TON February 2014

January/February 2014

www.TheOncologyNurse.com

Vol 7, No 1

Nutrition in Focus

Cancer Center Profile

Nutrition for Pre- and Postoperative Patients With Cancer: Improve Nutritional Status to Help Improve Outcomes

Via Christi Cancer Institute A Nurse Navigator Program for Patient Care

Tiffany DeWitt, MS, RD, LD Abbott Nutrition

M

alnutrition impacts many patients with cancer, yet the clinical consequences of malnutrition are often overlooked. The prevalence of malnutrition varies depending on cancer type, ranging from as little as 9% in urologic cancers to up to 85% in pancreatic cancers.1,2 Many factors contribute

to malnutrition, including nausea, vomiting, loss of appetite, diarrhea, and the catabolic effects of cancer. Common treatment practices such as keeping patients nil-bymouth for tests and procedures can further contribute to the development of malnutrition and weight loss, putting patients Continued on page 10

Empowering Patients and Survivors The Nurse Navigator Program at Via Christi Cancer Institute in Wichita, Kansas, includes Summit, a pet therapy dog. In this photo, Summit works with a patient.

Hide No Hair

V

Hair Loss and Head Coverings Then and Now

ia Christi Cancer Institute in Wichita, Kansas, is part of the larger Via Christi Health network serving the state of Kansas and northeast Oklahoma. Via Christi is the largest provider of healthcare services in Kansas, with its doctors, hospitals, senior villages, and other medical services. Its website states: “We serve as a healing presence with special concern for our neighbors who are vulnerable.”

Via Christi Cancer Institute in Wichita has a multitude of services available to cancer patients and their families, which include bone marrow transplants, chemotherapy administration, radiation therapy including brachytherapy, CyberKnife, and integrative therapies (eg, yoga, meditation, massage, and pet therapy). Via Christi has a patient advisory committee and a developing Nurse Navigator Program. The Oncology Nurse-APN/PA spoke with the institute’s oncology nurse navigator, Margaret (Maggie) Ward, MSN, APRN, AGCNS, OCN.

Angela Long

“I was going to buy a book on hair loss, but the pages kept falling out.”

Jay London

H

air loss was one of the biggest emotional struggles I faced as a young woman with cancer.

When I think back about losing my hair to chemo almost 10 years ago, I am struck by how both the cultural norms and headwear options have changed since then. I wonder if I would do things dif-

Highlights From ASH and SABCS Alice Goodman

T

he American Society of Hematology (ASH) and the San Antonio Breast Cancer Symposium (SABCS) held back-to-back meetings in December 2013. The ASH annual meeting hosted approximately 20,000 attendees in New Orleans,

Louisiana, where more than 5300 abstracts were presented, orally or as posters. About 7500 participants from more than 90 countries attended the breast cancer symposium. Below are selected brief highlights from these meetings.

Continued on page 12

inside

Continued on page 26

Conference News

ferently. Although there are many new options to help us rise above our hair loss, I believe the essential criteria for selecting headwear remain the same: cost, comfort, and self-confidence.

As a busy mom of 2 little ones, my goal was to get through breast cancer treatment looking as normal as possible, and without breaking the bank. My kids were only 2 and 5 years old at the time of my diagnosis, so I was not as worried

Breast Cancer Role of Radiation and Imaging in DCIS Explained . . . . . . . . . . . . . . . .

15

Eribulin Mesylate Plus Trastuzumab Yields High Response Rates as First-Line Metastatic Breast Cancer Treatment . . . . . . . . . . . . . .

19

Addressing Psychosocial and Physical Fallout From Breast Cancer. . . . . . . . . . . . . . . . .

20

Brain Metastasis and End-of-Life Care in Metastatic Breast Cancer . . .

21

Continued on page 6 ©2014 Green Hill Healthcare Communications, LLC

Genetic Counseling. . . . . . . .

Reproductive Options for Hereditary Cancer Syndromes

16

Side Effects Management. .

NEPA Superior to Palonosetron in CINV Prevention

18

Osteonecrosis of the Jaw Associated With Cumulative Dose in Myeloma Perspectives. . . . . . . . . . . . . . .

The Balancing Act

25

Standard definition is obsolete.

Why use SD vein illumination?

the

ONLY HD vein illumination.

VeinViewer

VeinViewer

VeinViewer

VeinViewer

VeinViewer

Christie Christie Christie

Christie Christie Christie

VeinViewer

Christie’s VeinViewer is the only vein illumination device shown to increase IV first-stick and patient satisfaction by up to 100%. We’re the only company in the market to pioneer HD imaging with Df2 (Digital full field) technology, providing near-perfect projected vein accuracy. When it comes to patient care, don’t settle for anything less.

The Christie Assure Program provides a 5 year customer commitment like no other.

Learn more by scanning the QR code or visiting www.ChristieDigital.com/Assure ©2013 Christie Medical Holdings Inc. 010-200177-02 Rev. 1 (08-2013)

Editorial Board EDITOR-IN-CHIEF

Beth Faiman,

Shannon Hazen, RN, BSN, OCN

PhD(c), MSN, APRNBC, AOCN

Novant Health Presbyterian Cancer Center Charlotte, NC

Catherine Bishop,

Patricia Irouer Hughes, RN, MSN,

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

DNP, NP, AOCNP

Melinda Oberleitner, RN,

Karla Wilson,

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

City of Hope National Medical Center Duarte, CA

Jayshree Shah, NP

Pharmacy John F. Aforismo,

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Johns Hopkins Kimmel Cancer Center/Sibley Infusion Washington, DC

BSN, OCN

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

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 Biodesix, Inc. Dallas, TX

Piedmont Healthcare Rex, GA

NP, MSN, ACNP-C

RN, MSN, FNP-C, CPON

DNS, APRN, CNS

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

MSN, NP, ANP-BC, AOCNP

Lori Stover, RN,

Arizona Cancer Center Tucson, AZ

Western Pennsylvania Cancer Institute Pittsburgh, PA

Ann McNeill,

Joseph D. Tariman,

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

RD, CSO

Somerset Medical Center Somerville, NJ

Sandra E. Kurtin, RN, MS, AOCN, ANP-C

Nutrition Karen Connelly,

Patient Advocacy Peg Ford

BSN

Ovarian Cancer Alliance San Diego, CA

PhD, APRN, BC

Northwestern University Myeloma Program Chicago, IL

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

Jacqueline Marie Toia, RN, MS,

Genetic Counseling Cristi Radford,

DNP

MS, CGC

Northwestern University Myeloma Program Chicago, IL

Ambry Genetics Sarasota, FL

Pamela Hallquist Viale, RN, MS,

Managed Care and Pharmaceutical Management Burt Zweigenhaft,

CS, ANP, AOCN Saratoga, CA

BS

OncoMed Onco360 Great Neck, NY

Sharon S. Gentry,

Ellen A. Neylon,

RN, MSN, AOCN, CBCN

MSN, FNP-BC, CCRP, OCN

Novant Health Derrick L. Davis Cancer Center Winston-Salem, NC

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

Cassandra J. Hammond, RN,

Dolores “Jeff” Nordquist, RN, MS,

Avid Education Partners, LLC Sharpsburg, MD

Mayo Clinic Rochester, MN

MSN, CRNP

www.TheOncologyNurse.com

CS, FNP

Connie Visovsky,

PhD, RN, ACNP-BC University of South Florida College of Nursing Tampa, FL

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

Jeanne Westphal, RN

Rita Wickham,

PhD, RN, AOCN

Isabell Castellano, RN

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

Meeker County Memorial Hospital Litchfield, MN

January/February 2014 I VOL 7, NO 1

3

From The Editor PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko ppawelko@the-lynx-group.com Group Director, Sales & Marketing

John W. Hennessy jhennessy2@the-lynx-group.com Publisher Russell Hennessy rhennessy@the-lynx-group.com Editorial Director Kristin Siyahian ksiyahian@the-lynx-group.com Managing Editor Kristen Olafson kolafson@the-lynx-group.com Copy Editors Mollie Friedman Peggy Roeske Editorial Assistant Jennifer Brandt Production Manager Cara Nicolini

The Lynx Group President/CEO Brian Tyburski

W

elcome to the first issue of The Oncology NurseAPN/PA (TON) for 2014. We’re looking forward to a year of keeping you up-to-date about what is happening in the world of oncology research and bringing you information that helps you in your day-to-day practice as a healthcare professional.

In this issue, we tell you about Beth Faiman, PhD(c), some of the news coming out of MSN, APRN-BC, AOCN the San Antonio Breast Cancer Editor-in-Chief Symposium (SABCS). Our coverage from SABCS includes an analysis of the psychosocial and physical challenges faced by survivors of breast cancer—a situation that has become more pressing as diagnostics and treatment have advanced. We also cover quality-of-life issues for patients with metastatic breast cancer, including the concern that many patients are not receiving appropriate end-of-life care and are often overtreated with chemotherapy that has little chance of benefit.

This issue also starts our coverage of the news from the

Reader Poll

Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore

Do patients talk to you about losing their hair because of their treatment?

Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno

o Yes

Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen

Green Hill Healthcare Communications, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-656-7935 • fax: 732-656-7938

4

January/February 2014 I VOL 7, NO 1

American Society of Hematology (ASH) annual meeting. You’ll see more news in the next issue of TON as we continue to cover the highlights from ASH. Be sure to read Angela Long’s Hide No Hair article about the options available to women who have lost their hair while undergoing chemotherapy. Angela tells us about her own experiences with hair loss and provides great tips to help us guide our patients through this process. This month’s Reader Poll asks if your patients talk to you about hair loss (see below). Please let us know what your patients are telling you and how you respond to their concerns.

Sue Bond, FNP-ANP, is a new voice to TON. She writes about the difficulty of balancing work and home life for those who work in the field of oncology, asking “Do overachieving busy people choose this profession, or does this profession make us overachieving busy people?”

As always, I encourage you to visit our website, www.

TheOncologyNurse.com. Be sure to tell us what topics you want to see covered in TON. Let us know if you would be interested in writing an article for TON. We want to hear from you, and we appreciate your feedback—positive and negative—about what you see in print and on the website. l

o No

©iStockphoto.com/Slobodan Vasic

A

ngela Long says that “hair loss was one of the biggest emotional struggles I faced as a young woman with cancer.” In her Hide No Hair article, she discusses how “cultural norms and headwear options” have changed since she lost her hair during

her chemo treatment almost 10 years ago. Do your patients talk to you about losing their hair? What do you say to them about hair loss? How do you assist your patients in finding what options are best for them? Please tell us about your experiences.

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

The Oncology Nurse-APN/PA®, ISSN 1944-9798 (print); ISSN 1944-9801 (online) is published 6 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 ©2014 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

Now enrolling

Investigating ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Phase II Open-Label Study of the Efficacy and Safety of ABT-199 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion N=100

ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use under investigation in this trial.

Primary Endpoint

Secondary Endpoints

• Overall response rate

• • • • • • • •

Complete remission rate Partial remission rate Duration of response Progression-free survival Time to progression Overall survival Percentage of patients who move on to stem-cell transplant Safety and tolerability of ABT-199

Key Inclusion Criteria • Adult patients ≥18 years of age • Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria (relapsed/refractory after receiving ≥1 prior line of therapy and 17p deletion) • ECOG performance score of ≤2 • Adequate bone marrow function • Adequate coagulation, renal, and hepatic function, per laboratory reference range

NCT#01889186 Reference: ClinicalTrials.gov.

@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.

To learn more about this study, please visit www.ClinicalTrials.gov.

Conference News Continued from cover

In postmenopausal women with early breast cancer, bisphosphonates in the adjuvant setting reduced the risk of recurrence in bone by 34% and breast cancer death by 17% according to a large meta-analysis conducted by the Early Breast Cancer Trialists’ Collaborative Group.

The risk reductions in bone recurrence and death with adjuvant bisphosphonates were observed in postmenopausal women regardless of estrogen receptor status, nodal status, and chemotherapy. Bisphosphonates had no effect on outcomes in premenopausal women.

“In addition to the 17% reduction in breast cancer–related mortality, adjuvant bisphosphonates led to an

Photo © San Antonio Breast Cancer Symposium.

Bisphosphonates Lower Risk of Recurrence and Death in Postmenopausal Early Breast Cancer “In addition to the 17% reduction in breast cancer–related mortality, adjuvant bisphosphonates led to an absolute reduction of 3.4% in all-cause mortality.”

Robert Coleman, MD

absolute reduction of 3.4% in allcause mortality,” stated lead author Robert Coleman, MD, University of Sheffield, United Kingdom.

“These results are likely to be practice changing, leading to a new option for standard of care,” said Peter Ravdin, MD,

who moderated a press conference at the San Antonio Breast Cancer Symposium at which these data were presented.

Ravdin, who was not involved in the study, is the director of the Breast Health Clinic at the Cancer Therapy & Research Center of the University of Texas Health

Noteworthy Numbers

Clinical Trials Clinical trials are a vital component of the continued search for safe and effective treatments. Along with the researchers, the patients and healthy volunteers who participate in testing devices, diagnostic procedures, new drugs, and new uses for established therapies contribute to the advancement of knowledge and patient care. The following data provide a glimpse into this important aspect of research.

The national website ClinicalTrials.gov, a service of the US National Institutes of Health (NIH) that provides information for patients and families, researchers, and study record managers, currently lists 158,491 clinical studies, including locations in all 50 states and in 185 countries.1 As of January 5, 2014, there were 31,642 studies recruiting participants; 44% of these are recruiting only in the United States.2 ClinicalTrials.gov was made available to the public on February 29, 2000. As of January 5, 2014, there were 84,392 interventional studies of drugs or biologics registered; 8645 studies had posted results.2 Established in 1953 and expanded in 2005, the NIH Clinical Center in Bethesda, Maryland, is the largest hospital in the United States dedicated entirely to clinical research. Currently, approximately 1500 clinical research

6

January/February 2014 I VOL 7, NO 1

projects are under way, about 50% of which are devoted to the study of diseases, especially rare diseases. Clinical trials of new drugs, predominantly phase 1 and phase 2, account for most of the remaining research. The NIH Clinical Center staff includes approximately 1200 physicians, dentists, and PhD researchers; 620 nurses; and 450 allied healthcare personnel.3 According to the American Cancer Society (ACS), only 5% of cancer patients currently participate in clinical trials.4 And although 61% of new cancer diagnoses are made in the elderly, they make up only 25% of the participants in cancer clinical trials.5 To help address this issue, the ACS website provides a video for clinicians titled Raising Awareness about Cancer Clinical Trials.4 Sources 1. www.ClinicalTrials.gov.

