Ton june 2013 issue web

June 2013

www.TheOncologyNurse.com

Vol 6, No 5

Survivorship

Cancer Center Profile

Survivorship Plans: Taking Care of the Details

Winship Cancer Institute of Emory University Bone Marrow Transplant Center

By Alice Goodman

By Alice Goodman

A

lthough planning for survivorship care is recognized as an important part of the continuum of cancer care, end-of-treatment summaries (TSs) and survivorship care plans (SCPs) are not universally provided to cancer patients, even at centers of excellence. That situation is about to change over the next few years, however, because the Commission on Cancer (CoC) says that these plans will be mandatory by 2015.

CoC recommends that the plan be

given to the patient on completion of treatment. It should include a record of the care received, important disease characteristics, and a written follow-up plan. TSs and SCPs should facilitate shared care coordination between oncology specialists and primary care providers (PCPs).

The details of SCPs still need to be worked out, according to Deborah K. Mayer, PhD, RN, AOCN, FAAN, associate professor at UNC-Chapel Hill Continued on page 26

Genetic Counseling

Genetic Susceptibility to Renal Cell Carcinoma The myeloma team at the Winship Cancer Institute (left to right): S. Lonial, MD; J. Kaufman, MD; M. Watson, RN; K. Valla, PharmD; A. Nooka, MD; C. Gleason, NP; D. Casbourne, NP; C. Lewis, NP; D. Harvey, PharmD; and K. Shah, PharmD.

By Cristi Radford, MS, CGC Ambry Genetics

T

I

he Winship Cancer Institute of Emory University is Georgia’s first and only National Cancer Institute–designated cancer center.

As part of Emory University, Emory’s Woodruff Health Sciences Center, and Emory Healthcare, Winship provides state-of-the-art cancer care and is heavily involved in clinical trials on research for prevention, diagnosis, and treatment of cancers, with the goal of cure.

The Oncology Nurse-APN/PA spoke with Charise Gleason, MSN, NP-BC, AOCNP, about her role at Emory as an advanced nurse practitioner in the Bone Marrow Transplant Center, where she specializes in treating patients with multiple myeloma.

n 2013, approximately 65,000 people will be diagnosed with kidney cancer and two-thirds will be men.1 The term kidney cancer generally refers to any cancer arising in the kidney or renal pelvis. However, this article will focus on the most common type of kidney cancer seen in adults, renal cell carcinoma (RCC).1 RCC arises from cells in the tubules of the filtration portion of

the kidney. There are several histologic subtypes. Clear cell is the most common form (75%-80%), followed by papillary types 1 and 2 (10%-15%), chromophobe (5%), and collecting duct (<1%).1-5 Each subtype possesses unique clinical characteristics, genetic alterations, and responses to therapy.

Similar to other types of cancer, the Continued on page 23

Continued on page 15

inside

Conference News

The 38th Annual Congress of the Oncology Nursing Society

By Alice Goodman

T

he cherry blossoms were in bloom, and the Washington, DC, Convention Center was a bustling hive of activity during the 38th Annual Congress of the Oncology Nursing Society (ONS), held April

25-28, 2013. Attendees were treated to a wealth of presentations in different formats. The following are some of the highlights from the ONS poster sessions.

Best Practices

Breast, Colorectal, and Lung Cancer Screening Guidelines Explored. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Home-Grown Research Project to Screen for Malglycemia . . . . . . . . . . . . .

6

Oral Chemotherapy: What Does the Oncology Nurse Need to Know?. . . . .

7

Continued on page 20 ©2013 Green Hill Healthcare Communications, LLC

Incorporating Caregivers Improves Physical Activity and Quality of Life in Patients With Cancer. . . . . . . 14 Through the eyes of an advocate . . . . . . . . . . . . . . . . . . . . . . . . . .

8

Significance of Mentoring THE WHOLE PATIENT. . . . . . . . . . . .

Addressing Spiritual Concerns

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eO seri Vie nc es w olo on the gy line Nu a rse t .co m

Faculty Perspectives

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A 4-part series The publishers of The Oncology Nurse-APN/PA, The Oncology Pharmacist, and Personalized Medicine in Oncology are proud to present Faculty Perspectives: The History of Bendamustine series.

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Colleen Ro ss, RN, MSN, MHA, OC

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Editorial Board EDITOR-IN-CHIEF

Beth Faiman,

PhD(c), MSN, APRNBC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Catherine Bishop, DNP, NP, AOCNP

Cassandra J. Hammond, RN,

Dolores “Jeff” Nordquist, RN, MS,

Rita Wickham,

PhD, RN, AOCN

Avid Education Partners, LLC Sharpsburg, MD

CS, FNP

Mayo Clinic Rochester, MN

Northern Michigan University Independent Oncology & Palliative Care Consultant Marquette, MI

Shannon Hazen,

Melinda Oberleitner, RN,

Karla Wilson, RN,

MSN, CRNP

RN, BSN, OCN Novant Health Presbyterian Cancer Center Charlotte, NC

Patricia Irouer Hughes, RN, MSN,

MSN, FNP-C, CPON

DNS, APRN, CNS

City of Hope National Medical Center Duarte, CA

Jayshree Shah, NP

Pharmacy John F. Aforismo,

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

Johns Hopkins Kimmel Cancer Center/Sibley Infusion Washington, DC

BSN, OCN

Piedmont Healthcare Rex, GA

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Deena Damsky Dell, MSN, RN-BC,

Taline Khoukaz,

Gary Shelton,

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

NYU Clinical Cancer Center New York, NY

Somerset Medical Center Somerville, NJ

Sandra E. Kurtin,

Lori Stover, RN,

Patient Advocacy Peg Ford

Arizona Cancer Center Tucson, AZ

Western Pennsylvania Cancer Institute Pittsburgh, PA

Ovarian Cancer Alliance San Diego, CA

Ann McNeill,

Joseph D. Tariman,

Social Work Carolyn Messner,

AOCN, LNC

Fox Chase Cancer Center Philadelphia, PA

Wendy DiSalvo,

DNP, APRN, AOCN Genentech New London, NH

Denice Economou,

RN, MN, CNS, AOCN City of Hope National Medical Center Duarte, CA

Constance Engelking, RN,

MS, CNS, OCN

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

Amy Ford, RN,

BSN, OCN Quintiles Dallas, TX

NP, MSN, ACNP-C

RN, MS, AOCN, ANP-C

MSN, RN, NP-C, OCN

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Kena C. Miller, RN, MSN, FNP

Roswell Park Cancer Institute Buffalo, NY

Patricia Molinelli, MS, RN, APN-C, AOCNS

Somerset Medical Center Somerville, NJ

MSN, NP, ANP-BC, AOCNP

BSN

PhD, APRN, BC

BSc Pharm, RPh, FASCP RJ Health Systems International, LLC Wethersfield, CT

Nutrition Karen Connelly, RD, CSO

Northwestern University Myeloma Program Chicago, IL

DSW, MSW, LCSW-R, BCD

Jacqueline Marie Toia, RN, MS, DNP

Genetic Counseling Cristi Radford,

Northwestern University Myeloma Program Chicago, IL

Pamela Hallquist Viale, RN, MS,

CS, ANP, AOCN Saratoga, CA

CancerCare New York, NY

MS, CGC

Ambry Genetics Sarasota, FL

Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS

OncoMed Onco360 Great Neck, NY

Sharon S. Gentry, RN, MSN, AOCN

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

www.TheOncologyNurse.com

Ellen A. Neylon, MSN, FNP-BC, CCRP, OCN

Columbia University Medical Center Center for Lymphoid Malignancies New York, NY

Connie Visovsky, RN, PhD, APRN

University of South Florida College of Nursing Tampa, FL

Isabell Castellano, RN

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

Jeanne Westphal, RN

Meeker County Memorial Hospital Litchfield, MN

June 2013 I VOL 6, NO 5

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From The Editor PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko phil@greenhillhc.com

Group Director, Sales & Marketing John W. Hennessy john@greenhillhc.com Publisher Russell Hennessy russell@greenhillhc.com Editorial Director Kristin Siyahian kristin@greenhillhc.com Managing Editor Kristen Olafson kristen@greenhillhc.com Copy Editors Mollie Friedman Peggy Roeske Editorial Assistant Jennifer Brandt Production Manager Stephanie Laudien

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June 2013 I VOL 6, NO 5

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t’s a busy time in the world of oncology. The Oncology Nursing Society (ONS) held its 38th Annual Congress in May while the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO) took place this month. The Oncology Nurse-APN/ PA (TON) was at both events. This issue presents our coverage of the news from the ONS. The next severBeth Faiman, PhD(c), al issues of TON will cover the news MSN, APRN-BC, AOCN from ASCO. Editor-in-Chief We talked to several nurse presenters at ONS and have articles that address issues ranging from malglycemia (high blood

glucose level in nondiabetic patients) to how incorporating caregivers into a patient’s exercise plan improves the patient’s physical activity and quality of life. These are concerns that oncology nurses can incorporate into their daily practice.

Also, we cover the issue of treatment summaries and survivorship care plans. These plans will be mandatory by the end of 2015, and oncology nurses will undoubtedly play an important role in their effective implementation. The topic of survivorship planning is the subject of our new reader poll (see page 15). Please go to www.TheOncologyNurse.com to participate in the poll and tell us how you discuss this topic with your patients.

While visiting the website, be sure to let us know what you think about TON and the website—good and bad! Please email us at editorial@greenhillhc.com. l

Ovarian Cancer

Antibody-Conjugate Encouraging in Platinum-Resistant Ovarian Cancer

By Alice Goodman

T

-DM1 was the first antibody-drug conjugate to gain US Food and Drug Administration approval for HER2 (human epidermal growth factor 2)-positive metastatic breast cancer. A preliminary study suggests that a second antibody-drug conjugate is active in platinum-resistant ovarian cancer, and if the encouraging early results are confirmed by clinical trials, this would fulfill an unmet need for a difficult-to-treat cancer with limited treatment options.

The antibody-drug conjugate DMUC5754A includes a monoclonal antibody that recognizes the MUC16 protein expressed by ovarian cancer cells, which is linked to a potent antimitotic toxin called MMAE (monomethyl auristatin E). The antibody targets MUC16 and the toxin is released selectively into tumor cells that express MUC16, limiting the effects of the toxin on healthy tissues and organs.

MMAE is so potent that it could

not be delivered directly to patients, explained lead author Joyce Liu, MD, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.

Fatigue was the most common adverse event at all dose levels.

The phase 1 study evaluated the safety, pharmacokinetics, and pharmacodynamics of DMUC5754A in 44 women with advanced, recurrent, platinum-resistant ovarian cancer. Among these heavily pretreated patients, 1 complete response and 4 partial responses were reported. All 5 of the responses were observed in patients with high expression of MUC16 in their tumor cells.

The maximum tolerated dose was

identified as 2.4 mg/kg, and the antibody-drug conjugate was given every 3 weeks. Dose-limiting toxicities included one grade 4 neutropenia and one grade 4 uric acid increase, occurring at a higher dose level. Grade 3 adverse events included fatigue in 9% of patients and neutropenia in 9%. Fatigue was the most common adverse event at all dose levels, occurring in 57% of patients. Nausea, vomiting, decreased appetite, diarrhea, and peripheral neuropathy were also reported.

“If the activity of this drug is confirmed in additional trials, this will represent a real step forward in finding new, effective treatments for advanced ovarian cancer,” Liu said. l Reference

Liu J, Moore K, Birrer M, et al. Targeting MUC16 with the antibody-drug conjugate (ADC) DMUC5754A in patients with platinum-resistant ovarian cancer: a phase I study of safety and pharmacokinetics.

Presented at: American Association for Cancer Research 2013 Annual Meeting; April 9, 2013; Washington, DC. Abstract LB-290.

The Oncology Nurse-APN/PA®, ISSN 1944-9798 (print); ISSN 1944-9801 (online) is published 11 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2013 by Green Hill Health­care Com­munications, LLC. All rights reserved. The Oncology Nurse-APN/PA® logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, The Oncology Nurse-APN/PA®, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: editorial@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues, $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in The Oncology Nurse-APN/PA® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in The Oncology Nurse-APN/PA® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications.

It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.

www.TheOncologyNurse.com

Best Practices

Breast, Colorectal, and Lung Cancer Screening Guidelines Explored

By Alice Goodman

www.TheOncologyNurse.com

and digital mammography for women at average risk.

The American Cancer Society guide-

lines promote annual mammography for average-risk women beginning at age Continued on page 6

S:7.25”

NOW RECRUITING

Investigators Study of the long-term safety and efficacy of darbepoetin alfa in anemic patients with Non-Small Cell Lung Cancer (NSCLC) receiving chemotherapy Phase 3 study with approximately 3,000 subjects at 500 study sites globally KEY ELIGIBILITY CRITERIA*

PRIMARY ENDPOINT

• Stage IV NSCLC

• Overall survival

• Receiving 1st-line myelosuppressive

SECONDARY ENDPOINTS

chemotherapy

• Progression-free survival

• Hemoglobin (Hb) ≤ 11 g/dL

• Incidence of ≥ 1 red blood cell (RBC) transfusion or Hb ≤ 8.0 g/dL

• ECOG score ≤ 1

S:9.75”

Breast Cancer Breast cancer is the second leading cause of cancer death in women in the United States, accounting for 14% of those deaths. Mortality from breast cancer had decreased by 30% since 1989, which has been attributed to widespread screening along with treatment advances. However, reservations about film mammography include whether finding cancers earlier actually reduces mortality or just delays it. Mammography can cause psychological harm and increase the use of healthcare resources, owing to false-positive findings resulting in unnecessary tests and biopsies.

Considering these concerns, the USPSTF recommended against routine screening for women aged 40 to 49 years at average risk, and recommended biennial screening for average-risk women aged 50 to 74. Furthermore, USPSTF

guidelines state that there is insufficient evidence to recommend clinical breast examination, breast self-examination,

Darbepoetin alfa 500-mcg Q3W

2:1 Randomization (darbepoetin alfa:placebo)

End of Investigational Product

End of Treatment Period

Long-term Follow-up

Placebo Q3W

Week 0

Week 1

Disease progression or end of chemotherapy treatment

*Complete inclusion/exclusion criteria and additional study details can be found in the protocol.

ECOG = Eastern Cooperative Oncology Group; Q3W = once every 3 weeks.

For more information, please email Cory Docken/Getty Images

E

vidence-based guidelines translate research into practice and are intended to reduce variations in cancer care and promote excellence.

However, it can be daunting to sift through the wealth of available guidelines for early detection of cancer, as existing guidelines from different agencies are not in agreement. At the 38th Annual Congress of the Oncology Nursing Society (ONS), 2 experts reviewed screening guidelines for common cancers and what nurses need to know about them.

“Nurses are the most trusted profession. Patients often come to us for advice. We need to educate ourselves so we can educate the public. It is important for us to know the cancer screening guidelines as well as the standard of care at your own facility.

Also, know the population you serve and their particular needs. There are a number of good resources for nurses to get reliable information on screening.

Communicate the message to patients effectively,” advised Joanne Ebner, RN, BSN, of Anne Arundel Medical Center at the DeCesaris Cancer Institute. Ebner reviewed screening guidelines for breast and colorectal cancer. Her colleague, Judith Smith, MSN, RN, AOCN, of the Division of Cancer Prevention at the National Cancer Institute (NCI), reviewed lung cancer screening guidelines.

Resources for current screening guidelines include websites for the NCI, US Preventive Services Task Force (USPSTF), the National Guideline Clearinghouse of the Agency for Healthcare Research and Quality, and ONS.

Study-20070782@amgen.com or call 1-866-965-0782.

Products under investigational study have not been approved by the FDA for the use under investigation in this trial.

© 2013 Amgen Inc. All rights reserved. Not for Reproduction.

AOCO3X0071_Recruitment782_AdAsize_r3.indd 1

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Best Practices

Breast, Colorectal, and Lung Cancer Screening... Continued from page 5 40, and magnetic resonance imaging (MRI) for high-risk women. Other organizations, including the American Medical Association, the American Academy of Family Physicians, and the American Congress of Obstetricians and Gynecologists, have variations on these guidelines.

Emerging technology for breast screening includes digital mammography, contrast-enhanced digital mammography, MRI, tomosynthesis, MRI spectroscopy, diffusion-weighted MRI, and positron emission mammography.

These technologies may be useful in high-risk women, but will increase the cost of screening.

Colorectal Cancer Colorectal cancer is the second leading cause of cancer-related deaths in men and women in the United States. Over the past 30 years, the incidence of colorectal cancer has declined, largely

because of colonoscopy.

“Colorectal cancer is the only cancer that we agree can absolutely be prevented. But only 60% of insured adults undergo screening,” Ebner said. Barriers

50 and repeated every 10 years in those with an average risk, at age 45 in African Americans, and at age 40 (or 10 years younger than age of an affected relative) in high-risk individuals. Colonoscopy

“Nurses need to know the research findings, the controversies, and the differences between guidelines. The more you know, the more you can teach patients.” Judith Smith, MSN, RN, AOCN to screening include fear, the unpleasant preparation for colonoscopy, no insurance, and lack of awareness.

There are several screening tests for colon cancer, including guaiac-based fecal occult blood testing, exfoliated DNA testing, sigmoidoscopy, colonoscopy, and virtual colonoscopy.

Most guidelines from professional societies and the USPSTF agree that colonoscopy should be initiated at age

should be stopped after age 75 or when life expectancy is less than 10 years, according to most guidelines.

Lung Cancer Lung cancer is the leading cause of cancer-related deaths for both men and women. Nearly 90% of all lung cancers are smoking related. Screening of asymptomatic individuals with no smoking history requires consideration of harms

Home-Grown Research Project to Screen for Malglycemia

By Alice Goodman

T

he cancer patient who develops malglycemia (another word for hyperglycemia experienced by nondiabetic patients)—either due to cancer itself or to drugs patients take for their cancer—is somewhat of a “hot potato.” If the oncologist refers the patient to the primary care physician Diane De Vos-Schmidt, (PCP), the PCP often sends the patient back to the oncologist.

RN, MSN, OCN At least that has been the experience of Diane De Vos-Schmidt, RN, MSN, OCN, a nurse at PCR Oncology in Pismo Beach, California.

De Vos-Schmidt was aware that some patients in her practice were developing blood glucose levels in the high 300s, but no one was treating this. “The sequelae from this can be very bad—even death. Malglycemia makes cancer cells grow faster, which is bad for most solid tumors, and insulin-like growth factor interferes with treatment. Patients with very high blood sugar have to fight a double whammy—cancer and the metabolic syndrome,” she noted.

When her friend and colleague developed malglycemia, De Vos-Schmidt decided to take action. Jacqueline Loughran-Hertzog, a fellow nurse in De Vos-Schmidt’s practice, had a symptomatic neuroendocrine tumor of the pancreas that caused diabetes.

“She now had two problems—cancer and diabetes. On routine testing, her blood sugar was in the range of 300 to 400 [mg/dL], and she became the ‘hot potato.’ Together we approached our boss, David Palchak, MD, and he agreed to lower her [blood sugar level]. We gave her insulin 3 times a day before meals and consulted with a diabetes nurse educator,” De Vos-Schmidt explained. Her colleague’s malglyce-

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June 2013 I VOL 6, NO 5

mia resolved, and the cancer treatment put her in remission.

This experience led to a “home-grown” research project, which was the subject of a poster presentation at the 38th Annual Congress of the Oncology Nursing Society. De VosSchmidt and a diabetes educator, Kris Dilworth, RN, MS, FNP, CDE, developed a treatment algorithm for patients taking corticosteroids (a known risk factor for malglycemia).

Their study included 26 patients who were screened over a 3-month period after their first chemotherapy treatment.

Patients with blood glucose readings in the range of 140 to 199 mg/dL received a glucose meter, training, and nutrition education limiting carbohydrate intake. Those with higher blood glucose readings were treated similarly and, in addition, had insulin initiated according to an insulin scale developed for this project. Of the 26 patients, 47% had high glucose levels that required intervention.

“All patients were kept euglycemic during the remainder of their treatment, and patient compliance was 100%,” she said. “But acceptance by the nursing staff was not universal.”

There is currently no evidence-based solution for malglycemia that occurs during cancer treatment, she continued.

De Vos-Schmidt hopes that this pilot study will generate further research. She noted that these patients were asymptomatic, and their extremely high blood sugar levels would not have been discovered unless they had been screened.

