TON July2013 by The Oncology Nurse

JuLY 2013

www.TheOncologyNurse.com

Vol 6, No 6

Best Practices

Cancer Center Profile

Mission SECU Cancer Center Patient-Centric Design for New Center

NCCN Updates Its Clinical Practice Guidelines By Audrey Andrews

pdates to the Clinical Practice Guidelines of the National Comprehensive Cancer Network (NCCN) were presented at the NCCN’s 2013 Annual Conference, held in Hollywood, Florida, in March. While for most tumor sites, updates were few and minor, the NCCN introduced inaugural guidelines for penile cancer. New Guidelines for Penile Cancer Penile cancer is a rare malignancy (0.5% of all cancers) whose management has

The oncology nursing team at Mission SECU Cancer Center (left to right): Leslie Verner, RN, BSN, OCN, CCRP, CBCN, Cancer Research/Outreach; Denise Steuber, RN, BSN, OCN, CBCN, Breast Program Navigator; Dawn Neuhauser, RN, MSN, OCN, NEA-BC, Nurse Manager; Karen Grogan, RN, MSOM, MHA, OCN, CENP, Executive Director, Cancer Services; Charlotte Lail, RN, BSN, OCN, Lung Program Navigator; Janet Magruder, RN, BSN, OCN, CBCN, Breast Program Navigator; and Carol Logan-Thompson, RN, MSN, OCN, Lung Program Navigator.

n November 2011, Mission Health, located in Asheville, North Carolina, opened the Mission SECU Cancer Center to provide comprehensive cancer care that includes state-of-the-art technology and comfortable, effective treatment delivery. The 5-story cancer center is Mission Health’s first LEED-certified green building, where patients find themselves in a healing atmosphere that incorporates integrative health modalities, natural light, and breathtaking views of the mountains. Mission Health serves approximately 3000 new cancer patients annually through a network of local and regional providers covering 18 Continued on page 11

By Alice Goodman

he 2013 American Society of Clinical Oncology (ASCO) Annual Meeting brought approximately 30,000 cancer specialists to Chicago, Illinois, from May 31 to June 4, 2013. The theme of this year’s meeting was Building Bridges

to Conquer Cancer. More than 4500 abstracts were available to scientists, oncologists, and healthcare workers involved in clinical research. Following are some of the highlights from ASCO 2013. Continued on page 8

Continued on page 12

FDA Approval Process

FDA Expected to Approve Surrogate End Point for Neoadjuvant Breast Cancer Trials By Caroline Helwick

or years, the cancer research community has pushed for the use of surrogate end points in clinical trials as a means of hastening the drug approval process. These efforts will soon bear fruit, with the release by the US Food and Drug Administration (FDA) of its final guidance for accelerated drug approval in the neoadjuvant breast cancer treatment

Conference News

The 2013 American Society of Clinical Oncology Annual Meeting

been heterogeneous. The standard of care remains complete tumor excision and eradication of negative margins, but in many patients, less-invasive management can be appropriate. For more superficial disease, less-invasive options can be considered, based on the stage and grade of the tumor. These include topical treatment with either imiquimod 5% or 5-fluorouracil cream, which can produce “excellent outcomes,” according to Philippe E. Spiess, MD,

setting. At the 2013 American Society of Clinical Oncology Annual Meeting, the speakers discussed the potential implications for researchers, providers, and patients. Under the new guidance for the pharmaceutical industry, accelerated approval could be granted based on a surrogate Continued on page 17

inside PREVENTION. . . . . . . . . . . . . . . . . . . . . . . .

Progress in Primary and Secondary Prevention of HPV-Associated Noncervical Cancers NOTEWORTHY NUMBERS . . . . . . . . .

Thyroid Cancer BEST PRACTICES . . . . . . . . . . . . . . . .

Tobacco Use Often Falls Through the Cracks in Oncology Practices

FACES AT THE ONS 38TH Annual Congress. . . . . . . . . . . . .

A View From the Floor

CONFERENCE NEWS: NCCN. . . . .

The Changing Oncology Landscape: Evolution of Revolution?

the

ONE Award

Vote Now for Your Choice at TheOncologyNurse.com/one-award See Our Ad on Page 2

Who Will Be the ONE?

