September Vol4 No6

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SEPTEMBER 2011

www.TheOncologyNurse.com

VOL 4, NO 6

CONFERENCE NEWS: ASCO

CANCER CENTER PROFILE

Children’s Memorial Hospital, Chicago, Illinois A Nurse Practitioner Shares in Her Patients’ Successes

Survivorship Care: An Emerging Medical Need Cost-Effectiveness of Programs Questioned

By Caroline Helwick

CHICAGO—The population of cancer survivors is growing rapidly. More than 12 million Americans are alive after a cancer diagnosis, with most living at least 5 years, and 16% living 20 years after their initial diagnosis.

This growing population of cancer survivors is at risk for many comorbid health

conditions, especially as they age. A study of 10,397 childhood cancer survivors found this group to be 8 times more likely to have a severe or life-threatening condition than their siblings (Oeffinger K, et al.

N Engl J Med. 2006;355:1572-1582).

Survivorship care, therefore, has become a topic of interest as oncologists aim Continued on page 14

SURVIVORSHIP

Nursing staff (and pharmacist, Sue Berg) at Children’s Memorial Hospital: Jessica Rivera, Erin Downs, Sandy Van Leeuwen, Amy Kaplan, Allison Parise, Monica Newmark, Jacquie Toia, Terri Gleason, Sally Hageman, Tara Krosschell, Sue Berg, Kristi Waddell, and Jane Kilian.

fter the Great Chicago Fire in 1871, Chicago became one of the fastest growing cities in the world. But in this time of prosperity and growth, the prognosis for children born in the city was grim.

A child had only a 50% chance of surviving to the age of 5 years, and those who survived were likely to be exposed to a host of diseases.

In 1882, Julia Foster Porter, a young widow who also lost a child to disease, took bold steps to transform the future of children’s health in Chicago. Ms Porter renovated a modest home at the corner of Belden and Halsted Streets for $13,000 and established Chicago’s

A

Continued on page 38

Breastfeeding May Be Compromised, But Is Still Important in Survivors of Childhood Cancer

By Rosemary Frei, MSc

A

lthough breastfeeding may be impaired in some survivors of childhood cancers as a result of treatments, such women who are able to successfully breastfeed should do so, because of the protective effects it can impart,1 according to research led by Susan W. Ogg, RN, MSN, a research nurse

in the Department of Epidemiology and Cancer Control, St. Jude Children’s Research Hospital, Memphis, Tennessee.

“Some nurses work with women and assess their lactation potential throughout pregnancy, labor, delivery, and postpartum,” Ogg said. “When working with a mother who has survived childhood canContinued on page 11

THE WHOLE PATIENT

Josh and Friends: The Healing Power of the Human–Animal Bond

By Michael Levesque

F

or the past 15 years, the Josh and Friends Project has been an enduring source of comfort to children aged between 2 and 9 years, who face anxieties related to medical procedures, surgery, chemotherapy, or other treatments arising from illness or injury.

Founded by Knoxville, Tennessee, vet-

INSIDE COMPLIMENTARY CE

...........

Cancer and the Workplace

24

GASTROINTESTINAL CANCER

..

Prolonged Treatment with Imatinib Recommended for High-Risk GIST

CONFERENCE NEWS

erinarian Randy Lange, the Josh and Friends Project captures the inimitable qualities of the human–animal bond to influence positively a child’s psychologic and physiologic outlook in anticipation of as well as throughout medical treatment and recovery. Child comfort and wellness are at this unique program.

American Society of Clinical Oncology . . . . . . . . . . . . . . . . . . . . . . . .14 FUNDRAISING FOR THE CAUSE

...............

Play for P.I.N.K.: Making a Difference THE WHOLE PATIENT . . . . . . . . . .

40

Shared Decision Making in Healthcare

Continued on page 20 ©2011 Green Hill Healthcare Communications, LLC

Q:

Ne Featuw re

Answered!

Your FAQs...

28

42

What are some treatment options for elderly patients with chronic lymphocytic leukemia?

Page 34

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Your inspiration, You guide your HER2+ breast cancer patients through their course of treatment with care and support. The HER Connection program can provide some extra help, including:

Text tips and email tailored to HER journey Live outreach call program Live 24/7 support line

Boxed WARNINGS and Additional Important Safety Information s 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 trial, one patient who developed CHF died of cardiomyopathy

s Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death

s Evaluate cardiac function prior to and during treatment. For adjuvant therapy, also evaluate cardiac function after completion of Herceptin.

Discontinue Herceptin for cardiomyopathy

s Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy

s Exacerbation of chemotherapy-induced neutropenia has also occurred

s Herceptin can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

Š2011 Genentech USA, Inc.

6391928 Onc Nurse Jrnl Ad AUG M01 indd 1-2

s The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia

So. San Francisco, CA

All rights reserved.

HER0000422100

6/11

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HER commitment

Adjuvant indications Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or nodenegative (ER/PR-negative or with one high-risk feature*) breast cancer:

s As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel s With docetaxel and carboplatin s As a single agent following multi-modality anthracycline-based therapy *High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Please see brief summary of full Prescribing Information, including Boxed WARNINGS and additional important safety information, on the following pages.

8/3/11 3:02 PM

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HERCEPTINÂŽ (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 s AS PART OF A TREATMENT REGIMEN consisting of doxorubicin, cyclophosphamide, and either PACLITAXEL OR DOCETAXEL s WITH DOCETAXEL AND CARBOPLATIN s AS A SINGLE AGENT FOLLOWING MULTI MODALITY ANTHRACYCLINE based therapy. Metastatic Breast Cancer Herceptin is INDICATED s )N COMBINATION WITH PACLITAXEL FOR lRST LINE TREATMENT OF (%2 OVEREXPRESSING METASTATIC BREAST CANCER s !S A SINGLE AGENT FOR TREATMENT OF (%2 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 mUOROURACIL 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 4â&#x2C6;&#x2019;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 â&#x2030;Ľ 16% absolute decrease in LVEF from PRE TREATMENT VALUES OR AN ,6%& VALUE BELOW INSTITUTIONAL limits of normal and â&#x2030;Ľ 10% absolute decrease in LVEF from pretreatment values [see Dosage and Administration]. The safety of continuation or resumption of Herceptin in patients WITH (ERCEPTIN INDUCED LEFT VENTRICULAR CARDIAC DYSFUNCTION has not been studied. Cardiac Monitoring Conduct thorough cardiac assessment, including history, physical examination, AND DETERMINATION OF ,6%& BY ECHOCARDIOGRAM OR -5'!

SCAN 4HE FOLLOWING SCHEDULE IS RECOMMENDED s "ASELINE LVEF measurement immediately prior to initiation of Herceptin s ,6%& MEASUREMENTS EVERY MONTHS DURING AND UPON COMPLETION OF (ERCEPTIN s 2EPEAT ,6%& MEASUREMENT AT WEEK INTERVALS IF (ERCEPTIN IS WITHHELD FOR SIGNIlCANT LEFT VENTRICULAR cardiac dysfunction [see Dosage and Administration= s ,6%& measurements every 6 months for at least 2 years following completion of Herceptin as a component of adjuvant therapy. )N 3TUDY OF PATIENTS DISCONTINUED (ERCEPTIN due to clinical evidence of myocardial dysfunction or SIGNIlCANT DECLINE IN ,6%& )N 3TUDY THE NUMBER OF PATIENTS who discontinued Herceptin due to cardiac toxicity was 2.6% )N 3TUDY A TOTAL OF PATIENTS IN THE TCH arm (1.5% during the chemotherapy phase and 1.4% DURING THE MONOTHERAPY PHASE AND PATIENTS IN THE !# 4( ARM DURING THE CHEMOTHERAPY PHASE AND 4.2% during the monotherapy phase) discontinued Herceptin DUE TO CARDIAC TOXICITY !MONG 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 !PPROXIMATELY HALF OF THE SURVIVING PATIENTS HAD RECOVERY TO A NORMAL ,6%& DElNED AS â&#x2030;Ľ 50%) on continuing MEDICAL MANAGEMENT AT THE TIME OF LAST FOLLOW UP )NCIDENCE of congestive heart failure is presented in Table 1. The safety of continuation or resumption of Herceptin in patients with (ERCEPTIN INDUCED LEFT VENTRICULAR CARDIAC DYSFUNCTION HAS not been studied.

Table 1 )NCIDENCE OF #ONGESTIVE (EART &AILURE IN !DJUVANT "REAST #ANCER 3TUDIES Study 1 & 2a

4

a

Regimen !#bâ&#x2020;&#x2019;Paclitaxel+ (ERCEPTIN #HEMOâ&#x2020;&#x2019;(ERCEPTIN !#bâ&#x2020;&#x2019;Docetaxel+ (ERCEPTIN Docetaxel+Carbo+ (ERCEPTIN

Incidence of CHF Herceptin Control

Includes 1 patient with fatal cardiomyopathy. !NTHRACYCLINE DOXORUBICIN AND CYCLOPHOSPHAMIDE

b

Table 2 Incidence of Cardiac Dysfunctiona in Metastatic "REAST #ANCER 3TUDIES

Study 5 !# b 5 (paclitaxel) 6

Incidence .9(! )Â&#x2013;)6 .9(! )))Â&#x2013;)6 Herceptin Control Herceptin Control

Event Cardiac $YSFUNCTION

Cardiac Dysfunction 11% 1% 4% 1% Cardiac c Dysfunction . !

. ! a #ONGESTIVE HEART FAILURE OR SIGNIlCANT ASYMPTOMATIC decrease in LVEF. b !NTHRACYCLINE DOXORUBICIN OR EPIRUBICIN AND cyclophosphamide. c Includes 1 patient with fatal cardiomyopathy. )N 3TUDY THE INCIDENCE OF .#) #4# 'RADE CARDIAC ischemia/infarction was higher in the Herceptin containing REGIMENS !# 4( AND 4#( AS COMPARED TO NONE IN !# 4 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 SIGNIlCANT 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 IDENTIlCATION 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 (ERCEPTIN DURING PREGNANCY resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal ABNORMALITIES AND NEONATAL DEATH !DVISE 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 INlLTRATES PLEURAL EFFUSIONS

NON CARDIOGENIC PULMONARY EDEMA PULMONARY INSUFlCIENCY and hypoxia, acute respiratory distress syndrome, and PULMONARY lBROSIS 3UCH 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 .#) #4# 'RADE Â&#x2013; 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 BENElT HAS BEEN SHOWN $UE TO DIFFERENCES IN TUMOR HISTOPATHOLOGY USE &$!

APPROVED TESTS FOR THE SPECIlC TUMOR TYPE BREAST OR GASTRIC gastroesophageal adenocarcinoma) to assess HER2 protein OVEREXPRESSION AND (%2 GENE AMPLIlCATION 4ESTS SHOULD BE PERFORMED BY LABORATORIES WITH DEMONSTRATED PROlCIENCY IN THE SPECIlC TECHNOLOGY BEING UTILIZED )MPROPER ASSAY PERFORMANCE INCLUDING USE OF SUBOPTIMALLY lXED TISSUE

FAILURE TO UTILIZE SPECIlED REAGENTS DEVIATION FROM SPECIlC assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results. Several &$! APPROVED COMMERCIAL ASSAYS ARE AVAILABLE TO AID IN THE selection of breast cancer and metastatic gastric cancer patients for Herceptin therapy. Users should refer to the PACKAGE INSERTS OF SPECIlC ASSAY KITS FOR INFORMATION ON THE Intended Use, and the validation and performance of each assay. Limitations in assay precision make it inadvisable to RELY ON A SINGLE METHOD TO RULE OUT POTENTIAL (ERCEPTIN BENElT Treatment outcomes for adjuvant breast cancer (Studies AND AND FOR METASTATIC BREAST CANCER 3TUDY AS A FUNCTION OF )(# AND &)3( TESTING ARE PROVIDED IN 4ABLES AND !SSESSMENT OF (%2 PROTEIN OVEREXPRESSION AND (%2 GENE AMPLIlCATION IN METASTATIC GASTRIC CANCER SHOULD BE PERFORMED USING &$! APPROVED TESTS SPECIlCALLY 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.

3TUDY DEMONSTRATED THAT GENE AMPLIlCATION AND PROTEIN overexpression were not as well correlated as with breast cancer. Treatment outcomes for metastatic gastric cancer 3TUDY BASED ON (%2 GENE AMPLIlCATION &)3( 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 s #ARDIOMYOPATHY ;see Warnings and Precautions= s )NFUSION REACTIONS ;see Warnings and

Precautions= s %MBRYO FETAL 4OXICITY ;see Warnings and Precautions= s 0ULMONARY TOXICITY ;see Warnings and Precautions= s %XACERBATION 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 !DVERSE REACTIONS REQUIRING interruption or discontinuation of Herceptin treatment include #(& SIGNIlCANT 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 (â&#x2030;Ľ 10%) that were increased (â&#x2030;Ľ 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 INmAMMATION NASOPHARYNGITIS AND DYSGEUSIA 4HE MOST common adverse reactions which resulted in discontinuation OF TREATMENT ON THE (ERCEPTIN CONTAINING ARM IN THE ABSENCE of disease progression were infection, diarrhea, and febrile neutropenia. Clinical Trials Experience "ECAUSE 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 REmECT THE RATES OBSERVED in practice. Adjuvant Breast Cancer Studies The data below REmECT EXPOSURE TO (ERCEPTIN ACROSS THREE RANDOMIZED OPEN LABEL STUDIES 3TUDIES

AND WITH N OR WITHOUT N TRASTUZUMAB IN THE ADJUVANT TREATMENT OF BREAST CANCER 4HE DATA SUMMARIZED IN 4ABLE BELOW FROM 3TUDY REmECT EXPOSURE TO (ERCEPTIN IN PATIENTS THE median treatment duration was 51 weeks and median number OF INFUSIONS WAS !MONG THE PATIENTS ENROLLED IN 3TUDY THE MEDIAN AGE WAS YEARS RANGE TO YEARS

OF PATIENTS WERE #AUCASIAN AND WERE !SIAN Table 3 !DVERSE 2EACTIONS FOR 3TUDY !LL 'RADESa :

!DVERSE 2EACTION

1 Year Herceptin Observation N N

Cardiac (YPERTENSION

$IZZINESS

%JECTION &RACTION $ECREASED

0ALPITATIONS

#ARDIAC !RRHYTHMIASb

#ARDIAC &AILURE #ONGESTIVE

#ARDIAC &AILURE

#ARDIAC $ISORDER

Ventricular Dysfunction 4 (0.2%) Respiratory Thoracic Mediastinal Disorders #OUGH

)NmUENZA

$YSPNEA

52)

2HINITIS

0HARYNGOLARYNGEAL 0AIN

3INUSITIS

Epistaxis 25 (2%) Pulmonary Hypertension 4 (0.2%) Interstitial Pneumonitis 4 (0.2%) Gastrointestinal Disorders $IARRHEA

.AUSEA

6OMITING

#ONSTIPATION

$YSPEPSIA

5PPER !BDOMINAL 0AIN

Musculoskeletal & Connective Tissue Disorders !RTHRALGIA

"ACK 0AIN

-YALGIA

"ONE 0AIN

-USCLE 3PASM

Nervous System Disorders (EADACHE

0ARAESTHESIA

Skin & Subcutaneous Tissue Disorders Rash 70 (4%) .AIL $ISORDERS

Pruritis 40 (2%) General Disorders Pyrexia 100 (6%) %DEMA 0ERIPHERAL

#HILLS

!ESTHENIA

)NmUENZA LIKE )LLNESS

Sudden Death 1 (0.06%) Infections .ASOPHARYNGITIS

54)

Immune System Disorders Hypersensitivity 10 (0.6%) !UTOIMMUNE 4HYROIDITIS

0 (0%)

1 (0.06%) 0 (0%) 0 (0%)

10 (0.6%)

10 (0.6%) 6 (0.4%)

0 (0%)

1 (0.06%)

4HE INCIDENCE OF 'RADE ADVERSE REACTIONS WAS IN both arms for each listed term. b Higher level grouping term.

4HE DATA FROM 3TUDIES AND WERE OBTAINED FROM PATIENTS OF WHOM RECEIVED (ERCEPTIN THE MEDIAN treatment duration was 50 weeks. The median age was YEARS RANGE Â&#x2013; OF PATIENTS WERE 7HITE

"LACK (ISPANIC AND !SIAN )N 3TUDY ONLY 'RADE Â&#x2013; ADVERSE EVENTS TREATMENT RELATED 'RADE EVENTS AND 'RADE Â&#x2013; DYSPNEA WERE COLLECTED DURING AND FOR UP TO MONTHS FOLLOWING PROTOCOL SPECIlED TREATMENT 4HE FOLLOWING NON CARDIAC ADVERSE REACTIONS OF 'RADE Â&#x2013; OCCURRED AT AN incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy ALONE ARTHRALGIA VS FATIGUE VS INFECTION VS HOT mASHES VS ANEMIA VS 7%), dyspnea (12% vs. 4%), rash/desquamation (11% vs. 7%), neutropenia (7% vs. 5%), headache (6% vs. 4%), and insomnia VS 4HE MAJORITY OF THESE EVENTS WERE 'RADE a

2 in severity. In Study 2, data collection was limited to the FOLLOWING INVESTIGATOR ATTRIBUTED TREATMENT RELATED ADVERSE REACTIONS .#) #4# 'RADE AND HEMATOLOGIC TOXICITIES

'RADE Â&#x2013; NON HEMATOLOGIC TOXICITIES SELECTED 'RADE Â&#x2013; toxicities associated with taxanes (myalgia, arthralgias, nail changes, motor neuropathy, sensory neuropathy) and Grade 1â&#x2C6;&#x2019;5 cardiac toxicities occurring during chemotherapy and/ OR (ERCEPTIN TREATMENT 4HE FOLLOWING NON CARDIAC ADVERSE reactions of Grade 2â&#x2C6;&#x2019;5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: ARTHRALGIA VS MYALGIA VS NAIL CHANGES VS AND DYSPNEA VS 4HE MAJORITY OF THESE events were Grade 2 in severity. Safety data from Study 4 REmECT EXPOSURE TO (ERCEPTIN AS PART OF AN ADJUVANT TREATMENT regimen from 2124 patients receiving at least one dose of STUDY TREATMENT ;!# 4( N 4#( N = 4HE OVERALL MEDIAN TREATMENT DURATION WAS WEEKS IN BOTH THE !# 4( and TCH arms. The median number of infusions was 26 in the !# 4( ARM AND IN THE 4#( ARM INCLUDING WEEKLY INFUSIONS during the chemotherapy phase and every three week dosing IN THE MONOTHERAPY PERIOD !MONG THESE PATIENTS THE MEDIAN AGE WAS YEARS RANGE TO YEARS )N 3TUDY THE TOXICITY PROlLE WAS SIMILAR TO THAT REPORTED IN 3TUDIES

AND WITH the exception of a low incidence of CHF in the TCH arm.

Metastatic Breast Cancer Studies 4HE DATA BELOW REmECT EXPOSURE TO (ERCEPTIN IN ONE RANDOMIZED OPEN LABEL STUDY

3TUDY OF CHEMOTHERAPY WITH N OR WITHOUT N trastuzumab in patients with metastatic breast cancer, and one SINGLE ARM STUDY 3TUDY N IN PATIENTS WITH METASTATIC breast cancer. Data in Table 4 are based on Studies 5 and 6. !MONG THE PATIENTS TREATED IN 3TUDY THE MEDIAN AGE WAS YEARS RANGE Â&#x2013; YEARS %IGHTY NINE PERCENT WERE 7HITE "LACK !SIAN AND OTHER RACIAL ETHNIC GROUPS !LL PATIENTS RECEIVED MG KG INITIAL DOSE OF (ERCEPTIN FOLLOWED by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for â&#x2030;Ľ 6 months and â&#x2030;Ľ 12 months were AND RESPECTIVELY !MONG THE PATIENTS TREATED IN SINGLE AGENT STUDIES PATIENTS FROM 3TUDY THE MEDIAN AGE WAS YEARS RANGE Â&#x2013; YEARS WERE 7HITE

WERE "LACK WERE !SIAN AND 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 â&#x2030;Ľ 6 months and â&#x2030;Ľ MONTHS WERE AND RESPECTIVELY Table 4 0ER 0ATIENT )NCIDENCE OF !DVERSE 2EACTIONS /CCURRING in â&#x2030;Ľ 5% of Patients in Uncontrolled Studies or at Increased )NCIDENCE IN THE (ERCEPTIN !RM 3TUDIES AND

Herceptin 3INGLE

0ACLITAXEL (ERCEPTIN !#b a !GENT 0ACLITAXEL !LONE !#b !LONE N N N N N

"ODY AS A 7HOLE Pain 47% 61% 62% 57% 42% !STHENIA

&EVER

#HILLS

(EADACHE

!BDOMINAL PAIN

"ACK PAIN

)NFECTION

Flu syndrome 10% 12% 5% 12% 6% !CCIDENTAL INJURY

!LLERGIC REACTION

Cardiovascular Tachycardia 5% 12% 4% 10% 5% #ONGESTIVE

heart failure Digestive .AUSEA

$IARRHEA

6OMITING

Nausea and VOMITING

!NOREXIA

Heme & Lymphatic !NEMIA

,EUKOPENIA

Metabolic Peripheral edema 10% 22% 20% 20% 17% %DEMA

Musculoskeletal "ONE PAIN

!RTHRALGIA

Nervous )NSOMNIA

$IZZINESS

0ARESTHESIA

$EPRESSION

Peripheral NEURITIS

.EUROPATHY

Respiratory Cough INCREASED

Dyspnea 22% 27% 26% 42% 25% Rhinitis 14% 22% 5% 22% 16% 0HARYNGITIS

3INUSITIS

Skin 2ASH

Herpes SIMPLEX

!CNE

Urogenital Urinary tract INFECTION

a Data for Herceptin single agent were from 4 studies, INCLUDING PATIENTS FROM 3TUDY b !NTHRACYCLINE DOXORUBICIN OR EPIRUBICIN AND cyclophosphamide.

M

I

TON_September 2011_FINAL_TON 9/13/11 10:06 AM Page 5

Metastatic Gastric Cancer The data below are based on THE EXPOSURE OF PATIENTS TO (ERCEPTIN IN COMBINATION WITH A mUOROPYRIMIDINE CAPECITABINE OR &5 AND CISPLATIN (Study 7). In the Herceptin plus chemotherapy arm, the initial DOSE OF (ERCEPTIN MG KG WAS ADMINISTERED ON $AY PRIOR to chemotherapy) followed by 6 mg/kg every 21 days until DISEASE PROGRESSION #ISPLATIN WAS ADMINISTERED AT MG M2 ON $AY AND THE mUOROPYRIMIDINE WAS ADMINISTERED AS EITHER capecitabine 1000 mg/m2 ORALLY TWICE A DAY ON $AYS OR mUOROURACIL MG M2/day as a continuous intravenous infusion Days 1 through 5. Chemotherapy was administered for SIX DAY CYCLES -EDIAN DURATION OF (ERCEPTIN TREATMENT WAS WEEKS MEDIAN NUMBER OF (ERCEPTIN INFUSIONS ADMINISTERED was eight.

"ODY 3YSTEM !DVERSE %VENT

Grades

FC .

N (%) !LL Grades Grades

?

17%

Time 0 is the date of randomization.

Figure 3 Study 4: Cumulative Incidence of Time to First LVEF Decline of â&#x2030;Ľ 0ERCENTAGE 0OINTS FROM "ASELINE AND TO "ELOW 50% with Death as a Competing Risk Event

0 (0)

0 (0)

Time 0 is the date of randomization.

,6%& AND !BSOLUTE $ECREASE FROM "ASELINE

!BSOLUTE ,6%& $ECREASE

LVEF â&#x2030;Ľ10% â&#x2030;Ľ DECREASE DECREASE

AND â&#x2030;Ľ10% â&#x2030;Ľ20%

!#â&#x2020;&#x2019;4 N

Study 3 (ERCEPTIN N

/BSERVATION N

Study 4c 4#( N

!#â&#x2020;&#x2019;4( N

!#â&#x2020;&#x2019;4 N

&OR 3TUDIES AND EVENTS ARE COUNTED FROM THE BEGINNING of Herceptin treatment. For Study 4, events are counted from the date of randomization.

a

Figure 2 3TUDY #UMULATIVE )NCIDENCE OF 4IME TO &IRST ,6%& Decline of â&#x2030;Ľ 0ERCENTAGE 0OINTS FROM "ASELINE AND TO "ELOW WITH $EATH AS A #OMPETING 2ISK %VENT

â&#x2030;¤1)

Studies 1 & 2b !#â&#x2020;&#x2019;4(

N

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

The following subsections provide additional detail regarding adverse reactions observed in clinical trials of adjuvant breast, METASTATIC BREAST CANCER METASTATIC GASTRIC CANCER OR POST marketing experience. Cardiomyopathy Serial measurement of cardiac function (LVEF) was obtained in clinical trials in the ADJUVANT TREATMENT OF BREAST CANCER )N 3TUDY THE MEDIAN DURATION OF FOLLOW UP WAS MONTHS MONTHS IN THE OBSERVATION ARM MONTHS IN THE YEAR (ERCEPTIN ARM AND IN 3TUDIES AND MONTHS IN THE !# 4 ARM MONTHS IN THE !# 4( ARM )N 3TUDIES AND OF PATIENTS WERE NOT PERMITTED TO INITIATE (ERCEPTIN FOLLOWING COMPLETION OF !# CHEMOTHERAPY DUE TO CARDIAC DYSFUNCTION ,6%& OR â&#x2030;Ľ POINT DECLINE IN ,6%& FROM BASELINE TO END OF !# 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 3TUDY SEE 4ABLE &IGURES AND Table 6a 0ER PATIENT )NCIDENCE OF .EW /NSET -YOCARDIAL $YSFUNCTION BY ,6%& 3TUDIES

AND

6%

!LL Grades

Investigations .EUTROPENIA

(YPOKALEMIA

!NEMIA

4HROMBOCYTOPENIA "LOOD !ND ,YMPHATIC System Disorders &EBRILE .EUTROPENIA ?