“Patients walk around with this dangerous asymptomatic condition that fuels their cancers. It is amenable to treatment if recognized, and the nurse does not need the doctor’s orders for a finger stick. This is easily done when patients on steroids come in on day 2 during treatment for growth factor support,” she noted. l Reference

De Vos-Schmidt D, Dilworth K. Management of steroid induced malglycemia during cancer treatment. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25, 2013; Washington, DC. Poster.

versus benefits. Potential harms include false-negative results, false-positive results setting into motion unnecessary use of resources, and detecting a lethal cancer without changing outcomes.

Several large clinical trials have shown that routine chest x-ray screening of the general population does not prevent lung cancer–related mortality.

“The bottom line is that chest x-ray does not lower lung cancer mortality rates,” stated Smith.

The low-dose computed tomography (CT) scan, formerly called spiral CT, holds promise for screening patients at higher risk due to a history of smoking cigarettes. When the large, randomized National Lung Screening Trial (NLST) compared low-dose helical CT with chest x-ray in more than 50,000 current or former smokers, the study was halted early because low-dose CT was found to be superior to chest x-ray in preventing lung cancer mortality. People who received low-dose CT had a 20% lower risk of dying of lung cancer than those who received a chest x-ray.

“NLST was a game-changer,” said Smith. New guidelines from a number of organizations are consistent and state that high-risk patients should be screened with low-dose CT. Caveats are that the screened population should fulfill the eligibility criteria of the NLST (ie, aged 55-74 years, asymptomatic or former smoker with at least a 30-pack-year history and no other cancers), and that the technique be performed at medical centers with special expertise in lung cancer screening and treatment. More recently, the National Comprehensive Cancer Network modified the recommendation to encompass a lower age limit and lower pack-year history, and stipulated that one risk factor be added.

The USPSTF has yet to weigh in on lung cancer, but new guidelines are expected in 2014. “Why should we care what USPSTF says? Money. If they recommend it, low-dose CT will be reimbursed with no copay,” Smith explained.

Summary Nurses have an important role to play in advising patients about cancer screening. “Nurses need to know the research findings, the controversies, and the differences between guidelines. The more you know, the more you can teach patients. It is helpful to have copies of the guidelines on hand for patient discussions,” Smith advised. l Reference

Ebner J, Smith J. Cancer screening guidelines: clarity and controversy. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 26, 2013; Washington, DC.

www.TheOncologyNurse.com

Best Practices

Oral Chemotherapy: What Does the Oncology Nurse Need to Know?

By Alice Goodman

O

ral chemotherapy presents unique issues, including safety and toxicity, and advance planning is essential, stated Kristine B. LeFebvre, MSN, RN, AOCN, nurse planner and project manager at the Oncology Nursing Society (ONS). She spoke about the nurse’s role in delivering oral chemotherapy at the ONS 38th Annual Congress.

“Oral chemotherapy is not just pills.

It is important to give the right drug to the right patient at the right dose and the right time,” she emphasized.

In recognition of the issues particular to oral chemotherapy, the American Society of Clinical Oncology and ONS have recently published administration safety standards for oral chemotherapy (Oncology Nursing Forum, May 2013; Journal of Oncology Practice, March 2013) to optimize care, LeFebvre said.

She suggested providing both oral and written instructions to patients undergoing oral chemotherapy. It is essential to document a written treatment plan and chemotherapy orders and to provide a summary treatment plan at the initial patient encounter.

In addition, “verbal orders can only be used for holding/stopping medications, but any dose adjustments must be documented in the patient’s records,” she emphasized. “This is essential with oral chemotherapy.”

“Stress the importance of follow-up visits, and emphasize the need for laboratory monitoring. Many patients may not realize they will need monitoring when they are taking pills,” she stated.

A patient calendar should include start and stop dates for therapy, dates for lab testing, and dates for follow-up appointments. Issues of insurance coverage and access to the drug should be discussed with the patient.

The nurse also needs to assess the patient’s ability to take the drug, including the ability to swallow, cognitive function, and the need for caregiver or family member assistance. Systems should be in place for managing dose or schedule adjustments. Other needs include triage guidelines or algorithms for changes in patient status and symptoms, and a method for communicating with prescribers. “Electronic medical records should help streamline communication,” LeFebvre stated.

Safe handling is important, she continued. “Many oral antineoplastic agents are hazardous. The staff and patients require education and training. Personal protective equipment may be required, as well as hand wash-

www.TheOncologyNurse.com

ing and gloves for family members,” she continued.

“Nurses need to know which drugs require safe handling. A list would be helpful, and hazardous drugs should be labeled as such,” she said.

oral now. We need to be concerned with side effects, safe handling, and adherence, and we need to be proactive in following these standards. Serious side effects can occur, including handfoot syndrome, nausea, vomiting, diar-

Barriers to patient adherence include the complexity of regimens, need for behavioral change, fear of side effects (including constipation and weight gain), lack of belief in efficacy, and financial limitations.

Drugs such as sorafenib, everolimus, capecitabine, erlotinib, pazopanib, gefitinib, and lapatinib have been associated with increased toxicity, including grade 3 and 4 adverse events, compared with the control arm in randomized controlled trials, she noted.

When the nurse administers the drug, independent double-checking of the appropriateness of therapy should be conducted.

“We must monitor clinical status and adherence, manage toxicity, educate patients about drug-drug and drug-food interactions, and ensure that treatment is coordinated in different treatment settings,” she explained.

Assessments should be drug and regimen specific. With oral treatment, document that the patient received the drug. Medication reconciliation is important, as are potential interactions. The orders should incorporate tests that may be needed: for example, with axitinib, orders should automatically include hepatic, thyroid, and urine testing.

“If a patient is admitted to the hospital, you need to know whether the drug should be continued [while there],” LeFebvre noted. A system is needed to notify the emergency department or the hospital that the patient is taking oral chemotherapy when he or she is admitted for other reasons.

At the same session, Kathleen Leifeste, RN, MSN, AOCN, oncology nurse educator at Overlook Medical Center in Summit, New Jersey, discussed additional considerations with oral chemotherapy.

“New oral chemotherapy agents are [continually] being approved. In fact, 25% of all antineoplastic agents are

rhea, and skin problems,” Leifeste told the audience.

Barriers to patient adherence include the complexity of regimens, need for

behavioral change, fear of side effects (including constipation and weight gain), lack of belief in efficacy, and financial limitations. Inadequate understanding of directions and difficulty reaching the healthcare provider can also interfere with compliance.

“If a patient is not adhering and you don’t know it, [and] if there is a recurrence or poor response, you may think the drug isn’t working,” she added.

Although some of the principles discussed by both nurses seem self-evident, Leifeste noted that a survey reported that almost half of nurses had no education on oral chemotherapy and more than half did not have patient education materials.

This emphasizes the need for better education and attention to this issue. l Reference

LeFebvre K, Leifeste K. Oral chemo, not just another pill: implications for staff education and practice.

Presented at: 38th Annual Congress of the Oncology Nursing Society; April 26, 2013; Washington, DC.

have you ever wanted to write an article for TON ?

Get ! d e v l o Inv ©iStockphoto.com/Shawn Gearheart

We’re interested in articles about the everyday issues that affect nurses—everything from chemotherapy safe handling to supportive care for patients to challenging cases.

Contact editorial@greenhillhc.com for information.

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Significance of Mentoring

By Peg Ford

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ccording to Wikipedia, “Mentorship is a personal relationship in which a more experienced or more knowledgeable person helps to guide a less experienced or less knowledgeable person. However, true mentoring is more than just answering occasional questions or providing ad hoc help. It is about an ongoing relationship of learning, dialog, and challenge.” This description of a mentor was to prove accurate for me, as I describe my recent experience as a Patient Representative Stakeholder Reviewer in the funding applications for the Patient-Centered Outcomes Research Institute (PCORI) Cycle II Merit Review Assessment of Prevention, Diagnosis, and Treatment Options. To say that it was challenging and absorbing is an understatement!

important telephone call about my ability to not only finish the job, but to get it done by the deadline. In one of her emails, she wrote, “I’ve always been a bit of a collector of quotes that I’ve found inspiring. I wanted to share this one with you, thinking you might like

S:7”

Important Safety Information WARNINGS AND PRECAUTIONS: • Treatment with ISTODAX has been associated with thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, monitor these hematological parameters during treatment with ISTODAX and modify the dose as necessary • Serious and sometimes fatal infections have been reported during treatment and within 30 days after treatment with ISTODAX and the risk of life threatening infections may be higher in patients with a history of extensive or intensive chemotherapy • Electrocardiographic (ECG) changes have been observed with ISTODAX • In patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions should be considered, such as monitoring electrolytes and ECGs at baseline and periodically during treatment • Ensure that potassium and magnesium are within the normal range before administration of ISTODAX • Tumor lysis syndrome has been reported during treatment with ISTODAX. Patients with advanced stage disease and/or high tumor burden should be closely monitored and appropriate precautions taken, and treatment should be instituted as appropriate • ISTODAX may cause fetal harm when administered to a pregnant woman. Advise women to avoid pregnancy while receiving ISTODAX. If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus (Pregnancy Category D) ADVERSE REACTIONS: Peripheral T-Cell Lymphoma The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 3 (N=131) were thrombocytopenia (24%), neutropenia (20%), anemia (11%), asthenia/fatigue (8%), and leukopenia (6%), and in Study 4 (N=47) were neutropenia (47%), leukopenia (45%), thrombocytopenia (36%), anemia (28%), asthenia/fatigue (19%), pyrexia (17%), vomiting (9%), and nausea (6%).

Infections were the most common type of serious adverse event reported in Study 3 (N=131) and Study 4 (N=47). In Study 3, 25 patients (19%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections.

The most common adverse reactions regardless of causality in Study 3 (N=131) were nausea (59%), asthenia/fatigue (55%), thrombocytopenia (41%), vomiting (39%), diarrhea (36%), and pyrexia (35%), and in Study 4 (N=47) were asthenia/fatigue (77%), nausea (75%),

thrombocytopenia (72%), neutropenia (66%), anemia (62%), leukopenia (55%), pyrexia (47%), anorexia (45%), vomiting (40%), constipation (40%), and diarrhea (36%).

Cutaneous T-Cell Lymphoma The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 1 (N=102) were infections (11%) and asthenia/fatigue (8%), and in Study 2 (N=83) were lymphopenia (37%), infections (33%), neutropenia (27%), leukopenia (22%), anemia (16%), asthenia/fatigue (14%), thrombocytopenia (14%), hypophosphatemia (10%), vomiting (10%), dermatitis/exfoliative dermatitis (8%), hypermagnesemia (8%), hyperuricemia (8%), hypocalcemia (6%), nausea (6%), and pruritus (6%).

Infections were the most common type of serious adverse event reported in both Study 1 (N=102) and Study 2 (N=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection.

The most common adverse reactions regardless of causality in Study 1 (N=102) were nausea (56%), asthenia/fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%) and in Study 2 (N=83) were nausea (86%), asthenia/fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG ST-T wave changes (63%), neutropenia (57%), lymphopenia (57%), infections (54%), anorexia (54%), vomiting (52%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), leukopenia (46%), dysgeusia (40%), and constipation (39%).

DRUG INTERACTIONS: • ISTODAX is metabolized by CYP3A4. Avoid concomitant use with strong CYP3A4 inhibitors and potent CYP3A4 inducers if possible • Caution should also be exercised with concomitant use of moderate CYP3A4 inhibitors and P-glycoprotein (P-gp, ABCB1) inhibitors • Physicians should carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered ISTODAX and warfarin sodium derivatives USE IN SPECIFIC POPULATIONS: • Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother • Patients with moderate and severe hepatic impairment and/or patients with end-stage renal disease should be treated with caution

Please see full Prescribing Information, including WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS.

ISTODAX® is a registered trademark of Celgene Corporation. ©2012 Celgene Corporation 09/12 US-IST120024

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Allow me to quote from my instructions, “PCORI’s review process embodies the uniquely patient-centered, outcomes-focused mission of PCORI: patients and stakeholders, as well as scientists, review applications against PCORI’s review criteria. Because PCORI’s review process differs from other peer review processes in important ways, PCORI requires that all reviewers complete online training.” I was to discover this statement was not misleading.

After the informative online training, I received the applications I was to review, and to my surprise, not one was about ovarian or any kind of gynecologic research (my specialty). This was a new challenge to undertake, and the process would require a great deal of time and effort to accomplish the work by the deadline. Each grant request was to be reviewed on the basis of 3 main criteria: innovation/potential for improvement, patient-centeredness, and team and environment.

An overall score and an outline of strengths and weaknesses would then be passed along to the research panel.

not have time to finish. However, I had someone in my corner who thought differently—my PCORI Mentor, Debra Madden, who assured me I was capable and did so with grace, talent, and encouragement. She never equivocated B:8.75” for a moment in T:8.125” her emails, or on that

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At the in-person Merit Review Panel Meeting, the grant requests would be discussed and voted on.

I generally face challenges with a determination to succeed, but this time, I thought perhaps I had taken on a task that either I could not or would

Through the Eyes of an Advocate it as well. Reach high, for stars lie hidden in your soul. Dream deep, for every dream precedes the goal. —Pamela Vaull Starr.”

I did finish, and before the deadline! And I hope to be a mentor like Deb to inspire others to go beyond what they thought they were capable of.

Now, reflecting on the experience, I thought about a story I wrote several years ago. I hope that by sharing it here, I will acknowledge my debt of gratitude

to Deb, and that this story will serve as a reminder about the inner critic that, still at my age, can stop me from facing my fears and growing beyond anything I thought possible.

Up Up Up Over the Rainbow There once was a Bluebird born into this world full of excitement and inner passion to experience all that life had to offer. For hours, this little Bluebird,

named Charlie, would sit and watch the birds that knew how to fly. He would gaze in awe at how high they could fly and with such a feeling of complete freedom. He wanted this for himself and could hardly wait for the day it would come true.

As twists of fate happen, a Cardinal moved into the neighborhood just days before the time arrived for Charlie to test his wings. Charlie sensed the

Cardinal was not happy and often kept to himself. “How sad,” thought Charlie, for, unlike the Cardinal, he was anxious to learn to fly so he could go and meet other birds and experience life!

One day the sun rose a little more brightly and the air seemed tinged with electricity. The day had arrived for Charlie to leave the nest and fly!

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INDICATIONS THE FIRST AND ONLY • Treatment of peripheral T-cell lymphoma (PTCL) in patients DRUG APPROVED IN BOTH who have received at least one prior therapy PTCL AND CTCL • Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

RECHARGE THE POSSIBILITIES

www.istodax.com Please see Important Safety Information on adjacent page.

Please see Brief Summary of full Prescribing Information on following pages.

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Significance of Mentoring He awoke happy, full of excitement and anticipation. He knew he was ready! His heart started to beat faster and faster. He thought his little breast was going to explode with the expectation. He was ready!

Just as he said to himself, “Okay, here

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I go!” with his natural inclination to just fall out of the nest, the Cardinal, sitting in the next tree, shouted to him, “That’s not the RIGHT way. You will only kill yourself! Jump off. Do it the right way!”

With this, Charlie’s heart started racing.

Regaining his balance, he sat down,

immobilized by fear. He sat, and sat, and sat. It was hard for him to breathe being so confused and anxious.

His little body was trembling and he felt so lost. Looking high in the sky, he saw an Eagle soaring proudly and effortlessly. Charlie sighed. Why hadn’t he

Only

ISTODAX® (romidepsin) for injection For intravenous infusion only The following is a brief summary only; see full prescribing information for complete product information.

1 INDICATIONS AND USAGE ISTODAX is indicated for: • Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

• Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information The recommended dose of romidepsin is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8 and 15 of a 28-day cycle.

Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the drug.

2.2 Dose Modification Nonhematologic toxicities except alopecia • Grade 2 or 3 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline, then therapy may be restarted at 14 mg/m2. If Grade 3 toxicity recurs, treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2.

• Grade 4 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2.

• Romidepsin should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.

Hematologic toxicities • Grade 3 or 4 neutropenia or thrombocytopenia: Treatment with romidepsin should be delayed until the specific cytopenia returns to ANC ≥1.5×109/L and/or platelet count ≥75×109/L or baseline, then therapy may be restarted at 14 mg/m2.

• Grade 4 febrile (≥38.5°C) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with romidepsin should be delayed until the specific cytopenia returns to ≤Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m2.

2.3 Instructions for Preparation and Intravenous Administration ISTODAX should be handled in a manner consistent with recommended safe procedures for handling cytotoxic drugs.

4 CONTRAINDICATIONS None.

5 WARNINGS AND PRECAUTIONS 5.1 Hematologic Treatment with ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, these hematological parameters should be monitored during treatment with ISTODAX, and the dose should be modified, as necessary [See Dosage and Administration (2.2) and Adverse Reactions (6)].

5.2 Infection Serious and sometimes fatal infections, including pneumonia and sepsis, have been reported in clinical trials with ISTODAX. These can occur during treatment and within 30 days after treatment, and the risk of life threatening infections may be higher in patients with a history of extensive or intensive chemotherapy [See Adverse Reactions (6)].

5.3 Electrocardiographic Changes Several treatment-emergent morphological changes in ECGs (including T-wave and ST-segment changes) have been reported in clinical studies. The clinical significance of these changes is unknown [See Adverse Reactions (6)].

In patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions should be considered, such as the monitoring of electrolytes and ECGs at baseline and periodically during treatment.

Potassium and magnesium should be within the normal range before administration of ISTODAX [See Adverse Reactions (6)].

5.4 Tumor Lysis Syndrome Tumor lysis syndrome (TLS) has been reported to occur in 1% of patients with tumor stage CTCL and 2% of patients with Stage III/IV PTCL. Patients

been born an Eagle so he too could fly so freely and so confidently?

Days passed and little Charlie kept very still, waiting for some clue or idea to help him out of his predicament.

Anything would help him feel better about himself. If jumping out of the nest,

with advanced stage disease and/or high tumor burden should be closely monitored, appropriate precautions should be taken, and treatment should be instituted as appropriate.

5.5 Use in Pregnancy There are no adequate and well-controlled studies of ISTODAX in pregnant women. However, based on its mechanism of action and findings in animals, ISTODAX may cause fetal harm when administered to a pregnant woman.

In an animal reproductive study, romidepsin was embryocidal and resulted in adverse effects on the developing fetus at exposures below those in patients at the recommended dose of 14 mg/m2/week. If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus [See Use in Specific Populations (8.1)].

6 ADVERSE REACTIONS 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 practice.

Cutaneous T-Cell Lymphoma The safety of ISTODAX was evaluated in 185 patients with CTCL in 2 single arm clinical studies in which patients received a starting dose of 14 mg/m2. The mean duration of treatment in these studies was 5.6 months (range: <1 to 83.4 months).

Common Adverse Reactions Table 1 summarizes the most frequent adverse reactions (> 20%) regardless of causality using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 3.0). Due to methodological differences between the studies, the AE data are presented separately for Study 1 and Study 2. Adverse reactions are ranked by their incidence in Study 1. Laboratory abnormalities commonly reported (> 20%) as adverse reactions are included in Table 1.

Table 1. Adverse Reactions Occurring in >20% of Patients in Either CTCL Study (N=185) Study 1 Study 2 (n=102) (n=83) Grade 3 Grade 3 Adverse Reactions n (%) All or 4 All or 4 Any adverse reaction 99 (97) 36 (35) 83 (100) 68 (82) Nausea 57 (56) 3 (3) 71 (86) 5 (6) Asthenia/Fatigue 54 (53) 8 (8) 64 (77) 12 (14) Infections 47 (46) 11 (11) 45 (54) 27 (33) Vomiting 35 (34) 1 (<1) 43 (52) 8 (10) Anorexia 23 (23) 1 (<1) 45 (54) 3 (4) Hypomagnesemia 22 (22) 1 (<1) 23 (28) 0 Diarrhea 20 (20) 1 (<1) 22 (27) 1 (1) Pyrexia 20 (20) 4 (4) 19 (23) 1 (1) Anemia 19 (19) 3 (3) 60 (72) 13 (16) Thrombocytopenia 17 (17) 0 54 (65) 12 (14) Dysgeusia 15 (15) 0 33 (40) 0 Constipation 12 (12) 2 (2) 32 (39) 1 (1) Neutropenia 11 (11) 4 (4) 47 (57) 22 (27) Hypotension 7 (7) 3 (3) 19 (23) 3 (4) Pruritus 7 (7) 0 26 (31) 5 (6) Hypokalemia 6 (6) 0 17 (20) 2 (2) Dermatitis/Exfoliative dermatitis 4 (4) 1 (<1) 22 (27) 7 (8) Hypocalcemia 4 (4) 0 43 (52) 5 (6) Leukopenia 4 (4) 0 38 (46) 18 (22) Lymphopenia 4 (4) 0 47 (57) 31 (37) Alanine aminotransferase increased 3 (3) 0 18 (22) 2 (2) Aspartate aminotransferase increased 3 (3) 0 23 (28) 3 (4) Hypoalbuminemia 3 (3) 1 (<1) 40 (48) 3 (4) Electrocardiogram ST-T wave changes 2 (2) 0 52 (63) 0 Hyperglycemia 2 (2) 2 (2) 42 (51) 1 (1) Hyponatremia 1 (<1) 1 (<1) 17 (20) 2 (2) Hypermagnesemia 0 0 22 (27) 7 (8) Hypophosphatemia 0 0 22 (27) 8 (10) Hyperuricemia 0 0 27 (33) 7 (8)

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Through the Eyes of an Advocate like the Cardinal said, was the right way to fly, then why did it feel so wrong to him? Charlie sat doubting himself more and more. Charlie’s depression grew, and not even the beautiful sun rising in the morning or watching the other birds could make him even want to try to spread his wings. What was supposed to be his flight to freedom and expression

only brought him sadness and misery.

