Oncology Nurse Advisor November/December 2014

ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014

November/December 2014

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FREE CONTINUING EDUCATION INSIDE Breast cancer and pregnancy: Overlapping disciplines, PAGE 18

FEATURE

Cancer prehabilitation: A step toward improved outcomes

MULTIDISCIPLINARY CARE

Managing patient care in pregnancy-associated breast cancer Both diagnostic tests and treatment options for breast cancer are impacted by pregnancy.

RADIATION & YOUR PATIENT

Monitoring psychosocial function in radiotherapy

COMMUNICATION CHALLENGES

Mirror, mirror

FROM CANCERCARE

A tool for conversations about cancer

ASK A PHARMACIST

VOLUME 5, NUMBER 6

Treatment options for HER2positive breast cancer

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EDITORIAL BOARD Ann J. Brady, MSN, RN-BC Huntington Cancer Center Pasadena, California Jia Conway, DNP, FNP-BC, AOCNP, NP-C Cancer Care Associates of York York, Pennsylvania Frank dela Rama, RN, MS, AOCNS Palo Alto Medical Foundation Palo Alto, California Marianne Davies, DNP, ACNP, AOCNP Smilow Cancer Center @ Yale New Haven New Haven, Connecticut Donald R. Fleming, MD Cancer Care Center, Davis Memorial Hospital Elkins, West Virginia Susanne Menon, NP, OCN Center for Gynecologic Oncology Massachusetts General Hospital Cancer Center Boston, Massachusetts Leah A. Scaramuzzo, MSN, RN-BC, AOCN Billings Clinic, Inpatient Cancer Care Billings, Montana Lisa A. Thompson, PharmD, BCOP Kaiser Permanente Colorado Rosemarie A. Tucci, RN, MSN, AOCN Lankenau Hospital Wynnewood, Pennsylvania

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 7

CONTENTS

November/December 2014

13

IN THE NEWS • Innovative program combats CAUTIs • Radiotherapy comparable in either breast • The navigator’s role in personalized medicine • Unsuspected mutations cause dramatic response to treatment

18

CONTINUING EDUCATION Breast cancer and pregnancy: Overlapping of two disciplines

13

Jiajoyce R. Conway, DNP, CRNP, AOCNP

49

28

FEATURES Cancer prehabilitation: A step toward improved outcomes Julie K. Silver, MD

33

Study validates effectiveness of MBSR programs for nurses John Schieszer, MA

45

47 FIND US ON

40

ONA INTERVIEW Breaking the barriers to effective palliative care

41

STAT CONSULT Ramucirumab (Cyramza)

45

RADIATION & YOUR PATIENT Monitoring psychosocial function in radiotherapy Bryant Furlow

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8 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

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JOIN OUR COMMUNITY Submit a question to an oncology nurse advisor Have a question? Our panel of oncology clinicians is available to answer your questions. Submit questions to editor.ona@HaymarketMedia.com.

47

Answer the ONA poll question

COMMUNICATION CHALLENGES Mirror, mirror Ann J. Brady, MSN, RN-BC

49

ISSUES IN CANCER SURVIVORSHIP Resection for lung cancer in the elderly: Lobectomy better than sublobar resection Bette Weinstein Kaplan

51

Subscribe to ONA newsletters Stay current with daily news reports and special series from key oncology conferences on our Web site, sign up for our e-newsletters at OncologyNurseAdvisor.com/subscribe.

FROM CANCERCARE A tool for conversations about cancer Sandra Tripodi, MSW, LCSW

52

ONA asks… Answer our poll question and compare your opinions with those of your colleagues on key nursing issues at OncologyNurseAdvisor.com

ASK A PHARMACIST Treatment options for HER2-positive breast cancer Lisa A. Thompson, PharmD, BCOP

ONCOLOGY NURSE ADVISOR FORUM • Impact of vitamins, supplements, and diet on treatment-related hair loss • Importance of sequence in chemotherapy administration • Polyphenols in green tea may interfere with this cancer therapy • Vaginal lubricant options for women with HR+ breast cancer ISSUES IN CANCER SURVIVORSHIP An episode of sudden-onset jaundice signaled pancreatic cancer in a healthy man

Earn CE credits Each issue offers one new CE activity co-provided by the Nurse Practitioner Healthcare Foundation. Activities are active for 2 years.

Socialize electronically Keep up with the oncology field through our social media. We’re on Twitter and Facebook. Now, we’re on Pinterest, too.

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Bette Weinstein Kaplan

FEATURE Eat better, work better: Good nutrition keeps nurses strong all shift long Lauren Evoy Davis

THE TOTAL PATIENT Effective use of hospice improves end-of-life care for patients with cancer Bette Weinstein Kaplan

ON THE

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www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 9

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Take a bite out of G-CSF acquisition costs* GRANIX is another option in short-acting G-CSF therapy TM

» GRANIX demonstrated a 71% reduction in duration of severe neutropenia (DSN) vs placebo1 – GRANIX significantly reduced DSN when compared to placebo (1.1 days vs 3.8 days; p<0.001)1 – Efficacy was evaluated in a multinational, multicenter, randomized, controlled, Phase III study of chemotherapy-naïve patients with high-risk breast cancer receiving doxorubicin (60 mg/m2 IV bolus)/docetaxel (75 mg/m2)1 *Based on wholesale acquisition cost (WAC) of all short-acting G-CSF products as of November 11, 2013. WAC represents published catalogue or list prices and may not represent actual transactional prices. Please contact your supplier for actual prices.

» Safety was evaluated in 3 Phase III clinical trials1

Indication

Important Safety Information (continued)

» GRANIX (tbo-filgrastim) Injection is a leukocyte growth factor indicated for reduction

» Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur

TM

in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis.

» Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-

Important Safety Information » Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colony-stimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX.

» Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.

» Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.

stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

» Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain.

Please see brief summary of Full Prescribing Information on adjacent page.

For more information, visit GRANIXhcp.com.

Reference: 1. GRANIX TM (tbo-filgrastim) Injection Prescribing Information. North Wales, PA: Teva Pharmaceuticals; 2013.

©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. All rights reserved. GRX-40137 January 2014.

Take a bite out of G-CSF acquisition costs* GRANIX is another option in short-acting G-CSF therapy TM

» GRANIX demonstrated a 71% reduction in duration of severe neutropenia (DSN) vs placebo1 – GRANIX significantly reduced DSN when compared to placebo (1.1 days vs 3.8 days; p<0.001)1 – Efficacy was evaluated in a multinational, multicenter, randomized, controlled, Phase III study of chemotherapy-naïve patients with high-risk breast cancer receiving doxorubicin (60 mg/m2 IV bolus)/docetaxel (75 mg/m2)1 *Based on wholesale acquisition cost (WAC) of all short-acting G-CSF products as of November 11, 2013. WAC represents published catalogue or list prices and may not represent actual transactional prices. Please contact your supplier for actual prices.

» Safety was evaluated in 3 Phase III clinical trials1

Indication

Important Safety Information (continued)

» GRANIX (tbo-filgrastim) Injection is a leukocyte growth factor indicated for reduction

» Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur

TM

in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis.

» Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-

Important Safety Information » Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colony-stimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX.

» Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.

» Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.

stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

» Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain.

Please see brief summary of Full Prescribing Information on adjacent page.

For more information, visit GRANIXhcp.com.

Reference: 1. GRANIX TM (tbo-filgrastim) Injection Prescribing Information. North Wales, PA: Teva Pharmaceuticals; 2013.

©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. All rights reserved. GRX-40137 January 2014.

BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR GRANIX™ (tbo-filgrastim) Injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

4 CONTRAINDICATIONS None.

5 WARNINGS AND PRECAUTIONS 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following administration of human granulocyte colony-stimulating factors. In patients who report upper abdominal or shoulder pain after receiving GRANIX, discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture.

5.2 Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) can occur in patients receiving human granulocyte colony-stimulating factors. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. 5.3 Allergic Reactions Serious allergic reactions including anaphylaxis can occur in patients receiving human granulocyte colony-stimulating factors. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.

5.4 Use in Patients with Sickle Cell Disease Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving human granulocyte colony-stimulating factors. Consider the potential risks and benefits prior to the administration of human granulocyte colony-stimulating factors in patients with sickle cell disease.

Discontinue GRANIX in patients undergoing a sickle cell crisis.

5.5 Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor through which GRANIX acts has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic Rupture [see Warnings and Precautions (5.1)] • Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)] • Serious Allergic Reactions [see Warnings and Precautions (5.3)] • Use in Patients with Sickle Cell Disease [see Warnings and Precautions (5.4)] • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.5)] The most common treatment-emergent adverse reaction that occurred at an incidence of at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group was bone pain.

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

GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-US-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 106/L after nadir was reached.

Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-US-approved filgrastim product).

Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving GRANIX has not been adequately determined.

7 DRUG INTERACTIONS No formal drug interaction studies between GRANIX and other drugs have been performed.

Drugs which may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone-imaging results.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of GRANIX in pregnant women. In an embryofetal developmental study, treatment of pregnant rabbits with tbo-filgrastim resulted in adverse embryofetal findings, including increased spontaneous abortion and fetal malformations at a maternally toxic dose. GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the embryofetal developmental study, pregnant rabbits were administered subcutaneous doses of tbo-filgrastim during the period of organogenesis at 1, 10 and 100 mcg/kg/day. Increased abortions were evident in rabbits treated with tbo-filgrastim at 100 mcg/kg/day. This dose was maternally toxic as demonstrated by reduced body weight. Other embryofetal findings at this dose level consisted of post-implantation loss‚ decrease in mean live litter size and fetal weight, and fetal malformations such as malformed hindlimbs and cleft palate. The dose of 100 mcg/kg/day corresponds to a systemic exposure (AUC0-24) of approximately 50-90 times the exposures observed in patients treated with the clinical tbo-filgrastim dose of 5 mcg/kg/day.

8.3 Nursing Mothers It is not known whether tbo-filgrastim is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GRANIX is administered to a nursing woman. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates.

8.4 Pediatric Use The safety and effectiveness of GRANIX in pediatric patients have not been established.

8.5 Geriatric Use Among 677 cancer patients enrolled in clinical trials of GRANIX, a total of 111 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

8.6 Renal Impairment The safety and efficacy of GRANIX have not been studied in patients with moderate or severe renal impairment. No dose adjustment is recommended for patients with mild renal impairment.

8.7 Hepatic Impairment The safety and efficacy of GRANIX have not been studied in patients with hepatic impairment.

10 OVERDOSAGE No case of overdose has been reported. ©2013 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.

GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. Manufactured by: Distributed by: Sicor Biotech UAB Teva Pharmaceuticals USA, Inc. Vilnius, Lithuania North Wales, PA 19454 U.S. License No. 1803 Product of Israel GRX-40189 January 2014 This brief summary is based on TBO-003 GRANIX full Prescribing Information.

IN THE NEWS

Innovative program combats CAUTIs

updating flow sheets to electronically track catheter usage. The approach also involved standardizing catheter supplies and maintenance practices. An example of the standard operating procedure for CAUTI maintenance bundle includes the following points.

• Perform a daily review of the need for the urinary catheter.

• Check the catheter has been continuously connected to the drainage system.

• Ensure patients are aware of their role in preventing urinary tract infection. If the patient is unable to be made aware, perform routine daily meatal hygiene.

• Empty urinary drainage bags as separate procedures, regularly and each into a clean container.

Education on use of catheter supplies will assist nurses in implementing a CAUTI maintenance bundle.

Oncology nurses need to constantly be on the lookout for more opportunities to prevent infections because their patients are predominantly immunocompromised.

• Perform hand hygiene and don gloves and apron prior to each catheter care procedure; on completion of the procedure, perform hand hygiene again.

McLaughlin said the infection control record was good before the CAUTI bundle was implemented, but since its implementation, the CAUTI infection rate has dropped to zero. She said the current goal is to maintain a zero-infection level, and to highlight this approach for a national audience so that other centers can adopt it.

As part of the initiative, vendors of the catheter supplies and bladder scanners were invited to the medical facility to assist with education about their products. In addition, nurse champions of the CAUTI bundle were identified and received additional education. Education was deemed mandatory for all clinical nurses. McLaughlin said prolonged use of a urinary catheter increases the risk for CAUTI by 5% each day. UTIs increase cost by approximately $600 and can increase length of stay by 1 day.

Oncology nurses need to constantly be on the lookout for more opportunities to prevent infections because their patients are predominantly immunocompromised. The bundle approach involves a collaboration of disciplines, and included eliciting input from clinical nurses to develop a patient care algorithm that would support autonomous decision-making by nurses. ■ To read the full report, go to www. oncologynurseadvisor.com/combatCAUTIs.

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 13

© THINKSTOCK

AN INNOVATIVE program that gives oncology nurses more autonomy to manage patients with catheters can dramatically reduce catheter-associated urinary tract infections (CAUTIs), according to data presented at the American Nurses Credentialing Center 2014 National Magnet Conference.

An interdisciplinary task force was established at Roswell Park Cancer Institute, in Buffalo, New York, to implement changes that would significantly reduce CAUTIs. The task force put in place a strategic methodology based on change theory, and set up a bundle consisting of interventions based on clinical evidence to allow for safer care of patients with urinary catheters and to support removal of catheters as soon as they are no longer medically necessary.

Pamela McLaughlin, BSN, RN, OCN, who presented the study finding at the meeting, said urinary tract infections (UTIs) are one of the most common types of health care-associated infection. Up to 25% of hospitalized patients receive urinary catheters during their hospital stay, and prolonged use of a urinary catheter is the most common risk factor for developing a CAUTI. The bundle implemented by the task force focused on prompting physicians to assess a patient’s urinary catheter status daily as well as

IN THE NEWS

Radiotherapy comparable in either breast OVERALL SURVIVAL is not impacted by whether a breast cancer tumor is on the left or right side in patients treated with breast-conserving surgery and adjuvant external beam radiation therapy, according to a new study.

This study examined the impact of tumor laterality on overall survival in a modern cohort of patients from the National Cancer Database (NCDB). This study analyzed 344,831 patients with a breast cancer diagnosis between 1998 and 2006.

Overall survival (OS) did not differ based on tumor laterality in all patients. At 5 years, OS was 92% in both left- and right-sided groups, and at 10 years, OS was 78% in both groups. A multivariate analysis adjusted for demographic and pathologic factors that could impact OS, including age, grade, estrogen receptor status, tumor size, number of positive nodes, receipt of chemotherapy, and receipt of endocrine therapy. The multivariate analysis showed no difference in OS by tumor laterality.