2. http://www.clinicaltrials.gov/ct2/resources/trends.

3. http://clinicalcenter.nih.gov/ccc/crc/index.html.

4. www.cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/ rasing-awareness-about-cancer-clinical-trials-video.

5. Lewis JH, et al. J Clin Oncol. 2003;21(7):1383-1389.

Science Center at San Antonio.

The large, individual patient metaanalysis was based on 36 randomized controlled trials with a total of 22,982 women that compared adjuvant use of bisphosphonate versus no bisphosphonate or placebo. Seven of the trials compared the bisphosphonate clodronate versus no bisphosphonate or placebo and 29 evaluated aminobisphosphonates versus no bisphosphonate or placebo (65% of the women taking aminobisphosphonates received zoledronic acid, 24% ibandronate, and 11% “other”).

In the overall trial, no significant difference was observed in the 10-year rate of all breast cancer recurrences or distant recurrences, including bone recurrences.

The effect of bisphosphonates was confined to 11,306 postmenopausal women (including women aged >55 years if menopausal status was unknown); bisphosphonates achieved a highly significant difference compared with no bisphosphonates in distant recurrence (18.4% vs 21.9%, respectively; P = .0003) and in bone recurrence (5.9% and 8.8%; P <.00001). Bisphosphonates did not significantly reduce distant recurrences other than in bone in postmenopausal women.

The rate of breast cancer mortality was 15.2% for postmenopausal women treated with bisphosphonates compared with 18.3% not receiving bisphosphonates (P = .004), and the rate of all-cause mortality was 21.5% versus 23.8%, respectively (P = .007). l Reference

Coleman R, Gnant M, Paterson A, et al; Early Breast Cancer Clinical Trials Collaborative Group (EBCTCG)’s Bisphosphonate Working Group. Effects of bisphosphonate treatment on recurrence and cause-specific mortality in women with early breast cancer: a meta-analysis of individual patient data from randomized trials. Presented at: San Antonio Breast Cancer Symposium; December 12, 2013; San Antonio, TX. Abstract S4-07.

Want to participate in TON’s new poll?

See page 4 for details. www.TheOncologyNurse.com

www.TheOncologyNurse.com

er

Conference News ASH List for Choosing Wisely Reduces Unnecessary Waste, Prevents Harm, and Saves Money Hematologists should not use 5 tests and procedures routinely, according to Choosing Wisely recommendations presented at the 2013 American Society of Hematology annual meeting.

In 2009, the Institute of Medicine estimated that $210 billion was wasted on unnecessary healthcare services in the United States across all specialties.

“If we could redirect even a fraction of this to real people with real unmet healthcare needs, think of the good that we can do,” said ASH’s Choosing Wisely Task Force Chair Lisa Hicks, MD, of St. Michael’s Hospital and the University of Toronto, Canada.

Following are the 5 tests and procedures that were selected by the Task Force: Computed tomography scans.

1.

Limit their use in asymptomatic patients following curative-intent treatment for aggressive lymphoma. They do not change outcomes.

2. Inferior vena cava filters should not be routinely used in patients with acute venous thromboembolism (VTE).

3.

Do not transfuse more than the minimum number of red blood cell units necessary to relieve symptoms of anemia or to return a patient to safe hemoglobin range (7 to 8 g/dL in stable noncardiac inpatients).

4. Do not test for thrombophilia in adults with VTE occurring in the setting of major transient risk factors such as surgery, trauma, or prolonged immobility.

5. Do not administer plasma or prothrombin complex concentrates for nonemergent reversal of vitamin K antagonists (ie, outside the setting of major bleeding, intracranial hemorrhage, or anticipated emergent surgery).

The evidence for these recommendations was analyzed and reviewed over a year-long process by the ASH Task Force with input from the ASH membership.

The list includes only recommendations with strong evidence, and the main guiding principle of the process of making recommendations was to “do no harm.” Other guiding principles were level of evidence, cost, frequency, and scope of practice.

Hicks acknowledged that these 5 recommendations are probably only the tip of the iceberg, but said they represent an important first step in providing top quality care and optimizing outcomes for patients and the healthcare system.

Choosing Wisely is a quality care initiative developed by the American

www.TheOncologyNurse.com

Board of Internal Medicine in collaboration with leading medical societies.

It is expected to include more than 250 unnecessary tests and procedures from 30 medical specialty societies.

An article was published online in Blood to coincide with the presentation of the Choosing Wisely list at the ASH meeting. The list can be viewed at www. hematology.org/choosingwisely. l

Reference

Hicks LK. ASH Choosing Wisely® list. Presented at: 2013 American Society of Hematology Annual Meeting; December 9, 2013; New Orleans, LA.

Conference News continued on page 8

pantone 188

converted

Faculty Perspectives

™

January/February 2014 I VOL 7, NO 1

7

Conference News Continued from page 7

Treatment with 5 years of anastrozole reduced the risk of developing a first breast cancer by 53% and reduced the risk of developing estrogen-receptor positive (ER+) invasive cancer by 58% in women at high risk for developing the disease. These results from the IBIS-II trial were reported at the San Antonio Breast Cancer Symposium.1 “We believe these results provide strong support for chemoprevention of breast cancer in high-risk women.

Longer-term follow-up is needed to determine if the preventive effect is sustained after treatment,” said lead author Jack Cuzick, PhD, Queen Mary University, Wolfson Institute of Preventive Medicine, London, United

Photo © San Antonio Breast Cancer Symposium.

Anastrozole Halves Risk of First Breast Cancer “We believe these results provide strong support for chemoprevention of breast cancer in high-risk women.”

Jack Cuzick, PhD

Kingdom.

IBIS-II randomized 3864 postmenopausal women at high risk of breast cancer, either because of family history and other risk factors (including atypia, lobular carcinoma in situ, or breast density), to treatment with anastrozole

or use of placebo for 5 years.

At 7 years of follow-up, primary breast cancers (including ductal carcinoma in situ) developed in 5.6% of women in the placebo group compared with 2.8% of the anastrozole group, representing a 53% decrease (P

New Standard of Care for Transplant-Ineligible Patients With Myeloma Continuous treatment with lenalidomide and low-dose dexamethasone (Rd) was superior to standard treatment with melphalan, prednisone, and thalidomide (MPT) for 72 weeks in newly diagnosed patients with multiple myeloma (MM) who were transplant ineligible. Experts said that these results represented a new standard of care for these patients.

Patients treated with Rd were 28% less likely to progress or die compared with those who received standard MPT (the primary end point of the trial). Rd was superior to MPT for all secondary end points, including overall survival, response rates, and duration of response. Patients treated with Rd had fewer secondary hematologic malignancies than those in the MPT arm.

“Traditionally, newly diagnosed MM patients have received short bursts of treatment, while continuous treatment was reserved for relapsed patients. However, we believe that these new results will help encourage more research on the efficacy and safety of continuous treatment for newly diagnosed patients to help maximize their changes for overall long-term survival,” stated lead author Thierry Facon, MD, Service des Maladies du Sang, Hôpital Claude Huriez, and CHRU Lille, France, at the American Society of Hematology annual meeting.

“For some patients with low-risk MM, this continuous regimen could make this disease a manageable, chronic condition,” he stated.

The multicenter, phase 3 FIRST (Frontline Investigation of Lenalidomide + Dexamethasone Versus Standard Thalidomide) trial enrolled 1623 newly diagnosed patients with MM who were ineligible for stem cell transplant because

of older age (>65 years) or other factors such as comorbidities.

Participants were randomized to 1 of 3 arms: 1.

Continuous Rd in 28-day cycles until disease progression, 2. Rd for 18 cycles (72 weeks), or 3. 12 cycles of MPT (72 weeks).

Antithrombotic prophylaxis was included in the protocol.

Doses of antimyeloma drugs were adjusted for adverse events.

At a median follow-up of 37 months, the primary end point of progression-free survival (PFS) was reached, with a highly significant 28% reduction in risk of disease progression or death for those treated with Rd versus MPT (P = .00006).

Median PFS was 25.5 months for continuous Rd compared with 21.2 months for MPT. Median survival was also significantly better for continuous Rd than for Rd for 18 cycles: 25.5 months versus 20.7 months (P = .00001).

Four-year overall survival was 59% with Rd compared with 51.4% for MPT; 4-year survival in patients receiving Rd for 18 cycles was 55.7%.

Adverse events were similar in both arms, with the exception of less myelosuppression and fewer secondary hematologic malignancies in the Rd arm. l Reference

Facon T, Dimopoulos MA, Dispenzieri A, et al. Initial phase 3 results of the First (Frontline Investigation of Lenalidomide + Dexamethasone Versus Standard Thalidomide) trial (MM-020/IFM 07 01) in newly diagnosed multiple myeloma (NDMM) patients (Pts) ineligible for stem cell transplantation (SCT). Presented at: 2013 American Society of Hematology Annual Meeting; December 8, 2013; New Orleans, LA. Abstract 2.

<.0001). ER+ invasive breast cancers developed in 3.3% of the placebo group versus 1.4% of the anastrozole group, representing a 58% decrease in risk (P = .001). Anastrozole had no protective effect against developing ER-negative tumors.

The full 5 years of the study was completed by 72% of placebo patients and 68% of those taking anastrozole.

Cuzick said this 4% difference in treatment continuation suggests that dropouts due to anastrozole-specific adverse effects were quite low.

Anastrozole was associated with bone fractures in 7.7% of placebo patients and 8.5% of those taking anastrozole.

Participants had a dual-energy X-ray absorptiometry (DEXA) scan at study initiation, and women with low bone mass were prescribed bisphosphonate treatment, which could account for the smaller-than-expected incidence of musculoskeletal/fracture adverse effects seen in this trial, Cuzick said.

Musculoskeletal aches and pains were 10% higher with anastrozole than in placebo patients. Cuzick said that at baseline, many women in both groups reported joint pain. Other joint symptoms observed more frequently in the anastrozole group were joint stiffness and carpal tunnel syndrome.

Surprisingly, the incidence of other primary cancers was reduced in the group taking anastrozole: 40 patients in the anastrozole group developed other cancers while 70 patients in the placebo group developed other cancers, mainly skin and colorectal cancers.

“This merits further study, and the reasons for this effect are unclear,” Cuzick noted.

Study results were published online in the Lancet to coincide with Cuzick’s presentation at the 2013 San Antonio Breast Cancer Symposium.2 l References

1. Cuzick J, Sestak I, Forbes JF, et al. Breast cancer prevention using anastrozole in postmenopausal women at high risk. Presented at: San Antonio Breast Cancer Symposium; December 12, 2013; San Antonio, TX. Abstract S3-01.

2. Cuzick J, Sestak I, Forbes JF, et al; IBIS-II Investigators.

Anastrozole for prevention of breast cancer in highrisk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial.

Lancet. December 12, 2013. Epublished ahead of print.

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.

8

January/February 2014 I VOL 7, NO 1

www.TheOncologyNurse.com

Conference News Obinutuzumab Plus Chlorambucil in CLL: New Standard of Care Results of the German CLL11 randomized controlled clinical trial promise to change the standard of care for first-line treatment of older, sicker patients with chronic lymphocytic leukemia (CLL).

The study showed that obinutuzumab (an anti-CD20 monocolonal antibody) plus chlorambucil (OC) was superior to rituximab plus chlorambucil (RC) with an acceptable safety profile, according to final results of the CLL11 trial, which were presented at the American Society of Hematology annual meeting. OC prolonged overall survival and progression-free survival, and also improved complete response rate, and minimal residual disease (MRD)-negative status versus RC. “These results suggest that obinutuzumab can replace rituximab in combination with chlorambucil as first-line therapy in the specific population studied, ie, older patients with comorbidities,” said Valentin Goede, MD, University Hospital Cologne, Germany.

“These findings are significant and potentially practice changing for this large patient population of older CLL patients with comorbidities.”

versus 65%, respectively. The rate of MRD negativity in bone marrow was 19.5% for OC compared with 2.6% for RC (P <.0001); MRD-negative status in blood was achieved in 37.3% versus 3.3%, respectively (P <.0001).

OC led to a 61% improvement in the

likelihood of achieving progression-free survival (the primary end point): median progression-free survival was 26.7 months versus 15.2 months for RC (P <.0001).

Overall survival data are not yet mature but, at present, survival is trending toward OC, Goede said. l

Reference

Goede V, Fischer K, Busch R, et al. Head-to-head comparison of obinutuzumab (GA101) plus chlorambucil (Clb) versus rituximab plus Clb in patients with chronic lymphocytic leukemia (CLL) and co-existing medical conditions (comorbidities): final stage 2 results of the CLL11 trial. Presented at: 2013 American Society of Hematology Annual Meeting; December 8, 2013; New Orleans, LA. Abstract 6.

The study showed that obinutuzumab (an anti-CD20 monocolonal antibody) plus chlorambucil was superior to rituximab plus chlorambucil.

Goede noted that OC has less toxicity than RC, which is especially important in this compromised patient population that resembles compromised patients with CLL seen in the real world.

CLL11 randomized 781 patients in a 2:1:2 ratio to 3 arms: OC for 6 cycles; chlorambucil for 6 cycles (control); and RC for 6 cycles. At ASH, Goede presented the first results of the direct comparison between OC and RC (but not vs chlorambucil alone).

More grade >3 infusion reactions were initially seen with OC, mainly occurring with the first infusion: 20% with OC compared with 4% with RC. Once this reaction became evident, prophylaxis is now used and fewer infusion reactions are seen. OC did not increase the risk of infection versus RC, he said.