He looked around and only saw the critical eye of the Cardinal watching his every move. He felt trapped, useless, and wishing he had not been born.

Obviously, he was a mistake.

One day, from high up, a wise old Owl, who had observed what happened, said, “Trust yourself, Charlie. Listen to

Serious Adverse Reactions Infections were the most common type of SAE reported in both studies with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection. Serious adverse reactions reported in > 2% of patients in Study 1 were sepsis and pyrexia (3%). In Study 2, serious adverse reactions in > 2% of patients were fatigue (7%), supraventricular arrhythmia, central line infection, neutropenia (6%), hypotension, hyperuricemia, edema (5%), ventricular arrhythmia, thrombocytopenia, nausea, leukopenia, dehydration, pyrexia, aspartate aminotransferase increased, sepsis, catheter related infection, hypophosphatemia and dyspnea (4%).

Most deaths were due to disease progression. In Study 1, there were two deaths due to cardiopulmonary failure and acute renal failure. In Study 2, there were six deaths due to infection (4), myocardial ischemia, and acute respiratory distress syndrome.

Discontinuations Discontinuation due to an adverse event occurred in 21% of patients in Study 1 and 11% in Study 2. Discontinuations occurring in at least 2% of patients in either study included infection, fatigue, dyspnea, QT prolongation, and hypomagnesmia.

Peripheral T-Cell Lymphoma The safety of ISTODAX was evaluated in 178 patients with PTCL in a sponsor-conducted pivotal study (Study 3) and a secondary NCI-sponsored study (Study 4) in which patients received a starting dose of 14 mg/m2.

The mean duration of treatment and number of cycles in these studies were 5.6 months and 6 cycles.

Common Adverse Reactions Table 2 summarizes the most frequent adverse reactions (≥ 10%) regardless of causality, using the NCI-CTCAE, Version 3.0. The AE data are presented separately for Study 3 and Study 4. Laboratory abnormalities commonly reported (≥ 10%) as adverse reactions are included in Table 2.

Table 2. Adverse Reactions Occurring in ≥10% of Patients with PTCL in Study 3 and Corresponding Incidence in Study 4 (N=178) Study 3 Study 4 (N=131) (N=47) Grade 3 Grade 3 Adverse Reactions n (%) All or 4 All or 4 Any adverse reactions 127 (97) 86 (66) 47 (100) 40 (85) Gastrointestinal disorders Nausea 77 (59) 3 (2) 35 (75) 3 (6) Vomiting 51 (39) 6 (5) 19 (40) 4 (9) Diarrhea 47 (36) 3 (2) 17 (36) 1 (2) Constipation 39 (30) 1 (<1) 19 (40) 1 (2) Abdominal pain 18 (14) 3 (2) 6 (13) 1 (2) Stomatitis 13 (10) 0 3 (6) 0 General disorders and administration site conditions Asthenia/Fatigue 72 (55) 11 (8) 36 (77) 9 (19) Pyrexia 46 (35) 7 (5) 22 (47) 8 (17) Chills 14 (11) 1 (<1) 8 (17) 0 Edema peripheral 13 (10) 1 (<1) 3 (6) 0 Blood and lymphatic system disorders Thrombocytopenia 53 (41) 32 (24) 34 (72) 17 (36) Neutropenia 39 (30) 26 (20) 31 (66) 22 (47) Anemia 32 (24) 14 (11) 29 (62) 13 (28) Leukopenia 16 (12) 8 (6) 26 (55) 21 (45) Metabolism and nutrition disorders Anorexia 37 (28) 2 (2) 21 (45) 1 (2) Hypokalemia 14 (11) 3 (2) 8 (17) 1 (2) Nervous system disorders Dysgeusia 27 (21) 0 13 (28) 0 Headache 19 (15) 0 16 (34) 1 (2) Respiratory, thoracic and mediastinal disorders Cough 23 (18) 0 10 (21) 0 Dyspnea 17 (13) 3 (2) 10 (21) 2 (4) Investigations Weight decreased 13 (10) 0 7 (15) 0 Cardiac disorders Tachycardia 13 (10) 0 0 0

your heart. Go for it. Don’t worry about if you are doing it right.” “But,” Charlie replied, “the Cardinal said I was doing it wrong. I’m supposed to jump off rather than fall out.” The Owl kindly responded, “The Cardinal thinks he is helping, but he is so focused on what others are doing that he forgets he does not have all the answers. Also notice,” the Owl

Continued on page 12

Serious Adverse Reactions Infections were the most common type of SAE reported. In Study 3, 25 patients (19%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections. Serious adverse reactions reported in ≥ 2% of patients in Study 3 were pyrexia (7%), pneumonia, sepsis, vomiting (5%), cellulitis, deep vein thrombosis, (4%), febrile neutropenia, abdominal pain (3%), chest pain, neutropenia, pulmonary embolism, dyspnea, and dehydration (2%). In Study 4, serious adverse reactions in ≥ 2 patients were pyrexia (17%), aspartate aminotransferase increased, hypotension (13%), anemia, thrombocytopenia, alanine aminotransferase increased (11%), infection, dehydration, dyspnea (9%), lymphopenia, neutropenia, hyperbilirubinemia, hypocalcemia, hypoxia (6%), febrile neutropenia, leukopenia, ventricular arrhythmia, vomiting, hypersensitivity, catheter related infection, hyperuricemia, hypoalbuminemia, syncope, pneumonitis, packed red blood cell transfusion, and platelet transfusion (4%).

Deaths due to all causes within 30 days of the last dose of ISTODAX occurred in 7% of patients in Study 3 and 17% of patients in Study 4. In Study 3, there were 5 deaths unrelated to disease progression that were due to infections, including multi-organ failure/sepsis, pneumonia, septic shock, candida sepsis, and sepsis/cardiogenic shock. In Study 4, there were 3 deaths unrelated to disease progression that were due to sepsis, aspartate aminotransferase elevation in the setting of Epstein Barr virus reactivation, and death of unknown cause.

Discontinuations Discontinuation due to an adverse event occurred in 19% of patients in Study 3 and in 28% of patients in Study 4. In Study 3, thrombocytopenia and pneumonia were the only events leading to treatment discontinuation in at least 2% of patients. In Study 4, events leading to treatment discontinuation in ≥ 2 patients were thrombocytopenia (11%), anemia, infection, and alanine aminotransferase increased (4%).

6.2 Postmarketing Experience No additional safety signals have been observed from postmarketing experience.

7 DRUG INTERACTIONS 7.1 Coumadin or Coumadin Derivatives Prolongation of PT and elevation of INR were observed in a patient receiving ISTODAX concomitantly with warfarin. Although the interaction potential between ISTODAX and Coumadin® (a registered trademark of BristolMyers Squibb Pharma Company) or Coumadin derivatives has not been formally studied, physicians should carefully monitor PT and INR in patients concurrently administered ISTODAX and Coumadin or Coumadin derivatives [See Clinical Pharmacology (12.3)].

7.2 Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes Romidepsin is metabolized by CYP3A4. Although there are no formal drug interaction studies for ISTODAX, strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase concentrations of romidepsin. Therefore, co-administration with strong CYP3A4 inhibitors should be avoided if possible. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors.

Co-administration of potent CYP3A4 inducers (e.g., dexamethasone, carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital) may decrease concentrations of romidepsin and should be avoided if possible. Patients should also refrain from taking St. John’s Wort.

7.3 Drugs that Inhibit Drug Transport Systems Romidepsin is a substrate of the efflux transporter P-glycoprotein (P-gp, ABCB1). If ISTODAX is administered with drugs that inhibit P-gp, increased concentrations of romidepsin are likely, and caution should be exercised.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D [See Warnings and Precautions (5.5)].

There are no adequate and well-controlled studies of ISTODAX in pregnant women. However, based on its mechanism of action and findings in animals, ISTODAX may cause fetal harm when administered to a pregnant woman.

In an animal reproductive study, romidepsin was embryocidal and resulted in adverse effects on the developing fetus at exposures below those in patients at the recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus.

Romidepsin was administered intravenously to rats during the period of organogenesis at doses of 0.1, 0.2, or 0.5 mg/kg/day. Substantial resorption or post-implantation loss was observed at the high-dose of 0.5 mg/kg/day, a maternally toxic dose. Adverse embryo-fetal effects were Cosmos Communications

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continued, “he is so busy telling you that you are not doing it right and watching your every move, that he is not flying and getting on with his own life.”

Like magic, right at that moment, a teenage Bluebird flew down and landed next to Charlie and said, “Hey, come with me. The Eagles have this neat nest

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Significance of Mentoring high on the top of this tree, and we’re all wind sailing from their platform.”

“Wait,” said Charlie, “how did you learn to fly?” “Well, it felt right for me to fall out backward at first,” said his new friend, “and since then, I have practiced taking off frontward. Boy, it sure did give my

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mother a scare the first few times I fell out backward! I knew she held her breath each time I did it, but she only had words of encouragement for me and was proud of my efforts. Then, unbelievably, my flock admired me for my uniqueness, and I started teaching others how to do my

noted at romidepsin doses of ≥0.1 mg/kg/day, with systemic exposures (AUC) ≥0.2% of the human exposure at the recommended dose of 14 mg/m2/week. Drug-related fetal effects consisted of folded retina, rotated limbs, and incomplete sternal ossification.

seen in mice after 4 weeks of drug administration at higher doses. Seminal vesicle and prostate organ weights were decreased in a separate study in rats after 4 weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m2/day), approximately 30% the estimated human daily dose based on body surface area. Romidepsin showed high affinity for binding to estrogen receptors in pharmacology studies. In a 26-week toxicology study in rats, atrophy was seen in the ovary, uterus, vagina and mammary gland of females administered doses as low as 0.1 mg/kg/dose (0.6 mg/m2/dose) following the clinical dosing schedule. This dose resulted in AUC0-inf. values that were 0.3% of those in patients receiving the recommended dose of 14 mg/m2/dose. Maturation arrest of ovarian follicles and decreased weight of ovaries were observed in a separate study in rats after four weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m2/day). This dose is approximately 30% the estimated human daily dose based on body surface area

8.3 Nursing Mothers It is not known whether romidepsin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use The safety and effectiveness of ISTODAX in pediatric patients has not been established.

8.5 Geriatric Use Of the approximately 300 patients with CTCL or PTCL in trials, about 25% were > 65 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out.

8.6 Hepatic Impairment No dedicated hepatic impairment study for ISTODAX has been conducted.

Mild hepatic impairment does not alter pharmacokinetics of romidepsin based on a population pharmacokinetic analysis. Patients with moderate and severe hepatic impairment should be treated with caution [See Clinical Pharmacology (12.3)]

16 HOW SUPPLIED/STORAGE AND HANDLING Keep out of reach of children.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-4 [See References (15)].

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling.

17.1 Instructions • Nausea and Vomiting Nausea and vomiting are common following treatment with ISTODAX. Prophylactic antiemetics are recommended to be used in all patients.

Advise patients to report these symptoms so that appropriate treatment can be instituted [See Adverse Reactions (6)].

• Low Blood Counts Patients should be informed that treatment with ISTODAX can cause low blood counts and that frequent monitoring of hematologic parameters is required. Patients should be instructed to report fever or other signs of infection, significant fatigue, shortness of breath, or bleeding [See Warnings and Precautions (5.1)].

• Infections Patients should be informed that infections may occur during treatment with ISTODAX. Patients should be instructed to report fever, cough, shortness of breath with or without chest pain, burning on urination, flu-like symptoms, muscle aches, or worsening skin problems [See Warnings and Precautions (5.2].

• Tumor Lysis Syndrome Patients at risk of tumor lysis syndrome (i.e, those with advanced stage disease and/or high tumor burden) should be monitored closely for TLS and appropriate measures taken if symptoms are observed [See Warnings and Precautions (5.4)].

• Use in Pregnancy If pregnancy occurs during treatment with ISTODAX, female patients should be advised to seek immediate medical advice and counseling.

[See Warnings and Precautions (5.5)].

• Patients should be instructed to read the patient insert carefully.

8.7 Renal Impairment No dedicated renal impairment study for ISTODAX has been conducted.

Based upon the population pharmacokinetic analysis, renal impairment is not expected to significantly influence drug exposure. The effect of end-stage renal disease on romidepsin pharmacokinetics has not been studied. Thus, patients with end-stage renal disease should be treated with caution [See Clinical Pharmacology (12.3)] 10 OVERDOSAGE No specific information is available on the treatment of overdosage of ISTODAX. Toxicities in a single-dose study in rats or dogs, at intravenous romidepsin doses up to 2.2 fold the recommended human dose based on the body surface area, included irregular respiration, irregular heart beat, staggering gait, tremor, and tonic convulsions.

In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., clinical monitoring and supportive therapy, if required.

There is no known antidote for ISTODAX and it is not known if ISTODAX is dialyzable.

12 CLINICAL PHARMACOLOGY 12.2 Pharmacodynamics Cardiac Electrophysiology The effect of romidepsin on the heart-rate corrected QTc/QTcF was evaluated in 26 subjects with advanced malignancies given romidepsin at doses of 14 mg/m2 as a 4-hour intravenous infusion, and at doses of 8, 10 or 12 mg/m2 as a 1–hour infusion. Patients received premedications with antiemetics. No large changes in the mean QTc interval (> 20 milliseconds) from baseline based on Fridericia correction method were detected in the trial. Small increase in mean QT interval (< 10 milliseconds) and mean QT interval increase between 10 to 20 milliseconds cannot be excluded because of the limitations in the trial design.

Romidepsin was associated with a delayed concentration-dependent increase in heart rate in patients with advanced cancer with a maximum mean increase in heart rate of 20 beats per minute occurring at the 6 hour time point after start of romidepsin infusion for patients receiving 14 mg/m2 as a 4-hour infusion.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with romidepsin.

Romidepsin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Romidepsin was not clastogenic in an in vivo rat bone marrow micronucleus assay when tested to the maximum tolerated dose (MTD) of 1 mg/kg in males and 3 mg/kg in females (6 and 18 mg/m2 in males and females, respectively).

These doses were up to 1.3-fold the recommended human dose, based on body surface area.

move. They were scared out of their wits to try. Imagine that! What came to me naturally, others were frightened just to attempt, and they soon appreciated how easy it was for me. My mother said I had been given a special gift. Boy, did this make me feel good about myself. Now I

Manufactured for: Celgene Corporation Summit, NJ 07901 Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 or Baxter Oncology GmbH Halle/Westfalen, Germany ISTODAX® is a registered trademark of Celgene Corporation © 2010-2012 Celgene Corporation. All Rights Reserved.

U.S. Patents: 4,977,138; 7,608,280; 7,611,724 ISTBAXPI.004/PPI.004 03/12

Based on non-clinical findings, male and female fertility may be compromised by treatment with ISTODAX. In a 26-week toxicology study, romidepsin administration resulted in testicular degeneration in rats at 0.33 mg/kg/dose (2 mg/m2/dose) following the clinical dosing schedule. This dose resulted in AUC0-inf. values that were approximately 2% the exposure level in patients receiving the recommended dose of 14 mg/m2/dose. A similar effect was Cosmos Communications

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only do my backflips in bird shows and on days I want to be reminded of my mother’s words of encouragement to keep growing and trusting myself.”

With this, his new friend flew away effortlessly. Charlie looked around and very abashed said out loud to himself, “Sometimes you’ve just got to say ‘what the heck’ and go for it!” With this, he took a deep breath and with his little body trembling in terror, fell out of the nest. The Cardinal was, of course, observing all of this and yelled out, “You’re not doing it right! You’re going to kill yourself!”

Charlie fell straight toward the ground.

His immediate reaction was that he had made a mistake. The earth was moving closer and closer! But suddenly, his natural instincts took over and he flew! Yes, awkwardly and wildly with erratic movements, but he was flying! He landed on a branch within earshot of his new friend, who smiled and said, “Hey, man, that was cool! Could you show me how you made those moves? I’ll meet you at the Eagle’s nest!”

With this, his new friend took off to the top of the tree to the Eagle’s nest.

Before Charlie joined him, however, he flew to a branch near to where the Cardinal shook his head in disbelief.

Charlie spoke from his heart how he felt humiliated and discouraged when the Cardinal told him he was not doing it right. He shared how much this prevented him from trusting himself and how insecure and fearful he had been, scared even to try. The Cardinal listened without comment. Relieved by sharing his feelings with the Cardinal, Charlie took off. In his own unique and shaky way, Charlie started to fly to the top of the tree. Looking back over his shoulder, to his wonder, Charlie noticed that the Cardinal had flown up to the wise old Owl and was listening intently to every word the Owl was saying.

Our little Bluebird, Charlie, went on to learn how to soar to new heights. You may not believe it, but one rainy day he risked flying higher than he had ever done before, and he and his best friend flew over the rainbow! A songwriter caught the Bluebirds flying and composed a song about freedom and flying over the rainbow. That song is famous to this day.

What happened to the Cardinal? He is still hanging around his favorite tree.

Except now he wind sails from the Eagles’ platform, demonstrating his graceful ability and setting an example for others to follow.

He learned that day from the wise old Owl and Charlie that it is more important to show others by example how to fly. For the greatest gift we can give to each other is to applaud one’s courage, rather than clip one’s wings! l

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www.TheOncologyNurse.com

Personalized Medicine

Drug Combination Potentially Effective in BRCA-Deficient Solid Tumors

By Alice Goodman

T

wo orally available experimental drugs achieved response in patients with BRCA-deficient solid tumors in a phase 1 study of 38 patients. Responders were patients with BRCA mutations and incurable pancreatic, breast, and ovarian tumors.

“There is definitely a group of responders who appear to benefit from this drug combination. This should be studied in a new, much larger prospective trial,” said lead author Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute and Harvard Medical School in Boston, Massachusetts, at the American Association for Cancer Research Annual Meeting.

Among the 38 patients, 16 had BRCAdeficient cancers. Patients received treatment with sapacitabine and seliciclib—2 drugs developed by Cyclacel Pharmaceuticals, Inc. Sapacitabine caus-

es single-strand DNA breaks that are converted to double-strand DNA breaks during replication. The investigators in the phase 1 trial hypothesized that seliciclib would interfere with the repair of damaged DNA and enhance the cytotoxicity of sapacitabine, Shapiro explained.

Patients were treated with sequential administration of both drugs for 10 days, followed by an 11-day rest period. During the dose-escalation phase of the study, patients without BRCA mutations had stable disease. Two observations during the dose-escalation phase had researchers focusing on the patients with BRCA mutations: one, it was reported that the repair of DNA breaks caused by sapacitabine is dependent on the homologous repair pathway, which includes BRCA proteins and is downregulated in their absence; the second was a partial response (PR) observed in a patient with pancreat-

ic cancer who was found to be a BRCAmutation carrier.

The trial was then limited to patients with BRCA-deficient cancers. Three additional PRs were observed (2 with breast cancer and 1 with ovarian cancer).

The PRs have been durable in 3 patients (from 9 to 21 months). These 3 patients are continuing on study.

In total, 6 of the 16 BRCA-mutation carriers benefited from the drug combination (4 with PRs and 2 with stable disease).

Shapiro said that nonresponders were heavily pretreated and too compromised to tolerate a cycle of the combination therapy, and were therefore not evaluable.