“Treatment planning and more advanced treatment techniques and technologies have reduced the risk to the heart,” said Charles E. Rutter, MD, lead author of the study and a fourth-year resident in the Department of Therapeutic Radiology at Yale School of Medicine in New Haven, Connecticut. ■

Navigator Notes The navigator’s role in personalized medicine Frank dela Rama, RN, MS, AOCNS Genomics coming of age In late October 2014, the National Comprehensive Cancer Network (NCCN) announced that molecular testing would be included in the latest edition of the prostate cancer treatment guidelines, version 1.2015. Through our care of patients with prostate cancer, many of us are already familiar with these tests, Prolaris and OncotypeDX, which aim to help further stratify risk in localized disease.

At a very basic level, molecular testing of prostate tumor tissue is a genomic analysis assigning a number to how overactive the cells are, compared with normal tissue. In clinical decision-making, this type of information could help a man with localized, low-risk prostate cancer choose between active surveillance or treatment. But these tests do not help answer the question of surgery vs radiation vs other.

First-hand experience For the men who have undergone this type of testing here in my practice, they still use the conventional variables (PSA, Gleason score) and their physicians’ advice to narrow down the treatment choices. If they are candidates for active surveillance, then likely the genomic tests come into play. With a low/less aggressive score or a middle-of-the-road score, men seem to be more inclined toward staying with active surveillance. With a high/aggressive score, men on the fence between active surveillance and treatment, often choose treatment.

In explaining the meaning of these tests to patients, I’ve often said that genomic testing is like a magnifying glass on your cancer. By looking more closely through the magnifying glass of genomics, perhaps we

can somehow gauge if the cancer is a less aggressive low-risk cancer that is okay to just watch versus a more aggressive low-risk cancer that would benefit from treatment sooner than later.

Developing the navigator role in personalized medicine Hopefully, as we learn more about these technologies, we can figure out how to best incorporate the data into health care decision making. As navigators, our roles of teacher and advocate are crucial in caring for men dealing with treatment decision making that involves new variables such as genomic testing. The navigator can gather updated information on the technologies to share with both providers and patients, even more important as entities such as NCCN are bringing more credibility to emerging technologies.

And finally, the shared experience among navigators is extremely valuable; as an early adopter, I learned so much from fellow providers outside my institution as we learned together how to counsel patients—and providers—around these new technologies.

Now, having more experience, it is a joy to share my experiences with colleagues new to the processes around molecular testing and personalized medicine. Ultimately, our patients benefit in ensuring quality and cutting-edge cancer care, as navigators connect the dots from technology to the reality of people dealing with the disease, day to day. ■ Frank dela Rama is a clinical nurse specialist, oncology/genomics, and prostate cancer navigator at Palo Alto Medical Foundation in Palo Alto, California.

14 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

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IN THE NEWS

FDA Update The FDA approved Akynzeo (netupitant and palonosetron), a fixed combination capsule comprised of two drugs, to treat nausea and vomiting in patients undergoing cancer chemotherapy. Oral palonosetron prevents nausea and vomiting during the acute phase after the start of cancer chemotherapy. Netupitant prevents nausea and vomiting during both the acute phase and delayed phase after the start of cancer chemotherapy.

Common side effects reported in the clinical trials were headache, weakness (asthenia), fatigue, indigestion (dyspepsia), and constipation.

Bevacizumab (Avastin) received FDA approval for use in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens. Adverse events were consistent with those seen in previous trials of the agent across tumor types for approved indications, but also included high blood pressure and pain, redness, or swelling of the hands or feet. With this approval, bevacizumab is approved in the United States to treat six distinct tumor types. ■

Unsuspected mutations cause dramatic response to treatment THE DNA of a woman whose lethal thyroid cancer unexpectedly melted away for 18 months has revealed new mechanisms of cancer response and resistance to the drug everolimus.

Investigators from Dana-Farber Cancer Institute and the Broad Institute of MIT and Harvard discovered two previously unknown mutations in the cancer’s DNA. One made the cancer extraordinarily sensitive to everolimus, accounting for the remarkably long-lasting response. The second mutation was found in the DNA of her tumor after it had evolved resistance to the drug 18 months after treatment started.

The single case study illustrates how repeatedly sequencing a patient’s cancer DNA can identify unsuspected response and resistance mutations that may help guide treatment of other patients.

Having identified the mutation, which occurred in the TSC2 gene, that caused the patient’s

ONA ASKS …

The single case study illustrates how repeatedly sequencing a patient’s cancer DNA can identify unsupected mutations that may help guide treatment of other patients.

dramatic response to everolimus, researchers at Dana-Farber have opened a clinical trial to test the drug’s effectiveness in other patients with TSC2 mutations.

The patient was a 56-year-old woman whose anaplastic thyroid cancer was diagnosed in 2010.

This form of thyroid cancer is almost always fatal within a few months. “No treatment has ever worked,” said Jochen Lorch, MD, a thyroid cancer specialist at the Head and Neck Treatment Center at Dana-Farber. The tumor spread to her lungs despite surgery, radiation, and chemotherapy.

Lorch, who was leading a clinical trial of everolimus for a more treatable type of thyroid cancer, decided to include the woman. After a few months the tumor shrank to a very small size. It remained that way for an unheard-of 18 months until it began to grow again. Using whole-exome DNA sequencing the investigators discovered a mutation in the TSC2 gene. ■

YES

NO

In the last election, Proposition 46, which included a mandate for physicians to undergo drug and alcohol testing, was voted down in California. It would have made the state the first to require drug testing of any clinicians. Do you think clinicians should undergo drug testing?

Go online to answer our poll question.

We’ll publish the results and a new question in the next issue. …AND YOU ANSWERED In the last issue we asked how long you worked at your first nursing job.

25% 1 year 20% 2 years

16 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

55% 3 years or longer

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CONTINUING EDUCATION Disclosure of Conflicts of Interest Medical Education Resources ensures balance, independence, objectivity, and scientific rigor in all our educational programs. In accordance with this policy, MER identifies conflicts of interest with its instructors, content managers, and other individuals who are in a position to control the content of an activity. Conflicts are resolved by MER to ensure that all scientific research referred to, reported, or used in a continuing education activity conforms to the generally accepted standards of experimental design, data collection, and analysis. MER is committed to providing its learners with high-quality activities that promote improvements or quality in health care and not the business interest of a commercial interest.

The faculty reported the following financial relationships with commercial interests whose products or services may be mentioned in this activity: Name of faculty Jiajoyce R. Conway, DNP, CRNP, AOCNP

Reported Financial Relationship No financial relationships to disclose

EDUCATIONAL OBJECTIVES After participating in this activity, clinicians should be better able to • List pregnancy-related physiologic changes that challenges making a diagnosis of breast cancer in this patient population • Identify the diagnostic imaging techniques that are accurate and safe in pregnant women • Describe treatment options that are safe during pregnancy

STATEMENT OF NEED/PROGRAM OVERVIEW Breast cancer in the pregnant woman presents unique challenges in patient care as the oncology nurse has two patients: the woman and her fetus. Oncology nurses should be familiar with the many challenges inherent with making an accurate diagnosis, treatment, and managing patient care in this subset of patients, as well as be familiar with the additional specialists needed on the care team.

The incidence of breast cancer in pregnant women is increasing in conjunction with the cultural trend of delaying childbearing until after age 30 years, and nurses need to understand how pregnancy impacts treatment decisions.

FACULTY Jiajoyce R. Conway, DNP, CRNP, AOCNP Cancer Care Associates of York York, Pennsylvania LEARNING GOAL/PURPOSE To better understand how cancer immunotherapies use the body’s natural defenses to identify and kill cancer cells.

The content managers reported the following financial relationships with commercial interests whose products or services may be mentioned in this activity:

NURSING CREDIT Medical Education Resources is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Name of Content Manager

Reported Financial Relationship

This CE activity provides 1 contact hour of continuing nursing education.

Joyce Pagán

No financial relationships to disclose

Planners and Manager from MER

No financial relationships to disclose

Disclaimer The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Medical Education Resources or Haymarket Medical. The authors have disclosed if there is any discussion of published and/or investigational uses of agents that are not indicated by the FDA in their presentations. The opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of Medical Education Resources or Haymarket Medical. Before prescribing any medicine, primary references and full prescribing information should be consulted. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

The information presented in this activity is not meant to serve as a guideline for patient management.

Medical Education Resources is a provider of continuing nursing education by the California Board of Registered Nursing, Provider #CEP 12299, for 1 contact hour.

METHOD OF PARTICIPATION There are no fees for participating in and receiving credit for this activity.

During the period December 2014 through December 2015, participants must 1) read the learning objectives and faculty disclosures, 2) study the educational activity, 3) complete the posttest by selecting the best answer to each question on the posttest, 4) complete the evaluation form, and 5) continue to next section to claim credits and view your certificate.

A statement of credit will be issued only upon receipt of a completed activity evaluation form and a completed posttest with a score of 70% or better.

Statements of credit are available at the conclusion of the activity.

MEDIA

Journal article and Web site (myCME.com; OncologyNurseAdvisor.com)

Co-provided by Medical Education Resources and Haymarket Media Inc.

18 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

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TARGET AUDIENCE

PROGRAM INFORMATION

• This activity has been designed to meet the educational needs of registered nurses and nurse practitioners involved in the management of patients with cancer.

• Estimated time to complete this activity: 1 hour • Release date: December 2014 • Expiration date: December 2015

Breast cancer and pregnancy: Overlapping of two disciplines Oncology nurses must anticipate a disciplinary crossover between oncology and obstetrics to care for this unique subgroup of women with breast cancer.

PHOTOS: ©IAN HOOTON / SCIENCE SOURCE; ©THINKSTOCK

Care for the pregnant woman with breast cancer is significantly different from care for the nonpregnant woman; however, outcomes can be similar in both groups.

JIAJOYCE R. CONWAY, DNP, CRNP, AOCNP

O

ver the past few decades the incidence of breast cancer has increased; however, mortality related to breast cancer is on the decline. This has been attributed to early detection and more effective treatment options.1 In the United States, a woman’s lifetime risk of developing breast cancer is estimated at 12.3%, based on the Gail model risk assessment criteria.1 Risk stratification has been pivotal in assessing risk of developing breast cancer. It identifies those women at normal risk compared with those women with high risk factors. Risk of developing breast cancer is increased per the following criteria: • Prior therapeutic thoracic irradiaton or mantle irradiation; • Age 35 years or older with a 5-year risk for invasive breast carcinoma of 1.7% or greater; • A lifetime risk for breast cancer greater than 20%, based on models largely dependent on family history; • A strong family history or genetic predisposition for the disease;

TO TAKE THE POST-TEST FOR THIS CE ACTIVITY

and apply for 1.0 contact hours, please go to myCME.com/CEDEC2014

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 19

CONTINUING EDUCATION | Breast cancer and pregnancy • Lobular carcinoma in situ (LCIS) or atypical hyperplasia; and • Prior history of breast cancer.2 Risk assessment, using the modified Gail model, assesses the risk for invasive breast cancer as a function of current age, age at menarche, age at first live birth or nulliparity, number of first-degree relatives with breast cancer, number of previous benign breast biopsies, atypical hyperplasia in a previous breast biopsy, and race.2 However, the list of risk factors that predispose a woman to breast cancer should include pregnancy.

The incidence of breast cancer during pregnancy is expected to increase as a result of the cultural trend of having children later in life. Breast cancer is diagnosed in pregnant women in approximately 1 in 3,000 pregnancies.3,4

Although often considered rare, breast cancer is the most common cancer in pregnant and postpartum women, after cervical cancer.

Statistics demonstrate that approximately 10% of patients younger than 40 years with a new diagnosis of breast cancer are pregnant.3 Given that clinicians in oncology and obstetrics have never had to speak the same language in terms of patient management, the increasing incidence of breast cancer during pregnancy is shifting this paradigm.

The delay of childbearing until after age 30 years is a major factor in the increasing incidence of pregnancy and breast cancer.2 Of great importance for nursing across the two disciplines is that care for the pregnant woman with breast cancer differs significantly from care for the nonpregnant woman with breast cancer. A greater understanding of the true biology and nature of breast cancer in pregnancy is needed to maximize the care of these women and reduce the health risks for both the mother and the fetus.

INCIDENCE AND PREVALENCE Cancer is the second most common cause of death in women of reproductive age, and accounts for 33% of maternal deaths during pregnancy.3 Pregnancy-associated breast cancer is defined as breast cancer during pregnancy and up to 1 year postpartum.5 Six million pregnancies occur in the United States annually, and of these pregnancies, approximately 4,058,000 result in a live birth.3 Although often considered rare, breast cancer is the most common cancer in pregnant and postpartum women, after cervical cancer, with an average

age of 32 to 38 years at the time of diagnosis.3,4,5 Worldwide, approximately 30,000 cases of breast cancer are diagnosed in pregnant women annually, and an estimated more than 40,000 women were affected in 2009 alone.5,6 In comparison with nulliparous women, the risk for a woman to develop breast cancer is increased in the years immediately following pregnancy, whereas all parous women, regardless of age, have higher incidence of breast cancer compared with nulliparous women.6 This risk is known to exist for a minimum of 10 years and increases up to 15 years after birth in women younger than 25 years at the time of delivery.7 For years, the cross-over effect has been that women who have children at a younger age have a protective benefit as it relates to the risk of breast cancer.