OC was significantly better than RC in achieving response rates and eradication of disease in blood and bone marrow; overall response rates were 78%

www.TheOncologyNurse.com

January/February 2014 I VOL 7, NO 1

9

Nutrition in Focus

Nutrition for Pre- and Postoperative Patients… Continued from cover at risk of poor outcomes. Weight loss in surgical pancreatic oncology patients was found to have a significant correlation with increased surgical site infections (P = .026) and longer hospital length of stay (LOS) (P = .035).3 Poor preoperative nutritional status, coupled with delayed and inadequate postoperative nutrition practices, has been associated with worse clinical outcomes among surgical oncology patients.3,4 Individuals who are malnourished prior to surgery may be at a disadvantage or ill-equipped to recover from the stress of surgery. Up to 50% of patients with cancer may present with some form of nutritional deficit at diagnosis.5 Patients are at further risk of developing malnutrition during cancer treatment because of a variety of other factors, such as increased energy requirements, decreased food intake resulting from adverse effects, and altered nutrient metabolism leading to reduced ability to process nutrients.6 A study by Garth and colleagues demonstrated the impact of malnutrition on clinical outcomes in surgical patients with gastrointestinal (GI) cancer.7 The study provided evidence for the relationship between preoperative malnutrition and postsurgical adverse outcomes.

Additionally, the findings highlight the importance of nutrition screening to identify patients at risk of malnutrition, which would allow for nutritional intervention to help improve outcomes.

The investigators examined select nutritional practices, such as preoperative nutritional status, postoperative intake, and number of days until soft diet commenced during the pre- and postoperative period, to determine any association with improvement in clinical outcomes in patients undergoing elective surgery for upper GI or colorectal cancer.7 A 2-part study design was used: the first part consisted of a retrospective medical record review of 95 patients (37 upper GI cancers and 58 colorectal cancers); the second part involved nutritional assessment

Tiffany DeWitt, MS, RD, LD

10

Table

elationship Between Length of Stay and Nutritional Status in Surgical R Patients With Upper GI or Colorectal Cancer

Well nourished

7.6 days

Malnourished

15.8 days P <.05

Malnutrition was measured using the validated Subjective Global Assessment.

Abbreviation: GI, gastrointestinal.

Figure

A Proposed Pathway Between Nutrition Intervention in Malnourished Patients and Functional and Clinical Outcomes

Appropriate nutritional intervention (dietary intervention, oral nutritional supplements, enteral tube feeding, parenteral nutrition)

Increased intake of energy, protein and other nutrients

Improved nutritional status

Improved body function and clinical outcome

Decreased health-care utilization and cost

Repurposed with permission. Stratton RJ, Green CJ, Elia M, eds; 2003; Disease-Related Malnutrition: An Evidence-Based Approach to Treatment; CAB International, Wallingford, UK.

using the validated Subjective Global Assessment tool prior to surgery in a subset of 25 patients.

The results support previously reported prevalence data on malnutrition, revealing that almost half (48%) of the

suggest that improving or maintaining the nutritional status of patients preoperatively can shorten hospital LOS. This is particularly relevant in today’s medical environment, which requires facilities to decrease LOS while continuing to

Providing nutritional intervention preand postoperatively to ensure patients consume adequate caloric intake can help correct malnutrition and maintain weight throughout cancer therapy.

consuming >75% of daily energy requirements. Patients who took 7 days or more to achieve adequate nutrition were significantly more likely to experience at least one complication compared with those who achieved adequate nutrition in less than 7 days (52% vs 13%, respectively; P <.01).

The authors raise a concern that many patients are discharged soon after tolerating a soft diet but are not consuming adequate intake.7 In their study, 68% of the patients were consuming less than half of their daily energy requirements at the time of discharge. This is of particular concern in the current healthcare environment, in which facilities are at financial risk owing to preventable readmissions within 30 days of discharge.

Readmissions were not measured in the study by Garth and colleagues, but it has been suggested that providing nutrition support to attain adequate nutrition can help reduce unplanned hospital admissions in oncology patients.8 Evidence supports the importance of identifying nutrition risk and intervening with appropriate nutrition to improve outcomes while decreasing healthcare cost, as shown in the Figure.2 For GI and colorectal surgical oncology patients, Garth and colleagues suggest that poor preoperative nutrition status and a delay in postoperative nutrition can result in worse clinical outcomes.7 This study adds to the evidence in support of identifying the risk of malnutrition early to provide proper intervention.

Correcting preoperative malnutrition, limiting nil-by-mouth days, and properly advancing postoperative diets may improve clinical outcomes for surgical oncology patients. Providing nutritional intervention pre- and postoperatively to ensure patients consume adequate caloric intake can help correct malnutrition and maintain weight throughout cancer therapy. l References

patients were malnourished—32% were mild-moderately malnourished and 16% were severely malnourished.7 Mean hospital LOS was twice as long in the malnourished patients compared with the well-nourished patients, 15.8 days versus 7.6 days (P <.05); see the Table. In the retrospective medical record review, patients with either weight loss or low albumin levels prior to surgery had significantly longer LOS. Furthermore, a significant correlation was found between low preoperative albumin and LOS (r = –0.325; P <.05). Mean hospital LOS was longer in patients with significant preoperative weight loss compared with those without significant weight loss, 17 days versus 10 days (P <.05). The findings

January/February 2014 I VOL 7, NO 1

improve quality of care.

Preoperative malnutrition was also associated with adverse postoperative clinical outcomes.7 Some of the common complications reported included wound dehiscence and prolonged postoperative ileus, as well as infections such as sepsis and wound and urinary tract infections.

Compared with well-nourished patients, malnourished patients were 2 times more likely to develop one or more complications (41.7% vs 15.4%); however, this did not reach statistical significance (P = .20).

Inadequate postoperative nutrition intervention negatively affected clinical outcomes.7 The investigators examined the time it took for patients to achieve adequate nutritional status, defined as

1. Bozzetti F. Nutritional support of the oncology patient. Crit Rev Oncol Hematol. 2013;87(2):172-200.

2. Stratton RJ, Green CJ, Elia M, eds. Disease-Related Malnutrition: An Evidence-Based Approach to Treatment.

Wallingford, UK: CABI Publishing; 2003.

3. La Torre M, Ziparo V, Nigri G, et al. Malnutrition and pancreatic surgery: prevalence and outcomes. J Surg Oncol. 2013;107(7):702-708.

4. Bruun LI, Bosaeus I, Bergstad I, et al. Prevalence of malnutrition in surgical patients: evaluation of nutritional support and documentation. Clin Nutr.

1999;18(3):141-147.

5. Halpern-Silveira D, Susin LR, Borges LR, et al.

Body weight and fat-free mass changes in a cohort of patients receiving chemotherapy. Support Care Cancer. 2010;18(5):617-625.

6. Heber D, Blackburn GL, Go VLW, eds. Nutrition Oncology. San Diego, CA: Academic Press; 1999.

7. Garth AK, Newsome CM, Simmance N, et al.

Nutritional status, nutrition practices and post-operative complications in patients with gastrointestinal cancer. J Hum Nutr Diet. 2010;23(4):393-401.

8. Odelli C, Burgess D, Bateman L, et al. Nutrition support improves patient outcomes, treatment tolerance and admission characteristics in oesophageal cancer. Clin Oncol (R Coll Radiol). 2005;17(8): 639-645.

www.TheOncologyNurse.com

Empowering Patients and Survivors

Hide No Hair Continued from cover about embarrassing them as some of my survivor friends with teen children were.

I did want to keep things as â&#x20AC;&#x153;normalâ&#x20AC;? as I could for my kids so as not to scare them. My son was in kindergarten, and I was the classroom mom. I searched for a wig as close as possible to my normal hair in an effort to draw the least

12

amount of attention to my situation and to ward off the questions from inquiring young minds, and other mothers. My daughter was in her fairy princess years, and she would touch my head and ask me why I did not grow my hair like the princesses in her books. I felt very much on my own navigating the topic of hair

January/February 2014 I VOL 7, NO 1

loss with my children.

Fortunately, women today have more resources and support to help them explain cancer and hair loss to their children. See below for information about contacting me for my recommended resources for some of my favorite books for helping mothers talk

about their hair loss with their children.

Minimizing the impact of my hair loss and cancer on my children was my top priority, but cost was another real concern. I was glad to learn that most insurance policies cover hair prostheses for cancer patients and that several organizations offer free

www.TheOncologyNurse.com

Empowering Patients and Survivors wigs, scarves, and hats to all cancer patients, regardless of insurance status.

Shopping for wigs proved to be more of a challenge than I expected. I began searching for a wig to match what my usual hairstyle was before my hair fell out. My first visit was to the American Cancer Society, which I was told offered free wigs to cancer patients.

Unfortunately, this trip did not turn

out well. Our local office was small, and its resources were limited. Although it offered a private consultation room and a caring volunteer to assist me, the selection consisted of just a few options, none of them attractive choices for a woman in her 30s. I learned the importance of having a private consultation room and a caring assistant with a tissue at the ready. When

that first wig was placed on my head, all of the emotions that I had pent up inside of me came pouring out in a waterfall of tears. When I think back on that day, I feel bad for the volunteer who was there to assist and console me. Survivor Guilt…another article for another time.

When I told my good friend about the depressing wig-searching experi-

ence, she suggested that she accompany me next time to make a day of it.

What a difference it made! It was so much more fun to have a friend by my side to lighten the mood. We visited a couple of wig shops, and I found myself even having a bit of fun. One of our stops was a trendy clothing boutique with a nice selection of stylish wigs in the back of the shop. Although the shop did not offer a private space to try on wigs, I was fortunate to have gone before my hair began to fall out.

Nonetheless, I made a mental note of the importance of wig shops that do offer private consultation rooms.

Selecting wigs and headwear became a process of weighing the pros and the cons. After trying and experimenting with various wigs, I realized that an exact match was not likely. Knowing what an itchy, fidgety person I was, I had visions of looking like someone out of a comedy skit by midday unless I could find a wig that was comfortable for me.

Shopping for wigs proved to be more of a challenge than I expected.

I ultimately selected a wig with my hair color, styled in a bob, and pulled back behind a comfortable black cloth headband. It was comfortable, and it was the most familiar option I could find. Mission complete…or so I thought.

The problem was that I grew tired of customizing my wardrobe around the permanent black headband. I was ready for something more versatile.

Since I had lost my hair by that time, I did my shopping online. By then I had tried on enough wigs to have an idea of what brand, color, and length matched my preference. I was able to order something close to what I was looking for from the privacy of my home. The length and style needed a little adjusting, so I wore it to my usual hairdresser, and he styled it for me.

I learned a lot about wigs and the benefits and disadvantages associated with the different wig options. Wigs can be made of human hair, synthetic hair, or a combination of the two.

Human hair wigs are a luxurious and versatile option. They can be cut, colored, and styled just like regular hair, and with appropriate care they can last several years. Whereas I opted for a synthetic wig, a friend of mine who had been diagnosed within months of Continued on page 14

www.TheOncologyNurse.com

January/February 2014 I VOL 7, NO 1

13

Empowering Patients and Survivors

Hide No Hair Continued from page 13 my own diagnosis chose a human hair wig. It looked a lot like her natural hair and was even affixed to her head with an adhesive, allowing her to sleep and shower in it. Although she did not have the worry of her hair blowing off or going askew, I did not think that a permanent attachment to my head would work for itchy, fidgety me. When my friend looks back, she recalls some of the downsides to her beautiful, natural hair wig, such as the daily maintenance and

styling and, most of all, the price. Because of the cost of human hair wigs, some survivors are inclined to hang on to their wigs for life.

Synthetic wigs are much more affordable and have come a long way in giving a natural appearance. They are lightweight, are prestyled, and offer a quick and easy option. Some patients take this opportunity to try out a new look and have fun with it! The drawbacks to synthetic wigs are that they are not as versatile in styling

as human hair wigs, they do not last as long, and they require special products for care and maintenance.

Although wigs can offer a sufficient solution for some patients, they do not quite work for others. Many women experience treatment-induced hot flashes that make wigs very uncomfortable. Some find it easier to wear a breathable and easily adjustable hat or scarf. Ultimately, most women opt for some combination of wigs, hats, and scarves, alternating among

4TH ANNUAL CONFERENCE

MAY 6-9, 2014

them depending on their needs.

Scarves, turbans, and hats have gone through a dramatic transformation in the past several years in meeting the needs of cancer patients. The prints and styles of years past were either very unfashionable or, at best, conjured images of a 1930’s movie starlet. If you could find a beautiful scarf, knowing how to tie it yourself to provide full coverage was another challenge. These days a variety of beautiful and stylish scarves are available, and there are online tutorials on how to tie them as well as in-person tutorials through the American Cancer Society’s Look Good Feel Better program. There are also many presewn and pretied scarves and turbans, offering beautiful and hip new options designed to address the limited style and coverage issues long faced by cancer patients in search of headwear.

Hats have always been an easy solution, but they too have the drawback of not fully covering the hairline. To address

LOEWS HOLLYWOOD HOTEL • LOS ANGELES, CA Government and Employers Co-Chairs Jayson Slotnik, JD, MPH

F. Randy Vogenberg, PhD, RPh

Vice President of Reimbursement Strategy & Innovation United BioSource Corporation

Principal Institute for Integrated Healthcare

Personalized Medicine and Payers Co-Chairs Michael A. Kolodziej, MD National Medical Director Oncology Solutions Aetna

Grant Lawless, RPh, MD, FACP Program Director Associate Professor University of Southern California

Oncology Practice Management, Advocacy, and Navigation Co-Chairs Linda Bosserman, MD, FACP

President Wilshire Oncology Medical Group

Vicki Kennedy, LCSW

Vice President, Program Development and Delivery Cancer Support Community

AVBCC Leadership Burt Zweigenhaft, BS President and CEO OncoMed

Gary M. Owens, MD

President Gary Owens Associates

www.AVBCConline.org

Craig K. Deligdish, MD Hematologist/ Oncologist Oncology Resource Networks

HELD IN PARTNERSHIP WITH

AVBCC2014chairs Asize_13114

NEW FOR 2014! Principles in Value and Market Access Educational sessions for Product Managers, Reimbursement Specialists, Account Managers, and Marketers focusing on access, reimbursement, proving product value, and international markets.

14

January/February 2014 I VOL 7, NO 1

A new and growing trend among cancer survivors is to keep it real and bare it all!

this issue, I used to cut off old T-shirt sleeves and wear those on my head under my hats. This was an inexpensive way to cover my otherwise exposed hairline. It also helped the hat fit better and more comfortably against my skin. Today there are hats designed to address these issues.

One company even offers a human hair option: you can send in your own hair, and they will attach your hair to one of their hats and send it back within a few days’ time.