Gastrointestinal Disorders $IARRHEA

3TOMATITIS

$YSPHAGIA

"ODY AS A 7HOLE &ATIGUE

&EVER

Mucosal )NmAMMATION

#HILLS

â&#x2030;¤1) -ETABOLISM !ND Nutrition Disorders 7EIGHT $ECREASE

)NFECTIONS !ND Infestations Upper Respiratory 4RACT )NFECTIONS

.ASOPHARYNGITIS

2ENAL !ND 5RINARY Disorders Renal Failure and )MPAIRMENT

Nervous System Disorders $YSGEUSIA

Herceptin +FC .

N (%)

Figure 1 Studies 1 and 2: Cumulative Incidence of Time to First LVEF Decline of â&#x2030;Ľ 0ERCENTAGE 0OINTS FROM "ASELINE AND TO "ELOW WITH $EATH AS A #OMPETING 2ISK %VENT

Table 5 3TUDY 0ER 0ATIENT )NCIDENCE OF !DVERSE 2EACTIONS OF !LL 'RADES )NCIDENCE â&#x2030;Ľ BETWEEN !RMS OR 'RADE )NCIDENCE BETWEEN !RMS AND (IGHER )NCIDENCE IN (ERCEPTIN !RM

3 TUDIES AND REGIMENS DOXORUBICIN AND CYCLO PHOSPHAMIDE FOLLOWED BY PACLITAXEL !#â&#x2020;&#x2019;T) or paclitaxel PLUS (ERCEPTIN !#â&#x2020;&#x2019;TH). c Study 4 regimens: doxorubicin and cyclophosphamide FOLLOWED BY DOCETAXEL !#â&#x2020;&#x2019;T) or docetaxel plus Herceptin !#â&#x2020;&#x2019;4( DOCETAXEL AND CARBOPLATIN PLUS (ERCEPTIN 4#( b

The incidence of treatment emergent congestive heart failure among patients in the metastatic breast cancer trials was CLASSIlED FOR SEVERITY USING THE .EW 9ORK (EART !SSOCIATION CLASSIlCATION SYSTEM )Â&#x2013;)6 WHERE )6 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 â&#x2030;Ľ 10% absolute decrease in LVEF from pretreatment values.

Infusion Reactions $URING THE lRST INFUSION WITH (ERCEPTIN 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 (ERCEPTIN INFUSION PERMANENT DISCONTINUATION OF (ERCEPTIN FOR INFUSIONAL TOXICITY WAS REQUIRED IN 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 OF PATIENTS AND WAS SEVERE IN AND of patients, on second or subsequent Herceptin infusions administered as monotherapy or in combination with CHEMOTHERAPY RESPECTIVELY )N 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 VS ;3TUDY = OF SELECTED .#) #4# 'RADE 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 .#) #4# 'RADE ANEMIA WAS )N 3TUDY (metastatic gastric cancer) on the Herceptin containing arm as compared to the chemotherapy alone arm the overall INCIDENCE OF ANEMIA WAS COMPARED AND OF .#) #4# 'RADE ANEMIA WAS COMPARED TO Neutropenia In randomized controlled clinical trials in the adjuvant setting, THE INCIDENCE OF SELECTED .#) #4# 'RADE Â&#x2013; NEUTROPENIA vs. 0.7% [Study 2]) and of selected Grade 2â&#x2C6;&#x2019;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 .#) #4# 'RADE NEUTROPENIA VS AND OF FEBRILE NEUTROPENIA VS 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 .#) #4# 'RADE NEUTROPENIA WAS COMPARED TO FEBRILE NEUTROPENIA COMPARED TO Infection The OVERALL INCIDENCES OF INFECTION VS ;3TUDY = OF SELECTED .#) #4# 'RADE Â&#x2013; INFECTION FEBRILE NEUTROPENIA

VS ;3TUDY = AND OF SELECTED 'RADE Â&#x2013; INFECTION FEBRILE NEUTROPENIA VS ;3TUDY = 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 (ERCEPTIN TO !# 4 BUT NOT TO 4#( ; !# 4( 4#(

!# 4 = 4HE INCIDENCES OF .#) #4# 'RADE Â&#x2013; INFECTION WERE SIMILAR ; !# 4( 4#( !# 4 = ACROSS THE three arms. In a randomized, controlled trial in treatment of metastatic breast cancer, the reported incidence of febrile NEUTROPENIA WAS HIGHER VS IN PATIENTS RECEIVING (ERCEPTIN IN COMBINATION WITH MYELO SUPPRESSIVE CHEMO therapy as compared to chemotherapy alone. Pulmonary Toxicity !DJUVANT "REAST #ANCER !MONG WOMEN RECEIVING adjuvant therapy for breast cancer, the incidence of selected .#) #4# 'RADE Â&#x2013; PULMONARY TOXICITY VS ;3TUDY = AND OF SELECTED .#) #4# 'RADE Â&#x2013; PULMONARY TOXICITY AND SPONTANEOUS REPORTED 'RADE DYSPNEA VS ;3TUDY = was higher in patients receiving Herceptin and chemotherapy compared with chemotherapy alone. The most common PULMONARY TOXICITY WAS DYSPNEA .#) #4# 'RADE Â&#x2013; VS ;3TUDY = .#) #4# 'RADE Â&#x2013; VS ;3TUDY = 0NEUMONITIS PULMONARY INlLTRATES OCCURRED IN OF PATIENTS RECEIVING (ERCEPTIN COMPARED WITH OF THOSE RECEIVING CHEMOTHERAPY ALONE &ATAL RESPIRATORY FAILURE OCCURRED IN PATIENTS RECEIVING (ERCEPTIN ONE AS A COMPONENT OF MULTI organ system failure, as compared to 1 patient receiving CHEMOTHERAPY ALONE )N 3TUDY THERE WERE CASES OF INTERSTITIAL PNEUMONITIS IN (ERCEPTIN TREATED PATIENTS COMPARED TO NONE IN THE CONTROL ARM -ETASTATIC "REAST #ANCER !MONG WOMEN RECEIVING (ERCEPTIN 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 INlLTRATES 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 VS ;3TUDY = AND VS ;3TUDY = AND VS ;3TUDY = Diarrhea !MONG WOMEN RECEIVING ADJUVANT THERAPY FOR BREAST CANCER THE INCIDENCE OF .#) #4# 'RADE Â&#x2013; DIARRHEA VS ;3TUDY = AND OF .#) #4# 'RADE Â&#x2013; DIARRHEA VS ;3TUDY = AND OF 'RADE Â&#x2013; DIARRHEA VS ;3TUDY = were higher in patients receiving Herceptin as compared to CONTROLS )N 3TUDY THE INCIDENCE OF 'RADE Â&#x2013; DIARRHEA WAS HIGHER ; !# 4( 4#( VS !# 4= AND OF 'RADE Â&#x2013; WAS HIGHER ; !# 4( 4#( VS !# 4= AMONG women receiving Herceptin. Of patients receiving Herceptin as a single agent for the treatment of metastatic breast cancer, EXPERIENCED DIARRHEA !N 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 (ERCEPTIN CONTAINING ARM AS COMPARED TO THE chemotherapy alone arm the incidence of renal impairment WAS COMPARED TO 3EVERE 'RADE RENAL FAILURE WAS ON THE (ERCEPTIN CONTAINING ARM COMPARED TO on the chemotherapy only arm. Treatment discontinuation for RENAL INSUFlCIENCY FAILURE WAS ON THE (ERCEPTIN CONTAINING ARM AND ON THE CHEMOTHERAPY ONLY ARM )N 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 MONTHS FROM INITIATION OF (ERCEPTIN THERAPY 0ATHOLOGIC lNDINGS INCLUDED MEMBRANOUS GLOMERULONEPHRITIS FOCAL GLOMERULOSCLEROSIS AND lBRILLARY GLOMERULONEPHRITIS Complications included volume overload and congestive heart failure. Immunogenicity !S WITH ALL THERAPEUTIC PROTEINS THERE IS A POTENTIAL FOR IMMUNOGENICITY !MONG WOMEN WITH METASTATIC BREAST CANCER HUMAN ANTI HUMAN ANTIBODY (!(!

TO (ERCEPTIN WAS DETECTED IN ONE PATIENT USING AN ENZYME LINKED IMMUNOSORBENT ASSAY %,)3! 4HIS PATIENT DID NOT experience an allergic reaction. Samples for assessment of (!(! WERE NOT COLLECTED IN STUDIES OF ADJUVANT BREAST CANCER The incidence of antibody formation is highly dependent on THE SENSITIVITY AND THE SPECIlCITY OF THE ASSAY !DDITIONALLY THE observed incidence of antibody (including neutralizing ANTIBODY POSITIVITY IN AN ASSAY MAY BE INmUENCED 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 IDENTIlED DURING POST APPROVAL USE OF (ERCEPTIN "ECAUSE 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 s )NFUSION REACTION ;see Warnings and Precautions] s /LIGOHYDRAMNIOS OR OLIGOHYDRAMNIOS SEQUENCE INCLUDING pulmonary hypoplasia, skeletal abnormalities, and neonatal death [see Warnings and Precautions= s 'LOMERULOPATHY ;see Adverse Reactions] DRUG INTERACTIONS In Study 5, the mean serum trough concentration of trastuzumab WAS CONSISTENTLY ELEVATED APPROXIMATELY 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 )N POST marketing 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 mUID INDEX INCREASED AFTER (ERCEPTIN was stopped. In one case, Herceptin therapy resumed after THE AMNIOTIC mUID 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.

4HE EFlCACY OF )6 HYDRATION IN MANAGEMENT OF OLIGOHYDRAMNIOS DUE TO (ERCEPTIN EXPOSURE IS NOT KNOWN !DVISE WOMEN OF THE potential hazard to the fetus resulting from Herceptin exposure during pregnancy. Encourage pregnant women with breast CANCER WHO ARE USING (ERCEPTIN TO ENROLL IN -OT(%2 THE (ERCEPTIN 0REGNANCY 2EGISTRY PHONE ;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 $AYS OF GESTATION OR LATE $AYS OF GESTATION FETAL DEVELOPMENT PERIODS AT LEVELS OF TO 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 MONTHS OF AGE HOWEVER

trastuzumab levels in animal breast milk may not accurately REmECT HUMAN BREAST MILK LEVELS "ECAUSE 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 (ERCEPTIN HAS BEEN ADMINISTERED TO PATIENTS WHO WERE YEARS OF AGE OR OVER IN THE ADJUVANT TREATMENT AND 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 PROlLE OF (ERCEPTIN IN OLDER PATIENTS IS different from younger patients. The reported clinical EXPERIENCE IS NOT ADEQUATE TO DETERMINE WHETHER THE EFlCACY improvements (ORR, TTP, OS, DFS) of Herceptin treatment in older patients is different from that observed in patients YEARS OF AGE FOR METASTATIC DISEASE AND ADJUVANT TREATMENT )N 3TUDY METASTATIC GASTRIC CANCER OF THE PATIENTS TREATED WITH (ERCEPTIN WERE YEARS OF AGE OR OLDER WHILE WERE AND OVER .O OVERALL differences in safety or effectiveness were observed.

OVERDOSAGE There is no experience with overdosage in HUMAN CLINICAL TRIALS 3INGLE DOSES HIGHER THAN MG KG HAVE not been tested. PATIENT COUNSELING INFORMATION s !DVISE 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= s !DVISE PREGNANT WOMEN and women of childbearing potential that Herceptin exposure can result in fetal harm [see Warnings and Precautions and Use in Specific Populations= s !DVISE WOMEN OF CHILDBEARING potential to use effective contraceptive methods during treatment and for a minimum of six months following Herceptin [see Warnings and Precautions= s !DVISE 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= s %NCOURAGE women who are exposed to Herceptin during pregnancy to ENROLL IN -OT(%2 THE (ERCEPTIN 0REGNANCY 2EGISTRY ;see Warnings and Precautions and Use in Specific Populations].

HERCEPTINÂŽ [trastuzumab] Manufactured by: Genentech, Inc. A Member of the Roche Group $.! 7AY 3OUTH 3AN &RANCISCO #!

)NITIAL 53 !PPROVAL 3EPTEMBER 2EVISION $ATE /CTOBER

HerceptinŽ is a registered trademark of Genentech, Inc. HER0000111000 Š 2010 Genentech, Inc.

3:02 PM

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Editorial Board EDITOR-IN-CHIEF

Cassandra J. Hammond, RN,

Dolores “Jeff” Nordquist, RN, MS,

Rita Wickham,

MSN, CRNP

CS, FNP

Avid Education Partners, LLC Sharpsburg, MD

Mayo Clinic Rochester, MN

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

Elizabeth Bilotti,

Shannon Hazen,

RN, MSN, APRN, BC, OCN

RN, BSN, OCN

Melinda Oberleitner, RN,

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

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Catherine Bishop, DNP, NP, AOCNP Virginia Cancer Care Lansdowne, VA

Karla Wilson, RN,

Novant Health Presbyterian Cancer Center Charlotte, NC

DNS, APRN, CNS

MSN, FNP-C, CPON

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

City of Hope National Medical Center Duarte, CA

Patricia Irouer Hughes, RN, MSN,

Jayshree Shah, NP

BSN, OCN Piedmount Healthcare Rex, GA

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Pharmacy John F. Aforismo, BSc Pharm, RPh, FASCP

Deena Damsky Dell, RN, MSN,

Taline Khoukaz,

Gary Shelton,

NP, MSN, ACNP-C

AOCN, BC

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

MSN, ARNP, AOCN

Fox Chase Cancer Center Philadelphia, PA

OCN, PhD, RN

NYU Cancer Institute New York, NY

R. J. Health Systems International, LLC Wethersfield, CT

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

Wendy DiSalvo,

Sandra E. Kurtin,

Lori Stover, RN,

DNP, APRN, AOCN

RN, MS, AOCN, ANP-C

BSN

Genentech New London, NH

Arizona Cancer Center Tucson, AZ

Denice Economou, RN,

Elizabeth Lima,

MN, CNS, AOCN

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

City of Hope National Medical Center Duarte, CA

Constance Engelking, RN, MS, CNS, OCN The CHE Consulting Group, Inc. Mt. Kisco, NY

PA-C

Ann McNeill, MSN, RN, NP-C, OCN John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Western Pennsylvania Cancer Institute Pittsburgh, PA

Joseph D. Tariman, PhD,

Patient Advocate Peg Ford Ovarian Cancer Advocacy Alliance Coronado, CA

APRN, BC Northwestern University Myeloma Program Chicago, IL

Jacqueline Marie Toia, RN, MS, DNP Northwestern University Myeloma Program Chicago, IL

Social Work Carolyn Messner, DSW, MSW, LCSW-R, BCD CancerCare New York, NY

Amy Ford, RN,

Kena C. Miller,

BSN, OCN

RN, MSN, FNP

Innovex Dallas, TX

Roswell Park Cancer Institute Buffalo, NY

CS, ANP, AOCN

Managed Care and Pharmaceutical Management Burt Zweigenhaft,

Saratoga, CA

BS

Sharon S. Gentry,

Patricia Molinelli,

Connie Visovsky,

RN, MSN, AOCN

MS, RN, APN-C, AOCNS

RN, PhD, APRN

Pamela Hallquist Viale, RN, MS,

BioPharma Partners LLC New York, NY

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

Somerset Medical Center Somerville, NJ

University of South Florida College of Nursing Tampa, FL

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

Jeanne Westphal, RN Meeker County Memorial Hospital Litchfield, MN

6

SepTember 2011 I VOL 4, NO 6

www.TheOncologyNurse.com

TON_September 2011_FINAL_TON 9/15/11 12:09 PM Page 7

In relapsed and refractory disease

The complications of multiple myeloma present clinical challenges The care of patients with relapsed and refractory multiple myeloma can be complicated by a number of factors related to the patient, prior therapies, stage of disease, and comorbidities.1 • 65% of patients with multiple myeloma are 65 years of age or older2 • Cumulative toxicities from prior therapies can impact treatment options1 • Multiple myeloma itself can damage the patient’s organs and nervous system3

Seeking a new approach to your patients’ needs Onyx Pharmaceuticals is committed to pursuing advances to address the unmet needs of patients with relapsed and refractory multiple myeloma.

©2011 Onyx Pharmaceuticals, Inc., South San Francisco, CA

1210-CARF-052

August 2011

References: 1. Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007;317-323. 2. Palumbo A, Gay F. How to treat elderly patients with multiple myeloma: combination of therapy or sequencing. Hematology Am Soc Hematol Educ Program.

2009;566-577. 3. Munshi NC, Anderson KC. Plasma cell neoplasms.

In: DeVita VT, Lawrence TS, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. 8th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2008:2305-2342.

TON_September 2011_FINAL_TON 9/13/11 10:06 AM Page 8

From the Editor

I

recently read that the Schwartz Center in Boston, Massachusetts, has proposed an agenda to promote compassionate healthcare (Health Affairs. 2011;30:1772-1778).

The article cites a survey the center conducted late last year, which found that just over half of patients (53%) and physicians (58%) believe that the healthcare system provides comBeth Faiman, RN, MSN, passionate care.

To counteract this trend, the APRN, BC, AOCN Editor-in-Chief authors recommended that the federal government include compassionate care measures in national quality standards, that the Patient-Centered Outcomes Research Institute fund comparative effectiveness research to determine which compassionate measures lead to improved outcomes, and that comprehensive training programs be developed to educate healthcare professionals on giving compassionate care.

Although the survey and the agenda are aimed at healthcare in general, how we treat our patients with cancer says a lot about our society. As an oncology nurse, I was pleased to read your responses to our reader survey—responses that

PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko phil@greenhillhc.com Publisher John W. Hennessy john@greenhillhc.com Editorial Director Kristin Siyahian kristin@greenhillhc.com Associate Editor Dawn Lagrosa dawn@greenhillhc.com Quality Control Director Barbara Marino Production Manager Stephanie Laudien Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Andrea Boylston Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732.992.1891 Fax: 732.656.7938

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Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2011 by Green Hill Healthcare Communications, LLC. All rights reserved. The Oncology Nurse®-APN/PA logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

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Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician.

Please convey any errors to the Editorial Director.

BPA Worldwide membership applied for April 2011.

8

SepTember 2011 I VOL 4, NO 6

echo my belief that, when it comes to our patients with cancer and their families, not only do they benefit from our compassion but we benefit from their spirit as well.

Our compassion is on display when we work with children with cancer. As detailed in our profile, one woman’s passion for children’s health has led to a hospital of caring professionals. And our work to help these young children understand and live with cancer, as illustrated in our article on the Josh and Friends Project, shows how far we go to provide comfort.

Adolescents and young adults with cancer also receive our compassionate care. As nurses, we not only treat our patients with anticancer and supportive medications, but also guide them to resources that help them achieve quality of life. Our CE article on guiding patients through the challenges of working during and after cancer treatment is just one example of all we do.

I invite you to participate in our community. This issue of The Oncology Nurse-APN/PA offers 2 new ways to get involved. Visit our website and answer this month’s readers’ survey or submit a question for our new column—Your FAQs... Answered!, a column devoted to providing you the information you requested. As always, I hope this issue benefits your practice. We look forward to hearing from you. ●

Recent FDA Approvals Brentuximab for HL and ALCL The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris; Seattle Genetics) to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

With brentuximab, an antibody-drug conjugate, the antibody directs the drug to the target CD30. The agent is to be used in patients with HL whose disease has progressed after autologous stem-cell transplant or, for those who cannot receive a transplant, after 2 lines of chemotherapy.

Brentuximab also may be used in patients with ALCL whose disease has progressed after 1 line of chemotherapy.

Approval was based on 1 clinical trial involving patients with HL. In the single-arm study, patients were treated solely with brentuximab. Of the study’s 102 patients, 73% achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months.

Effectiveness in ALCL also was evaluated in 1 single-arm study. Of 58 patients receiving brentuximab for ALCL, 86% experienced either a complete or partial response and responded, on average, for 12.6 months.

The most common side effects reported include neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia. Pregnant women should be aware that brentuximab could cause harm to their unborn baby.

Approval was granted under the FDA’s accelerated approval program. As such, the manufacturer is required to submit additional clinical information after approval to confirm the drug’s clinical benefit.

Crizotinib and Companion Diagnostic for ALK-Positive NSCLC The FDA has approved crizotinib (Xalkori; Pfizer) to treat patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Crizotinib has been approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular).

Crizotinib blocks protein kinases, including the protein produced by abnormal ALK. This oral agent is designed to be

taken twice daily as a single-agent treatment.

Approval was based on 2 multicenter, single-arm studies enrolling a total of 255 patients with late-stage ALKpositive NSCLC. In one study, the objective response rate (ORR) was 50%, with a median response duration of 42 weeks. In the other, the ORR was 61%, with a median response duration of 48 weeks. The Vysis ALK Break Apart FISH Probe Kit was approved on data from one of the studies.

The most common side effects reported with crizotinib include vision disorders, nausea, diarrhea, vomiting, edema, and constipation. Vision disorders included visual impairment, flashes of light, blurred vision, floaters, double vision, sensitivity to light, and visual field defects. Crizotinib use was associated with pneumonitis; patients with treatment-related pneumonitis should permanently stop treatment. In addition, the drug should not be used in pregnant women.

Crizotinib also was approved under the FDA’s accelerated approval program.

HE4 Test to Assess Risk of Ovarian Malignancy The FDA has issued 510(k) clearance to market HE4 Test in an algorithm (ROMA [HE4 EIA + ARCHITECT CA 125 II]; Fujirebio Diagnostics), which aids in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.

This Risk of Ovarian Malignancy Algorithm test uses the results from CA 125 and HE4 blood tests to identify patients presenting with adnexal mass as high or low likelihood for finding malignancy on surgery.

Approval was based on data from a study of 462 patients, which showed that, when used in conjunction with the methods a physician would normally use to assess likelihood of ovarian cancer in a combined pre- and postmenopausal patient population, ROMA had a sensitivity of 88.4%, a specificity of 67.2%, and a negative predictive value of 96.2%.

The ROMA test is indicated for women who are older than 18 years, have an ovarian pelvic mass for which surgery is planned, and have not yet been referred to an oncologist.

The test must be interpreted in conjunction with an independent clinical and radiological assessment, according to the manufacturer. ●

www.TheOncologyNurse.com

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Do you recognize these patients?

Before Cycle 1, identify your patients’ individual risk factors for CINV s In addition to the emetogenic potential of a chemotherapy regimen, consider a patient’s additional risk factors for emesis.1 — Female, age <50 years, history of low alcohol intake (<1.5 oz/day), history of morning or motion sickness, and preexisting anxiety or nausea1,2 s Because with every additional risk factor, the risk of emesis increases.1,2. s Because a 5-HT3 antagonist and a corticosteroid alone may not be enough to prevent CINV for 5 days.

Motion sickness Younger than age 50 ✔ Anxiety ✔

Female ✔ Light drinker ✔

✔

An antiemetic regimen with a 5-HT3 antagonist, a corticosteroid, and

EMEND—Helps provide superior CINV prevention for 5 days.

References: 1. Navari RM. Pathogenesis-based treatment of chemotherapy-induced nausea and vomiting—two new agents.

J Support Oncol. 2003;1(2):89–103. 2. Osoba D, Zee B, Pater J, et al; for Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Determinants of postchemotherapy nausea and vomiting in patients with cancer. J Clin Oncol. 1997;15(1):116–123.

EMEND, in combination with other antiemetic agents, is indicated in adults for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Selected Important Safety Information (continued)

EMEND has not been studied for treatment of established nausea and vomiting.

Chronic continuous administration of EMEND is not recommended.

Chronic continuous use of EMEND for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.

Selected Important Safety Information EMEND is contraindicated in patients who are hypersensitive to any component of the product.

EMEND is a dose-dependent inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4). EMEND should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.

EMEND should be used with caution in patients receiving concomitant medications, including chemotherapy agents, that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by EMEND could result in elevated plasma concentrations of these concomitant medications. Conversely, when EMEND is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When EMEND is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant.

Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, EMEND was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions. In separate pharmacokinetic studies, EMEND did not influence the pharmacokinetics of docetaxel or vinorelbine.

Because a small number of patients in clinical studies received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied.

Coadministration of EMEND with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of EMEND with each chemotherapy cycle.

Merck Oncology Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. ONCO-1001721-0004 emend.com

The efficacy of hormonal contraceptives may be reduced during coadministration with and for 28 days after the last dose of EMEND. Alternative or backup methods of contraception should be used during treatment with and for 1 month after the last dose of EMEND.