Age as a major risk factor for pregnancy-associated breast cancer is consistent throughout the evaluation of women who develop the disease during pregnancy. Women who are uniparous and complete their first pregnancy before age 25 years do still possess transient risks, but their overall lifetime risk of developing the disease is reduced by at least 36%.7 A critical point for pregnancy-associated breast cancer increases at age 35 years, as full-term pregnancy is associated with a permanent increase in breast cancer risks from this age on.6 PATHOPHYSIOLOGY AND CLINICAL ASSESSMENT Staging and evaluation of pregnancy-associated breast cancer does not differ from staging and evaluation in the premenopausal woman with breast cancer. Yet, pregnant women often have more advanced disease because the significance of a breast mass is not often considered in the pregnant state and/or because of the endogenous hormone stimulation that occurs.4 The interpretation of normal physiologic changes that occur during and after pregnancy must be clearly separated from the persistence of masses in pregnant or lactating women. The potential risks of misdiagnosis or late diagnosis due to attributing masses in pregnant or lactating women as benign can lend itself to a missed diagnosis of pregnancyassociated breast cancer.4 The significant changes that ensue in the breast during pregnancy such as edema, hypervascularization, and lobular and glandular hyperplasia can make tumor detection challenging.5 Physical assessment Estrogen, progesterone, prolactin, and human placental lactogen are key hormones produced during pregnancy that play a role in breast growth.4 Hormonal and immunologic changes have not been proven to contribute to a favorable environment for the growth of breast cancer cells, but they are thought to mask the detection of early tumors in women.5,6,7 A comprehensive

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baseline breast examination should be performed in the early stages of pregnancy, before hormonal changes are extremely pronounced and obvious.5,7 Pregnancy-induced changes to a woman’s breast include a doubling in size and weight and increased blood flow and fat due to estrogen and progesterone, which in turn increases the size of the milk-producing glands; the areola increases in size and darkens; Montgomery tubercules (small nodules around the areola) produce a lubricant and cleanse the nipple; and the glandularity and density of breast tissue increases.5,7 The baseline breast examination is critical to establishing any worrisome changes or differences that may be difficult to determine as the pregnancy progresses. A painless lump, thickening, or bloody discharge from the nipple are all manifestations of breast cancer.7 However, once the breast has become engorged, a bloody discharge from the nipple may be due to a benign condition related to breast changes during pregnancy. Any bloody discharge should be further evaluated for etiology.7 Clinical challenges with diagnosis One major contributor to the increased mortality in women with pregnancyassociated breast cancer is not related to the biology of these cancers, but the timing of diagnosis. Pregnancy-induced breast changes may be deceiving when assessing potentially abnormal changes in breast tissue. Late-stage diagnosis is not uncommon, and includes finding nodal involvement

Ultrasound images can be obtained safely during pregnancy, and are rapid and accurate. MRI and CT, however, are contraindicated. and distant metastases at the time of diagnosis. On average, diagnosis of pregnancy-associated breast cancer is delayed at least 5 to 7 months.6 Mammography has been associated with such delays given that the density of breast tissue during pregnancy can cause a very high number of false-negative findings in this population.5 A delay of 1 to 2 months increases the risk of metastasis to the axillary lymph nodes.5 In addition, worsened prognostic features are often appreciated in these women, such as higher grade, lower percentage of hormone receptor positivity, increased HER-2/neu overexpression, and higher Ki-67 nuclear antigen indices.6 With the challenges to diagnosis alone, independent of other high-risk factors, any concern of abnormal findings—either found on clinical examination or by patient report—should

be immediately investigated. The risks associated with a lack of early diagnosis and intervention extend beyond the life of the woman, to that of the fetus. This complex diagnosis leaves very little room for independent decision-making.

The multidisciplinary approach to managing breast cancer in the pregnant woman involves a collaboration between the oncologists, obstetrician, surgeon, nurse, radiation oncologist, pediatrician, and maternal-fetal medicine physician to provide care that encompasses the patient, her family, and the unborn child.5 If key disciplines are not at the forefront of the patient’s care, the outcomes for these women and their unborn fetus can be life threatening.

DIAGNOSIS IN THE PREGNANT WOMAN Treatment goals for pregnancy-associated breast cancer are aimed at pregnancy preservation, establishing a personalized treatment plan based on disease stage, biologic features, and appropriate treatment modalities with careful consideration of the potential risks to the developing fetus.3,5 The focus of care is the same approach as that for nonpregnant women with a diagnosis of breast cancer. Triple assessments consist of a thorough physical examination, assessing for lumps and regional lymph nodes; mammography or ultrasound to determine whether the lump is cystic or solid (ultrasound is preferred due to the density of breast tissue in pregnancy); and a fine needle aspiration or core biopsy to determine the type of cancer.7 Diagnostic imaging Selecting the most sensitive and specific diagnostic tool that will lead to an accurate diagnosis without hindrance or delay in treatment is imperative. Opinions vary on which diagnostic imaging tool is the most exact and concrete for diagnosing pregnancy-associated breast cancer. The validity of mammography during pregnancy has been questioned; however, the specificity by which mammograms can detect and establish important information about microcalcifications, masses, or multicentric disease is established, and these imaging tests can be safely performed during pregnancy with proper abdominal shielding.

Ultrasound images can be obtained safely during pregnancy, and are rapid and accurate. Magnetic resonance imaging (MRI) and computed tomography (CT), however, are contraindicated during pregnancy due to the risk of radiation exposure to the fetus.5 TREATMENT OPTIONS Once the diagnosis of pregnancy-associated breast cancer is confirmed and staging complete, treatment must proceed without delay. Any delay increases the risk of metastasis from 5% to 10%.5 Establishing the gestational age of the fetus at

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 21

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CONTINUING EDUCATION | Breast cancer and pregnancy the time of diagnosis is important, as this is a determining factor in choosing treatment options. Histologically, tumors in these patients are typically poorly differentiated, ER/PR negative, and HER2-positive.9 Surgery Traditional treatment regimens consisting of surgery (eg, lumpectomy, mastectomy, or radical mastectomy) combined with other modalities (eg, radiation, chemotherapy, hormone therapy, or biological therapy) must be tailored to the patient with regard to safety of the fetus. Surgery is the recommended primary treatment and can be performed without risk to the fetus.7 To avoid postsurgical radiation, a modified radical mastectomy is the

In the event that chemotherapeutic agents are needed, the preference is to administer chemotherapy during the second and third trimester. procedure of choice; however, breast-conserving surgery can be considered if diagnosis is made in the second or third trimester.7 Further treatment options should include axillary dissection because of the high-risk of metastasis.7 Radiation therapy External beam radiation to the breast, thoracic wall, and axilla are deferred until after delivery of the fetus, due to the risk of fetal exposure to internal radiation scatter.5 Radiation-induced deficits include microcephaly, urinary system defects, eye abnormalities, and skeletal deformities.

Chemotherapy The risk for spontaneous abortion and/or fetal malformations is higher if treatment involves chemotherapy administered during the first trimester. In the event that chemotherapeutic agents are needed, the preference is to administer chemotherapy during the second and third trimesters when organ development is complete; however, the fetus should still be monitored closely because approximately 50% of fetuses in cases of pregnancy-associated breast cancer are still at risk for intrauterine growth restriction, preterm delivery, or low birth weight.5,7 In addition to holding chemotherapy until the later trimesters, it should be discontinued at least 3 weeks before delivery to allow sufficient time for the mother and fetus to recover from myelosuppression, thus reducing the risk of hemorrhage and infection(s).5,7 The goal of chemotherapy in pregnancy-associated breast cancer is to minimize disease recurrence and prolong progression-free survival.5 Dose-attenuated chemotherapy may

be the standard recommendation given the hemodynamic status of the woman (ie, increased plasma volume may cause peak drug concentrations to decrease, which affects drug clearance).5 During the second and third trimesters, doxorubicin, epirubicin, 5-fluorouracil, and cyclophosphamide are relatively safe to administer to patients with pregnancyassociated cancer.5,7,9 Tamoxifen (a selective estrogen receptor modulator) is contraindicated in pregnancy due to the increased risk of fetal harm and death.

CONCLUSIONS The necessity of multidisciplinary care cannot be undermined in the management of women with breast cancer diagnosed during pregnancy. The anxiety, fear, and trauma that encapsulate women with this diagnosis, combined with concern for their unborn fetus, makes the management of this disease extend beyond that of physical care. Nurses are key to serving as mediators between the different disciplines that play a role in the care of these patients. Nurses must continue to educate themselves and their patients about the signs and symptoms of breast cancer, and the significance of completing a thorough initial examination.7 The rarity of this illness does not prohibit the incidence; therefore, pregnancy-associated breast cancer requires a personalized approach to managing treatment with careful and deliberate consideration for the mother and the unborn fetus.7 Nurses are at the forefront of providing wholistic oncology care that addresses the physical, psychological, and spiritual needs of these patients. A greater understanding of how the physiologic changes that occur during pregnancy complicate this disease and a timely diagnosis, the limitations to treatment options, and safe protocols for fetal protection will lead to better overall outcomes in this patient population.8 The literature does not support or even prove that aborting the fetus in the setting of a breast cancer diagnosis improves survival for the affected mother. Survival outcomes for both nonpregnant and pregnant women with breast cancer are equal. Despite the prognosis in these women being indeterminate, termination of pregnancy may be considered in extreme emergent cases of advanced disease.

But given that this is the exception rather than the rule,

TO TAKE THE POST-TEST FOR THIS CE ACTIVITY

and apply for 1.0 contact hours, please go to myCME.com/CEDEC2014

22 ONCOLOGY NURSE ADVISOR â&#x20AC;˘ NOVEMBER/DECEMBER 2014 â&#x20AC;˘ www.OncologyNurseAdvisor.com

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pregnancy-associated breast cancer is no longer a buzzword heard in the distant discussions of the examination room.

The prevalence and incidence of breast cancer in pregnant women are being weaved into the realm of everyday practice. The complexity of cancer in itself is enough in the absence of pregnancy; however, when two lives are impacted by the burden of cancer, the stakes are higher.

The more versed we become in the biology of this disease in this subset of patients, the better we can provide cancer care that is multidisciplinary, comprehensive, and in-depth. Pregnancy-associated breast cancer is becoming more prevalent due to current cultural choices in regard to childbearing. As a discipline, oncology can no longer regard pregnancy-associated breast cancer as an abnormally rare cancer. ■

breast cancer screening and diagnosis. J Natl Compr Canc Netw.

2009;7(10):1060-1096.

2. Carlson RW, Allred DC, Anderson BO, et al; NCCN Breast Cancer Clinical Practice Guidelines Panel. Breast cancer. Clinical practice guidelines in oncology. J Natl Compr Canc Netw.

2009;7(2):122-192.

3. Visco AG, Meyer LC, Xi S, Brown CG. One disease, two lives.

Clin J Oncol Nurs. 2009;13(4):426-432.

4. Longo DL. Breast masses in the pregnant or lactating woman. In: Longo DL, ed. Harrison’s Hematology and Oncology. New York, NY: McGraw Hill; 2010.

5. Czaplicki KL. Two lives intertwined: pregnancy-associated breast cancer.

Clin J Oncol Nurs. 2012;16(5): E183-E189.

6. Lyons TR, Schedin PJ, Borges VF. Pregnancy and breast cancer: when they collide. J Mammary Gland Biol Neoplasia. 2009;14(2):87-98.

7. Logue K. Pregnancy-associated breast cancer. Clin J Oncol Nurs.

Jia Conway is a nurse practitioner at Cancer Care Associates of York, in York, Pennsylvania.

8. Rimes S, Gano J, Hahn K, et al. Caring for the pregnant patients with

REFERENCES

9. Pegram MD, Takita C, Casciato DA. Breast cancer. In: Casciato DA, ed.

2009;13(1):25-27. breast cancer. Oncol Nurs Forum. 2006;33(6):1065-1069.

1. Bevers TB, Anderson BO, Bonaccio E, et al; National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology:

Manual of Clinical Oncology. 7th ed. New York, NY: Wolters Kluwer; 2012:316-317.

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NEW—LIQUID FORMULATION

Start with TREANDA® (bendamustine HCI) Injection for established front-line CLL therapy

Preparing for IV administration is:

Fast

Precise

Convenient

Less preparation time

No reconstitution necessary

Fewer steps prior to admixing

Important Safety Information Contraindication: TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.

Myelosuppression: TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. If myelosuppression occurs, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the ÿ rst day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, and death have occurred. Patients with myelosuppression following treatment with TREANDA are more susceptible to infections.

Anaphylaxis and Infusion Reactions: Infusion reactions to TREANDA have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their ÿ rst cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with TREANDA treatment has occurred. The onset tends to be within the ÿ rst treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly.

Learn more at TREANDAHCP.com

TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL).

Efÿ cacy relative to ÿ rst-line therapies other than chlorambucil has not been established.

Skin Reactions: Skin reactions have been reported with TREANDA treatment and include rash, toxic skin reactions, and bullous exanthema. In a study of TREANDA (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred.

TEN has been reported for rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely.

If skin reactions are severe or progressive, withhold or discontinue TREANDA. Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with TREANDA therapy has not been determined.

Extravasation Injury: TREANDA extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain. Ensure good venous access prior to starting TREANDA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA. Embryo-fetal Toxicity: TREANDA can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using TREANDA. Most Common Adverse Reactions: The most common non-hematologic adverse reactions for CLL (frequency ˜ 15%) are pyrexia, nausea, and vomiting. The most common hematologic abnormalities (frequency ˜ 15%) are anemia, thrombocytopenia, neutropenia, lymphopenia, and leukopenia.

Please see accompanying brief summary of Full Prescribing Information on the following pages.

727-40711

Page 1-2

DIGITAL

C

©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. TRE-40352 October 2014.

M

Y

K

Job Number: 20972 Revision No: 0 Date: 10/29/14

NEW—LIQUID FORMULATION

Start with TREANDA® (bendamustine HCI) Injection for established front-line CLL therapy

Preparing for IV administration is:

Fast

Precise

Convenient

Less preparation time

No reconstitution necessary

Fewer steps prior to admixing

Important Safety Information Contraindication: TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.

Myelosuppression: TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. If myelosuppression occurs, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the ÿ rst day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, and death have occurred. Patients with myelosuppression following treatment with TREANDA are more susceptible to infections.

Anaphylaxis and Infusion Reactions: Infusion reactions to TREANDA have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their ÿ rst cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with TREANDA treatment has occurred. The onset tends to be within the ÿ rst treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly.

Learn more at TREANDAHCP.com

TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL).

Efÿ cacy relative to ÿ rst-line therapies other than chlorambucil has not been established.

Skin Reactions: Skin reactions have been reported with TREANDA treatment and include rash, toxic skin reactions, and bullous exanthema. In a study of TREANDA (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred.

TEN has been reported for rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely.

If skin reactions are severe or progressive, withhold or discontinue TREANDA. Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with TREANDA therapy has not been determined.