“Among the BRCA-proficient group, several patients had prolonged stable disease, but the response was not as dramatic as in the BRCA-deficient group,” he said.

“Going forward, the combination therapy

has the most chance of efficacy in BRCAdeficient patients.”

Sequential administration of the 2 experimental agents was used in the trial.

Concurrent administration of sapacitabine and seliciclib will be studied, as will different dosing schedules.

PARP (poly ADP-ribose polymerase) inhibitors are effective in BRCA-deficient patients. Shapiro said the responders in the trial had not been pretreated with a PARP inhibitor. “We need to determine if the combination works in patients pretreated with PARP. Finally, we have some drug classes that address inherited cancers,” Shapiro stated. l Reference

Shapiro GI, Hilton J, Cleary JM, et al. Responses to sequential sapacitabine and seliciclib in patients with BRCA-deficient solid tumors. Presented at: American Association for Cancer Research 2013 Annual Meeting; April 9, 2013; Washington, DC. Abstract LB-202.

Squamous Cell Carcinoma

Genetic Analysis Identifies 4 Subsets of Squamous Cell Carcinoma of the Head and Neck

By Alice Goodman

C

omprehensive genetic analysis

by The Cancer Genome Atlas (TCGA) identified 4 different subtypes of squamous cell carcinoma of the head and neck (SCCHN). The analysis included 279 patients with previously untreated SCCHN. This is the eighth tumor type analysis of TCGA to be presented.

“Our study will likely become a landmark research tool for HNSCC for many years as we gradually unlock the secrets of this massive data set,” said David N. Hayes, MD, MPH, a medical oncologist who is associate professor at the University of North Carolina at Chapel Hill, at the American Association for Cancer Research (AACR) Annual Meeting.

SCCHN is the fifth most common cancer worldwide and the sixth most common type in the United States. Fortyfive thousand new cases are diagnosed each year. Smoking is a risk factor, as is the epidemic of human papillomavirus (HPV). Among the 279 patients included in the study, 80% were tobacco related and 13% were HPV positive.

“There is incredible pressure for these tumors to acquire a specific set of losses

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and gains. If you look across different tumor types, they have assumed a similar set of gains and losses across chromosomes; this may provide patterns that can be leveraged across a set of tumors,” he said. “We need to understand the mutations or individual alterations in the 15 most significant mutated genes in SCCHN.” In the study, significant mutations were found in the following genes: CDKN2A, TP53, PIK3CA, NOTCH1, HRAS, and NFE2L2.

Looking at all gene expression subtypes of SCCHN, tumors organize themselves into 4 groups that are reproducible. These subtypes tend to go along with differences in mutation patterns and chromosomal alterations, Hayes explained. The 4 subtypes are: 1.

Atypical subtype with no amplification of epidermal growth factor receptor (EGFR), HPV positive, and a high rate of phosphatidylinositide 3-kinase (PIK3CA) mutations 2.

Classical subtype, also seen in squamous cell lung cancer, associated with 2 key mutations: KEAP 1 and NFE2L2 3.

Mesenchymal subtype, mostly

mutations of FGR 1 and FGR, and 4.

Basal subtype, highly associated with SOX2 amplifications and overexpression.

Some of these alterations overlap with squamous cell carcinoma of the lung, which is also a tobacco-related cancer.

“We frequently see altered genomes in other tobacco-related cancers. One of the striking findings we observed was a high degree of similarity to other squamous tumors, including lung squamous cell carcinoma. Lessons learned from studying the similarities and differences between tumors, such as copy number alterations, will be an angle to pursue to better understand altered pathways in cancer. The idea that they share properties that go beyond the type of cancer means that this could be studied at a model systems level.”

Additional key observations of this study include: • Other patients as well as those who are HPV positive have infrequent EGFR gene amplification • HPV-positive tumors have a high rate of PIK3CA gene mutations • Patients infected with HPV almost never have p53 alterations • In patients who are HPV negative,

druggable mutations include EGFR, FGR, and CNCCC21.

“We have made a lot of observations, but this also makes things more complicated. We are able to recognize patterns, and some of these patterns may turn out to be druggable, or actionable in the future,” Hayes stated.

“This is robust information that gives us data on mutational analysis and copy numbers, expression, promoter methylation, and other aspects of SCCHN. This data set confirms other publications indicating that there is a clear difference between HPV-positive patients who usually have a better prognosis and are easier to treat than HPV-negative patients. HPVnegative patients have many more mutations than HPV-positive patients,” stated Giuseppe Giaccone, MD, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC. Giaccone moderated an AACR press conference at which these data were presented. l Reference

Hayes DN, Grandis J, El-Naggar AK. Comprehensive genomic characterization of squamous cell carcinoma of the head and neck in The Cancer Genome Atlas.

Presented at: American Association for Cancer Research 2013 Annual Meeting; April 7, 2013; Washington, DC. Abstract 1117.

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Best Practices

Incorporating Caregivers Improves Physical Activity and Quality of Life in Patients With Cancer

By Alice Goodman

R

eal-life experience translated into a research interest for Fedricker Barber, RN, ANP, AOCNP, of the MD Anderson Cancer Center in Houston, Texas. About 10 years ago, her husband was diagnosed with prostate cancer and was treated with 6 months of antiandrogen hormone therapy. During that relatively short course of treatment, he gained a lot of weight and was very tired. Barber was concerned, because he was a man in his late 40s, and she knew that lack of exercise and

“This is my passion, being an advocate of physical activity for cancer patients.”

Fedricker Barber, RN, ANP, AOCNP

weight gain were associated with the risk of developing heart disease, diabetes, a second primary cancer, and cancer recurrence. So she sprang into action, so to speak.

“This is my passion, being an advocate of physical activity for cancer patients. When I saw what was happening to my husband, I decided to become part of the solution. I helped

The Whole Patient

Addressing Spiritual Concerns

By Alice Goodman

E

vidence suggests that cancer patients commonly experience spiritual pain or distress but believe that their spiritual needs are not being adequately addressed by healthcare providers. At the 38th Annual Congress of the Oncology Nursing Society, Jill Burleson, MSN, ANP, spiritual care coordinator at Duke Medical Care in Durham, North Carolina, and Anne Belcher, PhD, RN, AOCN, associate professor at Johns Hopkins University School of Nursing in Baltimore, Maryland, discussed spirituality, religion, and the strategies nurses can use to help patients find meaning in their cancer experience.

Burleson made a distinction between spirituality and religion. “There are many definitions, but spirituality refers to a connection with something greater than oneself, personally meaningful experiences, or a deep sense of purpose and meaning in life. Some of these aspects overlap with religiosity, but in general, organized religion is associated with a specific set of beliefs and language that is based on a search for transcendent meaning in a personal way,” she explained.

“Terminally ill patients will seek a connection with a higher power, whether or not they consider themselves religious prior to this time and they may not adapt a spiritual practice.”

Cancer patients may ask themselves, “Why me?” This existential questioning usually occurs within 100 days of diagnosis, recurs at relapse and terminal diagnosis, and leads to a search for meaning, said Burleson. “Spirituality is for everyone, whether very religious, somewhat, or not at all. It is what drives a person. The search for meaning can lead to a return to childhood faith, turmoil with questioning, and peace with the diagnosis and outcome.”

Several coping mechanisms are associated with spirituality.

These can include direct action (such as prayer), denial/fatalism, seizing control (for type A personalities), information seeking, role reversal to childlike behavior, and depression.

Patients who consider themselves survivors have different needs from those who are terminally ill. Survivors will need to readjust their thinking and learn to live once more.

“They have to learn to dream again. They may feel guilty for surviving. Hope is considered to be a very effective strategy and helps to create meaning in life as well as dignity in death,” Burleson said. “Hope can be better than expectations.

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Maintaining hope is important for patients. There are different types of hope: hope for a good day, hope for a cure.”

Belcher discussed tools for nurses to use when assessing spirituality. Choice of a tool should encompass the patient’s age, culture, religious beliefs, and gender. Spiritual assessment should be performed for terminally ill patients and those who face existential crises, she said.

Some useful instruments include the Spiritual Perspective Scale (a 10-item self-questionnaire developed by Pamela G. Reed in 1986), the FICA (Faith/Importance/Community/ Address) Spiritual Assessment Tool (developed by Christina Puchalski in 1999), and the Spiritual Life Map (for more information, see Hodge DR. Soc Work. 2005;50:77-87).

“The Spiritual Life Map is one of the most clinically useful tools I have come across. This is a way for patients to express concerns nonverbally,” Belcher explained.

Nurses can ask patients what gives their life meaning, what brings them a sense of joy, what they hope for, what gives them strength, and who they love. Open-ended statements can also be used to elicit their responses; for example, Recently my spirits have been…; I would like help in boosting my spirits from….

Patients want to be asked about their spirituality, she continued. Some questions are: What can a nurse do to help nurture your spirits? What would you like your nurse to know about your spiritual practices and beliefs?

“People want to be touched, called by name, listened to when they talk, and be able to see a chaplain when needed,” Belcher noted.

“Let patients know you care and that you won’t forget them. Never underestimate the power of touch. Journey with your patient to find meaning. Understand beliefs that may help and ones that may hurt. I have come up with REST as an acronym for how nurses can help: R for respect, E for encouragement, S for support, T for trust—trust your own instincts and build trust between you and your patient,” Burleson said. l Reference

Burleson J, Belcher A. Spirituality versus religion. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25, 2013; Washington, DC.

him by buying exercise videos and doing the exercises with him,” she explained. “I emphasized to him that exercise would improve his immune system, reduce his fatigue, and prevent muscle wasting.”

The effort bore fruit. She found that her participation encouraged him to exercise, and soon he was losing weight and gaining energy.

This experience led to her “passion,” incorporating caregivers and spouses of cancer patients into an exercise plan in her practice. “I give all patients an education sheet on physical activity, even if they are advanced cancer patients.

Exercise helps fatigue, mood, function, and sleep. Some patients think that if they have fatigue they should stay in bed, but the opposite is true. If you exercise, the fatigue is reduced,” she explained.

Exercise has been found to prevent the recurrence of cancers of the gastrointestinal tract, ovaries, esophagus, and breast. It also helps reduce some of the late effects of cancer treatment, such as poor wound healing, bowel urgency, and outlet obstruction, and it helps build up immune function, she continued.

At the 38th Annual Congress of the Oncology Nursing Society, Barber presented a poster on the relationships between adult cancer survivors’ and caregivers’ social support, self-efficacy for physical activity, and quality of life (QOL), as well as actual physical activity behavior. The sample included 101 cancer survivors and caregivers with a median age of 62 years. Physical QOL was significantly higher in caregivers than in cancer survivors at baseline, but after 1 month of caregivers exercising with their patients, no differences in this parameter were observed between the two groups. Social support from caregivers or friends in performing physical activity was found to improve participation in physical activity.

“We found that cancer survivors and their caregivers rely on social support to encourage and motivate them to participate in physical activity. These findings suggest that priority should be given to strategies that encourage physical activity for both cancer survivors and their caregivers,” she said. l Reference

Barber F. Effects of social support on physical activity participation in adult cancer survivors and their caregivers. Poster presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC.

www.TheOncologyNurse.com

Cancer Center Profile

Winship Cancer Institute of Emory University... Continued from cover Tell me about your role at the Bone Marrow Transplant Center at Winship Emory Healthcare.

Charise Gleason (CG): I am a nurse practitioner [NP] in the bone marrow transplant and myeloma program here at Emory. I specialize in multiple myeloma and complications from transplant. I see patients for return visits, follow their lab test results, order diagnostic studies, and manage situations that arise in the infusion center. For example, I am consulted if a patient getting treatment develops a new side effect, and also nurses will come to me with questions or issues that arise.

I am the lead in my group, so I also have administrative responsibilities.

What approach does your center take to treating patients with multiple myeloma?

CG: Our practice is patient centered and focused on the individual.

We have a multidisciplinary team approach that includes nurses, NPs, PAs [physician assistants], physicians, social workers, and clinical pharmacists.

We see more than 1000 patients each year in our myeloma program.

We are an academic center, and clinical research is part of our mission.

This setting gives us multiple treatment modalities to offer our patients. Any patient who comes here gets a thorough diagnostic workup, and then we offer that patient the most appropriate treatment plan. That could include conventional treatment and/or a clinical trial.

We offer up-front clinical trials for newly diagnosed patients as well as clinical trials for relapsed/refractory patients with multiple myeloma. As a myeloma center, we have multiple trials to offer at any time.

How does the approach to care at your center translate to better outcomes for your patients?

CG: We offer a multidisciplinary team approach that focuses on the individual patient. Patients and family members meet the team members at consult. We are committed to providing the latest, most innovative techniques and treatments as well as supportive services. We have resources to help the family and trained supportive staff to manage side effects. We believe this approach does lead to better outcomes.

How has the role of the nurse practitioner changed in the past 5 years?

CG: There is a growing population of advanced practice providers, both NPs and PAs, in healthcare in general. Here at Winship, NPs and PAs are an integral part of the care teams. We provide care to patients in the clinic, infusion center, and inpatient setting. There is

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also more opportunity to participate in research and develop NP/PA-run clinics. Survivorship clinics are growing and are frequently managed by NP/ PAs. There are also more teaching opportunities. In Georgia, PAs were recently granted prescriptive authority.

This varies from state to state.

Transplant service and eventually specialized in myeloma. I started with the myeloma program about 10 years ago with Sagar Lonial, MD, and over time the program has really grown.

The landscape of myeloma has changed so much over the last 10 years that patients now have more

“There is a growing population of advanced practice providers, both NPs and PAs, in healthcare in general. Here at Winship, NPs and PAs are an integral part of the care teams.”

Charise Gleason, MSN, NP-BC, AOCNP

What inspired you to become a nurse practitioner and to specialize in multiple myeloma?

CG: I went to nursing school after I had children and was drawn to oncology from the start. I had a rotation on the hematology/oncology floor and loved it and stayed there. After NP school, I joined the Bone Marrow

treatment options leading to better outcomes. We see our patients frequently and therefore get to know them, as well as their family members. I feel very privileged to work in oncology.

What is a major challenge in your job?

CG: Getting patients what they need.

Appointments are not always available, and getting medications can be a challenge for some patients. Time can be an issue. NPs are involved in multiple working groups, and most of us are involved in academic endeavors as well. Maintaining a work/life balance can be an issue.

What advice would you give to a person entering oncology as a nurse practitioner?

CG: I would recommend taking the time to develop a solid medical foundation, especially for new practitioners. Most of us tend to specialize, so a strong medical background is essential. It is important to have a mentor for support and guidance.

We need to continue to expand our expertise by attending professional meetings and participating in education courses.

If you weren’t a nurse practitioner, what would you be doing?

CG: Traveling and writing about my traveling experiences. l

Reader Poll Do you talk to patients about survivorship care? o Yes o No

©iStockphoto.com/Slobodan Vasic

T

he “Survivorship Plans: Taking Care of the Details” article covers the presentation by Deborah K. Mayer, PhD, RN, AOCN, FAAN, at the 38th Annual Congress of the Oncology Nursing Society.

Mayer states that such plans are not always provided to cancer patients although this planning will be mandato-

ry by 2015. She also points out “The development and implementation of survivorship plans cannot be done by nurses alone. It requires teamwork.” Do you talk to patients about survivorship planning? Does your oncology program have an established policy to discuss the treatment summary and survivorship plan with patients?

Go to www.TheOncologyNurse.com to answer the question and add your comments.

June 2013 I VOL 6, NO 5

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Prostate Cancer

AUA Revises Its Guidelines for PSA-Based Prostate Cancer Screening Relaxing Its Support of General Screening, Now Limited to Ages 55-69

By Charles Bankhead

P

rostate cancer screening with about potential benefits and risks of benefit from being tested,” Carter said. prostate-specific antigen (PSA) screening. The decision to screen “The conclusion we came to, based on tests should focus on men aged 55 should be a shared one between phy- the evidence, was that the group more to 69 years, the group that is the most sician and patient. likely to benefit would be men ages 55 likely to benefit from screening, accord“It’s time to reflect on how we screen to 69, which is where we should be ing to a new clinical guideline issued by men for prostate cancer and take a focusing our efforts.” the American Urological Association more selective approach in order to The recommendation pertaining to (AUA) at its 2013 annual meeting, held in San Diego, California. This represents a significant shift from the “It’s time to reflect on how we screen men previous position held by the AUA for a strong support of PSA screening for for prostate cancer and take a more selective men of all age groups. approach in order to maximize benefit The new AUA position now does not recommend routine PSA screenand minimize harm….based on the evidence… ing tests for average-risk men aged 40 the group more likely to benefit would be to 54 years. The organization recommends against PSA screening for men men ages 55 to 69, which is where we aged <40 years. Screening for men should be focusing our efforts.” aged ≥70 years “is not recommended,” nor is screening for men of any age H. Ballentine Carter, MD who have a life expectancy of less than 10 to 15 years. The AUA acknowledges that some older men aged ≥70 years and in excellent health may benefit maximize benefit and minimize harm,” men aged 40 to 54 years is likely from screening and should be evaluat- said the guideline panel chair H. to be the most controversial aspect ed on an individual basis.

Ballentine Carter, MD, Professor of of the guideline, Carter added in a Regardless of age or recommen- Urology at Johns Hopkins University video interview released by the AUA. dation, the AUA emphasizes that in Baltimore, Maryland. “Our focus Patients in that age range have a low screening should proceed only after was to help urologists identify those risk of prostate cancer and a very long 1 8/20/12 9:44 1 likely to aWCMC_2013Conf_horizontalV382012_Layout careful discussion with the patient individuals whoAM arePage most lead time with respect to testing. If

SECOND ANNUAL CONFERENCE

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS

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• Melanoma • Basal Cell Carcinoma • Cutaneous T-Cell Lymphoma

• Squamous Cell Carcinoma • Merkel Cell Carcinoma

July 26-28, 2013 Hyatt Regency La Jolla • at Aventine 3777 La Jolla Village Drive • San Diego, California

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they are tested and are found to have prostate cancer, the disease is likely to be in a very early stage, including what many urologists and oncologists have termed “clinically insignificant” or “inconsequential” cancers.

If men in the 40- to 54-year-old age group are treated, they will “live with the harms of treatment for a very long time,” he emphasized.

“For all of those reasons, we concluded that these men, while some may benefit [from screening], there is probably more harm than benefit as compared with beginning screening at age 55,” said Carter.

The new guideline replaces an AUA Practice Statement that was issued in 2009. The practice statement supported screening of average-risk men in the 40- to 54-year-old age group. However, the statement also addressed risk stratification and prostate cancer management. The guideline has a sole focus on the use of PSA screening tests.

Moreover, the practice statement relied heavily on expert and consensus opinions. The guideline was derived from a review of published evidence through 2012.

In addition to the age-related recommendations, the guideline offers physicians the option to screen less frequently than annually in appropriately selected men. The decision to screen every other year, or even less frequently, should be preceded by a careful discussion with the patient, and should be guided by the patient’s baseline PSA value.

The US Preventive Services Task Force recommendation against routine screening for men of any age was targeted to primary care physicians, and was strongly objected to by urologists. By contrast, the AUA guideline emphasizes that the recommendations apply to urologists.

The AUA “is not dismissing the PSA test as the task force has done,” said guideline committee member Philip W. Kantoff, MD, prostate specialist at Dana-Farber Cancer Institute, Boston, Massachusetts. “There should be a more reasonable approach to the use of PSA.” In keeping with AUA policy, the guideline will be reviewed on a regular basis and updated as appropriate in response to new information about prostate cancer screening, said Carter. l

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Offering patients a choice may help improve long-term adherence $10 CO-PAY * FOR MOST PRESCRIPTIONS PLEASE SEE THE COMPLETE BLACK BOX WARNING AND BRIEF SUMMARY ON THE FOLLOWING PAGES. IMPORTANT SAFETY INFORMATION Tamoxifen citrate is contraindicated in patients with known hypersensitivity and also in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus. As with other additive hormonal therapy (estrogens and androgens), hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with tamoxifen. If hypercalcemia does occur, appropriate measures should be taken and, if severe, tamoxifen should be discontinued. There is evidence of an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during tamoxifen therapy.

When tamoxifen is coadministered with chemotherapy, there may be a further increase in the incidence of thromboembolic effects. Adverse reactions to tamoxifen are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients.