In clinical trials of EMEND in patients receiving highly emetogenic chemotherapy, the most common adverse events reported at a frequency greater than with standard therapy, and at an incidence greater than 10% were asthenia/fatigue (17.8% EMEND vs 11.8% standard therapy), nausea (12.7% vs 11.8%), hiccups (10.8% vs 5.6%), diarrhea (10.3% vs 7.5%), and anorexia (10.1% vs 9.5%).

In clinical trials of EMEND in patients receiving moderately emetogenic chemotherapy, the most common adverse events reported at a frequency greater than with standard therapy were alopecia (12.4% EMEND vs 11.9% standard therapy), dyspepsia (5.8% vs 3.8%), nausea (5.8% vs 5.1%), neutropenia (5.8% vs 5.6%), asthenia (4.7% vs 4.6%), and stomatitis (3.1% vs 2.7%).

In clinical trials, EMEND increased the AUC of dexamethasone, a CYP3A4 substrate, by approximately 2-fold; therefore, the oral dose of dexamethasone administered in the regimen with EMEND should be reduced by approximately 50% to achieve exposures of dexamethasone similar to those obtained without EMEND. EMEND increased the AUC of methylprednisolone by 1.34-fold and 2.5-fold on Days 1 and 3, respectively. The intravenous dose of methylprednisolone should be reduced by approximately 25% and the oral dose by 50% when coadministered with EMEND. Please see Brief Summary of Prescribing Information on the following pages. For copies of the Prescribing Information, call 800-672-6372, visit emend.com, or contact your Merck representative.

CINV=chemotherapy-induced nausea and vomiting.

Persons depicted are for illustrative purposes only and are not actual patients.

An antiemetic regimen including

TON_September 2011_FINAL_TON 9/13/11 10:06 AM Page 10

Brief Summary of the Prescribing Information for

INDICATIONS AND USAGE Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV): EMEND, in combination with other antiemetic agents, is indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses CAPSULES of moderately emetogenic cancer chemotherapy (MEC).

Prevention of Postoperative Nausea and Vomiting (PONV): EMEND is indicated for prevention of postoperative nausea and vomiting.

Limitations of Use: EMEND has not been studied for treatment of established nausea and vomiting.

Chronic continuous administration is not recommended.

CONTRAINDICATIONS EMEND is contraindicated in patients who are hypersensitive to any component of the product.

EMEND is a dose-dependent inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4). EMEND should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions [see Drug Interactions].

WARNINGS AND PRECAUTIONS CYP3A4 Interactions: EMEND, a dose-dependent inhibitor of CYP3A4, should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Moderate inhibition of CYP3A4 by aprepitant, 125-mg/80-mg regimen, could result in elevated plasma concentrations of these concomitant medications.

Weak inhibition of CYP3A4 by a single 40-mg dose of aprepitant is not expected to alter the plasma concentrations of concomitant medications that are primarily metabolized through CYP3A4 to a clinically significant degree.

When aprepitant is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When EMEND is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced and this may result in decreased efficacy of EMEND [see Drug Interactions].

Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, EMEND (125-mg/80-mg regimen) was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions.

In separate pharmacokinetic studies no clinically significant change in docetaxel or vinorelbine pharmacokinetics was observed when EMEND (125-mg/80-mg regimen) was coadministered.

Due to the small number of patients in clinical studies who received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied [see Drug Interactions].

Coadministration With Warfarin (a CYP2C9 substrate): Coadministration of EMEND with warfarin may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND for prevention of postoperative nausea and vomiting [see Drug Interactions].

Coadministration With Hormonal Contraceptives: Upon coadministration with EMEND, the efficacy of hormonal contraceptives during and for 28 days following the last dose of EMEND may be reduced. Alternative or backup methods of contraception should be used during treatment with EMEND and for 1 month following the last dose of EMEND [see Drug Interactions].

Patients With Severe Hepatic Impairment: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (ChildPugh score >9). Therefore, caution should be exercised when EMEND is administered in these patients.

Chronic Continuous Use: Chronic continuous use of EMEND for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.

ADVERSE REACTIONS The overall safety of aprepitant was evaluated in approximately 5300 individuals.

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 clinical practice.

Clinical Trials Experience: Chemotherapy-Induced Nausea and Vomiting: Highly Emetogenic Chemotherapy: In 2 well-controlled clinical trials in patients receiving highly emetogenic cancer chemotherapy, 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy. EMEND was given in combination with ondansetron and dexamethasone.

In Cycle 1, clinical adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 68% of patients treated with standard therapy. Following are the percentage of patients receiving highly emetogenic chemotherapy in Cycle 1 with clinical adverse experiences reported at an incidence of ≥3% for the aprepitant regimen (n=544) and standard therapy (n=550), respectively: Body as a whole/Site unspecified: asthenia/fatigue: 17.8, 11.8; dizziness: 6.6, 4.4; dehydration: 5.9, 5.1; abdominal pain: 4.6, 3.3; fever: 2.9, 3.5; mucous membrane disorder: 2.6, 3.1 Digestive system: nausea: 12.7, 11.8; constipation: 10.3, 12.2; diarrhea: 10.3, 7.5; vomiting: 7.5, 7.6; heartburn: 5.3, 4.9; gastritis: 4.2, 3.1; epigastric discomfort: 4.0, 3.1 Eyes, ears, nose, and throat: tinnitus: 3.7, 3.8 Hemic and lymphatic system: neutropenia: 3.1, 2.9 Metabolism and nutrition: anorexia: 10.1, 9.5 Nervous system: headache: 8.5, 8.7; insomnia: 2.9, 3.1 Respiratory system: hiccups: 10.8, 5.6 In addition, isolated cases of serious adverse experiences, regardless of causality, of bradycardia, disorientation, and perforating duodenal ulcer were reported in highly emetogenic CINV clinical studies.

Moderately Emetogenic Chemotherapy: During Cycle 1 of 2 moderately emetogenic chemotherapy studies, 868 patients were treated with the aprepitant regimen and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy. In the combined analysis of Cycle 1 data for these 2 studies, adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 72% of patients treated with standard therapy.

In the combined analysis of Cycle 1 data for these 2 studies, the adverse-experience profile in both moderately emetogenic chemotherapy studies was generally comparable to the highly emetogenic chemotherapy studies. Following are the percentage of patients receiving moderately emetogenic chemotherapy in Cycle 1 with clinical adverse experiences reported at an incidence of ≥3% for the aprepitant regimen (n=868) and standard therapy (n=846), respectively: Blood and lymphatic system disorders: neutropenia: 5.8, 5.6 Metabolism and nutrition disorders: anorexia: 6.2, 7.2 Psychiatric disorders: insomnia: 2.6, 3.7 Nervous system disorders: headache: 13.2, 14.3; dizziness: 2.8, 3.4 Gastrointestinal disorders: constipation: 10.3, 15.5; diarrhea: 7.6, 8.7; dyspepsia: 5.8, 3.8; nausea: 5.8, 5.1; stomatitis: 3.1, 2.7 Skin and subcutaneous tissue disorders: alopecia: 12.4, 11.9 General disorders and general administration site conditions: fatigue: 15.4, 15.6; asthenia: 4.7, 4.6 In a combined analysis of these 2 studies, isolated cases of serious adverse experiences were similar in the 2 treatment groups.

Highly and Moderately Emetogenic Chemotherapy: The following additional clinical adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with the aprepitant regimen in either HEC or MEC studies: Infections and infestations: candidiasis, herpes simplex, lower respiratory infection, oral candidiasis, pharyngitis, septic shock, upper respiratory infection, urinary tract infection Neoplasms benign, malignant, and unspecified (including cysts and polyps): malignant neoplasm, non–small-cell lung carcinoma Blood and lymphatic system disorders: anemia, febrile neutropenia, thrombocytopenia Metabolism and nutrition disorders: appetite decreased, diabetes mellitus, hypokalemia Psychiatric disorders: anxiety disorder, confusion, depression Nervous system: peripheral neuropathy, sensory neuropathy, taste disturbance, tremor Eye disorders: conjunctivitis Cardiac disorders: myocardial infarction, palpitations, tachycardia Vascular disorders: deep venous thrombosis, flushing, hot flush, hypertension, hypotension Respiratory, thoracic, and mediastinal disorders: cough, dyspnea, nasal secretion, pharyngolaryngeal pain, pneumonitis, pulmonary embolism, respiratory insufficiency, vocal disturbance Gastrointestinal disorders: abdominal pain upper, acid reflux, deglutition disorder, dry mouth, dysgeusia, dysphagia, eructation, flatulence, obstipation, salivation increased Skin and subcutaneous tissue disorders: acne, diaphoresis, pruritus, rash Musculoskeletal and connective tissue disorders: arthralgia, back pain, muscular weakness, musculoskeletal pain, myalgia Renal and urinary disorders: dysuria, renal insufficiency Reproductive system and breast disorders: pelvic pain General disorders and administrative site conditions: edema, malaise, pain, rigors Investigations: weight loss Stevens-Johnson syndrome was reported as a serious adverse experience in a patient receiving aprepitant with cancer chemotherapy in another CINV study.

Laboratory Adverse Experiences: Following are the percentage of patients receiving highly emetogenic chemotherapy in Cycle 1 with laboratory adverse experiences reported at an incidence of ≥3% for the aprepitant regimen (n=544) and standard therapy (n=550), respectively: Proteinuria: 6.8, 5.3 ALT increased: 6.0, 4.3 Blood urea nitrogen increased: 4.7, 3.5 Serum creatinine increased: 3.7, 4.3

EMEND® (aprepitant) capsules AST increased: 3.0, 1.3 The following additional laboratory adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with the aprepitant regimen: alkaline phosphatase increased, hyperglycemia, hyponatremia, leukocytes increased, erythrocyturia, leukocyturia.

The adverse-experience profiles in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.

Postoperative Nausea and Vomiting: In well-controlled clinical studies in patients receiving general anesthesia, 564 patients were administered 40-mg aprepitant orally and 538 patients were administered 4-mg ondansetron IV. Clinical adverse experiences were reported in approximately 60% of patients treated with 40-mg aprepitant compared with approximately 64% of patients treated with 4-mg ondansetron IV. Following are the percentage of patients receiving general anesthesia with clinical adverse experiences reported at an incidence of ≥3% in the combined studies for aprepitant 40 mg (n=564) and ondansetron (n=538), respectively: Infections and infestations: urinary tract infection: 2.3, 3.2 Blood and lymphatic system disorders: anemia: 3.0, 4.3 Psychiatric disorders: insomnia: 2.1, 3.3 Nervous system disorders: headache: 5.0, 6.5 Cardiac disorders: bradycardia: 4.4, 3.9 Vascular disorders: hypotension: 5.7, 4.6; hypertension: 2.1, 3.2 Gastrointestinal disorders: nausea: 8.5, 8.6; constipation: 8.5, 7.6; flatulence: 4.1, 5.8; vomiting 2.5, 3.9 Skin and subcutaneous tissue disorders: pruritus: 7.6, 8.4 General disorders and general administration site conditions: pyrexia: 5.9, 10.6 The following additional clinical adverse experiences (incidence >0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant: Infections and infestations: postoperative infection Metabolism and nutrition disorders: hypokalemia, hypovolemia Nervous system disorders: dizziness, hypoesthesia, syncope Vascular disorders: hematoma Respiratory, thoracic, and mediastinal disorders: dyspnea, hypoxia, respiratory depression Gastrointestinal disorders: abdominal pain, abdominal pain upper, dry mouth, dyspepsia Skin and subcutaneous tissue disorders: urticaria General disorders and administrative site conditions: hypothermia, pain Investigations: blood pressure decreased Injury, poisoning, and procedural complications: operative hemorrhage, wound dehiscence Other adverse experiences (incidence ≤0.5%) reported in patients treated with aprepitant 40 mg for postoperative nausea and vomiting included: Nervous system disorders: dysarthria, sensory disturbance Eye disorders: miosis, visual acuity reduced Respiratory, thoracic, and mediastinal disorders: wheezing Gastrointestinal disorders: bowel sounds abnormal, stomach discomfort There were no serious adverse drug-related experiences reported in the postoperative nausea and vomiting clinical studies in patients taking 40-mg aprepitant.

Laboratory Adverse Experiences: One laboratory adverse experience, hemoglobin decreased (40-mg aprepitant 3.8%, ondansetron 4.2%), was reported at an incidence ≥3% in a patient receiving general anesthesia.

The following additional laboratory adverse experiences (incidence >0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant 40 mg: blood albumin decreased, blood bilirubin increased, blood glucose increased, blood potassium decreased, glucose urine present.

The adverse experience of increased ALT occurred with similar incidence in patients treated with aprepitant 40 mg (1.1%) as in patients treated with ondansetron 4 mg (1.0%).

Other Studies: In addition, 2 serious adverse experiences were reported in postoperative nausea and vomiting (PONV) clinical studies in patients taking a higher dose of aprepitant: 1 case of constipation, and 1 case of subileus.

Angioedema and urticaria were reported as serious adverse experiences in a patient receiving aprepitant in a non-CINV/non-PONV study.

Postmarketing Experience: The following adverse reactions have been identified during postmarketing use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to the drug.

Skin and subcutaneous tissue disorders: pruritus, rash, urticaria Immune system disorders: hypersensitivity reactions including anaphylactic reactions DRUG INTERACTIONS Aprepitant is a substrate, a weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9.

Effect of Aprepitant on the Pharmacokinetics of Other Agents: CYP3A4 substrates: Weak inhibition of CYP3A4 by a single 40-mg dose of aprepitant is not expected to alter the plasma concentrations of concomitant medications that are primarily metabolized through CYP3A4 to a clinically significant degree. However, higher aprepitant doses or repeated dosing at any aprepitant dose may have a clinically significant effect.

As a moderate inhibitor of CYP3A4 at a dose of 125 mg/80 mg, aprepitant can increase plasma concentrations of concomitantly administered oral medications that are metabolized through CYP3A4 [see Contraindications]. The use of fosaprepitant may increase CYP3A4 substrate plasma concentrations to a lesser degree than the use of oral aprepitant (125 mg).

5-HT3 antagonists: In clinical drug interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).

Corticosteroids: Dexamethasone: EMEND, when given as a regimen of 125 mg with dexamethasone coadministered orally as 20 mg on Day 1, and EMEND when given as 80 mg/day with dexamethasone coadministered orally as 8 mg on Days 2 through 5, increased the AUC of dexamethasone, a CYP3A4 substrate, by 2.2-fold on Days 1 and 5. The oral dexamethasone doses should be reduced by approximately 50% when coadministered with EMEND (125-mg/80-mg regimen), to achieve exposures of dexamethasone similar to those obtained when it is given without EMEND. The daily dose of dexamethasone administered in clinical chemotherapy-induced nausea and vomiting studies with EMEND reflects an approximate 50% reduction of the dose of dexamethasone. A single dose of EMEND (40 mg) when coadministered with a single oral dose of dexamethasone 20 mg, increased the AUC of dexamethasone by 1.45-fold. Therefore, no dose adjustment is recommended.

Methylprednisolone: EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, increased the AUC of methylprednisolone, a CYP3A4 substrate, by 1.34-fold on Day 1 and by 2.5-fold on Day 3, when methylprednisolone was coadministered intravenously as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3. The IV methylprednisolone dose should be reduced by approximately 25% and the oral methylprednisolone dose should be reduced by approximately 50% when coadministered with EMEND (125-mg/80-mg regimen) to achieve exposures of methylprednisolone similar to those obtained when it is given without EMEND. Although the concomitant administration of methylprednisolone with the single 40-mg dose of aprepitant has not been studied, a single 40-mg dose of EMEND produces a weak inhibition of CYP3A4 (based on midazolam interaction study) and it is not expected to alter the plasma concentrations of methylprednisolone to a clinically significant degree. Therefore, no dose adjustment is recommended.

Chemotherapeutic agents: [see Warnings and Precautions] Docetaxel: In a pharmacokinetic study, EMEND (125-mg/80-mg regimen) did not influence the pharmacokinetics of docetaxel.

Vinorelbine: In a pharmacokinetic study, EMEND (125-mg/80-mg regimen) did not influence the pharmacokinetics of vinorelbine to a clinically significant degree.

CYP2C9 substrates (warfarin, tolbutamide): Aprepitant has been shown to induce the metabolism of S(–) warfarin and tolbutamide, which are metabolized through CYP2C9. Coadministration of EMEND with these drugs or other drugs that are known to be metabolized by CYP2C9, such as phenytoin, may result in lower plasma concentrations of these drugs.

Warfarin: A single 125-mg dose of EMEND was administered on Day 1 and 80 mg/day on Days 2 and 3 to healthy subjects who were stabilized on chronic warfarin therapy. Although there was no effect of EMEND on the plasma AUC of R(+) or S(–) warfarin determined on Day 3, there was a 34% decrease in S(–) warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14% decrease in the prothrombin time (reported as international normalized ratio or INR) 5 days after completion of dosing with EMEND. In patients on chronic warfarin therapy, the prothrombin time (INR) should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND for prevention of postoperative nausea and vomiting.

Tolbutamide: EMEND, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23% on Day 4, 28% on Day 8, and 15% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15.

EMEND, when given as a 40-mg single oral dose on Day 1, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 8% on Day 2, 16% on Day 4, 15% on Day 8, and 10% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of EMEND 40 mg and on Days 2, 4, 8, and 15. This effect was not considered clinically important.

Oral contraceptives: Aprepitant, when given once daily for 14 days as a 100-mg capsule with an oral contraceptive containing 35 mcg of ethinyl estradiol and 1 mg of norethindrone, decreased the AUC of ethinyl estradiol by 43%, and decreased the AUC of norethindrone by 8%.

In another study, a daily dose of an oral contraceptive containing ethinyl estradiol and norethindrone was administered on Days 1 through 21, and EMEND was given as a 3-day regimen of 125 mg on Day 8 and 80 mg/day on Days 9 and 10 with ondansetron 32 mg IV on Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/day on Days 9, 10, and 11. In the study, the AUC of ethinyl estradiol decreased by 19% on Day 10 and there was as much as a 64% decrease in ethinyl estradiol trough concentrations during Days 9 through 21. While there was no effect of EMEND on the AUC of norethindrone on Day 10, there was as much as a 60% decrease in norethindrone trough concentrations during Days 9 through 21.

In another study, a daily dose of an oral contraceptive containing ethinyl estradiol and norgestimate (which is converted to norelgestromin) was administered on Days 1 through 21, and EMEND 40 mg was given on Day 8. In the study, the AUC of ethinyl estradiol decreased by 4% and 29% on Day 8 and Day 12, respectively, while the AUC of norelgestromin increased by 18% on Day 8 and decreased by 10% on Day 12. In

TON_September 2011_FINAL_TON 9/14/11 3:46 PM Page 11

EMENDÂŽ (aprepitant) capsules

For detailed information, please read the Prescribing Information.

Rx only

Copyright Š 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. ONCO-1001721-0004

Survivorship Breastfeeding May Be Compromised... Continued from the cover cer, we recommend that nurses or other medical professionals conduct more frequent breast exams to monitor the survivorâ&#x20AC;&#x2122;s lactation potential. [That way], if it appears that the survivor may be unable to lactate, she can be better prepared to employ other nutritional options in the postpartum context.â&#x20AC;?

Ogg, James Klosky, PhD, a clinical psychologist at the St. Jude Childrenâ&#x20AC;&#x2122;s Research Hospital, and colleagues also strongly advocate for breastfeeding whenever possible among childhood cancer survivors. â&#x20AC;&#x153;It is one more health behavior that survivors can engage in to promote their own health and their childrenâ&#x20AC;&#x2122;s health,â&#x20AC;? Klosky said. â&#x20AC;&#x153;Furthermore, breastfeeding may alleviate some of the potential late effects of childhood cancer therapy experienced by these mothers.â&#x20AC;?

In the study, the researchers reviewed the scant amount of literature addressing lactation outcomes in patients with cancer, as well as the evidence for benefits of lactation to cancer survivors. â&#x20AC;&#x153;This is the first paper to provide an overview of the whole topic,â&#x20AC;? commented Pamela Berens, MD, professor of obstetrics and gynecology at the University of Texas Health Science Center at Houston, who was not one of the researchers. â&#x20AC;&#x153;We need better longterm research, and the time is ripe for both retrospective and prospective studies, as the authors point out, since quite a number of women have survived childhood cancer.â&#x20AC;?

The small number of studies on lactation and breastfeeding in cancer survivors all point to lower rates of lactation, and not only among breast cancer survivors. For example, a study of long-term survivors of Hodgkin lymphoma showed that only 61% of womenâ&#x20AC;&#x2122;s breastfeeding attempts were successful compared with 79% of attempts in a sibling control group.2 Another team reviewed the lactation experiences of 12 survivors of childhood acute lymphoblastic leukemia.3 Every woman had received 24 to 25 Gy of cranial radiation therapy and chemotherapy as part of treatment, and only 17% were able to breastfeed.

One mechanism for the lactation difficulties appears to be a growth hormone deficiency; cranial radiation is linked to a high risk for such a deficiency, the researchers point out. They also outline the salubrious effects of breastfeeding, including: â&#x20AC;˘ Well-established benefits to infants, such as lower infectious disease and malignancy rates, and benefits to mothers, such as lowered risk for postpartum hemorrhage and decreased rates of breast, ovarian, and uterine cancers â&#x20AC;˘ The potential to reduce the severity and risks associated with late effects of childhood cancer, such as low bone mineral density, metabolic syndrome, obesity, diabetes, cardiovascular disease, and second malignant neoplasms. â&#x20AC;&#x153;We propose that education of childbearing cancer survivors about the health benefits of breastfeeding should be added to the list of interventions that are commonly recommended to cancer survivors,â&#x20AC;? the researchers concluded. They also stressed that healthcare professionals who have patients with childhood cancer should be aware of the potential deleterious effects of the cancer treatment on lactation, as well as the likely benefits of breastfeeding for infants and mothers. â&#x2014;?

References 1. Ogg SW, Hudson MM, Randolph ME, et al. Protective effects of breastfeeding for mothers surviving childhood cancer. J Cancer Surviv. 2011;5:175-181.

2. McCullough L, Ng A, Najita J, et al. Breastfeeding in survivors of Hodgkin lymphoma treated with chest radiotherapy. Cancer. 2010;116:4866-4871.

3. Johnston K, Vowels M, Carroll S, et al. Failure to lactate: a possible late effect of cranial radiation. Pediatr Blood Cancer. 2008;50:721-722.

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ŠiStockphoto.com/Mats Persson

addition, the trough concentrations of ethinyl estradiol and norelgestromin on Days 8 through 21 were generally lower following coadministration of the oral contraceptive with EMEND 40 mg on Day 8 compared to the trough levels following administration of the oral contraceptive alone.

The coadministration of EMEND may reduce the efficacy of hormonal contraceptives (these can include birth control pills, skin patches, implants, and certain IUDs) during and for 28 days after administration of the last dose of EMEND. Alternative or backup methods of contraception should be used during treatment with EMEND and for 1 month following the last dose of EMEND. Midazolam: EMEND increased the AUC of midazolam, a sensitive CYP3A4 substrate, by 2.3-fold on Day 1 and 3.3-fold on Day 5, when a single oral dose of midazolam 2 mg was coadministered on Day 1 and Day 5 of a regimen of EMEND 125 mg on Day 1 and 80 mg/day on Days 2 through 5. The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these agents with EMEND (125 mg/80 mg). A single dose of EMEND (40 mg) increased the AUC of midazolam by 1.2-fold on Day 1, when a single oral dose of midazolam 2 mg was coadministered on Day 1 with EMEND 40 mg; this effect was not considered clinically important.

In another study with intravenous administration of midazolam, EMEND was given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, and midazolam 2 mg IV was given prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15. EMEND increased the AUC of midazolam by 25% on Day 4 and decreased the AUC of midazolam by 19% on Day 8 relative to the dosing of EMEND on Days 1 through 3. These effects were not considered clinically important. The AUC of midazolam on Day 15 was similar to that observed at baseline.

An additional study was completed with intravenous administration of midazolam and EMEND. Intravenous midazolam 2 mg was given 1 hour after oral administration of a single dose of EMEND 125 mg. The plasma AUC of midazolam was increased by 1.5-fold. Depending on clinical situations (eg, elderly patients) and degree of monitoring available, dosage adjustment for intravenous midazolam may be necessary when it is coadministered with EMEND for the chemotherapy-induced nausea and vomiting indication (125 mg on Day 1 followed by 80 mg on Days 2 and 3).

Effect of Other Agents on the Pharmacokinetics of Aprepitant: Aprepitant is a substrate for CYP3A4; therefore, coadministration of EMEND with drugs that inhibit CYP3A4 activity may result in increased plasma concentrations of aprepitant. Consequently, concomitant administration of EMEND with strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir) should be approached with caution. Because moderate CYP3A4 inhibitors (eg, diltiazem) result in a 2-fold increase in plasma concentrations of aprepitant, concomitant administration should also be approached with caution.