Extravasation Injury: TREANDA extravasations have been reported in postmarketing resulting in hospitalizations from erythema, marked swelling, and pain. Ensure good venous access prior to starting TREANDA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA. Embryo-fetal Toxicity: TREANDA can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using TREANDA. Most Common Adverse Reactions: The most common non-hematologic adverse reactions for CLL (frequency ˜ 15%) are pyrexia, nausea, and vomiting. The most common hematologic abnormalities (frequency ˜ 15%) are anemia, thrombocytopenia, neutropenia, lymphopenia, and leukopenia.

Please see accompanying brief summary of Full Prescribing Information on the following pages.

727-40711

Page 1-2

DIGITAL

C

©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. TRE-40352 October 2014.

M

Y

K

Job Number: 20972 Revision No: 0 Date: 10/29/14

TREANDA® (bendamustine hydrochloride) Injection

™

Brief Summary of Prescribing Information for Chronic Lymphocytic Leukemia 1 INDICATIONS AND USAGE 1.1 Chronic Lymphocytic Leukemia (CLL) TREANDA® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

2 DOSAGE AND ADMINISTRATION 2.1 Dosing Instructions for CLL Recommended Dosage: The recommended dose is 100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

Dose Delays, Dose Modifications and Reinitiation of Therapy for CLL: TREANDA administration should be delayed in the event of Grade 4 hematologic toxicity or clinically significant ≥ Grade 2 non-hematologic toxicity. Once nonhematologic toxicity has recovered to ≤ Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 109/L, platelets ≥ 75 x 109/L], TREANDA can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted. [See Warnings and Precautions (5.1)] Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on Days 1 and 2 of each cycle.

Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle.

Dose re-escalation in subsequent cycles may be considered at the discretion of the treating physician.

2.3 Preparation for Intravenous Administration Each vial of TREANDA Injection is intended for single use only. Aseptically withdraw the volume needed for the required dose from the 90 mg/mL solution.

Immediately transfer the solution to a 500 mL infusion bag of 0.9% Sodium Chloride Injection, USP (normal saline). As an alternative to 0.9% Sodium Chloride Injection, USP (normal saline), a 500 mL infusion bag of 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, may be considered. The resulting final concentration of bendamustine HCl in the infusion bag should be within 0.2 - 0.7 mg/mL. The admixture should be a clear colorless to yellow solution.

Use either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, for dilution, as outlined above. No other diluents have been shown to be compatible.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any unused solution should be discarded according to institutional procedures for antineoplastics.

2.4 Admixture Stability TREANDA Injection contains no antimicrobial preservative. The admixture should be prepared as close as possible to the time of patient administration.

Once diluted with either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, the final admixture is stable for 24 hours when stored under refrigerated conditions at 2°-8°C (36°-46°F) or for 2 hours when stored at room temperature (15°-30°C or 59°-86°F) and room light. Administration of TREANDA must be completed within this period.

3 DOSAGE FORMS AND STRENGTHS TREANDA Injection is supplied in single-use vials containing either 45 mg/0.5mL or 180 mg/2mL of bendamustine HCl. 4 CONTRAINDICATIONS TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. [See Warnings and Precautions (5.3)] 5 WARNINGS AND PRECAUTIONS 5.1 Myelosuppression TREANDA caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppressionrelated adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with Grade 3 thrombocytopenia, and pneumonia from an opportunistic infection (CMV).

In the event of treatment-related myelosuppression, monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. In the clinical trials, blood counts were monitored every week initially. Hematologic nadirs were observed predominantly in the third week of therapy. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle. Prior to the initiation of the next cycle of therapy, the ANC should be ≥ 1 x 109/L and the platelet count should be ≥ 75 x 109/L. [See Dosage and Administration (2.1)] 5.2 Infections Infection, including pneumonia, sepsis, septic shock, and death have occurred in adult and pediatric patients in clinical trials and in postmarketing

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reports. Patients with myelosuppression following treatment with TREANDA are more susceptible to infections. Advise patients with myelosuppression following TREANDA treatment to contact a physician if they have symptoms or signs of infection.

5.3 Anaphylaxis and Infusion Reactions Infusion reactions to TREANDA have occurred commonly in clinical trials.

Symptoms include fever, chills, pruritus and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Patients who experience Grade 3 or worse allergic-type reactions should not be rechallenged. Consider measures to prevent severe reactions, including antihistamines, antipyretics and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions. Discontinue TREANDA for patients with Grade 4 infusion reactions. Consider discontinuation for Grade 3 infusions reactions as clinically appropriate considering individual benefits, risks, and supportive care.

5.4 Tumor Lysis Syndrome Tumor lysis syndrome associated with TREANDA treatment has occurred in patients in clinical trials and in postmarketing reports. The onset tends to be within the first treatment cycle of TREANDA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. Allopurinol has also been used during the beginning of TREANDA therapy. However, there may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly [see Warnings and Precautions (5.5)].

5.5 Skin Reactions Skin reactions have been reported with TREANDA treatment in clinical trials and postmarketing safety reports, including rash, toxic skin reactions and bullous exanthema. Some events occurred when TREANDA was given in combination with other anticancer agents.

In a study of TREANDA (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab (see rituximab package insert). Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. The relationship to TREANDA cannot be determined.

Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue TREANDA. 5.6 Other Malignancies There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with TREANDA, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia and bronchial carcinoma. The association with TREANDA therapy has not been determined.

5.7 Extravasation Injury TREANDA extravasations have been reported in post marketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting TREANDA infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of TREANDA. 5.8 Embryo-fetal Toxicity TREANDA can cause fetal harm when administered to a pregnant woman.

Single intraperitoneal doses of bendamustine in mice and rats administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations, and decreased fetal body weights.

6 ADVERSE REACTIONS The following serious adverse reactions have been associated with TREANDA in clinical trials and are discussed in greater detail in other sections [See Warnings and Precautions] of the label: Myelosuppression (5.1); Infections (5.2); Anaphylaxis and Infusion Reactions (5.3); Tumor Lysis Syndrome (5.4); Skin Reactions (5.5); Other Malignancies (5.6); Extravasation injury (5.7). The data described below reflect exposure to TREANDA in 153 patients who participated in an actively-controlled trial for the treatment of CLL. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

6.1 Clinical Trials Experience in CLL The data described below reflect exposure to TREANDA in 153 patients with CLL studied in an active-controlled, randomized trial.The population was 45-77 years of age, 63% male, 100% white, and were treatment naïve.

All patients started the study at a dose of 100 mg/m2 intravenously over 30 minutes on Days 1 and 2 every 28 days.

Adverse reactions were reported according to NCI CTC v.2.0. Nonhematologic adverse reactions (any grade) in the TREANDA group that occurred with a frequency greater than 15% were pyrexia (24%), nausea (20%), and vomiting (16%).

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Job Number: 20972 Revision No: 0 Date: 10/29/14

TREANDA® (bendamustine hydrochloride) Injection

TREANDA® (bendamustine hydrochloride) Injection

Other adverse reactions seen frequently in one or more studies included asthenia, fatigue, malaise, and weakness; dry mouth; somnolence; cough; constipation; headache; mucosal inflammation and stomatitis.

Worsening hypertension was reported in 4 patients treated with TREANDA in the CLL trial and in none treated with chlorambucil. Three of these 4 adverse reactions were described as a hypertensive crisis and were managed with oral medications and resolved.

The most frequent adverse reactions leading to study withdrawal for patients receiving TREANDA were hypersensitivity (2%) and pyrexia (1%).

Table 1 contains the treatment emergent adverse reactions, regardless of attribution, that were reported in ≥ 5% of patients in either treatment group in the randomized CLL clinical study.

Table 1: Non-Hematologic Adverse Reactions Occurring in Randomized CLL Clinical Study in at Least 5% of Patients

In the CLL trial, 34% of patients had bilirubin elevations, some without associated significant elevations in AST and ALT. Grade 3 or 4 increased bilirubin occurred in 3% of patients. Increases in AST and ALT of Grade 3 or 4 were limited to 1% and 3% of patients, respectively. Patients treated with TREANDA may also have changes in their creatinine levels. If abnormalities are detected, monitoring of these parameters should be continued to ensure that further deterioration does not occur.

6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of TREANDA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylaxis; and injection or infusion site reactions including phlebitis, pruritus, irritation, pain, and swelling; pneumocystis jiroveci pneumonia and pneumonitis.

Skin reactions including SJS and TEN have occurred when TREANDA was administered concomitantly with allopurinol and other medications known to cause these syndromes. [See Warnings and Precautions (5.5)] 10 OVERDOSAGE The intravenous LD50 of bendamustine HCl is 240 mg/m2 in the mouse and rat. Toxicities included sedation, tremor, ataxia, convulsions and respiratory distress.

Across all clinical experience, the reported maximum single dose received was 280 mg/m2. Three of four patients treated at this dose showed ECG changes considered dose-limiting at 7 and 21 days post-dosing. These changes included QT prolongation (one patient), sinus tachycardia (one patient), ST and T wave deviations (two patients), and left anterior fascicular block (one patient). Cardiac enzymes and ejection fractions remained normal in all patients.

No specific antidote for TREANDA overdose is known. Management of overdosage should include general supportive measures, including monitoring of hematologic parameters and ECGs. 15 REFERENCES 1. OSHA Hazardous Drugs. OSHA. [Accessed on June 19, 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html] 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Safe Handling and Disposal As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of solutions prepared from TREANDA Injection. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage.

If a solution of TREANDA contacts the skin, wash the skin immediately and thoroughly with soap and water. If TREANDA contacts the mucous membranes, flush thoroughly with water.

TREANDA is a cytotoxic drug. Follow special handling and disposal procedures1.

16.2 How Supplied TREANDA (bendamustine hydrochloride) Injection is supplied as a 90 mg/mL clear colorless to yellow solution as follows: NDC 63459-395-02: 45 mg/0.5 mL of solution in an amber single-use vial NDC 63459-396-02: 180 mg/2 mL of solution in an amber single-use vial Vials are supplied in individual cartons.

16.3 Storage TREANDA Injection must be stored refrigerated between 2°-8°C (36°-46°F).

Retain in original package until time of use to protect from light.

Number (%) of patients TREANDA (N=153) System organ class Preferred term Total number of patients with at least 1 adverse reaction Gastrointestinal disorders Nausea Vomiting Diarrhea General disorders and administration site conditions Pyrexia Fatigue Asthenia Chills Immune system disorders Hypersensitivity Infections and infestations Nasopharyngitis Infection Herpes simplex Investigations Weight decreased Metabolism and nutrition disorders Hyperuricemia Respiratory, thoracic and mediastinal disorders Cough Skin and subcutaneous tissue disorders Rash Pruritus

Chlorambucil (N=143)

All Grades

Grade 3/4

All Grades

Grade 3/4

121 (79)

52 (34)

96 (67)

25 (17)

31 (20) 24 (16) 14 (9)

1 (<1) 1 (<1) 2 (1)

21 (15) 9 (6) 5 (3)

1 (<1) 0 0

36 (24) 14 (9) 13 (8) 9 (6)

6 (4) 2 (1) 0 0

8 (6) 8 (6) 6 (4) 1 (<1)

2 (1) 0 0 0

7 (5)

2 (1)

3 (2)

0

10 (7) 9 (6) 5 (3)

0 3 (2) 0

12 (8) 1 (<1) 7 (5)

0 1 (<1) 0

11 (7)

0

5 (3)

0

11 (7)

3 (2)

2 (1)

0

6 (4)

1 (<1)

7 (5)

1 (<1)

12 (8) 8 (5)

4 (3) 0

7 (5) 2 (1)

3 (2) 0

The Grade 3 and 4 hematology laboratory test values by treatment group in the randomized CLL clinical study are described in Table 2. These findings confirm the myelosuppressive effects seen in patients treated with TREANDA. Red blood cell transfusions were administered to 20% of patients receiving TREANDA compared with 6% of patients receiving chlorambucil.

Table 2: Incidence of Hematology Laboratory Abnormalities in Patients Who Received TREANDA or Chlorambucil in the Randomized CLL Clinical Study TREANDA N=150

Chlorambucil N=141

Laboratory Abnormality

All Grades n (%)

Grade 3/4 n (%)

All Grades n (%)

Grade 3/4 n (%)

Hemoglobin Decreased

134 (89)

20 (13)

115 (82)

12 (9)

Platelets Decreased

116 (77)

16 (11)

110 (78)

14 (10)

Leukocytes Decreased

92 (61)

42 (28)

26 (18)

4 (3)

Lymphocytes Decreased

102 (68)

70 (47)

27 (19)

6 (4)

Neutrophils Decreased

113 (75)

65 (43)

86 (61)

30 (21)

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Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 TREANDA is a trademark of Cephalon, Inc. or its affiliates. ©2008-2014 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. or its affiliates.

All rights reserved.

(Label Code: 00016287.06) 9/2013 TRE-40161 This brief summary is based on TRE-009 TREANDA full Prescribing Information.

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Job Number: 20972 Revision No: 0 Date: 10/29/14

FEATURE | Cancer prehabilitation

Cancer prehabilitation: A step toward improved outcomes As cancer care evolves toward anticipatory rather than reactionary care, oncology nurses should consider developing important new skills.

JULIE K. SILVER, MD

© THINKSTOCK

Establishing psychosocial and physical baselines can improve outcomes for patients with cancer and ensure adherence to emerging guidelines for patient-centered care.

O

ncology nurses are critical to the delivery of high-quality cancer care and, as such, they are frequently introduced to patients immediately following a diagnosis. Indeed, nurses often spend more time with survivors with newly diagnosed cancer than any other health care professional. This early access provides a perfect opportunity for them to not only provide education and moral support, but also administer assessments to determine how cancer prehabilitation could be used to improve patients’ health outcomes.

The future of high-quality cancer treatment will increasingly focus on patient-centered care, supported by a strong evidence base and highly skilled providers. Nurses, particularly navigators, are uniquely positioned to deliver efficacious prehabilitation services. With this unique opportunity comes the responsibility to understand the evidence-based research and incorporate it into a best practices clinical approach to improving cancer care. Because research in this area of medicine is rapidly evolving, nurses should consider pursuing formal training and continuing education in cancer prehabilitation and collaborate more closely with rehabilitation health care professionals.

