 26% 36% 28% 44% 31% Abdominal pain 22% 34% 22% 23% 18% Back pain 22% 34% 30% 27% 15% Infection 20% 47% 27% 47% 31% Flu syndrome 10% 12% 5% 12% 6% Accidental injury 6% 13% 3% 9% 4% Allergic reaction 3% 8% 2% 4% 2% Cardiovascular Tachycardia 5% 12% 4% 10% 5% Congestive 7% 11% 1% 28% 7% heart failure Digestive Nausea 33% 51% 9% 76% 77% Diarrhea 25% 45% 29% 45% 26% Vomiting 23% 37% 28% 53% 49% Nausea and vomiting 8% 14% 11% 18% 9% Anorexia 14% 24% 16% 31% 26% Heme & Lymphatic Anemia 4% 14% 9% 36% 26% Leukopenia 3% 24% 17% 52% 34% Metabolic Peripheral edema 10% 22% 20% 20% 17% Edema 8% 10% 8% 11% 5% Musculoskeletal Bone pain 7% 24% 18% 7% 7% Arthralgia 6% 37% 21% 8% 9% Nervous Insomnia 14% 25% 13% 29% 15% Dizziness 13% 22% 24% 24% 18% Paresthesia 9% 48% 39% 17% 11% Depression 6% 12% 13% 20% 12% Peripheral neuritis 2% 23% 16% 2% 2% Neuropathy 1% 13% 5% 4% 4% Respiratory Cough increased 26% 41% 22% 43% 29% Dyspnea 22% 27% 26% 42% 25% Rhinitis 14% 22% 5% 22% 16% Pharyngitis 12% 22% 14% 30% 18% Sinusitis 9% 21% 7% 13% 6% Skin Rash 18% 38% 18% 27% 17% Herpes simplex 2% 12% 3% 7% 9% Acne 2% 11% 3% 3% < 1% Urogenital Urinary tract infection 5% 18% 14% 13% 7% a Data for Herceptin single agent were from 4 studies, including 213 patients from Study 6. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide.

Metastatic Gastric Cancer The data below are based on the exposure of 294 patients to Herceptin in combination with a fluoropyrimidine (capecitabine or 5-FU) and cisplatin (Study 7). In the Herceptin plus chemotherapy arm, the initial dose of Herceptin 8 mg/kg was administered on Day 1 (prior to chemotherapy) followed by 6 mg/kg every 21 days until disease progression. Cisplatin was administered at 80 mg/m2 on Day 1 and the fluoropyrimidine was administered as either capecitabine 1000 mg/m2 orally twice a day on Days 1-14 or 5-fluorouracil 800 mg/m2/day as a continuous intravenous infusion Days 1 through 5. Chemotherapy was administered for six 21-day cycles. Median duration of Herceptin treatment was 21 weeks; median number of Herceptin infusions administered was eight.

b

c

Studies 1 and 2 regimens: doxorubicin and cyclophosphamide followed by paclitaxel (ACAT) or paclitaxel plus Herceptin (ACATH).

Study 4 regimens: doxorubicin and cyclophosphamide followed by docetaxel (ACAT) or docetaxel plus Herceptin (ACATH); docetaxel and carboplatin plus Herceptin (TCH).

Figure 1 Studies 1 and 2: Cumulative Incidence of Time to First LVEF Decline of *10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Table 5 Study 7: Per Patient Incidence of Adverse Reactions of All Grades (Incidence * 5% between Arms) or Grade 3 /4 (Incidence >1% between Arms) and Higher Incidence in Herceptin Arm Herceptin +FC (N = 294) N (%) Body System/ Adverse Event Investigations Neutropenia Hypokalemia Anemia Thrombocytopenia Blood And Lymphatic System Disorders Febrile Neutropenia Gastrointestinal Disorders Diarrhea Stomatitis Dysphagia Body as a Whole Fatigue Fever Mucosal Inflammation Chills Metabolism And Nutrition Disorders Weight Decrease Infections And Infestations Upper Respiratory Tract Infections Nasopharyngitis Renal And Urinary Disorders Renal Failure and Impairment Nervous System Disorders Dysgeusia

FC (N = 290) N (%)

Grades 3/4

All Grades Grades 3/ 4

230 (78) 83 (28) 81 (28) 47 (16)

101 (34) 28 (10) 36 (12) 14 (5)

212 (73) 83 (29) 69 (24) 16 (6) 61 (21) 30 (10) 33 (11) 8 (3)

_

15 (5)

_

8 (3)

109 (37) 72 (24) 19 (6)

27 (9) 2 (1) 7 (2)

80 (28) 43 (15) 10 ( 3)

11 (4) 6 (2) 1 ()1)

Time 0 is the date of randomization.

102 (35) 54 (18)

12 (4) 3 (1)

82 (28) 36 (12)

7 (2) 0 (0)

Figure 3 Study 4: Cumulative Incidence of Time to First LVEF Decline of * 10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

37 (13) 23 (8)

6 (2) 1 ()1)

18 (6) 0 (0)

2 (1) 0 (0)

69 (23)

6 (2)

40 (14)

7 (2)

56 (19) 37 (13)

0 (0) 0 (0)

29 (10) 17 (6)

0 (0) 0 (0)

53 (18)

8 (3)

42 (15)

5 (2)

28 (10)

0 (0)

14 (5)

0 (0)

LVEF <50% and Absolute Decrease from Baseline LVEF *10% *16% <50% decrease decrease

Absolute LVEF Decrease <20% and *10% *20%

18.3% (294)

11.7% (188)

33.4% (536)

9.2% (148)

ACAT (n=1488)

9.1% (136)

5.4% (81)

2.2% (33)

18.3% (272)

2.4% (36)

Study 3 Herceptin (n=1678)

8.6% (144)

7.0% (118)

3.8% (64)

22.4% (376)

3.5% (59)

Observation (n=1708)

2.7% (46)

2.0% (35)

1.2% (20)

11.9% (204)

1.2% (21)

Study 4 TCH (n=1056)

8.5% (90)

5.9% (62)

3.3% (35)

34.5% (364)

6.3% (67)

ACATH (n=1068)

17% (182)

13.3% (142)

9.8% (105)

44.3% (473)

13.2% (141)

ACAT (n=1050)

9.5% (100)

6.6% (69)

3.3% (35)

34% (357)

5.5% (58)

c

a

Figure 2 Study 3: Cumulative Incidence of Time to First LVEF Decline of * 10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Time 0 is the date of randomization.

The following subsections provide additional detail regarding adverse reactions observed in clinical trials of adjuvant breast, metastatic breast cancer, metastatic gastric cancer, or postmarketing experience. Cardiomyopathy Serial measurement of cardiac function (LVEF) was obtained in clinical trials in the adjuvant treatment of breast cancer. In Study 3, the median duration of follow-up was 12.6 months (12.4 months in the observation arm; 12.6 months in the 1-year Herceptin arm); and in Studies 1 and 2, 23 months in the AC-T arm, 24 months in the AC-TH arm. In Studies 1 and 2, 6% of patients were not permitted to initiate Herceptin following completion of AC chemotherapy due to cardiac dysfunction (LVEF < 50% or * 15 point decline in LVEF from baseline to end of AC).

Following initiation of Herceptin therapy, the incidence of new-onset dose-limiting myocardial dysfunction was higher among patients receiving Herceptin and paclitaxel as compared to those receiving paclitaxel alone in Studies 1 and 2, and in patients receiving Herceptin monotherapy compared to observation in Study 3 (see Table 6, Figures 1 and 2).

Table 6a Per-patient Incidence of New Onset Myocardial Dysfunction (by LVEF) Studies 1, 2, 3 and 4

Studies 1 & 2b ACATH 22.8% (n=1606) (366)

Time 0 is initiation of paclitaxel or Herceptin + paclitaxel therapy.

All Grades

For Studies 1, 2 and 3, events are counted from the beginning of Herceptin treatment. For Study 4, events are counted from the date of randomization.

The incidence of treatment emergent congestive heart failure among patients in the metastatic breast cancer trials was classified for severity using the New York Heart Association classification system (I−IV, where IV is the most severe level of cardiac failure) (see Table 2). In the metastatic breast cancer trials the probability of cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracyclines. In Study 7, 5.0% of patients in the Herceptin plus chemotherapy arm compared to 1.1% of patients in the chemotherapy alone arm had LVEF value below 50% with a * 10% absolute decrease in LVEF from pretreatment values.

Infusion Reactions During the first infusion with Herceptin, the symptoms most commonly reported were chills and fever, occurring in approximately 40% of patients in clinical trials. Symptoms were treated with acetaminophen, diphenhydramine, and meperidine (with or without reduction in the rate of Herceptin infusion); permanent discontinuation of Herceptin for infusional toxicity was required in <1% of patients. Other signs and/or symptoms may include nausea, vomiting, pain (in some cases at tumor sites), rigors, headache, dizziness, dyspnea, hypotension, elevated blood pressure, rash, and asthenia. Infusional toxicity occurred in 21% and 35% of patients, and was severe in 1.4% and 9% of patients, on second or subsequent Herceptin infusions administered as monotherapy or in combination with chemotherapy, respectively. In the post-marketing setting, severe infusion reactions, including hypersensitivity, anaphylaxis, and angioedema have been reported. Anemia In randomized controlled clinical trials, the overall incidence of anemia (30% vs. 21% [Study 5]), of selected NCI-CTC Grade 2-5 anemia (12.5% vs. 6.6% [Study 1]), and of anemia requiring transfusions (0.1% vs. 0 patients [Study 2]) were increased in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. Following the administration of Herceptin as a single agent (Study 6), the incidence of NCI-CTC Grade 3 anemia was < 1%. In Study 7 (metastatic gastric cancer) on the Herceptin containing arm as compared to the chemotherapy alone arm the overall incidence of anemia was 28% compared 21% and of NCI CTC Grade 3/4 anemia was 12.2% compared to 10.3%. Neutropenia In randomized controlled clinical trials in the adjuvant setting, the incidence of selected NCI-CTC Grade 4−5 neutropenia (2% vs. 0.7% [Study 2]) and of selected Grade 2−5 neutropenia (7.1% vs. 4.5% [Study 1]) were increased in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. In a randomized, controlled trial in patients with metastatic breast cancer, the incidences of NCI-CTC Grade 3/4 neutropenia (32% vs. 22%) and of febrile neutropenia (23% vs. 17%) were also increased in patients randomized to Herceptin in combination with myelosuppressive chemotherapy as compared to chemotherapy alone. In Study 7 (metastatic gastric cancer) on the Herceptin containing arm as compared to the chemotherapy alone arm, the incidence of NCI CTC Grade 3/4 neutropenia was 36.8% compared to 28.9%; febrile neutropenia 5.1% compared to 2.8%. Infection The overall incidences of infection (46% vs. 30% [Study 5]), of selected NCI-CTC Grade 2−5 infection/febrile neutropenia

(22% vs. 14% [Study 1]) and of selected Grade 3−5 infection/ febrile neutropenia (3.3% vs. 1.4%) [Study 2]), were higher in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. The most common site of infections in the adjuvant setting involved the upper respiratory tract, skin, and urinary tract. In Study 4, the overall incidence of infection was higher with the addition of Herceptin to AC-T but not to TCH [44% (AC-TH), 37% (TCH), 38% (AC-T)]. The incidences of NCI-CTC Grade 3−4 infection were similar [25% (AC-TH), 21% (TCH), 23% (AC-T)] across the three arms. In a randomized, controlled trial in treatment of metastatic breast cancer, the reported incidence of febrile neutropenia was higher (23% vs. 17%) in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to chemotherapy alone. Pulmonary Toxicity Adjuvant Breast Cancer Among women receiving adjuvant therapy for breast cancer, the incidence of selected NCI-CTC Grade 2−5 pulmonary toxicity (14% vs. 5% [Study 1]) and of selected NCI-CTC Grade 3−5 pulmonary toxicity and spontaneous reported Grade 2 dyspnea (3.4% vs. 1% [Study 2]) was higher in patients receiving Herceptin and chemotherapy compared with chemotherapy alone. The most common pulmonary toxicity was dyspnea (NCI-CTC Grade 2−5: 12% vs.

4% [Study 1]; NCI-CTC Grade 2−5: 2.5% vs. 0.1% [Study 2]).

Pneumonitis/pulmonary infiltrates occurred in 0.7% of patients receiving Herceptin compared with 0.3% of those receiving chemotherapy alone. Fatal respiratory failure occurred in 3 patients receiving Herceptin, one as a component of multiorgan system failure, as compared to 1 patient receiving chemotherapy alone. In Study 3, there were 4 cases of interstitial pneumonitis in Herceptin-treated patients compared to none in the control arm. Metastatic Breast Cancer Among women receiving Herceptin for treatment of metastatic breast cancer, the incidence of pulmonary toxicity was also increased. Pulmonary adverse events have been reported in the post-marketing experience as part of the symptom complex of infusion reactions. Pulmonary events include bronchospasm, hypoxia, dyspnea, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, and acute respiratory distress syndrome. For a detailed description, see Warnings and Precautions.

Thrombosis/Embolism In 4 randomized, controlled clinical trials, the incidence of thrombotic adverse events was higher in patients receiving Herceptin and chemotherapy compared to chemotherapy alone in three studies (3.0% vs. 1.3% [Study 1], 2.5% and 3.7% vs. 2.2% [Study 4] and 2.1% vs. 0% [Study 5]).

Diarrhea Among women receiving adjuvant therapy for breast cancer, the incidence of NCI-CTC Grade 2−5 diarrhea (6.2% vs.

4.8% [Study 1]) and of NCI-CTC Grade 3−5 diarrhea (1.6% vs.

0% [Study 2]), and of Grade 1−4 diarrhea (7% vs. 1% [Study 3]) were higher in patients receiving Herceptin as compared to controls. In Study 4, the incidence of Grade 3−4 diarrhea was higher [5.7% AC-TH, 5.5% TCH vs. 3.0% AC-T] and of Grade 1−4 was higher [51% AC-TH, 63% TCH vs. 43% AC-T] among women receiving Herceptin. Of patients receiving Herceptin as a single agent for the treatment of metastatic breast cancer, 25% experienced diarrhea. An increased incidence of diarrhea was observed in patients receiving Herceptin in combination with chemotherapy for treatment of metastatic breast cancer. Renal Toxicity In Study 7 (metastatic gastric cancer) on the Herceptin-containing arm as compared to the chemotherapy alone arm the incidence of renal impairment was 18% compared to 14.5%. Severe (Grade 3/4) renal failure was 2.7% on the Herceptin-containing arm compared to 1.7% on the chemotherapy only arm. Treatment discontinuation for renal insufficiency/failure was 2% on the Herceptin-containing arm and 0.3% on the chemotherapy only arm. In the postmarketing setting, rare cases of nephrotic syndrome with pathologic evidence of glomerulopathy have been reported.

The time to onset ranged from 4 months to approximately 18 months from initiation of Herceptin therapy. Pathologic findings included membranous glomerulonephritis, focal glomerulosclerosis, and fibrillary glomerulonephritis.

Complications included volume overload and congestive heart failure. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Among 903 women with metastatic breast cancer, human anti-human antibody (HAHA) to Herceptin was detected in one patient using an enzymelinked immunosorbent assay (ELISA). This patient did not experience an allergic reaction. Samples for assessment of HAHA were not collected in studies of adjuvant breast cancer.

The incidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Herceptin with the incidence of antibodies to other products may be misleading. Post-Marketing Experience The following adverse reactions have been identified during post approval use of Herceptin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Infusion reaction [see Warnings and Precautions] • Oligohydramnios or oligohydramnios sequence, including pulmonary hypoplasia, skeletal abnormalities, and neonatal death [see Warnings and Precautions] • Glomerulopathy [see Adverse Reactions] DRUG INTERACTIONS In Study 5, the mean serum trough concentration of trastuzumab was consistently elevated approximately 1.5-fold, when administered in combination with paclitaxel as compared to trough concentrations of trastuzumab when administered in combination with an anthracycline and cyclophosphamide.

In other pharmacokinetic studies, where Herceptin was administered in combination with paclitaxel, docetaxel or doxorubicin, Herceptin did not alter the plasma concentrations of these chemotherapeutic agents, or the metabolites that were analyzed. In a drug interaction substudy conducted in patients in Study 7, the pharmacokinetics of cisplatin,

capecitabine and their metabolites were not altered when administered in combination with Herceptin. USE IN SPECIFIC POPULATIONS Pregnancy: Category D [see Warnings and Precautions, Nonclinical Toxicology] Herceptin can cause fetal harm when administered to a pregnant woman. In postmarketing reports use of Herceptin during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These case reports described oligohydramnios in pregnant women who received Herceptin either alone or in combination with chemotherapy. In some case reports, amniotic fluid index increased after Herceptin was stopped. In one case, Herceptin therapy resumed after the amniotic fluid index improved, and oligohydramnios recurred. Monitor women exposed to Herceptin during pregnancy for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care.

The efficacy of IV hydration in management of oligohydramnios due to Herceptin exposure is not known. Advise women of the potential hazard to the fetus resulting from Herceptin exposure during pregnancy. Encourage pregnant women with breast cancer who are using Herceptin to enroll in MotHER-the Herceptin Pregnancy Registry: phone 1-800-690-6720. [see Patient Counseling Information]. No teratogenic effects were observed in offspring from reproduction studies in cynomolgus monkeys at doses up to 25 times the recommended weekly human dose of 2 mg/kg trastuzumab. In mutant mice lacking HER2, embryos died in early gestation. Trastuzumab exposure was reported at delivery in offspring of cynomolgus monkeys treated during the early (Days 20-50 of gestation) or late (Days 120-150 of gestation) fetal development periods, at levels of 15 to 28% of the maternal blood levels. Nursing Mothers It is not known whether Herceptin is excreted in human milk, but human IgG is excreted in human milk. Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Trastuzumab was present in the breast milk of lactating cynomolgus monkeys given 12.5 times the recommended weekly human dose of 2 mg/kg of Herceptin. Infant monkeys with detectable serum levels of trastuzumab did not have any adverse effects on growth or development from birth to 3 months of age; however, trastuzumab levels in animal breast milk may not accurately reflect human breast milk levels. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from Herceptin, a decision should be made whether to discontinue nursing, or discontinue drug, taking into account the elimination half-life of trastuzumab and the importance of the drug to the mother.

Pediatric Use The safety and effectiveness of Herceptin in pediatric patients has not been established. Geriatric Use Herceptin has been administered to 386 patients who were 65 years of age or over (253 in the adjuvant treatment and 133 in metastatic breast cancer treatment settings). The risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients in both those receiving treatment for metastatic disease in Studies 5 and 6, or adjuvant therapy in Studies 1 and 2. Limitations in data collection and differences in study design of the 4 studies of Herceptin in adjuvant treatment of breast cancer preclude a determination of whether the toxicity profile of Herceptin in older patients is different from younger patients. The reported clinical experience is not adequate to determine whether the efficacy improvements (ORR, TTP, OS, DFS) of Herceptin treatment in older patients is different from that observed in patients <65 years of age for metastatic disease and adjuvant treatment. In Study 7 (metastatic gastric cancer), of the 294 patients treated with Herceptin 108 (37%) were 65 years of age or older, while 13 (4.4%) were 75 and over. No overall differences in safety or effectiveness were observed.

OVERDOSAGE There is no experience with overdosage in human clinical trials. Single doses higher than 8 mg/kg have not been tested. PATIENT COUNSELING INFORMATION • Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Boxed Warning Cardiomyopathy]. • Advise pregnant women and women of childbearing potential that Herceptin exposure can result in fetal harm [see Warnings and Precautions and Use in Specific Populations]. • Advise women of childbearing potential to use effective contraceptive methods during treatment and for a minimum of six months following Herceptin [see Warnings and Precautions]. • Advise nursing mothers treated with Herceptin to discontinue nursing or discontinue Herceptin, taking into account the importance of the drug to the mother [see Use in Specific Populations]. • Encourage women who are exposed to Herceptin during pregnancy to enroll in MotHER- the Herceptin Pregnancy Registry (1-800-690-6720) [see Warnings and Precautions and Use in Specific Populations].

HERCEPTIN® [trastuzumab] Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 Initial US Approval: September 1998 Revision Date: October 29, 2010 Herceptin®is a registered trademark of Genentech, Inc. HER0000111000 © 2010 Genentech, Inc.

Editorial Board EDITOR-IN-CHIEF

Sharon S. Gentry,

Kena C. Miller,

Rita Wickham,

Beth Faiman,

RN, MSN, AOCN

RN, MSN, FNP

OCN, PhD, RN

Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

Roswell Park Cancer Institute Buffalo, NY

Rush University College of Nursing Rush-PresbyterianSt. Luke’s Medical Center Chicago, IL

Cassandra J. Hammond, RN,

Patricia Molinelli,

Karla Wilson, RN,

RN, MSN, APRN, BC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Elizabeth Bilotti, RN, MSN, APRN, BC, OCN

MS, RN, APN-C, AOCNS

MSN, FNP-C, CPON

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Avid Education Partners, LLC Sharpsburg, MD

Somerset Medical Center Somerville, NJ

City of Hope National Medical Center Duarte, CA

Catherine S. Bishop, DNP, NP,

Shannon Hazen,

Dolores “Jeff” Nordquist, RN, MS,

Pharmacy John F. Aforismo,

AOCNP

Novant Health Presbyterian Cancer Center Charlotte, NC

CS, FNP

Virginia Cancer Care Landsdowne, VA

Mayo Clinic Rochester, MN

BSc Pharm, RPh, FASCP R. J. Health Systems International, LLC Wethersfield, CT

Deena Damsky Dell, RN, MSN,

Patricia Irouer Hughes, RN, MSN,

Melinda Oberleitner, RN,

Nutrition Karen Connelly, RD, CSO Somerset Medical Center Somerville, NJ

MSN, CRNP

RN, BSN, OCN

AOCN, BC

BSN, OCN

DNS, APRN, CNS

Fox Chase Cancer Center Philadelphia, PA

Piedmount Healthcare Rex, GA

College of Nursing and Allied Health Professions University of Louisiana Lafayette, LA

Wendy DiSalvo,

Taline Khoukaz,

Gary Shelton,

DNP, APRN, AOCN

NP, MSN, ACNP-C

Genentech New London, NH

University of Southern California Norris Cancer Center & Hospital Los Angeles, CA

MSN, ARNP, AOCN

Denice Economou, RN,

Sandra E. Kurtin,

Lori Stover, RN,

RN, MS, AOCN, ANP-C

BSN

MN, CNS, AOCN

Patient Advocate Peg Ford Coronado, CA

NYU Cancer Institute New York, NY

Social Work Carolyn Messner,

Western Pennsylvania Cancer Institute Pittsburgh, PA

DSW, MSW, LCSW-R, BCD CancerCare New York, NY

Pamela Hallquist Viale, RN, MS,

Managed Care and Pharmaceutical Management Burt Zweigenhaft,

City of Hope National Medical Center Duarte, CA

Arizona Cancer Center Tucson, AZ

Constance Engelking, RN,

Elizabeth Lima,

MS, CNS, OCN

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Saratoga, CA

Amy Ford, RN,

Ann McNeill,

Connie Visovsky,

Isabell Castellano, RN

BSN, OCN

MSN, RN, NP-C, OCN

RN, PhD, APRN University of Nebraska College of Nursing Omaha, NE

Bristol-Myers Squibb Children’s Hospital Robert Wood Johnson University Hospital New Brunswick, NJ

The CHE Consulting Group, Inc. Mt. Kisco, NY

Innovex Dallas, TX

PA-C

The Cancer Center at Hackensack University Medical Center Hackensack, NJ

CS, ANP, AOCN

BS BioPharma Partners LLC New York, NY

Jeanne Westphal, RN Meeker County Memorial Hospital Litchfield, MN

6

RU RY 011 I VOL , NO 1

www.TheOncologyNurse.com

A pioneer in cancer innovation — exploring new directions

At Genentech BioOncology, we’re leading the fight against cancer with innovative science and are working to transform cancer treatment.

A family of firsts Our proven therapeutics are standards of care in 5 of the 6 leading causes of cancer mortality in the United States.

A robust pipeline Our molecules in development target the fundamental mechanisms of cancer growth and include a HER dimerization inhibitor, a Hedgehog pathway inhibitor, an antibody–drug conjugate, and antibodies targeting cancer cell-surface antigens.

A commitment to patients We actively pursue ways to ensure patient access to therapeutics through a variety of patient support programs so healthcare providers can remain focused on patient care.

Our goal is to fundamentally change the way cancer is treated with incremental advances, but with new standards of care.

www.BioOncology.com

© 2009 Genentech USA, Inc. All rights reserved. 9708100 Printed in USA.

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From the Editor

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PUBLISHING STAFF Publisher Philip Pawelko phil@greenhillhc.com

By Beth Faiman

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ith this issue, we introduce our four finalists for the Nurse Excellence Award.

By recognizing those among us who make outstanding contributions to oncology nursing, we not only acknowledge their accomplishments but

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RU RY 011 I VOL , NO 1

these patients in particular, ongoing quality of life is important.

Survivorship care, as we have come to call it, starts at diagnosis and continues until the end of life. We must be cognizant of not only their physical needs but also their emotional, social, and financial needs. As noted in our feature on how cancer affects the family, we also should be looking out for the needs of their loved ones. We can’t do it alone. Without these caregivers, many of our patients would suffer unnecessarily.

As always, I hope this issue provides you with information that helps you in your practice, in your career, and in meeting the ever-changing challenges of today’s healthcare environment. We look forward to your feedback. ●

News Notes

241 Forsgate Drive, Suite 205C Monroe Twp, NJ 08831

8

also realize our own potential—all oncology nurses have something to offer, be it to their patients, their community, or the profession at large.

As you read this issue of The Oncology Nurse-APN/PA, each study reported on, each case presented, each treatment discussed (and of course each nurse profiled) highlights the achievements of those in our chosen profession.

Our multidisciplinary tumor board case study illustrates the importance of including all team members in prospective case planning. Nurses should be involved in all phases of the patient care continuum. As our feature on head and neck reconstruction elucidates, this care does not end after initial treatment. For many patients, and

Cost of Care Projected to Rise Over Next 10 Years NIH study predicts the cost of cancer care will reach $158 billion in 2020

With the population expanding and aging, the costs of cancer care could reach at least $158 billion (in 2010 dollars) by 2020, according to a National Institutes of Health (NIH) analysis. This 27% increase over 2010 costs may rise even higher if newly developed tools for cancer diagnosis, treatment, and follow-up continue to be more expensive, potentially reaching as high as $207 billion (J Natl Cancer Inst.

Epub January 12, 2011).

Researchers at the National Cancer Institute calculated cancer prevalence from incidence and survival models estimated from Surveillance, Epidemiology and End Results data. Data from Medicare beneficiaries without cancer were used as controls.

Early detection and survivorship care are projected to add cost to the overall financial burden of cancer.

Researchers analyzed cost for continuing care, which they defined as the period between the first 12 months postdiagnosis and the last 12 months before death. Prostate cancer and breast cancer care during this period represented the largest increases.

Their projections—13.8 million and 18.1 million cancer survivors in 2010 and 2020, respectively—correlate with the cost of care rising from $124.57 billion in 2010 to $157.77 billion in 2020. The authors noted that their “findings have implications for policymakers in planning and allocation of resources.”