Aprepitant is a substrate for CYP3A4; therefore, coadministration of EMEND with drugs that strongly induce CYP3A4 activity (eg, rifampin, carbamazepine, phenytoin) may result in reduced plasma concentrations of aprepitant that may result in decreased efficacy of EMEND. Ketoconazole: When a single 125-mg dose of EMEND was administered on Day 5 of a 10-day regimen of 400 mg/day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold. Concomitant administration of EMEND with strong CYP3A4 inhibitors should be approached cautiously.

Rifampin: When a single 375-mg dose of EMEND was administered on Day 9 of a 14-day regimen of 600 mg/day of rifampin, a strong CYP3A4 inducer, the AUC of aprepitant decreased approximately 11-fold and the mean terminal half-life decreased approximately 3-fold.

Coadministration of EMEND with drugs that induce CYP3A4 activity may result in reduced plasma concentrations and decreased efficacy of EMEND. Additional Interactions: EMEND is unlikely to interact with drugs that are substrates for the P-glycoprotein transporter, as demonstrated by the lack of interaction of EMEND with digoxin in a clinical drug interaction study.

Diltiazem: In patients with mild to moderate hypertension, administration of aprepitant once daily, as a tablet formulation comparable to 230 mg of the capsule formulation, with diltiazem 120 mg 3 times daily for 5 days, resulted in a 2-fold increase of aprepitant AUC and a simultaneous 1.7-fold increase of diltiazem AUC. These pharmacokinetic effects did not result in clinically meaningful changes in ECG, heart rate, or blood pressure beyond those changes induced by diltiazem alone.

Paroxetine: Coadministration of once-daily doses of aprepitant, as a tablet formulation comparable to 85 mg or 170 mg of the capsule formulation, with paroxetine 20 mg once daily, resulted in a decrease in AUC by approximately 25% and C max by approximately 20% of both aprepitant and paroxetine.

USE IN SPECIFIC POPULATIONS Pregnancy: Teratogenic effects: Pregnancy Category B: Reproduction studies have been performed in rats at oral doses up to 1000 mg/kg twice daily (plasma AUC 0â&#x20AC;&#x201C;24hr >5 <26M7A <$ 01>DC C8<4B C74 7D<0= 4G?>BDA4 0C C74 A42><<4=343 3>B4 0=3 8= A0118CB 0C >A0; 3>B4B up to 25 mg/kg/day (plasma AUC 0â&#x20AC;&#x201C;24hr >5 <26M7A <$ 01>DC C8<4B C74 7D<0= 4G?>BDA4 0C C74 A42><<4=343 3>B4 0=3 70E4 A4E40;43 no evidence of impaired fertility or harm to the fetus due to aprepitant. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Aprepitant is excreted in the milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for possible serious adverse reactions in nursing infants from aprepitant and because of the potential for tumorigenicity shown for aprepitant in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of EMEND in pediatric patients have not been established.

Geriatric Use: In 2 well-controlled chemotherapy-induced nausea and vomiting clinical studies, of the total number of patients (N=544) treated with EMEND, 31% were 65 and over, while 5% were 75 and over. In well-controlled postoperative nausea and vomiting clinical studies, of the total number of patients (N=1120) treated with EMEND, 7% were 65 and over, while 2% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Greater sensitivity of some older individuals cannot be ruled out.

Dosage adjustment in the elderly is not necessary.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced a systemic exposure to aprepitant (plasma AUC 0â&#x20AC;&#x201C;24hr ) of 0.7 to 1.6 times the human exposure (AUC 0â&#x20AC;&#x201C;24hr <26M7A <$ 0C the recommended dose of 125 mg/day. Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals were treated with oral doses ranging from 2.5 to 2000 mg/kg/day. The highest dose produced a systemic exposure of about 2.8 to 3.6 times the human exposure at the recommended dose. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice.

Aprepitant was not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test, and the mouse micronucleus test.

Aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended human dose and exposure in female rats at about 1.6 times the human exposure).

PATIENT COUNSELING INFORMATION [See FDA-Approved Patient Labeling.] Instructions: Physicians should instruct their patients to read the patient package insert before starting therapy with EMEND and to reread it each time the prescription is renewed.

Patients should be instructed to take EMEND only as prescribed. For prevention of chemotherapy-induced nausea and vomiting (CINV), patients should be advised to take their first dose (125 mg) of EMEND 1 hour prior to chemotherapy treatment. For prevention of postoperative nausea and vomiting (PONV), patients should receive their medication (40-mg capsule of EMEND) within 3 hours prior to induction of anesthesia.

Allergic reactions, which may be serious, and may include hives, rash, and itching, and cause difficulty in breathing or swallowing, have been reported in general use with EMEND. Physicians should instruct their patients to stop taking EMEND and call their doctor right away if they experience an allergic reaction.

EMEND may interact with some drugs including chemotherapy; therefore, patients should be advised to report to their doctor the use of any other prescription or nonprescription medication or herbal products.

Patients on chronic warfarin therapy should be instructed to have their clotting status closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND 125 mg/80 mg with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND for prevention of postoperative nausea and vomiting.

Administration of EMEND may reduce the efficacy of hormonal contraceptives. Patients should be advised to use alternative or backup methods of contraception during treatment with EMEND and for 1 month following the last dose of EMEND.

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Editorial

I Am a Nurse Practitioner, NOT a Mid-Level Provider!

By Alison Moriarty Daley, MSN, APRN, PNP-BS Pediatric Nurse Practitioner and Associate Professor, Yale University School of Nursing, New Haven, Connecticut

I

vividly remember the first time I saw the term “mid-level provider” prominently displayed in the hallway of the hospital and thought, “Who are they referring to?” Within seconds, I received the answer in smaller script displayed below “(NPs/PAs)” and thought, “Why didn’t they just write NPs/PAs?” My reaction to that poster was visceral then and has remained the same every time I have seen or heard the term since.

My most recent encounter with this term was at a meeting where the term was used frequently, along with “physician extender.” As the only nurse practitioner in the room, I reflected on why this term made such a negative impression on me and how it may also serve to confuse and offend the many patients who I care for as well as the nurse practitioner students I educate. I recalled the other common “mid” words in my vocabulary: midnight, not a bad word unless you are having difficulty sleeping or have missed your curfew; midlife, which is usually accompanied by crisis; midwife, colleague, positive; midst, midair, midcycle, midi, midpoint, midriff, midterm, midway, or midwinter —how one considers these depends on one’s point of view and situation, but none are overwhelmingly positive. So I turned to the dictionary and found a positive definition of mid, “central.” I do believe nurse practitioners are central to the care of our patients and their fami-

I did not receive a mid-level education, and I do not provide mid-level care. I did not choose to be a nurse practitioner because I could not be a doctor. I chose to be a nurse practitioner because I wanted to be a nurse practitioner. lies, as well as to the education of our nurse practitioner students. We are central in the healthcare system, often as the primary care provider, advocate, and coordinator of care for our patients.

My very visceral reaction to being referred to as a mid-level provider is that it implies (loudly) that the care I provide and the knowledge that I have is in the middle, not the best or the worst, just in the middle, mediocre, okay. I did not receive a mid-level education, and I do not provide mid-level care. I did not choose to be a nurse practitioner because I could not be a doctor. I chose to be a nurse practitioner because I wanted to be a nurse practitioner. I believe in the philosophy of nursing and the manner in which nurse practitioners provide care. My education, philosophy, and scope of practice are different from those of physicians. That does not make what I do mid-level, mediocre, or less than that of physicians.

It is also curious that nurse practitioners have been lumped into the same category as physician assistants.

The education and scope of practice of each are similar but not the same.

Physical therapists, occupational therapists, and pharmacists have escaped being put into the same “box.” No one would argue that the roles of each are the same. Even midwives and nurse anesthetists have somehow escaped. If I look to other professions outside of healthcare, others do not seem to have the same issues; teachers are teachers, accountants are accountants. I could go on and on.

I also asked several of my nurse practitioner colleagues how they felt about the term “mid-level provider.” Their reactions were similar: “I hate it,” “It makes me crazy,” “It is offensive, derogatory,” and perhaps my favorite, “I refuse to buy into the paradigm.” Yet despite the instant outrage when asked about the term, it lives on. My search on the

Reader Poll Do you think “mid-level provider” is an accurate term or an insult?

To weigh in on this question, please log on to www.TheOncologyNurse.com.

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September 2011 I VOL 4, NO 6

Internet for the origin of the term yielded an article, “The Rise of the Midlevel Professional.”1 Fantastic. What or where have we risen from? Nurse practitioners have been a vital part of healthcare delivery in the United States since the mid-1960s. Research has demonstrated our effectiveness and versatility.2-7 Our patients appreciate the high-quality, cost-effective care we provide.8,9 The care nurse practitioners provide is, at the very least, as good as that of our physician colleagues.4 Isn’t there already enough confusion about who nurse practitioners are and what we do? Do we really need to allow more confusion? I can only imagine the reaction of an adolescent at the check-in desk when asked, “Are you here to see the mid-level provider?” or to a sign above the door reading, “Mid-Level Provider Office.”

I took the first step at that meeting, as the only nurse practitioner in the room—I pushed the microphone button and stated “as a nurse practitioner, I find the term mid-level provider offensive.”

There was silence, no argument or comment, but some nodding in agreement. I encourage all nurse practitioners and physician assistants to do the same.

Healthcare reform will change how Americans receive and experience healthcare. We need to talk about what we do and how well we do it. Enough is enough! I realize I am preaching to the choir so to speak, but if not us then who is going to speak up for us? There are too many people who need high-quality, dedicated providers; we are such providers and deserve the appropriate respect, recognition, and support from the healthcare community. ● References 1. Loeb M. The rise of the midlevel professional. June 15, 2007. MarketWatch. http://finance.yahoo.com/ career-work/article/103122/The-Rise-of-the-Mid level-Professional. Accessed June 15, 2010.

2. American College of Nurse Practitioners. What is a nurse practitioner? http://www.acnpweb.org/files/pub lic/What_is_a_Nurse_Practitioner.pdf. Accessed November 19, 2010.

3. Allen PJ, Fennie KP, Jalkut MK. Employment characteristics and role functions of recent PNP graduates.

Pediatr Nurs. 2008;34:151-158.

4. Mundinger MO, Kane RL, Lenz ER, et al. Primary care outcomes in patients treated by nurse practitioners or physicians: a randomized trial. JAMA. 2000; 283:59-68.

5. Newland JA. 2006 nurse practitioner salary & practice survey. Nurse Pract. 2006;31:39-43.

6. Pearson L. The Pearson report. Am J Nurse Pract.

2008;12:9-80.

7. Roblin DW, Becker ER, Adams EK, et al. Patient satisfaction with primary care: does type of practitioner matter? Medical Care. 2004;42:579-590.

8. Agosta LJ. Patient satisfaction with nurse practitioner-delivered primary healthcare services. J Am Acad Nurse Pract. 2009;21:610-617.

9. Bauer JC. Nurse practitioners as an underutilized resource for health reform: evidence-based demonstrations of cost-effectiveness. J Am Acad Nurse Pract.

2010;22:228-231.

www.theOncologyNurse.com

TON_September 2011_FINAL_TON 9/13/11 10:06 AM Page 13

Noteworthy Numbers

AYA Oncology By the Numbers

E

ach year, a significant number of adolescents and young adults (AYAs), aged 15 to 39 years, are faced with a cancer diagnosis. And yet, there has been a lack in progress when it comes to treating this age-group. To better understand the facts and figures associated with these patients, let’s take a closer look at AYA oncology by the numbers.

Over the past 30 years, cancer incidence in young adults has increased more than any other age-group…

However, survival rates among AYAs have not improved at the same rate as other age-groups.

Each year 70,000 AYAs aged 15 to 39 years are diagnosed with cancer. This is equivalent to 1 diagnosis every 8 minutes. The incidence of specific cancer types varies dramatically across the AYA age continuum. For example, leukemias, lymphomas, and germ-cell tumors (cancers that begin in cells that give rise to sperm or eggs, such as testicular cancer) are the most common cancer types in younger AYAs… However, by ages 25 through 39, these cancers decline in frequency, whereas other cancers—cervical, colorectal, and particularly breast— comprise a growing share of cancers in older AYAs. Among AYA women, cancer is the most common disease-related cause of death. For AYA men, cancer is the second most common disease-related cause of death. (Heart disease is the most common.)

Among AYAs, only unintentional injury, suicide, and homicide claim more lives than cancer.

There are more than 350,000 long-term childhood cancer survivors in the United States under the age of 40.

One AYA loses his or her fight with cancer approximately every hour.

Among the US college student population, 1 in 100 is a cancer survivor.

Sources: National Cancer Institute; The I’m Too Young For This!

Cancer Foundation.

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MC45038-D-6

04-10

2:29:08 PM

www.TheOncologyNurse.com

SepTember 2011 I VOL 4, NO 6

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Conference News The following articles are based on presentations at the 2011 Annual Meeting of the American Society of Clinical Oncology held June 3-7, in Chicago, Illinois.

Survivorship Care: An Emerging Medical Need Continued from cover to determine the best way to attend to these patients’ long-term needs.

“Patients report feeling abandoned at the end of their cancer treatment, and many complete treatment with persistent problems. Planning for recovery is important!” said Julia Rowland, PhD, of the National Cancer Institute, speaking at a special session on survivorship care.

Rowland cited several “lessons learned” recently about survivors and their need for personalized care: • The posttreatment survivorship phase brings its own set of unique needs and challenges—physical and medical, psychological, social, and existential/spiritual.

• Intervening early, when problems arise, leads to better outcomes.

• For many patients, cancer provides “a teachable moment.”

It is not only healthcare providers who are concerned, but also patients who are asking how they can reduce their risk of cancer recurrence and live healthier lives, she pointed out. It is important for healthcare providers to be prepared to answer their questions, she emphasized.

The Institute of Medicine and President’s Cancer Panel have recommended that survivors receive a summary record that includes important disease characteristics and the treatments received, and that they be provided with a follow-up care plan that incorporates evidence-based standards of care.

“But we have little information as to how this is being done and its impact in real practice,” Rowland said.

Whose Job Is It? A much debated issue is determining which healthcare provider should be in charge of survivorship care: the oncologist or the patient’s primary care physician (PCP). A recent survey suggests the primary care model may not be preferred.

Paul Han, MD, of Maine Medical Research Institute, Scarborough, discussed the early findings of the Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS). One survey was administered to 1100 PCPs and a second one to 1100 oncologists.

“We wanted to examine the attitudes, knowledge, and practices of PCPs and oncologists regarding the care of cancer survivors,” Han said. “We focused on breast and colon cancer survivors, and we looked at how physicians perceived their roles and responsibilities in the care of cancer survivors vis-à-vis one another.

We also looked at how much confidence

14

SepTember 2011 I VOL 4, NO 6

PCPs had low confidence in their knowledge of appropriate surveillance and of the long-term and late effects of cancer treatment. PCPs rated their skills for caring for cancer survivors as low, and oncologists agreed.

they have in one another’s skills and the knowledge that is required to take care of this group of patients.”

The study found, in general, that PCPs had low confidence in their knowledge of appropriate surveillance and of the long-term and late effects of cancer treatment. PCPs rated their skills for caring for cancer survivors as low, and oncologists agreed. “These data could have implications, considering that many groups have argued that we should move toward a system of shared care between PCPs and oncologists, with PCPs demonstrating greater responsibility for cancer survivor care,” Han suggested.

In spite of having received a formal survivorship care plan, the intervention group demonstrated no additional improvement in psychosocial adjustment.

Neither PCPs nor oncologists selected a PCP-led model as the ideal model for survivorship care, he reported.

In addition, although oncologists said they provide treatment summaries or care plans to PCPs most of the time, the PCPs reported they rarely receive these. Oncologists also reported frequent communication with other physicians to clarify their respective roles in follow-up care, but PCPs reported that this communication occurred infrequently. Both specialties tended to overuse surveillance testing, especially PCPs. “We need to explore models where there is greater sharing of care with PCPs, yet these findings show that

PCPs have very low confidence, and oncologists also rate PCPs’ skills and knowledge as very low. It suggests we have a long way to go before physicians are comfortable with the proposed shared-care model,” Han said.

Cost-Effectiveness Not Proven Certainly, survivorship care plans (SCPs) are well-meaning, but do they really improve health outcomes and are they cost-effective?

A research team from Canada concluded that the survivorship care plan adopted by their center had no impact on patient outcomes or adherence to follow-up guidelines and was not a cost-effective use of “scarce healthcare resources.”

In accordance with the Institute of Medicine’s recommendation for providing cancer survivors with formal SCPs, the multicenter study assessed the effect of such a program and its cost-effectiveness.

In a randomized trial, the researchers first evaluated an SCP for breast cancer survivors transitioning to routine follow-up care with their family physician. The study enrolled 408 patients with early-stage breast cancer who had completed treatment at a tertiary cancer center. In the intervention group, 200 patients received an SCP consisting of a treatment summary, a patient’s version of the follow-up guidelines, and brochures and information about local relevant supportive care resources. These were compiled into a binder and reviewed with the patient in a nurse-led 30-minute educational session. The family physicians received a copy of all documents plus the full guideline and a reminder table of recommended follow-up visits and tests.

The control group of 208 patients received a discharge visit and their physicians received a discharge letter, according to usual practice.

The primary outcome was psychosocial adjustment (measured on the Impact of Events Scale; IES) 12 months after intervention. The sec-

ondary outcomes were continuity of care, health-related quality of life (measured on the SF-36 health survey questionnaire), patient satisfaction, and adherence to guidelines. A shortterm study cannot adequately assess clinical outcomes, the investigators pointed out.

In spite of having received a formal SCP, the intervention group demonstrated no additional improvement in psychosocial adjustment or in any of the secondary outcomes studied, reported Eva Grunfeld, MD, of the University of Toronto.

The IES change from baseline was –2.9 points in the intervention group and –1.4 points in the control group, for a difference of 1.6 points that was not significant, she said.

The analysts used data from the trial, derived utility values for the outcomes, and put these together with the costs incurred for each 3-month period from baseline to 24 months after discharge.

Costs included physician visits, diagnostic tests, patient travel costs, lost productivity, and cost of recurrence. In the SCP analysis, costs included the cost of developing and, where necessary, revising the plan, which included labor, administrative support, materials, and postage, totaling approximately $60 per patient.

In the cost-effectiveness analysis, the base cost was $736.23 for the standard of care and $788.63 for the SCP. The analysis was performed from various perspectives, such as the healthcare system perspective, with inclusion and exclusion of lost productivity as measured by a human capital approach, and with exclusion and inclusion of recurrences.

Standard care remained dominant over the SCP when costs and benefits were not discounted, when the analysis adopted the healthcare system perspective, when lost productivity was excluded, and when estimates of the costs were included, according to Doug Coyle, PhD, of the University of Ottawa.

“The results of this study clearly suggest that the SCP adopted was not a cost-effective use of scarce healthcare resources,” Coyle suggested.

“Given the 22,500 new incident cases of breast cancer per year [in Canada], implementation of the SCP to all breast cancer patients would cost in excess of $1.3 million per year with no evidence of improved healthrelated outcomes.” ● Conference News continued on page 16

www.TheOncologyNurse.com

TON_September 2011_FINAL_TON 9/13/11 10:06 AM Page 15

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Conference News

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ASCO ANNUAL MEETING

Docetaxel Injection

Continued from page 14

Optimal Length of Treatment of Non-Hodgkin Lymphoma Debated

For intravenous infusion only.

Initial U.S. Approval: 1996

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

Shift in Clinical Practice Not Yet Confirmed

See full prescribing information for complete boxed warning

By Caroline Helwick

CHICAGO—Several studies addressed key questions in the treatment of non-Hodgkin lymphoma (NHL). One evaluated a shorter, more intense rituximab-based regimen, and another evaluated the benefit of autologous stem-cell transplantation (ASCT) in high-risk patients. The 21-day regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) is still the standard of care for this paient population.

Rituximab revolutionized the care of NHL and is essentially part of the treatment for all patients with this disease, but researchers continue to evaluate various schedules for delivering the drug.

One debate during ASCO 2011 focused on whether the standard 21-day regimen can be shortened to 14 days; however, investigators from the United Kingdom reported no advantage with the 14-day regimen.

This randomized phase 3 trial involved 1080 patients with diffuse large B-cell NHL, all of whom were to receive R-CHOP. The treatment-naïve patients were randomly assigned to receive either 8 cycles of R-CHOP for 21 days or 6 cycles of R-CHOP for 14 days plus granulocyte colony-stimulating factors, succeeded by 2 cycles of single-agent rituximab.

After a median follow-up of 37 months, the rates of overall survival (OS) and progression-free survival (PFS) were similar, as were objective response rates.

No subgroup appeared to derive a greater benefit from accelerated R-CHOP, reported David Cunningham, MD, of the Royal Marsden Hospital, who presented the results for the UK National Cancer Research Institute Lymphoma Clinical Study Group.

Neutropenia and febrile neutropenia were more frequent in patients receiving the 21day regimen, probably because the 14-day group received growth factors, although

CONTRAINDICATIONS • Hypersensitivity to docetaxel or polysorbate 80 (4) • Neutrophil counts of <1500 cells/mm3 (4) WARNINGS AND PRECAUTIONS • Acute myeloid leukemia: In patients who received docetaxel doxorubicin and cyclophosphamide, monitor for delayed myelodysplasia or myeloid leukemia (5.6) • Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe skin toxicity may require dose adjustment (5.7) • Neurologic reactions: Reactions including. paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. (5.8) • Asthenia: Severe asthenia may occur and may require treatment discontinuation. (5.9) • Pregnancy: Fetal harm can occur when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant when receiving Docetaxel Injection (5.10, 8.1)

Photo by © GMG/Silas Crews 2011

ADVERSE REACTIONS Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, myalgia (6) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

David Cunningham, MD

Manufactured by: Hospira Australia Pty., Ltd., Mulgrave, Australia Manufactured by: Zydus Hospira Oncology Private Ltd., Gujarat, India Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA GUJ DRUGS/G/28/1267

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thrombocytopenia was more frequent with R-CHOP-14, probably because of greater dose intensity.

According to Cunningham, the results do not support a shift in clinical practice from R-CHOP-21 to R-CHOP-14.

Transplant Improves Outcomes in HighGrade Aggressive NHL Julie M. Vose, MD, of the University of Nebraska Medical Center, Omaha, discussed the UK trial’s findings and agreed. But she added that in younger patients at high risk for recurrence, R-CHOP-21, followed by autologous transplantation of peripheral stem cells, should be offered as a standard of care.

Photo by © GMG/Silas Crews 2011

• Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m2 (5.1) • Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle (8.6) • Should not be given if neutrophil counts are < 1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia (4) • Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of Docetaxel Injection and administration of appropriate therapy (5.4) • Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 (4) • Severe fluid retention may occur despite dexamethasone (5.5)

Julie M. Vose, MD

This strategy was shown to be effective in the phase 3 intergroup SWOG S9704 trial of 253 patients with NHL that was presented at the meeting by Patrick J. Stiff, MD, of Loyola University Medical Center, Chicago.

ASCT after CHOP-based induction therapy improved PFS in patients who had an aggressive form of the disease, as indicated by their high or high-intermediate International Prognostic Index score.

Patients responding to CHOP, with or without rituximab, had a 2-year PFS rate of 69% with ASCT compared with 56% with the induction therapy alone, which translates to a 72% increase in PFS (P = .005).

The 2-year OS rates were similar between the 2 groups, at 74% and 71%, respectively; however, many patients in the control arm underwent a salvage transplant, which may have confused this analysis, Stiff pointed out.

The survival benefit was most apparent in patients with high International Prognostic Index score; in this subgroup, the 2-year PFS rate was 75% with transplant compared with 41% with standard care, and the 2-year OS rates were 82% and 64%, respectively. ●

www.theOncologyNurse.com

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Conference News

Novel Cancer Therapies in the Pipeline Promising Agents for NSCLC, Ovarian Cancer, Supportive Care

By Caroline Helwick

CHICAGO—The cancer drug pipeline is bursting with promising new therapies for a variety of tumors. Of the many investigational drugs presented, this article highlights some of the most promising agents now in phase 2 or 3 clinical trials.

Cabozantinib This oral inhibitor of MET kinase and the vascular endothelial growth factor (VEGF) receptor produced high rates of disease control in several solid tumor types, and fully or partially eliminated bone metastases in a randomized phase 2 study.

Disease control rates (demonstrated by response rate and stable disease) were 76% in liver cancer, 71% in prostate cancer, 58% in ovarian cancer, 45% in melanoma, 45% in breast cancer, and 40% in non–small-cell lung cancer (NSCLC).

Complete or partial resolution of bone metastases on bone scans was seen in 80% of patients. Several phase 3 trials are being planned.

Iniparib This poly ADP ribose polymerase (PARP) inhibitor, being studied for the treatment of ovarian cancer, showed promise in a phase 2 trial of 41 platinumsensitive patients in the setting of first recurrence. The overall response rate was 65%, and median progression-free survival (PFS) was 9.5 months. In a separate phase 2 study in the second line, the response rate was 25%, and 81% of patients derived clinical benefit.

Ganetespib Another agent investigated for NSCLC, treatment with the heat shock protein 90 inhibitor ganetespib was associated with a disease control rate of 54%. The drug was evaluated for single-agent activity in a phase 2 study of 76 patients with advanced disease, many of whom carried tumor mutations. A phase 2b/3 trial has been initiated for ganetespib in combination with docetaxel.