The Oncology Nurse Excellence Award Winner

The Oncology Nurse-APN/PA is pleased to announce the 2013 ONE (Oncology Nurse Excellence) Award. This annual award recognizes an oncology nurse for outstanding contribution to oncology nursing practice, patient care, or education in 2013. 速

Nominate a nurse before August 30, 2013. The 4 leading nominees will be profiled online and in the October issue of The Oncology Nurse-APN/PA速. Vote for the winner at TheOncologyNurse.com/one-award. The winner will be announced at the 2013 Academy of Oncology Nurse Navigators Conference, November 15-17, 2013, in Memphis, TN, and profiled in the December issue of The Oncology Nurse-APN/PA速.

KsizeTON_OneAward_71613

Nominate a nurse at

TheOncologyNurse.com/one-award

Editorial Board EDITOR-IN-CHIEF

Beth Faiman,

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

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

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Catherine Bishop, DNP, NP, AOCNP

Cassandra J. Hammond, RN,

Dolores “Jeff” Nordquist, RN, MS,

Rita Wickham,

PhD, RN, AOCN

Avid Education Partners, LLC Sharpsburg, MD

CS, FNP

Mayo Clinic Rochester, MN

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

Shannon Hazen,

Melinda Oberleitner, RN,

Karla Wilson, RN,

MSN, CRNP

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

Patricia Irouer Hughes, RN, MSN,

MSN, FNP-C, CPON

DNS, APRN, CNS

City of Hope National Medical Center Duarte, CA

Jayshree Shah, NP

Pharmacy John F. Aforismo,

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

Johns Hopkins Kimmel Cancer Center/Sibley Infusion Washington, DC

BSN, OCN

Piedmont Healthcare Rex, GA

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Deena Damsky Dell, MSN, RN-BC,

Taline Khoukaz,

Gary Shelton,

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

NYU Clinical Cancer Center New York, NY

Somerset Medical Center Somerville, NJ

Sandra E. Kurtin,

Lori Stover, RN,

Patient Advocacy Peg Ford

Arizona Cancer Center Tucson, AZ

Western Pennsylvania Cancer Institute Pittsburgh, PA

Ovarian Cancer Alliance San Diego, CA

Ann McNeill,

Joseph D. Tariman,

Social Work Carolyn Messner,

AOCN, LNC

Fox Chase Cancer Center Philadelphia, PA

Wendy DiSalvo,

DNP, APRN, AOCN Genentech New London, NH

Denice Economou,

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

Constance Engelking, RN,

MS, CNS, OCN

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

Amy Ford, RN,

BSN, OCN Quintiles Dallas, TX

NP, MSN, ACNP-C

RN, MS, AOCN, ANP-C

MSN, RN, NP-C, OCN

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Kena C. Miller, RN, MSN, FNP

Roswell Park Cancer Institute Buffalo, NY

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

Somerset Medical Center Somerville, NJ

MSN, NP, ANP-BC, AOCNP

BSN

PhD, APRN, BC

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

Nutrition Karen Connelly, RD, CSO

Northwestern University Myeloma Program Chicago, IL

DSW, MSW, LCSW-R, BCD

Jacqueline Marie Toia, RN, MS, DNP

Genetic Counseling Cristi Radford,

Northwestern University Myeloma Program Chicago, IL

Pamela Hallquist Viale, RN, MS,

CS, ANP, AOCN Saratoga, CA

CancerCare New York, NY

MS, CGC

Ambry Genetics Sarasota, FL

Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS

OncoMed Onco360 Great Neck, NY

Sharon S. Gentry, RN, MSN, AOCN

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

www.TheOncologyNurse.com

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

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

Connie Visovsky, RN, PhD, APRN

University of South Florida College of Nursing Tampa, FL

Isabell Castellano, RN

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

Jeanne Westphal, RN

Meeker County Memorial Hospital Litchfield, MN

JuLY 2013 I VOL 6, NO 6

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

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

President/CEO Brian Tyburski

n the April 2013 issue of The Oncology Nurse-APN/PA (TON), we published “The Devil Is in the Details.” This column was written by MMA as part of The Patient’s Voice series of articles. MMA talks about how much she appreciates her oncology nurses, but notes that there are some things they have not done. Please go to the TON website at www.TheOncologyNurse.com to Beth Faiman, PhD(c), read the full article. We received MSN, APRN-BC, AOCN the following letter in response to Editor-in-Chief MMA’s column: I sure enjoyed reading the article “The Devil Is in the Details” by MMA. I have been an RN for 33+ years and I remember the days when we paid attention to those “details.” Our patients were given back rubs, pedicures, baths, hand cloths to wash their hands prior to their meals, etc. Unfortunately those days are long gone. Nurses have had to wear so many new “hats” that it has become nearly impossible to fulfill the patient’s basic needs. Sure we have Patient Care Assistants that should be providing these basic need cares for our patients, but they too have been given so