PREHABILITATION: A BRIEF HISTORY Prehabilitation is not a new concept, nor is it specific to cancer. At its core, prehabilitation is designed to improve a person’s physical and psychological health in anticipation of an upcoming stressor. Furthermore, prehabilitation is part of the rehabilitation care continuum and is defined 28 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

High

Usual Care + Prehabilitation Assessments and Interventions

Quality of Cancer Care

Baseline established with physical and psychosocial assessments

Usual Care + Education No baseline established

Usual Care

Low

No baseline established

Specific interventions to improve physical and psychological health prior to acute cancer treatment are variable with poor control and no baseline to compare results

Specific interventions employed to improve physical and psychological health above baseline prior to acute cancer treatment

No specific interventions to improve physical and psychological health prior to acute cancer treatment

Low Ability to Assess and Potentially Improve Physical and Psychological Outcomes High Reproduced from the STAR Program and used with permission from McKesson Corporation and/or one of its subsidiaries. Copyright © 2014. All Rights Reserved

FIGURE 1. Comparison of the impact of usual care, with education, and with prehabilitation assessments on quality of cancer care

temporally as those assessments and interventions that occur after diagnosis but before acute treatment begins. In a 2013 review, prehabilitation, as it relates to oncology care, was specifically defined as “[A] process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment and includes physical and psychological assessments that establish a baseline functional level, identify impairments, and provide interventions that promote physical and psychological health to reduce the incidence and/or severity of future impairments.”1

Many of the early studies on cancer prehabilitation typically focused exclusively on building strength and stamina through an appropriate exercise regimen; however, more recent research has supported a multimodal approach that encompasses more than one intervention (ie, a combination of exercise, nutrition, and psychological strategies) to better prepare patients for the challenges associated with upcoming cancer treatments.2

A ROLE FOR ONCOLOGY NURSES Nurses have long been on the front lines of oncology care, and nearly every oncology nurse is an expert at providing patient and caregiver education that begins at diagnosis and continues throughout the cancer care continuum. This includes informally explaining procedures to patients, helping patients figure out how to navigate a complicated health care system, and offering general advice and reassurance. As oncologists and others witnessed the positive impact these informal interactions had on patients, they started to support more formal nursing interventions. For example, many patients with newly diagnosed cancer receive some form of nursing-directed preoperative counseling, and having nurses lead a chemo class (a chemotherapy education class) prior to the start of chemotherapy is commonplace at cancer centers.

Navigation, which ideally begins at diagnosis, may now involve assessments, patient and caregiver education, recognition and removal of barriers to care, and coordination of other interventions. In fact, nurse navigation has become so much

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 29

FEATURE | Cancer prehabilitation more formalized that it is now included as a patient-centered standard in the American College of Surgeons’ Commission on Cancer (CoC) accreditation process.

However, there is a distinct difference between what many nurses are currently doing prior to the start of cancer treatment and what would be considered prehabilitation (Figure 1). One of the most important factors in prehabilitation is the ability to formally assess patients and then implement specific interventions that improve outcomes through objective measures.

THE NEXT EVOLUTION: HIGH-QUALITY CANCER PREHABILITATION CARE

Health care in the United States is constantly evolving and is very much focused on translating the evidence base that supports distinct interventions at specific times into clinical care.

The translation of research into clinical care, however, is not enough. More and more, hospitals and individual clinicians are becoming responsible for reporting clinical outcomes and demonstrating that the care they provide is not only the standard of care, but also high-quality care. The bar has been raised, and what used to pass for good care is no longer good enough. Indeed, with the release of the Institute of Medicine’s 2013 report “Delivering High-Quality Cancer Care: Charting

Preventing future impairments may be one of the most important contributions toward improving patient outcomes. a New Course for a System in Crisis,” every hospital and cancer center in the United States was given the undeniable message to step it up.3 With the focus squarely on improving every aspect of oncology care, offering evidence-based prehabilitation care by well-trained nurses who are tracking and reporting outcomes makes sense. After all, prehabilitation can impact outcomes including health-related quality of life, return to work, and physical function. As people begin to understand the role of prehabilitation in improving outcomes, there will be an increasing demand for these services—by doctors and patients alike.

Trained rehabilitation specialists, such as physiatrists and physical, occupational, and speech therapists, treat existing physical impairments in cancer survivors, and although nurses with specific training may work within the auspices of skilled care in rehabilitation settings, the typical oncology nurse would not provide rehabilitation care. For example, a patient with

newly diagnosed breast cancer who presents with a painful shoulder when she lifts her arm overhead would be referred to a physiatrist or orthopedist who can determine whether further diagnostic testing is warranted (eg, an MRI), make a diagnosis (eg, rotator cuff impingement or adhesive capsulitis), and decide on the next steps regarding treatment (eg, corticosteroid injection, physical therapy, etc).

In contrast, prehabilitation, technically a part of the rehabilitation care continuum but entailing the period of time before cancer treatment begins, provides an opportunity to prevent or limit the development of future impairments.

Prehabilitation interventions ideally engage a multimodal and interdisciplinary approach to preparation for cancer treatment by bringing in additional specialists such as mental health professionals, dieticians, nurses, and depending on the patient population, respiratory or other types of therapists. The ideal prehabilitation protocol involves an interdisciplinary team, with each health care professional performing assessments and interventions within his or her area of expertise.

However, the reality is that prehabilitation care needs to be streamlined, and nurses with the appropriate training should be able to step in to perform certain early assessments and interventions efficiently and expertly.

Nurses, in particular, are uniquely positioned to participate in and even lead prehabilitation initiatives within their institutions. For example, consider the aforementioned case of newly diagnosed breast cancer. Two recent reviews highlighted an urgent need to better address upper body pain and dysfunction in patients with breast cancer, reporting that upper body impairments occur in up to 50% to 62% of breast cancer survivors.4,5 Undoubtedly, rehabilitation specialists should be involved in the care of these patients from diagnosis onward; however, if a physiatrist or a physical or occupational therapist is not available during a patient visit, a nurse-led prehabilitation protocol for screening shoulder problems could be employed.

The screening assessment might include a validated patientreport instrument such as the QuickDASH6 and/or a brief physical examination of the upper extremities, range of motion, and other evaluations. The assessment should also include a validated measure of general physical conditioning, such as the 6-Minute Walk Test. If the patient demonstrates a problem during the screening, a referral to a rehabilitation specialist would be made for further evaluation and treatment. If no impairments are identified, the nurse could provide instruction on preoperative shoulder range-of-motion exercises. In this scenario, the patient has now been routed more efficiently through prehabilitation assessments and interventions that research has demonstrated may improve pain and dysfunction outcomes better than pretreatment education alone.7 In addition, the patient’s medical record now

30 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

Excellent Health / Function

AB

REH

AB

EH

PR

BASELINE

NO PREHAB

REHAB NO REHA

B

B

REHA

Poor

NO REHAB

Diagnosis

Before Treatment

Acute Treatment

Survivorship

Reproduced from the STAR Program and used with permission from McKesson Corporation and/or one of its subsidiaries. Copyright © 2014. All Rights Reserved

FIGURE 2. Prehabilitation may improve baseline status and, combined with early rehabilitation, overall outcomes.

includes assessments that can be utilized during postoperative recovery and surveillance phases to facilitate earlier detection of impairments and referral for appropriate interventions.

Similarly, if a mental health specialist was not available during a patient visit, a nurse could conduct distress screening and refer the patient for specific stress reduction techniques, such as meditation or guided imagery. Preventing future impairments in patients with newly diagnosed cancer is something that oncology nurses can and should be trained to do. This may in fact be one of the most important contributions of nurse navigators in improving patient outcomes and the delivery of high-quality care.

SEIZING THE OPPORTUNITY TO IMPROVE CARE In a recent study, 401 members of the Academy of Oncology Nurse Navigators were surveyed, and approximately half of the respondents reported that their own knowledge of cancer rehabilitation and appropriate referrals for care was relatively

low.8 In the same survey, 90% of participants responded that cancer rehabilitation services were important.8 Clearly, while nurses value cancer rehabilitation care, many have not had specific training in this area of medicine. In the CoC model, the cancer committee would include a cancer rehabilitation specialist who would oversee staff training and implementation of physical assessments and interventions associated with prehabilitation. Similarly, a mental health professional is required to oversee, but not necessarily personally perform, distress screening (Standard 3.2) and report the results to the cancer committee.9 Ideally, in some settings nurses should be trained to perform prehabilitation physical assessments such as the QuickDASH and screening upper extremity evaluations, and trained to perform early distress screening.

As cancer prehabilitation has begun to evolve and is increasingly becoming part of high-quality care, initial screening has clearly become an important step in the cancer care process. Furthermore, because cancer and its treatments

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 31

FEATURE | Cancer prehabilitation may cause both emotional and physical issues in survivors, dual screening for physical and psychological impairments is crucial.10 These baseline screenings allow for an early understanding of the patient’s physical, psychological, and functional impairments, and provide information for directed interventions that may prevent or limit future impairments and/or disability. These pretreatment screenings are also essential to establishing objective baselines that demonstrate individual patient and survivor population outcomes while offering an opportunity to demonstrate lower health care costs and higher employment rates in survivors who are able

Prehabilitation assessments and interventions should be carefully timed to use whatever window of opportunity is available. to function at a higher level throughout and beyond their acute oncologic treatment (Figure 2).

Delays in cancer treatment may adversely affect prognosis, therefore prehabilitation assessments and interventions should be carefully timed to use whatever window of opportunity is available before treatment begins. Even if the time before treatment begins is very short, prehabilitation provides an opportunity to gather the baseline status of the patient, to provide interventions that can be utilized throughout treatment, and to encourage and empower the patient. In this way, whatever time is available to patients with new cancer diagnoses before treatment begins is utilized to enhance their physical, emotional, and functional health outcomes. For example, encouraging patients to begin an exercise program that can be carried into the treatment phase right away is beneficial, and even if the therapeutic benefits of exercise are not immediately demonstrable, it still may improve a number of outcomes including mood, comfort, and endurance. Moreover, starting the exercise program immediately may also improve adherence not only to physical activity recommendations but also to acute treatments such as chemotherapy.

Similarly, teaching patients specific strategies such as meditation or guided imagery to decrease stress provides them with tools they can use within days as they prepare for surgery or other upcoming treatments.

Whether prehabilitation is reimbursable by third-party payers depends on many factors including which assessments and interventions were performed, who performed them, and the setting in which they took place.11 For example, interventions

such as smoking cessation, anxiety reduction, and the identification and treatment of physical impairments are often covered by third-party payers. Notably, the last is typically covered only when provided by specialists such as physiatrists and physical, occupational, and speech therapists.

Direct reimbursement for nursing care, including navigation, is more challenging. Even when direct reimbursement for nursing care is not available, there are important ways to demonstrate economic value. For example, patients who are entered into a supportive prehabilitation protocol right after diagnosis may be more likely to receive their total cancer care at that institution. Even if they are intent on getting a second opinion, the value of having patients immediately bond with their health care team and empowering them with specific patient-centered interventions that can improve their outcomes cannot be understated. Demonstrating that a nurse navigatorled prehabilitation workshop decreased the outmigration rate is one way of showing value independent of reimbursement.

In fact, other measures of nursing and navigation value include improved access to services, better adherence to cancer treatment, reduced hospital length of stay or unplanned readmissions, increased patient satisfaction, increased physical and/or functional outcomes, reduced numbers of negative metastatic workups for untreated musculoskeletal pain problems (eg, rotator cuff impingement that causes night pain), and so on. Moreover, as payers become less focused on fee-for-service models, nurses will have more opportunities to deliver clinical services.

THE FUTURE OF CANCER PREHABILITATION Various models of cancer prehabilitation will undoubtedly emerge and be tested. The convenience of having nurse navigators present on the front end at diagnosis will provide an excellent opportunity for them to be involved. Nurses, too, will need to transition from what they are doing or have done in the past with new cancer patients and move toward incorporating more sophisticated, evidence-based protocols for pretreatment assessments, interventions, and documentation of improved outcomes. In a high-quality oncology model that includes prehabilitation services, there is a need to identify core competencies for nurses and other clinicians, provide training to develop the skills necessary to deliver high-quality care, and access ongoing continuing education as the research in this area rapidly expands. This will be challenging and require a commitment of the time and resources necessary to ensure expertise in the delivery of cancer prehabilitation care. With this challenge, however, comes a unique opportunity to show the value of nurses in high-quality cancer care from diagnosis onward. ■ Continues on page 50

32 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

FEATURE | Stress-reducing techniques

Study validates effectiveness of MBSR programs for nurses Mindfulness-based stress reduction programs can be incorporated into daily nursing practice routines to help oncology nurses de-stress.

JOHN SCHIESZER, MA

F

© THINKSTOCK

or oncology nurse Shannon Krus, RN, the hardest part of her job is when patients do not respond well to therapy and all treatment options fail. As every oncology nurse knows, Krus said some days can be highly stressful. “Even though it is not your fault, there can be an overwhelming amount of sadness to constantly losing patients to their disease. The best thing that we do is remind ourselves that we have worked hard to make their journey to the end of their lives better or easier for them,” said Krus, who is 34 years old.

Krus has been working as an oncology nurse for 10 years, and to help lower her stress levels and avoid burnout, she runs on a regular basis.

She runs 2 to 3 miles most days of the week.

Now, a new study suggests she may want to consider adding a stress reduction program to her running regimen. Researchers in Minnesota report that nurses may be able to improve their health, and possibly the health of their patients, through an innovative mindfulness-based stress reduction program.1 The study findings demonstrate that implementing a mindfulness-based stress reduction (MBSR) program can reduce employee stress and burnout.1 A PROVEN INTERVENTION MBSR was developed in 1979 by Jon KabatZinn at the University of Massachusetts Medical Center to teach patients with chronic medical conditions how to lead fuller and healthier lives. Lead author Dawn Bazarko,

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 33

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FEATURE | Stress-reducing techniques DNP, MPH, RN, describes mindfulness as a self-directed practice for relaxing the body and calming the mind by focusing on present-moment awareness.

Bazarko and her colleagues enrolled 41 female nurses from a large health care company in this study. The nurses participated in an 8-week course of guided instruction in mindfulness meditation practices. The program also included facilitated group discussions, stretching and yoga, home assignments, and individually tailored instruction and support.

“Nurses need interventions to help them with the challenges they face. Burnout is a real problem, and this is a program that could be beneficial,” said Bazarko, who is with the Center for Nursing Advancement, UnitedHealth Group, in Minnetonka, Minnesota. “The research in this area has just exploded, but we are one of the first to test this approach and study it in this manner.”