Semuloparin This experimental anticoagulant (an

ultra-low-molecular-weight heparin) reduced the risk of thromboembolic events by 64% in patients undergoing chemotherapy.

In the phase 3 Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy (SAVEONCO) study of 3212 patients, mostly with metastatic disease, 20 (1.2%) patients who received semuloparin and 55 (3.4%) who received placebo experienced a thromboembolic event (P <.001), with similar rates of bleeding.

Semuloparin is administered 20 mg daily subcutaneously. Based on the results of this trial, its manufacturer, sanofi oncology, will soon submit regulatory filing for semuloparin.

Ruxolitinib A Janus kinase inhibitor, ruxolitinib reduced spleen size in 2 separate phase 3 studies in the treatment of 3 forms of myelofibrosis. The manufacturer, Incyte, filed for marketing approval in June 2011.

Telatinib Two thirds of patients with advanced gastric or gastroesophageal junction cancer responded to a combination of telatinib (a small-molecule inhibitor of VEGF receptors 2 and 3), capecitabine, and cisplatin as first-line therapy in an open-label study of 39 patients.

Cixutumumab This monoclonal antibody that targets the insulin-like growth factor 1 receptor demonstrated in a phase 2 clinical trial that 57% of 113 patients with adipocytic sarcoma experienced stable disease when they received this new therapy.

Axitinib This selective VEGF receptor 1, 2, and 3 inhibitor extended PFS more than sorafenib as second-line therapy for metastatic renal-cell carcinoma.

The median PFS was 6.7 months with axitinib versus 4.7 months with sorafenib. ●

New Standard of Care with Busulfan/Melphalan Regimen for Childhood Neuroblastoma Overall and Event-Free Survival Prolonged

By Wayne Kuznar

CHICAGO—A new regimen of busulfan and melphalan extended eventfree survival over a regimen of carboplatin, etoposide, and melphalan (CEM) in a phase 3 clinical trial of patients with high-risk pediatric neuroblastoma.

The trial was terminated early after the superiority of the busulfan/melphalan myeloablative regimen became evident, said lead investigator Ruth Ladenstein, MD, associate professor of pediatrics, University of Vienna, and St. Anna Children’s Cancer Research Institute, Vienna.

The standard practice now should be the busulfan/melphalan combination for children with high-risk disease in whom the long-term survival rate was <40% before this regimen.

“The study’s results are important for patients with this extremely difficult-totreat disease,” said Ladenstein. “These results, combined with the recent report that an anti-GD2 ch14.18 antibodybased immune therapy can increase

www.TheOncologyNurse.com

“We overcome the 50% threshold in survival rates by choosing the right high-dose myeloablative regimen for these patients.”

—Ruth Ladenstein, MD

event-free and overall survival by 20% in high-risk patients, mean that we could potentially improve overall prognosis by up to 35%. We overcome the 50% threshold in survival rates by choosing the right high-dose myeloablative regimen for these patients.”

Neuroblastoma is the most common extracranial solid tumor in children and accounts for 15% of all childhood cancer deaths. Approximately 50% of children with neuroblastoma have high-risk characteristics, including widespread dissemination, age >18 months, and amplification of the MYCN oncogene.

The study included 563 patients (median age, 3 years) with stage IV, high-risk disease with distant metastases or local disease with MYCN oncogene amplification.

All patients received a rapid induction regimen known as COJEC (cisplatin, vincristine, carboplatin, etoposide, and cyclophosphamide). They then were randomized to oral busulfan/melphalan or the CEM regimen.

Local therapy included surgery and radiotherapy.

After a median follow-up of 3.5 years, the event-free survival rate was

49% in the busulfan/melphalan group compared with 33% in the CEM group. Randomization was stopped early at an interim analysis.

The busulfan/melphalan advantage on the primary end point was consistent across all disease stages and appeared to be most effective in patients with residual disease.

The 3-year overall survival was 60% with busulfan/melphalan versus 48% with CEM without immunotherapy.

The busulfan/melphalan group had a lower relapse rate and progression (47%) than the CEM group (60%).

The overall toxicity profile was significantly lower with busulfan/melphalan, despite some exceptions.

One possible explanation for the superior results observed with busulfan/melphalan in this study is that the rapid COJEC induction regimen used could have had a negative interaction with CEM, said Julie R. Park, MD, associate professor of pediatrics, University of Washington, Seattle. ●

SepTember 2011 I VOL 4, NO 6

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Reader Survey

What inspired you to become a hematology/oncology nurse, or physician assistant?

T

he Oncology Nurse-APN/PA recently asked its online reading community to share their inspiration for entering the oncology field.

The response was overwhelming. It is abundantly clear that those involved in the field are passionate, caring, and extremely optimistic. Repeatedly responses highlighted a single person who inspired a career choice and a desire to help those living with cancer.

On behalf of all of us at The Oncology Nurse-APN/PA, thank you for all you do to help your patients. Below, we share with you excerpts from several of the responses.

The Patients. I am and continue to be amazed by the strength and courage of my patients. Every day I am rewarded with stories of their lives, and I realize it is more and more about living with rather than dying from cancer.

Pamela G. Lincoln, Vermont In February 1992, my mother was diagnosed with a brain tumor. She died 4 months later. I was working in a large academic center in the internal medicine clinic and was asked by the cancer center nurse manager if I wanted to work in their clinic. I felt drawn to the cancer center because of my mother’s illness and felt as if I could truly connect with these brave patients and their families.

Catherine B. Vienna, Virginia In the mid-1980s, my mother-in-law was diagnosed with rectosigmoid colon cancer. After surgery, she had chemoradiation. Around the same time, the hospital where I worked was building a cancer center. I applied for a position as a chemotherapy-certified nurse to work in the radiation department. After 40 years of nursing, the courage I see every day in our patients continues to be an inspiration to me!

Vicki D. Fort Worth, Texas A coworker once stated: “The nicest people get cancer.” I have found this to

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be true. I have learned as much from my cancer patients about love, life, courage, and laughter as I have from anyone else who has touched my life.

Julie H. Marshall, Michigan

nothing else they could do for him. He died January 28, three months after his third birthday. I was naturally devastated as was my whole family. I was working as a teller at a bank. I could not bring myself to go back to work. I kept

When I changed jobs, a position was available on the oncology unit. I knew this was my chance to learn how to help people through their cancer experience.

Maureen B., Crofton, Maryland

When I went to apply for my first position as an RN, the nursing recruiter asked me what patient population touched me the most and I immediately answered, “the cancer patients.” I started my first job as an RN as the first new grad on a bone marrow transplant unit and have never looked back. I love working in oncology and firmly believe that there is something special about cancer patients that all touch my heart and soul.

Deborah L. Seattle, Washington I was blessed with 5 children. My youngest was a boy named Larry. A month after his second birthday he was diagnosed with leukemia and was hospitalized for induction chemotherapy.

He went into remission for 3 months.

When he relapsed, we were told that the only way he could survive was a bone marrow transplant. None of his 4 siblings were a match, so we did autologous bone marrow transplant. He spent 3 months in Texas Children’s Hospital in Houston. In December, he relapsed again and we were told that there was

thinking about the oncology nurses who took care of my son. I decided that I wanted to go back to school and become a nurse. So at the age of 42, I enrolled in college and got an associate’s degree in nursing. I worked 2 years in medical surgery then transferred to oncology. I retired May 31 of this year after 18 years of working in the outpatient chemotherapy unit.

Losing my precious 3-year-old son to cancer inspired me to become an oncology nurse.

Lucinda F. Las Vegas, Nevada When I was in college, my best friend was getting married. Her fiancé, diagnosed with colon cancer, wanted to marry her before he passed away. They married 3 days before he died. I was inspired by his spirit.

Laurin C. New Boston, New Hampshire It was 1986, and I was working at The Jewish Hospital in Cincinnati, Ohio, as a nursing technician while in The Jewish Hospital School of Nursing.

The unit I worked on became more “specialized” by being designated the oncology unit. At the same time, my mother was diagnosed with cancer. My mother’s battle with head and neck cancer made me a better nurse. I lost Mumsy 2 years ago, and I know I made her proud that I became an Oncology Certified Nurse. But SHE was my inspiration every day.

Gail D. Cincinnati, Ohio While working as a hospice nurse, the patients I cared for at the end of their lives inspired me to make a difference for patients that are actively being treated. So I reversed my role from end-of-life care to pursue oncology nursing.

Eileen D. New Haven, Connecticut Every patient I have met has added an element of substance to my life.

Even when they lose their fight, I benefit from helping them be all they can be while they are alive. I have met excellent nurses who inspire and humble me with their devotion to their patients.

S. Gayle M. Phoenix, Arizona I started my nursing career in a skilled nursing facility that took in patients with hospice care, if they had cancer. I had to research how to care for cancer patients, finding very little information available then. When I changed jobs, a position was available on the oncology unit. I knew this was my chance to learn how to help people through their cancer experience. I have not regretted working with oncology patients for the past 24 years.

Maureen B. Crofton, Maryland I floated to an oncology floor. I was with an oncology nurse when she was helping a young woman dying of cancer. The woman was telling her about her dying wishes. I was so taken by the way this nurse put her own feelings aside and helped this patient. When I started on the oncology floor, she was my mentor.

www.theOncologyNurse.com

TON_September 2011_FINAL_TON 9/14/11 2:23 PM Page 19

Reader Survey

©iStockphoto.com/Catherine Yeulet

Every patient I have met has added an element of substance to my life.

S. Gayle M., Phoenix, Arizona

I credit her with all that I have learned.

Theresa W. Wilkes-Barre, Pennsylvania My father was diagnosed with nonHodgkin lymphoma when I was in nursing school. I was so impressed by the way he was taken care of by the nurses. They really seemed to care about their patients and gave from their hearts. I wanted to be able to let oncology patients and their family members feel loved like we did.

Lisa G. Frankfort, Illinois I performed IV therapy for many years, giving chemotherapy and getting close to our patients with cancer. I think my real inspiration came with the diagnosis of pleural mesothelioma in a dear friend from back home in 1986, and her untimely death 6 months later.

The realization that cancer took her life stimulated me to do more for my patients. A move to a new city and hospital a few years later resulted in my working on an oncology unit, getting my certification and, most of all, giving patient care to all those assigned to me.

Nancy L. Cedar Park, Texas

www.TheOncologyNurse.com

It was after I experienced breast cancer that it was clear that in my role and with my story I could offer hope and credibility to support others on their breast cancer journey.

Marsha S. Flint, Michigan As a high school freshman, my older sister was diagnosed with stage IIIB Hodgkin lymphoma. She achieved remission and survived her disease.

Watching the human connection between the oncology nurse and my sister and mother inspired me. Over 20 years later, they still exchange Christmas cards. Seeing the miracle of that bond firsthand changed my plans forever. I knew this was my calling.

Erin T. Lone Jack, Missouri I realize that my patients have become my teachers...teachers on life and what really matters. I’ve learned how to LISTEN; I’ve learned the importance of having (and how to have) conversations about things that truly matter; I’ve learned to prioritize my life, to take care of my personal relationships in order to perhaps minimize the regrets and the need for reconciliations; I’ve

learned how to be thankful for the small things. Our patients repeatedly tell us how much we do for them, how much we mean to them, but the secret to how we oncology nurses can do what we do lies in what our patients leave with us. We receive their gifts of grace and humility and apply them to others we serve. It is a circle of love.

Robin A. Newport News, Virginia In 1990 I was a new nurse working on a women’s surgical unit. One evening I came on the 3:00 to 11:00 shift and one of my patients was a 30year-old who had come in through the emergency department with severe abdominal pain. Exploratory abdominal surgery found ovarian cancer, and she had been started on her first dose of cisplatin that afternoon. She had not had any chemotherapy teaching, and she was scared to death. I did not know much about chemotherapy and its side effects at that point, so I spent a few days educating myself and the patient and finding her literature to take home. I decided at that point to learn all I could about cancer, chemotherapy, and side effect management to prevent another patient from being started on a treatment without

the proper education. I eventually went back to school to become an Oncology Clinical Nurse Specialist and have loved it ever since.

Belinda R. Newport News, Virginia

Our most sincere gratitude to all who participated in this survey.

Want to Participate Next Month?

See page 12 for details www.TheOncologyNurse.com

SepTember 2011 I VOL 4, NO 6

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The Whole Patient Josh and Friends... Continued from cover When Lange’s 9-year-old daughter’s surgery at the local children’s hospital drew near, he recognized a familiar frightened, anxious gaze. It was the same fearful look that oftentimes was displayed by pets and their owners at the Lange Animal Hospital.

To better deal with his daughter Jessica’s questions and trepidation about surgery, Lange sought literature and other established means to help ease her growing distress. After reviewing the existing literature to help prepare children for the hospital, he determined that none actually dealt with the realities a child faces when going into the hospital. Lange had witnessed many times the incredible power of the human–animal bond in helping families deal with crises. It was that connection that would provide the foundation for Josh and Friends.

While visiting Jessica in the hospital, Lange could not help but notice the number of children alone in their rooms. It was then he first learned of the term “drop-offs.” Whether the circumstance was a single parent with more than 1 child or a parent with multiple jobs, the resulting byproduct was a child feeling fearful and isolated.

Vowing to create something affirmative, uplifting, and that thematically embraced the spirit of overcoming adversity, Lange wrote the book I’ll Be O.K. The story is about Josh, a fun-loving golden retriever puppy that goes to Dr Rick’s animal hospital because he is

The book shares the positive, reinforcing message of I’ll Be O.K. throughout, and encourages children to believe in and trust the doctors, nurses, and hospital staff who are charged with their hospital care.

sick. The narrative and illustrations depict Josh’s adventure in getting well.

The story chronicles the different stages Josh experiences going into the hospital, including the fear and anxiety felt prior to diagnostic tests or surgical procedures, the feeling of hopelessness (and sometimes helplessness) when an injury or illness suddenly forces itself into Josh’s (or, a child’s) life and, quite simply, the fear of the unknown. It is that fear that can have a negative impact on the eventual outcome of a child’s hospital stay. The book shares the positive, reinforcing message of I’ll Be O.K. throughout, and encourages children to believe in and trust the doctors, nurses, and hospital staff who are charged with their hospital care. Like Josh, child readers gain courage to get well sooner.

I’ll Be O.K. is paired with a plush version of Josh that provides a tactile, huggable component. The book and plush puppy combine to form the I’ll Be O.K. Gift Set—a therapy tool. The

plush Josh has weighted paws and appropriate size to have a real substantive presence. Josh becomes a constant physical companion throughout the child’s hospital stay and medical recovery. Unlike a therapy dog in the traditional sense, Josh is more akin to, and symbolic of, the unconditional love, comfort, and devotion provided by a family pet.

Melson and Fine report that children very often respond well to animal puppets and plush toys.1 Analytically, the play experience can be very revealing into a child’s unconscious behavior.

Children seem to respond more calmly and appear more willing to express their inner feelings by interacting with the toy animal. Many play therapists commonly use puppets as a method to help children explore their feelings by allowing them to act them out. That being said, it seems only logical that children with chronic health problems would feel safe talking through a friendly-looking animal and may use

Children gather around Josh at Loma Linda University Children’s Hospital. The event included children and families helped

by Josh, medical professionals, fundraisers (civic groups, veterinary students, medical students), educators, and the Josh and Friends team.

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the play experience to support his or her healing.1 The bond between a child and Josh is best illustrated by a little boy in southern California, by the name of Michael. Diagnosed at the age of 3 with neuroblastoma, now in remission, Michael faced numerous treatments with Josh by his side. During a gathering of Josh and Friends constituents that included child patients, families, fundraisers, medical professionals, and the Josh and Friends team, Michael’s mother emotionally described how his Josh was “God-sent” and how Michael and Josh went through all of his procedures together. Michael’s intravenous port was mirrored by Josh’s, as were his surgical scars, bandages, and identification bracelet. They wore masks together, got shots together, and also overcame the embarrassing time when they had to wear a diaper. To Michael, Josh became a companion and best friend.

During Michael’s crime-fighting MakeA-Wish experience, Josh was Robin to Michael’s Batman.

Sharon Riesen, MD, head of the re sidency program at Loma Linda Children’s Hospital in California, calls the gift set her “mind–body medicine tool.” She adds that when presented properly, Josh’s story in I’ll Be O.K. and the plush version of Josh can be “concretely linked in the child’s mind such that the plush Josh becomes a living, breathing thing…a companion.” To Riesen, there is a difference between just a toy and a therapeutic tool: Although a stuffed animal, in itself, is oftentimes used successfully to provide a degree of comfort to a sick child, the set—Josh plush and I’ll Be O.K.—becomes a therapeutic collaborator, the child’s unwavering partner in facing fears…transferring the idea that if Josh can get through his medical procedure, then so can the child. It is for that reason that Josh and Friends does not distribute the plush Josh independent of the book.

The Josh and Friends Project would not be complete without a real-life main character, Josh. Lange’s beautiful, red bandana–clad canine is the third golden retriever Josh to represent Josh and Friends. Josh is the embodiment of all the best characteristics of the breed. He has become a hit at pediatric and veterinarian conferences across the United States. The familiar “There’s Josh,” is repeatedly heard at American Academy of Pediatrics, National Association of Pediatric Nurse Practitioners, and American Veterinary Medical Association (AVMA) gatherings. This amazing dog personifies the loving and supportive Josh puppy in I’ll Be O.K. Over the years, the Josh and Friends Project has gained overwhelming support

www.TheOncologyNurse.com

TON_September 2011_FINAL_TON 9/13/11 10:07 AM Page 21

Need a reason to choose Evercare™ Hospice and Palliative Care?

How about seven?

Within our power, we are committed to providing the best hospice and palliative care experience available. That commitment is expressed in our Seven Point Pledge.

4. Respond to all patient-related calls within 15 minutes, 24 hours a day, 7 days a week. A patient’s condition doesn’t take a day off, and neither do we.

Evercare Hospice & Palliative Care pledges to:

5. Provide a hospice staff presence at the time of death. We’ll be there at this important time, as we have throughout the process, to provide comfort and support.

1. Admit all hospice-eligible referrals the same day, unless requested otherwise. Patients deserve timely care and action, especially as they approach end-of-life.

2. Provide direct, extensive physician involvement in the care of each patient. Experts highly trained in hospice and palliative care are involved and available to make personal visits.

3. Achieve acceptable pain control on all patients.

No patient should live in pain. That’s why we place such an emphasis on delivering pain management in a timely and caring manner.

6. Maintain an Unrestricted Options Philosophy regarding patient admissions. We believe in making hospice care available to all those who are eligible.

7. Offer palliative care consults and advanced care planning services. These continuing health care services are important, so we offer expertise in both areas.

Questions?

For questions or referrals, call Evercare Hospice and Palliative Care at:

1-877-273-5534 www.EvercareHospice.com Services are provided regardless of patient’s ability to pay.

Evercare™ Hospice and Palliative Care is committed to the policy that all persons shall have equal access to its programs, facilities, and employment without regards to race, sex, religion, color, age, national origin, disability, sexual orientation or other protected factor. Evercare Hospice and Palliative Care is offered by Evercare Hospice, Inc. © 2011 Evercare

TON_September 2011_FINAL_TON 9/14/11 11:33 AM Page 22

A child meets Josh skin to fur at the annual American Veterinary Medical Association convention.

Josh and the message of I’ll Be O.K. provide comfort to a child at J.N. France General Hospital.

from the pediatric community (hospitals, hospital foundations, private practices), veterinarians and veterinary organizations (AVMA, Student AVMA), civic

groups (the American Legion Family [Legionnaires, Sons of the American Legion, and Auxiliary], Kiwanis, Sertoma), and others.

For the past 8 years, veterinary schools from around the country have competed in the Josh Challenge.

Through various student-initiated

Courtesy of Paul Orchard, Ross University.

The Whole Patient fundraisers, these future veterinarians have raised money to purchase Josh and Friends Gift Sets to distribute directly to sick children in their local area. The challenge engages students in helping children through the use of the human–animal bond.

Lange’s daughter, Jessica, the catalyst and inspiration for Josh and Friends, is now in her first year of a medical residency in Winston-Salem, North Carolina, at Wake Forest University’s Baptist Medical Center.

Lange’s resolve to help provide comfort to children is as strong as it has ever been. The Josh and Friends Project looks to the next 15 years with the spirited enthusiasm of our namesake golden retriever, Josh.

For further information about the Josh and Friends Project: visit www. joshandfriends.com or look for Josh and Friends on Facebook. ● Reference 1. Melson GF, Fine AH. Animals in the lives of children. In: Fine AH, ed. Handbook on Animal-Assisted Therapy: Theoretical Foundations and Guidelines for Practice. San Diego, CA: Elsevier Press; 2010:223-247.

Josh and Friends in the Community

W

hen I first met Dr Lange and Josh at one of the exhibit booths during an American Academy of Pediatrics meeting in 2008, it was “love at first sight.” From the moment I became familiar with Josh and Friends, I knew that Josh had the capacity to be an incredible tool for healing through the power of mind–body medicine. My challenge was to figure out how to implement a program at Loma Linda University Children’s Hospital (LLUCH) where Josh could be used appropriately to help comfort and heal our pediatric patients.

LLUCH is a unique hospital environment where “whole person care” is part of our motto and openly embraced, so it was the perfect place to find the support I needed. It would take collaboration with multiple organizations, including volunteer services, Child Life Council, Western University College of Veterinary Medicine, University of California at Riverside, and our local American Legion post. Everyone was excited when they heard about the potential for Josh to help our LLUCH patients. With collaboration like this, it is no wonder that our experience with Josh and Friends at LLUCH has been amazing. We have now had more than $70,000 donated to our Josh Project and countless hours donated from volunteers.

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As a behavioral-developmental pediatrician, I knew that our best results with Josh would likely come from children aged between 3 to 8 years.

Younger children would not grasp the concept that Josh was sick just like them and got better with the help of the hospital. Older children would merely see the Josh puppy as a stuffed inanimate toy and not believe in the “magic of Josh.” I firmly believe that the success of our Josh program at LLUCH has been our focus on the correct presentation of the story I’ll Be O.K. with the Josh companion puppy given to the appropriately aged child.

Our volunteers are trained specially to deliver the Josh plush puppy and tell the story I’ll Be O.K. in a way that makes Josh come alive as a “therapeutic tool,” which helps each child feel comforted and promotes his or her healing process. We have taught our volunteers to modify the I’ll Be O.K. story so that they can quickly tell the story in 5 minutes or less, using the pictures in the book without necessarily reading every word. This was especially helpful for our young, very sick patients with short attention spans.

At LLUCH we have found that Josh and his story can do amazing things; however, if Josh is not appropriately presented then the plush puppy merely becomes another toy, not the therapeu-

tic tool it has the capacity to be. For this reason, patients at LLUCH are only given a Josh and Friends Gift Set when a trained volunteer or child life specialist can present the set personally. I am excited that Josh and Friends is in the process of developing teaching tools for hospitals, volunteers, and parents so that they can better use Josh to help children everywhere. There is no question in my mind that Josh has the power to comfort, but more importantly Josh has the ability to facilitate the healing process.

—Sharon Riesen, MD Loma Linda University Children’s Hospital

W

e had our first ever “Josh Day” on May 20 at the University of California Davis Children’s Hospital. Ten veterinary student volunteers passed out Josh dogs to the kids, read Josh’s story, and then helped the kids “take their Josh dogs to the vet” by playing with lots of medical supplies that Child Life Council staff provided for them, such as bandages, ECG leads, face masks, etc.

There also were 2 therapy dogs in attendance at our “Josh Day,” a collie named Jordi and a golden retriever named Cayenne. The kids got to listen

to the dogs’ hearts and check pupillary light reflexes with pen lights (which they absolutely loved). Several of the kids commented to me that they were surprised that a veterinary exam of a dog is so similar to what happens to them whenever they are examined by their own doctors. We also brought along some veterinary radiographs and had the kids help us interpret them, such as a pregnant dog with puppies, a broken leg, and a radiograph of a bird. This was especially good for some of the older patients who, by the end of the session, were confident in pointing out some of the anatomy on the radiographs, such as the animal’s spine and legs and started making diagnoses on their own.

All in all, everyone involved had an amazing time. This event truly showcased the human–animal bond at its best. My Josh Project volunteers simply could not stop talking about their experiences with the kids after we finished. Child Life Council staff at the hospital were very happy with the way the event turned out, and have invited us to come back to do further events as often as we are able.

—Brittany Stevens Student American Veterinary Medical Association Josh Project Coordinator University of California Davis School of Veterinary Medicine

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CONTINUING EDUCATION PROGRAM CE25 • RELEASE DATE: SEPTEMBER 16, 2011 • EXPIRATION DATE: SEPTEMBER 15, 2012 ESTIMATED TIME TO COMPLETE: 1.0 HOUR • COMPLETE THE POSTTEST AT WWW.THEONCOLOGYNURSE.COM

Cancer and the Workplace

By Carolyn Messner, DSW, MSW, LCSW-R, BCD Director of Education and Training, CancerCare, New York, New York Tatiana Vera Prep for Prep—Prep 9, Freshman, Barnard College, New York, New York

STATEMENT OF NEED Despite a number of laws protecting the rights of employees with cancer and their caregivers in the workplace, numerous obstacles confront anyone continuing to work during treatments or reentering the workplace after active cancer treatments. Sadness, anxiety, fear, uncertainty, shame, and other emotional concerns may arise. Psychosocial support and guidance in coping is critically important at this time. To assist these patients, healthcare professionals should not only acquaint themselves with the laws but also work to identify those in need of support and to develop and implement outreach programs and services to meet their needs— before, during, and after treatment.