WARNING In Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events were associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer. www.Soltamox.com www.DaraBiosciences.com

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SOLTAMOX - tamoxifen citrate solution Brief Summary: Consult package insert for full prescribing information FOR WOMEN WITH DUCTAL CARCINOMA IN SITU (DCIS) AND WOMEN AT HIGH RISK FOR BREAST CANCER Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women in the full prescribing information). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women years of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the incidence rate per 1,000 women years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer. * Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma. ** See Table 3 under (see CLINICAL PHARMACOLOGY, Clinical Studies in the full prescribing information) INDICATIONS AND USAGE Metastatic Breast Cancer Tamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate therapy. Adjuvant Treatment of Breast Cancer Tamoxifen citrate is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial. Tamoxifen citrate reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer. Ductal Carcinoma in Situ (DCIS) In women with DCIS, following breast surgery and radiation, tamoxifen citrate is indicated to reduce the risk of invasive breast cancer see (BOXED WARNING at the beginning of the label).

The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy. Current data from clinical trials support five years of adjuvant tamoxifen citrate therapy for patients with breast cancer. Reduction in Breast Cancer Incidence in High Risk Women Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years.

Twenty-five percent of the participants received drug for 5 years. The longer term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label).

Tamoxifen citrate is indicated only for high-risk women. “High risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer3 1.67%, as calculated by the Gail Model. Examples of combinations of factors predicting a 5-year risk³ 1.67% are: Age 35 or older and any of the following ombination of factors: One first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or At least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or CIS Age 40 or older and any of the following combination of factors: One first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or At least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or One first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia. Age 45 or older and any of the following combination of factors: At least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more. Age 50 or older and any of the following combination of factors: At least 2 first degree relatives with a history of breast cancer; or History of one breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or History of at least two breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more. Age 55 or older and any of the following combination of factors: One first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or History of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older. Age 60 or older and: 5-year predicted risk of breast cancer³ 1.67%, as calculated by the Gail Model. For women whose risk factors are not described in the above examples, the Gail Model is necessary to estimate absolute breast cancer risk. Health Care Professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-833-3533. There are no data available regarding the effect of tamoxifen citrate on breast cancer incidence in women with inherited mutations (BRCAl, BRCA2). After an assessment of the risk of developing breast cancer, the decision regarding therapy with tamoxifen citrate for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate therapy. In the NSABP P-1 trial, tamoxifen citrate treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk. CONTRAINDICATIONS Tamoxifen citrate is contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. Reduction in Breast Cancer Incidence in High Risk Women and Women with DCIS Tamoxifen is contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus. WARNINGS Effects in Metastatic Breast Cancer Patients. As with other additive hormonal therapy (estrogens and androgens), hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with tamoxifen. If hypercalcemia does occur, appropriate measures should be taken and, if severe, tamoxifen should be discontinued. Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.

An increased incidence of uterine malignancies has been reported in association with tamoxifen treatment. The underlying mechanism is unknown, but may be related to the estrogen-like effect of tamoxifen. Most uterine malignancies seen in association with tamoxifen are classified as adenocarcinoma of the endometrium. However, rare uterine sarcomas, including malignant mixed mullerian tumors, have also been reported. Uterine sarcoma is generally associated with a higher FIGO stage (III/IV) at diagnosis, poorer prognosis, and shorter survival. Uterine sarcoma has been reported to occur more frequently among long-term users (³ 2 years) of tamoxifen than nonusers. Some of the uterine malignancies (endometrial carcinoma or uterine sarcoma) have been fatal. In the NSABP P-1 trial, among participants randomized to tamoxifen there was a statistically significant increase in the incidence of endometrial cancer (33 cases of invasive endometrial cancer, compared to 14 cases among participants randomized to placebo (RR=2.48, 95% CI: 1.27-4.92). The 33 cases in participants receiving tamoxifen were FIGO Stage I, including 20 IA, 12 IB, and 1 IC endometrial adenocarcinomas. In participants randomized to placebo, 13 were FIGO Stage I (8 IA and 5 IB) and 1 was FIGO Stage IV. Five women on tamoxifen and 1 on placebo received postoperative radiation therapy in addition to surgery. This increase was primarily observed among women at least 50 years of age at the time of randomization (26 cases of invasive endometrial cancer, compared to 6 cases among participants randomized to placebo (RR=4.50, 95% CI: 1.78-13.16). Among women £ 49 years of age at the time of randomization there were 7 cases of invasive endometrial cancer,

compared to 8 cases among participants randomized to placebo (RR=0.94, 95% CI: 0.28-2.89). If age at the time of diagnosis is considered, there were 4 cases of endometrial cancer among participants £ 49 randomized to tamoxifen compared to 2 among participants randomized to placebo (RR=2.21, 95% CI: 0.4-12.0). For women³ 50 at the time of diagnosis, there were 29 cases among participants randomized to tamoxifen compared to 12 among women on placebo (RR=2.5, 95% CI: 1.3-4.9). The risk ratios were similar in the two groups, although fewer events occurred in younger women. Most (29 of 33 cases in the tamoxifen group) endometrial cancers were diagnosed in symptomatic women, although 5 of 33 cases in the tamoxifen group occurred in asymptomatic women. Among women receiving tamoxifen the events appeared between 1 and 61 months (average=32 months) from the start of treatment. In an updated review of long-term data (median length of total follow-up is 6.9 years, including blinded follow-up) on 8,306 women with an intact uterus at randomization in the NSABP P-1 risk reduction trial, the incidence of both adenocarcinomas and rare uterine sarcomas was increased in women taking tamoxifen. During blinded follow-up, there were 36 cases of FIGO Stage I endometrial adenocarcinoma (22 were FIGO Stage IA, 13 IB, and 1 IC) in women receiving tamoxifen and 15 cases in women receiving placebo [14 were FIGO Stage I (9 IA and 5 IB), and 1 case was FIGO Stage IV]. Of the patients receiving tamoxifen who developed endometrial cancer, one with Stage IA and 4 with Stage IB cancers received radiation therapy. In the placebo group, one patient with FIGO Stage IB cancer received radiation therapy and the patient with FIGO Stage IVB cancer received chemotherapy and hormonal therapy. During total follow-up, endometrial adenocarcinoma was reported in 53 women randomized to tamoxifen (30 cases of FIGO Stage IA, 20 were Stage IB, 1 was Stage IC, and 2 were Stage IIIC), and 17 women randomized to placebo (9 cases were FIGO Stage IA, 6 were Stage IB, 1 was Stage IIIC, and 1 was Stage IVB) (incidence per 1,000 women-years of 2.20 and 0.71, respectively). Some patients received post-operative radiation therapy in addition to surgery. Uterine sarcomas were reported in 4 women randomized to tamoxifen (1 was FIGO IA, 1 was FIGO IB, 1 was FIGO IIA, and 1 was FIGO IIIC) and one patient randomized to placebo FIGO IA); incidence per 1,000 women-years of 0.17 and 0.04, respectively. Of the patients randomized to tamoxifen, the FIGO IA and IB cases were a MMMT and sarcoma, respectively; the FIGO II was a MMMT; and the FIGO III was a sarcoma; and the one patient randomized to placebo had a MMMT. A similar increased incidence in endometrial adenocarcinoma and uterine sarcoma was observed among women receiving tamoxifen in five other NSABP clinical trials. Any patient receiving or who has previously received tamoxifen who reports abnormal vaginal bleeding should be promptly evaluated.

Patients receiving or who have previously received tamoxifen should have annual gynecological examinations and they should promptly inform their physicians if they experience any abnormal gynecological symptoms, e.g., menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, or pelvic pain or pressure.

In the P-1 trial, endometrial sampling did not alter the endometrial cancer detection rate compared to women who did not undergo endometrial sampling (0.6% with sampling, 0.5% without sampling) for women with an intact uterus. There are no data to suggest that routine endometrial sampling in asymptomatic women taking tamoxifen to reduce the incidence of breast cancer would be beneficial. NonMalignant Effects on the Uterus. An increased incidence of endometrial changes including hyperplasia and polyps has been reported in association with tamoxifen treatment. The incidence and pattern of this increase suggest that the underlying mechanism is related to the estrogenic properties of tamoxifen. There have been a few reports of endometriosis and uterine fibroids in women receiving tamoxifen.

The underlying mechanism may be due to the partial estrogenic effect of tamoxifen.

Ovarian cysts have also been observed in a small number of premenopausal patients with advanced breast cancer who have been treated with tamoxifen. Tamoxifen has been reported to cause menstrual irregularity or amenorrhea. Thromboembolic Effects of Tamoxifen. There is evidence of an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during tamoxifen therapy. When tamoxifen is coadministered with chemotherapy, there may be a further increase in the incidence of thromboembolic effects. For treatment of breast cancer, the risks and benefits of tamoxifen should be carefully considered in women with a history of thromboembolic events. Data from the NSABP P-1 trial show that participants receiving tamoxifen without a history of pulmonary emboli (PE) had a statistically significant increase in pulmonary emboli (18-tamoxifen, 6-placebo, RR=3.01, 95% CI: 1.15-9.27). Three of the pulmonary emboli, all in the tamoxifen arm, were fatal. Eighty-seven percent of the cases of pulmonary embolism occurred in women at least 50 years of age at randomization. Among women receiving tamoxifen, the events appeared between 2 and 60 months (average = 27 months) from the start of treatment. In this same population, a non-statistically significant increase in deep vein thrombosis (DVT) was seen in the tamoxifen group (30tamoxifen, 19-placebo; RR=1.59, 95% CI: 0.86-2.98). The same increase in relative risk was seen in women £ 49 and in women³ 50, although fewer events occurred in younger women. Women with thromboembolic events were at risk for a second related event (7 out of 25 women on placebo, 5 out of 48 women on tamoxifen) and were at risk for complications of the event and its treatment (0/25 on placebo, 4/48 on tamoxifen).

Among women receiving tamoxifen, deep vein thrombosis events occurred between 2 and 57 months (average=19 months) from the start of treatment.

There was a non-statistically significant increase in stroke among patients randomized to tamoxifen (24-placebo; 34-tamoxifen; RR=1.42; 95% CI 0.82-2.51).

Six of the 24 strokes in the placebo group were considered hemorrhagic in origin and 10 of the 34 strokes in the tamoxifen group were categorized as hemorrhagic.

Seventeen of the 34 strokes in the tamoxifen group were considered occlusive and 7 were considered to be of unknown etiology. Fourteen of the 24 strokes on the placebo arm were reported to be occlusive and 4 of unknown etiology. Among these strokes 3 strokes in the placebo group and 4 strokes in the tamoxifen group were fatal.

Eighty-eight percent of the strokes occurred in women at least 50 years of age at the time of randomization. Among women receiving tamoxifen, the events occurred between 1 and 63 months (average = 30 months) from the start of treatment. Effects on the Liver: Liver Cancer. In the Swedish trial using adjuvant tamoxifen 40 mg/day for 2-5 years, 3 cases of liver cancer have been reported in the tamoxifen treated group vs. 1 case in the observation group (See PRECAUTIONS,-Carcinogenesis). In other clinical trials evaluating tamoxifen, no cases of liver cancer have been reported to date. One case of liver cancer was reported in NSABP P-1 in a participant randomized to tamoxifen. Effects on the Liver: Non-Malignant Effects. Tamoxifen has been associated with changes in liver enzyme levels, and on rare occasions, a spectrum of more severe liver abnormalities including fatty liver, cholestasis, hepatitis

and hepatic necrosis. A few of these serious cases included fatalities. In most reported cases the relationship to tamoxifen is uncertain. However, some positive rechallenges and dechallenges have been reported. In the NSABP P-1 trial, few grade 3-4 changes in liver function (SGOT, SGPT, bilirubin, alkaline phosphatase) were observed (10 on placebo and 6 on tamoxifen). Serum lipids were not systematically collected. Other Cancers: A number of second primary tumors, occurring at sites other than the endometrium, have been reported following the treatment of breast cancer with tamoxifen in clinical trials. Data from the NSABP B-14 and P-1 studies show no increase in other (non-uterine) cancers among patients receiving tamoxifen.

Whether an increased risk for other (non-uterine) cancers is associated with tamoxifen is still uncertain and continues to be evaluated. Effects on the Eye: Ocular disturbances, including corneal changes, decrement in color vision perception, retinal vein thrombosis, and retinopathy have been reported in patients receiving tamoxifen.

An increased incidence of cataracts and the need for cataract surgery have been reported in patients receiving tamoxifen. In the NSABP P-1 trial, an increased risk of borderline significance of developing cataracts among those women without cataracts at baseline (540-tamoxifen; 483-placebo; RR=1.13, 95% CI: 1.00-1.28) was observed. Among these same women, tamoxifen was associated with an increased risk of having cataract surgery (101-tamoxifen; 63-placebo; RR=1.62, 95% CI 1.18-2.22). Among all women on the trial (with or without cataracts at baseline), tamoxifen was associated with an increased risk of having cataract surgery (201-tamoxifen; 129-placebo; RR=1.58, 95% CI 1.26-1.97). Eye examinations were not required during the study. No other conclusions regarding non-cataract ophthalmic events can be made. Pregnancy Category D. Tamoxifen may cause fetal harm when administered to a pregnant woman. Women should be advised not to become pregnant while taking tamoxifen or within 2 months of discontinuing tamoxifen and should use barrier or nonhormonal contraceptive measures if sexually active. Tamoxifen does not cause infertility, even in the presence of menstrual irregularity. Effects on reproductive functions are expected from the antiestrogenic properties of the drug. In reproductive studies in rats at dose levels equal to or below the human dose, nonteratogenic developmental skeletal changes were seen and were found reversible. In addition, in fertility studies in rats and in teratology studies in rabbits using doses at or below those used in humans, a lower incidence of embryo implantation and a higher incidence of fetal death or retarded in utero growth were observed, with slower learning behavior in some rat pups when compared to historical controls. Several pregnant marmosets were dosed with 10 mg/kg/day (about 2-fold the daily maximum recommended human dose on a mg/m2 basis) during organogenesis or in the last half of pregnancy. No deformations were seen and, although the dose was high enough to terminate pregnancy in some animals, those that did maintain pregnancy showed no evidence of teratogenic malformations.

In rodent models of fetal reproductive tract development, tamoxifen (at doses 0.002 to 2.4-fold the daily maximum recommended human dose on a mg/m2 basis) caused changes in both sexes that are similar to those caused by estradiol, ethynylestradiol and diethylstilbestrol. Although the clinical relevance of these changes is unknown, some of these changes, especially vaginal adenosis, are similar to those seen in young women who were exposed to diethylstilbestrol in utero and who have a 1 in 1,000 risk of developing clear-cell adenocarcinoma of the vagina or cervix. To date, in utero exposure to tamoxifen has not been shown to cause vaginal adenosis, or clearcell adenocarcinoma of the vagina or cervix, in young women. However, only a small number of young women have been exposed to tamoxifen in utero, and a smaller number have been followed long enough (to age 15-20) to determine whether vaginal or cervical neoplasia could occur as a result of this exposure. There are no adequate and well-controlled trials of tamoxifen in pregnant women. There have been a small number of reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths in pregnant women. If this drug is used during pregnancy, or the patient becomes pregnant while taking this drug, or within approximately two months after discontinuing therapy, the patient should be apprised of the potential risks to the fetus including the potential long-term risk of a DES-like syndrome. Reduction in Breast Cancer Incidence in High Risk Women -Pregnancy Category D For sexually active women of child-bearing potential, tamoxifen therapy should be initiated during menstruation. In women with menstrual irregularity, a negative b-HCG immediately prior to the initiation of therapy is sufficient (See PRECAUTIONS Information for Patients -Reduction in Breast Cancer Incidence in High Risk Women). PRECAUTIONS General Decreases in platelet counts, usually to 50,000-100,000/mm3, infrequently lower, have been occasionally reported in patients taking tamoxifen for breast cancer.

In patients with significant thrombocytopenia, rare hemorrhagic episodes have occurred, but it is uncertain if these episodes are due to tamoxifen therapy.

Leukopenia has been observed, sometimes in association with anemia and/or thrombocytopenia. There have been rare reports of neutropenia and pancytopenia in patients receiving tamoxifen; this can sometimes be severe. In the NSABP P-1 trial, 6 women on tamoxifen and 2 on placebo experienced grade 3-4 drops in platelet count (£ 50,000/mm3). Information for Patients Patients should be instructed to read the Medication Guide supplied as required by law when tamoxifen citrate is dispensed.

The complete text of the Medication Guide is reprinted at the end of the Full Prescribing Information. Reduction in Invasive Breast Cancer and DCIS in Women with DCIS Women with DCIS treated with lumpectomy and radiation therapy who are considering tamoxsifen to reduce the incidence of a second breast cancer event should assess the risks and benefits of therapy, since treatment with tamoxifen decreased the incidence of invasive breast cancer, but has not been shown to affect survival. Reduction in Breast Cancer Incidence in High Risk Women Women who are at high risk for breast cancer can consider taking tamoxifen therapy to reduce the incidence of breast cancer. Whether the benefits of treatment are considered to outweigh the risks depends on a woman’s personal health history and on how she weighs the benefits and risks. Tamoxifen therapy to reduce the incidence of breast cancer may therefore not be appropriate for all women at high risk for breast cancer.

Women who are considering tamoxifen therapy should consult their health care professional for an assessment of the potential benefits and risks prior to starting therapy for reduction in breast cancer incidence. Women should understand that tamoxifen reduces the incidence of breast cancer, but may not eliminate risk.

Tamoxifen decreased the incidence of small estrogen receptor positive tumors, but did not alter the incidence of estrogen receptor negative tumors or larger tumors. In women with breast cancer who are at high risk of developing a second breast cancer, treatment with about 5 years of tamoxifen reduced the annual incidence rate of a second breast cancer by approximately 50%. Women who are pregnant or who plan to become pregnant should not take tamoxifen to reduce her risk of breast cancer.

Effective nonhormonal contraception must be used by all premenopausal

women taking tamoxifen and for approximately two months after discontinuing therapy if they are sexually active. Tamoxifen does not cause infertility, even in the presence of menstrual irregularity. For sexually active women of child-bearing potential, tamoxifen therapy should be initiated during menstruation. in women with menstrual irregularity, a negative b-HCG immediately prior to the initiation of therapy is sufficient (See WARNINGS-Pregnancy Category D). Two European trials of tamoxifen to reduce the risk of breast cancer were conducted and showed no difference in the number of breast cancer cases between the tamoxifen and placebo arms. These studies had trial designs that differed from that of NSABP P-1, were smaller than NSABP P-1, and enrolled women at a lower risk for breast cancer than those in P-1.

Monitoring During Tamoxifen Therapy Women taking or having previously taken tamoxifen should be instructed to seek prompt medical attention for new breast lumps, vaginal bleeding, gynecologic symptoms (menstrual irregularities, changes in vaginal discharge, or pelvic pain or pressure), symptoms of leg swelling or tenderness, unexplained shortness of breath, or changes in vision. Women should inform all care providers, regardless of the reason for evaluation, that they take tamoxifen. Women taking tamoxifen to reduce the incidence of breast cancer should have a breast examination, a mammogram, and a gynecologic examination prior to the initiation of therapy. These studies should be repeated at regular intervals while on therapy, in keeping with good medical practice. Women taking tamoxifen as adjuvant breast cancer therapy should follow the same monitoring procedures as for women taking tamoxifen for the reduction in the incidence of breast cancer. Women taking tamoxifen as treatment for metastatic breast cancer should review this monitoring plan with their care provider and select the appropriate modalities and schedule of evaluation.

Laboratory Tests Periodic complete blood counts, including platelet counts, and periodic liver function tests should be obtained. Drug Interactions When tamoxifen is used in combination with coumarin-type anticoagulants, a significant increase in anticoagulant effect may occur. Where such coadministration exists, careful monitoring of the patient’s prothrombin time is recommended. In the NSABP P-1 trial, women who required coumarin-type anticoagulants for any reason were ineligible for participation in the trial (See CONTRAINDICATIONS). There is an increased risk of thromboembolic events occurring when cytotoxic agents are used in combination with tamoxifen. Tamoxifen reduced letrozole plasma concentrations by 37%. The effect of tamoxifen on metabolism and excretion of other antineoplastic drugs, such as cyclophosphamide and other drugs that require mixed function oxidases for activation, is not known. Tamoxifen and N-desmethyl tamoxifen plasma concentrations have been shown to be reduced when coadministered with rifampin or aminoglutethimide.