Bald Is Beautiful! A new and growing trend among cancer survivors is to keep it real and bare it all! This option takes extra courage, but it also comes with its own rewards. Janet Poelsma is one of those patients who chose to forgo any head covering while going through treatment. This was especially brave for someone working in a corporate environment with more than 200 employees. “Because I chose to show the world my bald head, cancer was out of the closet.” She said that reactions from people varied. Overall, people were kind, and it made her feel supported and empowered. She said, “I hope my bold confidence can change another sister’s feelings on not hiding her head.”

Henna crowns or tattoos are another alternative for head adornment.

This ancient art long associated with

www.TheOncologyNurse.com

Empowering Patients and Survivors enhancing the beauty of women is now being used by cancer patients.

Their bald heads become the canvas for intricate designs painted using herbal henna. Henna crowns help many cancer patients feel confident, beautiful, and adorned. Although they are called henna tattoos, no pricking with needles is involved as in regular body tattoos.

It is recommended that henna crowns be applied with natural brown dye by trained artists and that black henna dye should be avoided.

“I don't consider myself bald, I'm just taller than my hair.”

Lucius Annaeus Seneca Although hair loss is among the biggest fears for cancer patients, once the hair is gone many find that losing it was not nearly as difficult as the anticipation of losing it was. In fact, many of us manage to enjoy some of the perks that come

with it, like saving money from not having to go to the hair salon, quicker showers, and less time and effort needed to get ready in the morning. Some women enjoy the opportunity to try new looks and new styles with their wigs and scarves, while others feel newly empowered by their boldly honest and bald look. I am not sure what choices I would make if I were faced with hair loss today, but I know that comfort, confidence, and cost would still be my guideposts.

To assist your patients in finding what options are best for them, I leave you with these tips to pass on.

Money-Saving Tips • Check with your insurance company about your policy’s coverage for hair prosthesis and the proper steps for coverage • Research organizations that offer free wigs, scarves, and hats for cancer patients

Wig-Shopping Tips • Shop before your hair falls out • Take a friend and make a shopping day of it • Search for wig stores with private consultation rooms • Choose a shop with a large selection of styles, lengths, and colors • For those who already have a good idea of the brand, color, style, and length they are looking for, shop online Things to Consider When Selecting a Wig or Head Covering • Cost • Styling and maintenance • Versatility • A look that brings joy and confidence (and maybe that means trying something new!)

Email me at angela@breastinves tigators.com if you would like a free list of hair loss and headwear resources for cancer patients. l

Angela Long

Angela Long is the founder and creator of Breast Investigators, which serves as a comprehensive resource guide to help those affected by breast cancer readily gain access to quality information, care, assistance, and support.

Visit www.BreastInvestigators.com.

Breast Cancer

Role of Radiation and Imaging in DCIS Explained Phoebe Starr

M

anagement of ductal carcinoma in situ (DCIS) was the focus of 2 studies highlighted at a premeeting Press Cast for the American Society of Clinical Oncology Breast Cancer Symposium held in San Francisco, California.1,2 The studies showed: • Radiation to the breast as part of treatment of DCIS does not appear to increase cardiovascular toxicity, including risk of cardiovascular disease (CVD) and death from CVD or other causes • Perioperative magnetic resonance imaging (MRI) does not reduce the risk of locoregional recurrence (LRR) or contralateral breast cancer (CBC) in patients with DCIS undergoing surgery as part of their treatment program Women and their physicians can gain reassurance from the first study that radiation for DCIS does not increase cardiotoxicity, and the second study suggests that MRI should not be part of routine presurgical or surgical planning.

Radiation for DCIS DCIS is a precancerous lesion that may progress to invasive cancer in a small percentage of patients if left untreated.

At present there is no way to identify which patients with DCIS are at risk of progression, so DCIS is typically treated with surgery plus or minus radiation to reduce the risk of LRR. Concern has been raised about increased cardiotoxicity with radiation to

www.TheOncologyNurse.com

the breast area, and modern protocols have been adjusted to reduce exposure to the breast as well as radiation dose. Using modern techniques, the risk of CVD was not increased in women with DCIS treated with radiotherapy in a large population-based study in the Netherlands compared with women treated with surgery alone and with women in the general population.

According to the authors, this is the first large study to evaluate long-term effects of radiotherapy for DCIS on both the incidence of CVD and associated deaths. However, longer follow-up is needed to establish the cardiovascular safety of radiation with certainty in patients with DCIS, said lead author Naomi B. Boekel, MSc, a PhD student at the Netherlands Cancer Institute in Amsterdam. She said that 5 or 10 more years of follow-up should be sufficient.

The study included 10,468 women younger than 75 years of age diagnosed with DCIS between 1989 and 2004.

About 71% had surgery only (43% had mastectomy and the remaining women had lumpectomy), and 28% underwent both surgery and radiotherapy. DCIS survivors had similar death rates, as well as a 30% lower risk of dying of CVD compared with the general population.

Patients treated with surgery alone had a similar risk of developing CVD as did those treated with both surgery and radiotherapy (9% vs 8%, respectively); no difference in risk of CVD was observed between patients who received

left-sided radiotherapy (which includes a portion of the heart in the radiation field) or right-sided radiotherapy (which does not include the heart in the radiation field)—in these subgroups, the incidence of CVD was 7% versus 8%, respectively.

It is not clear why DCIS survivors had a slightly lower risk of CVD compared with the general population, but Boekel suggested that cancer survivors may be more concerned than the general population about a healthy lifestyle.

MRI in DCIS Perioperative MRI may not be necessary in all patients undergoing surgery for DCIS, according to results of the second study featured at the Press Cast. The risk of LRR or CBC was not lower in women who underwent MRI around the time of surgery, according to a retrospective study conducted at Memorial SloanKettering Cancer Center (MSKCC) in New York City.

Although no official guidelines for MRI in DCIS are available, many medical centers routinely order perioperative MRI with the hope of improving outcomes by finding additional cancers not detected by mammograms or other imaging studies. “Our findings indicate that MRI is not necessary for every patient with DCIS,” stated first author Melissa L. Pilewskie, MD, MSKCC in New York City and Commack, New York. She noted that perioperative MRI may be useful in specific patients with

DCIS, such as those with a palpable mass and nipple discharge not found on mammography screening.

The study analyzed rates of LRR and CBC in 2321 women who underwent a lumpectomy between 1997 and 2010 at MSKCC; 596 had an MRI before or immediately after surgery and 1725 did not. At a median follow-up of 59 months, 5-year LRR rates were 8.5% in those who had an MRI versus 7.2% for those who did not. After adjusting for patient characteristics and risk factors associated with recurrence, MRI was still not associated with lower rates of LRR. Additionally, no significant differences were seen in the 5-year rates of CBC (3.5 years in both groups).

At 8 years, the rate of LRR was 14.6% for those women who had an MRI versus 10.2% for those women who did not.

The rate of CBC at 8 years was 3.5% and 5.1%, respectively.

MRIs are typically ordered for women who have risk factors for breast cancer, such as younger age or family history.

Pilewskie said that this might explain the higher recurrence rates in that group. l References

1. Boekel NB, Schaapveld M, Gietema JA, et al.

Cardiovascular morbidity and mortality in patients treated for ductal carcinoma in situ of the breast. J Clin Oncol. 2013;31(suppl 26). Abstract 58.

2. Pilewskie ML, Olcese C, Eaton A, et al. Association of MRI and locoregional recurrence (LRR) rates in ductal carcinoma in situ (DCIS) patients treated with or without radiation therapy (RT). J Clin Oncol.

2013;31(suppl 26). Abstract 57.

January/February 2014 I VOL 7, NO 1

15

Genetic Counseling

Reproductive Options for Hereditary Cancer Syndromes Cristi Radford, MS, CGC Ambry Genetics

T

he majority of hereditary cancer syndromes are inherited in an autosomal dominant fashion.

Thus, offspring have a 50% chance of inheriting the condition, as well as a 50% chance of not inheriting it. Odds

5

change when both parents are carriers of a syndrome and in cases of X-linked or recessive conditions. For example, when both parents are carriers of a BRCA2 mutation, offspring also are at risk of developing an autosomal reces-

FIFTH ANNUAL

YEAR A N N I V E R S A RY

Navigation and 5 Survivorship Conference YEAR

ANNIVERSARY

September 18-21, 2014 Walt Disney World Dolphin Hotel • Orlando, Florida

TO DATE, THE CONFERENCE HAS HAD MORE THAN:

1,700

98

Total Attendees

Abstracts

Thank you again for a wonderful conference on the conference to my administration each year to help me get funding for the following year and so far...so good. I attend various national conferences throughout the year and stand amazed at your ability to continue

Expert Speakers

55

60 Abstracts Submitted

(only missed your first year). I submit a report

to provide new and motivating presentations.

– 2013 Conference Attendee

93%

108

93% of 2013 conference attendees said they intended to change their practice as a result of participating in the AONN+ Conference

50 40 30 20

20 10 0

23

9 2010

2011

2012

2013

Year of Submission

“WOW! I am so impressed with the growth of AONN. Lillie, Sharon, and their team are awesome. The speakers were knowledgeable about their subject matter and all the presentations were relevant to my practice. I will use the pearls of wisdom shared by the speakers to my team at

97%

97% of 2013 conference attendees rated the AONN+ Conference as Above Average or Excellent when compared with other continuing education activities

home. I arrived feeling we have a pretty good program and I am leaving with ideas to share to make it even better!”

– Donna Moore Wilson, BSN, RN, CBCN Oncology Nurse Navigator Bon Secours Cancer Institute Richmond, Virginia

AONN+ K-SIZE_11614

REGISTER TODAY

16

www.regonline.com/AONN2014

January/February 2014 I VOL 7, NO 1

sive disorder called Fanconi anemia. In the case of BRCA1, it is believed that inheriting a mutation from both parents is lethal, and the pregnancy would not be viable. Thus, the chance of a child having a BRCA1 mutation would be 75%, and the chance of not being a carrier would be 25%.

It is well known that individuals with a hereditary cancer syndrome sometimes worry about passing the gene mutation on to their children.1-3 This is true regardless of whether the carrier is a man or a woman. Both genders also have expressed interest in learning about reproductive options that prevent transmission of the mutated gene.

However, studies demonstrate that the majority of individuals are not aware of reproductive options, such as preimplantation genetic diagnosis (PGD).

For this reason, it is important that healthcare providers offering cancer genetic testing make themselves aware of such options. In fact, the NCCN Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast and Ovarian4 include a section on reproductive options in the management sections for BRCA1/2, Cowden syndrome, and Li-Fraumeni syndrome.

Such options include both post- and preconception genetic diagnosis.

For post- or preconception genetic diagnosis to occur, the causative gene mutation for the syndrome must be known. Postconception options involve testing during pregnancy to determine whether the fetus carries the mutation of interest. This is done by chorionic villus sampling (CVS) or amniocentesis. With CVS, placental cells are biopsied, whereas with amniocentesis, fluid around the fetus is sampled. Typically, CVS is performed between 10 and 12 weeks, and amniocentesis is done between 15 and 18 weeks. Both slightly increase the risk of miscarriage and have their own limitations. With both procedures, the condition of interest is diagnosed during pregnancy, and thus parents are faced with a decision about whether to terminate the pregnancy.

Many individuals do not want to be faced with this decision, and PGD provides another option.

What Is PGD? PGD provides an alternative to postconception diagnostic options. It involves in vitro fertilization (IVF) followed by removal of 1 or 2 cells at the 6- to 8-cell stage. The biopsied cells are

www.TheOncologyNurse.com

Genetic Counseling then analyzed for the condition of interest, which allows for the selection and transfer of only unaffected or affected embryos to the uterus. For example, in the case of a TP53 mutation (Li-Fraumeni syndrome), it would be determined which embryos have the TP53 mutation and which do not.

The parents then select to transfer either those with or without the TP53 mutation. CVS or amniocentesis is sometimes recommended to confirm the diagnosis.

The first birth of a baby utilizing PGD occurred in 1990. Early uses of PGD were for aneuploidy screening and for couples at risk for X-linked recessive diseases and involved sexing, as females would not be affected. Use then expanded to include other single-gene, highly penetrant conditions, such as cystic fibrosis, Tay-Sachs, and Huntington’s disease. The first use of PGD for an inherited cancer syndrome occurred in 1997 for familial adenomatous polyposis (FAP).5 Cancer syndromes, such as FAP, vary widely with regard to penetrance, age of onset, type of cancer, and prevention or treatment options. These variables make them unique from highly penetrant conditions for which PGD was initially used, and some experts find its use more controversial. However, when developing guidelines and policy, it is also important to seek the opinion of the affected group.

Several studies have examined the

knowledge and beliefs of PGD in the hereditary cancer community. The majority of studies have focused on the BRCA1/2 community and have found that most individuals with a BRCA mutation feel PGD should be an option regardless of whether they would personally use it.1,2,6,7 Additionally, more individuals would consider PGD over prenatal diagnosis.6 Similar views are shared by individuals with Peutz-Jeghers syndrome, Lynch syndrome, FAP, and multiple endocrine neoplasia (MEN).8,9

have a relationship with, such as their primary care provider, obstetrician, and/or oncologist.1 Although the focus of prenatal or preconception genetic diagnosis information dissemination is on individuals of reproductive age, it is important to take into consideration that many individuals are not diagnosed with cancer until after childbearing.

However, these individuals may inform their at-risk family members about such options. As oncology nurses often have long-term relationships with patients

As oncology nurses often have long-term relationships with patients and their families, even if they are not performing genetic testing, they should be aware of the option of PGD.

Furthermore, the majority of individuals were unaware of the option of PGD prior to the study.2,3,7,9 Data on how individuals would like to receive information about PGD are scarce. However, available results suggest carriers would like to be briefly informed about the subject and to receive a pamphlet with additional information. Also, they want the option of having a more detailed discussion at a later date. They may prefer to have that discussion with a clinician they already

and their families, even if they are not performing genetic testing, they should be aware of the option of PGD. Take-Home Messages • The majority of individuals with a hereditary cancer syndrome feel PGD should be an option regardless of whether they would use it themselves • Individuals who have completed childbearing may still be interested in reproductive options for family

members, such as children and/or siblings • Awareness of PGD is low, highlighting the importance of both patient and provider education l References

1. Hurley K, Rubin LR, Werner-Lin A, et al.

Incorporating information regarding preimplantation genetic diagnosis into discussions concerning testing and risk management for BRCA1/2 mutations: a qualitative study of patient preferences. Cancer.