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: • Identify provisions of legal protections relating to cancer and the workplace • Describe challenges specific to young adults with cancer

S

ignificant progress in the treatment of cancer, coupled with early detection, has led to meaningful improvement in survival and quality of life. Novel symptom and pain-control interventions have made it possible for more patients with cancer to continue to work while receiving chemotherapy and radiation therapy, as well as biologic, hormonal, and targeted agents. In addition, the trend of delivering cancer treatments in the outpatient setting, as opposed to inpatient hospital stays, has reduced time away from work during treatments. For many, personalized medicine and oral agents for the treatment of cancer have normalized further the cancer treatment experience.

Today’s cancer care paradigm has led to new challenges regarding cancer and the workplace. Despite a number of laws protecting the rights of employees with cancer and their caregivers in the workplace, numerous obstacles confront anyone continuing to work during treatments or reentering the workplace after active cancer treatments.

Many myths about cancer abound in our society, and also in the workplace.

Employers, supervisors, and coworkers may assume that patients with cancer will not be able to perform job responsi-

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bilities after cancer as they did before the cancer diagnosis. They also may perceive these individuals or their caregivers as a poor risk for promotion. Any or all of these attitudes may lead to subtle or blatant workplace discrimination.

In spite of the progress in the treatment of cancer, it is important to note that, for some, return to work may not be a feasible option. They might not be able to sustain a workday combined with their commute.1 The Meaning of Work “[Work] is about a search, too, for daily meaning as well as daily bread, for recognition as well as cash....”

—Studs Terkel Working: People Talk About What They Do All Day and How They Feel About How They Do It

There are a number of reasons to continue or return to work: independence, identity, economic necessity, health insurance, social support, sense of purpose, satisfaction from work, and productivity. Many cancer patients and survivors appreciate the distraction work offers from thinking about cancer. Most adults spend more than half of their waking hours in the workplace. Returning to work during or after cancer treatments restores an important sense of self apart from the disease—something that may have been lost while not working. Continuing to work may be emotionally, socially, and cognitively helpful to patients during and after treatment.

When a person living with cancer returns to work, deciding to tell an employer about his or her condition is a personal decision. Some workplace legal protections, however, require disclosure to human resources or one’s supervisor to benefit from these laws.

Thanks to new laws put into place in the past few decades, this information remains confidential.

Key Legal Protections The Americans with Disabilities Act (ADA). Enacted in 1990 by Congress, the ADA took effect in 1992. This national mandate eliminates discrimination against individuals with disabili-

ties. Organizations with 15 or more employees must comply with ADA guidelines. Patients with cancer are protected under the ADA if the following criteria are met2: • Classified as a “disabled person” under ADA • Qualified for the job • Able to perform the essential functions of the job • The employer has provided a reasonable accommodation; and this accommodation will not cause “undue hardship” to the employer • The patient does not pose a direct threat to his or her own or others’ health or safety.

The most frequent workplace accommodation required by patients with cancer is flexibility in their work hours.

They may need to leave early or come in late because of scheduled radiation or chemotherapy appointments. If flextime is required, it is critical the patient request a workplace accommodation by disclosing to his or her supervisor or human resources personnel the cancer diagnosis, so the flextime comes under the protection of the ADA.2 If no reason is given for a request of flex-

time, the employer could document time and leave problems, which could jeopardize job security.

The ADA protects people living with cancer and cancer survivors when they apply for a job. The ADA prohibits an employer from asking any questions regarding health history or current medical status during job interviews or any time before an offer is made. Patients living with cancer, as well as survivors, are not required to share their health history with prospective employers.

After a position is offered, however, if the company requires all employees to undergo a physical examination or drug testing, then it is prudent for the patient with cancer to provide full disclosure to the medical personnel conducting the examination.2 The Family and Medical Leave Act (FMLA). Enacted in 1993, the FMLA enables both patients with cancer and their family members to take an unpaid leave for health challenges that make them unable to perform their job functions. A person may take up to 12 weeks of unpaid leave within 1 year. The employer is required to

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.

vant 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.

METHOD OF PARTICIPATION

Disclosures are as follows: • Rosemary Hansen has nothing to disclose.

• Dawn Lagrosa has nothing to disclose.

• Carolyn Messner, DSW, MSW, LCSW-R, BCD, has nothing to disclose.

• Kristen Olafson has nothing to disclose.

• Kristin Siyahian has nothing to disclose.

• Tatiana Vera has nothing to disclose.

The staff of Science Care have nothing to disclose.

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 rele-

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.

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continue health benefits during FMLA leave. The FMLA applies to organizations with 50 or more employees, and the employee must have worked with his or her employer for at least 1 year, in which he or she has worked for 1250 hours (about 25 hours per week).3 The 12-week leave does not have to be taken all at once. Intermittent FMLA allows the employee to take time in blocks, such as several hours a day or 1 hour at a time. The FMLA also allows the employee to use accrued paid annual leave or accrued sick leave during family or medical leave. It is important to realize that the employer is not required to reinstate an employee who takes more than 12 weeks’ leave in a year. In addition, to be defined as “family members,” the employee must be either a parent (including parents of young and/or adult children), a child (including adult children), or a spouse. The employer may request a medical certification by a doctor or other healthcare provider.3 The Equal Employment Opportunity Commission (EEOC). This federal agency was created to address the needs of citizens who have been discriminated against in the workplace.

An employee who feels that there is subtle or blatant discrimination in the workplace should contact the EEOC directly before retaining a lawyer. This underused public resource is the federal enforcer of the ADA and FMLA. The EEOC will investigate any allegations against an employer or perceived discrimination or inappropriate behavior and policies. EEOC staff is helpful for people currently working, as well as for those seeking employment, who have questions about the job interview process and preoffer phase of work reentry. A charge must be filed with the EEOC within 180 days of the discrimination. The EEOC is invaluable in assisting with workplace complaints.

Knowing that they have the backing of the EEOC can provide strength to patients with cancer who are either reentering the workforce or who are in the workforce.4 The Health Insurance Portability and Accountability Act (HIPAA) of 1996. HIPAA ensures privacy of patient medical information. It protects medical diagnoses and/or treatment by limiting those who have access to the patient’s health records and by requiring the patient’s consent to share such information. It also protects the rights of people when they are part of group health plans and gives the option of bringing the patient’s health insurance to another job in the future.5

www.theOncologyNurse.com

The Genetic Information Nondiscrimination Act (GINA) of 2008.

This act prohibits discrimination based on genetic information, with respect to employment opportunities and health insurance companies. Therefore, if a patient is looking for new employment, his or her cancer or disease risk and/or family history of disease cannot be a reason for an employer to not hire.6

Knowing that they have the backing of the EEOC can provide strength to patients with cancer who are either reentering the workforce or who are in the workforce.

Psychosocial Aspects of Returning to the Workplace Cancer not only takes a toll on patients’ and survivors’ physical well-being, but also impacts their psychosocial outlook.

Sadness, anxiety, fear, uncertainty, shame, and other emotional concerns may arise. Psychosocial support and guidance in coping is critically important at this time.7 In surveying 421 cancer experts, Greenfield and colleagues found that many correlated the receipt of information on cancer’s late effects as a potential barrier for follow-up doctor visits.

Many also believed that such information potentially could increase patient anxiety.8 In addition, Carlson and colleagues assessed 3095 representative cancer patients over 4 weeks with the Brief Symptom Inventory-18, a common psychosocial problem checklist, and their awareness and use of psychosocial support services. They found that almost half of all patients who were distraught did not seek professional psychosocial support, nor did they intend to do so in the future.9 Informed and evidencebased practice, however, recommends that patients should be encouraged to seek psychosocial support during and after cancer treatments.7 The interdisciplinary healthcare team, therefore, should work hard to identify those in need of support and to develop and implement outreach programs and services to meet their needs.10 To help in this effort, Manicom described psychosocial challenges facing patients and their families along each step of the cancer journey.11 Whereas many clinicians are aware that, on diagnosis, many patients confront their mortality and experience overwhelming emotions, they may need to be remind-

ed that psychosocial challenges also are present at other stages of the continuum. For example, on ending treatment, patients may need to cope with a withdrawal of support from family and friends and adjust to a “new normal” that requires managing possible ongoing physical limitations. In addition, on terminal illness, patients will need to face the disappointment of stopping active treatment and moving to supportive care as well as plan for those who will be left behind.11 Young Adults with Cancer and the Workplace Young adults have unique priorities and psychosocial concerns related to their age and life-cycle developmental challenges. They experience particular lifecycle issues as they deal with the sequelae of cancer.12 Young adults may be entering the workforce for the first time as well as trying to figure out and plan the future direction of their career and life choices. Their specific psychosocial challenges focus on establishing independence, dating and romantic relationships, discovering the impact of cancer treatments on fertility and body image, seeking to establish their personal identity, choosing a career, deciding whether to continue school, and obtaining health insurance.12 More than one-third of cancer survivors are young adults.7 Yet, peer support may not be at its peak for young adults, who

tO receiVe credit, cOmpLete the pOStteSt at TheOncologyNurse.com

may be more focused on enhancing their education, starting a career, or handling the psychosocial challenges previously identified.

These developmental challenges may cause young adult cancer patients to experience significant isolation from peers as well as biological changes from their cancer and its treatments.12 Clinical trial data often are based on older cancer patients; therefore, treatment side effects and the impact of treatments on loss of muscle mass or changes in metabolic rate may impact young adults differently and require further study (A. Eckhard, oral communication, 2011). Fortunately, in the United States and in developed countries globally, there is increased interest in the needs of young adult cancer patients and survivors. There is a proliferation of support groups for young adults as well as specialized cancer centers conducting research focused on young adults and cancer. In spite of this progress, the unique issues young adults confront may leave them with more dif-

Table Tips for Returning to Work 1. Ask about follow-up care. If necessary, make sure you have a plan with your doctor, nurse, and/or social worker about any concerns regarding physical, emotional, or practical issues you may have. It is critically important that the medical team knows exactly what each patient’s job entails. This information helps in scheduling doctor visits and their impact on time out of the office, work projects, or work flow.

2. Set up an interview with the human resource department and/or manager to discuss your needs. It is always helpful to have a simple note from your treating oncologist to document any accommodations required. This can include flexible work schedule and necessary accommodations. Human resources and/or your manager can set up a plan to reasonably accommodate your requests.

3. Once back to work, move at your own pace. It is essential for your physical and emotional well-being that you do not try to place too many tasks on your plate. Scheduling periodic 10- to 15-minute breaks can help ease stress and the process of returning to work. Along with this, you must remember to…

4. Diminish as many unnecessary stresses as possible. With this, it is important be able to say “no” to tasks that are not imperative. This is so you do not become overburdened. Stress can be eased in a multitude of other ways too, from eating a well-balanced diet to going out for a walk.

5. Most importantly, stay true to yourself. If you are naturally open, feel free to tell your coworkers how you are doing and, if you need their help, let them know what they can do to help. If you are more private, just tell everyone that you are glad to be back at work, appreciate their asking, and thank them for their interest. This approach will help protect your privacy during this time.

Source: Cancer and Careers. Your mindset. www.cancerandcareers.org/en/at-work/Your-Mindset. Accessed August 29, 2011.

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CONTINUING EDUCATION ficulties when pursuing employment because of their lack of experience and knowledge of their legal protections and/or their many psychosocial concerns. These may put young adults at a competitive disadvantage in the labor market, especially if cancer has caused a noticeable physical disability or a perceived difference in the self-image of a young adult.7 Young adult survivors need opportunities to learn about the laws that protect them against discrimination as well as their rights for workplace accommodations due to cancer, its treatment, or long-term side effects. If a young adult is undergoing treatment and wants to continue working for financial or other reasons, legal protections exist to protect his or her job as long as he or she is able to perform the essential functions of the job.

There is no “right” way to cope with

Young adult survivors need opportunities to learn about the laws that protect them against discrimination as well as their rights for workplace accommodations due to cancer, its treatment, or long-term side effects.

cancer. Every individual is different and responds to psychosocial life crises in his or her own way. There are increasing numbers of young adults living with cancer, and survivors are using psychosocial and practical support services to cope with their cancer experience and journey. To help, Cancer and Careers, an organization that helps

Selected Resources for Cancer Patients and Survivors in the Workplace American Cancer Society www.cancer.org 800.227.2345 Americans with Disabilities Act www.ada.gov 800.514.0301

empower and educate people with cancer to thrive in their workplace, has devised tips for cancer patients and survivors looking to return to work (Table).

Financial Resources Unfortunately, many young adults do not have health insurance. In addition, their cancer may be diagnosed at a later stage because of their age. If not able to work, there are resources for financial assistance. They should start looking for this financial aid with the Social Security Administration. Supplemental Security Income (SSI) is what most young adults will receive if they have not worked enough quarters to qualify for Social Security.13 Older adults may apply for retirement benefits from their workplace, private insurance, or investments. Those who have worked adequate quarters can apply for Social Security Disability benefits.

Cancer and Careers www.cancerandcareers.org CancerCare www.cancercare.org 800.813.HOPE (4673) Equal Employment Opportunity Commission www.eeoc.gov 800.669.4000 I’m Too Young for This Cancer Foundation www.i2y.org or www.stupidcancer.com 877.735.4673 Intercultural Cancer Council www.iccnetwork.org 713.798.4614 LIVESTRONG www.livestrong.org 866.673.7205 National Cancer Institute www.cancer.gov 800.4.CANCER (22.6237) National Coalition for Cancer Survivorship www.canceradvocacy.org 888.650.9127 Planet Cancer www.planetcancer.org

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With supportive guidance and a dedicated healthcare team, the cancer journey becomes more manageable.

The SSI application process includes an interview. If a patient is rejected, he or she must make sure to appeal. During treatment, money is a concern, so any aid can be beneficial. Once determined eligible for SSI, the patient will be enrolled automatically for Medicaid, which will pay for medical expenses.

Patients also should apply for food stamps from the US Department of Agriculture.

The Patient Protection and Affordable Care Act (ACA) of 2010. This recent law helps patients with the struggles of health insurance companies denying coverage for any reason. These reasons may include health status and/or gender, which can cause rates to skyrocket. This act also requires most people to have health insurance by 2014.5

The Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1986.

This act provides the continuation of group health coverage that might otherwise be terminated. It offers the right to temporary continuation of health coverage for 18 months after an individual has left the company and lets the patient continue seeing his or her doctors, because the healthcare plan has remained unchanged.5 Help for Young Adults Young adults with cancer should never feel as if they are alone. There are a variety of specific resources available for them and more aid is being created every day (Sidebar). When reentering the workforce or if entering it for the first time, young adults should be aware of their rights. They should familiarize themselves with the laws that protect them, the psychosocial effects they may feel before, during, and after treatment, and the many ways to cope that would be beneficial for them. With supportive guidance and a dedicated healthcare team, the cancer journey becomes more manageable. ● References 1. Fleischman SB. Learn to Live Through Cancer: What You Need to Know and Do. New York, NY: Demos Health Publishing; 2011.

2. American Cancer Society. Americans with Disabilities Act: information for people facing cancer. December 7, 2010. www.cancer.org/Treatment/FindingandPayingfor Treatment/UnderstandingFinancialandLegalMatters/ame ricans-with-disabilities-act. Accessed August 30, 2011.

3. American Cancer Society. Family and Medical Leave Act (FMLA). May 19, 2010. www.cancer.org/Treat ment/FindingandPayingforTreatment/UnderstandingFin ancialandLegalMatters/family-and-medical-leave-act.

Accessed August 30, 2011.

4. The US Equal Employment Opportunity Commission. Questions and answers about cancer in the workplace and the Americans with Disabilities Act. January 19, 2011. www.eeoc.gov/facts/cancer.html.

Accessed August 30, 2011.

5. Cancer and Careers. New insurance legislation (HIPAA, COBRA, GINA, PPACA). www.cancerand careers.org/en/at-work/Legal-and-Financial/NewInsurance-Legislation-HIPAA-COBRA-GINAPPACA. Accessed August 29, 2011.

6. Sheppard Mullin Labor & Employment Law Blog.

The Genetic Information Nondiscrimination Act of 2008: civil rights or science fiction? May 22, 2008. www.laboremploymentlawblog.com/discrimination-thegenetic-information-nondiscrimination-act-of-2008civil-rights-or-science-fiction.html. Accessed August 29, 2011.

7. Adler NE, Page AEK, eds. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. Washington, DC: National Academies Press; 2008.

8. Greenfield DM, Absolom K, Eiser C, et al. Follow-up care for cancer survivors: the views of clinicians. Br J Cancer. 2009;101:568-574.

9. Carlson LE, Angen M, Cullum J, et al. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004;90:2297-2304.

10. Holland JC, Breitbart WS, Jacobsen PB, et al, eds.

Psycho-Oncology. 2nd ed. New York, NY: Oxford University Press; 2010.

11. Manicom C. Psychosocial cancer care: there is more to cancer than medical management. African Journals Online. 2010;28:58-63.

12. Odo R, Potter C. Understanding the needs of young adult cancer survivors: a clinical perspective. Oncology (Williston Park). 2009;23(11 suppl nurse ed):23-27, 33.

13. Social Security Administration. Understanding Supplemental Security Income: SSI eligibility requirements. 2011 Edition. www.ssa.gov/ssi/text-eligibilityussi.htm. Accessed August 30, 2011.

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Fundraising for the Cause

Play for P.I.N.K.: Making a Difference

G

olf balls may be small, but if struck by one, you would know that they have tremendous impact. So it was in the beginning of the Play for P.I.N.K. (PFP) organization when a small group of women proved to make a huge impact on funding for breast cancer research.

Driven by the elements of the PINK acronym (Prevention, Immediate diagnosis, New technology, Knowledge), PFP is a grassroots fundraising organization using lifestyle and sporting events to raise funds for breast cancer research.

An impressive 100% of all proceeds are donated to the group’s partner, the Breast Cancer Research Foundation, to fund top researchers.

This year’s theme was Support Our Heroes in honor of the women of Forsgate who are survivors or currently undergoing breast cancer therapy.

PFP began in New Jersey in 1990 when a small group of women, shocked and saddened by the news of their friend’s diagnosis of breast cancer, decided to do something to help their friend, themselves, and anyone touched by breast cancer. One of the founders suggested a golf tournament; she had experience in coordinating golf tournaments, so this seemed a perfect fit for a fundraiser. Indeed, it was.

In 1996, because of increased interest in PFP events and the desire of the founders to reach more people, the organization decided to reach out to individual country clubs throughout the tristate area of New Jersey, New York, and Connecticut in hope of inspiring each club to host its own event. In the first year of this expansion, PFP held golf tournaments at 6 clubs in New Jersey and raised an impressive $77,000 for breast cancer research. Since then, participation has grown to more than 220 clubs in more than 24 states across the United States.

Each year, an estimated 20,000 women, men, and children have participated in and enjoyed this fundraiser.

Although PFP originated as a golf tournament, their fundraising efforts have expanded to include other creative events—tennis tournaments, equestrian events, card games, knitting circles, and even spa days.

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The Play for P.I.N.K. golfers take to the links at Forsgate Country Club to raise money for breast cancer research, this year raising an estimated $37,000 for the Breast Cancer Research Foundation.

One of the charity’s most notable achievements is their significant 2010 contribution to the Breast Cancer Research Foundation in the amount of $3,250,000, bringing PFP’s total contribution to more than $22 million.

TON as Event Sponsor The publishers of The Oncology NurseAPN/PA were proud to support PFP through hole sponsorship at the Annual Forsgate Country Club Golfathon Event. (PFP “sells” hole

flags for a donation.) On June 22 of this year, a total of 42 golfers turned out to support the cause, raising an estimated $37,000.

Forsgate County Club remains among the top contributors to the PFP organization and is an excellent example of a grassroots effort supporting the cause of breast cancer research. The club graciously donates the use of the golf course, cart fees, and the support of their staff. Each year, they adopt a theme for their event—this year’s

theme was Support Our Heroes in honor of the women of Forsgate who are survivors or currently undergoing breast cancer therapy. As literal and figurative signs of support, the club displayed posters where members, Golfathon participants, and staff could write the names of their loved ones living with cancer. Forsgate Event coordinator Ernie McCarren was kind enough to speak to us about her involvement in this extraordinary event (Sidebar). ●

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Fundraising for the Cause Play for P.I.N.K.’s Annual Forsgate Country Club Golfathon An interview with Event Coordinator Ernie McCarren Thanks for taking the time to speak to us, Ernie. Can you tell us what motivated you to organize a P.I.N.K. event?

Ernie McCarren (EM): As a breast cancer survivor and as director of business development for MAMM, a magazine for women with breast cancer, I became keenly aware of the critical need for funding to support research to bring new and better therapies to market faster. By partnering with Play for P.I.N.K., we know that 100% of the funds that we raise will go directly to the Breast Cancer Research Foundation (BCRF).

What kind of support do you get from Play for P.I.N.K.?

EM: The single, most important contribution would have to be the generosity of Bloomberg, who underwrites all of the program expenses, which allows us to turn over all of our proceeds to BCRF. And overall, the organization is very supportive, hosting an annual statewide planning meeting and supplying event materials, prizes, and gifts (donated by Bloomberg, Estee Lauder, and Wilson).

Do you have a personal connection to the cause?

EM: I guess initially, the cause was particularly meaningful to me because of my own personal experience with the disease. But it has become more about joining in the fight to eradicate breast cancer so that future generations will not have to

experience this disease. The fact that finding a cure is within our grasp—possibly within our lifetime—is what compels so many of us to continue in the fight.

Thanks again, Ernie. The Oncology Nurse-APN/PA wishes you continued success with this program!

“A N E X T R AOR DI N A R Y AC H I E V E M E N T .” * WINNER WINNER O OF FT THE HE IINAUGURAL NAUGURAL P PEN EN/E.O. W WILSON ILSON A AWARD WARD F FOR OR LITERARY LITERARY SCIENCE SCIENCE WRITING WRITING NATIONAL ATIONAL BOOK CRITICS CIRCLE SHOR RTLISTED FOR THE NA SHORTLISTED A AWARD WARD AND THE LOS ANGELES TIMES PRIZE

“Powerful and ambitious . . . .

Ernie McCarren

N o w iin Now n ppaa pper e r b aack ck THE NEW YYORK ORK TIMES BESTSELLER NAMED OP-TEN BOOK BOOK OF OF 2010 BY A TTOP BY The N New ew Y Yor York orrk T Times imes Time T ime Magazine O, The Oprah M agazine Entertainment E ntert ntertain nment Weekly Weekly San Chronicle S an Francisco Fran ncisco Chr oonicle

One of the most extraordinary —

How do you go about fundraising?

What kind of event do you hold?

EM: I believe we are the only club to use a golfathon format where participants solicit sponsors to pledge monetary support on a per-hole basis. The women then push the limits of their endurance to play as many holes as they can, with some reaching 36, 45, 70+ holes! In addition, we sell sponsorships for hole flags and signs and run other simultaneous activities like raffles and putting contests.

“M one of

“Remar em discov the credi faces

“It’s render intel

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“It’s tim const

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The Emperor of All Maladies

Excerpt from The Emperor of All Maladies

© Deborah Feingold

Siddhartha Mukherjee is a cancer physician and researcher. He is an assistant professor of medicine at Columbia University and a staff physician at Columbia University Medical Center. A former Rhodes Scholar, he graduated from Stanford University, University of Oxford, and Harvard Medical School. He has published articles in Nature, The New England Journal of Medicine, The New York Times Magazine, and The New Republic. He lives in New York with his wife and daughters. We are grateful to Dr Mukherjee and his publisher for allowing us to reprint this excerpt from his Pulitzer Prize–winning book.

Prologue Diseases desperate grown By desperate appliance are relieved, Or not at all.

then woke up feeling so overwhelmingly tired that she needed to haul herself back to the couch again to sleep.

Carla and her husband saw a general physician and a nurse twice during those four weeks, but she returned each time with no tests and without a diagnosis. Ghostly pains appeared and disappeared in her bones. The doctor fumbled about for some explanation.

Perhaps it was a migraine, she suggested, and asked Carla to try some aspirin.

The aspirin simply worsened the bleeding in Carla’s white gums.

—William Shakespeare, Hamlet Cancer begins and ends with people. In the midst of scientific abstraction, it is sometimes possible to forget this one basic fact. . . . Doctors treat diseases, but they also treat people, and this precondition of their professional existence sometimes pulls them in two directions at once.

—June Goodfield

O

n the morning of May 19, 2004, Carla Reed, a thirtyyear-old kindergarten teacher from Ipswich, Massachusetts, a mother of three young children, woke up in bed with a headache. “Not just any headache,” she would recall later, “but a sort of numbness in my head. The kind of numbness that instantly tells you that something is terribly wrong.”

Something had been terribly wrong for nearly a month. Late in April, Carla had discovered a few bruises on her back.

They had suddenly appeared one morning, like strange stigmata, then grown and vanished over the next month, leaving large map-shaped marks on her back.