Induction of CYP3A4-mediated metabolism is considered to be the mechanism by which these reductions occur; other CYP3A4 inducing agents have not been studied to confirm this effect. One patient receiving tamoxifen with concomitant phenobarbital exhibited a steady state serum level of tamoxifen lower than that observed for other patients (i.e., 26 ng/mL vs. mean value of 122 ng/mL). However, the clinical significance of this finding is not known. Rifampin induced the metabolism of tamoxifen and significantly reduced the plasma concentrations of tamoxifen in 10 patients. Aminoglutethimide reduces tamoxifen and N-desmethyl tamoxifen plasma concentrations. Medroxyprogesterone reduces plasma concentrations of N-desmethyl, but not tamoxifen. Concomitant bromocriptine therapy has been shown to elevate serum tamoxifen and N-desmethyl tamoxifen. Drug/Laboratory Testing Interactions During postmarketing surveillance, T4 elevations were reported for a few postmenopausal patients which may be explained by increases in thyroid-binding globulin. These elevations were not accompanied by clinical hyperthyroidism.

Variations in the karyopyknotic index on vaginal smears and various degrees of estrogen effect on Pap smears have been infrequently seen in postmenopausal patients given tamoxifen. In the postmarketing experience with tamoxifen, infrequent cases of hyperlipidemias have been reported. Periodic monitoring of plasma triglycerides and cholesterol may be indicated in patients with pre-existing hyperlipidemias (See ADVERSE REACTIONS Postmarketing Experience section).

Carcinogenesis A conventional carcinogenesis study in rats at doses of 5, 20, and 35 mg/kg/day (about one, three and seven-fold the daily maximum recommended human dose on a mg/m2 basis) administered by oral gavage for up to 2 years revealed a significant increase in hepatocellular carcinoma at all doses. The incidence of these tumors was significantly greater among rats administered 20 or 35 mg/ kg/day (69%) compared to those administered 5 mg/kg/day (14%). In a separate study, rats were administered tamoxifen at 45 mg/kg/ day (about nine-fold the daily maximum recommended human dose on a mg/m2 basis); hepatocellular neoplasia was exhibited at 3 to 6 months. Granulosa cell ovarian tumors and interstitial cell testicular tumors were observed in two separate mouse studies. The mice were administered the trans and racemic forms of tamoxifen for 13 to 15 months at doses of 5, 20 and 50 mg/kg/day (about one-half, two and five-fold the daily recommended human dose on a mg/m2 basis). Mutagenesis No genotoxic potential was found in a conventional battery of in vivo and in vitro tests with pro-and eukaryotic test systems with drug metabolizing systems. However, increased levels of DNA adducts were observed by 32P post-labeling in DNA from rat liver and cultured human lymphocytes. Tamoxifen also has been found to increase levels of micronucleus formation in vitro in human lymphoblastoid cell line (MCL-5). Based on these findings, tamoxifen is genotoxic in rodent and human MCL-5 cells. Impairment of Fertility Tamoxifen produced impairment of fertility and conception in female rats at doses of 0.04 mg/kg/day (about 0.01-fold the daily maximum recommended human dose on a mg/m2 basis) when dosed for two weeks prior to mating through day 7 of pregnancy. At this dose, fertility and reproductive indices were markedly reduced with total fetal mortality. Fetal mortality was also increased at doses of 0.16 mg/kg/day (about 0.03-fold the daily maximum recommended human dose on a mg/m2 basis) when female rats were dosed from days 7-17 of pregnancy. Tamoxifen produced abortion, premature delivery and fetal death in rabbits administered doses equal to or greater than 0.125 mg/kg/day (about 0.05-fold the daily maximum recommended human dose on a mg/ m2 basis). There were no teratogenic changes in either rats or rabbits. Pregnancy Category D Nursing Mothers Tamoxifen has been reported to inhibit lactation. Two placebo-controlled studies in over 150 women have shown that tamoxifen significantly inhibits early postpartum milk production. In both studies tamoxifen was administered within 24 hours of delivery for between 5 and 18 days. The effect of tamoxifen on established milk production is not known. There are no data that address whether tamoxifen is excreted into human milk. If excreted, there are no data regarding the effects of tamoxifen in breast milk on the breastfed infant or breastfed animals.

However, direct neonatal exposure of tamoxifen to mice and rats (not via breast milk) produced 1) reproductive tract lesions in female rodents (similar to those seen in humans after intrauterine exposure to diethylstilbestrol) and 2) functional defects of the reproductive tract in male rodents such as testicular atrophy and arrest of spermatogenesis. It is not known if tamoxifen is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from tamoxifen, women taking tamoxifen should not breast feed. Reduction in Breast Cancer Incidence in High Risk Women and Women with DCIS It is not known if tamoxifen is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from tamoxifen, women taking tamoxifen should not breast feed. Pediatric Use The use of SOLTAMOX™ in pediatric patients has not been evaluated. Geriatric Use In the NSABP P-1 trial, the percentage of women at least 65 years of age was 16%. Women at least 70 years of age accounted for 6% of the participants. A reduction in breast cancer incidence was seen among participants in each of the subsets: A total of 28 and 10 invasive breast cancers were seen among participants 65 and older in the placebo and tamoxifen groups, respectively. Across all other outcomes, the results in this subset reflect the results observed in the subset of women at least 50 years of age. No overall differences in tolerability were observed between older and younger

patients. In the NSABP B-24 trial, the percentage of women at least 65 years of age was 23%. Women at least 70 years of age accounted for 10% of participants. A total of 14 and 12 invasive breast cancers were seen among participants 65 and older in the placebo and tamoxifen groups, respectively. This subset is too small to reach any conclusions on efficacy. Across all other endpoints, the results in this subset were comparable to those of younger women enrolled in this trial. No overall differences in tolerability were observed between older and younger patients. ADVERSE REACTIONS Adverse reactions to tamoxifen are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients. Continued clinical studies have resulted in further information which better indicates the incidence of adverse reactions with tamoxifen as compared to placebo. In one single-dose pharmacokinetic study in healthy perimenopausal and postmenopausal female volunteers, throat irritation was reported by 3 of 60 evaluable subjects (5.0%) in the SOLTAMOX™ treatment groups while none of the subjects in the tamoxifen reference group reported this event. All events were mild and occurred within an hour after dosing. All events were resolved within 24 hours. Metastatic Breast Cancer Increased bone and tumor pain and, also, local disease flare have occurred, which are sometimes associated with a good tumor response. Patients with increased bone pain may require additional analgesics. Patients with soft tissue disease may have sudden increases in the size of preexisting lesions, sometimes associated with marked erythema within and surrounding the lesions and/or the development of new lesions. When they occur, the bone pain or disease flare are seen shortly after starting tamoxifen and generally subside rapidly. In patients treated with tamoxifen for metastatic breast cancer, the most frequent adverse reaction to tamoxifen is hot flashes. Other adverse reactions which are seen infrequently are hypercalcemia, peripheral edema, distaste for food, pruritus vulvae, depression, dizziness, light-headedness, headache, hair thinning and/ or partial hair loss, and vaginal dryness. Premenopausal Women The following table summarizes the incidence of adverse reactions reported at a frequency of 2% or greater from clinical trials (Ingle, Pritchard, Buchanan) which compared tamoxifen therapy to ovarian ablation in premenopausal patients with metastatic breast cancer.

Table 1.

Summary of Incidence of Adverse Reactions Reported at Frequency of ≥2% From Clinical Trials Tamoxiden Ovarian Ablation All Effects All Effects % of Women % of Women Adverse Reactionsa n = 104 n = 100 Flush 33 46 Amenorrhea 16 69 Altered Menses 13 5 Oligomenorrhea 9 1 Bone Pain 6 6 Menstrual Disorder 6 4 Nausea 5 4 Cough/Coughing 4 1 Edema 4 1 Fatigue 4 1 Musculoskeletal Pain 3 0 Pain 3 4 Ovarian Cyst(s) 3 2 Depression 2 2 Abdominal Cramps 1 2 Anorexia 1 2 a = Some women had more than 1 adverse reaction.

Male Breast Cancer Tamoxifen is well tolerated in males with breast cancer. Reports from the literature and case reports suggest that the safety profile of tamoxifen in males is similar to that seen in women. Loss of libido and impotence have resulted in discontinuation of tamoxifen therapy in male patients. Also, in oligospermic males treated with tamoxifen, LH, FSH, testosterone and estrogen levels were elevated. No significant clinical changes were reported. Adjuvant Breast Cancer In the NSABP B-14 study, women with axillary node-negative breast cancer were randomized to 5 years of tamoxifen 20 mg/day or placebo following primary surgery. The reported adverse effects are tabulated below (mean follow-up of approximately 6.8 years) showing adverse events more common on tamoxifen than on placebo. The incidence of hot flashes (64% vs. 48%), vaginal discharge (30% vs. 15%), and irregular menses (25% vs. 19%) were higher with tamoxifen compared with placebo. All other adverse effects occurred with similar frequency in the 2 treatment groups, with the exception of thrombotic events; a higher incidence was seen in tamoxifen-treated patients (through 5 years, 1.7% vs. 0.4%). Two of the patients treated with tamoxifen who had thrombotic events died. In the Eastern Cooperative Oncology Group (ECOG) adjuvant breast cancer trial, tamoxifen or placebo was administered for 2 years to women following mastectomy. When compared to placebo, tamoxifen showed a significantly higher incidence of hot flashes (19% vs. 8% for placebo). The incidence of all other adverse reactions was similar in the 2 treatment groups with the exception of thrombocytopenia where the incidence for tamoxifen was 10% vs. 3% for placebo, an observation of borderline statistical significance.

NSABP B-14 Study Table 2.

Comparison of Tamoxifen to Placebo Administered for 2 Years to Women Following Mastectomy % of Women Adverse Reactions Tamoxifen (n = 1422) Placebo (n = 1437) Hot Flashes 64 48 Fluid Retention 32 30 Vaginal Discharge 30 15 Nausea 26 24 Irregular Menses 25 19 Weight Loss (>5%) 23 18 Skin Changes 19 15 Increased SGOT 5 3 Increased Bilirubin 2 1 Increased Creatinine 2 1 2 1 Thrombocytopeniaa Thrombotic Events Deep Vein Thrombosis 0.8 0.2 Pulmonary Embolism 0.5 0.2 Superficial Phlebitis 0.4 0.0 a = Defined as a platelet count of <100,000/mm3.

SGOT = Serum glultamic oxalo-acetic transaminase.

In other adjuvant studies, Toronto and tamoxifen Adjuvant Trial Organization (NATO), women received either tamoxifen or no therapy. In the Toronto study, hot flashes were observed in 29% of patients for tamoxifen vs. 1% in the untreated group. In the NATO trial, hot flashes and vaginal bleeding were reported in 2.8% and 2.0% of women, respectively, for tamoxifen vs. 0.2% for each in the untreated group. Ductal Carcinoma in Situ (DCIS) The type and frequency of adverse events in the NSABP

B-24 trial were consistent with those observed in the other adjuvant trials conducted with tamoxifen. Reduction in Breast Cancer Incidence in High Risk Women In the NSABP P-1 Trial, there was an increase in five serious adverse effects in the tamoxifen group: endometrial cancer (33 cases in the tamoxifen group vs. 14 in the placebo group); pulmonary embolism (18 cases in the tamoxifen group vs. 6 in the placebo group); deep vein thrombosis (30 cases in the tamoxifen group vs. 19 in the placebo group); stroke (34 cases in the tamoxifen group vs. 24 in the placebo group); cataract formation (540 cases in the tamoxifen group vs. 483 in the placebo group) and cataract surgery (101 cases in the tamoxifen group vs. 63 in the placebo group). The following table presents the adverse events observed in NSABP P-1 by treatment arm.

Only adverse events more common on tamoxifen than placebo are shown. NSABP P-1 Trial: All Adverse Events Table 3.

Adverse Events Observed in NSABP P-1 by Treatment Arm: Adverse Events More Common on Tamoxifen Than Placebo % of Women Treatment Arm/ Tamoxifen Placebo Adverse Event (n = 1422) (n = 1437) N = 6469a Self-Reported N = 6441a Symptoms Hot Flashes 80 68 Vaginal Discharges 55 35 Vaginal Bleeding 23 22 N = 6535b Laboratory N = 6520b Abnormalities Platelets Decreased 0.7 0.3 Adverse Effects N = 6492c N = 6484a Other Toxicities Mood 11.6 10.8 Infection/Sepsis 6.0 5.1 Constipation 4.4 3.2 Alopecia 5.2 4.4 Skin 5.6 4.7 Allergy 2.5 2.1 a = Number with quality of life questionnaires. b = Number with treatment follow-up forms. c = Number with adverse drug reaction forms.

In the NSABP P-1 trial, 15.0% and 9.7% of participants receiving tamoxifen and placebo therapy, respectively, withdrew from the trial for medical reasons. The following are the medical reasons for withdrawing from tamoxifen and placebo therapy, respectively: Hot flashes (3.1% vs. 1.5%) and Vaginal Discharge (0.5% vs.

0.1%). In the NSABP P-1 trial, 8.7% and 9.6% of participants receiving tamoxifen and placebo therapy, respectively, withdrew for non-medical reasons. On the NSABP

P-1 trial, hot flashes of any severity occurred in 68% of women on placebo and in 80% of women on tamoxifen. Severe hot flashes occurred in 28% of women on placebo and 45% of women on tamoxifen. Vaginal discharge occurred in 35% and 55% of women on placebo and tamoxifen respectively; and was severe in 4.5% and 12.3% respectively. There was no difference in the incidence of vaginal bleeding between treatment arms. Postmarketing Experience Less frequently reported adverse reactions are vaginal bleeding, vaginal discharge, menstrual irregularities, skin rash and headaches. Usually these have not been of sufficient severity to require dosage reduction or discontinuation of treatment. Very rare reports of erythema multiforme, Stevens-Johnson syndrome, bullous pemphigoid, interstitial pneumonitis, and rare reports of hypersensitivity reactions including angioedema have been reported with tamoxifen therapy. In some of these cases, the time to onset was more than one year. Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of tamoxifen (see PRECAUTIONS, Drug/Laboratory Testing Interactions section). OVERDOSAGE Signs observed at the highest doses following studies to determine LD50 in animals were respiratory difficulties and convulsions. Acute overdosage in humans has not been reported. In a study of advanced metastatic cancer patients which specifically determined the maximum tolerated dose of tamoxifen in evaluating the use of very high doses to reverse multidrug resistance, acute neurotoxicity manifested by tremor, hyperreflexia, unsteady gait and dizziness were noted. These symptoms occurred within 3-5 days of beginning tamoxifen and cleared within 2-5 days after stopping therapy.

No permanent neurologic toxicity was noted. One patient experienced a seizure several days after tamoxifen was discontinued and neurotoxic symptoms had resolved. The causal relationship of the seizure to tamoxifen therapy is unknown. Doses given in these patients were all greater than 400 mg/m2 loading dose, followed by maintenance doses of 150 mg/m2 of tamoxifen given twice a day. In the same study, prolongation of the QT interval on the electrocardiogram was noted when patients were given doses higher than 250 mg/m2 loading dose, followed by maintenance doses of 80 mg/m2 of tamoxifen given twice a day. For a woman with a body surface area of 1.5 m2 the minimal loading dose and maintenance doses given at which neurological symptoms and QT changes occurred were at least 6 fold higher in respect to the maximum recommended dose. No specific treatment for overdosage is known; treatment must be symptomatic. DOSAGE AND ADMINISTRATION For patients with breast cancer, the recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening). A 20 mg dose of SOLTAMOX™ is administered as 10 mL (equivalent to 2 teaspoons) of the oral solution. In three single agent adjuvant studies in women, one 10 mg tamoxifen citrate tablet was administered two (ECOG and NATO) or three (Toronto) times a day for two years. In the NSABP B-14 adjuvant study in women with node-negative breast cancer, one 10 mg tamoxifen citrate tablet was given twice a day for at least 5 years. Results of the B-14 study suggest that continuation of therapy beyond five years does not provide additional benefit. In the EBCTCG 1995 overview, the reduction in recurrence and mortality was greater in those studies that used tamoxifen for about 5 years than in those that used tamoxifen for a shorter period of therapy. There was no indication that doses greater than 20 mg per day were more effective. Current data from clinical trials support 5 years of adjuvant tamoxifen citrate therapy for patients with breast cancer. Ductal Carcinoma in Situ (DCIS) The recommended dose is tamoxifen citrate 20 mg daily for 5 years. Reduction in Breast Cancer Incidence in High Risk Women The recommended dose is tamoxifen citrate 20 mg daily for 5 years. There are no data to support the use of tamoxifen citrate other than for 5 years.

RX only Dated: 9/14/2006 Manufactured by: Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street Leeds, LS11 9XE, UK. Distributed by: Cytogen Corporation Princeton, NJ 08540, USA.

Address medical enquiries to: Cytogen Corporation • 650 College Road East Suite 3100, Princeton, NJ 08540 1-800-833-3533. © 2004-6, Rosemont Pharmaceuticals Ltd. Printed in the U.K.

Conference News: ONS Continued from cover

Code Blue: A Model to Increase Staff Confidence By participating in a simulated model for dealing with “Code Blue” emergencies, oncology nursing staff at UCLA Medical Center in Santa Monica, California, increased their knowledge and confidence in handling this situation.

“The potential for a Code Blue is high on oncology floors. Many of these patients are receiving highly toxic chemotherapy and are at the end of their lives. One year ago, the Code Blue simulated model was identified as a project that would help increase staff confidence. Although we have some experienced nurses, some of our staff members are young and are new graduates,” explained Deborah Lorick, RN, MSN/MHA, CMSRN, OCT. Lorick coauthored a poster describing results of the Code Blue project.

UCLA Medical Center in Santa Monica is a 266-bed combination community and academic center. The Oncology Unit has 26 beds and provides acute care for cancer patients.

The experience level of the staff ranges from newly graduated to expert.

Lorick noted that nurses experience anxiety and lack of confidence regarding resuscitations regardless of their level of experience.

Previous studies showed that simulation training that included “surprise” CPR training involving a simulated model resulted in a gradual and steady improvement in skills.

In the UCLA study, skills regarding what to do at the first “Code Blue” alarm and confidence were improved from pre- to postsimulation.

For this study, approximately 45 staff members were asked what they would do when they first heard the Code Blue alarm. Before the test, 27% said that they would wait for an experienced RN to help; after the test, only 13% gave that answer. Before the test, 27% said they would finish their current task of giving medi-

In the UCLA study, skills regarding what to do at the first “Code Blue” alarm and confidence were improved from pre- to postsimulation.

cations and then head to the room; after the test, 0% gave this answer.

Before the test, 46% said that they would rush to the room and engage in action, whereas this percentage rose to 87% after the test.

Confidence was improved at all levels after participation in the simulated Code Blue. Pretest, 13% were “confident,” with the figure rising to 33% posttest; 34% were “somewhat confident” pretest, with the number

rising to 67% posttest; 47% were “not so confident” pretest, and 0% gave this answer posttest. Prior to participation in the simulation, 6% were “totally lost,” with the percentage decreasing to 0% posttest.

The Code Blue simulation is given monthly at the UCLA Medical Center, Santa Monica, on a day shift and a night shift to nursing staff members who have not yet participated, Lorick said.

Reference

Lorick D, Queyquep M, Jakel P. Code Blue: journey to confidence. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 179.

Reducing Falls in the Outpatient Setting At most hospitals and other inpatient facilities, procedures are in place for identifying patients at risk of falling, and there are guidelines for the prevention of falls. However, such procedures and guidelines are not routinely present in outpatient centers where cancer patients are treated, explained Sara Lantowski, BSN, OCN, of the Smilow Cancer Hospital at Yale-New Haven in Connecticut.

“We had a substantial number of reports of falls at our center, but we had no ambulatory fall screening or prevention plan in our outpatient setting. Since this was an unmet need, as well as a nurse-sensitive indicator of quality, we formed a committee to draft proposals for identifying patients at risk for falls and documenting them in our new electronic medical records system. The next steps are to implement prevention strategies and patient and family education,” said Lantowski.

The simple and easy-to-use Fall Risk Screening Tool that the committee developed includes 4 questions for patients: 1. Do you use any assistive device to ambulate?

2. Do you need any physical assistance with standing or walking (ie, walker, cane)?

3. Do you have periods of forgetfulness or don’t know where you are at times?

4. Have you had a fall in the last 6 months?

A “yes” answer to any of these questions indicates high risk of falling, she said.

With the use of this new tool, 80% to 100% of patients at Smilow are screened for risk of falls and are identified in the electronic medical record. The screening effort is led by patient care and medical assistants.