Chief Operating Officer Pam Rattananont Ferris

Director, Human Resources Blanche Marchitto

Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno

Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen

1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-656-7935 fax: 732-656-7938

JuLY 2013 I VOL 6, NO 6

Cindy Covington raises some important issues that pertain to the daily practice of oncology nurses and their colleagues and how they meet the needs of patients. In her letter, she reflects on the changes she has seen over her career in how nurses provide “bedside” care to patients. We want your reaction to MMA’s original article and to Cindy Covington’s letter—how do you perceive this issue? Please participate in our reader poll (see below) and let us know what you think. l

Do you think the role of oncology nurses has changed when it comes to meeting the basic care needs of patients?

Associate Editorial Director, Projects Division Terri Moore

Director, Creative & Design Robyn Jacobs

Sincerely, Cindy Covington, RN, Infusion Nurse Hiram, Georgia

Reader Poll

Vice President of Finance Andrea Kelly

Director, Production & Manufacturing Alaina Pede

many new “hats” that they are unable to perform all their “hat” duties. I base all this on experience, no scholarly articles needed for reference, just many years of experience and observations of how times have changed. Even the new graduated do not have a clue to what “bedside” nursing involves. I, for one, fear the future as I will have to depend on these same nurses and PCAs to care for me when I am older. MMA, thanks for sharing your perspective from the patient’s view; we, nurses, need to hear this and be reminded that we are there for the patients!

©iStockphoto.com/Slobodan Vasic

MA wrote in “The Devil Is in the Details” that some of her needs as a patient were not met when she was in the hospital. Cindy Covington responded with a letter (see above) noting the changes she has seen in how nurses are able

o Yes

o No

to provide—or not provide—the type of care MMA said was lacking. What is your perspective on this issue? Has the role of the oncology nurse changed? Do you feel your institution meets the basic care needs of patients?

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 11 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2013 by Green Hill Healthcare Communications, LLC. All rights reserved. The Oncology Nurse-APN/PA® logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, The Oncology Nurse-APN/PA®, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: editorial@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues, $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in The Oncology Nurse-APN/PA® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in The Oncology Nurse-APN/PA® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.

www.TheOncologyNurse.com

Prevention

Progress in Primary and Secondary Prevention of HPV-Associated Noncervical Cancers By Alice Goodman

oncervical human papilloma virus (HPV)–associated oral and anal cancers are on the rise in the United States in men and women. The good news is that the HPV vaccine can be used for primary prevention of HPVassociated cancers, and some promising biomarkers have been identified that would advance the search for secondary prevention strategies for these cancers, explained Aimée Kreimer, PhD, Division of Cancer Epidemiology & Genetics at the National Cancer Institute, during the 2013 annual meeting of the American Association for Cancer Research. “The goal of primary prevention is to remove exposure, and for that we have arrived, because we have prophylactic HPV-16 vaccination. For secondary prevention, the goal is to screen patients and interrupt progression. The future holds promise for secondary prevention of HPV-associated anal and oropharyngeal cancer,” she told listeners at a session on HPV-associated cancers.

95% effective at cervical sites. Gardasil is effective against anal, vaginal, and vulvar cancers as well as most genital

Continued on page 6

NOW RECRUITING

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

PRIMARY ENDPOINT

• Stage IV NSCLC

• Overall survival

• Receiving 1st-line myelosuppressive

SECONDARY ENDPOINTS

chemotherapy

• Progression-free survival

• Hemoglobin (Hb) ≤ 11 g/dL

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

• ECOG score ≤ 1

S:9.75”

www.TheOncologyNurse.com

Gardasil is also effective at the penis, but Cervarix has not been evaluated at

S:7.25”

In more-developed countries, including the US, the gender ratio for HPV-associated cancers is becoming more even. Resources should be directed to men as well as women.