Too Many Screening Options May Lead to Confusion, Decreased Adherence Oncology nurses may be more effective in screening education with a less-is-more approach

New empirical evidence linking confusion about the multiple screening options for colorectal cancer with a reduced likelihood of adherence to screening guidelines should help oncology nurses tailor information when involved in patient education and outreach activities.

The cross-sectional study found that patients confused about their options were 1.8 times more likely to be nonadherent with screening recommendations (Cancer

Epidemiol Biomarkers Prev. 2010;19:2821-2825).

For their study, researchers at Virginia Commonwealth University Massey Cancer Center surveyed 6100 patients aged 50 to 75 years who had visited a physician within the previous 2 years. Of the responses, 1707 patients reported being presented with more than one screening option.

Using weighted frequencies and multivariate logistic regression, they found that nonadherent patients reported greater confusion (P <.01). Among patients presented with two or more options, confusion was 1.6 times more likely than among those presented with one option (95% CI, 1.08-2.26). In turn, those who reported being more confused were less likely to be adherent than unconfused patients (95% CI, 1.14-2.75).

Nanoparticle-encapsulated Prodrug Delivery May Reduce Side Effects Reduced, but equally effective amount of chemotherapy delivered in the form of a prodrug encapsulated in a nanoparticle targeted to tumor cells

With just one third of the standard dose of cisplatin, researchers successfully shrank tumors in mice, without sacrificing efficacy. They were able to do this by encapsulating the prodrug form of the agent in a nanoparticle, which they then targeted to prostate tumor cells.

Because less drug is used, the hope is that potentially severe side effects will be reduced, for cisplatin, those include kidney and nerve damage.

In addition, the nanoparticle delivery system, which included a coating of molecules that bind to prostate-specific membrane antigen, increased the amount of cisplatin that reached the tumor. By encasing a derivative of cisplatin in a hydrophobic nanoparticle, researchers found that the drug circulated in the bloodstream for 24 hours, which is five times longer than conventional cisplatin. They also noted less accumulation in the kidneys.

The researchers, from Massachusetts Institute of Technology and Brigham and Women’s Hospital, published their findings online January 11, 2011, in the Proceedings of the National Academy of Sciences of the United States of America. This research updates their previous efforts, which showed that the technology worked in vitro. The team now plans to move to human trials. ●

www.TheOncologyNurse.com

Conference News ONS ADVANCED PRACTICE NURSING CONFERENCE

APNs Can Improve Cancer Care for Diverse... Continued from cover represent diverse, underserved, and underrepresented minorities.

This is important because, as highlighted in a poster presented by Theresa Pluth Yeo, PhD, MPH, AOCNP, associate professor and coordinator of the Oncology Nurse Practitioner Program at Thomas Jefferson University School of Nursing, and her colleague Anne Delengowski, MSN, RN, AOCN, oncology clinical nurse specialist at Thomas Jefferson University Hospital’s Department of Nursing in Philadelphia, there will be a 100% increase in new cancer cases among underrepresented minority populations in the United States by 2030.

“Advanced practice nurses can play a big role in alleviating some of these disparities,” noted Yeo, who is the program’s codesigner along with Delengowski.

“Number one is just being aware of what the statistics are, and what the problems are in this country. Also knowing what the resources are for minorities, what is available for them to obtain care, get proper screening, and get better access to better cancer treatments.

“We didn’t focus on attracting nurses from minority backgrounds, although we did increase our number of minority nurses in the program by 30% over the 3-year program,” said Yeo. “The fact is we were limited in that we did not have scholarships to offer, because the training program does not support scholarships.”

Theresa Pluth Yeo, PhD, MPH, AOCNP; and Anne Delengowski, MSN, RN, AOCN

The program was designed to give nursing professionals expertise about how race and ethnicity influence cancer diagnosis, treatment, prognosis, and outcomes, and also to increase awareness about available screening opportunities and related resources.

The existing master’s curriculum was revised and expanded to focus on disparities in cancer care, web-based tools for patients and healthcare providers, and both state and federal cancer care initiatives.

The nurses in the program learned how to assess their cultural knowledge and attitudes, how to interview patients from different ethnic and cultural backgrounds, and how to analyze national reports on healthcare disparities. They also learned about health-

care practices, preferences, and influences among minorities.

The program has been very successful, said Yeo. “Students report overwhelmingly that their knowledge and awareness of cancer disparities in this country have increased, both in terms of incidence and outcomes for those patients,” she said.

Thirteen students have graduated from the master’s program and there are 16 in the pipeline. All graduates have been offered APN positions and have either passed or are eligible for national certifying examinations.

Most patients from minority populations are diagnosed with cancer at a later stage, are less likely to be seen at a university-based cancer treatment or specialized center, and are much more like-

ly to seek care in the community from private doctors who may or may not be oncologists.

“They are much less likely to receive state-of-the-art treatment and they have worse outcomes because of a lack of resources,” said Yeo. “They lack ability to pay for the medications. And even if they know they are sick, they delay coming for treatment, either for lack of insurance, or for family commitments, putting others first. People from minority backgrounds are also less likely to participate in cancer screening programs.

The exception is mammograms—we are doing very well with mammograms because of the federal program that covers minority women,” she said.

Delengowski added that it is important for APNs to understand the different nuances and implications around screening for different cancers. “For example, knowing the incidence of colorectal cancer in African Americans would help the nurses target a population for screening. It is important for them to get this education so that they can understand the populations at higher risk, and perhaps teach these different cultures about these risks. The result, we hope, would be to improve screening rates and access,” she said.

“We believe that graduates of this program will make important contributions to culturally competent care in the United States,” concluded Yeo. ●

Physical Exam of Little Value in Follow-up of Stage I Nonseminomatous Testicular Cancer ORLANDO—Computed tomography the Netherlands, told The Oncology (CT) scanning and blood tests to deter- Nurse-APN/PA. mine tumor markers are very important After orchiectomy, most patients in the follow-up of stage I nonsemino- (70%) appear to be free of metastases. matous testicular cancer (NSTC), but Deemed to have stage I disease, they the physical examination is are started on an intensive of limited value, according “wait-and-see” regimen that to new research presented includes 25 outpatient visits in a poster session. in 5 years, 18 of which occur “To be quite frank, I’ve in the first 24 months. At done the physical examinaeach visit, patients have a tion of these nonseminoblood test to determine matous stage I patients tumor markers alpha-fetoabout 1800 times and my protein, beta-human choricolleague has done 700 onic gonadotropin, and lacsuch exams, and rarely tate dehydrogenase. In the have we found anything. Kees Meijer, RN, MS, MA first year, they also undergo At some point, we began to a CT scan of the chest and talk and ask each other if we’d seen any- abdomen every 3 to 4 months, and this thing yet, and we began to wonder if the frequency is tapered in later months, so physical exam was worth it,” Kees that in all, they undergo nine scans.

Meijer, RN, MS, MA, nurse practitioner They also have a physical examinain the department of surgical oncology at tion, which consists of palpation of the University Medical Center Groningen, scrotum and remaining testis, locore-

10

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gional and supraclavicular lymph nodes, and the abdomen, as well as a check for the presence of gynecomastia.

To assess the value of the physical examination, Meijer and his team retrospectively studied all stage I NSTC patients in follow-up from October 1999 to June 2010. During this time, 133 patients made a total of 2547 visits to the outpatient clinic. Of these, 104 patients remained free of disease and 29 (22%) developed metastatic disease.

In 16 patients, the recurrence was first detected by CT. Elevated tumor markers detected recurrence in 12 patients, one of whom also reported groin swelling. Only one patient was diagnosed with a recurrence on physical examination.

“It wasn’t even us who were the first to detect it. The patient noticed a swelling in his groin, and detected it himself, so on the whole we saw many patients and did many physical exami-

nations with hardly any results,” Meijer noted.

Freeing these men from having to come to the clinic for useless examinations would be a distinct benefit to many of them, he added. Blood can be drawn by the patient’s family doctor or general practitioner, and then sent to the clinic.

The only time a patient needs to visit in person is when the CT scan is due.

“There is no harm in doing the test, but there is inconvenience,” said Meijer.

“The patient has to take time off work, drive here, which in our case can take up to 2 hours since we are in the north and many patients do not live close to the hospital, all for something which is not really useful. If you teach them well, you can keep them assured that if they don’t want to come in that often, they are still OK. It is a false reassurance they are getting every time I examine them and I say there is nothing.” —FL ● Conference News continued on page 12

www.TheOncologyNurse.com

Conference News ONS ADVANCED PRACTICE NURSING CONFERENCE

Most Cancer Care Nurses at Risk for Compassion Fatigue

By Fran Lowry

ORLANDO—Most nurses who care for seeing that they were having what patients with cancer are at risk for com- looked like burnout issues.” passion fatigue and burnout and may Askren and her colleagues identified leave the profession as a result, accord- the prevalence of compassion fatigue ing to a new survey. using the Professional Quality of Life: The results of the survey have implica- Compassion Satisfaction and Fatigue tions for changing some aspects of nurs- Subscales—Revision IV (ProQOL Ring education and highlight the impor- IV) by B. Hudnall Stamm. The scale is tance of the advanced practice designed to diagnose compassion fatigue and nurse (APN) in providing more support for the nursing staff. burnout (Table). The researchers offered the scale APNs also may help nurses to be on the lookout for warning to all 32 nurses on the signs and characteristics of medical oncology unit compassion fatigue, and may and received 20 responses, help healthcare institutions to for a response rate of 63%. recognize the risks and predicAll of the respondents tors of compassion fatigue, said were women; 19 of the 20 Heather Askren, NP-C, RN, where white; mean age Heather Askren, NP-C, BSN, MSN, OCN, from St. was 38 years, ranging from RN, BSN, MSN, OCN Elizabeth Regional Health in 23 to 60 years. Most Lafayette, Indiana, during her poster (74%) were married. session.

The survey showed that the mean “Cancer nurses provide a high level of risk score for compassion fatigue was 18, care to acutely ill patients and their and ranged from a low of 7 to a high of family members. They give medications 46. The mean risk score for burnout was and treatments and emotional support, 25, and ranged from 10 to 37. and they also share pieces of themThe survey also showed that nurses selves,” she said in an interview with aged between 40 and 49 years were at The Oncology Nurse-APN/PA. “Looking the highest risk of developing compasat the nurses I was working with, I was sion fatigue compared with younger and

Table ProQOL R-IV Scale Score <8 8-17 ≥18 Score <9 19-28 >28

Risk for Compassion Fatigue Low risk Moderate risk High risk Risk for Burnout Low risk Moderate risk High risk

older nurses. Other factors associated with a heightened risk were having a family member with cancer, having a bachelor of science degree in nursing or a diploma in nursing, and working in oncology for less than 5 years or for more than 10 years.

Insomnia, headaches, gastrointestinal complaints, fatigue, and job dissatisfaction were the most frequently reported symptoms in nurses caring for cancer patients, Askren said. Twelve nurses said they had insomnia and headaches; of these, eight said their headaches occurred two to three times per week and six nurses reported being unable to sleep two to three times per week. The second most common complaints were fatigue, in 10, and gastrointestinal problems, also

in 10 nurses. Eight nurses complained of job dissatisfaction.

Askren said she tried support groups but these were not successful. “They just weren’t into coming in large groups and talking with each other,” she told The Oncology Nurse-APN/PA. “A lot of our staff is younger, and they’d rather get their support online than physically in a group with other nurses. It could also be a reluctance to admit they are having trouble with compassion fatigue and feel that this makes them a bad nurse. Of course, this is not the case, it’s just something we need to work on together to make it better.”

The fact that the 40- to 49-year-old age group had the most compassion fatigue and burnout could be due to their being part of the sandwich generation, taking care of children at one end of the age spectrum and aging parents at the other, she added.

Being an oncology nurse can be very stressful, and it is important for this to be acknowledged. “It is definitely not a sign of weakness. It goes with the territory. This study is important for cancer nurses to help educate them on the effects of compassion fatigue,” Askren concluded. ●

Emergency Department Nurses Ideally Placed to Foster Mammography ORLANDO—Nurse practitioners are in an ideal position to assess whether nonurgent emergency department patients are undergoing recommended mammography for breast cancer screening, a new study has found.

“Even though they know that breast cancer is a serious disease, many women are still not being screened with mammography,” said Karen Paraska, CRNP, PhD, assistant professor of nursing at Duquesne University, Pittsburgh, Pennsylvania, during her poster presentation.

“When women are in the emergency department for nonurgent problems, the nurse can form an alliance with them and become their advocate, creating a health promotion environment right there in the emergency department.”

Emergency department use for nonurgent problems has increased recently, and nurse practitioners have been enlisted to help deal with the extra patient population. “Since many patients use the emergency department as their primary care providers, the

12

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emergency department may be the only place women have for receiving information about mammography screening,” she said.

In her study, Paraska first determined

sists of true and false questions. This tool has been used for years to assess breast cancer and perceived risk among women in a primary care setting, Paraska noted.

“Since many patients use the emergency department as their primary care providers, the emergency department may be the only place women have for receiving information about mammography screening.” —Karen Paraska, CRNP, PhD whether it was feasible to have nurse practitioners collect information about mammography screening behaviors in the emergency department. Next, she determined the level of knowledge of the female patients in the emergency department regarding mammography screening.

The nurses administered the Breast Cancer Knowledge Test, which con-

The mean age of the women was 52, ranging from 40 to 70 years. Most were white, and most had 12 years of education or more.

The survey found that 78% of the women had been told at some time to get a mammogram, but only 56% actually underwent screening. On the test, the women scored low (66%) for knowledge but high (89%) about the

seriousness of the disease, Paraska said.

“They didn’t get the mammogram because they just felt that it wasn’t necessary. They understood that breast cancer is a serious disease, as shown by the high seriousness score, but yet they did not think they were susceptible to it,” she said.

Paraska admitted she was surprised by her finding. “Even though we are located in a somewhat suburban area outside of Pittsburgh in Washington County, and the women predominantly had higher education—12 years and higher—they are still not getting mammograms,” she said.

She hopes her study will increase awareness that the emergency department can be an important place for educating women about the necessity for mammography screening for breast cancer.

“Hopefully after my intervention there will be a higher adherence to mammograms,” she said. —FL ● Conference News continued on page 14

www.TheOncologyNurse.com

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Outpatient Chlorhexadine Scrubs Help Hospital Reduce Surgical Site Infections

By Fran Lowry

ORLANDO—A pilot program that instituted some small changes, including use of chlorhexadine scrubs the evening before surgery and then again 12 hours later on the morning of surgery, was able to reduce surgical site infections in one Ohio cancer center by almost 20% after 12 months.

“Oncology patients are immunocompromised due to chemotherapy and radiation therapy, and they often have many comorbidities. These factors increase the risk of surgical site infections and poor wound healing,” Lisa Parks, MS, RN, CNP, a surgical oncology nurse at Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio States University, in Columbus, told The Oncology Nurse-APN/PA. “The guidelines from the Centers for Medicare & Medicaid Services stipulate that a hospitalization that is complicated by a surgical site infection will not be reimbursed, so not only is reducing surgical site infections important for the patient, it’s important for the hospital as well,” she said.

Parks and her coauthor Meghan Routt, RN, MSN, GNP/ANP, also of the James Cancer Hospital, presented the results of their pilot study in a poster session.

Parks and Routt discovered that their center was not complying with the estab-

Lisa Parks, MS, RN, CNP; and Meghan Routt, RN, MSN, GNP/ANP

lished literature that had been published in the area of surgical site infection prevention. “We did a review of the literature and identified areas that we were not complying with in terms of the established standard. Once we identified those areas, we came up with a plan to try to improve outcomes in those areas, and then we implemented the areas within our division of surgical oncology, and then looked at the results,” Parks explained.

In addition to the chlorhexadine scrubs, they implemented other changes: • Preoperative shaving was banned because the microscopic cuts that can occur often lead to bacterial

proliferation. Instead, clipping was the preferred method of hair removal.

• Antibiotics were ordered to be delivered within 1 hour of surgery to reduce the microbial burden of intraoperative contamination.

• Ertapenem was used in order sets for all patients before gastrointestinal surgery.

• Modified Nickel’s bowel preparation was eliminated.

• A sterile dressing covered the incision for 24 to 48 hours after surgery.

They also instituted tight glucose control, before, during, and after surgery.

“We are very much more cognizant

now of the importance of controlling the blood sugar,” Routt noted. “This is an area that we continue to try to refine.

There are a number of undiagnosed diabetics who come in for surgery, and they come in with very high blood sugars. We are doing a better job in the preoperative period of identifying these people. We start them on insulin drips in the operating room and continue that in the postoperative period because we found that the glucose control really helps reduce infections.”

Blood glucose was maintained perioperatively at less than 200 mg/dL in all patients.

In addition, patients were instructed to abstain from cigarette smoking or consuming tobacco products for at least 30 days before any elective surgery.

By the end of 6 months, these measures had reduced surgical site infections by 18.6%, and by 12 months, by 19.2%.

“That’s a great result. That’s a reduction by a fifth, so we were very pleased with that,” commented Parks.

“Since we’ve looked at these results we have identified other areas that need improvement so we are going to continue to refine our plan to try to reach our desired outcome, which is to be better than the other institutions that currently we are benchmarking ourselves against,” she added. ●

PATIENT COMMUNICATION

Communicating Bad News Requires Deep Empathy Continued from cover es, because communicating bad news is really difficult, she said.

Although few researchers have gathered empirical data about communicating bad news, Borneman cited a study that illustrated difficulties and misconceptions (Wittenberg-Lyles EM, et al.

Soc Sci Med. 2008;66:2356-2365). In observing palliative care teams, researchers noted three misconceptions: • Healthcare workers imagined that they could plan the time and place to deliver bad news. In reality, they must be prepared for spontaneous conversations. For example, when a patient receives a computed tomography scan showing her cancer has progressed from stage III to stage IV, a discussion about what this means might not be easy to postpone.

• Healthcare workers pictured a one-on-one conversation between a physician and patient. In reality,

14

RU RY 011 I VOL , NO 1

caregivers can and should be included.

• Healthcare workers pictured delivering the bad news as one conversation. “You can’t just lower the boom on a patient and think they’ve got

Often getting the news that death is imminent blots out everything else the healthcare worker says. At the same time, many patients believe that it is important to get only the truth. it,” said Borneman. “It has to be repeated many times in different places and in different ways.”

Often getting the news that death is

imminent blots out everything else the healthcare worker says. At the same time, many patients believe that it is important to get only the truth.

“Anything else is playing games,” said Borneman. “It’s wasting time, and they don’t have time to waste.”

Borneman asked her audience to draw a series of timelines with birth at one end and death at the other, and to imagine themselves very near death. She then asked them to think of all the things they would like to do with the time they have left and to consider what kind of legacy they would like to leave behind.

Patients often feel isolated when they get a terminal diagnosis, said Borneman.

Their disease sets them apart, and they are losing the roles they had in their families and in society in general. “We need each other, especially when we are facing the end of life,” she said.

Often the crisis prompts patients to review their lives, she said. “If we listen

to what they’re saying, we will validate that their life had meaning,” she said.

Many patients confronting death want to forgive people against whom they have grudges and to ask forgiveness for themselves, she said. She asked her audience to consider what would be necessary for them to forgive people in their lives.

“Sometimes having this terminal illness provides the impetus for taking this inner journey, psychological and spiritual, they would not otherwise have the ability to do,” said Borneman.

She suggested that healthcare workers list their values, their moments of fun, and aspects of their lives that give meaning or inspire hope or gratitude.

“These are things you can walk patients through to show them they have had value and meaning in life,” she said. “Ask yourself, ‘Am I helping my patient prepare to die or to embrace living?’” ●

www.TheOncologyNurse.com

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Conference News The following articles are based on presentations at the 52nd American Society of Hematology Annual Meeting & Exposition held December 4-7, 2010, in Orlando, Florida.

Nurses Should Communicate More Clearly about Hematologic Malignancies

By Debra Wood

ORLANDO—Patients often do not understand the terms clinicians use to describe their hematologic malignancies, such as myelodysplastic syndrome, which may lead to misunderstandings about their disease.

“Oncology nurses and doctors should not be scared to use the term ‘blood cancer’ or ‘bone marrow cancer,’” said Caroline Besson, MD, PhD, from the Université Paris Sud, Assistance Publique Hôpitaux de Paris Hôpital Bicêtre, France. “When patients are told they have myelodysplastic syndrome, they are not clear that it’s a cancer, and that makes huge anxiety about whether it is cancer or is not cancer. And patients are scared to ask the doctor.”

Besson and colleagues surveyed 150 members of Connaître et Combattre les Myélodysplasies, the French association of patients with myelodysplastic syndromes, from November 2009 to January 2010, aiming to analyze patients’ feelings

“Oncology nurses and doctors should not be scared to use the term ‘blood cancer’ or ‘bone marrow cancer.’”

—Caroline Besson, MD, PhD

and experiences concerning disclosure of information about their disease. The four-page questionnaire with open-ended

questions and multiple-choice questions was tested through eight telephone interviews conducted by a psychologist.

Seventy-three people returned the survey. Ambiguous answers were followed up with telephone interviews.

Researchers were able to classify 53 of the respondents as having positive or negative feelings about the disclosure of their disease. Twenty-two fell into the positive or neutral group, expressing serenity, reassurance, calm, and in receipt of clear explanations; 31 patients expressed negative feelings or were upset, such as having concern about imminent death, having only a short time to live, or the diagnosis being a shock and thinking the doctor must be talking to the wrong patient. Women were more likely to report negative feelings than men.

In comparing patients’ expectations concerning disclosure of the diagnosis with their experience, investigators found similarities in expectations be-

tween the positive and negative groups but a discrepancy between those expectations and the actual experience in patients with negative feelings. Only half of the patients believed that the physician provided full information, only half said the doctor adapted to their needs, and less than half felt reassured.

Younger patients reacted badly to being told they had a disease of the elderly. Patients also did not appreciate being told there is no known cure when there are treatments available. For the most part, patients understood they had a chronic bone marrow disease, but some complained about the disease being a mystery or difficult to understand. Many expressed that if the disease is cancer, physicians should say the word.

The team concluded that although patients want physicians to behave with humanity, Besson said, they also want full information in terms they can understand. ●

Nurse Counseling Improved Patients’ Adherence to TKIs ORLANDO—A study of physicians from five countries found that nurses and hematologists counseling patients with chronic myeloid leukemia about the importance of adherence to prescribed tyrosine kinase inhibitors (TKIs) or having an established adherence protocol, such as medication diaries, pill organizers, or informational calendars, was associated with improved adherence, and those patients who took the drugs as prescribed had significantly better therapeutic milestones.

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FEBRUARY 2011 I VOL 4, NO 1

John Coombs; and François Guilhot, MD

“Adherence is a problem because it’s a chronic disease, and after 6, 12, or 18 months, the patients do not feel sick,” said lead author François Guilhot, MD, from University Hospital Center of Poitiers, France. “They don’t have signs of leukemia, and they have some side effects from the therapy.”

Guilhot and colleagues surveyed 405 physicians in Brazil, France, Italy, Russia, and Spain online about their adherence perceptions and practices used to increase patients’ willingness to continue on the drugs and reviewed 1155 patient treatment histories and

compliance records, with the dates of all initial and refill prescriptions.

Overall, 47% to 57% of patients had missed some doses, with an average of more than 10% of patients missing 10% or more of their prescribed daily dose.

Greater adherence to the drugs was significantly correlated with achievement of better therapeutic milestones, which may affect the long-term outcomes.

“When healthcare providers are involved in counseling, it has an impact of improving missed doses,” said coauthor John Coombs, with Novartis Pharmaceuticals. Patient record reviews showed

that patients in France, Italy, and Spain demonstrated improved adherence to their therapy if they received individual counseling by the nurse and/or hematologist.

Guilhot said he meets with returning patients for about 20 to 25 minutes, talking about the importance of taking their medications as ordered. He also sends them follow-up letters to improve results. In addition, nurses from the center’s clinical results department provide additional education.

“I spend time to make sure the treatment is taken by my patients,” Guilhot said.

Most physicians surveyed said they discussed adherence with patients at each appointment, but only approximately half of the doctors considered adherence a priority or viewed nonadherence as a major driver of disease progression, with physicians in Italy and Brazil expressing neutral feelings about the link between adherence and improved outcomes.

Physicians surveyed said they believed they take an appropriate level of responsibility about adherence education, but that they also thought nurses and pharmacists could play a more active role.

They indicated that they felt forgetfulness was a major contributor to nonadherence as well. —DW ●

www.TheOncologyNurse.com

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SAN ANTONIOâ&#x20AC;&#x201D;Researchers are reporting â&#x20AC;&#x153;woefully inadequateâ&#x20AC;? mammography rates in American women, even in those with healthcare coverage.