In the study, an MBSR program that replaced 6 of 8 traditional in-person sessions with group teleconference sessions was implemented. Bazarko said using teleconferences in place of in-person sessions allowed the program to be tailored to the needs and time constraints of nurses.

All the nurses in this study were surveyed at three points: at baseline, at the end of the 8-week intervention, and 4 months after the intervention. The nurses were asked about their overall health, stress levels, burnout, self-compassion, serenity, and empathy.

The study demonstrated statistical improvements in the overall health and wellness of the nurses at each point of intervention. In addition, the nurses who continued their MBSR practice after the intervention showed even better outcomes than those nurses who did not continue the program. Bazarko said this type of MBSR program is a low-cost, feasible way to help health care providers who are unable to access traditional, on-site programs, and it may ideal for oncology nurses. “You are facing issues of death and dying, and the family issues and the social issues around it. So, I think it could be really helpful,” said Bazarko in

an interview with Oncology Nurse Advisor. “Health reform and the pace of change continue to excel, and a tool such as mindfulness can help with all that.”

LASTING EFFECTS Bazarko notes that stress is extraordinarily expensive for hospitals and cancer centers due to an increased risk for errors and high turnover rates. The nurses who participated in the study reported utilizing new strategies in the workplace as a result of participating in the program. For example, some nurses report beginning their staff meetings with a brief meditation. Promoting mindfulness may be a way to increase compassion and improve workplace culture, which can ultimately improve patient care and the organization as a whole.

“There are no studies that show mindfulness lowers health care costs, but all the findings suggest [it does]. Nurses have high turnover rates, so keeping them healthy and happy will allow them to be more compassionate. They will also stay longer and have better patient outcomes,” said Bazarko.

Krus, who is with the Siteman Cancer Center at BarnesJewish Hospital in St. Louis, Missouri, said she and her colleagues have group team-building sessions 3 to 5 days a week. The sessions help lower stress, Krus explained.

“We meet in an open area in our treatment room after patients have finished infusions, and we do a 15-minute workout together that includes stretching and strengthening exercises. We discuss what went good with the day and often air the frustrations of the day. Then we talk about non-work-related things. It is a great way to end the day and helps us to de-stress before going home.” ■ John Schieszer is a medical journalist based in Seattle, Washington.

REFERENCES 1. Bazarko D, Cate RA, Azocar F, Kreitzer MJ. The impact of an innovative mindfulness-based stress reduction program on the health and wellbeing of nurses employed in a corporate setting. J Workplace Behav Health. 2013;28(2):107-133. doi:10.1080/15555240.2013.779518.

FROM THE ONA FACT SHEETS LIBRARY

ON THE

WEB

Coping with Cancer During the Holidays

Breast Cancer: Coping with Your Changing Feelings

Living with Grief: How Can You Help Yourself?

Share these and other Fact Sheets with your colleagues and patients.

For these and more fact sheets on oncology topics go to www.OncologyNurseAdvisor.com/fact-sheets

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 39

THE ONA INTERVIEW

Breaking the barriers to effective palliative care

P Asking openended questions allows the patient to name what they are feeling, process the information, and talk about their fears and concerns.

atients with advanced cancer are asked to make decisions on how they want their care managed once treatment is no longer helping: Hospice. Patients who are benefiting from cancer treatment need help coping with the side effects of both their cancer and its treatments: Palliative care.

How are they different? When are they the same? Oncology Nurse Advisor (ONA) talked with Diane E. Meier, MD, about what nurses need to know about quality palliative care programs, the impending changes from the Affordable Care Act (ACA), and how to engage patients in palliative care discussions.

Meier is director of the Center to Advance Palliative Care (CAPC), vice-chair for public policy, and professor of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai in New York City.

She is also co-author of a new book on palliative care, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform.

ONA: What are barriers to more effective use of palliative care?

MEIER: Barriers to more effective use of pal-

liative care include a misunderstanding among clinicians in general about the fact that palliative care is a concurrent—at the same time as disease treatment—model and not the same as hospice. A lack of training on the core principles and practices of palliative care also hinders more effective use of palliative care.

ONA: How will the expansion of access to palliative care under the ACA impact oncology care?

MEIER: The ACA does not call explicitly

for palliative care, but its attention to

value-improving quality while controlling costs is a major incentive for developing systemwide palliative care services, which do both.

ONA: When is the best time to open a discussion on palliative care?

MEIER: The best time to open this discussion

is at the point of diagnosis of any serious illness. Asking open-ended questions allows the patient to name what they are feeling, process the information, and talk about their fears and concerns.

ONA: How do caregiver/family dynamics impact palliative care?

MEIER: Family dynamics and their assess-

ment and support is central to good medical care of any type and is especially important during serious illnesses, when stress and disagreement tend to emerge because of the stress and anxiety of their loved one’s illness.

ONA: What can nurses do to improve patient outcomes through effective palliative care?

MEIER: Just like doctors, most nurses have

had little to no training in the main elements of palliative care. Nurses can pursue training through ELNEC or CAPC or Vital Talk—all of which can be used on a mobile device or tablet during short periods of down time such as a break, waiting for the bus, or in line at the grocery store. These superb online resources are an effective and efficient way to improve skills and knowledge on these crucial elements of quality patient and family care.

To read the complete ONA Interview with Diane E. Meier, MD, go to www.OncologyNurseAdvisor. com/ONAinterview-Meier. ■

40 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

STAT CONSULT Ramucirumab (Cyramza) Drug type

• Human vascular endothelial growth factor receptor 2 antagonist

Indications

Dose adjustments

• Treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma ——As a single agent, or ——In combination with paclitaxel, after prior fluoropyrimidine- or platinum-containing chemotherapy

• Infusion-related reactions (IRRs) ——Grade 1 or 2 IRRs ■■ Reduce infusion rate by 50% ——Grade 3 or 4 IRRs ■■ Permanently discontinue • Hypertension ——Interrupt for severe hypertension until controlled with medical management ——Permanently discontinue for severe hypertension that cannot be controlled with antihypertensive therapy • Proteinuria ——Interrupt for urine protein levels ≥2 g/24 hours; reinitiate at 6 mg/kg every 2 weeks once urine protein level returns to <2 g/24 hours ——If protein levels ≥2 g/24 hours recur, interrupt ramucirumab and reduce dose to 5 mg/kg every 2 weeks until urine protein level returns to <2 g/24 hours ——Permanently discontinue for urine protein level >3 g/ 24 hours or in the setting of nephrotic syndrome • Wound healing complications ——Interrupt ramucirumab prior to scheduled surgery until wound is fully healed • Arterial thromboembolic events, gastrointestinal perforation, or grade 3 or 4 bleeding ——Permanently discontinue

Mechanism of action

• Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist that specifically binds VEGF receptor 2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D • Ramucirumab inhibits ligand-stimulated activation of VEGF receptor 2, thereby inhibiting ligand-induced proliferation, and migration of human endothelial cells Dosage and administration

• Dosage ——Gastric Cancer ■■ Ramucirumab 8 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity • Administration ——Administer by IV infusion over 60 minutes ——Use of a protein sparing 0.22 micron f ilter recommended ——Premedicate with ■■ An H1-antagonist (eg, diphenhydramine) ■■ Dexamethasone and acetaminophen »» If patient has experienced grade 1 or 2 infusion reaction

Special populations

• Pregnancy category C Continues on page 42

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 41

STAT CONSULT • Lactation ——Unknown whether excreted in human breast milk ——Discontinue drug or nursing

——Epistaxis ——Fatigue ——Neutropenia

Warnings/precautions

Drug interactions

• Arterial thromboembolic events (ATEs) ——Serious, sometimes fatal ATEs have been reported in clinical trials ——Discontinue ramucirumab for severe ATEs • Hypertension ——Monitor blood pressure and treat hypertension ——Temporarily suspend ramucirumab for severe hypertension ——Discontinue ramucirumab if hypertension cannot be medically controlled • Infusion-related reactions ——Monitor for signs and symptoms during infusion ——Premedicate with an H1 antagonist • Gastrointestinal perforation ——Discontinue ramucirumab • Impaired wound healing ——Withhold ramucirumab prior to surgery • Clinical deterioration in patients with cirrhosis ——New onset or worsening encephalopathy, ascites, or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis • Reversible posterior leukoencephalopathy syndrome ——Discontinue ramucirumab

• No pharmacokinetic interactions were observed between ramucirumab and paclitaxel.

Adverse effects

• Most common adverse reactions as a single-agent ——Diarrhea ——Hypertension • Most common adverse reactions in combination with paclitaxel ——Diarrhea

What to tell your patient

• Ramucirumab can cause severe bleeding.

——Contact your health care provider if you experience bleeding or symptoms of bleeding such as lightheadness • Your risk of an arterial thromboembolic event is increased.

• You will need routine blood pressure monitoring.

Contact your health care provider ——If your blood pressure is elevated ——If you experience symptoms of hypertension, including severe headache, lightheadedness, or neurologic symptoms • Notify your health care provider if you experience severe diarrhea, vomiting, or severe abdominal pain • Ramucirumab has the potential to impair wound healing.

——You should not have any surgery without first discussing this potential risk with your health care provider.

• Ramucirumab may harm the fetus if you are pregnant or become pregnant while taking this medication.

——Tell your doctor if you are or may be pregnant ——You should avoid becoming pregnant for at least 3 months following your last dose of ramucirumab.

• You should discontinue nursing while you are undergoing treatment with ramucirumab. ■ Prepared by Jason Hoffman, PharmD, RPh.

STAT CONSULT SLIDESHOWS

ON THE

WEB

Tamoxifen

Cisplatin (Platinol)

Erlotinib (Tarceva)

Trastuzumab (Herceptin)

Vincristine

Pertuzumab (Perjeta)

Axitinib (Inlyta)

Ipilimumab (Yervoy)

For these and more Stat Consult slideshows go to www.OncologyNurseAdvisor.com/stat-consult

42 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

©THINKSTOCK

RADIATION & YOUR PATIENT

Monitoring psychosocial function in radiotherapy Bryant Furlow Psychosocial decline occurs in an estimated one-third of patients undergoing radiotherapy for cancer, according to a recently published evidence review. These declines are associated with poor patient quality of life but may sometimes be ameliorated by vigilant recognition of the need to refer patients for psychosocial support interventions. There are myriad psychometric instruments available for assessing and monitoring patients’ psychosocial function status before and during treatment, including a recently promulgated, very simple self-report tool, the NCCN Distress Thermometer for Patients.

P

sychosocial functioning is a complex construct, referring to social, emotional, and cognitive performance and well-being; psychosocial declines can involve fear, anxiety,

depression, panic, social isolation, fatigue, and existential and spiritual crisis.1 These declines can be accompanied and exacerbated by declines in cognitive function such as chemo-brain or advanced age.2 Concomitant cognitive disorders such as Alzheimer’s disease profoundly impair patients’ working memory and decision-making abilities, and can complicate the frequently already-ambiguous legal landscapes surrounding medical care.2 But radiation therapy (RT) team members should be alert for the more subtle signs of psychosocial decline as well. Declines in psychosocial function correlate with impaired resilience and lower quality of life, and can increase patients’ psychological, and possibly physical, suffering during their remaining lifetime.2,3 The Nationa l Comprehensive Cancer Network (NCCN) therefore includes patient distress management in its standards of care.1 The NCCN uses the term distress rather than psychosocial, psychiatric, or emotional because the term is less potentially stigmatizing, has been deemed less embarrassing to patients, and is readily measured with self-report instruments. The timely recognition, monitoring, documentation, and treatment of distress starts with initial screening at diagnosis and is repeated at appropriate intervals and as clinically indicated, particularly when disease status changes (eg, at remission, recurrence, or tumor progression).1 The guideline also recommends developing educational/training programs for all appropriate staff on assessment and management of distress in patients.1 Licensed mental health professionals experienced in the psychosocial aspects of cancer should be available for patient referrals by staff.1

MEASURING IMPACT ON PSYCHOSOCIAL FUNCTION

Psychological screening for patients undergoing cancer radiotherapy has been relatively little studied, and research efforts have been poorly coordinated, resulting in myriad different screening and psychosocial function assessment tools used at different centers.4 “These uncoordinated efforts have amassed inconsistent data, leaving many unanswered questions regarding psychosocial function maintenance in radiation oncology,” report Hess and Chen, authors of a systematic literature review of 93 published English-language studies of psychosocial function measurement in radiotherapy clinics.4 These authors conducted their review to assess what is known about the prevalence of psychosocial decline in patients undergoing radiothera-

Before referrals can be made, declines must be reliably detected. py, the risk factors for decline, and intervention strategies.4 Their review identif ied more than a dozen risk factors associated with psychosocial decline in radiotherapy in two or more reviewed studies; five of the risk factors were particularly robust: female sex, younger age, point in treatment course, severity of physical symptoms, and treatment includes chemotherapy4 (Table 1). The association with point in treatment course requires further study, but several of the reviewed

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 45

RADIATION & YOUR PATIENT studies suggest that decline accelerates during or after radiotherapy, whereas anxiety is higher before treatment begins.4 “Psychosocial function declines in approximately one-third of RT patients,” Hess and Chen report.4 TABLE 1. Risk factors reported as predictive of psychosocial decline in ≥2 studies4 Age <60 years Concomitant chemotherapy Female sex Impaired baseline psychosocial (cognitive/ social/emotional) and physical function Pain Palliative treatment intent Patient history of depression Postmastectomy status Pre-radiotherapy anxiety levels Prior laryngectomy, in patients with head and neck cancer Severe physical symptoms (eg, pain) Time point during radiotherapy Tumor stage

“Anxiety can dissipate after initiation of RT, whereas depression can persist throughout and after RT.” Severe physical symptoms and timerelated factors are the greatest predictors of psychosocial function decline.

Psychotherapy and interventions by the radiotherapy team aimed to

ONCOLOGY NURSE ADVISOR FORUM

Jia R. Conway, DNP, FNP-BC, NP-C, oncology nurse practitioner at Cancer Care Associates of York in York, Pennsylvania.

Abimbola Farinde, PharmD, MS, BCPP, CGP, LCDC, PM/ PRC, FASCP, FACA, FNAP, Rsci, ARSPharmS, clinical pharmacist specialist, Clear Lake Regional Medical Center, Webster, Texas Donald R. Fleming, MD, hematologist/oncologist, Cancer Care Center, Davis Memorial Hospital, Elkins, West Virginia.