Darbepoetin alfa 500-mcg Q3W

2:1 Randomization (darbepoetin alfa:placebo)

End of Investigational Product

End of Treatment Period

Long-term Follow-up

Placebo Q3W

Week 0

Week 1

Disease progression or end of chemotherapy treatment

*Complete inclusion/exclusion criteria and additional study details can be found in the protocol. ECOG = Eastern Cooperative Oncology Group; Q3W = once every 3 weeks.

For more information, please email Cory Docken/Getty Images

HPV causes nearly all cervical cancers and most anal cancers, as well as some head and neck cancers including oropharyngeal cancers. Trends have shown increases over time in the incidence of HPV-associated anal and oropharyngeal cancers in the United States, while HPV-associated cervical cancer is dominant in less-developed areas of the world, she said. “In more-developed countries, including the US, the gender ratio for HPV-associated cancers is becoming more even. Resources should be directed to men as well as women,” she stated. Currently, there are 2 prophylactic HPV vaccines: Gardasil (Merck & Co., Inc.), targeted to HPV types 6, 11, 16, and 18; and Cervarix (GlaxoSmithKline), targeted to HPV 16 and 18. Both vaccines are more than

warts in females. It is also protective in males against most genital warts and anal cancers.

Study-20070782@amgen.com or call 1-866-965-0782. Products under investigational study have not been approved by the FDA for the use under investigation in this trial.

AOCO3X0071_Recruitment782_AdAsize_r3.indd 1

72140-R2-V1

02-13

2/12/13 9:38 AM JuLY 2013 I VOL 6, NO 6 5

Prevention

Progress in Primary and Secondary Prevention... Continued from page 5 that site. Cervarix is highly effective against HPV infection at the oropharynx, but Gardasil has not been evaluated at that site. The Costa Rica HPV-16/18 Vaccine Trial included 7466 women aged 18 to 25 years who were randomized to control vaccine or Cervarix. After 4 years, the efficacy of the vaccine was high against HPV infection at the cervix, anus, and oral sites. Protection from the vaccine persists at the cervix for up to 8 years, but more long-term data are needed for the other sites. “The vaccine should provide coverage for at least a decade. The immunogenicity of this vaccine looks strong, but longer follow-up is needed,” Kreimer said.

In some countries, including Australia, nationally funded HPV prevention programs have made excellent inroads in eradicating cervical precan-

to 12 years and about 1% of boys in this age range have had the vaccine. “The current generation at risk for HPV-associated cancer will not be well

In some countries, including Australia, nationally funded HPV prevention programs have made excellent inroads in eradicating cervical precancer. However, the uptake of the vaccine is inadequate in the US. cer. However, the uptake of the vaccine is inadequate in the US and other countries in the developed world. In the US, only about 10% to 20% of girls aged 11

protected in the US, because of the low percentages of uptake,” she said. “The barriers to uptake of the HPV vaccine need to be explored and addressed.”

Noteworthy Numbers

Thyroid Cancer The thyroid gland, though relatively small, plays a large role in the function of the body. According to the American Thyroid Association (ATA), the gland “produces thyroid hormones which help the body use energy, stay warm and keep the brain, heart, muscles, and other organs working normally.”1 Although cancer of the thyroid and the treatments associated with the disease can affect these functions, early detection of this disease often results in a high survival rate and an acceptable quality of life. Let’s take a closer look at thyroid cancer.

The American Cancer Society (ACS) estimates that 60,220 new cases of thyroid cancer (45,310 in women and 14,910 in men) and 1850 deaths from thyroid cancer (1040 women and 810 men) will occur in 2013.2 Risk factors for thyroid cancer include gender and age. According to Cancer.net, women are 2 to 3 times more likely to develop thyroid cancer than men. About two-thirds of all thyroid cancer cases are found in people between the ages of 20 and 55 years.3 The ATA describes the following 4 types of thyroid cancer: 1. P apillary carcinoma comprises 70% to 80% of all thyroid cancer cases.1 2. 1 0% to 15% of thyroid cancer cases are follicular carcinoma.1 3. M edullary carcinoma accounts for 5% to 10% of cases of thyroid cancer.1