2012;118(24):6270-6277.

2. Ormondroyd E, Donnelly L, Moynihan C, et al.

Attitudes to reproductive genetic testing in women who had a positive BRCA test before having children: a qualitative analysis. Eur J Hum Genet. 2012;20(1):4-10.

3. Quinn GP, Vadaparampil ST, Miree CA, et al. High risk men’s perceptions of pre-implantation genetic diagnosis for hereditary breast and ovarian cancer.

Hum Reprod. 2010;25(10): 2543-2550.

4. NCCN Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 4.2013. http://www.nccn.org/ professionals/physician_gls/f_guidelines.asp#genetics_ screening. Accessed December 23, 2013.

5. Ao A, Wells D, Handyside AH, et al. Preimplantation genetic diagnosis of inherited cancer: familial adenomatous polyposis coli. J Assist Reprod Genet.

1998;15(3):140-144.

6. Menon U, Harper J, Sharma A, et al. Views of BRCA gene mutation carriers on preimplantation genetic diagnosis as a reproductive option for hereditary breast and ovarian cancer. Hum Reprod. 2007;22(6): 1573-1577.

7. Vadaparampil ST, Quinn GP, Knapp C, et al.

Factors associated with preimplantation genetic diagnosis acceptance among women concerned about hereditary breast and ovarian cancer. Genet Med. 2009;11(10):757-765.

8. van Lier MG, Korsse SE, Mathus-Vliegen EM, et al.

Peutz-Jeghers syndrome and family planning: the attitude towards prenatal diagnosis and pre-implantation genetic diagnosis. Eur J Hum Genet. 2012;20(2):236239.

9. Rich TA, Miu M, Etzel CJ, et al. Comparison of attitudes regarding preimplantation genetic diagnosis among patients with hereditary cancer syndromes. Fam Cancer. 2013. Epublished ahead of print.

Reader Survey Have you treated patients who are healthcare professionals?

©BigStock.com/Nyul

I

n the December 2013 issue, we published an article

by Tania Homonchuk. Tania gives us a unique perspective—she is an emergency room doctor who was diagnosed with stage 3C ovarian cancer. She tells us that her “journey since diagnosis has been chockfull of experiences on the patient side of things.” We asked our readers to let us know if they have been involved with the treatment of other healthcare professionals. All who responded had treated healthcare professionals dealing with a cancer diagnosis.

One respondent who had worked as a telephonic oncology nurse educator for a cancer support program noted that “nurses were the least receptive; the majority of nurses who were offered our services declined.” This contrasted with physicians, who “readily accepted their

lack of knowledge about cancer drugs.” Regarding nurses, this respondent continued “While I respect their decision, many oncology-related issues (ie, CINV) can be treated differently than [similar issues] related to other disease processes. For this reason, it is important that all healthcare professionals maintain humility [and be] honest with themselves as to the areas of medicine where they lack experience.”

Other responses included: • I always keep in mind that they are also cancer patients and react the way a cancer patient would—anxious, fearful, not hearing everything…

• It is like treating family—challenging but rewarding • I am one

Want to participate in TON’s new poll? See page 4 for details.

www.TheOncologyNurse.com

www.TheOncologyNurse.com

January/February 2014 I VOL 7, NO 1

17

Side Effects Management

NEPA Superior to Palonosetron in CINV Prevention Caroline Helwick

N

EPA, a fixed-dose combination of netupitant and palonosetron, proved more effective than palonosetron alone in preventing chemotherapy-induced nausea and vomiting (CINV) in a large multinational study of 1455 patients, according to data presented at the 2013 San Antonio Breast Cancer Symposium.

Hope S. Rugo, MD, Director of Breast Oncology and Clinical Trials at the Helen Diller Family Comprehensive Cancer Center of the University of California San Francisco, presented the

“NEPA has been developed to allow patients to receive guideline-based targeted antiemetic prophylaxis in a single, convenient oral dose.”

Hope S. Rugo, MD

results of a phase 3, randomized, double-blind trial of chemotherapy-naive patients undergoing doxorubicin/cyclophosphamide (AC) chemotherapy.

“Breast cancer patients receiving AC are at significant risk for developing CINV due not only to the emetogenicity of the chemotherapy but also to

Osteonecrosis of the Jaw Associated With Cumulative Dose in Myeloma

D

ata from a large population of patients with multiple myeloma receiving zoledronic acid infusions indicate that osteonecrosis of the jaw (ONJ) remains a significant complication, especially for patients who receive it for prolonged periods, investigators from Greece reported at the 2013 American Society of Hematology annual meeting.

“The risk increases with the number of zoledronic acid infusions,” according to Efstathios Kastritis, MD, of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine.

“The risk is associated mainly with the cumulative dose.”

Zoledronic acid can reduce skeletal-related events in patients with symptomatic myeloma, and possibly improve survival, but its use increases the risk of ONJ. “Longer exposures and more infusions of zoledronic acid have been associated with a higher incidence of ONJ, and it has been suggested that longer intervals between infusions may reduce the risk; however, this has not been proven,” Kastritis said.

The investigators determined the incidence of ONJ in a prospective study of patients receiving zoledronic acid, specifically looking at dosing and scheduling as potential risk factors. The study included patients who received zoledronic acid and survived at least 6 months after their first infusion.

The relative dose frequency (RDF) was calculated as the average number of weeks between infusions. Time of exposure was calculated from the date of the first infusion until the date of the last infusion. All patients underwent dental evaluations before initiating treatment and were instructed to avoid procedures that predispose to ONJ. The 266 patients were followed for a median of 36 months; their median survival was 64 months, median number of zoledronic acid infusions was 16, median duration of exposure was 29 months, and median RDF was 7.9 weeks. Half the patients had an RDF of less than 8 weeks.

ONJ developed in 26 (10%) patients. The median time of exposure to zoledronic acid was not significantly associated with risk: 28 months for patients who developed ONJ versus 24 months for those who did not (P = .2). The

18

January/February 2014 I VOL 7, NO 1

median number of infusions, however, proved important: 23 infusions for those who developed ONJ compared with 14 for those who did not (P = .004), Kastritis reported.

“Increasing number of zoledronic acid infusions was associated with higher risk of ONJ,” he said. ONJ developed in 2.3% of patients who received less than 10 infusions versus 12% of patients who received 10 to 19 infusions and 15% who received 20 or more (P = .012), he indicated.

The time period in which patients received the drug was not associated with risk. The incidence rate of ONJ for patients who started zoledronic acid before 2008 was 0.31 per 100 person-months compared with 0.26 per 100 person-months for those who started it after 2008 (P = .4).

Number of Infusions Most Important The incidence of ONJ at 3 years was 13.6% for patients with an RDF less than 8 weeks versus 2.6% when the RDF was 8 weeks or longer (P = .018).

“After adjusting for RDF, only the number of infusions remained significant (P = .03) for the development of ONJ,” he said.

The multivariate analysis showed that both the number and frequency of zoledronic acid infusions were associated with a shorter time to ONJ development. More explicitly, the average frequency of infusions in less than 8 weeks was associated with a 15-fold increase in the risk of ONJ, and for every infusion the risk of ONJ increased by 9% (both, P <.001). Cumulative dose, therefore, was the chief risk factor, he concluded.

Prospective studies should determine whether less frequent administration of the drug can reduce the risk of ONJ without compromising its antiresorptive effect, the investigators suggested. l —CH

Reference

Kastritis E, Terpos E, Melakopoulos I, et al. The cumulative dose but not the frequency of infusions is a risk factor for the development of osteonecrosis of the jaw (ONJ) in myeloma patients who receive zoledronic acid (ZA). Poster presented at: 2013 American Society of Hematology Annual Meeting; December 8, 2013; New Orleans, LA. Abstract 3196.

their young age and gender,” Rugo noted. “As recommended by international antiemetic guidelines, targeting multiple molecular pathways involved in emesis is important for maximizing control of CINV and improving the functional status of breast cancer patients during chemotherapy.”

She pointed out that in patients receiving AC, the guidelines now consistently recommend the prophylactic combination of an NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone, but adherence to these guidelines is suboptimal. “Many patients still suffer from CINV, particularly during the delayed phase following chemotherapy,” she indicated.

NEPA is a fixed-dose combination of netupitant (300 mg), a highly selective NK1 receptor antagonist, and the 5-HT3 receptor antagonist palonosetron (0.50 mg), which allows this 1 drug to target dual antiemetic pathways.

“NEPA has been developed to allow patients to receive guideline-based targeted antiemetic prophylaxis in a single, convenient oral dose,” Rugo said.

Randomized Study Details The study involved 1455 chemotherapy-naive patients (97% with breast cancer) scheduled to receive their first course of AC chemotherapy. They were randomly assigned to receive oral NEPA or oral palonosetron, each with oral dexamethasone 12 mg. The primary end point was complete response (no emesis, no rescue medication) during the delayed (25-120 hours) phase postchemotherapy.

Each patient completed a diary from the start of chemotherapy on day 1 through day 6, capturing the frequency and duration of each emetic episode, severity of nausea, and rescue medications taken.

The treatment’s impact on daily living was assessed with the Functional Living Index-Emesis (FLIE) questionnaire.

“NEPA showed superior complete response rates during the acute, delayed, and overall phases following chemotherapy compared with palonosetron. This superior prevention of CINV correlated with a significantly greater proportion of NEPA-treated patients experiencing no impact on daily living as a result of CINV, based on all domains of the FLIE,” Rugo reported. See the Table.

Similarly, NEPA was consistently more effective than palonosetron during the delayed and overall phases for the secondary efficacy end points of no emesis, no significant nausea, and complete protection, as well as during the acute phase for no emesis, she said.

www.TheOncologyNurse.com

Side Effects Management Adverse Events Similar “NEPA was well tolerated, with a similar safety profile to palonosetron,” Rugo reported.

Overall, the incidence, type, and intensity of treatment-emergent adverse events were comparable between the treatment groups. Among patients reporting these, the majority (85%) indicated these events were mild-to-moderate in intensity. There were no treatment-related adverse events leading to discontinuation and very few (0.7%) severe treatmentrelated adverse events for NEPA-treated patients, and none were serious. There

was also no evidence of any cardiac safety concerns for either drug, Rugo reported.

She concluded that as a fixed single-dose, guideline-recommended, convenient antiemetic drug combination, “NEPA offers improved efficacy and reduced interference with daily functioning” over palonosetron alone. l Reference

Rugo HS, Rossi G, Rizzi G, et al. NEPA, a fixed-dose combination of netupitant and palonosetron, prevents chemotherapy-induced nausea and vomiting (CINV) more effectively and reduces the impact on daily living for breast cancer patients compared with palonosetron.

Presented at: San Antonio Breast Cancer Symposium; December 12, 2013; San Antonio, TX. Poster P3-09-01.

Table

Key End Points for NEPA Versus Palonosetron

End Point

NEPA (%)

Palonosetron (%)

P Value

Complete Response Acute phase Delayed phase Overall

88.4 76.9 74.3

85.0 69.5 66.6

.047 .001 .001

No Impact on Daily Living (FLIE) Nausea domain Vomiting domain Overall

71.5 90.1 78.5

65.8 84.4 72.1

.015 .001 .005

Abbreviation: FLIE, Functional Living Index-Emesis.

Breast Cancer

Eribulin Mesylate Plus Trastuzumab Yields High Response Rates as First-Line Metastatic Breast Cancer Treatment Caroline Helwick

F

or the first-line treatment of HER2positive metastatic breast cancer, the combination of eribulin mesylate and trastuzumab yields higher response rates, with manageable toxicity.

In the phase 3 EMBRACE trial, eribulin mesylate demonstrated a survival benefit relative to commonly used agents in women with metastatic breast cancer who had received at least 2 prior regimens, which led to the drug’s approval in 2010 for later lines of treatment.

At the 2013 San Antonio Breast Cancer Symposium, Sharon Wilks, MD, of US Oncology–Cancer Care Centers of South Texas, presented the final results for the primary and secondary end points of a multicenter phase 2 trial that explored the efficacy and safety of eribulin mesylate plus trastuzumab as first-line treatment for patients with locally recurrent or metastatic HER2-positive breast cancer.

“This is the first study to look at this combination,” Wilks said in an interview. She noted that numerous studies have shown that trastuzumab is “still active” in combination with later lines of chemotherapy. “This is another piece of evidence that supports that,” she said.

Study Details Among the 52 patients in the study (mean age 59), 45 completed treatment; 8 patients remained in the extension phase of the treatment at the time of data cut-off.

Patients received 6 cycles of eribulin

www.TheOncologyNurse.com

mesylate 1.4 mg/m2 on days 1 and 8 of each 21-day cycle and standard-dose trastuzumab on day 1 of each cycle.

Dose reductions for eribulin, but not for trastuzumab, were permitted, and eribulin could be considered as monotherapy if trastuzumab was discontinued. The primary end point was antitumor activity (objective response rate) of eribulin plus trastuzumab.

tumor shrinkage. The median percent change from baseline was –62.4%, Wilks reported.

Encouraging Progression-Free Survival, Manageable Toxicity Median progression-free survival (PFS) was 11.6 months, and the estimated PFS rates were 96% at 3 months, 82% at 6 months, 67% at 9

Eribulin mesylate demonstrated a survival benefit relative to commonly used agents in women with metastatic breast cancer who had received at least 2 prior regimens.

High Response Rates Observed Investigators determined the objective response rate to be 71.2%, the disease-control rate to be 96.2% (complete and partial responses plus stable disease), and the clinical benefit rate (complete and partial responses plus stable disease >6 months) to be 84.6%.

By investigator assessment, complete responses were observed in 5.8% of patients and partial responses in 65.4%.

The waterfall plot, showing the change in the total sum of target lesion diameters from baseline to postbaseline nadir, revealed that all but 2 patients had some degree of

months, and 49% at 12 months. For all patients, median time to response was 1.3 months and median duration of response was 11.1 months.

“This is a great PFS,” Wilks said, “and it’s an easy regimen to give and well tolerated.”

Patients received a median of 10 cycles of eribulin and 11 of trastuzumab, indicating that most patients given this regimen are able to complete treatment. Treatment-emergent adverse events were reported by all patients, but they were manageable, according to Wilks.