Kerstin L. Lappen, RN, MS, ACNS, ACHPN, clinical nurse specialist, palliative care consult service, Abbott Northwestern Hospital, Allina Health System, Minneapolis, Minnesota.

K. Lynne Quinn, RN, MSN, CRNP, AOCNP, director of oncology, Bryn Mawr Hospital and Bryn Mawr Health Center, Bryn Mawr, Pennsylvania.

Ideally, a patient navigation tool is easy for the patient to use, and the patient can easily understand the information provided. Many patients are savvy Internet users and have at least one device with which to access the Internet; therefore, web-based resources are helpful. Other advantages include the resource is more likely to be upto-date each time the patient refers to it; the resource is usually available 24 hours a day, 7 days a week; and a greater selection of resources may be available. In addition, some web-based tools are designed specifically for navigators for monitoring patient status and where patients are along the continuum of care. This method usually also allows for creating end-of-treatment documentation that can be shared with the patient and their primary care physicians. This tool then allows all who might be caring for the patient (now survivor) to correctly order needed follow up studies, etc, to do lifetime monitoring.

Printed materials, however, have a few advantages as well. They can be handed to the patient and easily reviewed in person. Patients can show their nurses which information is confusing to them and ask questions, and nurses can be more confident the patient is referring to reliable information. Disadvantages include the increased administrative work to maintain the supply of materials, as well as keeping the supply up-to-date.

The ideal time to introduce a patient navigation tool is at the first patient-education session with the patient’s nurse. Then, at each subsequent visit, the navigation tool can be reviewed, updated, and adjusted to the patient’s information needs. As with many aspects of cancer care, an approach tailored to the patient’s needs is the most effective one. For many patients, a combination of both Web-based resources and printed materials would provide the information they need in a format that enables them to navigate their cancer journey. —The Editors

SOME PORT MAINTENANCE IS OUTSIDE THE SCOPE OF NURSING PRACTICE Is it within a nurse’s scope of practice to flip a port over with a physician’s order? I am getting mixed responses from colleagues, and cannot find any literature that either supports or refutes nurses performing this task. —Jennifer Edwards, RN, BSN, OCN

Lisa A. Thompson, PharmD, BCOP, clinical pharmacy specialist in oncology, Kaiser Permanente, Colorado

Rosemarie A. Tucci, RN, MSN, AOCN, manager for oncology research & data services, Lankenau Hospital, Wynnewood, Pennsylvania

This is a controversial question, as nursing practice can differ from state to state. That being said however, Oncology Nursing Society’s standards for caring for vascular

DO YOU HAVE A QUESTION FOR OUR CONSULTANTS? Send it to editor.ona@haymarketmedia.com.

www.OncologyNurseAdvisor.com • MARCH/APRIL 2014 • ONCOLOGY NURSE ADVISOR 13

© DAVID MACK / SCIENCE SOURCE

CREATING EFFECTIVE NAVIGATION TOOLS FOR PATIENTS Would a patient navigation tool be Web-based resources, printed materials, or both? Which member of the treatment team is the ideal person to introduce the resource to the patient and when? — Robert Mark Baldridge

Ann J. Brady, RN, BSN, symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California.

Bryant Furlow is a medical journalist based in Albuquerque, New Mexico.

REFERENCES 1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Distress Management, Version 2.2013. http://www. nccn.org/professionals/physician_gls/pdf/ distress.pdf. Accessed November 13, 2014.

2. Kuśnierkiewicz M, Kędziora J, JaroszykPawlukiewicz J, Nowak-Jaroszyk M. Psychosocial and legal aspects of oncological treatment in patients with cognitive impairment. Rep Pract Oncol Radiother.

2014;19(3):157-164.

3. Brix C, Schleussner C, Füller J, et al. The need for psychosocial support and its determinants in a sample of patients undergoing radiooncological treatment of cancer. J Psychosomatic Res. 2008;65(6):541-548.

4. Hess CB, Chen AM. Measuring psychosocial functioning in the radiation oncology clinic: a systematic review. Psychooncology.

2014;23(8):841-854.

5. Lowery AE, Holland JC. Screening cancer patients for distress: guidelines for routine implementation. Community Oncol.

2001;8(11):502-504. http://www.oncologypractice.com/fileadmin/content_images/co/ articles/0811502.pdf. Accessed November 13, 2014.

6. National Comprehensive Cancer Network (NCCN). NCCN distress thermometer for patients. http://www.nccn.org/patients/ resources/life_with_cancer/pdf/nccn_ distress_thermometer.pdf. Accessed November 13, 2014.

ASK A PHARMACIST

QUESTIONS & ANSWERS

Our Consultants

improve patient education are effective mitigating strategies. For example, two studies in the review reported that psychosocial decline was alleviated by patient education sessions; however, one reported only stress reaction improved, not overall quality of life.4 But before referrals for psychology services or other interventions can be made, declines must be reliably detected. NCCN has promulgated distress management guidelines.5 “The gold standard psychiatric interview is optimal to assess the multifaceted components of human psychosocial response,” note Hess and Chen; “but is reportedly too time-consuming for practically widespread implementation in busy clinics.”4 Many clinics and researchers therefore use quicker instruments such as questionnaires patients complete on their own or with help from a nurse, such as the Beck Depression Index (BDI).4 Perhaps the simplest instrument is the NCCN Patient Distress Thermometer, a selfreport questionnaire.6 However, the evidence base for its use is immature; only five (5.4%) of the studies reviewed

by Hess and Chen utilized it.4 Oncology nurses should be familiar with the risk factors of psychosocial decline, their institution’s preferred instrument for measuring psychosocial function and its administration, as well as education or referral procedures when psychosocial decline is detected. ■

Conceptual illustration of a stimulated site of pain (ball of barbed wire)

Managing peripheral neuropathy related to vincristine Has any medicine or supplement been shown to help lessen severity of peripheral neuropathy related to vincristine? Glutamine or gabapentin has not been successful in our experience.

—Carrie L Lewis, RN, MSN, CPNP, CPON

Vincristine (Oncovin) is used in the treatment of a variety of cancers, including some leukemias and lymphomas. Rates of peripheral neuropathy with vincristine vary between regimens and patient populations, and have been reported in 35% to 45% of patients in some studies. Risk factors for development of peripheral

neuropathy include higher doses of vincristine, larger cumulative doses of vincristine, the presence of baseline neuropathy, and some drug-drug interactions. Patients experiencing peripheral neuropathy due to vincristine may experience pain, tingling, numbness, and reduced sensation in the hands and feet.

Management of peripheral neuropathy may depend on the severity of symptoms and the patient’s treatment course.

Patients with clinically significant neuropathy during vincristine therapy should be monitored closely and considered for a dose-reduction or vincristine discontinuation. Improvement or resolution of neuropathy may take up to 2 years, and some patients may experience a worsening of their neuropathy symptoms after vincristine is discontinued.

Unfortunately, some patients may have ongoing neuropathy even after this time.

Treatment options for vincristine and other chemotherapy-induced peripheral neuropathy include tricyclic antidepressants (eg, amitriptyline [Elavil]), anticonvulsants (eg, carbamazepine [Tegretol]), gabapentin (Neurontin), pregabalin (Lyrica), and serotoninnorepinephrine reuptake inhibitors (eg, duloxetine [Cymbalta]). Some supplements, such as glutamine and pyridoxine, have also been studied in the prevention of peripheral neuropathy.

Although multiple agents have been studied to treat chemotherapy-induced peripheral neuropathy, no agents have consistently shown a benefit in randomized phase 3 clinical trials. Opioids

or other analgesics may be required to control pain symptoms in patients whose pain is not managed.

Early detection of vincristine-induced peripheral neuropathy with appropriate adjustment of a patient’s vincristine therapy is critical to reduce the risk of long-term neuropathy symptoms after treatment. Patients with persistent symptoms should be referred to a neurologist for a thorough work-up and consideration of alternate therapies. Working with an occupational therapist may also be helpful to restore lost function due to neuropathy.

TIP FOR PATIENTS National Drug Take-Back Day: April 26, 2014

Spring 2014 DEA Drug Take Back Day events will be held on Saturday, April 26, from 10 AM to 2 PM. These events are a great way for patients to dispose of expired or unwanted medications, including controlled substances such as pain medications. Since beginning in 2010, these events have disposed of more than 1,733 tons of prescription medications. For more information, including collection sites in your area, please visit www.deadiversion.usdoj.gov/ drug_disposal/takeback/ after April 1st.

For information on how to advise patients regarding other ways to dispose of nonchemotherapy medications, please visit www.oncologynurseadvisor.com/ educating-patients-about-the-properdisposal-of-old-drugs/article/168850/. ■

Let us answer your questions!

E-mail us at editor.ona@haymarketmedia.com with your general questions for our expert Advisor Forum and your drug-related questions for Ask a Pharmacist!

Lisa A. Thompson, PharmD, BCOP Clinical Pharmacy Specialist in Oncology Kaiser Permanente, Colorado

52 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2014 • www.OncologyNurseAdvisor.com

46 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

COMMUNICATION CHALLENGES

Mirror, mirror

© THINKSTOCK

Ann J. Brady, MSN, RN-BC

Do we take better care of the patients we readily identify with?

C

an we see the empathy gap in our own practice? How do we manage the challenge of caring for patients/families we do not relate to? Do we take better care of the patients we readily identify with?

CASE “Magic mirror on the wall, who is the fairest one of all?” The wicked Queen in the movie “Snow White” was threatened by the beauty of her stepdaughter, so she poisoned her with an apple and put her into a deep sleep.1 Fairy tales fill a specific niche in childhood books—they teach us valuable lessons by breaking down moral teachings into understandable stories.

At a recent conference on pain management I was reminded of the Brothers Grimm fairy tale. I remembered watching the Disney movie as a young girl, and I pictured the scene where the terrible queen stood in front of the mirror asking who was the fairest of all.

Why would a pain conference remind me of

this fairy tale? It started with a question from a nurse in attendance. Her question was so extreme I was certain she was planted in the audience to help the speaker make her point.

She stood and cleared her throat, “The video makes it seem so easy: A white nurse assessing the pain of a white patient. What happens when the patient is homeless and dirty?”

Turned out she was not a plant. She went on to explain, defend actually, her struggle caring for a patient she did not relate to and who she believed had exaggerated their need for pain medication. Was it not reasonable, she argued, to profile our patients based on their appearance? There was a collective gasp in the room. I imagine those next to her shifted their seats away. I had to force myself to keep from turning around and staring at her. The presenter re-framed the question so that the information presented morphed into a discussion about the impact of bias on nursing practice. She was polite yet direct in her response: We have an ethical responsibility to provide care to our patients regardless of the view we have of them or whether we feel a connection to them. After the conference that one question stood out in everyone’s mind as it seemed to exemplify the worst in nursing. Comments about how wonderful the conference was were quickly followed by the statement, “Can you believe that nurse asked that question?” None of us wanted our practice to be associated with her proclamation.

And yet, as extreme as her view was, it reminded me that we all have levels of bias.

Each patient makes a first impression, and sometimes the impression is a negative one.

We may form an impression based on the report given to us by other nurses, “her whining is kind of driving me crazy,” or “he

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 47

COMMUNICATION CHALLENGES

There is a link between mirroring and the empathy gap.

How do we traverse it?

is not what you would call a ‘happy camper’.”

It would be unreasonable to expect that we would react to every patient in the same neutral way. But my internal reaction does not matter as much as my external actions.

Admitting a bias is one thing; it is another to craft my practice around it. That one question made everyone a little uncomfortable, and maybe because it openly acknowledged that there are times when we are challenged to be objective in our outlook.

The second speaker at the conference discussed the impact racial bias has on pain management and tied it to the concept of the empathy gap. Many studies show that racial bias negatively impacts the care received by people of color. But the empathy gap may be created by variables besides racial bias, such as gender or age bias, educational bias, economic bias, political bias, or personality bias. Empathy is defined as the ability to understand and feel someone else’s feelings as opposed to sympathy, which means you have compassion but do not have an actual sense of sharing the other person’s experience.

Empathy is reflected by the idiom “walk a mile in my shoes.” What happens when those shoes don’t fit? What if they pinch or hurt, if they don’t suit me for some reason?

What if I don’t like them?

The empathy gap exists because of the way we respond to others. All of us have people in our lives who push our buttons and we can have patients who push our buttons too.

It is how we address those biases, how we

JOIN THE CONVERSATION • Can you think of an instance in your practice where you realized that bias had impacted your patient care? What was the impact of that experience?

• How do you handle the situation where a co-worker voices obvious bias that creates an empathy gap?

ON THE

WEB

Go to OncologyNurseAdvisor.com/challenges-biased to share how you overcome communication barriers and cultural differences when interacting with patients and families.

acknowledge bias in ourselves and how they impact our care. Acknowledging their presence reminds us to pay attention to them.

DISCUSSION On a personal level I was struck by the converse idea, too. At times I have a positive bias with people who “look” like me. In this case it may not be because they actually look like me, that they are racially similar to me, but because there is something in their personality I relate to. A young mom with breast cancer is not who I am, but as she talks about her children and taking them to games and parties, I am reminded of my own young motherhood and suddenly I relate to that patient more completely. Does that translate to preferential treatment?

There is a link between mirroring and the empathy gap. How do we traverse it?

By changing our mirror? By seeing the reflection the person has of themselves rather than the one we have. Then the homeless patient becomes relatable, the curmudgeon is accepted for who he is, the whining patient is appreciated for her limited coping skills, the patient who is of a different race or ethnicity is seen as a person, not a description or definition.

Can you see the empathy gap in your practice?

I try to remember to pause before I meet a new patient. I don’t know who is on the other side of the door: it could be an important politician, a glamorous movie star, a frail and frightened elderly grandma, or a toothless former meth user. I pause to regroup and remind myself that there is an empathy gap.

I don’t want to fall into that gap. As long as a gap exists, I want to be sure I end up on the same side of it as my patients. ■ Ann Brady is the symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California.

REFERENCES 1. Snow White and the Seven Dwarfs. Burbank, CA: Walt Disney Productions, 1937. Animated feature film.