4. L ess than 2% of all thyroid cancer cases are anaplastic carcinoma.1 The ACS advises that the best approaches to treating thyroid cancer often use 2 or more of the following methods: surgery, radioactive iodine treatment, thyroid hormone therapy, external beam radiation therapy, chemotherapy, or targeted therapy.4 Based on SEER data from 2003 to 2009 among 18 geographic areas, the overall 5-year relative survival rate for patients with thyroid cancer was 97.7%.5 Although the survival rate is high for many patients with thyroid cancer, follow-up care is essential and may occur for many years, since “most thyroid cancers grow slowly and can recur even 10 to 20 years after initial treatment,” according to the ACS.6

Sources 1. http://www.thyroid.org/thyroid-cancer-faq/. 2. http://www.cancer.org/cancer/thyroidcancer/detailedguide/thyroid-cancer-key-statistics. 3. http://www.cancer.net/cancer-types/thyroid-cancer/risk-factors. 4. http://www.cancer.org/cancer/thyroidcancer/detailedguide/thyroid-cancer-treating-general-info. 5. http://seer.cancer.gov/statfacts/html/thyro.html. 6. http://www.cancer.org/cancer/thyroidcancer/detailedguide/thyroid-cancer-after-follow-up.

JULY 2013 I VOL 6, NO 6

Secondary Prevention “Secondary prevention will remain necessary for the next several decades. There is no validated secondary prevention for HPV-associated cancer beyond the Pap smear at the cervix,” she stated. To make secondary prevention a reality, a test is needed to detect precancers and asymptomatic cancers at noncervical sites. Effective treatment will reduce mortality. Kreimer also said there are promising developments for secondary prevention for HPV-associated anal cancer and oropharyngeal cancer. Although it is still rare, the incidence of anal cancer is increasing. The trajectory of the increase has steepened. In males, 28% of anal cancer is attributable to the HPV epidemic, yet only 1% of female anal cancer is explained by HPV infection. There are no national requirements for screening for HPV at the anus, she said. It is possible that an anal Pap smear could be used to detect asymptomatic anal cancer, and that the same biomarkers used for cervical cancer would apply at this anatomic site, she said. Randomized controlled trials are needed to characterize the natural history of anal cancer and to identify effective treatments, she said. It is possible to identify men at high risk, she added. Regarding HPV-associated oropharyngeal cancer, which is also increasing, L1 antibodies have been identified as markers of exposure to HPV-16, and HPV-16 E6 antibodies are likely to identify this disease. The European Prospective Investigation Into Cancer and Nutrition (EPIC) study evaluated HPV serologic markers in 400,000 participants. HPV E6 was absent in controls without cancer but was present in 34.8% of oropharyngeal cancers. This study needs replication to establish HPV-16 E6 antibodies as a marker for HPV-associated oropharyngeal cancers. Kreimer said that this marker is present more than 10 years before the development of oropharyngeal cancer. “The future looks promising for screening for some HPV-associated noncervical cancers. We are enthusiastic about the possibilities of secondary prevention for anal cancer, but better biomarkers are needed. We are enthusiastic about screening for oropharyngeal cancer for the opposite reason—a promising biomarker has been identified. We still need additional studies,” Kreimer stated. l Reference

Kreimer A. Prevention of non-cervical HPV-associated cancers. Presented at: American Association for Cancer Research 2013 Annual Meeting; April 9, 2013; Washington, DC.

www.TheOncologyNurse.com

For postmenopausal women with HR+ breast cancer

It’s breast cancer.

She deserves more.* And you’ve got more to oﬀer with ARIMIDEX Direct.

*Only

ARIMIDEX Direct works with your patients who prefer brand-name ARIMIDEX instead of the generic to get ARIMIDEX delivered to their home, and provides comprehensive patient support.

No insurance issues for you—just the knowledge that your eligible† patients get the #1 most-prescribed branded aromatase inhibitor1 for $40 or less a month. Visit www.ARIMIDEX.com to ﬁnd out how you can get more for you and your patients from ARIMIDEX Direct.

DIRECT Not valid for prescriptions purchased under Medicaid or similar medical assistance programs.