Almost indiscernibly, her gums had begun to turn white. By early May, Carla, a vivacious, energetic woman accustomed to spending hours in the classroom chasing down five- and six-yearolds, could barely walk up a flight of stairs. Some mornings, exhausted and unable to stand up, she crawled down the hallways of her house on all fours to get from one room to another. She slept fitfully for twelve or fourteen hours a day,

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Outgoing, gregarious, and ebullient, Carla was more puzzled than worried about her waxing and waning illness.

She had never been seriously ill in her life. The hospital was an abstract place for her; she had never met or consulted a medical specialist, let alone an oncologist. She imagined and concocted various causes to explain her symptoms—overwork, depression, dyspepsia, neuroses, insomnia. But in the end, something visceral arose inside her—a seventh sense—that told Carla something acute and catastrophic was brewing within her body.

On the afternoon of May 19, Carla dropped her three children with a neighbor and drove herself back to the clinic, demanding to have some blood tests. Her doctor ordered a routine test

to check her blood counts. As the technician drew a tube of blood from her vein, he looked closely at the blood’s color, obviously intrigued.

Watery, pale, and dilute, the liquid that welled out of Carla’s veins hardly resembled blood.

Carla waited the rest of the day without any news. At a fish market the next morning, she received a call.

“We need to draw some blood again,” the nurse from the clinic said.

“When should I come?” Carla asked, planning her hectic day. She remembers looking up at the clock on the wall. A half-pound steak of salmon was warming in her shopping basket, threatening to spoil if she left it out too long.

In the end, commonplace particulars make up Carla’s memories of illness: the clock, the car pool, the children, a tube of pale blood, a missed shower, the fish in the sun, the tightening tone of a voice on the phone. Carla cannot recall much of what the nurse said, only a general sense of urgency. “Come now,” she thinks the nurse said. “Come now.”

I heard about Carla’s case at seven o’clock on the morning of May 21, on a train speeding between Kendall Square and Charles Street in Boston. The sentence that flickered on my beeper had the staccato and deadpan force of a true medical emergency: Carla Reed/New patient with leukemia/14th Floor/Please see as soon as you arrive. As the train shot out of a long, dark tunnel, the glass towers of the Massachusetts General Hospital suddenly loomed into view, and I could see the windows of the fourteenth floor rooms.

Carla, I guessed, was sitting in one of those rooms by herself, terrifyingly alone. Outside the room, a buzz of frantic activity had probably begun. Tubes of blood were shuttling between the ward and the laboratories on the second floor. Nurses were moving about with specimens, interns collecting data for morning reports, alarms beeping, pages being sent out. Somewhere in the depths of the hospital, a microscope was flickering on, with the cells in Carla’s blood coming into focus under its lens.

I can feel relatively certain about all of this because the arrival of a patient

with acute leukemia still sends a shiver down the hospital’s spine—all the way from the cancer wards on its upper floors to the clinical laboratories buried deep in the basement. Leukemia is cancer of the white blood cells— cancer in one of its most explosive, violent incarnations. As one nurse on the wards often liked to remind her patients, with this disease “even a paper cut is an emergency.”

For an oncologist in training, too, leukemia represents a special incarnation of cancer. Its pace, its acuity, its breathtaking, inexorable arc of growth forces rapid, often drastic decisions; it is terrifying to experience, terrifying to observe, and terrifying to treat. The body invaded by leukemia is pushed to its brittle physiological limit—every system, heart, lung, blood, working at the knife-edge of its performance. The nurses filled me in on the gaps in the story. Blood tests performed by Carla’s doctor had revealed that her red cell count was critically low, less than a third of normal. Instead of normal white cells, her blood was packed with millions of large, malignant white cells—blasts, in the vocabulary of cancer.

Her doctor, having finally stumbled upon the real diagnosis, had sent her to the Massachusetts General Hospital.

In the long, bare hall outside Carla’s room, in the antiseptic gleam of the floor just mopped with diluted bleach, I ran through the list of tests that would be needed on her blood and mentally rehearsed the conversation I would have with her. There was, I noted ruefully, something rehearsed and robotic even about my sympathy. This was the tenth month of my “fellowship” in oncology— a two-year immersive medical program to train cancer specialists—and I felt as if I had gravitated to my lowest point. In those ten indescribably poignant and difficult months, dozens of patients in my care had died. I felt I was slowly becoming inured to the deaths and the desolation—vaccinated against the constant emotional brunt.

There were seven such cancer fellows at this hospital. On paper, we seemed like a formidable force: graduates of five medical schools and four teaching hospitals, sixty-six years of medical and scientific training, and twelve postgraduate

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The Emperor of All Maladies degrees among us. But none of those years or degrees could possibly have prepared us for this training program.

Medical school, internship, and residency had been physically and emotionally grueling, but the first months of the fellowship flicked away those memories as if all of that had been child’s play, the kindergarten of medical training.

Cancer was an all-consuming presence in our lives. It invaded our imaginations; it occupied our memories; it infiltrated every conversation, every thought. And if we, as physicians, found ourselves immersed in cancer, then our patients found their lives virtually obliterated by the disease. In Aleksandr Solzhenitsyn’s novel Cancer Ward, Pavel Nikolayevich Rusanov, a youthful Russian in his midforties, discovers that he has a tumor in his neck and is immediately whisked away into a cancer ward in some nameless hospital in the frigid north. The diagnosis of cancer—not the disease, but the mere stigma of its presence—becomes a death sentence for Rusanov. The illness strips him of his identity. It dresses him in a patient’s smock (a tragicomically cruel costume, no less blighting than a prisoner’s jumpsuit) and assumes absolute control of his actions. To be diagnosed with cancer, Rusanov discovers, is to enter a borderless medical gulag, a state even more invasive and paralyzing than the one that he has left behind. (Solzhenitsyn may have intended his absurdly totalitarian cancer hospital to parallel the absurdly totalitarian state outside it, yet when I once asked a woman with invasive cervical cancer about the parallel, she said sardonically, “Unfortunately, I did not need any metaphors to read the book.

The cancer ward was my confining state, my prison.”)

As a doctor learning to tend cancer patients, I had only a partial glimpse of this confinement. But even skirting its periphery, I could still feel its power— the dense, insistent gravitational tug that pulls everything and everyone into the orbit of cancer. A colleague, freshly out of his fellowship, pulled me aside on my first week to offer some advice. “It’s called an immersive training program,” he said, lowering his voice. “But by immersive, they really mean drowning. Don’t let it work its way into everything you do. Have a life outside the hospital. You’ll need it, or you’ll get swallowed.”

But it was impossible not to be swallowed. In the parking lot of the hospital, a chilly, concrete box lit by neon floodlights, I spent the end of every evening after rounds in stunned incoherence, the car radio crackling vacantly in the background, as I compulsively tried to reconstruct the events of the day. The

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stories of my patients consumed me, and the decisions that I made haunted me.

Was it worthwhile continuing yet another round of chemotherapy on a sixty-six-yearold pharmacist with lung cancer who had failed all other drugs? Was is better to try a tested and potent combination of drugs on a twenty-six-year-old woman with Hodgkin’s disease and risk losing her fertility, or to choose a more experimental combination that might spare it? Should a Spanish-speaking mother of three with colon cancer be enrolled in a new clinical trial when she can barely read the formal and inscrutable language of the consent forms?

Immersed in the day-to-day management of cancer, I could only see the lives and fates of my patients played out in color-saturated detail, like a television with the contrast turned too high. I could not pan back from the screen. I knew instinctively that these experiences were part of a much larger battle against cancer, but its contours lay far outside my reach. I had a novice’s hunger for history, but also a novice’s inability to envision it.

mean curing more.

Roiling underneath these medical, cultural, and metaphorical interceptions of cancer over the centuries was the biological understanding of the illness—an understanding that had morphed, often radically, from decade to decade. Cancer, we now know, is a disease caused by the uncontrolled growth of a single cell. This growth is unleashed by mutations—changes in DNA that specifically affect genes that incite unlimited cell growth. In a normal cell, powerful genetic circuits regulate cell division and cell death.

In a cancer cell, these circuits have been broken, unleashing a cell that cannot stop growing.

That this seemingly simple mechanism—cell growth without barriers— can lie at the heart of this grotesque and multifaceted illness is a testament to the unfathomable power of cell growth. Cell division allows us as organisms to grow, to adapt, to recover, to repair—to live. And distorted and unleashed, it allows cancer cells to

Roiling underneath these medical, cultural, and metaphorical interceptions of cancer over the centuries was the biological understanding of the illness—an understanding that had morphed, often radically, from decade to decade.

But as I emerged from the strange desolation of those two fellowship years, the questions about the larger story of cancer emerged with urgency: How old is cancer? What are the roots of our battle against this disease? Or, as patients often asked me: Where are we in the “war” on cancer? How did we get here? Is there an end? Can this war even be won?

This book grew out of the attempt to answer these questions. I delved into the history of cancer to give shape to the shape-shifting illness that I was confronting. I used the past to explain the present. The isolation and rage of a thirty-six-year-old woman with stage III breast cancer had ancient echoes in Atossa, the Persian queen who swaddled her diseased breast in cloth to hide it and then, in a fit of nihilistic and prescient fury, possibly had a slave cut it off with a knife. A patient’s desire to amputate her stomach, ridden with cancer—“sparing nothing,” as she put it to me—carried the memory of the perfection-obsessed nineteenth-century surgeon William Halsted, who had chiseled away at cancer with larger and more disfiguring surgeries, all in the hopes that cutting more would

grow, to flourish, to adapt, to recover, and to repair—to live at the cost of our living. Cancer cells can grow faster, adapt better. They are more perfect versions of ourselves.

The secret to battling cancer, then, is to find means to prevent these mutations from occurring in susceptible cells, or to find means to eliminate the mutated cells without compromising normal growth. The conciseness of that statement belies the enormity of the task. Malignant growth and normal growth are so genetically intertwined that unbraiding the two might be one of the most significant scientific challenges faced by our species. Cancer is built into our genomes: the genes that unmoor normal cell division are not foreign to our bodies, but rather mutated, distorted versions of the very genes that perform vital cellular functions.

And cancer is imprinted in our society: as we extend our life span as a species, we inevitably unleash malignant growth (mutations in cancer genes accumulate with aging; cancer is thus intrinsically related to age). If we seek immortality, then so, too, in a rather perverse sense, does the cancer cell.

How, precisely, a future generation might learn to separate the entwined

strands of normal growth from malignant growth remains a mystery. (“The universe,” the twentieth-century biologist J. B. S. Haldane liked to say, “is not only queerer than we suppose, but queerer than we can suppose”—and so is the trajectory of science.) But this much is certain: the story, however it plays out, will contain indelible kernels of the past. It will be a story of inventiveness, resilience, and perseverance against what one writer called the most “relentless and insidious enemy” among human diseases. But it will also be a story of hubris, arrogance, paternalism, misperception, false hope, and hype, all leveraged against an illness that was just three decades ago widely touted as being “curable” within a few years.

In the bare hospital room ventilated by sterilized air, Carla was fighting her own war on cancer. When I arrived, she was sitting with peculiar calm on her bed, a schoolteacher jotting notes. (“But what notes?” she would later recall. “I just wrote and rewrote the same thoughts.”) Her mother, red-eyed and tearful, just off an overnight flight, burst into the room and then sat silently in a chair by the window, rocking forcefully. The din of activity around Carla had become almost a blur: nurses shuttling fluids in and out, interns donning masks and gowns, antibiotics being hung on IV poles to be dripped into her veins.

I explained the situation as best I could. Her day ahead would be full of tests, a hurtle from one lab to another.

I would draw a bone marrow sample.

More tests would be run by pathologists. But the preliminary tests suggested that Carla had acute lymphoblastic leukemia. It is one of the most common forms of cancer in children, but rare in adults. And it is—I paused here for emphasis, lifting my eyes up— often curable.

Curable. Carla nodded at that word, her eyes sharpening. Inevitable questions hung in the room: How curable?

What were the chances that she would survive? How long would the treatment take? I laid out the odds. Once the diagnosis had been confirmed, chemotherapy would begin immediately and last more than one year. Her chances of being cured were about 30 percent, a little less than one in three.

We spoke for an hour, perhaps longer. It was now nine thirty in the morning. The city below us had stirred fully awake. The door shut behind me as I left, and a whoosh of air blew me outward and sealed Carla in. ● From The Emperor of All Maladies by Siddhartha Mukherjee. Copyright © 2010

by Siddhartha Mukherjee, MD. Reprinted by permission of Scribner, a Division of Simon & Schuster, Inc.

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Answered!

Your FAQs...

Q:

A:

What are some treatment options for elderly patients with chronic lymphocytic leukemia?

darabine-based regimens. Dose-reduced regimens, therefore, were developed to ameChronic lymphocytic leukemia (CLL) is a neoplastic disease charliorate treatment toxicity while maintaining efficacy. Several small studies have acterized by the accumulation of monoclonal lymphocytes in reported decent response rates and modest toxicity of either low-dose fludarabine blood, bone marrow, and lymphoid tissue.1 It is the most common form of leukemia in adults worldwide, with prevalence increasing monotherapy or low-dose fludarabine/cyclophosphamide combination. Foon and with age. The median age at diagnosis of CLL is 70 years.2 CLL colleagues evaluated a regimen with decreased doses of fludarabine/cyclophosis diagnosed by the presence of at least phamide, dubbed FCR-Lite, in untreated CLL patients. Results 5000/µL monoclonal B lymphocytes (positive for CD5, showed a 79% CR, with a 95% ORR and a reduction in grade Older patients CD19, CD20, and CD23) by peripheral flow cytometry of 3/4 neutropenia (13%) compared with 52% in the full-dose the blood. Patients typically are followed with a watch-and- (18 of 64 patients >70 FCR regimen. The median age, however, was 58 years, which wait approach until indications for treatment are met. does not represent the median age for patients with CLL. Of Decisions regarding treatment selection are based on sever- years) tolerated PCR 7 patients >70 years, 4 achieved a CR and completed 6 cycles ity of CLL in addition to patient characteristics, including as well as younger of FCR-Lite (full course of treatment); 3 achieved partial comorbidities.3 remission, but none completed 6 cycles of therapy. In addipatients and were Results of German CLL Study Group-8 and the internation, 1 patient aged 69 years also did not complete 6 cycles, tional Study of Relapsed Chronic Lymphocytic Leukemia suggesting that FCR-Lite is better tolerated in a younger just as likely to (REACH) showed that combination therapy with fludarapatient population.9 complete 6 cycles of Pentostatin/cyclophosphamide/rituximab (PCR) also has bine/cyclophosphamide/rituximab (FCR) improves the been studied in older patients with CLL. Shanafelt and coloverall response rate (ORR) and complete remission (CR) therapy and to leagues found that older patients (18 of 64 patients >70 rate, as well as prolongs progression-free survival (PFS) and achieve complete years) tolerated PCR as well as younger patients and were overall survival (OS) when used in the first line.4,5 FCR, therefore, currently is accepted as the gold standard in or partial remission just as likely to complete 6 cycles of therapy and to achieve physically fit patients. Further analysis of the data, howevcomplete or partial remission without excess grade 3/4 toxiwithout excess er, showed that the FCR regimen provided no benefit in city.10 More data are needed, however, to answer the ques6 the 10% of patients who were 70 years of age or older. grade 3/4 toxicity. tion of whether pentostatin is less toxic than fludarabine in There is no clearly superior first-line therapy for elderly elderly/comorbid patients. patients with CLL, and despite the fact that two-thirds of Bendamustine is a chemotherapy agent that combines the the patients diagnosed with CLL are aged older than 65 years, few studies have properties of an alkylating agent and a purine analog. In a study of treatment-naïve explored the efficacy and toxicities of therapies in this population. Clinicians patients with CLL, bendamustine was shown to be more efficacious than chloramoften have concern about offering elderly patients chemotherapy because of their bucil, with a CR rate of 31% and PFS of 21.6 months.11 However, the median age of these patients was 64 years and the number of elderly patients enrolled was small, increased comorbidity and higher rates of treatment-related toxicities. making it difficult to determine if it is appropriate for this population.

First-Line Treatment Options for Elderly/Comorbid Patients Danese and colleagues recently published an observational study of patients Current recommendations by the National Comprehensive Cancer Network (NCCN) for frail patients or those with significant comorbidity (unable to tolerate purine analogs, ie, fludarabine) include chlorambucil with/without prednisone, single-agent rituximab, and pulse steroids.3 Chlorambucil was first used for the treatment of CLL in the 1950s and remains the standard treatment for frail elderly patients. Of the several possible dosing schedules for chlorambucil, the most optimal regimen has not yet been identified.

For patients aged 70 years or older, NCCN Guidelines currently recommend 8 different regimens: chlorambucil, with/without prednisone; bendamustine/rituximab; Taussig Cancer Institute cyclophosphamide/prednisone, with/without rituximab; alemtuzumab/rituximab/flu3 darabine, with/without rituximab; and cladribine. None are specified as preferred.

Cleveland Clinic Foundation German CLL Study Group-5, which focused on the elderly, randomized 193 patients Cleveland, Ohio aged 65 years or older to receive therapy with fludarabine or chlorambucil. Results demonstrated higher response rates with fludarabine, but these did not translate to prolonged PFS or OS. Hillmen and colleagues compared alemtuzumab and chlorambucil as initial therapy for CLL. Results showed a higher response rate with alemDo you have a question you’d like answered? tuzumab (83% vs 55%).7 However, in a subgroup analysis of 105 patients aged 65 E-mail us at editorial@greenhillhc.com years or older, median PFS did not increase, remaining at 12.5 months.8 Myelotoxicity and infection are potential complications of treatment with flu-

This Month’s FAQ

Answered by:

James Karol, MS, PA-C

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Your FAQs... aged 66 years or older with CLL who were registered in the Surveillance, Epidemiology and End Results program.

Of 6433 patients, 2040 received infused therapy: 16% received rituximab monotherapy, 14% rituximab plus chemotherapy, and 70% chemotherapy alone.

Rituximab plus chemotherapy was associated with a 25% lower risk of overall mortality compared with chemotherapy alone.6 These results suggest that initial treatment with rituximab was associated with improved survival in a heterogeneous group of older CLL patients.

Future Directions Results of a recent phase 2 study to evaluate the therapeutic potential of lenalidomide in elderly patients for initial treatment were recently published.8 Len alidomide, an immunomodulatory agent that activates the T and natural killer cells, downregulates several critical prosurvival cytokines, and affects antibodydependent cell-mediated cytotoxicity.

ORR was 65%, with a 2-year OS rate of 88%, which compares favorably with studies involving chlorambucil, fludarabine, or alemtuzumab monotherapy.

Neutropenia was the most common side effect, occurring in 34% of cycles. Grade 1 and 2 tumor flare reactions were common; no severe reactions were noted.

Study investigators noted that tumor flare was associated with a higher likelihood of response, as suggested by other published findings in patients with CLL. Additional phase 2 clinical trials are ongoing to evaluate combination immunomodulating agents and rituximab in untreated patients with CLL. Conclusion Optimal treatment of elderly patients with CLL has not been clearly defined.

Patients aged 70 years or older have been underrepresented in past clinical trials, making the selection of treatment regimens complex compared with selection for younger patients. Multiple chemotherapy regimens exist for elderly patients with good performance stat us and without comorbidities. Chlorambucil is the current standard treatment for elderly frail patients. Supportive therapy is always an option for severely comorbid patients. Promising new agents, such as lenalidomide with or without monoclonal antibody therapy, are being studied. Ongoing clinical trials enrolling patients older than 70 years hopefully will improve survival and quality of life in this population in the future. ● References

2. Rai KR, Keating MJ. Initial treatment of chronic lymphocytic leukemia. June 13, 2011. www.uptodate.com/ contents/initial-treatment-of-chronic-lymphocyticleukemia. Accessed August 26, 2011.

3. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Non-Hodgkin’s Lymphomas. Version 4.2011. www.nccn.org/professionals/physi cian_gls/pdf/nhl.pdf. Accessed August 26, 2011.

4. Hallek M, Fingerle-Rowson G, Fink AM, et al. Firstline treatment with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) improves overall survival (OS) in previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL): results of a randomized phase III trial on behalf of an international group of investigators and the German CLL Study

Answered!

8. Badoux XC, Keating MJ, Wen S, et al. Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia. Blood. July 1, 2011. Epub ahead of print.

9. Foon KA, Boyladzis M, Land SR, et al. Chemoimmunotherapy with low-dose fludarabine and cyclophosphamide and high dose rituximab in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol.

2009;27:498-503.

10. Shanafelt TD, Lin T, Geyer SM, et al. Pentostatin, cyclophosphamide, and rituximab regimen in older patients with chronic lymphocytic leukemia. Cancer.

2007;109:2291-2298.

11. Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009;27:4378-4384.

Group. Blood (ASH Annual Meeting Abstracts). 2009; 114:Abstract 535.

5. Robak T, Dmoszynska A, Solal-Céligny P, et al.

Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol. 2010;28:1756-1765.

6. Danese MD, Griffiths RI, Gleeson M, et al. An observational study of outcomes after initial infused therapy in Medicare patients diagnosed with chronic lymphocytic leukemia. Blood. 2011;117:3505-3513.

7. Hillmen P, Skotnicki AB, Robak T, et al.

Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol.

2007;25:5616-5623.

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Navigation & Survivorship

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SHARE Program Improves Bone Health Behaviors Among Adolescent Survivors

O

ur research suggests that health education programs such as SHARE may have an important impact on improving bone health behaviors among adolescent survivors of childhood cancer,” lead author Darren Mays, PhD, MPH, Lombardi Comprehensive Cancer Center, tells the Academy of Oncology Nurse Navigators. His research, a randomized controlled trial of adolescent survivors of childhood cancer, found that a single, half-day, group-based health education and health-behavior counseling intervention, the Survivor Health and Resilience Education (SHARE) program, produced a significant impact on self-reported bone health behaviors among this population.

The SHARE intervention included messages and skill-building exercises that addressed relevant risk-reducing and health-promoting behaviors, with the goal of increasing awareness of cancer’s late effects, reducing barriers to and increasing perceived benefits of health-promoting behaviors, and improving self-efficacy to lead a

healthy lifestyle. Instruction placed a strong emphasis on nutrition and bone health behaviors and included didactic presentations of bone health, demonstrations of healthy and unhealthy bone, and a discussion of meeting US Department of Agriculture–recommended daily calcium consumption levels of 1300 mg. Also included was reading and understanding food labels, taste-tasting calciumrich foods, and role playing of making calcium-rich food choices.

For the trial, Mays and colleagues randomized adolescents aged 11 to 21 years who were treated for an oncologic malignancy and were ≥1 years posttreatment as well as ≥1 years cancerfree. In total, 38 patients attended the intervention. For the control group, 37 patients completed the same baseline assessment and follow-up telephone assessment interviews as the intervention group. The researchers analyzed 4 outcome measures: milk consumption frequency, any calcium supplementation, days of calcium supplementation in the past month, and dietary calcium intake.

At 1 month postintervention, average milk consumption frequency was higher among the intervention group (mean, 3.36; standard deviation [SD], 0.72) compared with the control group (mean, 2.93; SD, 0.88; t63 = 2.16; P = .03). Also at 1 month, a greater portion (82.9%) of patients reported taking any calcium supple-

[Instruction] included reading and understanding food labels, tastetasting calcium-rich foods, and role playing of making calcium-rich food choices. mentation compared with control patients (24.1%; P <.001). In addition, the mean number of days with calcium supplementation was higher among intervention patients (mean, 14.45; SD, 10.97) compared with control patients (mean, 3.03; SD, 7.86; t62 = 4.47; P <.001). Dietary calcium

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intake, in contrast, was similar among all participants (intervention, mean, 1263.7 mg; SD, 736.2 mg; control, mean, 1152.1 mg; SD, 891.6 mg; t64 = 0.56; P = .58).

“Such programs may help reduce young survivors’ risk for low bone density and other adverse bone health outcomes that stem from cancer treatment,” Mays says, noting that oncology nurses can help “identify young survivors who may be at risk for bone health issues, such as those who undergo certain cancer therapies, and ensure these patients have access to health education programs.” Nurse navigators also can help.

Adolescent survivors can be put in contact with late-effects programs at cancer centers or referred to nutritionists with experience working with those who have survived childhood cancer, shares Mays.

“Further research is needed to examine the long-term impact of the SHARE program on clinically relevant outcomes (eg, bone density),” cautions Mays, “but our initial results are promising.”

The complete study is published in the August issue of the Annals of Behavioral Medicine. ●

Navigators Correctly Estimate the Time Requirements of Their Services

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September 2011 I VOL 4, NO 6

©iStockphoto.com/Visual Field

B

ecause cancer patients vary in their needs for cancer services, patients vary in the amount of navigation time they require. On a patient-by-patient basis, however, navigators congruously estimated the navigation intensity, and therefore the time requirement, that would be needed, reveals a first-of-its-kind study.

Lay navigators working with patients as part of a larger, randomized, controlled trial to evaluate the effectiveness of patient navigators in Rochester, New York, used a 1-item measure to guess the amount of navigation service time each patient would require. To begin, a patient completed a preliminary assessment of his or her perceived navigation needs with their navigator. Next, the navigator reviewed the needs assessment and completed the Navigator Perceived Time of Patient Navigation tool, which was developed for this study and based on expert opinion and team consensus as well as met face-validation. On this simple sheet, the navigators circled the time intensity for each barrier, along the spectrum from “not very time intensive” to “very time intensive.” Lastly, navigation

services began, during which the navigator documented each activity taken on behalf of the patient and the time it took to complete as well as circled all barriers

to care that applied from a list of 22 potential barriers.