Milayna Subar, MD, National Practice Leader, Medco Oncology TheraALOXIÂŽ (palonosetron HCl) injection BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE Chemotherapy-Induced Nausea and Vomiting ALOXI is indicated for: L =23@/B3:G 3;3B=53<71 1/<13@ 163;=B63@/>G K >@3D3<B7=< =4 /1CB3 /<2 23:/G32 </CA3/ /<2

D=;7B7<5 /AA=17/B32 E7B6 7<7B7/: /<2 @3>3/B 1=C@A3A L 756:G 3;3B=53<71 1/<13@ 163;=B63@/>G K >@3D3<B7=< =4 /1CB3 </CA3/ /<2 D=;7B7<5 /AA=17/B32 E7B6 7<7B7/: /<2 @3>3/B 1=C@A3A DOSAGE AND ADMINISTRATION Recommended Dosing Chemotherapy-Induced Nausea and Vomiting =A/53 4=@ 2C:BA / A7<5:3 ;5 ) 2=A3 /2;7<7AB3@32 =D3@ A31=<2A =A7<5 A6=C:2 =11C@ />>@=F7;/B3:G ;7<CB3A 034=@3 B63 AB/@B =4 163;=B63@/>G Instructions for I.V. Administration "+ 7A AC>>:732 @3/2G 4=@ 7<B@/D3<=CA 7<831B7=< "+ A6=C:2 <=B 03 ;7F32 E7B6 =B63@ 2@C5A :CA6 B63 7<4CA7=< :7<3 E7B6 <=@;/: A/:7<3 034=@3 /<2 /4B3@ /2;7<7AB@/B7=< =4 "+ #/@3<B3@/: 2@C5 >@=2C1BA A6=C:2 03 7<A>31B32 D7AC/::G 4=@ >/@B71C:/B3 ;/BB3@ /<2 27A1=:=@/B7=< 034=@3 /2;7<7AB@/B7=< E63<3D3@ A=:CB7=< /<2 1=<B/7<3@ >3@;7B CONTRAINDICATIONS "+ 7A 1=<B@/7<271/B32 7< >/B73<BA 9<=E< B= 6/D3 6G>3@A3<A7B7D7BG B= B63 2@C5 =@ /<G =4 7BA 1=;>=<3<BA [see Adverse Reactions (6) 7< 4C:: >@3A1@707<5 7<4=@;/B7=< ] WARNINGS AND PRECAUTIONS Hypersensitivity G>3@A3<A7B7D7BG @3/1B7=<A ;/G =11C@ 7< >/B73<BA E6= 6/D3 3F6707B32 6G>3@A3<A7B7D7BG B= =B63@ '

@313>B=@ /<B/5=<7ABA ADVERSE REACTIONS 31/CA3 1:7<71/: B@7/:A /@3 1=<2C1B32 C<23@ E723:G D/@G7<5 1=<27B7=<A /2D3@A3 @3/1B7=< @/B3A =0A3@D32 7< B63 1:7<71/: B@7/:A =4 / 2@C5 1/<<=B 03 27@31B:G 1=;>/@32 B= @/B3A 7< B63 1:7<71/: B@7/:A =4 /<=B63@ 2@C5 /<2 ;/G <=B @3J 31B B63 @/B3A @3>=@B32 7< >@/1B713 < 1:7<71/: B@7/:A 4=@ B63 >@3D3<B7=< =4 </CA3/ /<2 D=;7B7<5 7<2C132 0G ;=23@/B3:G =@ 6756:G 3;3B=53<71 163;=B63@/>G

/2C:B >/B73<BA @3137D32 >/:=<=A3B@=< 2D3@A3 @3/1B7=<A E3@3 A7;7:/@ 7< 4@3?C3<1G /<2 A3D3@7BG E7B6 "+ /<2 =<2/<A3B@=< =@ 2=:/A3B@=< =::=E7<5 7A / :7AB7<5 =4 /:: /2D3@A3 @3/1B7=<A @3>=@B32 0G â&#x2030;Ľ =4 >/B73<BA 7< B63A3 B@7/:A '/0:3

Table 1: Adverse Reactions from ChemotherapyInduced Nausea and Vomiting Studies â&#x2030;Ľ 2% in any Treatment Group ALOXI Ondansetron Dolasetron Event 0.25 mg 32 mg I.V. 100 mg I.V. (N=410) (N=633) (N=194) 3/2/163

=<AB7>/B7=<

7/@@63/

7HH7<3AA

/B75C3

02=;7</: #/7<

<A=;<7/

< =B63@ ABC273A AC0831BA 3F>3@73<132 A3D3@3 1=<AB7>/B7=< 4=::=E7<5 / A7<5:3 >/:=<=A3B@=< 2=A3 =4 />>@=F7;/B3:G ;5 B6@33 B7;3A B63 @31=;;3<232 2=A3 "<3 >/B73<B @3137D32 / ;15 95 =@/: 2=A3 7< / >=AB=>3@/B7D3 </CA3/ /<2 D=;7B7<5 ABC2G /<2 =<3 63/:B6G AC0831B @3137D32 / ;5 ) 2=A3 7< / >6/@;/1=97<3B71 ABC2G < 1:7<71/: B@7/:A B63 4=::=E7<5 7<4@3?C3<B:G @3>=@B32 /2D3@A3 @3/1B7=<A /AA3AA32 0G 7<D3AB75/B=@A /A B@3/B;3<B @3:/B32 =@ 1/CA/:7BG C<9<=E< =11C@@32 4=::=E7<5 /2;7<7AB@/B7=< =4 "+ B= /2C:B >/B73<BA @3137D7<5 1=<1=;7B/<B 1/<13@ 163;=B63@/>G /@27=D/A1C:/@ <=< ACAB/7<32 B/16G1/@27/ 0@/2G1/@27/ 6G>=B3<A7=< 6G>3@B3<A7=< ;G=1/@27/: 7A163;7/ 3FB@/AGAB=:3A A7<CA B/16G1/@27/ A7<CA /@@6GB6;7/ AC>@/D3<B@71C:/@ 3FB@/AGAB=:3A /<2 $' >@=:=<5/B7=< < ;/<G 1/A3A B63 @3:/B7=<A67> B= "+ E/A C<1:3/@ 3@;/B=:=571/: /::3@571 23@;/B7B7A @/A6 3/@7<5 /<2 )7A7=< ;=B7=< A719<3AA B7<<7BCA 3G3 7@@7B/B7=< /<2 /;0:G=>7/ /AB@=7<B3AB7</: &GAB3; 27/@@63/ 2GA>3>A7/ /02=;7</: >/7< 2@G ;=CB6 6711C>A /<2 J /BC:3<13

18

FEBRUARY 2011 I VOL 4, NO 1

peutic Resource Center in Franklin Lakes, New Jersey, and colleagues analyzed medical claims data obtained in more than 1.5 million women between 2006 and 2009. All of the women had health insurance through their employer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ostmarketing Experience '63 4=::=E7<5 /2D3@A3 @3/1B7=<A 6/D3 033< 723<B7I 32 2C@7<5 >=AB/>>@=D/: CA3 =4 "+ 31/CA3 B63A3 @3/1B7=<A /@3 @3>=@B32 D=:C<B/@7:G 4@=; / >=>C:/B7=< =4 C<13@B/7< A7H3 7B 7A <=B /:E/GA >=AA70:3 B= @3:7/0:G 3AB7;/B3 B637@ 4@3?C3<1G =@ 3AB/0:7A6 / 1/CA/: @3:/B7=<A67> B= 2@C5 3F>=AC@3 )3@G @/@3 1/A3A

=4 6G>3@A3<A7B7D7BG @3/1B7=<A /<2 7<831B7=< A7B3 @3/1B7=<A 0C@<7<5 7<2C@/B7=< 27A1=;4=@B /<2 >/7< E3@3 @3>=@B32 4@=; >=AB;/@93B7<5 3F>3@73<13 =4 "+ ;5 7< B63 >@3D3<B7=< =4 163;=B63@/>G 7<2C132 </CA3/ /<2 D=;7B7<5 DRUG INTERACTIONS #/:=<=A3B@=< 7A 3:7;7</B32 4@=; B63 0=2G B6@=C56 0=B6 @3</: 3F1@3B7=< /<2 ;3B/0=:71 >/B6E/GA E7B6 B63 :/BB3@ ;327/B32 D7/ ;C:B7>:3 ,# 3<HG;3A C@B63@ 7< D7B@= ABC273A 7<271/B32 B6/B >/:=<=A3B@=< 7A <=B /< 7<6707B=@ =4 ,# ,# ,# ,# ,# ,# /<2 ,# ,# E/A <=B 7<D3AB75/B32 <=@ 2=3A 7B 7<2C13 B63 /1B7D7BG =4 ,#

,# =@ ,# '63@34=@3 B63 >=B3<B7/: 4=@ 1:7<71/::G A75<7I 1/<B 2@C5 7<B3@/1B7=<A E7B6 >/:=<=A3B@=< />>3/@A B= 03 :=E =/2;7<7AB@/B7=< =4 ;5 ) >/:=<=A3B@=< /<2 ;5 ) 23F/;3B6/A=<3 7< 63/:B6G AC0831BA @3D3/:32 <= >6/@;/1=97<3B71 2@C5 7<B3@/1B7=<A 03BE33< >/:=<=A3B@=< /<2 23F/;3B6/A=<3 < /< 7<B3@/1B7=< ABC2G 7< 63/:B6G AC0831BA E63@3 >/:=<=A3B@=< ;5 ) 0=:CA E/A /2;7<7AB3@32 =< 2/G

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regnancy '3@/B=53<71 4431BA /B35=@G '3@/B=:=5G ABC273A 6/D3 033< >3@4=@;32 7< @/BA /B =@/: 2=A3A C> B= ;5 95 2/G B7;3A B63 @31=;;3<232 6C;/< 7<B@/D3<=CA 2=A3 0/A32 =< 0=2G AC@4/13 /@3/ /<2 @/007BA /B =@/: 2=A3A C> B= ;5 95 2/G B7;3A B63 @31=;;3<232 6C;/< 7<B@/D3<=CA 2=A3 0/A32 =< 0=2G AC@4/13 /@3/ /<2 6/D3 @3D3/:32 <= 3D723<13 =4 7;>/7@32 43@B7:7BG =@ 6/@; B= B63 43BCA 2C3 B= >/:=<=A3B@=< '63@3 /@3 6=E3D3@ <= /23?C/B3 /<2 E3:: 1=<B@=::32 ABC273A 7< >@35</<B E=;3< 31/CA3 /<7;/: @3>@=2C1B7=< ABC273A /@3 <=B /:E/GA >@3271B7D3 =4 6C;/< @3A>=<A3 >/:=<=A3B@=< A6=C:2 03 CA32 2C@7<5 >@35</<1G =<:G 74 1:3/@:G <33232 Labor and Delivery #/:=<=A3B@=< 6/A <=B 033< /2;7<7AB3@32 B= >/B73<BA C<23@5=7<5 :/0=@ /<2 23:7D3@G A= 7BA 34431BA =< B63 ;=B63@ =@ 167:2 /@3 C<9<=E< Nursing Mothers B 7A <=B 9<=E< E63B63@ >/:=<=A3B@=< 7A 3F1@3B32 7< 6C;/< ;7:9 31/CA3 ;/<G 2@C5A /@3 3F1@3B32 7< 6C;/< ;7:9 /<2 031/CA3 =4 B63 >=B3<B7/: 4=@ A3@7=CA /2D3@A3 @3/1B7=<A 7< <C@A7<5 7<4/<BA /<2 B63 >=B3<B7/: 4=@ BC;=@753<717BG A6=E< 4=@ >/:=<=A3B@=< 7< B63 @/B 1/@17<=53<717BG ABC2G / 2317A7=< A6=C:2 03 ;/23 E63B63@ B= 27A1=<B7<C3 <C@A7<5 =@ B= 27A1=<B7<C3 B63 2@C5 B/97<5 7<B= /11=C<B B63 7;>=@B/<13 =4 B63 2@C5 B= B63 ;=B63@

or Medicare.

The results, reported at the San Antonio Breast Cancer Symposium, showed that only 50% of women between 40 and 85 years of age had a mammogram in any given year and Pediatric Use &/43BG /<2 34431B7D3<3AA 7< >/B73<BA 03:=E B63 /53 =4

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/2C:B 1/<13@ >/B73<BA 7< 1:7<71/: ABC273A =4 >/:=<=A3B@=<

E3@3 â&#x2030;Ľ G3/@A =:2 E67:3 E3@3 â&#x2030;Ľ G3/@A =:2 != =D3@/:: 27443@3<13A 7< A/43BG =@ 34431B7D3<3AA E3@3 =0A3@D32 03BE33< B63A3 AC0831BA /<2 B63 G=C<53@ AC0831BA 0CB 5@3/B3@ A3<A7B7D7BG 7< A=;3 =:23@ 7<27D72C/:A 1/<<=B 03 @C:32 =CB != 2=A3 /28CAB;3<B =@ A>317/: ;=<7B=@7<5 /@3 @3?C7@32 4=@ 53@7/B@71 >/B73<BA "4 B63 /2C:B >/B73<BA 7< "+ #"!) 1:7<71/: ABC273A E3@3 â&#x2030;Ľ G3/@A =:2 != =D3@/:: 27443@3<13A 7< A/43BG E3@3 =0A3@D32 03BE33< =:23@ /<2 G=C<53@ AC0831BA 7< B63A3 ABC273A B6=C56 B63 >=AA707:7BG =4 63756B3<32 A3<A7B7D7BG 7< A=;3 =:23@ 7<27D72C/:A 1/<<=B 03 3F1:C232 != 27443@3<13A 7< 34I 1/1G E3@3 =0A3@D32 7< 53@7/B@71 >/B73<BA 4=@ B63 !) 7<271/B7=< /<2 <=<3 /@3 3F>31B32 4=@ 53@7/B@71 #"!) >/B73<BA =E3D3@ "+ 34I 1/1G 7< 53@7/B@71 >/B73<BA 6/A <=B 033< /23?C/B3:G 3D/:C/B32 Renal Impairment 7:2 B= ;=23@/B3 @3</: 7;>/7@;3<B 2=3A <=B A75<7I 1/<B:G /4431B >/:=<=A3B@=< >6/@;/1=97<3B71 >/@/;3B3@A '=B/: AGAB3;71 3F>=AC@3 7<1@3/A32 0G />>@=F7;/B3:G 7< A3D3@3 @3</: 7;>/7@;3<B @3:/B7D3 B= 63/:B6G AC0831BA =A/53 /28CAB;3<B 7A <=B <313AA/@G 7< >/B73<BA E7B6 /<G 235@33 =4 @3</: 7;>/7@;3<B Hepatic Impairment 3>/B71 7;>/7@;3<B 2=3A <=B A75<7I 1/<B:G /4431B B=B/: 0=2G 1:3/@/<13 =4 >/:=<=A3B@=< 1=;>/@32 B= B63 63/:B6G AC0831BA =A/53 /28CAB;3<B 7A <=B <313AA/@G 7< >/B73<BA E7B6 /<G 235@33 =4 63>/B71 7;>/7@;3<B Race <B@/D3<=CA >/:=<=A3B@=< >6/@;/1=97<3B71A E/A 16/@/1B3@7H32 7< BE3<BG 4=C@ 63/:B6G />/<3A3 AC0831BA =D3@ B63 2=A3 @/<53 =4 K ;15 95 '=B/: 0=2G 1:3/@/<13 E/A 67563@ 7< />/<3A3 AC0831BA 1=;>/@32 B= *67B3A 6=E3D3@ <= 2=A3 /28CAB;3<B 7A @3?C7@32 '63 >6/@;/1=97<3B71A =4 >/:=<=A3B@=< 7< :/19A 6/A <=B 033< /23?C/B3:G 16/@/1B3@7H32 OVERDOSAGE '63@3 7A <= 9<=E< /<B72=B3 B= "+ "D3@2=A3 A6=C:2 03 ;/</532 E7B6 AC>>=@B7D3 1/@3 74BG /2C:B 1/<13@ >/B73<BA E3@3 /2;7<7AB3@32 >/:=<=A3B@=< /B / 2=A3 =4 ;15 95 3?C7D/:3<B B= ;5 I F32 2=A3 /A >/@B =4 / 2=A3 @/<57<5 ABC2G '67A 7A />>@=F7;/B3:G B7;3A B63 @31=;;3<232 2=A3 =4 ;5 '67A 2=A3 5@=C> 6/2 / A7;7:/@ 7<1723<13 =4 /2D3@A3 3D3<BA 1=;>/@32 B= B63 =B63@ 2=A3 5@=C>A /<2 <= 2=A3 @3A>=<A3 34431BA E3@3 =0A3@D32 7/:GA7A ABC273A 6/D3 <=B 033< >3@4=@;32 6=E3D3@ 2C3 B= B63 :/@53 D=:C;3 =4 27AB@70CB7=< 27/:GA7A 7A C<:793:G B= 03 /< 34431B7D3 B@3/B;3<B 4=@ >/:=<=A3B@=< =D3@2=A3 A7<5:3 7<B@/D3<=CA 2=A3 =4 >/:=<=A3B@=< /B ;5 95 /<2 B7;3A B63 6C;/< 2=A3 4=@ @/BA /<2 ;713 @3A>31B7D3:G 0/A32 =< 0=2G AC@4/13 /@3/ E/A :3B6/: B= @/BA /<2 ;713 '63 ;/8=@ A75<A =4 B=F717BG E3@3 1=<DC:A7=<A 5/A>7<5 >/::=@ 1G/<=A7A /<2 1=::/>A3 PATIENT COUNSELING INFORMATION &33 FDA-Approved Patient Labeling (17.2) in 4C:: >@3A1@707<5 7<4=@;/B7=< Instructions for Patients L #/B73<BA A6=C:2 03 /2D7A32 B= @3>=@B B= B637@ >6GA717/< /:: =4 B637@ ;3271/: 1=<27B7=<A /<G >/7< @32<3AA =@ AE3::7<5 7< /<2 /@=C<2 B63 7<4CA7=< A7B3 -see Adverse Reactions (6) 7< 4C:: >@3A1@707<5 7<4=@;/B7=<.

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only 60% had two or more mammograms over a 4-year period.

The average yearly mammography rates were 47% for women aged 40 to 49 years, 54% for women aged 50 to 64 years, and 45% for women 65 years of age and older.

Subar, who is a Medco vice president, noted that her study did not examine reasons for the low screening rates but suggested that inconsistent guidelines for breast cancer screening using mammography may be a factor.

Multiple organizations have issued guidelines for mammography, she said.

Such organizations include the American College of Obstetricians and Gynecologists, the American Cancer Society, the National Cancer Institute, the National Comprehensive Cancer Network, and the Society of Breast Imaging/American College of Radiology.

Patient concerns regarding cost, procedure-related discomfort, and fear are also likely to contribute to noncompliance, she said.

In addition, access to breast cancer screening may interfere with compliance. Notably, the number of mammogram facilities decreased from 9400 to 8600 between 2000 and 2003. There is also an ongoing need for more specialists in breast imaging, which may be the result of a lack of adequate training programs as well as a fear of litigation, according to Subar.

She commented that the prevalence of mammography in her study was â&#x20AC;&#x153;considerably lower than expectedâ&#x20AC;? given the public outcry following a recommendation by the US Preventive Services Task Force (USPSTF) last year that women undergo their first mammographic screening at age 50 rather than 40. In fact, around 75% of women surveyed after the USPSTF recommendation was issued maintained that they intended to undergo or continue mammographic testing during their forties.

She also pointed out that her study shows that the Healthy People 2010 goal of achieving 70% compliance with the recommendation of getting a mammogram within the past 2 years for women 40 years of age or older has still not been met. â&#x20AC;&#x153;In 2005, the last time data were available, 67% of women had had mammograms within the previous 2 years; however, this information was based on self-reports,â&#x20AC;? she noted. â&#x20AC;&#x153;We found that the current annual mammography rate is only 50%.â&#x20AC;?

Finally, Subar said that the findings underscore the need for continued public education and access to mammography to reach targets for breast cancer screening. â&#x2014;?

www.TheOncologyNurse.com

Oncology Nurse Excellence Award Finalists

Vote Now for Your Choice

www.TheOncologyNurse.com/award It was not easy, but we have selected four finalists from among the peers you nominated for the inaugural Oncology Nursing Excellence award. All the nominees were outstanding, but these four individuals stood out for their commitment to evidence-based practices and displays of leadership and compassion.

Now, it's your turn. After reading about each finalist, go to www.TheOncologyNurse.com/award and tell us your pick for the ONE. We will announce the readers' choice in the June issue of The Oncology Nurse-APN/PA. Lisa K. Rioux, RN, BSN, OCN Presbyterian Hospital Charlotte, North Carolina Finalist Lisa Rioux’s oncology nursing experience spans more than two decades and encompasses a range of roles. She began her career as a clinical nurse and today serves as staff educator for Presbyterian Hospital in Charlotte, North Carolina. “One reason I was attracted to the nurse educator position was my desire to mentor other nurses and challenge their personal and professional commitment to oncology nursing the way my mentor had challenged me,” Rioux explained.

In nominating Rioux, her colleagues described her as “the practice expert for all things involving central lines and oncology care,” “a tireless patient advocate,” and a “mentor” for novice nurses. Rioux credits her leadership skills to the mentoring she received from Shirley Edwards, MSN, AOCN, early in her career. “I worked with and beside Shirley for 7 years before my family relocated from the West Coast to the East Coast, but her belief in me and training has lasted my entire career.”

A look at her efforts reveals a commitment not only to patients at her facility but also to patients nationwide. In addition to working to improve patient

Martha Polovich, PhD, RN, AOCN Duke Oncology Network Durham, North Carolina Martha Polovich’s storied career has taken her across the country, from a staff nurse at Mt. Sinai Hospital Medical Center in Chicago, Illinois, to her current position as associate director of clinical practice for the Duke Oncology Network in Durham, North Carolina. Polovich said she learned much of what she knows about oncology nursing after nursing school. “As I gained experience in the specialty, I wanted to know more, and then I wanted to share it with other nurses.”

She started as a preceptor, eventually expanding her role to include classroom instruction—a role with ramifications she takes very seriously. “Whenever I teach nurses about oncology, I am influencing the care they will provide to their patients,” Polovich explained. “Many more patients than I could care for myself will benefit...I love having a hand in that.”

Not satisfied with improving oncology nursing care in her home state of North Carolina, Polovich has traveled across the country and even overseas to educate oncology nurses. Last year, she instructed a retinue of Japanese nurses on Oncology Nursing Society practice standards. Nor is she satisfied with limiting her outreach to the nursing profession. According to the colleagues who

care at Presbyterian Hospital by promoting evidence-based practices and helping individual patients deal with their challenges, Rioux is a chemotherapy biotherapy instructor with the Oncology Nursing Society and a speaker for the Oncology Nursing Internship Program. She described her experiences with these two programs as “probably the most important reasons why I have enjoyed being a nurse educator,” praising them for providing her with an “opportunity to model excellent patient care…at a national and local level.”

Rioux also expressed appreciation for having the chance to participate in clinical nursing research and contribute to what she described as the evolution of nursing into an “evidence-based practice.” She noted that today’s nurse is no longer consigned to “taking orders and checking boxes.” Instead, said Rioux, “Nurses impact outcomes for oncology patients and have a vital role in the quality of life of those suffering from cancer.” nominated Polovich, she helped develop chemotherapy administration standards for the American Society of Clinical Oncology and briefed Medicare representatives on the appropriate standards for oncology patient care. “Marty Polovich is the consummate oncology educator,” her colleagues summarized. “The quality and content of the information presented is always evidence-based and up-to-date.”

Staying informed is a priority for Polovich, who said, “As an educator, I have to keep up with what is new in oncology nursing.” In fact, she described the need to read new oncology books as she prepares instructional programs for the Duke Oncology Network affiliates as one of her favorite aspects of the position she holds. She also likes how “every day is unique,” which she said keeps her work fresh and interesting. Polovich strives to impart the same joy she feels at acquiring new information to her students. “I believe that a good teacher not only shares knowledge and skills, but also stimulates curiosity and enthusiasm,” she said.

ONE award finalists continued on page 20

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FEBRUARY 2011 I VOL 4, NO 1

19

the

ONE Award Janet C. Stocker, RN, MS, NP-C, AOCNS Wentworth Douglass Hospital Dover, New Hampshire

Finalist Janet Stocker, who started her nursing career in 1982 as part of a medical surgical oncology unit, said she always knew she wanted to work in a “helping, caring profession.” She has worn several hats over the years, including practitioner, educator, and researcher. Stocker currently has a dual role as an oncology clinical nurse specialist and an oncology adult nurse practitioner at Wentworth Douglass Hospital in Dover, New Hampshire. Colleagues said her drive and focus are readily apparent no matter what assignment she is handling.

At the hospital’s outpatient cancer center, Stocker evaluated chemotherapy delivery and developed a checklist to improve safety for employees in the infusion center and patients. She also worked with the cancer center’s medical oncologists to establish care plans for the center’s new electronic health records (EHRs) database. “Prior to implementing the EHR, Janet ensured that all steps of the delivery of chemo were safe,” wrote her colleagues.

Patricia Shearburn, RN, MSN, AOCN John & Dorothy Morgan Cancer Center Lehigh Valley Health Network Allentown, Pennsylvania Patricia Shearburn began her career as a staff nurse but soon realized she wanted to specialize in oncology. Her love of teaching led her to become a nurse educator, a challenging position that requires finding ways to reach people with vastly different backgrounds. As a clinical nurse specialist in oncology for the past 7 years with the John & Dorothy Morgan Cancer Center, which is part of the Lehigh Valley Health Network, Shearburn instructs patients, nurses, caregivers, and the community at large.

“Teaching a nurse, patient, family member, or someone in the community—it all [has] the same potential outcome of putting them in a better position to navigate their lives,” said Shearburn. She explained that knowledge plays an important role in decreasing anxiety or fear. “It assists with gaining control over a fluid and confusing experience or situation and helps with processing facts to make decisions.”

In submitting Shearburn for consideration, her associates detailed several ways in which Shearburn has enhanced the practice of oncology nursing at the center. She retooled courses designed to educate new nurses and prepare seasoned nurses for the Oncology Certified Nurse examination.

She researched and wrote clinical practice guidelines for various supportive care concerns and secured agreement from the center’s physicians to implement them. She has remained diligent about evaluating new therapeutic options and instructing staff members on their application.

In addition, Shearburn has helped her institution embrace new technologies, such as electronic health records. “Pat initially took the lead on building care plans that provide comprehensive care of patients receiving chemotherapy,” wrote her colleagues. They noted that all the care plans are evidence-based and well referenced. She also helped develop a webbased program for ordering biotherapeutics and ensures that treatment protocols for the program are updated regularly.

Shearburn’s efforts have touched on all levels of patient care at the cancer center, and she said the return visits from patients and their families follow-

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FEBRUARY 2011 I VOL 4, NO 1

This is you ra

ward to giv e.

Vote now fo r your choic e.

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ncologyN

urse.com/a The winner ward will be anou n c e d in the June issue.

As liaison to educators of the facility’s inpatient nurses, Stocker developed a successful protocol for insertion of vascular access devices that is now used hospital-wide. Stocker’s efforts to educate the nursing staff and her treatment decisions are all evidence-based, and she stresses the importance of using evidence-based practices to the nurses that she mentors.

Stocker’s caring nature was a major factor in her coworkers’ decision to nominate her for this award. “She is comforting to patients as she makes treatment decisions, in addition to supporting their symptoms as they go through treatment,” they wrote. Her concern for her patients extends beyond the treatment phase, and she has been active in enhancing the hospital’s offerings for survivors.

An ovarian cancer survivor herself, Stocker said she appreciates the need for nurses to connect with their patients. After chemotherapy, she briefly switched to emergency nursing but missed the “joy” she experiences when helping patients navigate their journey through cancer. Stocker acknowledged that “joy” might seem like an odd word choice. “The joy comes from the ability to impact a patient’s life through education and helping a patient understand how to manage life with cancer,” she explained. “Hopefully, by being part of their journey, I can lessen their fears, anxiety, and concerns,” she added.

ing therapy completion continually reaffirm the value that nurses and educators bring to oncology care. This, along with the support from her colleagues and the enthusiasm her students exhibit for oncology nursing, is what Shearburn likes best about being an oncology nurse educator.

Honorable Mentions Beth Alvey, RN, BSN, OCN

Robin Herman, RN, MS, CNS, OCN

Oncology Hematology of Loudoun and Reston

Los Angeles County University of Southern California Medical Center

Donna Ashmore, RN, OCN University of California Los Angeles Santa Clarita Valley Cancer Center

Una Hopkins, MSN, FNP-BC

Robin Atkins, RN, OCN

Laurie Kautz, RN

Montefiore Medical Center

Riverside Cancer Infusion Center Riverside Regional Medical Center

Jefferson Regional Medical Center

Irene Balowski, RN, ONS, CRNI Spectrum Health Reed City Campus

Resurrection Health Care Saints Mary and Elizabeth Medical Center

Carol S. Blecher, RN, BS, APN, AOCN

Laura Milligan, MSN, FNP, OCN

Rhea L. Locquiao, BS, RNBC, ONS

Trinitas Comprehensive Cancer Center

Medical University of South Carolina

Carmen Bonilla, RN, BSN, OCN

Judith Moyer, NP

Maimonides Cancer Center

University of Michigan

Nancy Davis, RN, OCN

Donna Offenbacker, RN, OCN

Alamance Regional Cancer Center

Rosa Davis, RN, OCN Alamance Regional Cancer Center

Holly Demro, RN, BSN

New York Oncology Hematology Outpatient Stem Cell Transplant

Kemi Ogunyemi, RN, MHA, OCN Emory University Hospital

Texas Health Presbyterian Hospital of Plano

Betty Orton, RN, ONS

Catherine Downs-Holmes, MSN, CNS, CNP

Vicki Rocconi, RN, BSN, OCN

Seidman Cancer Center University Hospitals Case Medical Center

John Muir Health

Amy Summers, RN, BSN

Eva Edwards, BSN, OCN

Cancer Center of Kansas

Orange Regional Medical Center

Donna Vasichko, CMSRN, OCN

Michelle Estling, BSN, OCN Mercy Medical Center

Texas Health Presbyterian Hospital of Plano

Diane Fisher, RN, OCN

Debbie Whitmire, RN

Scotland County Hospital

New York Oncology Hematology-Rexford

St. Vincent’s East Outpatient Infusion

Linda Flemm, APN, CNS, AOCN

AnnMarie Wiesniewski, BSN, MS, OCN

Loyola University Medical Center

Kim Hamilton, RN, BSN

Hackensack University Medical Center John Theurer Cancer Center

Cleveland Clinic Taussig Cancer Institute

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SARCOMA: THE ONLY THING PROGRESSING IS THE DISEASE T H E 5 - Y E A R S U R VI VA L R AT E I S 17 % F O R PAT I E N T S W IT H ME TA S TAT I C S O F T T IS S U E S A R C OMA , Y E T S I GN I F I C A NT T H E R A P E U T IC A D VA N C E ME N T S A R E L A G G I NG .1

NEW TREATMENTS ARE URGENTLY NEEDED.