“Falls can result in injury, and providing patients with early education on fall risk and prevention would be expected to minimize falls in ambulatory oncology settings [and] the home setting and [would] potentially translate to fewer inpatient falls,” she stated.

The committee has developed an educational brochure for patients that includes steps for preventing falls during outpatient visits (wear nonslip footwear, bring walking assistive devices, wear clothes that allow you to walk freely, and wear your eyeglasses). The brochure includes safety measures for patients to take during outpatient visits, such as asking for help walking if needed, letting the staff know about a recent fall, not using an IV pole as a support, and alerting the staff if there is a slippery floor area or torn carpet.

The brochure also lists fall prevention tips for family members and other visitors who accompany patients on their outpatient visit.

Reference

Blasiak E, Lantowski S, Bursey C, et al. The ins and outs of fall prevention: improving awareness, providing education, and promoting early fall prevention in the outpatient oncology setting. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 178.

Take action: get YOUR cancer center profiled!

We are looking to interview oncology nurses from cancer centers around the country.

It’s an easy process—a short phone interview and you need to submit some photos.

Contact editorial@greenhillhc.com for information.

20

June 2013 I VOL 6, NO 5

www.TheOncologyNurse.com

Conference News: ONS Screening Tool for Older Outpatients at Risk of Decline Cancer is predominantly a disease associated with aging, and with the graying of America the number of older patients with cancer is expected to increase.

Treatments for cancer, such as chemotherapy and radiation, can be associated with impaired physical and cognitive function. As more older patients enter treatment for cancer, it is important to identify who will be at risk for treatment-related decline in order to institute interventions that will allow them to return to pretreatment functioning level. To that end, investigators at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City developed and implemented a screening tool for outpatients aged 65 years and older and for identifying at-risk patients.

“This was a multidisciplinary collaborative endeavor to identify and manage older patients at risk for age-related functional, cognitive, or physiological decline

before they got treatment,” explained lead author Lorraine McEvoy, DNP, MSN, RN, OCN, nurse leader of Ambulatory Services at MSKCC.

“The most profound indicator of decline turned out to be inpatient delirium,” McEvoy said.

In 2010, the authors implemented

“The most profound indicator of decline turned out to be inpatient delirium.”

Lorraine McEvoy, DNP, MSN, RN, OCN

“Patients come in with various comorbid conditions. Not all patients the same age are in the same condition. The nurse can screen for geriatric syndromes that are indicators for decline,” she explained.

Geriatric syndromes that signal potential age-related decline include dehydration, malnutrition, depression, pain, falls, incontinence, constipation, sleep deprivation, deconditioning, immobility, and delirium.

use of the 65+ Ambulatory Health Screening Tool at MSKCC’s outpatient services. This instrument consists of a list of questions to be answered by the patient or caregiver. If the patient is identified as at risk for decline, a “G” is placed next to that person’s name. The “G” triggers electronic nursing referral orders for a geriatrician to manage that patient, providing support services that can include nutritional support, pain

management, social work, and case management.

The investigators of this National Cancer Institute–supported initiative are still collecting data. Quarterly electronic compilation of nursing quality data demonstrates substantial user compliance and effectiveness in identifying comorbid conditions, geriatric syndromes, and the initiation of multidisciplinary collaboration to support the overall treatment plan.

“The goal of this screening tool is to get older patients through their treatment and back to life in their pretreatment condition. This new tool has become a necessity, as our society is aging,” said McEvoy.

Reference

McEvoy L. Care of the older adult with cancer: a 65+ ambulatory health screening tool. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 182.

Measures to Preserve Fertility Cancer patients are often at risk for impaired fertility related to their treatments. A quality improvement initiative at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City showed that education, developing an algorithm for discussions with patients, documenting those discussions, and supplying patients and providers with a list of referrals for fertility preservation specialists are an important aspect of oncology nursing that can improve the quality of care provided to patients.

The study included 26 patients with sarcoma or melanoma between the ages of 18 and 45 years treated at MSKCC over a 12-month period. All patients were eligible for fertility preservation options.

Meetings were conducted with physicians and nurses to identify barriers to discussing fertility, which included a lack of knowledge, undefined roles, the absence of a standardized work flow, no documentation system, and the difficulty of discussing fertility with patients with a poor prognosis.

At baseline, 69% of the oncologists discussed fertility risks associated with treatment, 54% explained fertility preservation options, and 54% referred interested patients to fertility specialists. Among the nurses, 0% discussed fertility, 0% discussed fertility preservation options, and 17% referred patients in response to an oncologist’s direction.

The research team provided education for oncologists and nurses regarding the need for discussion of fertility with the patient and options and referrals for interested patients. The team developed an algorithm for oncologists and nurses

www.TheOncologyNurse.com

The research team provided education for oncologists and nurses regarding the need for discussion of fertility with the patient and options and referrals for interested patients. to use in discussions with patients, a method of data collection, and strategies for implementing improvements, as well as a list of fertility preservation resources

and processes for making referrals and documenting care provided.

After a 3-month evaluation and follow-up of this initiative, dramat-

ic improvement was seen among the nurses: 57% discussed fertility with patients, 71% discussed options, and 80% provided referrals.

Among the oncologists, after the education initiative, 60% gave patients referrals for fertility preservation options.

Reference

Clark R, Baldwin A, Frankel Kelvin J. Fertility preservation: standardizing education and patient referral.

Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 193.

Melanoma Intermittent Vemurafenib May Overcome Resistance Vemurafenib is a relatively new effective option for the treatment of melanoma, but most patients who respond will develop resistance. Studies by researchers at Novartis suggest that an intermittent dosing strategy may be able to overcome the resistance that occurs with standard continuous dosing.

“We were excited about the translational science that led to approval of the BRAF inhibitor vemurafenib, which extends survival in these patients. But most patients relapse with lethal drug-resistant disease,” explained Darrin Stuart, PhD, Novartis Institutes for Biomedical Research in Emeryville, California, who presented results of early animal and human studies at the American Association for Cancer Research Annual Meeting.

In a previous study, Stuart and colleagues implanted xenografts of BRAF-expressing tumors in mice and found that the tumors developed resistance to vemurafenib. But possibly more important was the observation that the tumors were dependent on the drug for their proliferation.

When drug treatment was withdrawn, the tumors stopped growing and regressed.

The next step was to determine if the drug dependency of the tumors was exhibited in humans. The investigators

collaborated with scientists at the Royal Marsden Hospital in London, United Kingdom, and evaluated 42 patients with vemurafenib-resistant tumors. Of these, 19 patients had computed tomography scans obtained after drug treatment was stopped. Fourteen of 19 scans showed regression in the rate of tumor growth.

Stuart and colleagues then performed another experiment on mice implanted with BRAF-expressing tumor xenografts and treated them with vemurafenib 4 weeks on and 4 weeks off (intermittent strategy) or continuous vemurafenib. None of the tumors in the animals treated intermittently developed resistance.

This suggests that a drug holiday and intermittent treatment could be beneficial in patients taking vemurafenib and might overcome resistance. Stuart was not at liberty to discuss Novartis’ plans for the future, but stated that intermittent dosing was a strategy that he hopes researchers will pursue. l Reference

Das Thakur M, Fisher R, Salangsang F, et al. Modeling vemurafenib resistance in melanoma reveals a strategy to forestall drug resistance. Presented at: American Association for Cancer Research 2013 Annual Meeting; April 8, 2013; Washington, DC. Abstract LB-144.

June 2013 I VOL 6, NO 5

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Conference News: ONS Nurse-Led Symptom Management Clinic A nurse-led interdisciplinary symptom management team has been implementâ&#x20AC;&#x153;Palliative care is often thought of as end-of-life ed at the Billings Clinic Cancer Center care, but it really relates to quality of life from the in Montana, part of a top 100 hospital, according to Truven Health Analytics. time of diagnosis.â&#x20AC;? Alison Weber, RN, BSN The team was put together in response to the Commission on Cancerâ&#x20AC;&#x2122;s mandate for making palliative care services developed. These teams would include a worker, a mental health clinician, and a available and suggesting that interdisci- provider and a nurse trained in palliative chaplain. plinary symptom management be Pagecare â&#x20AC;&#x153;Palliative care is often thought of as GBC2013Asize20813_Layout 1 2/8/13 teams 11:12 AM 1 and hospice, a pharmacist, a social

ANNUAL CONFERENCE

"! !

!

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Professor Rob Coleman, MBBS, MD, FRCP Yorkshire Cancer Research Professor of Medical Oncology Director, Sheffield Cancer Research Centre Associate Director, National Institute for Health Research Cancer Research Network Department of Oncology, Weston Park Hospital Sheffield, United Kingdom

*

3:00 pm - 7:00 pm

Registration

5:30 pm - 7:30 pm

Welcome Reception and Exhibits

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 8:30 am

Welcome to the Second Annual Conference of the Global Biomarkers Consortiumâ&#x20AC;&#x201D;Setting the Stage for the Meeting Professor Rob Coleman, MBBS, MD, FRCP

8:15 am - 11:45 am

General Session I â&#x20AC;˘ Personalized Medicine in Oncology: Evolution of Cancer Therapy from Nonspecific Cytotoxic Drugs to Targeted Therapies â&#x20AC;˘ Taking Stock of Molecular Oncology Biomarkers â&#x20AC;˘ Genomics â&#x20AC;˘ Bioinformatics â&#x20AC;˘ Validating Biomarkers for Clinical Use in Solid Tumors - Professor Rob Coleman, MBBS, MD, FRCP â&#x20AC;˘ Validating Biomarkers for Clinical Use in Hematologic Malignancies Jorge E. Cortes, MD â&#x20AC;˘ The Challenges of Biomarker-Based Clinical Trials â&#x20AC;˘ Keynote Lecture: Understanding Cancer at the Molecular Level

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 4:30 pm

This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

General Session II â&#x20AC;˘ Introduction to Case Studies - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part I â&#x20AC;˘ Lung Cancer â&#x20AC;˘ Breast Cancer â&#x20AC;˘ Multiple Myeloma â&#x20AC;˘ Prostate Cancer â&#x20AC;˘ Leukemia â&#x20AC;˘ Lymphoma â&#x20AC;˘ Panel Discussion: Management Controversies and Accepted Guidelines for the Personalized Management of Solid Tumors and Hematologic Malignancies â&#x20AC;˘ Keynote Lecture: The Medical-Legal Issues Surrounding the Use of Biomarkers in Oncology

4:30 pm - 6:30 pm

Meet the Experts/Networking/Exhibits

Jorge E. Cortes, MD Chair, CML and AML Sections D.B. Lane Cancer Research Distinguished Professor for Leukemia Research Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX

The only global meeting dedicated to advancing the understanding of value and clinical impact of biomarker research in oncology. Guided by the expertise of leaders in this field, participants will receive a thorough understanding of the current and future landscape of the relevance of tumor biomarkers and how to effectively personalize cancer care in the clinical setting.

This meeting will be directed toward medical oncologists and hematologists, pathologists, geneticists, advanced practice oncology nurses, research nurses, clinical oncology pharmacists, and genetic counselors involved in the management of patients with solid tumors or hematologic malignancies, and interested in the use of molecular tumor biomarkers to help optimize patient care.

Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Assess emerging data and recent advances in the discovery of molecular biomarkers and their impact on the treatment of patients with solid tumors or hematologic malignancies â&#x20AC;˘ Discuss the role of molecular biomarkers in designing personalized therapy for patients with solid tumors or hematologic malignancies â&#x20AC;˘ Outline the practical aspects of integrating molecular biomarkers into everyday clinical practice in the treatment of patients with cancer

Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

7:00 am - 8:00 am

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Symposium/Product Theater/Exhibits General Session IV â&#x20AC;˘ Keynote Lecture: Making Personalized Medicine a Reality: The Realization of Genomic Medicine â&#x20AC;˘ The Future of Personalized Medicine: Measuring Clinical Outcomes â&#x20AC;˘ Cost-Effective Technologies That Can Drive Therapeutic Decision Making â&#x20AC;˘ Regulatory Perspectives on PMO â&#x20AC;˘ PMO: The Payerâ&#x20AC;&#x2122;s Perspective â&#x20AC;˘ Panel Discussion: Can We Afford PMO? A Value-Based Analysis â&#x20AC;˘ Practical Considerations in Incorporating PMO into Everyday Cinical Management â&#x20AC;˘ Reimbursement Challenges

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22

June 2013 I VOL 6, NO 5

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Weber A, Waitman K, Blaseg K, et al. A nurse-led symptom management clinic: serving cancer patients across the continuum. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25-28, 2013; Washington, DC. Poster 172.

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end-of-life care, but it really relates to quality of life from the time of diagnosis,â&#x20AC;? said Alison Weber, RN, BSN, who presented this poster. â&#x20AC;&#x153;Palliative care encompasses psychosocial, spiritual, physical, and advanced care planning.â&#x20AC;?

Patients undergoing cancer treatment at the center were screened for distress, and the sources of distress were identified.

The top 6 sources of distress were (in descending order) fatigue, pain, sleep, peripheral neuropathy, skin problems, and difficulty concentrating.

Assessment, triage, and protocols were developed for various symptoms. The team held weekly meetings. After the program was put in place, patients attended a weekly symptom management clinic.

Weberâ&#x20AC;&#x2122;s impression is that patients love the attention and care they get, and that their quality of life is improved.

When symptoms arise, the nurses identify which team members are needed for help in symptom management. For example, if the patient has taste changes, a dietitian might be called in; if the patient is in pain, a pain management staff member will be consulted. If symptoms do not resolve, then a provider is consulted; urgent care and even emergency care are provided if needed. â&#x20AC;&#x153;This program has been ongoing for the past 4 years. Patients who engage with the nurse-led team seem to love it.

They feel their complaints are heard and that they are given attention. The main challenge in implementing this type of interdisciplinary team is to get providersâ&#x20AC;&#x2122; buy-ins. We need to convince providers that this effort provides added value,â&#x20AC;? said Weber.

She said that the information in her poster provides a model for cancer center personnel who want to implement a symptom management team, and she sees this approach gaining favor in the future. â&#x20AC;&#x153;This care is reimbursable for NPs and PAs, and it is billed as a clinic visit,â&#x20AC;? she said. l

See page 15 for details. www.TheOncologyNurse.com

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GENETIC COUNSELING

Genetic Susceptibility to Renal Cell Carcinoma Continued from cover majority of RCC cases are sporadic.

Sporadic RCC typically presents as a solitary lesion and is diagnosed in the sixth decade of life and beyond.5,6 Hereditary RCC, on the other hand, typically develops earlier in life and often involves bilateral, multifocal tumors.4 Unlike sporadic RCC, which is more common in men, the gender distribution in hereditary forms tends to be equal7 or have a greater female preponderance.8 The most well-recognized RCC syndromes are von Hippel-Lindau (VHL), hereditary leiomyomatosis and renal cell carcinoma (HLRCC), BirtHogg-Dubé (BHD), and hereditary papillary renal carcinoma (HPRC).

Approximately 4% of all RCC cases are due to an inherited susceptibility.6 As RCC continues to be associated with additional genes, however, and because it is believed that the majority of hereditary RCC cases go unrecognized, it is likely that this is an underestimate.6 With the exception of HPRC, each syndrome is associated with its own, unique extrarenal manifestations. In some syndromes, extrarenal manifestations are the most common, and RCC develops only in a small subset. There are 2 primary goals for medical management of RCC: prevention of metastatic disease and preservation of renal function.6 Some suggest a surveillance protocol for VHL, HPRC, and BHD, which observes the patient with serial imaging until the largest renal lesion becomes 3 cm in size, at which time surgical intervention in the form of nephron-sparing surgery is warranted.9 At present, preventive screening measures for RCC are applied only in people with an increased risk of developing the condition. Thus, genetic diagnosis is imperative in helping to obtain surveillance for at-risk family members and developing tailored medical management for the patient with RCC. A summary of VHL, HLRCC, BHD, and HPRC follows. Genetic counseling and possibly genetic testing should be included in patients with a personal or family history of any of the following: • Bilateral and/or multifocal RCC • RCC under age 50 • RCC and another primary cancer in the same individual • RCC and a family history of cancer • RCC and nonrenal manifestations associated with hereditary RCC (in patient and/or family members), such as hemangioblastomas, pheochromocytomas, cutaneous leiomyomas, fibrofolliculomas, and pneumothorax VHL Syndrome Of the 4 syndromes—VHL, HLRCC, BHD, and HPRC—VHL is the most

www.TheOncologyNurse.com

recognized and described. It is an autoRenal findings include both cysts and somal-dominant, multisystem condi- RCC. Of those with VHL syndrome, tion linked to mutations in the VHL the lifetime risk of developing RCC is gene. Penetrance is high, approaching 25% to 45%, almost always clear cell.2 90% to 100%, and expressivity var- Individuals may develop 600 tumors ies greatly. Manifestations include kid- and 1100 cysts per kidney.3,9 The ney, adrenal, pancreatic, reproductive average age at onset of renal manifestaadnexal organs, and central nervous tions is 39 years.2 Approximately 10% VBCC0112_VBMAsize_Layout system (CNS) lesions. 1 2/15/12 3:28 PM Pageto2 20% of individuals will have adrenal

findings in the form of pheochromocytomas, either in one or both glands.10 Pancreatic findings consist of both pancreatic cancer and cysts, which may be numerous but are usually simple cysts.

Up to 17% of individuals with VHL may develop neuroendocrine tumors of the pancreas.11 Men often have epiContinued on page 24

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23

GENETIC COUNSELING

Genetic Susceptibility to Renal Cell Carcinoma Continued from page 23 by the spinal cord (20%).10 Retinal hemangioblastomas, sometimes called retinal angiomas, are often the initial manifestation of VHL, affecting up to 70% of individuals; the average age at diagnosis is 25 years, but they may present in childhood.11 Approximately 10% of individuals with VHL develop endolymphatic sac tumors, which result in varying severities of deafness; these are often misdiagnosed as

didymal tumors, which typically do not cause problems; in women, papillary cystadenoma of the broad ligament may be seen, although rarely.11 CNS involvement is high, with the majority of patients having hemangioblastomas (60%-80%) and some developing endolymphatic sac tumors (10%15%).10 CNS hemangioblastoma is the cardinal feature of VHL, the majority found in the brain (80%), followed

Menière disease and may be an initial presenting feature of VHL.11 HLRCC Syndrome HLRCC is unique among other hereditary RCC syndromes in that most kidney tumors seen in HLRCC are unifocal and unilateral.12 Similar to the other RCC syndromes, HLRCC is inherited in an autosomal-dominant fashion. The syndrome was initially reported in 200113

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Over the past decade, significant progress has been made in the management of multiple myeloma, including new standards of care and the development and approval of several novel, effective agents. Despite this progress, more work needs to be done and numerous questions remain regarding the application and interpretation of recent clinical advances.

In this sixth annual “Considerations in Multiple Myeloma” newsletter series, we continue to explore unresolved issues related to the management of the disease and new directions in treatment. To ensure an interprofessional perspective, our faculty is comprised of physicians, nurses, and pharmacists from leading cancer institutions, who provide their insight, knowledge, and clinical experience related to the topic at hand. In this second issue, experts from Dana-Farber Cancer Institute answer questions related to the management of patients in the maintenance setting.

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Sincerely, Sagar Lonial, MD Professor Vice Chair of Clinical Affairs Department of Hematology and Medical Oncology Winship Cancer Institute Emory University School of Medicine Atlanta, GA

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June 2013 I VOL 6, NO 5

and is associated with mutations in the FH gene. The number of families who develop renal cancer varies widely in the literature; therefore, a specific renal cancer risk for carriers of the FH mutation has not yet been determined. The incidence in families is believed to range from 10% to 40%.2,14 Age of onset is also challenging; patients are diagnosed between the ages of 30 and 45, but on occasion, onset occurs prior to age 20.12 Surveillance recommendations for these families also vary, but intensive screening for renal cancer is usually suggested beginning at age 18 or 20, and due to reports of childhood onset, the youngest being age 11, some authors suggest surveillance even in childhood.12 The associated renal cancer, papillary type 1, is also more aggressive and more prone to metastasis than with other RCC syndromes. Early radical treatment by nephrectomy has been proposed due to the aggressive natures of these tumors.

It has also been suggested that renal cancer surveillance be restricted to families with previous cases of renal cancer or specific FH mutations, but there is no evidence that family history or type of FH mutation can predict renal cancer risk. Therefore, current data indicate that surveillance should be aimed at all carriers of the FH mutation. Collectingduct RCC and mixed cystic, papillary, and tubulopapillary RCC have also been reported in HLRCC families.2 In addition to RCC, individuals with HLRCC are at risk of developing cutaneous and uterine leiomyomas. Cutaneous leiomyomas are typically distributed on the head, neck, trunk, and extremities.