Analyzing the data, Carroll and colleagues found that the total number of

barriers was a better predictor of total navigation time compared with type of barrier, with navigation time increasing 16% for each additional barrier identified by the navigator. Despite this finding, some barriers were associated with increased navigator time: 62% more time with women patients; and 34% more time with African Americans and 26% more time with others (mainly Hispanics in this population) compared with whites.

In addition, the investigators achieved the first step in validating their assessment tool. For each predicted intensity unit on the 10-point scale, navigation time increased 29%. The investigators cautioned that they do not know with certainty how the navigators estimated the time requirements. They concluded, however, that “understanding of time needed to address barriers with patients in cancer navigation is one initial step towards systematically improving the delivery of psychosocial aspects of cancer care.”

The complete study is published online in the May 10 issue of the Journal of Cancer Education. ●

www.theOncologyNurse.com

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BUILDING

pillars of knowledge

IN SUPPORTIVE CARE CINV LOG ON TODAY TO PARTICIPATE

www.coexm.com/ace07 Release Date: July 11, 2011 Expiration Date: July 10, 2012

TARGET AUDIENCE The educational series is intended for nurses, pharmacists, and others with clinical, research, and management interests in CINV treatment

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: â&#x20AC;˘ Describe recent advances in the treatment of cancer patients with chemotherapy-induced nausea and vomiting (CINV) â&#x20AC;˘ Outline key barriers and challenges that impact the supportive care of patients with CINV â&#x20AC;˘ Examine strategies for achieving optimal control of CINV, based on recent evidence-based data and updated clinical practice guidelines

ACCREDITATION STATEMENTS Creative Educational Concepts, Inc. (CEC) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This knowledge-based activity has been assigned ACPE # 0245-0000-11019-H01-P and will award 1.0 contact hour (0.10 CEUs) of continuing pharmacy education credit. CEC complies with the Criteria for Quality for continuing education programming.

FACULTY Regina Cunningham, PhD, RN, AOCN Senior Director, Oncology The Tisch Cancer Institute Mount Sinai Medical Center New York, NY

Shawna Kraft, PharmD, BCOP Clinical Pharmacist/Oncology Adjunct Clinical Assistant Professor Department of Pharmacy Services College of Pharmacy University of Michigan Ann Arbor, MI

For further information and to participate, please go to: www.coexm.com/ace07

NURSING Creative Educational Concepts, Inc. (CEC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Centerâ&#x20AC;&#x2122;s Commission on Accreditation.

CEC provides this activity for 1.0 contact hour.

Learners are advised that accredited status does not imply endorsement by the provider or ANCC of any commercial products displayed in conjunction with an activity.

Your statement of credit will be issued immediately upon successful completion of the posttest and evaluation form.

This activity is supported by an educational grant from Eisai, Inc. $!)

TON_September 2011_FINAL_TON 9/14/11 3:48 PM Page 38

Cancer Center Profile Children’s Memorial Center... Continued from cover first—and still its only—hospital dedicated exclusively to caring for children. From these modest roots, with the support of many community partners, Julia’s cottage would eventually become Children’s Memorial Hospital.

One hundred twenty-nine years later, Children’s Memorial Hospital is guided by the belief that all children need to grow up in a protective and nurturing environment in which each child is given the opportunity to reach his or her potential. Its vision is inspired by the courageous children and families it serves and is sustained by the extraordinary contributions of compassionate, knowledgeable, and dedicated staff and volunteers.

Jacqueline Marie Toia, RN, MS, DNP, a pediatric hematology/oncology nurse practitioner, graciously answered our questions about her experiences working at Children’s Memorial Hospital.

Children’s Memorial is consistently ranked among the top children’s hospitals in the country by U.S. News & World Report. In 2010, Children’s Memorial placed in the top 10 for children’s cancer centers. How have these honors impacted your career?

Jacqueline Marie Toia (JMT): Children’s Memorial has such a rich background, and this legacy is just one of our treasures. We are especially proud to be recognized as one of the 30 best children’s hospitals in the United States in 9 pediatric specialties. The hospital ranked among the top 10 in 5 pediatric specialties. We scored particularly well on carerelated measures assessed for each specialty, ranking No. 5 in urology and No. 10 in oncology, gastroenterology, kidney

diseases, and neurology/neurosurgery.

We are the largest pediatric hospital in Illinois, providing specialists in every pediatric specialty, and we are the pediatric educational facility for Northwestern University Feinberg School of Medicine. Last year we served more than 140,000 children.

As a nurse at Children’s Memorial, I am especially proud of the specialty care we provide. Of the 1200 nurses who work at the hospital, 128 are advanced practice nurses. In January 2009, the American Nurses Association recognized the hospital as the first pediatric hospital in the nation, and the first hospital in the state, to receive its prestigious Magnet Award for Nursing Excellence.

Children’s Memorial has now received Magnet designation for the third time.

These awards and acknowledgments foster pride among us. Our pride in practice creates new benchmarks in excellence and encourages collaboration both internally and within the broader nursing community. Nurses are at the heart and core of our patient care. And because our nursing practice is open to endless possibilities, we attract and retain talented and caring practitioners.

How does your parental advisory committee translate to better patient care?

JMT: Not only do we have a Family Advisory Board (FAB; the parents’ committee), we also have a Kids Advisory Board (KAB). Both of these boards serve to create a true partnership and are pivotal to the care we provide. We rely on families’ unique experiences and perspectives to help us make decisions about the hospital’s programming and policies.

The FAB was founded in 1992 to formalize the partnership between parents and hospital leadership and to seek parents’ consultation on an ongoing basis.

The board is made up of parents of children who have had extensive inpatient and outpatient experiences at Children’s Memorial; the FAB advises administration and medical leadership on patient needs and hospital priorities from a family perspective.

The purpose of the KAB is to give a voice to kids who are treated here and to share with staff what is important to children, teens, and siblings during healthcare experiences. The current KAB is made up of 10 members who range in age from 11 to 17 years. Its mission is to recommend change that positively affects patient care and contributes greatly to making the hospital an even better place for kids.

What is your role on the treatment team, and how has that role changed over the years?

JMT: I have had the unique and privileged experience to practice as a nurse in various roles at Children’s Memorial for the past 24 years. I started as a staff nurse on the oncology unit in 1986. It was, and is, a fabulous unit in which to begin a nursing career. I had so many amazing mentors who taught and encouraged me to grow and question the art and science of pediatric oncology nursing. From the inpatient unit I went on to practice as a registered nurse in the outpatient oncology clinic. During this period of my career I continued to expand my knowledge base, participated in care provisions governed by clinical trials, served on hospital-wide committees, and became a

nursing member of the national Children’s Oncology Group, all while attending graduate school, which was completely financed by the hospital.

After I completed my first master’s degree, I worked as a clinical nurse specialist in oncology and helped develop the pediatric Survivors Taking Action & Responsibility (STAR) Program, which provides long-term follow-up for survivors of pediatric cancer. That was an exciting time and a great opportunity to participate in program development in an emerging field within oncology. As I completed my second master’s degree and my Doctorate of Nursing Practice, I began to practice as a pediatric nurse practitioner, which I continue to do today.

Our team has evolved over time to include many disciplines. We are truly a multidisciplinary team. In addition to the primary medical team, comprised of attending physicians, fellows, advanced practice nurses, and registered nurses, our families receive support from social work, pastoral care, child life, art therapy, parent support team, as well as a caring mix of ancillary support staff and volunteers.

Do you have a patient success story to share?

JMT: I love this question. There are so many wonderful success stories. Today in the field of oncology, it is estimated that 80% of children will survive their disease. I have had the pleasure to care for so many beautiful children throughout my career. Many of them have gone on to great success. I have cared for children who have gone on to become doctors, nurses, lawyers, teachers, moms and

Children’s Memorial Hospital Timeline 1896 Julia’s cottage

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SepTember 2011 I VOL 4, NO 6

2010 - Kids Advisory Board members with landscape architect Mikyoung Kim in Crown Sky Garden, where many of their designs will be implemented.

2011 - The new facility, Ann & Robert H. Lurie Children’s Hospital of Chicago, which completed shell construction and is on schedule to open in June 2012. www.TheOncologyNurse.com

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Cancer Center Profile dads, and everything in between. I have even had the pleasure to watch a few of them go on to become oncologists.

I have a few success stories that are so very special. One in particular is a patient, IB, who was diagnosed with high-risk leukemia when he was a junior in high school. He was a quiet young man with so much depth of character; he was funny, insightful, and loving. He would come to clinic with his mother and always managed a smile even in the worst of times. His dad would call me after each visit for an explanation of the day. This became our routine with every visit. Clinically IB went on to do well; he progressed through 3 years of therapy and maintained a clinical remission.

I managed for 20 years. It was one of the most special moments of my career to be able to pass this program into IB’s management. IB went on to marry his high school sweetheart, and they now have a 1-year-old daughter. He graduated from law school and has a successful private practice, and to this day he continues to run the program each summer at camp One Step at a Time.

Not only does he manage the program for the youngest campers, he also

serves as legal counsel for the camp. I would call that a great success.

Ms Lurie once worked at Children’s Memorial as a critical care nurse. We will be moving to the heart of downtown Chicago in 2012, to the medical campus of Northwestern University Feinberg School of Medicine. The new hospital will be a 23-story, state-of-the-art children’s hospital. This collaborative effort involvies skilled architects, our FAB and KAB, community and cultural organizations, and more than 800 Children’s Memorial employees and physicians. ●

What is in the future for Children’s Memorial?

JMT: Children’s Memorial will soon take on a new name at a new location.

The Ann & Robert H. Lurie Children’s Hospital of Chicago, named in recognition of Ann Lurie who pledged a $100million gift, is especially meaningful as

What’s Hot in

SEPTEMBER 2011

www.AONNonline.org

VOL 2, NO 5

Seasons of Survival: Redefining the Paradigm for Cancer Survivorship for 2011 When a Doctor Isn’t Enough: Nurse Navigators Help Patients Through Maze of Cancer-Treatment Decisions, Fears

“As a nurse at Children’s Memorial, I am especially proud of the specialty care we provide. Nurses are at the heart and core of our patient care.”

—Jacqueline Marie Toia, RN, MS, DNP

SPECIAL SECTION: Second Annual AONN Conference Abstracts

© 2011 Green Hill Healthcare Communications, LLC

This Month—September 2011 • Seasons of Survival: Redefining the Paradigm for Cancer

Survivorship for 2011

By Kenneth Miller, MD; Irit Ben-Aharon, MD, PhD; Lindsay Haines, BA

I have always been a huge supporter of our oncology camp, One Step at a Time. I have to admit that on occasion I have been known to “push” a little when it comes to recruiting kids who I think will enjoy camp life. During the course of IB’s therapy, when I employed my tactics to get him interested in going to camp, I was always met with a polite “I don’t think so, Jacquie.” We rehearsed this interaction for years until IB reached an age where he was old enough to participate in camp as a counselor. I convinced him it was time for him to come and work with the children. He finally agreed.

And the rest, as they say, is history.

IB went on to take over the camp program designed for the youngest kids who

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• Abstracts from the Second Annual Navigation and Survivorship

Conference

Join Today to Receive the Next Issue

www.AONNonline.org/join September 2011 I VOL 4, NO 6

39

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The Whole Patient The Salzburg Global Seminar is a nongovernmental organization that brings together experts and imaginative thinkers from diverse cultures, institutions, backgrounds, and experiences to address issues that present a global concern.

© 2011 Satzburg Global Seminar.

Last winter, Peg Ford, a patient advocate and one of our editorial board members, was invited to participate in a Salzburg Global Seminar to contemplate the importance of patients’ involvement in healthcare decision making. Ms Ford was joined by a group of 57 other experts in healthcare. On behalf of all of us at The Oncology Nurse-APN/PA, congratulations to Ms Ford on this honor. It is our pleasure to present the following report from Ms Ford regarding this extraordinary experience.

Session participants in the Marbel Hall.

Shared Decision Making in Healthcare: Results from the Salzburg Global Seminar

By Peg Ford

T

he setting is an 18th-century palace, Schloss Leopoldskron, and the adjoining Meierhof building. This is the home of the Salzburg Global Seminar, an international institution that challenges current and future leaders to develop creative ideas and innovative strategies for solving universal problems. Located on the outskirts of Salzburg, Austria, and dating back to 1740, the palace is situated on a spacious, private estate with a spectacular view of the Alps. It has a colorful history. Mozart played there under the sponsorship of one the palace’s owners, Count Laktanz. In 1918 it was acquired by Max Reinhardt, a cofounder of the Salzburg Festival of music and drama. The grounds and interiors of Schloss Leopoldskron served as inspiration for many scenes in the movie The Sound of Music, with the palace’s Venetian Room, designed by Reinhardt, recreated in a studio to serve as the Von Trapp family ballroom.

Here, I was extremely fortunate to convene and participate with 58 people from 18 countries in December 2010 to discuss the role patients can and should play in healthcare decisions. This session, entitled “The Greatest Untapped Resource in Healthcare? Informing and Involving Patients in Decisions about Their Medical Care,” was the second in a series of seminars focusing on health and healthcare. The session was organized in collaboration with the Foundation for Informed Medical Decision Making (www.informedmedicaldeci sions.org), a nonprofit organization based in the United States that works to ensure fully informed patients are active participants in decisions involving their healthcare. The seminar received support from the Wellcome Trust, Bupa,

40

September 2011 I VOL 4, NO 6

The Salzburg Statement on Shared Decision Making We call on clinicians to: • Recognize that they have an ethical imperative to share important decisions with patients • Stimulate a two-way flow of information and encourage patients to ask questions, explain their circumstances, and express their personal preferences • Provide accurate information about options and the uncertainties, benefits, and harms of treatment in line with best practice for risk communication • Tailor information to individual patient needs and allow them sufficient time to consider their options • Acknowledge that most decisions do not have to be taken immediately, and give patients and their families the resources and help to reach decisions.

We call on clinicians, researchers, editors, journalists, and others to: • Ensure that the information they provide is clear, evidence-based, and up to date, and that conflicts of interest are declared.

I was extremely fortunate to convene and participate with 58 people from 18 countries in December 2010 to discuss the role patients can and should play in healthcare decisions. and Health Dialog.

The participants developed the Salzburg Statement on Shared Decision Making, which was released worldwide on February 7, 2011, in many languages, including English, German, Spanish, Hindi, Mandarin, Portuguese, Dutch, French, Cantonese, Greek, Albanian, Macedonian, Farsi, Serbian, and Bulgarian. The statement also was published in the British Medical Journal. The consensus statement (Sidebar) calls on patients and clinicians to work together to be coproducers of health. ●

We call on patients to: • Speak up about their concerns, questions, and what’s important to them • Recognize that they have a right to be equal participants in their care • Seek and use high-quality health information.

We call on policymakers to: • Adopt policies that encourage shared decision making, including its measurement, as a stimulus for improvement • Amend informed consent laws to support the development of skills and tools for shared decision making.

Why? Much of the care patients receive is based on the ability and readiness of individual clinicians to provide it, rather than on widely agreed standards of best practice or patients’ preferences for treatment.

Clinicians are often slow to recognize the extent to which patients wish to be involved in understanding their health problems, in knowing the options available to them, and in making decisions that take account of their personal preferences.

Many patients and their families find it difficult to take an active part in healthcare decisions. Some lack the confidence to question health professionals. Many have only a limited understanding about health and its determinants and do not know where to find information that is clear, trustworthy, and easy to understand.

Salzburg Global Seminar: The Greatest Untapped Resource in Healthcare?

Informing and Involving Patients in Decisions about Their Medical Care. 12-17 December 2010 (Session 477). Further details: www.SalzburgGlobal.org/go/477.

www.theOncologyNurse.com

TON_September 2011_FINAL_TON 9/13/11 10:09 AM Page 41

Newsletter Series

YOUR QUESTIONS ANSWERED

Editor in Chief

Editor in Chief

Sagar Lonial, MD

Stephanie A. Gregory, MD

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

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;˘ Hodgkin Lymphoma 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, Millennium Pharmaceuticals, Inc., and Seattle Genetics, 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.

This activity is jointly sponsored by Global Education Group and Medical Learning Institute, Inc. Coordination for this activity provided by Center of Excellence Media, LLC.

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

COEKsize40611MM

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Gastrointestinal Cancer

Prolonged Treatment with Imatinib Recommended for High-Risk GIST 3-Year Treatment Reduces Risk of Recurrence

By Audrey Andrews

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Photo by Š GMG/Scott Morgan 2011.

esults from an important phase 3 trial presented at the plenary session of the Annual Meeting of the American Society of Clinical Oncology (ASCO) could lead to prolonged treatment with adjuvant imatinib for gastrointestinal stromal tumors (GISTs).

The extension of imatinib treatment to 3 years, compared with the usual 1 year, resulted in a 54% reduced risk of recurrence and 55% reduced risk of death within 5 years for patients with high-risk disease, reported Heikki Joensuu, MD, of Helsinki University Central Hospital in Finland.

versus 12 months of adjuvant imatinib administered after surgical resection to 400 GIST patients considered to have a high risk of recurrence.

At a median follow-up of 54 months, recurrences or death were observed in 50 of 198 (25%) patients receiving 36 months of imatinib compared with 84 of

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â&#x20AC;&#x153;The entire oncology community was extremely excited when we saw the survival curve and those numbers at 5 years. Itâ&#x20AC;&#x2122;s one of the amazing stories in oncology, and it is the kind of data that change guidelines.â&#x20AC;? â&#x20AC;&#x201D;Mark G. Kris, MD

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â&#x20AC;&#x153;These data are pretty compelling,â&#x20AC;?

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Mark G. Kris, MD, who moderated a press briefing and is chair of the ASCO Cancer Communications Committee, agreed. â&#x20AC;&#x153;The entire oncology community was extremely excited when we saw the survival curve and those numbers at 5 years. Itâ&#x20AC;&#x2122;s one of the amazing stories in oncology, and it is the kind of data that change guidelines,â&#x20AC;? he said.

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42

September 2011 I VOL 4, NO 6

Ĺ&#x2DC; Product Safety Testing. PROVENGE is released for infusion based on the microbial DQG VWHULOLW\ UHVXOWV IURP VHYHUDO WHVWV PLFURELDO FRQWDPLQDWLRQ GHWHUPLQDWLRQ E\ *UDP VWDLQ HQGRWR[LQ FRQWHQW DQG LQ SURFHVV VWHULOLW\ ZLWK D GD\ LQFXEDWLRQ WR GHWHUPLQH DEVHQFH RI PLFURELDO JURZWK 7KH ĹľQDO GD\ LQFXEDWLRQ VWHULOLW\ WHVW UHVXOWV DUH QRW DYDLODEOH DW WKH WLPH RI LQIXVLRQ ,I WKH VWHULOLW\ UHVXOWV EHFRPH SRVLWLYH IRU PLFURELDO FRQWDPLQDWLRQ DIWHU 3529(1*( KDV EHHQ DSSURYHG IRU LQIXVLRQ Dendreon will notify the treating physician. Dendreon will attempt to identify the PLFURRUJDQLVP SHUIRUP DQWLELRWLF VHQVLWLYLW\ WHVWLQJ RQ UHFRYHUHG PLFURRUJDQLVPV and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.

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199 (42%) patients receiving 12 months of treatment. The recurrence-free survival rate was 86.6% at 3 years and 65.6% at 5 years with 36 months of treatment compared with 60.1% and 47.9%, respectively, with 12 months of treatment. This represented a 54% reduction in risk of recurrence that was highly significant (P <.0001), Joensuu reported.

Overall survival was 96.3% at 3 years and 92.0% at 5 years with 36 months of treatment compared with 94.0% and

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Table 1 Incidence of Adverse Events Occurring in â&#x2030;Ľ5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Any Adverse Event Chills Fatigue )HYHU %DFN SDLQ Nausea Joint ache Headache Citrate toxicity Paresthesia Vomiting $QHPLD Constipation Pain Paresthesia oral Pain in extremity 'L]]LQHVV Muscle ache $VWKHQLD Diarrhea ,QĹśXHQ]D OLNH LOOQHVV 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)

247 (41.1)

186 (30.9)

7 (1.2)

291 (96.0)

Grade 3-5 n (%) 97 (32.0)

(Table 1 continued on next page.)

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TON_September 2011_FINAL_TON 9/13/11 10:09 AM Page 43

Gastrointestinal Cancer 81.7%, respectively, with 12 months of imatinib, representing a 55% mortality risk reduction (P = .019).

Grade 3 or 4 adverse events were more common with longer treatment, and more patients discontinued treatment in the 36-month arm.

More May Be Better, Discussant Agreed Charles D. Blanke, MD, chief of medical oncology, University of British

Columbia, Vancouver, critiqued the SSGXVIII/AIO study, noting that its conclusions were â&#x20AC;&#x153;valid.â&#x20AC;? He suggested that oncologists who typically initiate imatinib on relapse might want to rethink this strategy. â&#x20AC;&#x153;If you have a patient who has high-risk GIST, at least as defined by the study, giving him or her 3 years of imatinib represents the new gold standard,â&#x20AC;? he maintained. â&#x20AC;&#x153;The overall survival benefit demonstrated

with immediate postoperative imatinib means it is no longer acceptable to withhold treatment in the adjuvant setting, hoping to â&#x20AC;&#x2DC;catch upâ&#x20AC;&#x2122; when a patient has recurrent metastatic disease.â&#x20AC;?

He acknowledged, however, staying on treatment for 3 years could be problematic for many patients, as suggested by a higher rate of side effects and more than a doubling in the dropout rate among patients who received imatinib

for that long. Although it is possible that treatment even beyond 3 years could be even more beneficial, he noted, â&#x20AC;&#x153;Difficulties on the 3-year arm of SSGXVIII/AIO may bode poorly for therapy lasting even longer.â&#x20AC;? â&#x20AC;&#x153;For now, if I were a patient with a resected GIST and I had a compliant oncologist, I would request more,â&#x20AC;? he said. â&#x20AC;&#x153;As a compliant oncologist, I personally will offer patients treatment to eternity, meaning indefinitely.â&#x20AC;? â&#x2014;?

Table 1 Incidence of Adverse Events Occurring in â&#x2030;Ľ5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Hypertension $QRUH[LD %RQH SDLQ Upper respiratory tract infection ,QVRPQLD 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 (%)

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Cerebrovascular Events. ,Q FRQWUROOHG FOLQLFDO WULDOV FHUHEURYDVFXODU HYHQWV LQFOXGLQJ KHPRUUKDJLF DQG LVFKHPLF VWURNHV ZHUH UHSRUWHG LQ RI SDWLHQWV LQ WKH 3529(1*( JURXS FRPSDUHG ZLWK RI SDWLHQWV LQ WKH FRQWURO JURXS (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 Seattle, Washington 98101

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P-A-11.10-073.01

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SepTember 2011 I VOL 4, NO 6

43

TON_September 2011_FINAL_TON 9/13/11 8:23 PM Page 44

In asymptomatic or minimally symptomatic metastatic castr castrate ate resistant resistant prostate prostate cancer

Before, Frank's immune cells could barely recognize a prostate cancer cell.

Now, they are focused on it.

PROVENGE is the first in a new class of therapy that is designed to activate a patient patient’s’s own antigen-presenting antigen-presenting cells to stimulate an immune rresponse esponse against prostate prostate cancer. cancer.

« Extends Extends median survival beyond 2 years—25.8 years—25.8 months compar compared ed with 21.7 months for patients in the contr control* ol* gr group oup (P=.032) ( « Reduction in risk of death—22.5% (HR=0.775, 95% CI: 0.614, 0.979) « cycles—3 infusions, at appr « Therapy completed in 3 cycles—3 approximately oximately 2-week intervals† e primarily mild or moderate— « Most Most common adverse events ar are e, fever r,, back pain, nausea, joint ache, and headache chills, fatigue, fever, *

Contr Control ol was nonactivated, autologous, autologous, peripheral blood mononuclear cells. from controlled The dosing interval ranged fr om 1 to 15 weeks in contr olled clinical trials.

†

INDICATION: INDIC ATION: PROVENGE® PROVENGE® (sipuleucel-T) (sipuleucel-T) is an autologous cellular immunotherapy immunother indicated for the treatment of asymptomatic or minimally symptomatic metastatic castr castrate resistant (hormone refractory) prostate cancer.

IMPOR TANTT SAFETYY INFORMA RMA ATION: TION: PROVENGE is intended solely for autologous use and is not routinely tested for IMPORTANT INFORMATION: transmissible tr ansmissible infectious dise diseases.

In controlled 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 eported in 3.5% of patients in the PROVENGE PRO reported 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 adjacent page.

©2011 Dendreon Corporation.

All rights reserved. August 2011. Printed in the U.S.A. Dendreon, the Dendreon logo, and PROVENGE are registered trademarks of Dendreon Corporation.

P-A-08.11-145.00

Proud Supporter of Prostate e ncer Awareness Aw A w Cancer Month tember 2011 2011 September

www.PROVENGE.com

Stimulate a Response