Reference: 1. National Cancer Institute. Surveillance Epidemiology and End Results. seer.cancer.gov/statfacts/html/soft.html. Accessed March 19, 2010.

Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. 21003100(5)-ARI

Multidisciplinary Tumor Board Case Study

Treatment of Metastatic Gastrointestinal Stromal Tumor: A Multidisciplinary Approach

By Lindsay C. Overton, MD1,2; Joseph Bubalo, PharmD, BCPS, BCOP2; Anne C. Kratz, RN, BSN, OCN2; Michael C. Heinrich, MD, FACP1,2 1

Division of Hematology and Medical Oncology, Portland VA Medical Center; 2Division of Hematology and Medical Oncology, Oregon Health and Science University Knight Cancer Institute, Portland, Oregon

Case Presentation Chief complaint: Abdominal pain and weight loss for 3 months.

History of present illness: A 53-year-old white man with a history of hyperlipidemia treated with atorvastatin originally presented in 2007 to the emergency department with worsening constipation, abdominal pain, and a 20-lb weight loss. Given concerns about diverticular disease or colon cancer, computed tomography (CT) imaging was done that showed a 6-cm small bowel mass with evidence of partial small bowel obstruction.

No other masses were visible on CT imaging.

The patient underwent surgical resection. Pathology revealed a gastrointestinal stromal tumor (GIST) with spindle cell morphology, dimensions of 6 cm x 4 cm x 3 cm with 12 mitotic figures per 50 high power fields. Given the primary site, tumor size, and mitotic rate, the patient was believed to have an 85% risk of recurrent disease. At the time of his diagnosis, there were no published data regarding adjuvant therapy, and the patient was monitored clinically for recurrence.

Three years after resection, the patient presented to his primary care provider with abdominal bloating and fatigue.

Laboratory tests revealed worsening iron deficiency anemia.

Repeat CT scan showed multiple peritoneal implants; the largest measured 2 cm x 2 cm. A CT-guided biopsy was performed, with pathology consistent with GIST. At that time, mutational testing was performed on the patient’s original surgical tumor specimen, which showed a KIT exon 9 mutation.

He was started on standard-dose imatinib (400 mg/day), and

Physicians’ perspective Gastrointestinal stromal tumor (GIST) is the most common sarcoma arising in the abdominal cavity. GIST usually arises from the muscular wall of the stomach, but can arise in the small or large intestine (including the rectum). In the United States, there are an estimated 4000 to 6000 new cases diagnosed annually.1 Before 2000, there was no active medical treatment for metastatic GIST.2 As will be discussed, the introduction of small-molecule tyrosine kinase inhibitors (TKIs) has revolutionized the treatment of GIST. Currently, there are two US Food and Drug Administration (FDA)- approved treatments for advanced GIST: imatinib for first-line treatment, and sunitinib for treatment of patients who are intolerant of imatinib or whose disease has progressed on imatinib therapy. A number of other TKIs have been tested in the third-line or later clinical setting in phase 2 clinical trials. Overall, the prognosis for patients with metastatic GIST has markedly improved over the past decade, with median survival increasing from an estimated 1 to 1.5 years to the current 4 to 5 years.3-5 A landmark study by Hirota and colleagues in 1998 reported that most

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then after 1 month of treatment, his imatinib dose was increased to 400 mg twice daily. Given the interaction between imatinib and atorvastatin, the patient was changed to pravastatin. In addition, the patient was advised to discontinue use of St. John’s wort. The patient was also treated for iron deficiency anemia. Six months later, repeat CT imaging showed decreased size of all peritoneal masses, the largest now 1.0 cm x 0.8 cm.

Medical history: Hyperlipidemia; mild depression treated with St. John’s wort.

Surgical history: Tonsillectomy, 1965; small bowel resection, 2007.

Family history: Mother: 75 years old with diabetes and hypertension. Father: deceased at age 45 in motor vehicle accident.

Paternal uncle: colon cancer at 72. No other family history of cancer.

Social history: Patient is divorced with two grown children. He works as a foreman at a construction site. He quit smoking 30 years ago, with a 10 pack-year history. He drinks 1 to 2 drinks per week and occasionally smokes marijuana.

Medications: Pravastatin, 40 mg by mouth daily; aspirin, 81 mg by mouth daily; daily multivitamin.

Allergies: Penicillin causes hives.

Physical examination: General: Overweight man who appears older than stated

age, well groomed in no acute distress.

Vital signs: Temperature: 98.1°F; heart rate: 93 bpm; blood pressure: 134/86 mm Hg; oxygen saturation: 98% on room air; height: 70 inches; weight: 100 kg.

Head, ears, eyes, nose, throat: Pupils equal, round, reactive to light; conjunctiva pale, no sclera icterus; mucous membranes moist.

Neck: Soft, supple; no appreciated jugular venous distension; no cervical, supraclavicular or infraclavicular lymphadenopathy.

Respiratory: Clear to auscultation bilaterally; no wheezing, rhonchi, or rales.

Cardiovascular: Regular rate and rhythm; no murmur, rubs, or gallops noted.

Abdomen: Well-healed midline laparotomy scar noted; normoactive bowel sounds; distended abdomen; no fluid wave appreciated; no tenderness to palpation noted.

Extremities: Trace bilateral edema to ankles.

Laboratory values: White blood cell: 3.2 K/cu mm; hemoglobin: 10.3 g/dL; hematocrit: 30.1%; platelet count: 200 K/cu mm; segmented neutrophils: 63%; lymphocytes: 30%; eosinophils: 2%; basophils: 1%; monocytes: 4%; sodium: 144 mmol/L; potassium: 4.1 mmol/L; chloride: 104 mmol/L; carbon dioxide: 26 mmol/L; blood urea nitrogen: 20 mg/dL; creatinine: 1.1 mg/dL; glucose: 95 mg/dL; ferritin: 21 ng/mL

Lindsay C. Overton, MD

Michael C. Heinrich, MD, FACP

GISTs (~80%) harbored a gain of function mutation in the KIT receptor tyrosine kinase (Figure).6 Approximately 8% of GISTs have an activating mutation of the homologous platelet-derived growth factor receptor-alpha (PDGFRα) tyrosine kinase.7 Ten to fifteen percent of adult GISTs lack mutations of KIT or PDGFRα and are referred to as wildtype GIST.1 Shortly thereafter, in vitro data demonstrated the potency of the small-molecule kinase inhibitor imatinib (formerly STI-571) against mutant and wild-type KIT kinases.8 These studies led to the hypothesis that imatinib might be active against advanced GIST. In 2000, imatinib was used on a compassionate

basis to treat one patient with metastatic GIST.9 Notably, this patient had a remarkable clinical and imaging response to treatment, leading to further testing in phase 2 studies.10,11 In the pivotal phase 2 study (B2222) leading to FDA approval of imatinib for treatment of GIST, 147 patients were treated in a multicenter study, with 82% of patients having partial response or stable disease.10 Similarly, the European Organisation for Research and Treatment of Cancer (EORTC) phase 1/2 study reported an overall response rate of 68.1%.12 During the phase 2 studies, various

imatinib dosing regimens were used, varying from 400 mg daily to 1000 mg daily. Based on these studies, 800 mg total daily dose was established as the maximally tolerated dose. Parallel phase 3 trials were performed to determine the optimal imatinib dose for treatment of metastatic GIST. Both the EORTC/ Italian/Australasian and the Southwest Oncology Group (SWOG)/National Cancer Institute (NCI) Canada studies compared 400 mg/day with 800 mg/day as the target imatinib dose. The results of these studies have been published separately.5,13 Notably, these two studies were intentionally designed to be evaluated in a meta-analysis (known as MetaGIST), involving a total of 1640 patients. The MetaGIST study found a small but significant progression-free survival (PFS) advantage for patients treated in the high-dose arm (hazard ratio [HR], 0.89; P = .04). No difference was observed between the two arms for overall survival (OS; HR, 1.00; P = .97) or objective response.3 Translational studies using tumor samples from these clinical studies have identified tumor genotype as a strong predictor of clinical benefit for patients with metastatic GIST treated with imatinib. Specifically, patients

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Multidisciplinary Tumor Board Case Study

whose tumor harbors a KIT exon 11 mutation (~70% of GIST) have the highest rates of objective response, PFS, and OS compared with patients whose tumors have no kinase mutations (wild-type GIST, approximately 10%-15% of GIST) or GIST with somatic KIT exon 9 mutations (~10% of patients).14 In the SWOG/NCI Canada study, PFS for these three groups was 24.7 months for KIT exon 11–mutant tumors compared with 16.7 months for wild-type GIST and 12.8 months for patients with KIT exon 9–mutant tumors. In terms of the effect on OS, KIT exon 11–mutant GIST patients had a median OS of 60 months compared with 38.4 months for wild-type GIST patients and 49 months for KIT exon 9– mutant GIST patients.15 The effect of tumor genotype and imatinib dose on clinical outcomes also was analyzed in the MetaGIST study. Within patients in KIT exon 9–mutant GIST, PFS was significantly longer for patients treated in the high-dose arm (P = .017).

For patients whose tumor had a different genotype, no difference was observed between treatment arms. In terms of OS, there was a trend toward a survival advantage for patients with KIT exon 9– mutant GIST treated with high-dose therapy (P = .15).3 Overall, imatinib has revolutionized the treatment of GIST, as it has for treatment of chronic myeloid leukemia (CML). For most patients, imatinib 400 mg once daily is the optimal dose (Figure). However, in patients with KIT exon 9–mutant tumors, data support a target dose of 400 mg twice daily. These dosing recommendations have recently been incorporated into the National Comprehensive Cancer Network clinical practice guidelines for GIST.16 Based on these guidelines, our patient was started on imatinib 400 mg once daily to assess drug tolerance and then underwent dose escalation to 400 mg twice daily after his first month of therapy.

At the time when this patient underwent surgical resection of his primary tumor, there were no data regarding adjuvant therapy with imatinib. Consequently, this patient was monitored for recurrence. However, risk analysis of his tumor (based on size, origin, and mitotic rate) indicated that he had a greater than 85% chance of recurrence.17 It was not until 2009 that data regarding the adjuvant use of imatinib were published by DeMatteo and colleagues.18 This study showed that adjuvant therapy with imatinib prolonged PFS after 1 year of therapy. Currently, patients with intermediate- or high-risk resected primary GIST should be considered

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for treatment with at least 1 year of adjuvant imatinib.16 Notable findings in this patient were iron deficiency and anemia. Iron deficiency is a common finding in GIST patients and usually a consequence of bleeding from the primary tumor. The patient’s anemia is likely due to his iron deficiency, although an element of anemia of chronic disease and/or imatinib-induced myelosuppression also could exist. It is important to recognize and treat iron deficiency in GIST patients, as anemia is a common side effect of imatinib treatment. Patients with metastatic GIST and uncorrected iron deficiency anemia may experience severe anemia and fatigue during imatinib treatment. It is important to recognize that oral iron replacement may not be effective in patients with previous total/subtotal gastrectomy or patients treated with proton pump inhibitors, because an acidic environment is required for iron absorption.

Nurse’s perspective The initial visit to an oncologist can be a stressful experience. Hearing about one’s cancer diagnosis, assimilating prognosis, treatment plans, and follow-up care can be emotionally overwhelming.

Timing of the first appointment is critical to the start of treatment but the patient may still be in shock. This shock

Patients should have easy written access to the clinic phone number to report all side effects and receive reliable phone triage of their symptoms and reported side effects of therapy.

—Anne C. Kratz, RN, BSN, OCN

can be lessened by the oncology nurse specialist. The oncology nurse should assess the patient and care partner’s learning style and educational needs in order to offer appropriate information related to the disease process and treatment plan. If the treatment plan contains oral targeted cancer treatment

Imatinib 400 mg/day Imatinib 800 mg/day

Exon 9 (10%) Exon 11 (70%) Exon 13 (2%) Exon 17 (1%) Representation of the KIT protein with the location and approximate frequencies of KIT mutations in GIST. Dosing recommendations based on the site of KIT mutation are shown (green boxes 400 mg once daily, red boxes 400 mg given twice daily).1,2 Dosing recommendations for other tumor genotypes are as follows: (1) patients with wild-type GIST (no mutation of KIT or PDGFRα) genes should be treated with 400 mg/day of imatinib; (2) patients with mutations of exon 12 or 14 of PDGFRα should be treated with 400 mg/day; (3) patients with mutations of exon 18 of PDGFRα should be considered for treatment with 400 mg twice daily, but expert consultation is advised for this uncommon GIST subtype.

References 1. Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28:1247-1253.

2. Demetri GD, von Mehren M, Antonescu CR, et al. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010;8(suppl 2):S1-S41.

Figure. Dosing Recommendations for KIT-mutant GIST Based on Tumor Genotype

such as imatinib, the nurse hopes to instill trust and empower the patient to be an active partner in the treatment of their disease. Patients should have easy written access to the clinic phone number to report all side effects and receive reliable phone triage of their symptoms and reported side effects of therapy.

The patient’s imatinib prescription will be written by the physician. An important role of the oncology nurse is to help guide the patient through the maze of insurance authorizations, copays, mail-order pharmacies, and patient-assistance programs. Again, this partnership with the patient instills trust and opens the patient to active participation in his or her care.

Medication adherence strategies are very important with imatinib and other oral agents, because the patient is responsible for his or her own therapy.

Skipped doses, patient drug holidays, or simple forgetfulness can all result in suboptimal clinical outcomes, such as loss of tumor response and/or decreased duration of response. Although not as well studied in GIST, patient noncompliance during imatinib treatment of CML has been shown to be a common problem.

For example, Wu and colleagues estimated average imatinib medication compliance to be only 79% during a 6-year study of 592 patients. Imatinib noncompliance in CML patients is associated with higher overall healthcare costs and less favorable treatment results.19 Health literacy screening at the onset of therapy and ongoing follow-up is nec-

essary to remove any barriers the patient may have to achieving good medication adherence. Nurses can provide practical tools such as calendars, electronic reminders, and enlisting phone calls from family and friends to ensure adherence to the treatment regimen. By enlisting patients as partners, the oncology nurse, in partnership with the oncology pharmacist, hopes to empower them to learn, question, and report side effects. Each patient should have a planned drug supply (these are expensive medications), guidance for managing side effects, a list of which side effects require prompt follow-up, phone numbers to call, and a plan to integrate this medication into everyday life to improve patient quality of life and to maintain lifestyle expectations.

A patient taking imatinib may experience myriad side effects or none at all.20 Drug side effects can make a patient feel unsure and vulnerable with continuing the treatment plan. Upfront education about side effects and a partnership between the physician/patient/nurse/ pharmacist to manage these effects empowers the patient to report and comply with side-effect management strategies. Common side effects in which the GIST patient receiving imatinib should be counseled on and given management strategies for include gastric irritation with nausea and vomiting and, although rare, gastrointestinal hemorrhage, edema, electrolyte imbalances (especially potassium and magneContinued on page 24

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Multidisciplinary Tumor Board Case Study Treatment of Metastatic Gastrointestinal Stromal Tumor... Continued from page 23 Table

Clinically Significant Inducing or Inhibiting Medications and Probable or Known Natural Productsa

CYP3A4 inducers

CYP3A4 inhibitors

Carbamazepine Dexamethasone Fosphenytoin Nevirapine Oxcarbazepine Phenobarbitol Phenytoin Primidone Rifabutin Rifampin

Amprenavir Atazanavir Clarithromycin Erythromycin Indinavir Itraconazole Ketoconazole Nefazodone Nelfinavir Posaconazole Ritonavir Saquinavir Telithromycin Voriconazole

CYP3A4 inducing supplements Gingko Grape seed extract Guggul Quercetin St. John’s wort

CYP3A4 inhibiting supplements American elder Berberine Bishop’s weed Bitter orange Cat’s claw Devil’s claw Dehydroepiandrosterone Echinacea Eucalyptus oil Feverfew Garlic

German chamomile Goldenseal Goldthread Grapefruit juice Kava kava Pomegranate Red clover Schisandra Star fruit Valerian Wild cherry

Common CYP3A4 substrates Alprazolam Amiodarone Atorvastatin Buspirone Citalopram Cyclosporine Felodipine Lovastatin Simvastatin Sirolimus Tacrolimus Triazolam CYP2C9 Warfarin

This is not a comprehensive listing. Readers are advised to carefully consult additional references when checking for potential drug–drug interactions between imatinib and other medicinal or natural products.

a

Sources: References 22 and 23.

sium), rashes, alopecia, hepatotoxicity, and liver function test abnormalities.

Gastrointestinal side effects can be managed by dosing with food or judicious use of antiemetics, electrolytes with oral supplementation, and edema with salt and fluid management strategies. Rashes often respond to topical corticosteroid or moisturizing creams but should be followed closely as severe bullous reactions (including erythema multiforme and StevensJohnson syndrome) have occurred with imatinib. The oncology care team should encourage patients to report side effects and the effectiveness of supportive care interventions to ensure continued adherence to imatinib therapy.20 Imatinib can also cause bone marrow suppression or have adverse effects on liver enzymes. Patients should expect frequent lab draws to monitor blood counts and liver tests. The nurse should be a partner in explaining the blood test results and the meaning of the values to help patients understand this complex assessment tool.

As will be discussed, patients should understand that oral targeted therapies may interact with other medications they are taking. Patients should be encouraged to disclose all their prescribed and complementary medications.

As partners in therapy, patients should know that becoming pregnant or fathering a child while taking imatinib is not advised. Open discussion of sexuality is always encouraged.

The management of patients being treated for GIST is complicated and requires a multidisciplinary approach.

The role of the nurse is pivotal in patient education, side-effect management, and ongoing patient support.

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Pharmacist’s perspective The oncology pharmacist should interact with the patient on a variety of levels to increase medication understanding, safety, and success with imatinib therapy.

Notably, careful review of drug–drug interactions between imatinib and other agents is a common and important area of focus for oncology phar-macists. In vivo, imatinib is a strong, competitive inhibitor of CYP3A4 and CYP2C9 and a relatively weak inhibitor of CYP2D6.

Imatinib is metabolized primarily by CYP3A4, with minor contributions from CYP1A2, CYP2D6, CYP2C9, and CYP2C19.21 Thus, imatinib is not only affected by CYP3A4 inducers and inhibitors, but it also inhibits the metabolism of other drugs metabolized by CYP3A4. Although many agents are metabolized via the CYP enzyme systems, these interactions are critically important when the affected medication has a narrow therapeutic margin, is metabolically affected to a large degree, or is a critical element of patient care (Table).

In this case, our patient was taking St. John’s wort, a dietary supplement sometimes used for managing mild depression and a known potent inducer of multiple enzyme systems. In a drug interaction study in 12 healthy volunteers, those taking St. John’s wort had a 43% reduction in the imatinib area under the curve (AUC) from baseline.24 This magnitude of change could significantly diminish the clinical response in our patient.

Other potent inducers (Table) have been shown to affect imatinib to a similar or greater degree and should be avoided when possible. If the inducing agents cannot be avoided, then the dose of imatinib may need to be adjust-

ed upward, but there are no clear guidelines for this situation.

Significant CYP3A4 inhibitors (Table) need to be addressed in a similar fashion. For example, ketoconazole has been shown to raise the AUC of imatinib by 40% after a single dose and could greatly increase side effects in patients in whom the interacting agent was not discontinued or replaced with another agent.25

Each medication or supplement that a patient is receiving should be reviewed…to look for common CYP substrates.

In this case, the St. John’s wort was discontinued because its clinical benefits were uncertain. The patient also was cautioned to have any additional dietary supplements being contemplated for use reviewed by the team, because there are multiple agents known to modify CYP activity.

With respect to imatinib’s effects on other agents, atorvastatin is a CYP3A4 substrate and imatinib increases the blood levels of a similarly metabolized statin, simvastatin, by 2- to 3.5-fold. This degree of increased drug exposure can significantly increase the risk for side effects, such as myalgias, hepatotoxicity, and rhabdomyolysis.26 In the current case, we substituted pravastatin for atorvastatin.

This agent is expected to provide similar antilipid benefits, but is only a minor CYP substrate. It is important for the

GIST patient care team, especially the oncology pharmacist, to review each medication or nutritional supplement in the patient’s medication list for potential drug–drug interactions and/or overlapping side effects.

Many other medications can be similarly affected, because CYP3A4 is among the most common pathways used for medication metabolism. Medications with narrow therapeutic margins, where small changes in blood level can cause profound physiologic effects, are the most concerning when reviewing for drug interactions. For example, although imatinib inhibition of CYP2C9 is not as significant as its effects on CYP3A4, CYP2C9 is the primary enzyme that metabolizes warfarin. Imatinib treatment can inhibit CYP2C9 sufficiently to decrease warfarin metabolism and cause patients to become excessively anticoagulated and at increased risk for bleeding events. Each medication or supplement that a patient is receiving should be reviewed in a similar manner to look for common CYP substrates (Table) and to assess the risk of interaction or overlapping side effects. Patients should be advised to contact the oncology care team whenever any change in medication profile is considered (including both adding and subtracting medications).

Conclusions The introduction of TKIs has revolutionized the treatment of metastatic GIST. However, obtaining optimal treatment results requires a multidisciplinary approach by physicians, oncology nurses, and oncology pharmacists. In particular, patient education to ensure medical compliance, and successfully manage side effects and concomitant medications are critical elements for successful treatment of patients with GIST. Although this review has emphasized first-line treatment of metastatic GIST with imatinib, similar multidisciplinary coordination of care is required when using sunitinib for second-line treatment of metastatic GIST. ● Disclosures Funding was provided in part by a Merit Review Grant from the Veterans Affairs Administration (MCH) as well as from the GIST Cancer Research Fund (MCH) and the Life Raft Group (MCH).

All potential conflicts of interest have been reviewed and managed by Conflict of Interest Committees at the Portland VA Medical Center and the Oregon Health and Science University. ● References 1. Corless CL, Heinrich MC. Molecular pathobiology of gastrointestinal stromal sarcomas. Annu Rev Pathol.

2008;3:557-586.

www.TheOncologyNurse.com

Prostate Cancer 2. DeMatteo RP, Heinrich MC, el-Rifai W, Demetri G. Clinical management of gastrointestinal stromal tumors: before and after STI-571. Hum Pathol. 2002;33:466-477.

3. Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol.

2010;28:1247-1253.

4. Blanke CD, Demetri GD, von Mehren M, et al. Longterm results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008;26:620-625.

5. Verweij J, Casali PG, Zalcberg J, et al. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004; 364:1127-1134.

6. Hirota S, Isozaki K, Moriyama Y, et al. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors.

Science. 1998;279:577-580.

7. Heinrich MC, Corless CL, Duensing A, et al. PDGFRA activating mutations in gastrointestinal stromal tumors.

Science. 2003;299:708-710.

8. Heinrich MC, Griffith DJ, Druker BJ, et al. Inhibition of c-kit receptor tyrosine kinase activity by STI 571, a selective tyrosine kinase inhibitor. Blood. 2000;96:925-932.

9. Joensuu H, Roberts PJ, Sarlomo-Rikala M, et al. Effect of the tyrosine kinase inhibitor STI571 in a patient with a metastatic gastrointestinal stromal tumor. N Engl J Med. 2001;344:1052-1056.

10. Demetri GD, von Mehren M, Blanke CD, et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002;347: 472-480.

11. Van Oosterom AT, Judson I, Verweij J, et al. STI571, an active drug in metastatic gastrointestinal stromal tumors (GIST) an EORTC phase I study. Proc Am Soc Clin Oncol.

2001;20(1A):Abstract 2.

12. Van Oosterom AT, Judson I, Verweij J, et al; for the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. Lancet. 2001; 358:1421-1423.

13. Blanke CD, Rankin C, Demetri GD, et al. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008; 26:626-632.

14. Heinrich MC, Corless CL, Demetri GD, et al. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol.

2003;21:4342-4349.

15. Heinrich MC, Owzar K, Corless CL, et al. Correlation of kinase genotype and clinical outcome in the North American Intergroup Phase III Trial of imatinib mesylate for treatment of advanced gastrointestinal stromal tumor: CALGB 150105 Study by Cancer and Leukemia Group B and Southwest Oncology Group. J Clin Oncol.

2008;26:5360-5367.

16. Demetri GD, von Mehren M, Antonescu CR, et al.

NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw.

2010;8(suppl 2):S1-S41.

17. Miettinen M, Lasota J. Gastrointestinal stromal tumors: pathology and prognosis at different sites. Semin Diagn Pathol. 2006;23:70-83.

18. DeMatteo RP, Ballman KV, Antonescu CR, et al; for the American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team.

Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebocontrolled trial. Lancet. 2009; 373:1097-1104.

19. Wu EQ, Johnson S, Beaulieu N, et al.

Healthcare resource utilization and costs associated with non-adherence to imatinib treatment in chronic myeloid leukemia patients.

Curr Med Res Opin. 2010;26:61-69.

20. Joensuu H, Trent JC, Reichardt P. Practical management of tyrosine kinase inhibitor-associated side effects in GIST. Cancer Treat Rev. May 28, 2010. Epub ahead of print.

21. Peng B, Lloyd P, Schran H. Clinical pharmacokinetics of imatinib. Clin Pharmacokinet.

2005;44:879-894.

22. Lacy CF, Armstrong LL, Goldman MP. Drug Information Handbook. Hudson, OH: Lexi-Comp, Inc; 2010.

23. Therapeutic Research Faculty. Natural Medicines Comprehensive Database. http:// naturaldatabase.therapeuticresearch.com/nd/ products.aspx?AspxAutoDetectCookieSup port=1. Accessed October 6, 2010.

24. Frye RF, Fitzgerald SM, Lagattuta TF, et al.

Effect of St John’s wort on imatinib mesylate pharmacokinetics. Clin Pharmacol Ther.

2004;76:323-329.

25. Dutreix C, Peng B, Mehring G, et al.

Pharmacokinetic interaction between ketoconazole and imatinib mesylate (Glivec) in healthy subjects. Cancer Chemother Pharmacol.