48 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

ISSUES IN CANCER SURVIVORSHIP

© THINKSTOCK

Resection for lung cancer in the elderly: Lobectomy better than sublobar resection Bette Weinstein Kaplan

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ung cancer is the leading cause of cancer-related deaths in the United States, and the American Cancer Society estimates 224,210 new cases and 159,260 deaths in 2014 for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) combined. Experts expect those numbers to change.1 One explanation is that the spiral computed tomography (CT) scan is rapidly becoming the screening tool of choice, especially for patients who have been long-term smokers. Results from the National Lung Screening Trial (NLST) showed that low-dose CT screening accounted for a 20% relative reduction in mortality from lung cancer.2 As a result, the US Preventive Services Task Force (USPSTF) recommended CT screening for long-term smokers.3 In addition, the baby boomer population, many of whom have years of smoking behind them, is now at the age when lung cancer usually develops.

This population brings with them a host of confounding illnesses such as chronic obstructive pulmonary disease (COPD), kidney disease, and cardiovascular disease (CVD).

EVALUATING TREATMENTS There are few evidence-based guidelines for treating early stage lung cancer, according to Shervin M. Shirvani, MD, adjunct professor at the University

of Texas MD Anderson Cancer Center, in Houston, Texas, and attending radiation oncologist at Banner MD Anderson Cancer Center, in Gilbert, Arizona. Shirvani and colleagues note

Those patients treated with lobectomy had better outcomes. that there have not been any recent randomized trials that compare modalities for treating lung cancer in the elderly.4 Several trials have recently launched; however, accrual is slow, some of the studies have closed, and the trials that are now active will not have results for a number of years.4 Shirvani and colleagues launched their own review to ascertain which of the modalities would be best for treating the burgeoning population of elderly patients with lung cancer. The goal was a retrospective population-based analysis to compare the commonly used lobectomy (removal of the entire lobe of lung) with sublobar resection (removal of the part containing the tumor) and stereotactic ablative radiotherapy (SABR), a type of radiation therapy comprising 3 to 5 sessions.4

For their research, the MD Anderson investigators used the latest version of the Surveillance, Epidemiology, and End Results (SEER) database linked to Medicare (SEER-Medicare database) to determine the effect each of the three methods had on survival of elderly patients with early stage lung cancer.5 They found a total of 9,093 patients age 66 years or older with a lung cancer diagnosis reported in the SEER-Medicare group. All the patients underwent 1 of 3 treatment methods: 7,215 patients (79.3%) underwent lobectomy; 1,496 (16.5%), sublobar resection; and 382 patients (4.2%), SABR. BIGGER SURGERY HAD BETTER RESULTS

The researchers found that those patients treated with lobectomy had better outcomes—their overall and lung cancerspecific survival were better than those associated with the other methods. They had thought that the smaller sublobar resection with minimal surgical complications would be best for an older person with several comorbidities; however, they were surprised to realize that their theory was wrong. Many elderly patients with multiple diseases or health problems would prefer to face the risk of the more complicated lobectomy in order to have their cancer eradicated.

When the authors compared lobectomy to SABR, the overall and lung

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 49

ISSUES IN CANCER SURVIVORSHIP

cancer-specific survival rates were similar. They noted that this result demonstrates that SABR can be an alternative treatment modality for those frail elderly patients with comorbidities who cannot tolerate surgery.

The researchers conclude that lobectomy is the treatment of choice for patients with early stage lung cancer, except for very frail patients with advanced age.

Those patients should receive treatment with SABR. ■

REFERENCES

Recommendation. Evidence Synthesis, No. 105.

1. American Cancer Society. Cancer Facts and

Rockville, MD: Agency for Healthcare Research

Figures 2014. Atlanta, GA: American Cancer Society; 2014. http://www.cancer.org/acs/

4. Shirvani SM, Jiang J, Chang JY, et al.

groups/content/@research/documents/

Lobectomy, sublobar resection, and ste-

webcontent/acspc-042151.pdf. Accessed

reotactic ablative radiotherapy for early-

November 11, 2014.

stage non–small cell lung cancers in the

2. National Lung Screening Trial Research

elderly [published online ahead of print

Team, Aberle DR, Adams AM, et al. Reduced

October 15, 2014]. JAMA Surg. doi:10.1001/

lung-cancer mortality with low-dose com-

jamasurg.2014.556.

puted tomographic screening. N Engl J Med. 2011;365(5):395-409.

5. Howlader N, Noone AM, Krapcho M, et al, eds. SEER Cancer Statistics Review, 1975-2011,

3. Humphrey L, Deffebach M, Pappas M, et al.

Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

and Quality; 2013. AHRQ No. 13-05188-EF-1.

Bethesda, MD: National Cancer Institute;

Screening for Lung Cancer: Systematic Review

2014. http://seer.cancer.gov/csr/1975_2011/.

to Update the U.S. Preventive Services Task Force

Accessed November 11, 2014.

Cancer prehabilitation

morbidity, increase cancer treatment options,

Continued from page 32

and improve physical and psychological

opportunity to decrease treatment-related mor-

health outcomes. Am J Phys Med Rehabil.

bidity, increase cancer treatment options, and

2013;92(8):715-727.

improve physical and psychological health out-

Julie Silver is associate professor, Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts; attending physician, Spaulding Rehabilitation Hospital Network, Boston; clinical associate, Massachusetts General Hospital, Boston; and associate in physiatry, Brigham and Women’s Hospital, Boston.

3. Levit LA, Balogh EP, Nass SJ, Ganz PA, eds. Delivering High-Quality Cancer Care:

comes. Am J Phys Med Rehabil. 2013;92(8):715-727.

8. Shockney LD, Silver JK, Bantug E, et al.

Charting a New Course for a System in Crisis.

Healthcare providers’ knowledge of the ben-

Washington, DC: The National Academies

efits of cancer rehabilitation. J Oncol Navig

Press; 2013. http://books.nap.edu/openbook. php?record_id=18359&page=R1. Accessed September 30, 2014.

Acknowledgment The author acknowledges and thanks Julie A. Poorman, PhD, for her assistance with manuscript preparation.

7. Silver JK, Baima J. Cancer prehabilitation: an

Surviv. 2013;4(2):12-18.

9. 3.2 Psychosocial distress screening [video].

American College of Surgeons Web site.

4. Stubblefield MD, Keole N. Upper body pain

https://www.facs.org/quality-programs/

and functional disorders in patients with

cancer/coc/standards/video/chap31/chap32.

breast cancer. PM R. 2014;6(2):170-183.

Published online February 28, 2013. Accessed

5. Hidding JT, Beurskens CH, van der Wees PJ, REFERENCES

et al. Treatment related impairments in

1. Silver JK, Baima J, Mayer RS. Impairment-

September 30, 2014.

10. Silver JK. Cancer rehabilitation and prehabili-

arm and shoulder in patients with breast

tation may reduce disability and early retire-

driven cancer rehabilitation: an essential

cancer: a systematic review. PLoS One.

ment [published online ahead of print April

component of quality care and survivorship.

2014;9(5):e96748.

18, 2014]. Cancer. 2014;120(14):2072-2076.

CA Cancer J Clin. 2013;63(5):295-317.

2. Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related

FIND US ON

6. The DASH Outcome Measure: The QuickDASH.

11. Silver J. Cancer prehabilitation may reduce

Institute for Work & Health. http://dash.iwh.

healthcare costs and improve outcomes.

on.ca/quickdash. Accessed September 30, 2014.

Value-Based Cancer Care. 2013;4(8).

linkedin.com/company/oncology-nurse-advisor

plus.google.com/+Oncologynurseadvisor

@ONAcom

OncologyNurseAdvisor.com/app-download

facebook.com/OncologyNurseAdvisor

OncologyNurseAdvisor.com

50 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

FROM

A tool for conversations about cancer Sandra Tripodi, MSW, LCSW

The most effective therapeutically based creative projects will foster family identification to strengthen the family unit.

C

ancer is a difficult subject to talk about, and many parents coping with a diagnosis or a loved one’s diagnosis may try to avoid the topic in fear that they will scare their children. What to say about cancer, how to say it, and how much information to share are common concerns. Cancer is a topic that needs to be handled carefully and sensitively; according to a recent report, children of patients with cancer may be at a significantly increased risk for mental and behavioral health problems.1 The report concludes, “Psychological services need to be both family-oriented and child-centered and focus on family dysfunction to prevent mental health problems in children.”1 The most effective therapeutically based creative projects will foster family identification to strengthen the family unit. Along with promoting normalization of the family’s thoughts, feelings, and reactions to a cancer diagnosis in the family, projects should increase positive communication within the family system; establish a time of reflection and common memory of a family bonding experience; and create an object of comfort and strength for patients, loved ones, and the bereaved.

An example of a creative project that can bring families together to talk about cancer is Pillow Talk: Conversations about Cancer, a free at-home activity developed by CancerCare, with a sponsorship from Bayer. The Pillow Talk care package includes a hands-on, pillowdecorating project as well as materials that will help initiate those often-difficult conversations.

With this care package, patients and their

families bring a blank pillow to life—it has a sleeve for pictures or notes, fabric markers, and decorative materials that lets families’ creative expression drive the discussion.

CancerCare client Susan was faced with figuring out the best way to start the difficult cancer conversation with her 5-year-old son after her husband Chris’ cancer diagnosis.

Susan and her son sat together and colored the pillow that now features her son’s favorite things: superheroes, rainbows, planets, and rocket ships. On those long days when Chris is away at treatment, Susan’s son pulls out the pillow and reads the special messages his father left for him in the pouch.

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any organizations offer creative interventions that bring families together free of charge, or for a small fee. The American Cancer Society offers a kids’ activity book, Because … Someone I Love Has Cancer. Another great activity book for kids is The Children’s Treehouse Foundation’s interactive workbook, Talking with my Treehouse Friends about Cancer. And, Kids Konnected offers a Hope The Bear Care Package. ■ Sandra Tripodi is senior director of Community Engagement at CancerCare.

REFERENCES 1. Möller B, Barkmann C, Krattenmacher T, et al.

Children of cancer patients: prevalence and predictors of emotional and behavioral problems. Cancer.

2014;120(15):2361-2370.

www.OncologyNurseAdvisor.com • NOVEMBER/DECEMBER 2014 • ONCOLOGY NURSE ADVISOR 51

ASK A PHARMACIST intracellular domains of both HER2 and epidermal growth factor receptor (EGFR), inhibiting cell growth.2 Lapatinib is used in the treatment of metastatic disease in patients who have previously received trastuzumab.

Lapatinib may be used in combination with trastuzumab or capecitabine (Xeloda), and is taken orally.2

© AMI IMAGES / SCIENCE SOURCE

Color-enhanced scanning electron micrograph of a breast cancer cell

Ad o - t ra s t u z u m a b e mt a n s i n e

Treatment options for HER2-positive breast cancer What are the treatment options for recurrent metastatic HER2positive breast cancer after trastuzumab therapy?

—Name withheld on request

There are now multiple agents available that target human epidermal growth factor receptor 2 (HER2)positive breast cancers.

Trastuzumab (Herceptin) is a monoclonal antibody that binds to the HER2 receptor, triggering antibodydependent cellular cytotoxicity and cell death.1 Trastuzumab is utilized in the neoadjuvant, adjuvant, and metastatic disease settings. It may be used as monotherapy, but is most frequently administered in combination with chemotherapy.1 Lapatinib (Tykerb) is a tyrosine kinase inhibitor that inhibits the

(Kadcyla; also known as TDM-1) is a HER2-targeted antibody-drug conjugate.3 Trastuzumab is bound to DM1, a microtubule inhibitor. The antibody portion binds to the HER2 receptor and is degraded intracellularly, releasing DM1 and resulting in cell cycle arrest and apoptosis. Ado-trastuzumab emtansine is used in the treatment of patients with metastatic disease who have previously received trastuzumab and a taxane. Ado-trastuzumab emtansine is given as monotherapy.3 Pertuzumab (Perjeta) is a monoclonal antibody that blocks heterodimerization of HER2 with other HER family receptors (EGFR, HER3, HER4).4 This inhibits intracellular signaling, causing cell growth arrest and apoptosis. Pertuzumab also mediates antibody-dependent cellular cytotoxicity. Pertuzumab is indicated for use in combination with trastuzumab and a taxane in both the neoadjuvant setting as well as for patients receiving first-line treatment for metastatic disease.4 First-line treatment options for pat ient s w it h H E R 2 - po s it ive

metastatic breast cancer include trastuzumab (with or without chemotherapy) or trastuzumab in combination with pertuzumab and a taxane (docetaxel [Taxotere] or paclitaxel [Taxol]).5 HER2-targeted treatment should be continued in patients who have disease progression on first-line therapy.

When patients progress on firstline treatment regimens, subsequent HER2-targeted therapies may include ado-trastuzumb emtansine, a lapatinib-containing regimen, or continuation of trastuzumab (in combination with a new chemotherapy regimen).

The HER2-targeted agent should be selected after considering patient specific factors such as disease course, comorbid conditions, organ function, and patient preference.5 The optimal sequencing of HER2-targeted treatments is not established and remains to be clarified by future studies. ■ REFERENCES 1. Herceptin [package insert]. South San Francisco, CA: Genentech Inc; 2014.

2. Tykerb [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2013.

3. Kadcyla [package insert]. South San Francisco, CA: Genentech Inc; 2014.

4. Perjeta [package insert]. South San Francisco, CA: Genentech Inc; 2013.

5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer.

Version 3.2014. Port Washington, PA: National Comprehensive Cancer Network; 2014.

Lisa A. Thompson, PharmD, BCOP Clinical Pharmacy Specialist in Oncology Kaiser Permanente, Colorado

52 ONCOLOGY NURSE ADVISOR • NOVEMBER/DECEMBER 2014 • www.OncologyNurseAdvisor.com

www.OncologyNurseAdvisor.com • NOVEMBER/DECMBER 2014 • ONCOLOGY NURSE ADVISOR PB

Joan is more than just a patient going through

CHEMOTHERAPY We see so much more than just cancer

Joan is already busy enough with hockey practices, dance recitals, and science fair supply shopping.

Now sheâ&#x20AC;&#x2122;s making room on the kitchen calendar for Q3W therapy sessions.

People like Joan are at the heart of what drives Teva Oncology. With over 100 years of global pharmaceutical expertise, our mission is to develop and deliver solutions that advance cancer care and improve the lives of people affected by cancer.

We treat the person, not just the cancer

Š2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.

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