“Most patients don’t have much nausea and vomiting, and their over-

all condition remains good, but they do lose their hair,” she acknowledged.

Alopecia was observed in 88.5% of patients, fatigue in 69.2% (7.7% grade 3-4), peripheral neuropathy in 69.2% (26.9% grade 3-4), and neutropenia in 59.6% (38.5% grade 3-4).

“What is novel about this drug, however, is that even when patients continue therapy their hair grows back after 3 to 4 cycles, and you don’t usually see that with other drugs that cause alopecia,” she added.

She acknowledged that neuropathy can be difficult for patients, “but keep in mind that these patients have had other drugs that affect the nerve beds, and that may be a reason why we see neuropathy,” she said. “When we adjust the dosing or hold the drug for neuropathy, patients usually return to baseline.”

In the study, 40% needed dose reductions, 42.3% had dose interruptions or delays, and 21.2% discontinued the study medication(s).

“The take-away message from this study is this: when you are looking for later-line options, after you have used the [FDA-approved] up-front treatments—pertuzumab (Perjeta) and ado-trastuzumab emtansine (Kadcyla)—this is an active and tolerable third- or fourth-line regimen,” Wilks suggested. l Reference

Wilks S, Puhalla S, O’Shaughnessy J, et al. Phase 2, multicenter, single-arm study of eribulin mesylate + trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer. Presented at: San Antonio Breast Cancer Symposium; December 13, 2013; San Antonio, TX. Poster P4-12-12.

January/February 2014 I VOL 7, NO 1

19

Breast Cancer

Addressing Psychosocial and Physical Fallout From Breast Cancer Alice Goodman

A

dvances in breast cancer diagnostics and treatment have led to improved survival for patients with breast cancer. However, survivors still face psychosocial and physical challenges.

“Progress does not come without cost.

Breast cancer patients experience considerable psychosocial and treatmentrelated harms, and some of these effects can be acute and long-term,” said Lesley Fallowfield, DPhil, BSc, Professor of Psycho-Oncology at Sussex Medical School, United Kingdom.

“Patients will experience a plethora of physical, functional, emotional, financial, and social challenges. Furthermore, patients do not live in a vacuum and their problems affect everyone in their milieu,” she told listeners at the 2013

San Antonio Breast Cancer Symposium.

Fallowfield credited formal and informal support groups established over the past decades with helping patients through the journey from diagnosis to treatment and posttreatment. Also, clinical nurse specialists have been extremely helpful in navigating the patient through treatment and beyond, she said.

Anxiety and depression may be the most common emotional reactions to a diagnosis of cancer; about 30% of patients are reported to experience one or both. In a 2013 analysis, anxiety was the biggest emotional issue patients faced.

“But I have a problem with these percentages, because the diagnostic criteria for anxiety and depression were developed for psychiatrically ill individuals. Many women with breast cancer

confront the very real threat that cancer will come back, so anxiety is not an inappropriate response and our management strategies should consider that,” she told listeners. “In a recent study of 3000 long-term breast cancer survivors, 47% said they had constant anxiety related to the threat of recurrence.”

Anxiolytics and/or antidepressants are effective. Nonpharmacologic interventions may appeal to patients who do not want to take additional drugs: these include yoga, aromatherapy and massage, visualization, expressive therapeutic writing, and art and music therapy. Recent studies have shown that mindfulness-based stress reduction workshops can reduce anxiety and depression, Fallowfield noted.

Fatigue has now replaced nausea and

Lymphoma

Same-Day G-CSF Shown Acceptable for Patients With NHL Caroline Helwick

F

or patients with non-Hodgkin lymphoma (NHL) receiving chemotherapy, primary prophylaxis against febrile neutropenia (FN) can safely be administered on the same treatment day, if necessary, according to a review of patients from the Cleveland Clinic, presented at the 2013 American Society of Hematology annual meeting.

Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy for patients with NHL carries a significant risk for FN, a potentially life-threatening complication that typically requires hospital admission and can mandate delays and dose reduction of drugs. To ameliorate this potential complication, granulocyte colonystimulating factor (G-CSF) is indicated for primary prophylaxis in high-risk patients.

“Prescribing guidelines recommend that G-CSF not be given until 24 hours after the receipt of chemotherapy, but due to logistical issues of outpatient insurance coverage, travel, and patient convenience, it is not always practical to delay G-CSF administration until the day after chemo,” said James Karol, MD, PA-C, of the Hematologic Oncology and Blood Disorders section of the Cleveland Clinic. “Based upon existing but limited safety data, some patients at our institution received G-CSF on the same day as chemotherapy, beginning in 2006.”

Karol and his colleagues evaluated the safety and efficacy of giving G-CSF early. They identified 113 patients with NHL treated with R-CHOP who received G-CSF primary prophylaxis at the Cleveland Clinic between June 2004 and July 2012. They retrospectively analyzed the incidence of FN and associated outcomes for patients who received prophylaxis on the same day (D1) as chemotherapy (n = 31), compared with

20

January/February 2014 I VOL 7, NO 1

those receiving it at least 24 hours afterward (D2+) (n = 82).

FN Incidence, Clinical Outcomes Similar The FN incidence was almost identical between the groups, occurring in 8 of 31 of the D1 patients (25.8%) and in 21 of the 82 patients in the D2+ group (25.6%) (P = .91). This contradicts previous prospective studies in small cohorts showing a higher rate of FN with D1 treatment, and more severe and prolonged neutropenia.

No significant differences in relapse-free or overall survival were observed. Risk factors associated with mortality in the multivariate analysis included the development of FN (hazard ratio [HR] 4.33; P <.001) and receipt of R-CHOP while hospitalized as an inpatient (HR 7.16; P <.001).

After a median follow-up of 26.8 months, of the 113 patients, 3 developed therapy-related myelodysplastic syndrome (MDS). One of 31 patients developed therapy-related MDS in the D1 group, while 2 of 82 developed it in the D2+ group. No cases of acute leukemia were observed, Karol reported.

“For patients who require G-CSF support, next-day administration remains the recommended schedule; however, same-day administration can be considered if you are concerned about access to care or patient compliance,” he told The Oncology Nurse-APN/PA. l Reference

Karol J, Rybicki L, Sweetenham J, et al. Similar incidence of febrile neutropenia with same-day versus subsequent day G-CSF administration in non-Hodgkin lymphoma patients receiving R-CHOP chemotherapy. Poster presented at: 2013 American Society of Hematology Annual Meeting; December 9, 2013; New Orleans, LA. Abstract 4357.

vomiting as one of the biggest problems for survivors. “5-HT antagonists help nausea and vomiting, but many women report persistent and unremitting fatigue,” she said.

Fatigue has a multifactorial etiology, and it contributes to inactivity, impaired concentration, and poor health-related quality of life.

“Telling patients with fatigue to rest is obviously wrong. Many studies have shown that aerobic exercise, not resistance training, improves mood and fatigue. We need to make sure patients know about this,” she said.

Lymphedema is another common long-term problem in up to 20% of patients, and it is related to the extent of surgery and number of nodes removed.

Standard therapies include compression therapy and complex decongestive therapy (massage, exercise, skin care).

Prevention of lymphedema with optimum surgery is vital, she said.

Adverse effects of endocrine therapy also plague breast cancer survivors who take these drugs for 5 to 10 years. The effects can include vasomotor symptoms, sexual problems, and joint pain.

“Self-reports from patients show that these quality-of-life–threatening side effects are underrecognized, underreported, and undertreated,” she stated.

Antidepressants can relieve hot flashes, and so can relaxation exercises.

Moisturizers, pelvic floor exercises, and relaxation exercises can also improve sex.

The economic burden of a cancer diagnosis encompasses indirect costs related to work disability. Indirect costs are estimated at $16,000 for the first year and then $4500 per year afterward.

Communication and information can help patients cope with their problems, she continued. “Without appropriate information, patients worry and can be anxious. One study showed that when informational needs were unmet, patients were anxious, but when they got more information, the anxiety lessened,” Fallowfield said.

“Googling can be dangerous. There is a lot of incorrect information on the web. But there are also good web-based options, YouTube videos, and DVDs that address treatment uncertainties and clinical trial enrollment. Providing these resources helps patients make better-informed decisions,” she stated. l Reference

Fallowfield L. Psychsocial/survivorship issues: are we doing better? Presented at: San Antonio Breast Cancer Symposium; December 13, 2013; San Antonio, TX.

www.TheOncologyNurse.com

Breast Cancer

Brain Metastasis and End-of-Life Care in Metastatic Breast Cancer Alice Goodman

O

f all newly diagnosed breast cancer, 6% to 10% is metastatic, and a proportion of women with early breast cancer eventually develop metastasis. Treatment of metastatic breast cancer has improved considerably, and patients are living longer with metastatic disease. Thus, quality of life (QOL) is an important consideration, explained Polly Niravath, MD, Baylor College of Medicine, Houston, Texas.

At the 2013 San Antonio Breast Cancer Symposium, Niravath addressed 2 important considerations for patients with metastatic breast cancer: the management of brain metastasis and end-oflife (EOL) care.

Brain metastasis occurs in up to 15% of patients with metastatic breast cancer, and additional patients may have occult brain metastasis.

Studies have shown that surgery is superior to whole-brain radiotherapy (WBRT) for treatment of patients with an isolated brain metastasis. Surgery improves overall survival, decreases local recurrence, and increases functional independence, Niravath said.

WBRT following surgery reduces recurrences in the brain as well as neurologic deaths. The technique is suitable for treatment of patients with 3 or more lesions. However, WBRT comes with the cost of increased toxicity, in particular, cognitive decline. This has led to adjusted protocols using smaller doses of radiation given over more fractions.

Amended protocols of WBRT are used to treat brain metastasis in patients who

have a somewhat longer life expectancy.

According to Niravath, a recent study suggests that administering memantine during radiation may reduce cognitive decline. However, further study is needed to validate this drug’s usefulness.

Stereotactic surgery (SRS) is a technique that promises to spare cognition, she said. Studies comparing SRS with WBRT show that SRS is associated with less toxicity.

SRS without WBRT is appropriate for treatment of patients with 1 to 3

is treated with SRS and has a recurrence after a disease-free interval, she could undergo repeat SRS; if she has another recurrence, she could be treated with WBRT and SRS. This type of treatment prolongs QOL, Niravath told the audience.

End-of-Life Care Niravath said that many patients with breast cancer and metastatic disease are not receiving appropriate EOL care.

Often they are overtreated with chemo-

Many patients with breast cancer and metastatic disease are not receiving appropriate end-of-life care. Often they are overtreated with chemotherapy that has little chance of benefit.

smaller lesions of 8 to 10 cc, she said.

When used on larger lesions, it can cause edema of the brain.

SRS reduces cognitive decline, is more convenient, and is associated with quicker recovery than WBRT, allowing for less delay in initiating chemotherapy. SRS leads to improved functional independence and overall survival compared with WBRT. This has led to a paradigm shift, she said.

An example of how WBRT and SRS can be integrated into management of brain metastasis was offered: If a patient

5

Y EAR

therapy that has little chance of benefit.

“Misuse of treatments results in higher rates of hospitalization and ER visits, and worse QOL,” she noted.

Hospice care is appropriate EOL care. However, hospice is underused and misused, she continued. Many physicians refer patients to hospice less than 3 days before death, when in actuality the patients should have been under hospice care for several months.

Physicians and nurses should strive for good communication with patients about EOL care, she stated. “In a survey

of patients with metastatic breast cancer at EOL, more than one-third said they had conversations with their physicians, and these women had less hospitalization, less treatment, and were referred to hospice earlier,” Niravath told listeners.

By contrast, patients who had more medical interventions had decreased QOL. The evidence suggests that oncologists implement more aggressive EOL care when patients are treated in the last month of life. Oncologists are more likely to order computed tomography scans and refer patients to hospice within 3 days of death.

“Oncologists want to provide hope and are worried about not meeting the patient’s and family’s expectations. It may be easier to offer chemotherapy and treatment than to initiate EOL discussions with patients,” Niravath stated.

She gave some suggestions for improved EOL communication with patients and families. “Be frank and up-front. Do not offer treatment with a minimal possibility of benefit or a high chance of risk. Pain control is a priority at this time. Encourage communication with loved ones and advise patients to mend relationships. Give them a sense of control by informing them about what to expect next,” she advised.

Patients have a right to a meaningful death, she concluded. l Reference Niravath P. Symptom management and quality of life in metastatic breast cancer. Presented at: San Antonio Breast Cancer Symposium; December 10, 2013; San Antonio, TX.

REGISTER TODAY

A N N IV E R S A RY

FIFTH ANNUAL

Navigation and Survivorship Conference September 18-21, 2014 • Walt Disney World Dolphin Hotel • Orlando, FL

www.regonline.com/AONN2014 www.TheOncologyNurse.com

January/February 2014 I VOL 7, NO 1

21

Fourth Annual AONN+ Conference

Cancer Program Standards: Navigation and Survivorship What’s Happening in the Field?

Lisa A. Raedler, PhD, RPh

T

he keynote address of the Fourth Annual Conference of the Academy of Oncology Nurse & Patient Navigators (AONN+) was delivered by Linda W. Ferris, PhD. Ferris is vice president, Oncology System Service Line, at Centura Health in Colorado and Kansas, as well as chair of the Commission on Cancer (CoC) Accreditation Committee.

The CoC is a consortium of more than 50 professional organizations that is dedicated to improving survival and quality of life for patients with cancer through standard-setting, prevention, research, education, and the monitoring of comprehensive quality care. The CoC Accreditation Committee is responsible for developing and interpreting standards for cancer programs. Accreditation is granted to facilities that voluntarily commit to provide optimal cancer diagnosis and treatment, and that comply with established CoC standards. To maintain accreditation, facilities with accredited cancer programs must undergo an on-site performance review every 3 years. The 1500 CoC-accredited cancer programs that exist in the United States represent 30% of all hospitals that provide care to more than 70% of newly diagnosed patients with cancer each year.1 During her engaging presentation at AONN+, Ferris shared insights and suggestions regarding 2 important CoC accreditation standards that are being phased in for 2015: Patient Navigation Process (Standard 3.1) and Survivorship Care Plan (Standard 3.3).