2004;54:290-294.

26. O’Brien SG, Meinhardt P, Bond E, et al.

Effects of imatinib mesylate (STI571, Glivec) on the pharmacokinetics of simvastatin, a cytochrome p450 3A4 substrate, in patients with chronic myeloid leukaemia. Br J Cancer.

2003;89:1855-1859.

www.TheOncologyNurse.com

Adding Radiation to ADT May Increase Survival in Locally Advanced Prostate Cancer Patients

By John Schieszer

SAN DIEGO—Prostate cancer patients who are treated with a combination of androgen deprivation therapy (ADT) and radiotherapy may have a substantially improved chance of survival compared with patients who do not receive radiotherapy, according to British researchers. They reported at the 52nd annual meeting of the American Society for Radiation Oncology that combination therapy resulted in substantial benefits in overall survival and disease-specific survival in men with locally advanced prostate cancer.

“If the figures from the interim analysis are similar to the final analysis, we would expect a 43% reduction in the chance of death from prostate cancer in men with this regimen,” said lead study author Malcolm Mason, MD, who is professor of clinical oncology at the Cardiff University School of Medicine, Wales, United Kingdom. “This would translate into a reduction in the chance of deaths from prostate cancer in many thousands of men worldwide.”

From 1995 to 2005, 1205 men with high-risk prostate cancer in the United States, the United Kingdom, and Canada were randomly assigned to receive ADT alone or ADT plus radiotherapy. They were all followed for at least 6 years. Interim results presented at

“This study is practice changing...It shows that the standard treatment for these patients should now be hormone therapy plus radiation.”

—Malcom Mason, MD

this meeting demonstrated there were no increased long-term side effects associated with the combination treatment.

Today, as most oncology pharmacists are aware, there is considerable variation in the treatment of men with local-

ized, high-risk prostate cancer, and it is a hotly debated topic. Although the number of men treated with combined ADT and radiotherapy has increased in recent years, many patients are still treated with ADT alone. This multicenter, randomized trial examined the effects of external beam radiation therapy (EBRT) added to lifelong ADT. “This study is practice changing, as it highlights the importance of radiation in the treatment of high-risk prostate cancer patients and clearly demonstrates its benefits,” said Mason in an interview with The Oncology Nurse-APN/PA. “It shows that the standard treatment for these patients should now be hormone therapy plus radiation.”

The type of radiation a man receives also makes a difference. Men with prostate cancer treated with intensitymodulated radiation therapy (IMRT) appear to have fewer gastrointestinal complications compared with patients treated with conventional three-dimensional conformal radiotherapy (3DCRT), according to a large, retrospective, observational study also presented at the meeting.

“Some of the most common side effects were rectal bleeding and diarrhea. We found that IMRT minimized Continued on page 26

8th Annual

Oncology Nursing Advanced Practice: INNOVATION

THROUGH

PRACTICE

F r i d a y, M a r c h 4 – S u n d a y, M a r c h 6 , 2 0 1 1 Hilton San Diego Bayfront, San Diego, California

This two and a half day conference aims to update advanced practice professionals on a wide variety of topics affecting practice today and is designed to provide pertinent educational sessions along with ample networking opportunities.

Conference Highlights s #OMPREHENSIVE PRESENTATIONS OF THE LATEST ADVANCES IN CANCER DIAGNOSIS AND TREATMENT WITH A STRONG PATIENT CARE FOCUS s 3MALL GROUP WORKSHOPS ALLOWING FOR ADDITIONAL INTERACTION WITH EXPERT FACULTY ON PERTINENT TOPICS s !UDIENCE 2ESPONSE 3YSTEM USED FOR INSTANT FEEDBACK AND INTERACTIVE LEARNING s -ULTIPLE NETWORKING AND ONE ON ONE DISCUSSION OPPORTUNITIES THROUGHOUT THE COURSE s 53" DRIVE CONTAINING SYNCHRONIZED AUDIO AND lNAL PRESENTATIONS SENT TO ALL ATTENDEES WEEKS AFTER THE CONFERENCE California Board of Registered Nursing and American Academy of Nurse Practitioners CE credits available!

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FEBRUARY 2011 I VOL 4, NO 1

25

The Patientâ&#x20AC;&#x2122;s Voice PROSTATE CANCER

Adding Radiation to ADT May Increase Survival...

Continued from page 25

the rates of bleeding and proctitis,â&#x20AC;? said lead study author Justin Bekelman, MD, who is a radiation oncologist at the University of Pennsylvania, Philadelphia, in an interview with The Oncology Nurse-APN/PA. Using the Surveillance, Epidemiology and End Resultsâ&#x20AC;&#x201C;Medicare database, Bekelmanâ&#x20AC;&#x2122;s team studied 12,598 men 65 years and older who were diagnosed with nonmetastatic prostate cancer between 2002 and 2004. The authors followed the patients through 2006 and identified complications that were serious enough to require invasive procedures (including surgery) and/or hospitalization.

The researchers found that among men who received IMRT, 18.8% had serious bowel complications during the 2 years after treatment compared with 22.5% of men treated with 3D-CRT. 3D-CRT uses imaging studies, including computed tomography, magnetic resonance imaging, and positronemission tomography scans to map the size, shape, and location of tumors and other organs in the area. IMRT is a more advanced version of 3D-CRT, offering a more targeted dose of radiation to the cancerous prostate gland. Although Medicare and private insurers typically cover both IMRT and 3D-CRT, little research has been conducted to show which treatment is associated with fewer side effects, an important consideration for men choosing among the various treatment options for the disease.

This new study showed that IMRT was associated with a reduction in proctitis and rectal bleeding. Urinary complications, such as cystitis and hematuria, did not significantly differ between the groups. No substantial differences were noted in the incidence of urinary or sexual side effects, such as erectile dysfunction; however, Bekelman noted that the study was limited to complications involving invasive surgical procedures.

He noted that this study may not have captured the true prevalence of sexual side effects following treatment, for which patients may have sought less invasive remedies. â&#x2014;?

A Patientâ&#x20AC;&#x2122;s Journey with GIST

By Margo Chevers

I

discovered my tumor by accident, shortly after taking custody of my two granddaughters. I was playing on the floor with them when one straddled my stomach and plopped down.

The pain was unbelievable; I knew

learned that the surgeon didnâ&#x20AC;&#x2122;t perform a hysterectomy, but instead called in an expert to remove a 17.5-cm tumor attached to my bowel that had burst on the operating table. Because of this, my focus was more on the miracle of having

JOIN THE LARGEST Nurse & Patient Navigator Association BLOGS Experts from various disciplines will be featured in blog segments over the course of the year, allowing members to interact with their colleagues on multiple subject areas.

RESOURCES Informational/educational resources to help you and your patients navigate their cancer treatment and improve their quality of life.

Member Benefits Include: *

â&#x20AC;˘ Best Practices â&#x20AC;˘ Continuing Education â&#x20AC;˘ Networking â&#x20AC;˘ Expert Opinion Blogs

PUBLICATIONS DECEMBER 2010

â&#x201E;˘

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CANCER CENTER PROFILE

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Geisinger Medical Cancer Institute Centerâ&#x20AC;&#x2122;s Joins the NCCCP

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By Dawn Lagrosa our cancer Regardless through to track guiding patients as they present themselves. of the Yearâ&#x20AC;&#x201D; of the Year you will need Navigator ARNP, impact of coming barriers you are using, Navigator Lung Cancer RN, MSN, (VA) model investand the financial Affairs of the navigation return on Laura Hunnibell, clinical outcomes to show a West the Veterans . Most and report AOCN, of Healthcare System and You will have patient satisfaction ut is making ty and develop patient navigation.

Connectic works to as sustainabili that navigation role, and ment, as wellyou will need to show Haven Campus the the navigator presented importantâ&#x20AC;&#x201D; the bottom line. implement facility in improving with program were on annual an impact to justify a navigation ors at the third assists her for patients and diagnosis Strategies nationally and administrat College of Oncology stage at CBCN She speaks of nurses Davis Forsyth program position the American by a panel Derrick L. lung cancer. standard Update of each presenterâ&#x20AC;&#x2122;s navigation Cancer CenterCarolina develop a rs in the the outcomes Regional Oncology group to rs/navigato em, North tors. Because specific needs, advisory Winston-Sal care coordinato Administra for its communityâ&#x20AC;&#x2122;s of doing so vary. leads an 2 cancer page for on RN Continued was designed description and the methods System. of Nicole Messier, Center Navigator Cancer measures tracked VA Healthcare Vermont tinal CancerRN, BSN, of Vermont Gastrointes Burlington, Pope, OCN ENGES Regional RN, BSN, the Yearâ&#x20AC;&#x201D;Julie IAL CHALL L. Davis Forsyth Pamela Matten, alem, North FINANC the Derrick Hospital Winston-S and their St. Joseph Cancer Center, patients Orange, California empowers about their Mammography OCN, CBCN Carolina, technologist knowledge she RN, BSN, Partners In addition, and disciplinary breast cancer Jessica Davis, RT(R) (M), is part families with Elaine Sein, of a multiCancer Center resources. care team working caring screening, treatment, a Fox Chase care and to improve access through her and research.

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MS, RN his past April, Geisinger compassion Medical Centerâ&#x20AC;&#x2122;s Tricia Strusowski,Cancer Center of the stitute became (GMC) Cancer one Navigator OCN, InHelen F. GrahamHealth System Institute Community of 14 sites added to the National Care RN, Breast Cancer Cancer Cancer Centers Christiana York this national network an Bowman, Program (NCCCP). with canRosenberg Health at Yearâ&#x20AC;&#x201D;Sus Joining Newark, Delaware for patients

By Karen ia, and opportunity to expand of community cancer centers Wellspan are a key issue protocols offers GMC the MPH, PhD(c) MSW, of York, Pennsylvan northeast Pennsylvania.its state-of-the-art cancer care with treatment presented at the for nearly Linda Fleisher, inancial challenges and research in Cancer Center, interfere Cancer Center navigator a study can to nurse and n, sup-GMC is a part of Geisinger Clinical a Fox Chase , Pennsylvania cer According has been informatio aher Society of Health System (Geisinger), to Cheltenham She offers CBCN n for mostly rural population patient adherence.of the American of patients turn which 10 years. and has cancer RN, CBEC, meeting her State College, Barre, one third centers in Danville, serves clinical coordinatio Gardner, these barriers. and Hazleton. Geisinger 2010 annual only about Susan M. port, and Wilkesalso extended overcome Center tive approach to however, develShe has takes pride in its help them Los Angeles, healthcare delivery Valley Medical Oncology, p care by includes patients. innovaResearch, (AOSW), workers to to this Washington social survivorshi lifelong Kelton many population, elderly patients.

Renton, oncology role into with their underserved e project by OCN In addition, a significant which also Social Workers diagnosed survivors RN, BSN, because of socioeconomic In a collaborativ of Oncology portion is on page 2 to support surveyed newly about the Jay R. Swanson,Cancer Institute Continued problems. Thanjavur status and transportation and the Association oping a curriculum and his associates Surgical Innovation, Ravikumar, MD, FACS, director Saint Elizabeth AOSW members process. completed of the Center for and co-chair of Martin Eichholz caregivers, and recovery Lincoln, Nebraska Surveys were CRNI the oncology patients, OCN, service line at cancer on page 2 RN, BSN, of cancer treatment.

Continued Carol Lewis, financial impact Continued on page Hermann 18

By Dawn

Multigene Signature Breast Cancer 2010 Scores and

By Deena Damsky Dell, Clinical Nurse Specialist,MSN, RN-BC, AOCN Fox Chase Cancer Philadelphia Center,

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Social OncologyCan Help Workers with Financial Patients s of Treatment Challenge

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he addition of new biomarkers for available establishing a prognosis in the United States: for pa- DX (Genomic Oncotype tients with breast Health) and MammaPrint cancer has been recommended in (Agendia). the 2010 American Joint Committeeedition of the of Cancerâ&#x20AC;&#x2122;s 21-gene Cancer Staging Handbook.1 recurrence score Human epiderassay mal growth factor Available since 2004, Oncotype DX (HER2) status and receptor type 2 uses a process called reverse-transcriptase multigene signature â&#x20AC;&#x153;scoresâ&#x20AC;? have been polymerase chain added to estrogen reaction (RT-PCR) receptor (ER) and to progesterone receptor look at 21 genes: 16 are linked to breast (PR) determinations.1 cancer and five are reference genes used regarding multigene So, where are we for normalizing the expression of the signature scores? At this time, two tests cancer-related genes.

The chosen genes are commercially have Continued on page

CONFERENC E NEWS

Oncology Nursing Advanced PracticeSocietyâ&#x20AC;&#x2122;s 11th Annual Nursing Conference Institutes of Learning /

Orlando, Florida, November 11-14, 2010.

See who was there: page 8.

T

F

Memorial Texas The Woodlands,

AONN Staff Sean T. Walsh Director Executive online.org sean@AONN

TH R PA E OU Affiliate, GU aID or Regional Local, State, ittee Start

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Hill Healthcare

Fostering a Dialogue

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Submit your cases online today at

www.myelomac ases.com

Lung Cancer Stereotactic Radiation Nonâ&#x20AC;&#x201C;small-cell Lung for Cancers

Kimberly Gessner, Holly Gentry, and Dads, a book by Marlene Ferguson keynote speaker display copies of Bruce Feiler.

The Council of

Inside

Page 20

Fast Neutron Radiotherapy

Page 25

ns, LLC Communicatio

Continuing Education Maintenance Therapy in Patients with Advanced Nonâ&#x20AC;&#x201C;small-cell Lung Cancer

Page 30

Journal of Oncology

NAVIGATION & SURVIVORSHIP The Official Journal of

DECEMBER 2010

Pamela Matten, RN, BSN, OCN St. Joseph Hospital Orange, California Elaine Sein, RN, BSN, OCN, CBCN Fox Chase Cancer Center Rockledge, Pennsylvania Partners Tricia Strusowski, MS, RN Helen F. Graham Cancer Christiana Care Health Center System Newark, Delaware Linda Fleisher, MPH, PhD(c) Fox Chase Cancer Center Cheltenham, Pennsylvania Susan M. Gardner, RN, Valley Medical Center CBEC, CBCN Renton, Washington Jay R. Swanson, RN, Saint Elizabeth Cancer BSN, OCN Institute Lincoln, Nebraska Carol Lewis, RN, BSN, OCN, CRNI Memorial Hermann The Woodlands, Texas

AONN Staff Sean T. Walsh Executive Director sean@AONNonline.org

VOL 1, NO 7

Continued on page

TRAINING

â&#x201E;˘

Nurse Navigators ÂŽ

T

he George Washington Cancer the network, Institute (GWCI) recently re- embedded and patient navigators are and a secure ceived a $2.4 million at every site, said Steven tion process, Internet-based data collecthe DC Cancer Consortiumgrant from Patierno, PhD, which allows the navigators executive director to establish and coordinate of to upload their a City-wide Patient the GWCI. navigation logs and Navigation Network their patient interactions in real time.

(CPNN) in Washington, DC. The CPNN will create a seamless, cohesive framework for â&#x20AC;&#x153;The CPNN will cancer care throughout coordination of create a seamless, that all city residents the city to ensure cohesive framework get appropriate canfor cer screening and treatment regardless cancer care throughout coordination of of their ability to pay. the city. â&#x20AC;?

The help patients identify network will also â&#x20AC;&#x201D;Steven Patierno, PhD throughout the cancer support services cluding posttreatment continuum, insurvivorship.

Twenty-five separate institutions, including hospitals, The program, he cancer explained, provides community organizationscenters, and training once a He gave an example month to every navigator of how coordinain the and every Washington, DC, tion of care works. navigatorâ&#x20AC;&#x2122;s supervisor. area are members â&#x20AC;&#x153;If a patient is seen It also of provides a central communications portal a community advocacy group that at does

NAVIGATION

Center Provides Platform for Discussion Cancer Survivorship, of Navigation, and Policy

Journal of Oncology Navigation & Survivorshipâ&#x201E;˘

12

Members receive subscriptions to the Journal of Oncology Navigation & Survivorship and The Oncology Nurse-APN/PA (a more than $190 value).

2

By Karen Rosenberg

T

he Center for the Advancement policy analysis, and of Cancer Survivorship, education.

NavicaSNP grew out of gation, and Policy the understanding (caSNP), a that collaboration of the there is â&#x20AC;&#x153;overlap George Cancer Institute (GWCI) Washington navigation, survivorship,between patient and the uni- both and policy and versityâ&#x20AC;&#x2122;s School of of these intersect Public with local and Health Services DepartmentHealth and national healthcare policy,â&#x20AC;? explained of Health Steven Policy, was established Patierno, PhD, executive in 2009 with director support from Pfizer of the GWCI. â&#x20AC;&#x153;We and the Pfizer wanted to create Foundation. The a platform to talk about centerâ&#x20AC;&#x2122;s navigation and suradvance patient navigationgoals are to vivorship in the context of policy and cancer united in a survivorship efforts program.â&#x20AC;? both locally and nationally through The center offers training training, research, programs at three levels:

â&#x20AC;˘ Navigation training is navigators, including designed for nurses, social workers, and lay persons. Trainees from institutions across try learn about barriers the counthat affect their patients, are trained to launch or improve programs, gain tools for implementing and institutional change. â&#x20AC;˘ Executive level training is designed for chief executive officers, chief financial officers, hospital adminis-

GUIDE OUR PATH Start a Local, State, or Regional Join a Committee Affiliate,

www.AONNonline.org Š2010 Green Hill

Healthcare Communications,

the Academy of Oncology

www.AONNonline.org CARE COORDINATION

City-wide Patient Navigation Network Coordinates Washington, DC, Cancer Care

By Karen Rosenberg

Leadership Council Lillie Shockney, RN, Johns Hopkins Breast BS, MAS Center Johns Hopkins University School of Medicine Baltimore, Maryland Sharon Gentry, RN, MSN, AOCN, CBCN Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, North Carolina Nicole Messier, RN Vermont Cancer Center Burlington, Vermont

Breast Cancer Prolonging Chemotherapy Breast Cancer Improves in Metastatic Survival

Page 44 Š2010 Green Hill

Did You Know?

Employment for registered nurses is projected to grow faster than any other occupation through 2012.

there was something very wrong. The many tests that followed were inconclusive, and my doctors thought it was a growth in my uterus so I was scheduled for a hysterectomy.

When I awoke from that surgery, I

Healthcare Communications,

LLC

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2

between pages 34 and 35

LLC

www.AONNonline.org /join AONNKsize2711lt

â&#x20AC;&#x201D;US Bureau of Labor Statistics

26

FEBRUARY 2011 I VOL 4, NO 1

www.TheOncologyNurse.com

The Patient’s Voice survived the ordeal than on my future.

After I recovered, my doctor gave me the news that I had a rare cancer, called gastrointestinal stromal tumor (GIST).

That was May 2006, the start of my journey with GIST. Since then, I’ve had two recurrences and one surgery.

It was important for me to educate myself about GIST by speaking to my physicians and researching online. I went

to a well-known cancer institute to get a second opinion and became an active member of The Life Raft Group and GIST Support International. These online support groups enabled me to speak with other “GISTers,” who could relate to my situation. Through these resources and discussions with GIST specialists, I’ve not only received knowledge, but also ideas, understanding, and crucial

emotional support.

The compassion of my medical team has been a blessing. Twice, my oncologist has had to tell me that another tumor appeared on my computed tomography scan. Each time, I knew that he cared about me as a person. Knowing that my healthcare team is on this journey with me brings me peace of mind. No matter what the outcome, I’m not alone along

Second Annual Navigation and Survivorship Conference

©iStockphoto.com/YinYang

September 16-18, 2011 - San Antonio, Texas

Register Online at

www.AONNonline.org/conference Conference Overview AONN’s second annual conference will further advance navigation and survivorship in cancer care through the addition of a variety of sessions, topics, and networking events. Attendees will receive a thorough understanding of the state of navigation and survivorship in today’s evolving healthcare system.

Who Should Attend All clinical and nonclinical professionals involved or interested in patient navigation and survivorship. This conference will enhance the skills and knowledge of: • Oncology Nurse Navigators • Administrators • Patient Navigators • Oncology Social Workers • Oncology Nurses & • Case Managers Nurse Practitioners • Practice Managers

CURRENT MEMBERS - $295

Recent FDA Approval

(Save $200 off full registration of $495.)

NEW MEMBERS - $335 (Registration includes member dues.)

NONMEMBERS - $495 CONFERENCE LOCATION San Antonio Marriott Rivercenter Hotel 101 Bowie Street San Antonio, TX 78205-3901 Phone: 210.223.1000

Topics Include • Navigation and Survivorship Program Planning and Implementation • Best Practices • Collaborative Navigation • Psychosocial Care and Distress Management • Compassion Fatigue • Tumor-site Focused Breakouts/Workshops

NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARE

TM

AONNKsize2711rt

www.TheOncologyNurse.com

this difficult path. This experience has also brought me closer to family and friends. We say “I love you” more often, but gratefully they don’t coddle me—or at least they try not to.

I’ve always known that today is the most important day of my life. If I spend time worrying about tomorrow, then I’ve wasted a portion of today. I now live with an urgency to make each “today” count. I have two granddaughters to think of. I took on the commitment and responsibility for their well-being and they are my treasure. I awe at who they’re becoming, and I make the most of my time with them.

Every day I marvel at the things I do that make a difference in others’ lives.

Although I have stopped the inspirational speaking and training I had been doing as a profession for the past 24 years, I’m now coaching others and helping them develop their careers in that field. I am also writing my fourth book and continue to be active in my community by organizing charitable events and fundraisers.

I would advise others who are diagnosed with GIST to educate themselves about this disease. Develop a supportive network of family, friends, and online groups, and become partners with your medical team. Above all, live with an urgency to make each day meaningful.

Focus your thoughts on the things you’re grateful for, that bring you joy, and that help you bring joy to others. Don’t worry about tomorrow. Do everything today that will make your tomorrows significant—that which matter most to you and those you love. ●

Gardasil for Prevention of Anal Cancer The FDA has approved a new indication for Gardasil—the prevention of anal cancer and associated precancerous lesions caused by the human papillomavirus (HPV) types 6, 11, 16, and 18 in patients 9 to 26 years of age.

The vaccine is already approved for the prevention of cervical, vulvar, and vaginal cancer in the female cohort of this population, as well as the prevention of genital warts in men and women.

Approval was based on a randomized, controlled trial of men who have sex with men, a population with high incidence of anal cancer.

Gardasil was 78% effective in the prevention of anal cancer related to HPV 16 and 18. Because the disease is the same in both sexes, approval was granted for prevention in men and women.

FEBRUARY 2011 I VOL 4, NO 1

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CONTINUING EDUCATION PROGRAM CE5 • RELEASE DATE: FEBRUARY 15, 2011 • EXPIRATION DATE: FEBRUARY 15, 2012 ESTIMATED TIME TO COMPLETE: 1.0 HOUR • COMPLETE THE POSTTEST AT WWW.THEONCOLOGYNURSE.COM

Risk of Cardiovascular and Thromboembolic Disease after Prostate Cancer Treatment

By Mieke Van Hemelrijck, MSc, PhD King’s College London, School of Medicine, Division of Cancer Studies, Cancer Epidemiology Group, United Kingdom

STATEMENT OF NEED

In the United States, more than one fourth (approximately 600,000) of patients with prostate cancer receive endocrine treatment (ET). Among others, a recently investigated side effect of ET is that of increased risk for heart disease. In animal experiments, castration increased arterial stiffness, central blood pressure, and possibly insulin resistance. Oncology nurses need to be aware of the potential for increased risk for cardiovascular outcomes and thromboembolic side effects during and following ET. In addition, nurses need to understand the evidence to explain the risks and benefits of ET to patients.

TARGET AUDIENCE

Advanced practice nurses, registered nurses, and other interested healthcare professionals, especially those caring for cancer patients LEARNING OBJECTIVES

After completing this activity, the reader should be able to: • Discuss the risk differences for cardiovascular or thromboembolic disease associated with endocrine treatment for prostate cancer • Help patients weigh the risks for cardiovascular or thromboembolic disease versus the benefits of endocrine treatment for men with prostate cancer

E

ndocrine treatment (ET), which interrupts testosterone regulation of the prostate tumor, has been the cornerstone treatment for men with locally advanced or metastatic prostate cancer since the 1940s.1 In the United States, about 600,000 of the 2 million patients with prostate cancer are treated with ET.2 Moreover, the use of ET has increased over time and it is given in earlier stages of the disease, which results in more men being on castrating treatment for longer times. Most patients receive gonadotropin-releasing hormone (GnRH) agonists, but some take antiandrogens (AA) or estrogens, undergo orchiectomy, or receive a combination of several types of ET.2 A number of metabolic side effects have been reported, including increased body weight, insulin resistance, dyslipidemia, and hyperglycemia.3-6 One of the more recently investigated side effects of ET is the increased risk of heart disease, which is believed to be a result of the reduced cardioprotective effect normally provided by testosterone. It is suggested that testosterone treatment promotes vascular smooth muscle and endothelial cell proliferation and

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FEBRUARY 2011 I VOL 4, NO 1

improves vascular reactivity.7 Animal experiments have shown that castration increased arterial stiffness, central blood pressure, and possibly insulin resistance.8 Recently, there has been growing interest in this potential risk for cardiovascular outcomes (eg, ischemic heart disease) during ET.9 The current studies focused on both cardiovascular and thromboembolic side effects after ET, but also curative treatment and surveillance.10,11 Two population-based studies in the Swedish PCBaSe The Prostate Cancer Base (PCBaSe) Sweden is based on the National Prostate Cancer Register of Sweden, which started in 1996 and captures more than 96% of all newly diagnosed, biopsyconfirmed prostate cancers.

We analyzed the relationship between different types of prostate cancer treatment and the following subtypes of cardiovascular disease: ischemic heart disease, acute myocardial infarction, arrhythmia, heart failure, and stroke, as well as the following subtypes of thromboembolic disease: deep vein thrombosis, pulmonary embolism, and arterial embolism.

Because PCBaSe is based on the entire Swedish population, standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs; calculated only for cardiovascular diseases) could be calculated by comparing observed events in the selected cohort (prostate cancer patients) with the expected events in the Swedish male population. The SIRs and SMRs were thus defined as the ratios of the observed number of a particular cardiovascular/thromboembolic disease to the expected number of that cardiovascular/thromboembolic disease, taking age, calendar time, number of and time since previous cardiovascular/thromboembolic event into account.

Results show increased risk of cardiovascular and thromboembolic diseases Between 1997 and 2006, 30,642 prostate cancer patients received ET as primary treatment; 11% of these received AA, 17% orchiectomy, 30% GnRH agonists, and 38% GnRH agonists and short-term AA. The remaining men (4%) were treated with other types or combinations of ET. Another 42,668

patients were recommended curative treatment (54%) or surveillance (46%).

Cardiovascular diseases We found that the SIRs were elevated for each cardiovascular disease studied in all prostate cancer patients, with the highest SIR for those treated with ET, independent of circulatory disease history (SIR for myocardial infarction in men without circulatory disease history: 1.40 [95% confidence interval (CI), 1.31-1.49], 1.15 [95% CI, 1.011.31], and 1.20 [95% CI, 1.11-1.30] for men on ET, curative treatment, and surveillance, respectively). Absolute risk differences (ARDs) showed that two (arrhythmia) to eight (ischemic heart disease) extra cases of cardiovascular disease would occur per 1000 personyears in men with prostate cancer. The SMRs showed similar patterns with ARDs of zero (arrhythmia) to three (ischemic heart disease) per 1000 person-years.