The majority of individuals (76%) will present with 1 or more cutaneous leiomyomas, with mean age of presentation being 25 years.14 Uterine leiomyomas are present in all females with HLRCC and are distinct from those found in the general population in that the age of onset is younger (often under age 30) and the fibroids are numerous and larger; myomectomy or hysterectomy is sometimes required.14 BHD Syndrome Similar to HLRCC, BHD has been associated with renal tumors and cutaneous manifestations. Additionally, BHD is associated with pulmonary cysts and spontaneous pneumothoraces.

Inheritance is also autosomal dominant, and the syndrome is linked to mutations in the FLCN gene. Similar to VHL and HPRC, renal tumors tend to be bilateral and multifocal. Kidney tumor types are more diverse than in the other RCC syndromes and include oncocytic hybrid tumor (67%), chromophobe RCC (23%), and renal oncocytoma (3%); clear cell RCC and papillary renal carcinoma

www.TheOncologyNurse.com

GENETIC COUNSELING have also been reported. The average age at diagnosis is 48 years.15 Similar to other syndromes, a specific renal cancer risk has not yet been definitely determined; however, the prevalence of kidney tumors in families ranges from 6.5% to 34%.15 As the associated tumors tend to be slow growing, bilateral, and multifocal, the use of nephron-sparing surgery to preserve functioning renal tissue is recommended.

Numerous cutaneous findings are associated with BHD and include fibrofolliculomas, trichodiscomas, acrochordons, perifollicular fibromas, and angiofibromas.15 The follicular tumors are typically distributed over the face, neck, and upper trunk.15,16 As fibrofolliculomas are the only skin finding specific for BHD, a dermatologic diagnosis can be made when 5 or more facial or truncal papules are present with at least one being a histologically confirmed fibrofolliculoma.15 The average age of onset is in the third and fourth decades of life.15 In addition to being at increased risk for renal neoplasms and cutaneous findings, individuals are also at risk for pulmonary disease consisting of multiple lung cysts and spontaneous pneumothoraces.16 Almost 90% of individuals have multiple, bilateral lung cysts, which are typically asymptomatic, and 24% of individuals have a history of pneumothorax.15 HPRC Syndrome Unlike the other syndromes, the sole manifestation of HPRC is type 1 papillary renal carcinoma. However, it is

important to keep in mind that type 1 and type 2 papillary renal carcinomas are often not distinguished in the initial pathology. This syndrome is also inherited in an autosomal-dominant fashion with variable penetrance and is associated with mutations in the MET gene.

Similar to VHL and BHD, individuals are at risk of developing multiple and/ or bilateral tumors. The risk is greatest in the sixth through eighth decades.2,6

by a particular histologic subtype of renal cancer and other associated features.

• Genetic diagnosis can help obtain surveillance for at-risk family members. Additionally, with the exception of HLRCC, surgical management tries to focus on nephron-sparing surgery.

• Pathology can be useful in diagnosing hereditary RCC. However,

It is important to realize that von HippelLindau, hereditary leiomyomatosis and renal cell carcinoma, Birt-Hogg-Dubé, and hereditary papillary renal carcinoma are not the only inherited syndromes associated with RCC. Other Syndromes It is important to realize that VHL, HLRCC, BHD, and HPRC are not the only inherited syndromes associated with RCC; other syndromes reported in the literature include Cowden syndrome, hereditary paraganglioma and pheochromocytomas associated with SDHB mutations, tuberous sclerosis, Li-Fraumeni syndrome, and Lynch syndrome.17 Take-Home Messages • Typically, hereditary renal cancer presents at an earlier age and is often multifocal and/or bilateral.

Most syndromes are characterized

as it is believed most hereditary RCC cases remain undiagnosed, it is likely we may see expanded phenotyping in the future. l References

1. American Cancer Society. Kidney Cancer (Adult)— Renal Cell Carcinoma. Atlanta, GA: American Cancer Society; 2012. http://www.cancer.org/acs/groups/ cid/documents/webcontent/003107-pdf.pdf. Revised January 18, 2013. Accessed May 13, 2013.

2. Chan-Smutko G. Genetic testing by cancer site: urinary tract. Cancer J. 2012;18(4):343-349.

3. Linehan WM, Pinto PA, Srinivasan R, et al.

Identification of the genes for kidney cancer: opportunity for disease-specific targeted therapeutics. Clin Cancer Res. 2007;13(2 pt 2):671s-679s.

4. Lipworth L, Tarone RE, Lund L, et al. Epidemiologic characteristics and risk factors for renal cell cancer. Clin Epidemiol. 2009;1:33-43.

5. Rosner I, Bratslavsky G, Pinto PA, Linehan WM. The clinical implications of the genetics of renal cell carcinoma. Urol Oncol. 2009;27(2):131-136.

6. Barrisford GW, Singer EA, Rosner IL, et al. Familial renal cancer: molecular genetics and surgical management. Int J Surg Oncol. 2011;2011:658767.

7. Azeem K, Kollarova H, Horakova D, et al. Genetic syndromes associated with renal cell carcinoma: a review. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011;155(3):231-238.

8. Mester JL, Zhou M, Prescott N, et al. Papillary renal cell carcinoma is associated with PTEN hamartoma syndrome. Urology. 2012;79(5):1187.e1-7.

9. Singer EA, Bratslavsky G, Middelton L, et al.

Impact of genetics on the diagnosis and treatment of renal cancer. Curr Urol Rep. 2011;12(1):47-55.

10. Wind JJ, Lonser RR. Management of von HippelLindau disease-associated CNS lesions. Expert Rev Neurother. 2011;11(10):1433-1441.

11. Frantzen C, Links TP, Giles RH. Von HippelLindau disease. In: Pagon RA, Bird TD, Dolan CR, et al, eds. GeneReviews. Seattle, WA: University of Washington, Seattle; 2000. http://www.ncbi.nlm. nih.gov/books/NBK1463/. Updated June 21, 2012.

Accessed May 13, 2013.

12. van Spaendonck-Zwarts KY, Badeloe S, Oosting SF, et al. Hereditary leiomyomatosis and renal cell cancer presenting as metastatic kidney cancer at 18 years of age: implications for surveillance. Fam Cancer.

2012;11(1):123-129.

13. Launonen V, Vierimaa O, Kiuru M, et al. Inherited susceptibility to uterine leiomyomas and renal cell cancer. Proc Natl Acad Sci U S A. 2001;98(6):33873392.

14. Pithukpakorn M, Toro JR. Hereditary leiomyomatosis and renal cell cancer. In: Pagon RA, Bird TD, Dolan CR, et al, eds. GeneReviews. Seattle, WA: University of Washington, Seattle; 2006. http:// www.ncbi.nlm.nih.gov/books/NBK1252/. Updated November 2, 2010. Accessed May 13, 2013.

15. Toro JR. Birt-Hogg-Dubé syndrome. In: Pagon RA, Bird TD, Dolan CR, et al. GeneReviews. Seattle, WA: University of Washington, Seattle; 2006. http:// www.ncbi.nlm.nih.gov/books/NBK1522/. Updated September 9, 2008. Accessed May 13, 2013.

16. Tefekli A, Akkaya AD, Peker K, et al. Staged, open, no-ischemia nephron-sparing surgery for bilateral-multiple kidney tumors in a patient with Birt-HoggDubé syndrome. Case Rep Med. 2012;2012:639629.

17. Lodish MB, Stratakis CA. Rare and unusual endrocrine cancer syndromes with mutated genes.

Semin Oncol. 2010;37(6):680-690.

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25

Survivorship

Survivorship Plans: Taking Care of the Details Continued from cover School of Nursing in North Carolina.

Speaking at the 38th Annual Congress of the Oncology Nursing Society, Mayer said, “The development and implementation of survivorship plans cannot be done by nurses alone. It requires teamwork.”

The end of treatment is the best opportunity for providing an SCP, she said. “At that time, I map out what is next for the patient. Often I have to review the treatment they received and why they got it. After the treatment is over, they are hit with the reality and may seem depressed. I use this as a transition visit,” she said.

improved outcomes with survivorship plans, the results of smaller studies suggest that end-of-treatment visits with SCPs lead1 to high patient Project1_Layout 5/9/13 3:03 PM Page 1 satisfaction, reduced patient anxiety/unmet needs,

and improved preparedness to manage healthcare. PCPs like them too, she said.

“Survivorship planning makes good common and clinical sense,” Mayer said.

Fourth Annual Navigation and

November 15-17, 2013 • The Peabo PRELIMINARY AGENDA* FRIDAY, NOVEMBER 15

“The development and implementation of survivorship plans cannot be done by nurses alone. It requires teamwork.”

Deborah K. Mayer, PhD, RN, AOCN, FAAN

Mayer advised making a special appointment to present the treatment summary and survivorship plan, with a written copy for the patient and spouse or caregiver. One must also make sure that the PCP receives the summary and the plan. It does not matter which template is used for the summary, but the information should be simple and clear to both the patient and the PCP, especially avoiding “oncospeak” with abbreviations that others may not understand, Mayer continued.

“Studies suggest that patients only retain about 10% of what you tell them at visits, so it is important to have a written plan about what treatments they have had and what will happen next, as well as the order of what will happen next,” she explained.

Even though randomized controlled trials have yet to show significantly

26

June 2013 I VOL 6, NO 5

The treatment summary and SCP should be simplified and should include the diagnosis, the basics of treatment received, and the potential side effects and complications. “I would discourage

12:00 pm - 12:30 pm Welcome • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 12:30 pm - 2:00 pm PRE-CONFERENCE WORKSHOPS Basic Navigation Track • Tricia Strusowski, MS, RN • Nicole Messier, RN, BSN OR Advanced Navigation Track • Elaine Sein, RN, BSN, OCN, CBCN • Danelle Johnston, RN, MSN, OCN, CBCN 2:00 pm - 2:45 pm BREAK IN THE EXHIBIT HALL 2:45 pm - 3:30 pm General Session 1: Top 10 Best Practices • Moderators – Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 3:30 pm - 5:00 pm Administrator’s Track • Mandi Pratt-Chapman, MA • Michele O’Brien, MSN, ACNS-BC, RN, BA OR

5:00 pm - 6:00 pm 6:00 pm - 8:00 pm

Case Manager’s Track FREE TIME Welcome Reception/Posters in the Exhibit Hall

SATURDAY, NOVEMBER 16 6:30 am - 7:30 am

Breakfast/Product Theater (non–CME-certified activity) 7:45 am - 8:00 am Welcome and Introductions • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 8:00 am - 8:30 am General Session 2: The Future of AONN (The AONN Business Meeting) • Sharon Gentry, RN, MSN, AOCN, CBCN • Lillie D. Shockney, RN, BS, MAS 8:30 am - 9:15 am General Session 3: Community Needs and Navigation • Lillie D. Shockney, RN, BS, MAS, on behalf of the Global Breast Health Initiative • Jennifer Klemp, PhD, MPH, MS 9:15 am - 10:00 am General Session 4: Development and Application of Evidence-Based Guidelines in Cancer Care: The NCCN Perspective • Liz Danielson, MHA 10:00 am - 10:45 am BREAK IN THE EXHIBIT HALL 10:45 am - 11:30 am Keynote: Update on Guidelines • Linda Ferris, PhD 11:45 am - 12:45 pm Lunch/Product Theater (non–CME-certified activity) 1:00 pm - 1:45 pm General Session 5: Onco-Politic Barriers • Dan O’Connor 1:45 pm - 2:30 pm General Session 6: Addressing Disparities of Care • Swann Arp Adams, PhD, MS • Michelle Weaver Knowles, RNC, BSN

2:30 pm - 3:15 pm 3:15 pm - 3:45 pm 3:50 pm - 4:35 pm

4:35 pm - 5:20 pm 5:30 pm - 7:30 pm

General Session 7: Oncology Medical Home BREAK IN THE EXHIBIT HALL General Session 8: Meeting the Needs of the Adult and Child Survivor Throughout the Life Span • Christy Roberts, RN, BSN, OCN General Session 9: The Role of Complementary Therapies in Navigation • Linda Lee, MD, AGAF Poster Award Reception

SUNDAY, NOVEMBER 17 6:30 am - 7:30 am

Breakfast/Product Theater (non–CME-certified activity) 7:45 am - 8:00 am Welcome and Introductions • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 8:30 am - 8:45 am General Session 10: Navigator’s Role in Tumor Boards • Laurie Mathis, RN, BS, MAS 8:45 am - 10:30 am DISEASE SITE–SPECIFIC BREAKOUTS • Breast Cancer Navigation & Survivorship • Karen Dow Meneses, PhD, RN, FAAN • Vinnie Myers • Thoracic Oncology Navigation • Gean Brown, RN, OCN • GI & Colorectal Cancer Navigation • Darcy Doege, RN, BSN • Kristen Vogel, MS, CGC • GYN Cancers Navigation • Penny Daugherty, BSN, RN, OCN • Prostate Cancer Navigation • Head, Neck, & Neuro Navigation • Tamara Bowen, RN, BSN, MHA • Pediatric Oncology • Kathy Ruble, RN, CPNP, PhD • Hematology/Oncology Navigation • Melanoma Navigation • Sherry Riggins, RN, BSN, OCN 10:30 am - 11:15 am BREAK IN THE EXHIBIT HALL 11:15 am - 12:00 pm General Session 11: Understanding the Role of the Primary Care Physician • Michael Kolodziej, MD 12:15 pm - 1:15 pm Lunch/Product Theater (non–CME-certified activity) 1:30 pm - 2:15 pm General Session 12: Navigator’s Role in End-of-Life Care • Lillie D. Shockney, RN, BS, MAS 2:15 pm - 3:00 pm General Session 13: Music & Medicine: A Dynamic Partnership • Deforia Lane, PhD, MT-BC 3:00 pm - 3:15 pm Conclusion of the Conference/Final Remarks • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS *Preliminary agenda, subject to change.

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Survivorship you from making the plan longer and more complex than it needs to be,” she told listeners.

Templates are available from several organizations, including American Society of Clinical Oncology and Journey Forward, but these templates

may be too complicated or long for practical utility, she continued. “The template should be patient- and primary care provider–friendly and no longer than 2 pages for the treatment summary if possible,” Mayer added.

Overly detailed technical informa-

tion is not helpful, she said. In the template Mayer developed for breast cancer patients, she spells out relevant medical terms and explains what they mean; for example, that “ER-positive” means that the tumor is sensitive to hormones.

Survivorship Conference

ody Memphis • Memphis, Tennessee CONFERENCE CO-CHAIRS Program Director: Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Depts of Surgery and Oncology Adm Director, Johns Hopkins Breast Center Adm Director, Johns Hopkins Cancer Survivorship Programs Associate Professor, JHU School of Medicine Depts of Surgery, Oncology & Gynecology and Obstetrics Associate Professor, JHU School of Nursing Baltimore, MD

FACULTY* Swann Arp Adams, PhD, MS Tamara Bowen, RN, BSN, MHA Gean Brown, RN, OCN

Penny Daugherty, BSN, RN, OCN Darcy Doege, RN, BSN Karen Dow Meneses, PhD, RN, FAAN Linda Ferris, PhD Sharon Gentry, RN, MSN, AOCN, CBCN

Jennifer Klemp, PhD, MPH, MS Michael Kolodziej, MD Deforia Lane, PhD, MT-BC Linda Lee, MD, AGAF

CONFERENCE OVERVIEW

AONN’s Fourth Annual Conference will continue to advance the navigation profession by expanding the scope of educational sessions, networking opportunities, and poster presentations. In addition, this year’s conference will address the evolving challenges of program improvement, the role of personalized medicine, and implementing best practices in navigation, survivorship, and psychosocial care.

TARGET AUDIENCE

This activity was developed for oncology nurse navigators, patient navigators, social workers, and case managers.

CONTINUING EDUCATION INFORMATION

Learning Objectives Upon completion of this activity, the participant will be able to: • Discuss the evolution of the role of navigation in healthcare.

• Assess strategies for navigating diverse patient populations by cancer type and environmental factors.

• Define methods for providing patient support and guidance in the age of personalized cancer care.

• Evaluate best practices regarding survivorship and psychosocial care.

Nicole Messier, RN, BSN Vinnie Myers Michele O’Brien, MSN, ACNS-BC, RN, BA

Liz Danielson, MHA

Danelle Johnston, RN, MSN, OCN, CBCN

Sharon Gentry, RN, MSN, AOCN, CBCN Breast Nurse Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

Laurie Mathis, RN, CBCN, OCN

Dan O’Connor Mandi Pratt-Chapman, MA Sherry Riggens, RN, BSN, OCN Christy Roberts, RN, BSN, OCN Kathy Ruble, RN, CPNP, PhD Elaine Sein, RN, BSN, OCN, CBCN Lillie D. Shockney, RN, BS, MAS Tricia Strusowski, MS, RN Kristen Vogel, MS, CGC Michelle Weaver Knowles, RNC, BSN *For full information visit www.aonnonline.org

SPONSORS

This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

COMMERCIAL SUPPORT ACKNOWLEDGMENT

Grant requests are currently being reviewed by numerous supporters.

Support will be acknowledged prior to the start of the educational activities.

REGISTERED NURSE DESIGNATION

Medical Learning Institute Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for up to 16.25 contact hours.

2013 CONFERENCE REGISTRATION

www.aonnonline.org /conference

Mayer predicted that, as experience is gained with SCPs, templates for survivorship plans will eventually become more simplified and standardized and integrated into electronic health records.

“Surgical oncologists and radiation oncologists typically provide summary notes at the end of treatment, but medical oncologists rarely do this. If they did, your survivorship care plan would take about 15 minutes to prepare,” she said.

Taking care of a cancer patient after treatment can become a bit of a turf war between the oncologist and the PCP. “Tumor groups at your hospital need to decide when survivors should move on to the PCP,” she said. “We need to prevent the gap between oncology and primary care from developing.”

Mayer suggested up-front partnering with the PCP when the patient begins treatment and when he or she ends it.

“This could avoid the need for specialists to treat hypertension or other common conditions that the PCP can manage,” she explained. “All forms should include the name and contact information of the PCP, and the nurse should make sure that the PCP gets the notes on the patient.”

Survivorship plans for patients with advanced metastatic cancer are a neglected topic thus far. CoC has not provided any recommendations for this group of patients. “The needs of the advanced cancer patient will be different,” she predicted.

However, at some centers hospice and palliative care specialists are called in earlier in the course of the disease.

“We can facilitate those discussions, and this could affect their planning,” she said.

Remaining issues regarding implementation of SCPs that need to be addressed in each practice setting are: • Which patients will receive a treatment summary and an SCP? • When will they receive it?

• Who will develop it?

• Who will deliver it?

• Who will get a copy of it?

• Where will the plan be filed, how will it be updated, how will it be tracked?

Remaining challenges include implementation issues, educating patients and providers about survivorship care, and evaluating effectiveness.

“Many are preparing to meet the CoC 2015 standard and will need to address these challenges,” Mayer noted. l Reference

L-AONN-13_Ksize 50813

www.TheOncologyNurse.com

Mayer DK. Development and implementation of survivorship care plans: the devil is in the details. Presented at: 38th Annual Congress of the Oncology Nursing Society; April 25, 2013; Washington, DC. Editor Chat.

June 2013 I VOL 6, NO 5

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Th

eO seri Vie nc es w olo on the gy line Nu a rse t .co m

2ND ANNUAL

CONQUERING THE ANCER ARE C C CONTINUUM

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CONQUERING THE CANCER CARE CONTINUUM CONQUERING CANCER CARTHE C E CONT I

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The publishers of The Oncology Nurse-APN/PA, The Oncology Pharmacist, and Personalized Medicine in Oncology are proud to present our 2nd annual Conquering the Cancer Care Continuum series.

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Challenges Patients Face in Cancer Care: Implications for the Healthcare Team Lea Ann Hansen, PharmD, BCOP Associate Professor, Virginia Commonwealth University

ancer is an illness associated with substantial cancer.1 More than half are living well beyond 5 years physical, emotional, social, and financial ramafter diagnosis. Women comprise a majority of longifications for affected individuals and their term survivors due to the favorable outcomes with families. In a significant number of cases, the diagnosis breast, cervical, and uterine cancers.2 The number of of cancer is either preceded by a period people living with a history of cancer

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