Patient Navigation Process (Standard 3.1) Standard 3.1 states “A patient navigation process, driven by a community needs assessment, is established to address health care disparities and barriers to care for patients. Resources to address identified barriers may be provided either on-site or by referral to community-based or national organizations. The navigation process is evaluated, documented, and reported to the cancer committee annually. The patient navigation process is modified or enhanced each year to address additional barriers identified by the community needs assessment.”1 To comply with CoC Standard 3.1 in 2015, navigation programs will be asked to: • Conduct a community needs assessment at least once during the 3-year survey cycle.

• Establish a patient navigation process that provides resources

22

Linda W. Ferris, PhD, gave the keynote address the Fourth Annual AONN+ Conference, which was held November 15-17, 2013, in Memphis, Tennessee.

to overcome barriers to cancer care. Resources can be provided to patients with cancer on-site or through referral to community-based or national organizations.

• Evaluate your patient navigation process each year, documenting findings and reporting these findings to your cancer committee.

• Modify your patient navigation process to address newly identified barriers to care.

When conducting a needs assessment, Ferris reminded the navigators to take advantage of the many resources that are already available to help define your community. Examples of

data mining. She envisions a future in which cancer registrars support navigators in both identifying specific patients’ needs and developing targeted survivorship care plans.)

Navigators can also access state-specific cancer statistics from the American Cancer Society (ACS), the Susan G. Komen Foundation, and the National Cancer Institute, as well as state governments’ websites. (As an illustration, an internet search for “Pennsylvania cancer statistics” resulted in the state government’s “Cancer Statistics” web page, which allows one to download annual and 5-year cancer incidence and mortality statistics for the state since 2010. These data are provided

She advised the navigators to customize programs based on organizational structure, community needs, and resources available. local data sources include the marketing department of your hospital or cancer center, your cancer committee, and your cancer registrar. Registrar data are particularly helpful in learning more information about your cancer population’s age, race, income, education, insurance status, travel distance to facility, and time to first treatment.

“Mine your data,” she reminded the audience. (As an aside, Ferris predicted that the role of cancer registrars will evolve as technology advances to allow rapid data reporting and faster

January/February 2014 I VOL 7, NO 1

by county and municipality, and by age, sex, race, primary site, and cancer stage.) “Do not overcomplicate the needs assessment process. This is not a huge initiative. Keep it simple,” Ferris advised.

The primary goal of your needs assessment is to identify barriers to cancer care in your local area. Ferris noted the common barriers to care in communities throughout the United States: lack of insurance coverage, patient fear and/or anxiety, transportation access issues, distrust of Western medicine, poor

communication, language barriers, and low health literacy. She recommended focusing on these issues when evaluating your community’s resources and gaps.

Ferris reassured the conference attendees that there is no “right” way to organize your patient navigation program. “Design it your way,” she said. She advised the navigators to customize programs based on organizational structure, community needs, and resources available. She recommended collaborating with social workers, case managers, oncology nurses, physicians, community navigators, other hospital staff, and hospital volunteers, as well as local cancer organizations (ie, ACS, Cancer Support Community, LIVESTRONG Foundation), to design and implement a navigation program.

For navigators who wish to attend training programs, Ferris noted that several effective options are available: • “Patient Navigation Fundamentals,” University of Colorado • “Patient Navigation: From Outreach to Survivorship,” George Washington Cancer Institute Center for the Advancement of Cancer Survivorship • “Patient Navigation Program,” Harold P. Freeman Patient Navigation Institute • “Patient Navigator Certificate,” Sonoma State University • “Breast Patient Navigator Certification Programs,” National Consortium of Breast Centers After outlining the specifics of CoC Standard 3.1, Ferris shared her answers to frequently asked questions about this requirement: • How can the CoC expect small rural programs to hire a patient navigator to fulfill this standard?

CoC does not require rural hospitals or cancer centers to hire a patient navigator if one is not on staff.

• Does the patient navigator need to be a nurse? No. CoC does not stipulate requirements for the staff tasked with designing and implementing patient navigation programs.

• My cancer program is being surveyed in 2014. What will the surveyor be assessing during the survey? Throughout 2014, surveyors will engage cancer committee members and individuals involved with the navigation process in dialogue and answer your questions. Ferris explained that surveyors will clarify Standard

www.TheOncologyNurse.com

Fourth Annual AONN+ Conference 3.1 requirements and listen to your feedback related to challenges and concerns. CoC is dedicated to evolving this standard (and others) to reflect the realities of the process involved, such that navigators’ input is critical.

Referring to the results of a recent survey of 690 navigation programs, Ferris was pleased to report that 54% of these programs already address the entire Patient Navigation Program Standard (Figure 1). Survey results provided by Nina Miller of CoC; Stephanie Van Winkle of ACS; Nina Wendling of National Coalition for Cancer Survivorship; Chris Gayer and Vicki Kennedy of Cancer Support Community; and Ruth Rechis, Saray Arvey, Haley Gardiner, Gema Lane, Stephanie Nutt, and Kathryn Kelly of LIVESTRONG. Survivorship Care Plan (Standard 3.3) CoC Standard 3.3: Survivorship Care Plan is also required for CoC accreditation after 2015. This standard requires the cancer committee to develop and implement a process to disseminate a comprehensive care summary and follow-up plan to patients with cancer who are completing cancer treatment. The process must be monitored, evaluated, and presented at least annually to the cancer committee and documented in minutes.

To comply with CoC Standard 3.3 in 2015, cancer committees will be asked to: • Develop a process to disseminate a comprehensive care summary and follow-up plan to patients with cancer within 6 months of completing cancer treatment.

• Each year, the process implemented, monitored, evaluated, and presented to the cancer committee.1 When asked to rationalize this standard, Ferris recalled the 2005 Institute of Medicine (IOM) report, “From Cancer Patient to Cancer Survivor: Lost in Transition.”2 The transition of cancer survivors from oncology practices to primary care practitioners (PCPs) has been identified by IOM as a significant area of unmet need. Today, more than 13.7 million cancer survivors need specialized follow-up care that includes monitoring of late effects of cancer treatment, surveillance for secondary cancers, and initiatives that optimize their quality of life.

As context, Ferris noted that literature from the National Cancer Institute defines cancer survivorship as including physical, psychological, and economic issues that start at the point of cancer diagnosis and continue until death.

These survivorship issues are relevant to the patient, as well as his or her family, friends, and caregivers (Figure 2).

www.TheOncologyNurse.com

Figure 1 S urvey Results on Navigation 54% of respondents are addressing the entire standard!

Of those not addressing the entire standard, help is needed in the following areas: Information about how to evaluate the patient navigation process

84%

Tools that could be used to conduct the needs assessments

80%

Additional information about what is required to successfully implement

75%

Recommendations for organizations that could help your program

75%

Figure 2 W hy the New Standard?

• The National Cancer Institute (NCI) describes cancer survivorship as covering “the physical, psychosocial, and economic issues of cancer,” from diagnosis until the end of life. It focuses on the health and life of a person with cancer beyond the diagnosis and treatment phases.1 •S urvivorship includes issues related to the ability to get healthcare (may be relieved with the Affordable Care Act/Obamacare) and follow-up treatment, late effects of treatment, second cancers, and quality of life.

• The NCI states that “Family members, friends and caregivers are also part of the survivorship experience.”2 National Cancer Institute. NCI Dictionary of Cancer Terms. http://www.cancer. gov/dictionary?cdrid=445089. Accessed January 20, 2014.

2 National Cancer Institute. Facing Forward: Life After Cancer Treatment. http://www.cancer.gov/cancertopics/coping/life-after-treatment. Accessed January 20, 2014.

1

CoC survey results related to Standard 3.3 indicate that more than half of the navigators queried are “somewhat” to “not at all” confident in their ability to implement its requirements by 2015.

Ferris observed that most of the survey respondents want more information about evaluating survivorship care plan processes, tools to develop comprehensive care plans and survivorship documents, and more information about specific requirements of Standard 3.3.

Uncertainty and a need for more

sense [in terms of survivorship plan dissemination]. Each program will be different based on your local resources.”

To illustrate, Ferris noted that patients with metastatic cancer in her center do not receive survivorship plans.

In the context of treatment plan preparation, Ferris suggested that navigators, “Make [the patient’s treatment plan] a living document, rather than doing it all at the end when patients have completed all cancer treatments. Collect and document the

“If you were the patient, what would you want to know? Put yourself in their shoes; what is the right thing to do for them?”

Linda W. Ferris, PhD

concrete details about Standard 3.3 requirements were mirrored by the navigators participating at the AONN+ Conference. In the question-and-answer session following Ferris’s address, attendees focused on patient targeting: Should all cancer patients receive survivorship plans? Can it be a subset? If so, which ones? Concerns about program staffing and the time needed for data collection and reporting prompted these queries.

Ferris reassured AONN+ attendees that they are not alone in their concerns. Navigators throughout the country are feeling “real anxiety” about their ability to comply with this new standard. “You as the cancer committee should decide what makes the most

patient’s treatment experience after each phase—after radiation, after completion of chemotherapy, etc.” When asked who should deliver this information to the patient, Ferris recommended that navigators collaborate with oncologists to communicate the goals and content of the treatment plan summary and the survivorship plan to their patients.

Ferris reassured the AONN+ audience, “Many resources are available,” including the CoC Best Practices Repository (http://www.facs.org/cancer /coc/bestpractices.html), CoC Standards Resource Repository, and the CoC Answers Forum. She explained that her hospital provides patients with cancer a “very simple” 2-page

treatment summary for patients, and a 2-page follow-up plan for PCPs. “The information you provide must be clear to the patient and to their PCP; keep it simple for both parties….If you were the patient, what would you want to know? Put yourself in their shoes; what is the right thing to do for them?”

Ferris has worked with electronic medical record (EMR) vendors to design and report relevant patient information in this user-friendly format. While many conference attendees indicated that they have been underwhelmed with their current EMR vendors’ capabilities, several navigators noted success in collaborating with EMR vendors to prepare and report patients’ treatment plans. The topic of working with EMR vendors to facilitate compliance with Standard 3.3 was suggested as an area for AONN+ to address through webinars and at the next annual conference.

The Evolution of Survivorship Services As 2015 approaches, and as effective strategies for meeting Standard 3.3 requirements materialize, Ferris predicted exciting opportunities for entrepreneurial care providers. She expects PCPs, oncologists, and others to institute various types of cancer patient survivorship clinics in academic centers and community settings. Viable alternatives include tumor-specific survivor clinics run by oncology specialists, primary care clinics that manage care for all types of cancer survivors, and “hybrid” practice models that offer both oncology and primary care services.

When survivorship care models like these come to fruition, Ferris also identified significant opportunities for researchers to evaluate outcomes and characterize best practices: Do patients and physicians associate tangible benefits with survivorship plans? Which survivorship care models ensure consumer-focused, evidence-based medicine for cancer survivors? Robust research initiatives to understand and document experiences of cancer survivors who participate in various care models will be critical. “We know that survivors are not prepared for the persistence of or development of long-term toxicities. It will be key to collect data on these patients to better understand their needs.”

In this context, Ferris cited a poignant article written by Fitzhugh Mullan, MD, regarding his personal cancer survivorship experience.3 In this publication, Mullan describes 3 phases of survivorship: 1. Acute stage: This stage includes the time from diagnosis through the end of treatment when the focus is on the actual disease. Navigation and Continued on page 24

January/February 2014 I VOL 7, NO 1

23

Fourth Annual AONN+ Conference

Cancer Program Standards... Continued from page 23 support services available through healthcare professionals and loved ones are especially important to help patients through this journey.

2. Extended survivorship: This begins when and if the patient responds to treatment. Patients and caregivers often feel positive, yet uncer-

tain. Fear of recurrence is present.

Recovery focuses on the physical, emotional, and psychological effects of treatment. Emotions can be varied and extreme. Because medical services are typically not needed on a regular basis, patients and families often rely on community

and peer networks for psychosocial support.

3.

Permanent survivorship: In this phase, recovery is celebrated. At the same time, survivors must manage the long-term physical and psychological effects of their cancer.

Survivors require continued care

OFFICIAL WEBSITE FOR

LynxCME is the new home of COEXM activities CONTINUING EDUCATION 6th Annual

Visit our NEW website

MAY 2013 • VOLUME 6 • NUMBER 2

CONSIDERATIONS in

Multiple Myeloma

™

www.lynxcme.com

ASK THE EXPERTS: Maintenance Settings PUBLISHING STAFF Group Director, Sales & Marketing John W. Hennessy john@greenhillhc.com Editorial Director Susan A. Berry susan@coexm.com Senior Copy Editor BJ Hansen Copy Editors Dana Delibovi Rosemary Hansen Grants/Project Associate Susan Yeager The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Director of Human Resources Blanche Marchitto Associate Editorial Director, Projects Division Terri Moore

LETTER

FROM THE

EDITOR-IN-CHIEF

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.

to learn more!

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

by PCPs and specialists who have knowledge about long-term (late) effects of their cancer, and their management. Navigators help to develop specific plans for patients’ ongoing healthcare needs.

Extensive resources are available to help navigators prepare Standard 3.3–compliant cancer treatment plan summaries and survivorship care plans. Ferris suggested that navigators review document templates that are provided by the American Society of Clinical Oncology, Journey Forward, Memorial Sloan-Kettering Cancer Center, Prescription for Living Plan, LIVESTRONG, and the Minnesota Cancer Alliance.

Extensive resources are available to help navigators prepare Standard 3.3–compliant cancer treatment plan summaries and survivorship care plans.

Director, Quality Control Barbara Marino Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean

FACULTY Kenneth C. Anderson, MD Director, Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics Kraft Family Professor of Medicine Harvard Medical School Dana-Farber Cancer Institute, Boston, MA

Tina Flaherty, ANP-BC, AOCN Nurse Practitioner Division of Hematologic Malignancies Dana-Farber Cancer Institute Boston, MA

Houry Leblebjian, PharmD, BCOP Clinical Pharmacy Specialist in MARCH 2013 • VOLUME 4 • NUMBER 2 Hematology/Oncology Dana-Farber Cancer Institute Boston, MA

Ferris concluded her presentation with a touching quote from Mullan’s 1985 article to illustrate the real value that navigators’ attention to survivorship offers to patients with cancer. “Whatever our wishes, the person who has come through a cancer experience is indelibly affected by it. The Humpty Dumpty idea of ‘as good as new’—a powerfully appealing notion for cancer patients—simply does not pertain. For better and for worse, physically and emotionally, the experience leaves an impression. No matter how long we live, cancer patients are survivors—at once wary and relieved, bashful and proud.” Sharing of best practices to facilitate compliance with both of these new CoC standards (3.1 and 3.3) will remain a focus area for both the CoC and AONN+. l

Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma

Supported by educational grants from Onyx Pharmaceuticals and Millennium: The Takeda Oncology Company.

Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen

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

Center of Excellence Media, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512

Discussions in Personalized Treatment for Lymphoma: Do We Have Consensus?

CONTRIBUTING FACULTY Chair Stephanie A. Gregory, MD

The Elodia Kehm Chair of Hematology Professor of Medicine Director, Lymphoma Program Rush University Medical Center/Rush University Chicago, IL

Sonali M. Smith, MD

Associate Professor Section of Hematology/Oncology Director, Lymphoma Program The University of Chicago Medical Center Chicago, IL

Mitchell R. Smith, MD, PhD Director of Lymphoid Malignancies Program Taussig Cancer Institute Cleveland Clinic Cleveland, OH

2014 PROSPECTUS

Steve M. Horwitz, MD

Assistant Attending Medical Oncologist Lymphoma, Cutaneous Lymphomas, T-Cell Lymphoma Memorial Sloan-Kettering Cancer Center New York, NY

Supported by an educational grant from Celgene Corporation

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

5

© 2013 Green Hill Healthcare Communications, LLC

YEAR ANNIVERSARY

5

YEAR ANNIVERSARY

FIFTH ANNUAL

Navigation and Survivorship Conference SEPTEMBER 18-21, 2014 WALT DISNEY WORLD DOLPHIN HOTEL ORLANDO, FLORIDA

www.AONNonline.org

References

Scan Here to Register To use 2D barcodes: Visit the app store to download a QR Code reader for your smartphone

lynxcmeAsize_021714

24

January/February 2014 I VOL 7, NO 1

1. Commission on Cancer. Cancer program standards 2012: ensuring patient-centered care. Version 1.2. http://www.facs.org/cancer/coc/programstandards2012. html. Accessed January 20, 2014.

2. Institute of Medicine. From cancer patient to cancer survivor: lost in transition. http://books.nap.edu/ openbook.php?record_id=11468. Washington, DC: The National Academies Press; 2006.

3. Mullan F. Seasons of survival: reflections of a physician with cancer. N Engl J Med. 1985;313:270-273.

www.TheOncologyNurse.com

Perspectives

The Balancing Act Sue Bond, FNP-ANP

B

alancing work and home life is difficult, especially when you work in oncology. Which patient do you not call back on a busy day? How do you decide who you can squeeze in to your already full schedule and who can wait? And what do you tell your son when you miss another game, or stand up your daughter yet again? I knew that my life was out of balance when all the local takeouts on the way home not only recognized my phone number but knew my order. I was recycling pizza boxes more often than running the dishwasher.

As an advanced practice professional you will never have a 40-hour week; more often than not it’s more like 50 or 60.

Eventually you have to start evaluating how you are using your time. I work with 2 of the busiest doctors and have my own clinic 4 days a week. It seems there is a never-ending list of patients and needs.

Some have simple questions, others more complicated, and then there are those patients that we all have, the ones that no matter how much time you give them always need more.

With this large and (justifiably) needy patient group I was feeling that all I did was work, come home, eat, sleep, and go back to work. This is a schedule that is ready for burnout. So we tried a new way of triaging patients and their needs, and I was no longer getting scheduling and prior authorization calls. But I still had difficulty leaving the office. I used the extra time checking up on my patients, so my life was still out of balance. My work appeared to still be the biggest expenditure of my life.

I admit I like being busy. I enjoy days when I am running around, seeing a lot of patients, putting out fires, and wearing my mask and cape. I have always prided myself on the amount I can accomplish. This is typical of most advanced practitioners I know. Which makes me wonder, do overachieving busy people choose this profession, or does this profession make us overachieving busy people?

I find that when I have a minute and can sit down and relax, I don’t, or possibly even can’t. I look for things to do and I multitask. When I watch TV I always have the laptop, or I am folding laundry, or knitting, or anything. I can’t ever “just” watch TV. The same goes for reading, which is something that I have always loved. I rarely read anymore unless I am on vacation, sitting on the beach with a piña colada in my hand. I find that reading allows me to stretch my mind and to see different perspectives, and good books linger with me. If I come back from

www.TheOncologyNurse.com

Do overachieving busy people choose this profession, or does this profession make us overachieving busy people?

Sue Bond, FNP-ANP

vacation rested and relaxed, couldn’t I conclude that reading at home might do the same for me on a daily basis?

Downtime can help rejuvenate us, let us escape from the daily grind and from thinking about those patients that are not doing so well.

This makes me consider another possibility. Could this dilemma be related to our patients and their prognosis?

Every day I see just how short life

can be, how precious time is, and as I age into my fabulous fifties, many of my patients are younger than me and are dealing with decreasing time equity. Is that what motivates me? Us? Are we afraid of “wasting” time?

When I look at my lack of balance from this perspective, I realize I need to practice what I preach to my patients. “We need to focus on quality and not quantity.” How many times

have we heard the expression about no one on their deathbed wishing they had worked more?

I like the term “spending” in reference to time, as if it were a commodity that I could control. Maybe that should be my goal, spending my time doing more of what I like.

So what do I like to do? I’ve already mentioned that I like to read; I also like to hike with my dogs, hang out with my children, and go out with my husband.

I like to go to Book (aka Wine) Club with my friends. I just enjoy being with people.

If we look at time as a commodity, then I need to approach it from the same perspective I would for any other commodity, meaning having a budget and a plan. I find that when I have plans I become more efficient and get out on time. In order to improve my quality of life I am going to invest some time in me. I may not know how much time I have in the bank, but I am going to spend more of it wisely. l

Best Practices

Clinical Practice Guidelines Should Include Patient Preferences Caroline Helwick

C

linicians want to provide excellent patient care without having to appraise every new study in their field, but producing the “authoritative, instructive resource for most clinical scenarios” is not as straightforward as it would seem, according to David Garcia, MD, Professor of Medicine at the University of Washington in Seattle.

At a Special Symposium on Quality Care and Clinical Practice Guidelines at the 2013 American Society of Hematology annual meeting, Garcia discussed the challenges of guideline development and emphasized the need to include the preferences of patients, whose lives are impacted by these guidelines.

“Our job is to apply evidence and guideline recommendations within the context of individual patient preferences and values, and these can never be predicted or accounted for by people writing the guidelines,” he stated.

Consider the Patients The best guidelines are based on “strong evidence,” and the proper ingredients of a “strong recommendation” are 2-fold: the inclusion of high-quality evidence that proves the impact on important clinical outcomes, as opposed to surrogate outcomes that may not matter to the patient, and the demonstration that any risks associated with the intervention are clearly outweighed by benefits, Garcia said.

“These seem obvious, but as physicians we may not always predict accurately what the patient sees as being worthwhile in terms of the risks they are willing to accept for the benefits we can offer,” he noted.

Future guideline writers need to focus on patient-im-

portant (not surrogate) outcomes whenever possible, he suggested, and to be equipped with better knowledge about how patients view the trade-offs associated with treatment options. l Reference

Garcia D. Clinical guidelines: balancing methodologic rigor and user-friendliness. Special symposium presented at: 2013 American Society of Hematology Annual Meeting; December 7, 2013; New Orleans, LA.

Proposals for Guideline Developers • Minimize conflicts of interest but still harness the expertise held by “conflicted” individuals; this can be controlled by limiting the power of those with conflicts of interest • Focus on patient-important outcomes • Consider trade-offs from the patient’s perspective • M aintain transparency regarding the evidence and methods used to create the guideline and any possible conflicts of interest • P rovide key recommendations in synthesis form that can be used at the bedside: a summary, checklist, algorithm—with strength clearly labeled From David Garcia, MD, Professor of Medicine, University of Washington

January/February 2014 I VOL 7, NO 1

25

Cancer Center Profile

Via Christi Cancer Institute... Continued from cover

What does your job entail?

MW: I wear 2 hats. The first involves our insurance program based on a federal grant linked to the Affordable Care Act (ACA). The other hat is for working with cancer inpatients.

I am working with a team of insurance navigators to identify underinsured and uninsured individuals in and around Sedgwick County in order to provide them with the appropriate education and resources for enrolling in insurance through the ACA. We educate and provide resources for patients regarding the need for screening with mammography, Pap smear, and colonoscopies, and encourage them to participate based on the American Cancer Society’s screening guidelines for cancer. If they are diagnosed with cancer, they return to me as the point person for communication with the primary care physician, the oncologist, the surgeon, and the rest of the healthcare team. So far, since I have been the nurse navigator, I have assisted 3 patients who were lacking insurance and in need of cancer screening or follow-up cancer services.

I also work with inpatients, mainly educating them about their diagnosis, treatments, and discharge planning.

Some patients remain in the hospital

I know it is a new position, but what is your greatest challenge thus far?

MW: A patient with a cancer diagnosis faces a maze. I want to be sure to offer the best possible treatment and path to each individual, which means personalized care, because this will not be the same for every patient.

Photos from Via Christi Cancer Institute.

Tell me about the Nurse Navigator Program.

Maggie Ward (MW): It’s brand-new, and I am the first nurse navigator to be hired. I have been here since September 2013. Currently we are located on the St. Francis campus, but we plan to expand the program to the other 2 hospitals in Wichita.

Some of the staff at the Via Christi Cancer Institute (left to right): Lois Millspaugh, Financial Compliance Specialist; Lisa McCall, RN; Julia Burford, Clinical Care Coordinator—Research; Keisha Humphries, Oncology Service Line Administrator; Samantha Pennel, Clinical Care Coordinator—Research; Megan Langhofer, RN; Andy Sherman, PCCT; and Brandi Gutzmer, Clinical Care Coordinator—Cancer Institute.

Maggie Ward, MSN, APRN, AGCNS, OCN

for up to 6 weeks, and many for less time, depending on the treatment they are receiving. Patients who come in with an infection or who develop an infection in hospital are continued on antibiotic therapy and are educated about the signs and symptoms that

warrant a call to me, in an effort to reduce the readmission rates.

Our Cancer Center is distinguished from some other centers by its integrative services, which include massage, yoga, meditation, and pet therapy. I am particularly excited about the pet therapy. We have teamed up with Victory in the Valley, which provides dogs and their handlers who come to visit the inpatients. These handlers and dogs are TDI [Therapy Dogs International]certified and are allowed into patients’ rooms to offer them companionship and affection. Patients love this program. Even a 10- to 15-minute visit is enough to brighten their days, keeping them in the moment and enjoying themselves.

We also offer 1 free massage to all inpatients. And we have a movie theater where they can take their intravenous poles with them and watch a movie. We even have popcorn.

What is your greatest reward?

MW: My greatest reward is linking patients with the insurance side. Due to previous insurance regulations, many current cancer patients were dropped from their insurance coverage and had no means to pay for treatments and follow-up visits. Now, through the ACA, patients cannot be denied insurance for preexisting conditions, and, therefore, treatment may continue as needed and recommended. In addition, as a result of insurance coverage, patients will be diagnosed earlier and get treated earlier, hopefully leading to improved outcomes.

This will also reduce hospital readmissions, which are so hard on patients and families. Some of our patients have to travel from rural communities in West Kansas to be readmitted.

What led you to become an oncology nurse?

MW: I had a friend in high school who was diagnosed with cancer. I saw firsthand how much help the nurses gave her. I started to volunteer and fell in love with nursing. During nursing school, I started working at Via Christi, and 8 years ago I began working in oncology. I was blessed to help write the grant for the Nurse Navigator Program and was hired as the first nurse navigator. l

VISIT OUR RECENTLY ENHANCED USER-FRIENDLY WEB SITE www.TheOncologyNurse.com In addition to Web-only exclusives, news coverage, journal articles, contests, and polling questions, you’ll have the opportunity to earn Continuing Education credits at NO CHARGE by participating in a number of activities offered!

TONSept_Webad.indd 1

26

January/February 2014 I VOL 7, NO 1

9/9/13 3:59 PM

www.TheOncologyNurse.com

5

FIFTH ANNUAL

Y E AR A N N I V E R S A RY

Navigation and 5 Survivorship Conference YEAR

A N N I V E R S A RY

September 18-21, 2014 Walt Disney World Dolphin Hotel • Orlando, Florida

TO DATE, THE CONFERENCE HAS HAD MORE THAN:

1,700

98

Total Attendees

Abstracts

Thank you again for a wonderful conference on the conference to my administration each year to help me get funding for the following year and so far...so good. I attend various national conferences throughout the year and stand amazed at your ability to continue

Expert Speakers

55

60 Abstracts Submitted

(only missed your first year). I submit a report

to provide new and motivating presentations.

– 2013 Conference Attendee

93%

108

93% of 2013 conference attendees said they intended to change their practice as a result of participating in the AONN+ Conference

50 40 30 20

20 10 0

23

9 2010

2011

2012

2013

Year of Submission

“WOW! I am so impressed with the growth of AONN. Lillie, Sharon, and their team are awesome. The speakers were knowledgeable about their subject matter and all the presentations were relevant to my practice. I will use the pearls of wisdom shared by the speakers to my team at

97%

97% of 2013 conference attendees rated the AONN+ Conference as Above Average or Excellent when compared with other continuing education activities

home. I arrived feeling we have a pretty good program and I am leaving with ideas to share to make it even better!”

– Donna Moore Wilson, BSN, RN, CBCN Oncology Nurse Navigator Bon Secours Cancer Institute Richmond, Virginia

AONN+ K-SIZE_11614

REGISTER TODAY

www.regonline.com/AONN2014

Kyprolis® (carfilzomib) for Injection

Now Has a Permanent J Code: J9047

Takes Flight

For more information Visit KYPROLIS.com/HCP

Onyx, Onyx Pharmaceuticals, Onyx Pharmaceuticals logo, Kyprolis and Kyprolis logo are all trademarks of Onyx Pharmaceuticals, Inc. ©2013 Onyx Pharmaceuticals, Inc., South San Francisco, CA 1112-CARF-436R1

December 2013