Thromboembolic diseases We found that the SIRs for men on CONTINUING NURSING EDUCATION ACCREDITATION AND CONTACT HOURS STATEMENT

Science Care is approved by the California Board of Registered Nursing, Provider number 15559, for 1.0 Contact hour.

METHOD OF PARTICIPATION

1. Read the article in its entirety 2. Go to www.TheOncologyNurse.com 3. Select “Continuing Education” 4. Click on this article’s title from the list shown 5. Select “Click here to complete the posttest and obtain a CE certificate online” 6. Complete and submit the CE posttest and CE Activity Evaluation 7. Print your Certificate of Credit This activity is provided free of charge to participants.

FACULTY DISCLOSURES

As a provider accredited by the California Board of Registered Nursing, Science Care must ensure balance, independence, objectivity, and scientific rigor in all its activities. All course directors, faculty, planners, and any other individual in a position to control the content of this educational activity are required to disclose to the audience any relevant financial relationships with any commercial interest. Science Care must determine if the faculty’s relationships may influence the educational content with regard to exposition or conclusion and resolve any conflicts of interest prior to the commencement of the educational activity.

Disclosures are as follows: • Dawn Lagrosa has nothing to disclose.

• Jamie Mastrodomenico, RN, BS, OCN, has nothing to disclose.

ET were increased for all thromboembolic diseases studied, especially deep vein thrombosis and pulmonary embolism (2.48 [95% CI, 2.25-2.73] and 2.00 [95% CI, 1.81-2.22]). We also observed increased SIRs for curatively treated men and men on surveillance (eg, SIR for deep vein thrombosis in curatively treated men 1.73 [95% CI, 1.47-2.01] and men on surveillance 1.27 [95% CI, 1.081.47]). Increased thromboembolic risks were maintained when men were stratified by age and tumor stage. ARDs showed that two extra cases of deep vein thrombosis and two extra cases of pulmonary embolism would occur per 1000 person-years in men treated with ET. Importance of absolute risks Although the relative risk estimates (SIR and SMR) in our two studies indicated that all prostate cancer patients (especially those treated with ET) were at increased risk of cardiovascular and thromboembolic disease, the absolute risk estimates tell us that the effect is rather modest. In proportion to the • Kimberly A. Pacewicz, RN, MHA, OCN, has nothing to disclose.

• Karen Rosenberg has nothing to disclose.

• Mieke Van Hemelrijck, MSc, PhD, has nothing to disclose.

The staff of Science Care have nothing to disclose.

DISCLAIMER

The opinions and recommendations expressed by faculty, authors, and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of Science Care or Green Hill Healthcare Communications, LLC. COPYRIGHT STATEMENT

Copyright © 2011 Science Care. All rights reserved.

EDITORIAL BOARD

Jamie Mastrodomenico, RN, BS, OCN Memorial Sloan-Kettering Cancer Center 136 Mountain View Boulevard Basking Ridge, NJ 07920 Kimberly A. Pacewicz, RN, MHA, OCN Memorial Sloan-Kettering Cancer Center 136 Mountain View Boulevard Basking Ridge, NJ 07920 Mieke Van Hemelrijck, MSc, PhD King’s College London School of Medicine Division of Cancer Studies Cancer Epidemiology Group 42 Weston Street London SE1 3QD United Kingdom

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To Receive Credit, Complete the Posttest at www.TheOncologyNurse.com absolute risk of dying from prostate cancer in men on ET and the total absolute risk of dying from cardiovascular disease, the ARDs for cardiovascular diseases were small. From a public health point of view, both the absolute risk and ARD were largest for men undergoing ET. Thus, the largest number of extra cases of cardiovascular and thromboembolic diseases are likely to be seen in this patient group.

Study strengths and limitations The major strength of our studies is that PCBaSe Sweden includes more than 76,000 men with prostate cancer and provides complete follow-up data for each patient, as well as linkage to other registers allowing for detailed information on cardiovascular morbidity and mortality and thromboembolic disease morbidity. The same information about circulatory disease was available for the entire standard population, which enabled us to adjust all comparisons for history of cardiovascular or thromboembolic disease.

The above notwithstanding, however, there might be some residual bias that we cannot account for. Men with prostate cancer may receive more intensive medical surveillance and may thus be more likely to be diagnosed with a cardiovascular or thromboembolic disease event when it occurs. Furthermore, the combination of prostate cancer,

especially advanced disease, with cardiovascular or thromboembolic disease might strengthen the indication for hospitalization, therefore biasing the SIR estimates upward. Furthermore, an unknown proportion of men treated curatively, on surveillance, or on AA subsequently changed to GnRH agonists, which could dilute a true difference in risk between AA and GnRH agonists. There was no information about smoking habits, diabetes, body mass index, or hypertension, but none of these factors are strongly associated with prostate cancer risk, and are therefore unlikely to explain the current findings.

What we do not know • Because these were observational studies it was not possible to tease out exactly how much the increased risks were due to the treatment, the tumor, or intrinsic patient characteristics such as age.

• In the current studies, we assumed that patients did not change their original treatment. In future studies, however, we will be able to use the Swedish Drug Registry (launched in July 2005) to study how these treatment changes affect the risk for cardiovascular and thromboembolic diseases.

Summary and conclusion What we now know • All men with prostate cancer are at increased risk for fatal and nonfatal cardiovascular disease (myocardial infarction, ischemic heart disease, arrhythmia, heart failure, and stroke), those treated with ET being at greatest risk.

• All men with prostate cancer are at increased risk for thromboembolic disease (deep vein thrombosis and pulmonary embolism), those treated with ET being at greatest risk.

• The ARDs indicate that less than 10 extra cases of cardiovascular or thromboembolic disease per 1000 person-years would occur after ET.

Cardiovascular and thromboembolic risk should be considered when prescribing ET, but not constitute a contraindication.

Based on the small ARDs, the high absolute risk of dying from prostate cancer when treated with ET, and the fact that ET is currently the only effective treatment for metastatic disease, these findings indicate that cardiovascular and thromboembolic risk should be consid-

ered when prescribing ET, but not constitute a contraindication when the expected gain is tangible. ● References 1. Huggins C, Stevens RE, Hodge CV. Studies on prostate cancer: II. The effects of castration on advanced carcinoma of the prostate gland. Arch Surg.

1941;43:209-223.

2. Smith MR. Androgen deprivation therapy for prostate cancer: new concepts and concerns. Curr Opin Endocrinol Diabetes Obes. 2007;14:247-254.

3. Braga-Basaria M, Dobs AS, Muller DC, et al. Metabolic syndrome in men with prostate cancer undergoing longterm androgen-deprivation therapy. J Clin Oncol.

2006;24:3979-3983.

4. Keating NL, O’Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006;24:4448-4456.

5. McLeod DG, Iversen P, See W, et al; for the Casodex Early Prostate Cancer Trialists’ Group. Bicalutamide 150 mg plus standard care vs standard care alone for early prostate cancer. BJU Int. 2006;97:247-254.

6. Petrylak PJ, Moul JW. Androgen ablation for prostate cancer: mechanisms and modalities. In: Kantoff PW, Carroll PR. D’Amico AV, eds. Prostate Cancer: Principles and Practice. Philadelphia, PA: Lippincott Williams & Wilkins; 2002.

7. Jones RD, Nettleship JE, Kapoor D, et al. Testosterone and atherosclerosis in aging men: purported association and clinical implications. Am J Cardiovasc Drugs.

2005;5:141-154.

8. Smith JC, Bennett S, Evans LM, et al. The effects of induced hypogonadism on arterial stiffness, body composition, and metabolic parameters in males with prostate cancer. J Clin Endocrinol Metab. 2001;86:4261-4267.

9. Keating NL, O’Malley AJ, Freedland SJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy: observational study of veterans with prostate cancer. J Natl Cancer Inst. 2010;102:39-46.

10. Van Hemelrijck M, Adolfsson J, Garmo H, et al. Risk of thromboembolic diseases in men with prostate cancer: results from the population-based PCBaSe. Lancet Oncol.

2010;11:450-458.

11. Van Hemelrijck M, Garmo H, Holmberg L, et al.

Absolute and relative risk of cardiovascular disease in men with prostate cancer: results from the population-based PCBaSe Sweden. J Clin Oncol. 2010;28:3448-3456.

COMMENTARY

Oncology Patients’ Risk of VTE within the Ambulatory Setting: Nursing Considerations

By Kimberly A. Pacewicz, RN, MHA, OCN; Jamie Mastrodomenico, RN, BS, OCN Memorial Sloan-Kettering Cancer Center, Basking Ridge, New Jersey

I

t has been well documented within the oncology literature that a cancer diagnosis puts patients at an increased risk for development of venous thromboembolism (VTE), including both pulmonary embolus and deep vein thrombosis.1 Cancer treatments including oral endocrine therapies, surgery, and chemotherapy may also increase the risk of thromboembolic disease. Increased acuity of patients being treated in the ambulatory setting requires greater critical thinking and assessment skills of nurses, particularly when triaging symptoms over the phone.

Ambulatory care nurses need to have an increased awareness of signs and symptoms of VTE and should assess patients at every visit to rule out any signs or symptoms of VTE. Providing patient education is one of

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the most important roles of the oncology nurse in caring for outpatient cancer patients. Written and verbal instructions for patients and caregivers before treatment initiation should include VTE awareness. Providing comprehensive VTE education can help increase awareness of early signs or symptoms and encourage self-reporting. Ensuring that the patients are informed about VTE facilitates early intervention throughout their trajectory of treatments.

Standardized evidence-based guidelines can be established for consistency across an organization. Patient education can be standardized as well to improve consistency of patient care and improve patient outcomes.

A patient education project In 2009, nurses at our ambulatory

site conducted a performance improvement project designed for educating patients about VTE. We composed a patient education packet containing all pertinent teaching information. In the packet, we included education materials such as: If You Have a Blood Clot, information about the specific low-molecular-weight heparin (dalteparin, enoxaparin) and warfarin fact cards, Directions for Giving Yourself an Injection Below the Skin with a Blood Thinning Medication in a Prefilled Syringe, Common Medications Containing ASA [aspirin] and NSAIDs [nonsteroidal anti-inflammatory drugs], and Disposal of Your Home Medical Sharps. The nursing staff was educated about the new materials, and an implementation plan was instituted.

Patients were surveyed to determine

learning and satisfaction with the materials. The nursing staff was surveyed for satisfaction with the materials and the process. Overall, 86% of the patients strongly agreed that the education packet was helpful, and 100% of the nursing staff agreed that it helped them incorporate all pertinent aspects into their teaching. The feedback provided us with a better understanding of the effectiveness of the materials and with teaching.

Overall, the project demonstrated that an organized and comprehensive teaching packet and a consistent approach by nurses can help improve patients’ understanding of diagnosis and treatment. ● Reference 1. Goldsmith M, Whitelaw G, Cannaday DA. VTE as a quality indicator. J Natl Compr Canc Netw.

2008;6:754-759.

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Navigation & Survivorship

Brought to you by

Cancer-related Chronic Pain Among Survivors

C

ancer-related pain does not stop after the initial treatment period for almost 20% of survivors.

In a first-of-its-kind study, researchers also found racial, in this study blacks, and sex, in this study women, disparities in cancer-related chronic pain.

Defining survivorship as beginning at diagnosis, Carmen R. Green, MD, and colleagues at the University of Michigan, Ann Arbor, surveyed diverse cancer survivors with breast, colorectal, lung, and prostate cancer as well as multiple myeloma to evaluate the impact of cancer-related chronic pain on quality of life (QOL). To ensure consistency, the researchers analyzed data using diagnosis plus 2 years.

Of 199 patients, 31% were black, 49% were women, 20% experienced current pain, and 43% reported pain since diagnosis. Although the rate of pain among blacks did not significant-

ly differ from that of whites, blacks reported greater pain severity (P = .001), as well as interference and disability (P <.05). Compared with men, women experienced more pain (P <.001) and greater severity (P = .04).

When the researchers looked at the impact of this pain, they found that patients with current pain reported poorer general health (P = .001) and physical (P <.001), role (P <.001), and social (P <.001) functioning. In addition, patients with past pain reported greater financial difficulty (P = .003).

In an effort to identify those at risk for pain, the researchers looked at age, race, sex, and cancer type and treatment. They found no significant predictors for current pain; however, female sex predicted having had pain since diagnosis (β = –.43; P = .02), as did black race (β = .45; P <.001).

“This is where nurses really can have

a tremendous role in improving pain care, because they are really good at methods to improve a patient’s quality of life,” said Green in an interview with the Academy of Oncology Nurse Navigators, noting that asking patients about pain and informing them of the potential for pain and working with them to improve their QOL is important. She suggested that nurses can “get the patient to talk about the fact that they may have pain, and acknowledge that the pain is not necessarily a sign that the cancer has gotten worse or that the cancer has come back.

They can let patients know that there are a number of different things that healthcare providers can do to assess and treat pain, from acupuncture to psychological counseling to medications to nerve blocks.”

Awareness and continued research are equally important. “This is a sig-

www.AONNonline.org

nificant survivorship issue and health policy issue,” said Green. “If you think about one in three people having cancer and, if our numbers hold up in other studies, that 20% of people have cancer-related chronic pain, we are talking about millions of people who are impacted in their quality of life and health and well-being when we can do something to improve all these.”

As the first study to identify these disparities, Green suggested that much research remains to be done. For example, we do not currently know if there are additional barriers that we need to address, such as financial, emotional, or social barriers, or if there are cultural norms that make these populations more at risk.

The complete study is published online in Cancer (November 18, 2010). ●

Patient Navigators Address Barriers to Cancer Screening for Elderly Latinos

P

atient navigators facilitated almost 700 cancer screenings among Latino Medicare beneficiaries through a cancer prevention and treatment demonstration project for ethnic and racial minorities at the University of Medicine and Dentistry of New Jersey (UMDNJ). The project seeks to address disparities in cancer screening rates in the elderly Latino population in the Newark, New Jersey, area. The project also is evaluating the impact of navigators to facilitate that screening.

Building on Dr Harold Freeman’s original model of navigation, Ana NatalePereira, MD, MPH, and her team of patient navigators have enrolled 1273 Latino Medicare beneficiaries into a randomized, controlled trial. To date, patients in the intervention group, that is, those who had direct contact with a navigator, have completed 289 mammograms, 136 Pap smears, 139 prostate screening tests, and 129 colonoscopies as a direct result of the facilitation of servic-

es provided through patient navigation.

Part of the success of the program stems from identifying the appropriate people to be patient navigators. “Navigators by nature have to be related to the community that the patients come from—understanding the community and its cultural side, not just geographically knowing the community,” explains Natale-Pereira, who is the project’s principal investigator and associate professor of medicine and the UMDNJ-New Jersey Medical School. “Our program navigators are all Spanish speaking; the entire program has been done in Spanish. They come from the community we serve.” In addition, the navigators have selfless personalities and the ability to problemsolve. “These are people who know how to get from point A to point B to point C and have the same easiness in communication speaking with the patients and with the doctors. They are highly wired connectors of the healthcare system.

Their job is to reduce barriers.”

Natale-Pereira’s previous projects identified the main barriers for their population, which provided a framework for the current interventions: language, transportation, cultural/religious beliefs, fear of and lack of trust in the healthcare system, and a lack of knowledge about cancer prevention.

All participants completed a baseline questionnaire and received educational materials on a quarterly basis. The control group, however, did not receive access to a navigator, allowing the researchers to see if the educational materials alone would influence their medical decision-making. Members of the intervention group were in direct and ongoing contact with patient navigators. This contact offered many benefits. Natale-Pereira gave this example: After asking patients about their previous cancer screenings, the navigators followed-up by obtaining medical records, which can confirm the information’s validity and facilitate the

JOIN THE LARGEST NURSE AND PATIENT NAVIGATOR NETWORK www.AONNonline.org/join and begin receiving Journal of Oncology

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FEBRUARY 2011 I VOL 4, NO 1

appropriate screenings. “Some participants will tell you they get a mammogram every year, but then when you actually get medical records, they don’t.

Some people will say that they haven’t had any screening tests done in 3 years, but they actually did and the records will show it. Navigation becomes more efficient this way.”

Additional benefits are realized when navigators encounter issues that interfere with a patient’s ability to adhere to screening guidelines, such as issues related to housing or transportation. The navigators then address those barriers.

“We facilitate the process, we help them make appointments, we help them keep the appointments, we remind them about the colonoscopy procedure and the preparation for the colonoscopy,” Natale-Pereira tells the academy.

These efforts show not only that patient navigation can increase screening rates among minorities but also that it can increase this population’s satisfaction with the healthcare system. The UMDNJ demonstration project’s preliminary data show participant satisfaction with the navigator to be more than 90%. Most importantly, on a subsequent assessment of satisfaction, participants were significantly more successful in identifying “what is a navigator” compared with baseline. This has major implications in defining the navigator in the Latino community as a resource and trustworthy helper. ●

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Newsletter Series

YOUR QUESTIONS ANSWERED

Editor in Chief

Editor in Chief

Associate Professor of Hematology and Oncology Emory University School of Medicine

The Elodia Kehm Chair of Hematology Professor of Medicine Director, Section of Hematology Rush University Medical Center/Rush University

Stephanie A. Gregory, MD

Sagar Lonial, MD

Topics include: â&#x20AC;˘ Newly Diagnosed Patients â&#x20AC;˘ Maintenance Therapy â&#x20AC;˘ Transplant-Eligible Patients â&#x20AC;˘ Retreatment â&#x20AC;˘ Transplant-Ineligible Patients â&#x20AC;˘ Cytogenetics â&#x20AC;˘ Side-Effect Management â&#x20AC;˘ Bone Health

Topics include: â&#x20AC;˘ Hodgkinâ&#x20AC;&#x2122;s Disease â&#x20AC;˘ Follicular Lymphoma â&#x20AC;˘ Mantle Cell Lymphoma â&#x20AC;˘ Waldenstromâ&#x20AC;&#x2122;s Macroglobulinemia â&#x20AC;˘ Diffuse Large B-Cell Lymphoma â&#x20AC;˘ T-Cell Lymphoma

This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

This activity is supported by educational grant from Cephalon Oncology and Millennium Pharmaceuticals, Inc.

Target Audience These activities were developed for physicians, nurses, and pharmacists.

Accreditation This activity has been approved for 1.0 AMA PRA Category 1 Creditâ&#x201E;˘ (a total of 14.0 credit hours will be issued for completion of all activities). Nursing and Pharmacy credit hours will also be provided.

For complete learning objectives and accreditation information, please refer to each activity.

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For information about the physician accreditation of this activity, please contact Global at 303-395-1782 or inquire@globaleducationgroup.com.

COEKsize21111MM

Cancer Center Profile Waukesha Memorial Hospital’s Regional Cancer Center... Continued from cover “One of the things that are really hard for patients is the amount of information coming at them when they first are diagnosed with breast cancer, understanding what that all means. In addition, they hear about meeting a surgeon and the treatment the surgeon might offer, and that they might be meeting a radiation oncologist, and later even a medical oncologist. It is all these nebulous specialists they are hearing about out in their future,” explained Katherine M. Bayliss, MD, medical director of the Center for Breast Care. “Instead what we do is create this team of specialists that they can meet and sort of get their arms around upfront; they are real people. The patients can get an understanding upfront about the various roles the specialists play. They are also then connected with the other team members, such as the geneticist or others that offer supportive services.”

Building the approach The Center for Breast Care instituted its comprehensive breast services in phases. At its beginning in 1995, the center served mainly as a screening/ diagnostic center, where patients received immediate results of their imaging. Also available since that time are two nurse care coordinators who “help navigate the patients in our health system, providing education and support from the time of abnormal mammogram and breast cancer diagnosis to follow-up care, including surgical visits and periodic phone checks.

We link them with our community resources,” explained Michelle Willman, RN, BSN, OCN, CBCN, one of the nurse care coordinators.

In September 2009, an onsite breast surgeon was installed and the interdisciplinary clinic begun. To round out the staff, a group of surgeons is available to see patients, as are medical and radiation oncologists, specially trained radiologists and technologists dedicated to breast imaging, and pathologists specializing in breast cancer diagnosis. Support services are also

offered, including a dietitian, a genetic counselor, a supportive care coordinator, a social worker, and a financial counselor.

Intercommunicating The weekly conferences allow all the specialists to discuss as a group what is in the best interest of each patient. These discussions provide an avenue for all disciplines to interact and learn. Bayliss, a pathologist, gave this example: “Over time as you share these discussions and treatment plans, there is greater understanding of what each other’s roles are, what each other’s issues might be, what information I might have that might

“Over time as you share these discussions and treatment plans, there is greater understanding of what each other’s roles are, what each other’s issues might be, what information I might have that might matter to physicians taking care of that specific patient or vice versa.”

—Katherine M. Bayliss, MD matter to physicians taking care of that specific patient or vice versa. The lines of communication become much better, and our understanding of what each person does and what the nuances are of the pieces that they need to know becomes more evident. From a pathology standpoint, I think that I have done a better job of presenting information for my colleagues who treat the patient because I have a better understanding of what they are up against. Conversely, I think that my clinical colleagues have come to better understand things that aren’t so black and white for us, things that can be challenging for us, how they can help us interpret a patient’s pathology specimen by providing us the right information.”

This holds true for the radiologists as well. “It gets us more involved. As breast imagers, we like to be more involved in patient care, and the weekly tumor conferences give us a way of

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Johnson, MD, a medical oncologist. “We will then incorporate that new information into the plan and see the patient at the clinic visit.”

It also offers each physician a chance to “know exactly what the surgeon was thinking or why something happened,” James C. Jones, MD, a radiation oncologist, told The Oncology Nurse-APN/PA. In addition, all team members “can express a concern, explaining why they would rather do this than that.”

And this interaction can involve specialists beyond just medical, surgical, and radiation oncologists. If a radiologist is needed, for example, when a patient comes from another healthcare system, then the radiologist is involved prior to the patient’s day of appointment, talking to the patient and the other care providers, explained Bergin.

“It is extremely rewarding, just being able to talk with the physicians and talk with the genetic counselors. Having that interaction is really rewarding and important, and having everybody in one place fosters that communication,” said Kelli K. Pettit, MD, a surgical oncologist. This face-to-face real-time interaction with colleagues during a patient visit not only provides the specialists an opportunity to understand what information the patients receive from the other physicians but also gives patients information about their treatment, according to Pettit.

Improving patient care All this communication leads to enhanced patient outcomes. Over time

www.TheOncologyNurse.com 32

making recommendations and lending expertise to their care,” said Jennifer T. Bergin, MD, a radiologist, who is the director of breast imaging.

Now that everyone can interact daily in the clinic, discussion has been turned up a notch. “Typically, we will discuss a patient in that week’s conference, for which we have gathered as much information that is available, then come up with a plan. Then, we may meet that patient later in the week, or even that same day. There may or may not be additional information available at that time, for example, the hormone receptor profile may have returned in the interim or radiographic data,” explained Peter

the ongoing interaction between pathologists and surgeons has improved the ability to accurately assess margins, ensuring that the orientation of the specimen is optimized, and confidence that the tumor was completely excised, according to Bayliss.

Moreover, patient waiting times are kept short. Willman gave these examples: “If a patient needs a biopsy, the time from abnormal mammogram to biopsy may be as soon as same day to within 1 to 2 weeks per patient preference. The time to get to the surgeon appointment is 1 to 2 days. Many of our patients are having surgery within 1 to 2 weeks of their diagnosis. Once we have all the pathology, oncologist consults occur quickly.”

In addition, the Center for Breast Care offers a more holistic approach to patient care. To complement traditional oncology treatments, the center incorporates supportive oncology including dietary nutrition support, emotional support, and Reiki and relaxation therapy.

For Pettit who finished her fellowship training in June 2009, “I probably offer my patients more of those healing therapies and talk to them more about the supportive aspects of our care as opposed to focusing just on the medicine aspect. Obviously, we talk about the surgery, we talk about chemotherapy. But I’ve also realized that most patients at some point during their treatment are looking for something else, something to make them feel empowered. I think that some of those other therapies, the nutrition, the Reiki therapy, the counseling, provide this for the patients.”

The team believes that the multidisciplinary aspect affords optimal care in general and that the clinic provides the best vehicle for that approach.

“Having the multidisciplinary clinic after not having one for 16 years,” said Jones, “has been more beneficial than I might have imagined it would have been for communication and providing the best care for the cancer patients.”

Johnson seconds that opinion: “We have had excellent feedback from patients about how they have come away from their visits quite gratified and reassured that they at that point have received a comprehensive assessment of their situation and a plan for dealing with it.”

The Center for Breast Care has not only received positive feedback from patients. It also has received recognition from peers. ProHealth Care’s Regional Cancer Center, of which the breast center is a part, has been awarded a contract to the National Cancer Institute Community Cancer Centers Program, making it one of 30 such community cancer centers in the nation. ●

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Nursing Life RECIPE

BOOK REVIEW

Multiple Myeloma

Purple Potato and Leek Soup

A Textbook for Nurses

S

Edited by Joseph D. Tariman, PHC, MN, APRN-BC, OCN Pittsburgh, PA: Oncology Nursing Society Publishing; 2010. 280 pages.

Reviewed by Sandra Kurtin, RN, MS, AOCN, ANP-C

M

ultiple myeloma (MM) is a disease with variable presentation, disease trajectory, prognosis, and options for treatment.

Integrating the plethora of scientific discovery relative to plasma cell disorders, molecular and cytogenetic attributes and their implications for prognosis and treatment, identification of key components of the bone marrow microenvironment, and the development of novel therapies targeting many of these attributes requires a thorough review of multiple sources of information. Multiple Myeloma: A Textbook for Nurses, edited by Joseph D. Tariman, is a well-organized, comprehensive, nursing- and patient-focused guide to understanding the complexity of MM and clinically relevant practical tools for management.

Tariman and his colleagues have succeeded in assimilating the key scientific discoveries of the past two decades relative to plasma cell disorders, including MM. The contributing authors represent

years of nursing expertise from a variety of practice settings and nursing roles.

Nursing’s unique contributions to scientific developments, clinical management, and support of patients and families with MM are celebrated in this book.

The text begins with a historical perspective of the disease, with thoughtful reflections on the challenges faced by patients and care providers. A review of the anatomy and physiology of plasma cells, the immune system, and the pathophysiology associated with MM uses detailed figures and tables to foster integration of complex concepts. Subsequent chapters provide a logically organized tool for nurses, including advanced practitioners in oncology, describing diagnostic evaluation, risk-adapted treatment selection, and strategies for management. Treatment options for the newly diagnosed patient, transplant-eligible or -ineligible patients, salvage therapy, and stemcell transplant are described, with details of recent clinical trials and advances in supportive care. Each chap-

ter includes detailed tables and figures that summarize key points and provide practical tools for day-to-day clinical practice throughout the continuum of care. The final chapters address strategies for patient education, development and support of a survivorship plan, and the importance of continued nursing research.