†

Important Safety Information About ARIMIDEX® • ARIMIDEX is only for postmenopausal women. ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment with ARIMIDEX, pregnancy must be excluded. ARIMIDEX is contraindicated in patients with demonstrated hypersensitivity to ARIMIDEX or any of its excipients. Observed reactions include anaphylaxis, angioedema, and urticaria (see CONTRAINDICATIONS section of full Prescribing Information) • In women with preexisting ischemic heart disease 465/6186 (7.5%), an increased incidence of ischemic cardiovascular events occurred with ARIMIDEX (17%) vs tamoxifen (10%). In this patient population, angina pectoris was reported in 25/216 (11.6%) vs 13/249 (5.2%) and myocardial infarction was reported in 2/216 (0.9%) vs 8/249 (3.2%) patients receiving ARIMIDEX and tamoxifen, respectively • Compared to baseline, ARIMIDEX showed a mean decrease in both lumbar spine and total hip bone mineral density. Tamoxifen showed a mean increase in these measurements. Nine percent of patients receiving ARIMIDEX had an elevated serum cholesterol vs 3.5% of patients receiving tamoxifen • In the early breast cancer (ATAC) study, the most common (occurring with an incidence of >10%) side effects occurring in women taking ARIMIDEX included: hot ﬂashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema and lymphedema, regardless of causality • In the advanced breast cancer studies, the most common (occurring with an incidence of >10%) side effects occurring in women taking ARIMIDEX included hot ﬂashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis, and peripheral edema. Joint pain/stiffness has been reported in association with the use of ARIMIDEX

• Clinical and pharmacokinetic results suggest that tamoxifen should not be administered with ARIMIDEX. Estrogen-containing therapies should not be used with ARIMIDEX as they may diminish its pharmacologic action

Approved Uses ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. ARIMIDEX is indicated for the ﬁrst-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

Please see brief summary of full Prescribing Information on next page. If you can’t afford your medication, AstraZeneca may be able to help. For more information, please visit www.AstraZeneca-us.com You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088. References: 1. Source: IMS NPA Monthly, February 2001-December 2012.

Conference News: ASCO Continued from cover Photo by © ASCO/Scott Morgan 2013

HPV Oropharyngeal Cancer Risk in Spouses of Patients

Gypsyamber D’Souza, PhD, MPH, MSA

Spouses and partners of patients with human papillomavirus (HPV)positive oropharyngeal cancer (OPC) can gain reassurance from a study showing that they did not have an increased risk of HPV-related cancer. Most patients with HPV-OPC are male, and their spouses/partners have a great deal of anxiety over whether

they are likely to also develop the cancer. “The Human Papillomavirus Oral Transmission Study in Partners Over Time [HOTSPOT] is the first study to examine oral HPV prevalence among spouses of HPV-positive OPC patients. Patients and their spouses worry about oral HPV transmission and wonder about

TRIM: 7.25 x 9.75 ®

TABLETS

Rx only BRIEF SUMMARY of Prescribing Information.

INDICATIONS AND USAGE Adjuvant Treatment ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. First-Line Treatment ARIMIDEX is indicated for the ﬁrst-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Second-Line Treatment ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

RECOMMENDED DOSE The dose of ARIMIDEX is one 1 mg tablet taken once a day. For patients with advanced breast cancer, ARIMIDEX should be continued until tumor progression. ARIMIDEX can be taken with or without food. No dosage adjustment is necessary for patients with renal impairment or for elderly patients. No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. ARIMIDEX has not been studied in patients with severe hepatic impairment.

CONTRAINDICATIONS ARIMIDEX may cause fetal harm when administered to a pregnant woman and offers no clinical beneﬁt to premenopausal women with breast cancer. ARIMIDEX is contraindicated in women who are or may become pregnant. ARIMIDEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria.

WARNINGS AND PRECAUTIONS In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with ARIMIDEX in the ATAC trial (17% of patients on ARIMIDEX and 10% of patients on tamoxifen). Consider risk and beneﬁts of ARIMIDEX therapy in patients with pre-existing ischemic heart disease. Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving ARIMIDEX had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline. Consider bone mineral density monitoring in patients treated with ARIMIDEX. During the ATAC trial, more patients receiving ARIMIDEX were reported to have elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively).