Each chapter is thoughtfully prepared and provides insight that can be offered only by nursing colleagues who have a passion for their work and continue to strive for excellence in oncology nursing. The book offers something for oncology nursing professionals of all levels of expertise. ●

ummer is not the only time you can get the phytochemicals found in the blue and red pigments of blueberries, raspberries, blackberries, and strawberries. Look no further than the potato. There are hundreds of varieties of potatoes, and the pigmented potato is a nutrient powerhouse. Potatoes are high in vitamin C, fiber, B vitamins, potassium, and iron. The pigmented varieties boast an additional amount of antioxidants.

There is no need to sacrifice the nutritional benefits that purple-pigmented fruits offer just because it is winter, especially when those free radical–scavenging antioxidants can help keep us healthy during the cold and flu season. Make a pot of this month’s recipe of purple potato and leek soup; it is a hearty soup that is sure to satisfy on a cold winter’s day.

You can find purple, red, blue, or pink potatoes at your local market. If you have difficulty locating pigmented potatoes you can substitute a yellow-fleshed potato, such as the Yukon Gold. This potato will fit nicely into the recipe as well as help boost the vitamin A content.

Ingredients 3 pounds purple potatoes, diced large

INTERNATIONAL NEWS

Reports from the 35th Congress of the European Society for Medical Oncology, and by Researchers in England

By Jill Stein

Everolimus/Octreotide LAR Combo Shows Potential for Advanced Carcinoid Tumors MILAN—A combination of the mammalian target of rapamycin inhibitor everolimus and the somatostatin analog octreotide LAR postpones tumor progression in patients with advanced neuroendocrine tumors, researchers announced at the 35th Congress of the European Society for Medical Oncology.

The data, from the phase 3 RAD001 in Advanced Neuroendocrine Tumors (RADIANT-2) study, showed that patients who received the everolimus– octreotide LAR combination had a median progression-free survival (PFS) of 16.4 months compared with 11.3 months in patients treated with placebo plus octreotide LAR. “Conventional chemotherapy has limited efficacy for patients with advanced neuroendocrine tumors, and there remains a significant unmet medical need in this population,” principal

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FEBRUARY 2011 I VOL 4, NO 1

investigator Marianne Pavel, MD, head of the Neuroendocrine Tumor Section at Charity University in Berlin, noted.

The 5.1-month extension in PFS represents a “clinically meaningful” improvement, she added.

The study included 429 patients with advanced low- or intermediate-grade neuroendrocine tumors and a history of symptoms due to carcinoid syndrome.

The tumor site was the small intestine in about half of the study participants.

Patients were randomized to treatment with oral everolimus (10 mg/day) plus octreotide LAR (30 mg administered by intramuscular injection every 28 days) or placebo plus octreotide LAR. Treatment continued until disease progression.

Although neuroendocrine tumors are rare, the incidence has increased fivefold over the past 40 years, Pavel said. Most patients are diagnosed with advanced disease, and roughly two thirds die within the first 5 years after diagnosis.

Poor Awareness of Lung Cancer Symptoms LONDON—The British public does a poor job of recognizing lung cancer symptoms, according to the results of a recent online survey of 2120 adults conducted by the Royal Pharmaceutical Society of Great Britain.

Overall, only 33% of adults surveyed identified a cough as a warning sign of lung cancer, and only 11% specifically cited a persistent cough, which is a major symptom. Fewer than half of respondents (48%) knew that dyspnea, respiratory difficulties, and wheezing were warning signs. Only 29% identified bloody phlegm or coughing up blood as possible indicators of lung cancer.

A spokesman for the organization urged patients who are unable to “shake off” symptoms that are similar to cold and flu symptoms, such as a persistent cough or chest infection, to seek advice from a pharmacist rather than self-prescribing over-the-counter medications. ●

2 quarts low-sodium vegetable broth 3 leeks, cleaned and the whites diced small 1 tablespoon olive oil 4 Yukon Gold potatoes, small diced and cooked ¼ cup sliced scallions

Directions • In a medium saucepan, heat oil and add leeks. Sauté until soft.

• Add purple potatoes and cold vegetable stock.

• Bring to a boil, and simmer for about 20 minutes or until cooked.

• Purée.

• Pour soup into cups, and garnish with Yukon Gold potatoes and scallions.

Serves 8

Nutritional Information Each serving provides: 120 calories, 0 g saturated fat, 40 mg sodium, 22 g total carbohydrate, 2 g dietary fiber, 1 g sugar, 5 g protein Recipe courtesy of Peter Pascale, CCC. Executive Chef, Somerville, New Jersey

www.TheOncologyNurse.com

THANK YOU FOR MAKING US

#1

In a recent survey, oncology nurse parctitioners (NPs) ranked The Oncology Nurse-APN/PA their favorite tabloid publication in the oncology nursing market. *Source: Š Kantar Media, custom study of Oncology Nursing publications among The Oncology Nurse-APN/PA circulation (December 2010).

ead The #1 R rsing y Nu Oncolog blication* u Tabloid P

The Oncology Nurse-APN/PA

Survivorship Cancer in the Family... Continued from cover at 5 years after diagnosis. Caregivers experienced a decrease in appreciating life, and women in particular were less likely to accept what had happened.

Those who were still actively providing care after 5 years reported being less close with their families.

Kim speculated that many caregivers energetically respond to the initial diagnosis, unaware that cancer may be a chronic illness often requiring longterm care. “Some family members might have dedicated their time and effort when they heard the C word in the family for the first time and observed their loved one going through cancer treatment, with the idea and hope it would be a temporary 24/7 dedication,” Kim noted. “When it gets extended without much notice or education in advance, even family members or close friends would feel resentful about their role as a caregiver, being exhausted and distant to their family.” In other cases, Kim suggested that families may be going through an anticipatory grief process.

tal health,” writes Spillers. “This could be explained by the possible cultural differences among non-whites (ie, African American, Asian, Hispanic, etc) and whites with regard to their perception of adequate social support.”

Another study identified caregivers’ need for education and assistance.

Ostomy care is a challenge for patients and caregivers alike. This challenge is heightened by comorbidities that come with aging. Kaiser Permanente’s Mark C. Hornbrook, PhD, and other researchers looked into how survivorship care plans can help address these difficulties. Sixtyfour pairs of survivors with ostomies and

March 29-30, 2011 Philadelphia, PA Loews Philadelphia Hotel

First Annual Stakeholder Integration Conference Integrating Payers, Providers, and the Entire Oncology Team PROGRAM OVERVIEW

PRIMARY CONFERENCE LOCATION

This is the first national stakeholder integration meeting dedicated to advancing the understanding of value in cancer care. Guided by the expertise of leaders in these fields, attendees will receive a thorough understanding of the evolution of the value equation as it relates to cancer therapies and will be able to implement, improve, and sustain their companies and institutions, while improving access for patients and ultimately patient care.

WHO SHOULD ATTEND All stakeholders in a position to impact cancer patient care are invited to join this exciting forum. Specifically this conference is intended for: • Medical Oncologists • Advanced Practitioners • Hematologists/Oncologists • Managed Care Professionals • Surgical Oncologists • Medical Directors • Nurses • Practice Managers/Administrators • Pharmacists • Pharmacy Benefit Managers (PBMs)

“Some family members might have dedicated their time and effort when they heard the C word in the family for the first time and observed their loved one going through cancer treatment, with the idea and hope it would be a temporary 24/7 dedication.”

—Youngmee Kim, PhD In a related study led by Rachel L. Spillers, BS, researchers found that race plays a significant role in the support provided to caregivers by significant others. Level of support from significant others among non-white caregivers was associated with poorer mental functioning and better physical functioning.

“Perhaps non-white spousal caregivers perceived the high level of social support they received from their significant other to be inadequate, thus creating an adverse effect on their own men-

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FEBRUARY 2011 I VOL 4, NO 1

their caregivers participated in this ethnographic study, which employed interviews and participant observation methodologies. Results were thematically coded and analyzed.

Researchers found that caregivers with health problems had “limited...ability to assist with many aspects of ostomy care,”

CONTINUING EDUCATION INFORMATION Goal The Association for Value-Based Cancer Care’s First Annual Stakeholder Integration Conference will foster an open dialogue between providers, payers, and/or other members of the oncology team in order for attendees to gain a better understanding of various points of view regarding cost, quality, and access in cancer care.

Objectives • Examine the impact of healthcare reform on all stakeholders involved in the management of patients with cancer • Identify issues and potential solutions to challenges with access and affordability of oncology therapeutics • Determine the value equation of cost, quality, and access when evaluating the diagnosis, treatment, and overall management of cancer patients • Define appropriate comparative effectiveness research and clinical pathways as tools to evaluate current recommendations for patient management • Analyze trends in the delivery of care in the management of cancer patients Co-Chairs

Gary Owens, MD

Burt Zweigenhaft, BS

President, Gary Owens Associates

President, CEO, OncoMed

Loews Philadelphia Hotel 1200 Market Street, Philadelphia, PA 19107-3615 Phone: 215-627-1200 http://www.loewshotels.com/en/Philadelphia-Hotel

ACCREDITATION INFORMATION PHYSICIAN ACCREDITATION Science Care designates this activity for a maximum of 6.0 AMA PRA Category 1 Credit(s)™. Science Care is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians should only claim credit commensurate with the extent of their participation in the activity.

REGISTERED NURSE DESIGNATION Medical Learning Institute, Inc. (MLI) Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 6.0 contact hours.

REGISTERED PHARMACY DESIGNATION Medical Learning Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 7.50 contact hours (0.750 CEUs) of continuing education credit.

The Universal Activity Number for General Sessions is: 0468-9999-11-072-L01-P. The Universal Activity Number for the lunch symposium is: 0468-9999-11-071-L01-P.

CONFERENCE REGISTRATION Register Online at

www.regonline.com/avbcc-2011 $250 Includes 1-year association membership $355 Includes 3-year association membership

CONTACT/SUPPORT If you have any questions please contact: Association for Value-Based Cancer Care™ 241 Forsgate Drive, Suite 205B, Monroe Township, NJ 08831 Phone: 732-992-1040 association@valuebasedcancer.com

REGISTER ONLINE AT

www.regonline.com/avbcc-2011

www.TheOncologyNurse.com

Survivorship whereas caregivers with â&#x20AC;&#x153;low health literacy demonstrated poor problem recognition, persistence with obsolete care regimens, and lower likelihood of asking for help.â&#x20AC;? The study also found that survivors only received unpaid ostomy care assistance from spouses, and that â&#x20AC;&#x153;obese patients and those with hernias needed more help with wafer placement.â&#x20AC;?

Researchers concluded that survivorship care plans should be particularly

attuned to colorectal cancer survivors without a spousal caregiver, and pay special attention to factors such as obesity, hernias, family health, and changes in living situation.

Another team of researchers led by Kaiser Permanenteâ&#x20AC;&#x2122;s Carmit K. McMullen, PhD, studied the factors that contribute to caregiver advocacy.

Caregivers who view â&#x20AC;&#x153;ostomy care as part of the marriage commitmentâ&#x20AC;?

Tuesday, March 29 1:30 â&#x20AC;&#x201C; 3:30 pm PAYER PRE-CONFERENCE (Off-site) Ritz-Carlton Philadelphia 10 Avenue of the Arts, Philadelphia, PA 19102 Payer Trends in Oncology - Panel Discussion MODERATOR Burt Zweigenhaft, BS PANEL Scott Breidbart, MD â&#x20AC;&#x201D; CMO, Empire BCBS Nick J. Calla, RPh â&#x20AC;&#x201D; VP, Trade Relations, Walgreens Specialty Pharmacy Maria Lopes, MD â&#x20AC;&#x201D; CMO, AMC Health Mona Chitre, PharmD â&#x20AC;&#x201D; Director, Clinical Strategy, Policy, and Services, Excellus

GENERAL PRE-CONFERENCE SESSIONS Loews Philadelphia Hotel 1200 Market Street, Philadelphia, PA 19107-3615 Value-Based Insurance Design in Oncology CHAIR A. Mark Fendrick, MD â&#x20AC;&#x201C; Co-Director, University of Michigan Center for Value-Based Insurance Design Cancer Care from a Large Insurerâ&#x20AC;&#x2122;s Perspective Donald Liss, MD â&#x20AC;&#x201C; Senior Medical Director, Independence Blue Cross of Philadelphia The Role of Diagnostics from a PBMâ&#x20AC;&#x2122;s Standpoint Jane F. Barlow, MD, MPH, MBA â&#x20AC;&#x201C; VP, Clinical Innovation, MEDCO Health Solutions Panel Discussion

Welcome/Networking Reception

Wednesday, March 30

Corporate-Sponsored Breakfast Symposium Havalenâ&#x201E;˘ (eribulin mesylate) Injection: A New FDA-approved Treatment Funded by Eisai Inc.

were more likely to advocate on behalf of the survivorâ&#x20AC;&#x2122;s needs, â&#x20AC;&#x153;which may facilitate prompt detection and treatment of disability-related complications.â&#x20AC;? Other factors include the survivorâ&#x20AC;&#x2122;s desire to receive such assistance, a clear understanding of roles, and the caregiverâ&#x20AC;&#x2122;s acceptance of the ostomy and its implications. Poor family relationships can, however, pose barriers to caregiver advocacy.

Oncology Practicesâ&#x20AC;&#x201D;Issues with Managed Care Craig Deligdish, MD â&#x20AC;&#x201C; Medical Director, Florida Comprehensive Care Network Yu-Ning Wong, MD â&#x20AC;&#x201C; Fox Chase Cancer Center Winston Wong, PharmD â&#x20AC;&#x201C; Associate VP, Pharmacy Management, CareFirst BCBS PAYER TRACK Medicare and Reimbursement Issues Kip Piper, MA, FACHE â&#x20AC;&#x201C; President, Health Results Group Jayson Slotnik, JD â&#x20AC;&#x201C; Counsel, Foley Hoag Oncology Drug Reimbursement and Administration Issues John Aforismo, BSc Pharm, RPh, FASCP â&#x20AC;&#x201C; President & CEO, RJ Health Systems Peyton Howell, MBA â&#x20AC;&#x201C; AmerisourceBergen Scott Breidbart, MD â&#x20AC;&#x201C; CMO, Empire BCBS Evolutions in Oncology Pharmacy Management MODERATOR Burt Zweigenhaft, BS ROUNDTABLE Alan Lotvin, MD â&#x20AC;&#x201C; President, ICORE Kristen M. Reimers, RPh â&#x20AC;&#x201C; Clinical Pharmacy Operations Manager, Excellus Jeff Ulanet â&#x20AC;&#x201C; VP, Oncology, MEDCO

LUNCH SYMPOSIUM Best Practices for Management of CINV: A Value-Based Approach Supported by an educational grant from Eisai Inc. Shawna Kraft, PharmD, BCOP â&#x20AC;&#x201C; Hematology/Oncology Clinical Pharmacist, University of Michigan Health System Beth Faiman, RN, MSN, CNP, AOCN â&#x20AC;&#x201C; Nurse Practioner, Cleveland Clinic Taussig Cancer Center

Cancer Care and the New Healthcare Legislation: What to Expect Next MODERATOR Jayson Slotnik, JD PANEL Scott Gottlieb, MD â&#x20AC;&#x201C; Resident Fellow, American Enterprise Institute Joseph Bailes, MD â&#x20AC;&#x201C; Texas Oncology

Strategies for Improving Oncology Pharmacy and Care Management Models MODERATOR Burt Zweigenhaft, BS PANEL Ira M. Klein, MD â&#x20AC;&#x201C; Medical Director, Aetna Oncology Strategy Dan McCrone, MD â&#x20AC;&#x201C; CMO, New Century Health Jeffery Scott, MD â&#x20AC;&#x201C; SVP/CMO, P4 Healthcare, Cardinal Health Winston Wong, PharmD

Stephen C. Malamud, MD â&#x20AC;&#x201C; Beth Israel Medical Center

Intro/Opening

NCCN Guidelines Acceptance and Compliance Al Benson, MD â&#x20AC;&#x201C; President, ACCC

The Impact of Personalized Oncology Therapies MODERATOR Gary Owens, MD PANEL Perry Dimas â&#x20AC;&#x201C; VP, Premier Source Diagnostics Richard Bender, MD â&#x20AC;&#x201C; CMO, Agendia Beth Davis â&#x20AC;&#x201C; Senior Director, Managed Care, Agendia Gene Morse, PharmD â&#x20AC;&#x201C; University of Buffalo

Afternoon Break in the Exhibit Hall

Morning Break in the Exhibit Hall

Clinical Fragmentation: Impact of Oral, Injected, and Infused Therapies MODERATOR Gary Owens, MD ROUNDTABLE Atheer Kaddis, RPh â&#x20AC;&#x201C; VP, Managed Markets, Diplomat Pharmacy Services Kirby Eng, RPh â&#x20AC;&#x201C; Director, Oncology Management Services, CVS Caremark Ellen Scharaga, BS â&#x20AC;&#x201C; SVP, Pharmacy Operations, OncoMed

Cocktails/Networking in the Exhibit Hall

BREAKOUT SESSIONS PROVIDER TRACK Community Oncology: Trends Ted Okon â&#x20AC;&#x201C; Executive Director, Community Oncology Alliance Patient Navigation/Patient Assistance Steven Patierno, PhD â&#x20AC;&#x201C; Executive Director, George Washington University Cancer Institute Dawn Holcombe, MBA, FACMPE, ACHE â&#x20AC;&#x201C; President, DGH Consulting Monica Knoll â&#x20AC;&#x201C; Executive Director/Founder, CANCER101

Researchers recommend increased support for caregivers.

Psychosocial needs of survivors often overlooked Grace J. Yoo, PhD, of San Francisco State University and her fellow researchers studied the social support for racial and ethnic minority breast cancer survivors. Researchers used in-depth qualitative interviews and quantitative survey measures to analyze the posttreatment experience of 176 survivors, including 45 African Americans, 52 Asian/Pacific Islander Americans, 54 white Americans, and 25 Latino Americans. Survivors of all races were able to access the same levels of information and tangible support, but African Americans reported the greatest level of spiritual support. Researchers concluded that providers should pay more attention to racial and ethnic variation in survivorship strategies, some of which may be religious. â&#x20AC;&#x153;Traditionally, social support has been measured along the domains of informational, tangible, and emotional types of support,â&#x20AC;? writes Yoo. â&#x20AC;&#x153;There has been a lack of studies on the need and access to spiritual support posttreatment.â&#x20AC;?

Ofelia O. Villero and Nancy Burke, PhD, of the University of California San Franciscoâ&#x20AC;&#x2122;s Helen Diller Family Comprehensive Cancer Center explored a similar issue, looking at the role of religion among Filipino-American breast cancer survivors. Researchers conducted 72 in-depth interviews and observed 63 support groups. They found that religion played a major role in recovery for Filipino-American survivors. Family and friends are also critical, because they are often asked to pray for survivors or form prayer groups. â&#x20AC;&#x153;Our study hopes to contribute to the development of culturally resonant healthcare and sustainable support services for this sector of the population through an analysis of how FilipinoAmerican women perceive and deal with breast cancer in the context of their religious beliefs and practices.â&#x20AC;?

Villero suggests that educational campaigns reach out to informal religious groups, and that the particulars of Filipino-American culture be provided for when designing support services.

Daniel Dohan, PhD, of the University of San Franciscoâ&#x20AC;&#x2122;s Institute for Health Policy Studies and fellow researchers discovered that low-income and medically underserved cancer survivors came to identify other members of a support group as â&#x20AC;&#x153;family.â&#x20AC;? Participants were also more oriented to fighting the disease than adjusting to a life of survival.

Researchers suggest that this orientation â&#x20AC;&#x153;reflected the social circumstances of cancer and survivorship among the underserved, especially survivorsâ&#x20AC;&#x2122; general Continued on page 38

www.TheOncologyNurse.com

FEBRUARY 2011 I VOL 4, NO 1

37

Survivorship Cancer in the Family... Continued from page 37 social isolation and the lack of role models within the community of survivors who had coped with the psychosocial impact of cancer.” This study reveals how the function and effect of support groups differ among various patient populations.

carcinoma of lacrimal sac, adenocarcinoma of orbit, neuroendocrine carcinoma of orbit, and basal cell carcinoma of eyelid—and 14 family members.

Patients do not experience stigmatization among friends and family. But “unsolicited attention” from acquain-

“If they are informed and if caregivers are knowledgeable about the events and conditions engendering stigma, the overall well-being of survivors and their families will be significantly improved.” —Alessandro Bonanno, PhD Patients with orbitofacial disfigurement confront a number of social challenges. Alessandro Bonanno, PhD, a sociologist at Sam Houston State University, and Bita Esmaeli, MD, of The M. D. Anderson Cancer Center, conducted in-depth interviews with 14 survivors—including of adenoid cystic carcinoma of lacrimal gland, squamous cell carcinoma of conjunctiva/eyelid, conjunctival melanoma, eyelid sebaceous gland carcinoma, transitional cell

tances or strangers is stigmatizing, whereas “benign neglect” in a large group is not. Sympathy has different results depending on what is expressed and the size of the group.

“Patients and their families are not adequately informed about the circumstances generating stigma,” writes Bonanno. “If they are informed and if caregivers are knowledgeable about the events and conditions engendering stigma, the overall well-being of sur-

Recent FDA Approvals Denosumab for Prevention of Skeletal-related Events The FDA has approved denosumab (XGEVA, Amgen) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. This receptor activator of nuclear factor kappaB ligand inhibitor is the first in its class to be approved for this indication. Denosumab is not approved for patients with multiple myeloma or other cancers of the blood.

After a 6-month priority review, approval was based on three phase 3 head-to-head trials comparing denosumab (120 mg subcutaneous injection every 4 weeks) with zoledronic acid (15-minute intravenous infusion every 4 weeks). The trials totaled 5723 patients. One trial focused on patients with breast cancer; another on patients with prostate cancer; a third on patients with a variety of cancers.

In prostate cancer, median time to an SRE was 21 months with denosumab compared with 17 months with zoledronic acid. In breast cancer, median time to an SRE was 26 months with zoledronic acid and has not yet been reached with denosumab. In other solid tumors, time to development of an SRE was similar for both groups.

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FEBRUARY 2011 I VOL 4, NO 1

Transmucosal Tablets for Breakthrough Cancer Pain The FDA has approved a fentanyl immediate-release transmucosal tablet (Abstral, ProStraken) for breakthrough cancer pain in adults, making it the only fast-acting lingual tablet on the US market. The tablet is indicated for those patients who already use opioid pain medication and can safely use high doses of an additional opioid medication.

This schedule II opioid is available only through a risk evaluation and mitigation strategies (REMS) program. The manufacturer’s REMS program will allow prescriptions to be filled at retail pharmacies and access to be available in the hospital setting.

Approval of the transmucosal form of the drug (fentanyl buccal tablets and patches are already approved) was based on data from safety studies.

Based on data from 311 opioid-tolerant patients with breakthrough pain, common adverse reactions included nausea, constipation, drowsiness, and headache. Serious adverse reactions have been previously reported in patients on other immediate-release transmucosal fentanyl products; however, deaths have been attributed to improper patient selection and/or improper dosing.

vivors and their families will be significantly improved.”

Survivors of prostate cancer must often live with erectile dysfunction commonly caused by prostatectomy. Men and their partners experience associated difficulties in sexual functioning that are rarely addressed in their medical appointments. This, along with their own discomfort with discussing the problem, makes them less likely to seek help.

Daniela Wittmann, MSW, and other researchers from the University of Michigan, Ann Arbor’s Department of Urology undertook a 1-day retreat to facilitate increased communication and sexual recovery.

“It didn’t take me long to realize that if you want to work with men who want to work on their sexual capacity, you have to work with their partners as well,” says Wittmann. “The female partners are mostly postmenopausal and have their own sexual issues and concerns, so working on it together was the most powerful way to do it.

Most people don’t know much about how to help their sexual functioning when they start having problems due to an illness such as cancer.”

Researchers suggest that a future study should test a larger sample size if the positive effects continue at 6 months.

Importance of family long term Families have a particularly important role to play in the recovery of children with cancer, taking the lead not only in medical decision-making but also in providing information to young survivors. Amii Corbisiero, PhD, of The Research Institute at Nationwide Children’s Hospital’s Center for Biobehavioral Health, and her fellow researchers recruited 110 of 125 eligible families of children aged 5 to 17 years, 1 to 2 months after diagnosis. Although physicians reported a risk of 25% to 32% for late effects in physical, cognitive, and qualify-of-life measures, parents estimated risks to be at 19% to 25%. “Although parents agreed that talking to children about late effects was somewhat to very important,” the study found, “they had discussed this only on occasion. Parents had more discussions with older children.”

“Understandably, with all the other information parents have to process early in their child’s treatment, the possibility

“We always think in terms of increasing something. But maybe it’s enough that increased knowledge and more open communication lead to more intimacy within the couples.”

—Daniela Wittmann, MSW

Twenty-six couples attended the retreat, filling out satisfaction questionnaires directly after the retreat, and a survey on sexual health before the retreat and then at 3 and 6 months after. The retreat got high marks for the information and peer support provided. Preliminary results (at 3 months) show increased knowledge about dealing with the side effects of a prostatectomy, awareness of sexual issues common after age 50, and confidence in speaking to their partner about sexual issues. Twenty couples responded at baseline and 3 months.

There was, however, no increase in the frequency of sexual activity. But Wittmann suggests that a quantitative approach may not be the best when it comes to sexual activity.

“We always think in terms of increasing something,” she says. “But maybe it’s enough that increased knowledge and more open communication lead to more intimacy within the couples. Maybe their sex is better even if they’re not having more of it. So I don’t know if ‘no increase in the frequency of sexual activity’ is really a negative finding.”

of late effects are often secondary to the immediate urgency of starting treatment and getting their child into remission,” writes Corbisiero. “The risk for long-term side effects or late effects is something that can easily get pushed aside to think about later, or they plan to deal with it when or if it becomes a problem down the road. Quite simply, parents want and need to be optimistic about their child’s future; they hope for the best.”

Researchers recommend a more “prospective approach to family education,” so that families and survivors are better able to navigate the years of long-term follow-up.

“It might not be the highest priority for healthcare providers or families soon after diagnosis, but we have the most opportunities for education and regular contact with families during treatment,” he writes. “Written materials, ongoing conversations initiated by the child’s nurses and physicians, as well as family educational seminars should be available early on and throughout treatment and survivorship.” ●

www.TheOncologyNurse.com

Head and Neck Cancer

Reconstructive Surgery for Cancer Patients. Part 2: Head and Neck Reconstruction

By Deena Damsky Dell, MSN, RN-BC, AOCN; Linda Schiech, MSN, RN, AOCN-R Clinical Nurse Specialists, Fox Chase Cancer Center, Philadelphia, Pennsylvania

T

oday, plastic surgery has achieved great strides in restoring appearance and function.1 In patients with cancer, reconstructive surgery must allow for adequate resection of tumor with clear margins, facilitate initiation of adjuvant therapy, and maximize quality of life by making the most of function and esthetics. For patients with head and neck cancer, the goals of reconstructive surgery combine enhanced cosmesis and improved overall functionality. As discussed in part 1 (October 2010), considerations for timing and type of reconstruction include patient age, gender, and body habitus; tumor stage and prognosis; functional status of patient; available donor sites; and psychosocial state. The patient defect should be matched with the most appropriate reconstructive method2 (Figure 1).

Part 2 of this article will focus on surgery for head and neck reconstruction.

Head and neck reconstruction Reconstructive surgery allows surgeons to complete a thorough “cancer” surgery—adequate resection of tumor with clear margins, facilitation of adjuvant therapy—on the patient. Removing all of the cancer often involves removal of vital organs, and reconstructive surgery permits the patient to appear and function as close to “normal” as possible. Patients who are diagnosed at an early stage generally do well with surgery and radiation treatments.

Debilitating and disfiguring treatments can, however, cure patients of their disease only to have to live a long life with functional and cosmetic issues.1,3 Contraindications for reconstructive surgery include insufficient cardiac or respiratory reserves needed for 8 to 12 hours of surgery and inadequate peripheral vascular circulation to the limbs.

There are many different areas in the head and neck region, and thus there are some areas that are easier to reconstruct than others.1,3 Skin grafts The simplest form of reconstruction in the head and neck region involves a skin graft, which can often be performed by a general surgeon. When an area cannot be sutured by primary intention, whether it is a surgical incision or a trauma injury such as a burn, a skin graft is often used.

This consists of removing skin from one area and placing it over another area.

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This will provide stability and security to an open area. If the entire dermis is used to cover the defect, it is referred to as a full-thickness skin graft. If just a portion of the dermis is used, it is referred to as a split-thickness skin graft (STSG). These grafts are used in the head and neck region to close floor-of-mouth resections, some tongue resections, some resections of the buccal mucosa, and, after the maxilla is removed, to help close that defect and line the cavity in preparation for a prosthesis placement.4,5 A full-thickness skin graft has the advantages of some bulk, which may be needed in certain areas for stability; better color in areas that will be visible; and less contraction. Full-thickness skin grafts also tend to stretch and grow as needed. Therefore, they are often used in pediatric cases. Often, however, an STSG from another area is needed to close the defect from the full-thickness skin graft. Donor sites for a full-thickness skin graft include the upper thigh or upper inner arms; the scalp is often used for small grafts.5 STSGs are much thinner and therefore are used more frequently. STSGs can be used on the small spaces in the head and neck region, such as the tongue; and can survive in situations that are not ideal. STSGs are fragile, however, and can break down easily; they often contract similar to scar tisFree flap

Pedicled flap

Random-pattern flap

Tissue expansion

Full-thickness skin graft

Split-thickness skin graft

Delayed primary closure

Primary closure

Healing by secondary intention Figure 1. Reconstruction ladder.

Sources: References 1 and 2.

sue, which can prevent appropriate mouth opening; and their color is pale, which often does not match the skin tone of the visible areas. Donor sites for STSG spontaneously heal because of the remaining cells and blood supply to that area. The anterior and lateral thigh is often the donor site for STSGs because of the large skin surface.4 Skin or acellular dermal matrix (ADM) have been used along with a patient’s own thin layer of skin to act as the foundation for more stable coverage of a primary opening after surgery.4 This combination can often be used as a stronger, more viable, substitute in place of an STSG. To care for the graft and donor sites with an STSG alone or in concert with an ADM, nurses should work to prevent constriction of the area that has been grafted. This will help maintain an adequate blood supply to the new tissue as well as allow the tissue to establish its own blood supply over time. The donor site is cared for according to surgeon preference. The site will be raw and painful, and tends to have a substantial amount of drainage. Some surgeons prefer to cover the donor site for several days with a transparent porous dressing.

Others prefer to allow the site to be open to air. The goal is to keep the site as dry as possible, allowing for new cell and dermis growth.

Free myocutaneous flaps Myocutaneous flaps are frequently used in the reconstruction of head and neck defects after surgical resection.

The use of muscle provides bulk and protection for the surgical area. The bulk and constriction in the head and neck area limits the use of pedicle flaps (flaps that maintain their native blood supply).

In addition, pedicle flaps do not achieve the cosmetic goal. Therefore, myocutaneous free flaps are often used to reconstruct the tongue, floor of the mouth, and the upper portion of the esophagus that connects to the larynx. A free flap must have vessels connected in the new area to provide new blood supply to this completely removed and reattached muscle. A portion of the quadriceps muscle, the anterolateral thigh flap, can be used and formed into a tube to reconstruct the top of the esophagus.1 The workhorse muscle for the head and neck region is the radial forearm free flap. This muscle tends to be the optimal size and

Deena Damsky Dell, MSN, RN-BC, AOCN

Linda Schiech, MSN, RN, AOCN-R

thickness to replace the resected portion of the tongue, for example, after a hemiglossectomy (Figure 2). Without use of a major portion of the tongue, a patient’s speech and swallowing are affected. Patients are unable to speak clearly and are not able to propel the food into the back of the throat to be swallowed.3,6 Immediately after the surgery, a muscle free flap is very swollen because it is no longer performing its original function of lifting and carrying objects. Eventually it will assist the remaining tongue to thrust food boluses into the back of the mouth to be swallowed. The muscle flap will atrophy over time to match the size and shape of the original portion of the remaining tongue. These free muscle flaps have no nerve transference, and therefore, no feeling in that portion of the tongue. With postsurgical decrease in edema and strict patient adherence to speech rehabilitation, patients should be able to learn to use the tongue remnant to help with swallowing and speaking intelligibly.1,3,6 Free muscle flaps in other areas of the head and neck will have a similar course.

A muscle free flap will always atrophy and then with therapy permit the patient to be able to swallow or function in as close to preoperative fashion as possible.

For a patient with a free myocutaneous flap, nurses need to observe the surgical area closely. Characteristics to Continued on page 40

FEBRUARY 2011 I VOL 4, NO 1

39

Head and Neck Cancer Reconstructive Surgery for Cancer Patients... Continued from page 39 struction with the best outcome.8-10 Donor bone for a mandibular reconstruction can be harvested from several different areas of the body; however, the two most common areas are the iliac crest and the fibular osteocutaneous flap.

Iliac crest sites have excellent size, shape, and blood supply, but the muscle from that area may be large and bulky. In addition, the surgery to harvest the flap tends to cause a great amount of abdominal pain when dissecting through the abdominal wall muscles.8,9 Surgeons often prefer the fibular osteocutaneous flap for reconstruction of the mandible. The size and shape of the fibula is optimal, the possible length being up to 25 cm of usable bone. It has a good blood supply and muscle size, and the bone is nonweight-bearing, which optimizes fairly rapid mobility and decreases normal postoperative side effects. Peripheral vascular disease will definitely hinder the use of the fibula as the donor site.

The flexor hallucis longus muscle that sits along the fibula can be used for the muscle portion of the surgery. A portion of the fibula must be left at both the knee and ankle to provide stability to those joints in the future. Disadvantages to this type of flap are pain and numbness at the donor site and the foot. An STSG must be used to close the defect on the leg. Reconstructive surgeons use titanium, either as one large shaped piece or in smaller sections, to assist in Photo courtesy of Sameer Patel, MD, Fox Chase Cancer Center, Philadelphia. connecting the fibular bone into the open defect left at Figure 2. Reconstructed tongue following hemiglossectomy. the mandible. If the titaniBone free flaps um is used in one long piece, it can be The mandible is generally the only shaped closely to match the patient’s area that is reconstructed with bone. original jaw line. The titanium supplies Usually, mandibular reconstruction re- stability to the bone while the blood quires both bone and muscle for ade- vessels are healing. Similar to the free quate facial formation and reconstruc- muscle flap, the area will be very edetion. Over the years, reconstructive matous immediately postoperatively. surgeons have tried foreign substances In addition, that portion of the jaw will such as bars and plates to form the be edentulous.8 There is exciting new technology missing portion of bone. The body may recognize this substance as foreign, available to assist the head and neck and however, and try to reject it. Other reconstructive surgeon when performing complications with these types of lengthy and extensive mandible surgermaterials are breaking or cracking of ies. Three-dimensional images and actuthe bar or plate, extrusion or forcing al models of the surgical site are providthe material through the skin, and ed to the surgeon before the surgery to most commonly exposure of the object assist in determining where to make the where the skin might wear away. Using cut, and knowing where to make the nonvascularized autologous bone grafts cuts to align the bone correctly. This does not allow for the usual function of advanced planning aids in decreasing bone, such as resorption. In addition, surgical time, which may translate into there is no real soft-tissue coverage as decreased length of stay for the patient. well as less stability. Therefore, free Surgeons find these models extremely flaps including both bone and muscle useful and expect they will assist in leadare the most reliable form of recon- ing to better outcomes. assess include color, time for capillary refill, Doppler reading, temperature, and flap or tissue fullness (Table). Flap checks are performed at least hourly, if not more frequently, for the first 48 hours to allow for an intervention. This can mean taking the patient back to the operating room for a replacement flap or repair to the flap’s blood supply.

If the flap is to replace a portion of the tongue, the nurse must observe for bleeding because the tongue is very vascular. Patients at Fox Chase are kept sedated and intubated to allow for decreased patient movement of the new flap and quick response for a compromised flap. Patients may need a tracheotomy for the edema immediately following surgery. The radial forearm area that had the muscle removed will have an STSG over the site for protection and require wound care and dressing changes as well as limited use of that limb for a period of time. As mentioned previously, patients will need the services of a capable speech therapist after an initial 5 to 7 days of rest to regain speech and swallowing function.

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FEBRUARY 2011 I VOL 4, NO 1

Table Circulatory Assessment of Reconstructed Flap Venous circulation occlusion Redness and dusky Rapid; <1 second

Arteriole circulation occlusion Pale or mottled Slow; >3 seconds

Clinical assessment Color Time for capillary refill

Normal assessment Pink 1-3 seconds

Doppler reading

Positive for normal Weak or absent arterial circulation; Doppler reading positive for normal venous circulation

Weak or absent Doppler reading

Temperature

Warm

Warm to cool

Cool

Flap or tissue fullness

Full

Swollen or taut

Depressed or hollow

Sources: References 6 and 7.

After a bone flap surgery, the patient will require intubation and sedation for 24 to 48 hours. Nurses should perform flap checks every hour during the first 48 to 72 hours, which allows for rapid intervention as needed. Patients will have a tracheotomy because of edema in the neck area as well as need for a feeding tube, which could be in place for up to 6 to 8 months. Patients will not be able to swallow enough nutrition by mouth for healing and survival.

The newly reconstructed jaw will not be able to be used to masticate food or have any pressure placed on it until the bone heals. The patient may never be able to chew anything firmer than chopped food, and will have to wait at least 1 year before dental implants or dentures can be completed. Again, therapy by a qualified speech therapist is required to adequately rehabilitate jaw opening, speech, and swallowing.

Patients will not be allowed to bear weight on the affected leg for 5 to 7 days after surgery. Partial weight bearing with a walker is permitted for 2 to 4 weeks, with a slow increase to full weight bearing. Full healing after these types of reconstructive surgeries takes time and effort for cosmetic and functional outcomes.

Surgery of the maxilla Patients who have their maxilla removed as a result of cancer have various anatomical deformities. The hard and soft palates provide stability for teeth and divide the nasal passage from the oral cavity. After the maxilla is removed, something has to fill that defect. Often an STSG is used to reinforce the maxillary sinus cavity, and then a prosthesis, referred to as an obturator is formed by a prosthodontist to fill that defect. The obturator is molded and reshaped over time as the patient heals postoperatively, until the final product is produced. Dentures can be added to the obturator for a better cosmetic result.

Patients are taught to remove the obtu-

rator and clean the cavity and the prosthesis after eating.11 If radiation is needed after any of these reconstructive surgeries, 6 weeks of healing must take place before radiation can begin. The flap must be observed closely during radiation for signs of skin breakdown. Patients will require speech therapy again after radiation is completed because of fibrosis on skin and tissues.

Summary Especially in patients with head and neck cancer, reconstruction can restore some lost function and enhance appearance. This improvement in quality of life requires diligent attention to detail by all members of the healthcare team as well as physical rehabilitation by the patient.

Reconstruction can, however, help reestablish normalcy for a patient who experienced psychological, physical, and nutritional detriment. ● References 1. Lin SJ, Rabie AN. Head and neck cancer—reconstruction. March 9, 2009. emedicine.medscape.com/arti cle/1289799-overview. Accessed September 15, 2010.

2. Patel S. Reconstructive surgery for head and neck cancer. Presented at: Fox Chase Cancer Center conference; December 2009; Philadelphia, PA. 3. Chrysopoulo MT. Flaps, classification. January 11, 2008. emedicine.medscape.com/article/1284474-over view. Accessed September 15, 2010.

4. Wood BC, Kirman CN, Molnar JA. Skin, grafts.

January 29, 2010. emedicine.medscape.com/article/129 5109-overview. Accessed September 15, 2010.

5. Weber SM, Ghanem TA, Wax MK. Skin grafts, splitthickness. May 11, 2010. emedicine.medscape.com/ article/876290-overview. Accessed September 15, 2010.

6. Nahabedian MY. Flaps, free tissue transfer. July 7, 2010. emedicine.medscape.com/article/1284841-over view.

Accessed September 15, 2010.

7. Flint PW, Haughey BH, Lund VL, et al. Free tissue transfer. In: Cummings Otolaryngology: Head & Neck Surgery. 5th ed. Philadelphia, PA: Mosby; 2010.

8. Wenig BL, Zenn MR. Mandibular and palatal reconstruction in patients with head and neck cancer. October 3, 2008. www.uptodate.com/online/content/topic.do? topicKey=head_can/6257&view=print. Accessed September 15, 2010.

9. Smith JE, Blackwell K, Ducic Y. Mandibular reconstruction, plating. March 16, 2009. emedicine.medscape. com/article/881542-overview. Accessed September 15, 2010.

10. Bak M, Jacobson AS, Burchbinder D, Urken ML. Contemporary reconstruction of the mandible. Oral Oncol. 2009;46:71-76.

11. Bedard JF, Toljanic JA. Management of large maxillary defects: prosthetic rehabilitation. April 19, 2010. www.uptodate.com/online/content/topic.do?topicKey=h ead_can/13669. Accessed September 15, 2010.

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Challenging Cases in Multiple Myeloma A WEBINAR SERIES A Dialogue Between Community and Academic Clinicians to Improve Patient Care and Outcomes

Register online today at www.myelomacases.com/webinar PROGRAM DESCRIPTION

LIVE WEBINAR DATES

This continuing medical education webinar series will serve as a forum for discussion of current questions and concerns regarding the treatment and management of patients through the multiple myeloma (MM) life cycle. By thoroughly engaging participants with interactive cases and physician point-counterpoint–style discussions, this activity will provide evidence-based treatment and management recommendations and address new treatment regimens and management strategies based on recent clinical trials and emerging data. In addition, barriers and/or limitations faced by community cancer centers and private-practice oncologists will be debated.

Monday, March 7 2011

LEARNING OBJECTIVES

Tuesday, March 15 2011

At the end of this activity participants will be able to: • Apply early management strategies that consider new diagnostic and staging criteria for SMM, MGUS, and MM and new imaging studies in order to improve prognosis for your patients.

• Evaluate novel therapeutic regimens as induction therapy for your patients considering an SCT in order to provide the most rapid response and allow the largest amount of stem cell collection, while maintaining safety and tolerance.

• Integrate novel agent–based regimens that provide optimal outcomes and a survival benefit into your management strategy for patients ineligible for SCT after appraising emerging data from clinical trials.

• Identify patient- and disease-associated factors that impact choice of therapeutic agent and formulate management strategies using a risk-adapted approach to treatment of MM. • Construct optimal treatment regimens based on novel combinations and make informed treatment decisions in order to improve the long-term outlook for myeloma patients across the life cycle of the disease.

TARGET AUDIENCE This activity has been developed for hematologists and medical oncologists, as well as nurses, pharmacists, and other allied health professionals who are interested in meeting the challenges faced when treating patients with multiple myeloma in academic and community settings.

12:00 PM ET • 11:00 AM CT • 10:00 AM MT • 9:00 AM PT

Tuesday, March 8 2011 3:00 PM ET • 2:00 PM CT • 1:00 PM MT • 12:00 PM PT

9:00 PM ET • 8:00 PM CT • 7:00 PM MT • 6:00 PM PT

Friday, March 25 2011 1:00 PM ET • 12:00 PM CT • 11:00 AM MT • 10:00 AM PT

Thursday, March 31 2011 6:00 PM ET • 5:00 PM CT • 4:00 PM MT • 3:00 PM PT

FACULTY G. David Roodman, MD, PhD Professor of Medicine Vice Chair for Research Department of Medicine Director, Myeloma Program Director, Bone Biology Center University of Pittsburgh Medical Center Pittsburgh, PA

ACCREDITATION INFORMATION Physician Accreditation

The University of Cincinnati designates this activity for a maximum of 1 AMA PRA Category 1 Credit ™.

The University of Cincinnati is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians should only claim credit commensurate with the extent of their participation in the activity.

Registered Nurse Designation

Medical Learning Institute, Inc. (MLI) Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 1.0 contact hour.

Hakan Kaya, MD Oncologist/Hematologist, Cancer Care Northwest Director, Inland Northwest Myeloma/ Lymphoma & Transplant Program Clinical Asst. Professor of Medicine, University of Washington School of Medicine Spokane, WA

Registered Pharmacy Designation

Medical Learning Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 1.0 contact hour (0.1 CEU) of continuing education credit.

The universal activity number for this activity is 0468-9999-11-010-L01-P.

Fostering a Dialogue to Improve Patient Care & Outcomes

ACKNOWLEDGMENT This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

This activity is jointly sponsored by the University of Cincinnati, Medical Learning Institute, Inc., a nonprofit medical accreditation company, and Center of Excellence Media, LLC. COEKsize21411MMweb

Meetings APRIL 2011

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MARCH 2011

2-5

MAY 2011

2-6 ORLANDO, FL

Apr 28-May 1 5-7

American Association for Cancer Research 102nd Annual Meeting www.aacr.org

BOSTON, MA 36th Oncology Nursing Society Annual Congress www.ons.org

SAN ANTONIO, TX Society of Surgical Oncology Annual Cancer Symposium www.surgonc.org

PROVENGE® (sipuleucel-T)

6-9

DOSAGE AND ADMINISTRATION • For Autologous Use Only.

• The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals.

• Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine.

• Before infusion, confirm that the patient’s identity matches the patient identifiers on the infusion bag.

• Do Not Initiate Infusion of Expired Product.

• Infuse PROVENGE intravenously over a period of approximately 60 minutes.

Do Not Use a Cell Filter.

• Interrupt or slow infusion as necessary for acute infusion reactions, depending on the severity of the reaction.

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ORLANDO, FL Society of Gynecologic Oncologists Annual Meeting on Women’s Cancer www.sgo.org

Suspension for Intravenous Infusion

Rx Only

BRIEF SUMMARY — See full Prescribing Information for complete product information INDICATIONS AND USAGE: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

(See Dosage and Administration [2] of full Prescribing Information.)

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS • PROVENGE is intended solely for autologous use.

9-13

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HOLLYWOOD, FL National Comprehensive Cancer Network Annual Congress www.nccn.org

• Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia. In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction.

In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. The incidence of severe events was greater following the second infusion (2.1% vs 0.8% following the first infusion), and decreased to 1.3% following the third infusion. Some (1.2%) patients in the PROVENGE group were hospitalized within 1 day of infusion for management of acute infusion reactions. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

Closely monitor patients with cardiac or pulmonary conditions. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed.

• Handling Precautions for Control of Infectious Disease. PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Universal precautions should be followed.

12-16 LAS VEGAS, NV National Interdisciplinary Breast Center Conference www.breastcare.org

• Concomitant Chemotherapy or Immunosuppressive Therapy. Use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied.

PROVENGE is designed to stimulate the immune system, and concurrent use of immunosuppressive agents may alter the efficacy and/or safety of PROVENGE. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE.

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• Product Safety Testing. PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.

(See Warnings and Precautions [5] of full Prescribing Information.)

24-26 WASHINGTON, DC Association of Community Cancer Centers Annual National Meeting www.accc-cancer.org

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FEBRUARY 2011 I VOL 4, NO 1

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four

BRUSSELS, BELGIUM IMPAKT Breast Cancer Conference www.esmo.org

randomized, controlled clinical trials. The control was non-activated autologous peripheral blood mononuclear cells.

The most common adverse events, reported in patients in the PROVENGE group at a rate ≥15%, were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4.0% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group.

Serious adverse events were reported in 24.0% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions (see Warnings and Precautions), cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare.

PROVENGE was discontinued in 1.5% of patients in Study 1 (PROVENGE group n=341; Control group n=171) due to adverse events. Some patients who required central venous catheters for treatment with PROVENGE developed infections, including sepsis. A small number of these patients discontinued treatment as a result. Monitoring for infectious sequelae in patients with central venous catheters is recommended.

Each dose of PROVENGE requires a standard leukapheresis procedure approximately 3 days prior to the infusion. Adverse events that were reported ≤1 day following a leukapheresis procedure in ≥5% of patients in controlled clinical trials included citrate toxicity (14.2%), oral paresthesia (12.6%), paresthesia (11.4%), and fatigue (8.3%).

Table 1 provides the frequency and severity of adverse events reported in ≥5% of patients in the PROVENGE group of randomized, controlled trials of men with prostate cancer.

The population included 485 patients with metastatic castrate resistant prostate cancer and 116 patients with non-metastatic androgen dependent prostate cancer who were scheduled to receive 3 infusions of PROVENGE at approximately 2-week intervals. The population was age 40 to 91 years (median 70 years), and 90.6% of patients were Caucasian.

Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Any Adverse Event Chills Fatigue Fever Back pain Nausea Joint ache Headache Citrate toxicity Paresthesia Vomiting Anemia Constipation Pain Paresthesia oral Pain in extremity Dizziness Muscle ache Asthenia Diarrhea Influenza-like illness Musculoskeletal pain Dyspnea Edema peripheral Hot flush Hematuria Muscle spasms

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

591 (98.3) 319 (53.1) 247 (41.1) 188 (31.3) 178 (29.6) 129 (21.5) 118 (19.6) 109 (18.1) 89 (14.8) 85 (14.1) 80 (13.3) 75 (12.5) 74 (12.3) 74 (12.3) 74 (12.3) 73 (12.1) 71 (11.8) 71 (11.8) 65 (10.8) 60 (10.0) 58 (9.7) 54 (9.0) 52 (8.7) 50 (8.3) 49 (8.2) 46 (7.7) 46 (7.7)

186 (30.9) 13 (2.2) 6 (1.0) 6 (1.0) 18 (3.0) 3 (0.5) 11 (1.8) 4 (0.7) 0 (0.0) 1 (0.2) 2 (0.3) 11 (1.8) 1 (0.2) 7 (1.2) 0 (0.0) 5 (0.8) 2 (0.3) 3 (0.5) 6 (1.0) 1 (0.2) 0 (0.0) 3 (0.5) 11 (1.8) 1 (0.2) 2 (0.3) 6 (1.0) 2 (0.3)

291 (96.0) 33 (10.9) 105 (34.7) 29 (9.6) 87 (28.7) 45 (14.9) 62 (20.5) 20 (6.6) 43 (14.2) 43 (14.2) 23 (7.6) 34 (11.2) 40 (13.2) 20 (6.6) 43 (14.2) 40 (13.2) 34 (11.2) 17 (5.6) 20 (6.6) 34 (11.2) 11 (3.6) 31 (10.2) 14 (4.6) 31 (10.2) 29 (9.6) 18 (5.9) 17 (5.6)

Grade 3-5 n (%) 97 (32.0) 0 (0.0) 4 (1.3) 3 (1.0) 9 (3.0) 0 (0.0) 5 (1.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 7 (2.3) 3 (1.0) 3 (1.0) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0) 2 (0.7) 3 (1.0) 0 (0.0) 3 (1.0) 3 (1.0) 1 (0.3) 1 (0.3) 3 (1.0) 0 (0.0)

(Table 1 continued on next page.)

www.TheOncologyNurse.com

Meetings MAY 2011

JUNE 2011

SEPTEMBER 2011

8-12

3-7 CHICAGO, IL

23-25

8-10

LONDON, UNITED KINGDOM European Society for Therapeutic Radiation and Oncology International Oncology Forum www.estro-events.org

American Society of Clinical Oncology Annual Meeting www.asco.org

ATHENS, GREECE Multinational Association of Supportive Care in Cancer/ International Society of Oral Oncology International Symposium www.mascc2011.org

SAN FRANCISCO, CA Breast Cancer Symposium www.breastcasymposium.org

Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Hypertension Anorexia Bone pain Upper respiratory tract infection Insomnia Musculoskeletal chest pain Cough Neck pain Weight decreased Urinary tract infection Rash Sweating Tremor

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

Grade 3-5 n (%)

45 (7.5) 39 (6.5) 38 (6.3) 38 (6.3)

3 (0.5) 1 (0.2) 4 (0.7) 0 (0.0)

14 (4.6) 33 (10.9) 22 (7.3) 18 (5.9)

0 (0.0) 3 (1.0) 3 (1.0) 0 (0.0)

37 (6.2) 36 (6.0)

0 (0.0) 2 (0.3)

22 (7.3) 23 (7.6)

1 (0.3) 2 (0.7)

35 (5.8) 34 (5.7) 34 (5.7) 33 (5.5) 31 (5.2) 30 (5.0) 30 (5.0)

0 (0.0) 3 (0.5) 2 (0.3) 1 (0.2) 0 (0.0) 1 (0.2) 0 (0.0)

17 (5.6) 14 (4.6) 24 (7.9) 18 (5.9) 10 (3.3) 3 (1.0) 9 (3.0)

0 (0.0) 2 (0.7) 1 (0.3) 2 (0.7) 0 (0.0) 0 (0.0) 0 (0.0)

*Control was non-activated autologous peripheral blood mononuclear cells.

Cerebrovascular Events. In controlled clinical trials, cerebrovascular events, including hemorrhagic and ischemic strokes, were reported in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

(See Adverse Reactions [6] of full Prescribing Information.)

To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dendreon Corporation 3005 First Avenue Seattle, Washington 98121

©2010 Dendreon Corporation.

All rights reserved. November 2010. Printed in the U.S.A. Dendreon, the Dendreon logo, and PROVENGE are registered trademarks of Dendreon Corporation.

P-A-11.10-073.00

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FEBRUARY 2011 I VOL 4, NO 1

43

In the fight against asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer...

Extends Survival PROVENGE® is the first FDA-approved autologous cellular immunotherapy—activating a patient’s own antigen-presenting cells to stimulate an immune response against prostate cancer.

• Extended median survival beyond 2 years—25.8 months compared with 21.7 months for patients in the control group (P=.032) • Reduction in risk of death—22.5% (HR=0.775, 95% CI: 0.614, 0.979) • Most common adverse events—Chills, fatigue, fever, back pain, nausea, joint ache, and headache • Therapy complete in 3 cycles—3 infusions, at approximately 2-week intervals* *Each infusion is preceded by a standard leukapheresis procedure. The dosing interval ranged from 1 to 15 weeks in controlled clinical trials.

Now Available—To learn more about getting access to PROVENGE, call Dendreon ON Call at 1-877-336-3736.

INDICATION: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION: PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence ≥15%) reported in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Please see Brief Summary of full Prescribing Information on the next page.

©2010 Dendreon Corporation.

All rights reserved. November 2010. Printed in the U.S.A. Dendreon, the Dendreon logo, and PROVENGE are registered trademarks of Dendreon Corporation.

P-A-11.10-072.00

www.PROVENGE.com