ADVERSE REACTIONS Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling. In the early breast cancer (ATAC) study, the most common (occurring with an incidence of >10%) side effects occurring in women taking ARIMIDEX included: hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema and lymphedema, regardless of causality. In the advanced breast cancer studies, the most common (occurring with an incidence of >10%) side effects occurring in women taking ARIMIDEX included: hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis and peripheral edema. Ischemic Cardiovascular Events Between treatment arms in the overall population of 6186 patients, there was no statistical difference in ischemic cardiovascular events (4% ARIMIDEX vs. 3% tamoxifen). In the overall population, angina pectoris was reported in 71/3092 (2.3%) patients in the ARIMIDEX arm and 51/3094 (1.6%) patients in the tamoxifen arm; myocardial infarction was reported in 37/3092 (1.2%) patients in the ARIMIDEX arm and 34/3094 (1.1%) patients in the tamoxifen arm. In women with preexisting ischemic heart disease 465/6186 (7.5%), the incidence of ischemic cardiovascular events was 17% in patients on ARIMIDEX and 10% in patients on tamoxifen. In this patient population, angina pectoris was reported in 25/216 (11.6%) patients receiving ARIMIDEX and 13/249 (5.2%) patients receiving tamoxifen; myocardial infarction was reported in 2/216 (0.9%) patients receiving ARIMIDEX and 8/249 (3.2%) patients receiving tamoxifen. Bone Mineral Density Findings Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving ARIMIDEX had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline. Because ARIMIDEX lowers circulating estrogen levels it may cause a reduction in bone mineral density. A post-marketing trial assessed the combined effects of ARIMIDEX and the bisphosphonate risedronate on changes from baseline in BMD and markers of bone resorption and formation in postmenopausal women with hormone receptor-positive early breast cancer. All patients received calcium and vitamin D supplementation. At 12 months, small reductions in lumbar spine bone mineral density were noted in patients not receiving bisphosphonates. Bisphosphonate treatment preserved bone density in most patients at risk of fracture. Postmenopausal women with early breast cancer scheduled to be treated with ARIMIDEX should have their bone status managed according to treatment guidelines already available for postmenopausal women at similar risk of fragility fracture. Cholesterol During the ATAC trial, more patients receiving ARIMIDEX were reported to have an elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively). A post-marketing trial also evaluated any potential effects of ARIMIDEX on lipid profile. In the primary analysis population for lipids (ARIMIDEX alone), there was no clinically significant change in LDL-C from baseline to 12 months and HDL-C from baseline to 12 months. In secondary population for lipids (ARIMIDEX+risedronate), there also was no clinically significant change in LDL-C and HDL-C from baseline to 12 months. In both populations for lipids, there was no clinically significant difference in total cholesterol (TC) or serum triglycerides (TG) at 12 months compared with baseline. In this trial, treatment for 12 months with ARIMIDEX alone had a neutral effect on lipid profile. Combination treatment with ARIMIDEX and risedronate also had a neutral effect on lipid profile. The trial provides evidence that postmenopausal women with early breast cancer scheduled to be treated with ARIMIDEX should be managed using the current National Cholesterol Education Program guidelines for cardiovascular risk-based management of individual patients with LDL elevations. Second-Line Therapy ARIMIDEX was tolerated in two controlled clinical trials (i.e., Trials 0004 and 0005), with less than 3.3% of the ARIMIDEX-treated patients and 4.0% of the megestrol acetate-treated patients withdrawing due to an adverse reaction. The principal adverse reaction more common with ARIMIDEX than megestrol acetate was diarrhea.

JULY 2013 I VOL 6, NO 6

The incidences of the following adverse reaction groups potentially causally related to one or both of the therapies because of their pharmacology, were statistically analyzed: weight gain, edema, thromboembolic disease, gastrointestinal disturbance, hot flushes, and vaginal dryness. These six groups, and the adverse reactions captured in the groups, were prospectively defined. The results are shown in the following table. Table 1 – Number (n) and Percentage of Patients with Pre-specified Adverse Reactions in Trials 0004 and 0005 ARIMIDEX 1 mg ARIMIDEX 10 mg Megestrol Acetate 160 mg (N=262) (N=246) (N=253) Adverse Reaction Group N (%) N (%) N (%) Gastrointestinal Disturbance 77 (29) 81 (33) 54 (21) Hot Flushes 33 (13) 29 (12) 35 (14) Edema 19 (7) 28 (11) 35 (14) Thromboembolic Disease 9 (3) 4 (2) 12 (5) Vaginal Dryness 5 (2) 3 (1) 2 (1) Weight Gain 4 (2) 10 (4) 30 (12)

Post-Marketing Experience These adverse reactions are reported voluntarily from a population of uncertain size. Therefore, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The following have been reported in post-approval use of Arimidex: • Hepatobiliary events including increases in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-GT, and bilirubin; hepatitis; • Rash including cases of mucocutaneous disorders such as erythema multiforme and StevensJohnson syndrome; • Cases of allergic reactions including angioedema, urticaria and anaphylaxis; • Myalgia, trigger ﬁnger and hypercalcemia (with or without an increase in parathyroid hormone).

DRUG INTERACTIONS Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the coadministration of anastrozole and tamoxifen did not affect the pharmacokinetics of tamoxifen or N-desmethyltamoxifen. At a median follow-up of 33 months, the combination of ARIMIDEX and tamoxifen did not demonstrate any efﬁcacy beneﬁt when compared with tamoxifen in all patients as well as in the hormone receptor-positive subpopulation. This treatment arm was discontinued from the trial [see Clinical Studies (14.1) in Full Prescribing Information ]. Based on clinical and pharmacokinetic results from the ATAC trial, tamoxifen should not be administered with anastrozole. Estrogen-containing therapies should not be used with ARIMIDEX as they may diminish its pharmacological action.

USE IN SPECIFIC POPULATIONS Pregnancy PREGNANCY CATEGORY X ARIMIDEX may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. ARIMIDEX is contraindicated in women who are or may become pregnant. If ARIMIDEX is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus and potential risk for pregnancy loss. Nursing Mothers It is not known if anastrozole is excreted in human milk. Because many drugs are excreted in human milk and because of the tumorigenicity shown for anastrozole in animal studies, or the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Clinical studies in pediatric patients included a placebo-controlled trial in pubertal boys of adolescent age with gynecomastia and a single-arm trial in girls with McCune-Albright Syndrome and progressive precocious puberty. The efﬁcacy of ARIMIDEX in the treatment of pubertal gynecomastia in adolescent boys and in the treatment of precocious puberty in girls with McCune-Albright Syndrome has not been demonstrated. Geriatric Use In studies 0030 and 0027 about 50% of patients were 65 or older. Patients ≥65 years of age had moderately better tumor response and time to tumor progression than patients <65 years of age regardless of randomized treatment. In studies 0004 and 0005 50% of patients were 65 or older. Response rates and time to progression were similar for the over 65 and younger patients. In the ATAC study 45% of patients were 65 years of age or older. The efficacy of ARIMIDEX compared to tamoxifen in patients who were 65 years or older (N=1413 for ARIMIDEX and N=1410 for tamoxifen, the hazard ratio for disease-free survival was 0.93 [95% CI: 0.80, 1.08]) was less than efficacy observed in patients who were less than 65 years of age (N=1712 for ARIMIDEX and N=1706 for tamoxifen, the hazard ratio for disease-free survival was 0.79 [95% CI: 0.67, 0.94]). The pharmacokinetics of anastrozole are not affected by age. Renal Impairment Since only about 10% of anastrozole is excreted unchanged in the urine, the renal impairment does not inﬂuence the total body clearance. Dosage adjustment in patients with renal impairment is not necessary [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in Full Prescribing Information]. Hepatic Impairment The plasma anastrozole concentrations in the subjects with hepatic cirrhosis were within the range of concentrations seen in normal subjects across all clinical trials. Therefore, dosage adjustment is also not necessary in patients with stable hepatic cirrhosis. ARIMIDEX has not been studied in patients with severe hepatic impairment [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in Full Prescribing Information].

OVERDOSAGE Clinical trials have been conducted with ARIMIDEX, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were tolerated. A single dose of ARIMIDEX that results in life-threatening symptoms has not been established. There is no specific antidote to overdosage and treatment must be symptomatic. In the management of an overdose, consider that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because ARIMIDEX is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated. These highlights do not include all the information needed to use ARIMIDEX safely and effectively. See full Prescribing Information for ARIMIDEX. To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca Pharmaceuticals LP at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ARIMIDEX is a registered trademark of the AstraZeneca group of companies. © 2009 AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. All rights reserved. Rev 5/13 2633500 5/13

the risk of cancer for the spouses. These findings show that prevalence of oral HPV infection is not increased among spouses, and their risk of developing an HPV-related oral cancer is low,” said lead author Gypsyamber D’Souza, PhD, MPH, MSA, of Johns Hopkins University in Baltimore, Maryland. “Long-term couples have already shared whatever infections they have, and no changes in their physical intimacy are required,” she added. The pilot study enrolled 166 patients with HPV-OPC and 94 spouses/longterm partners. The test for HPV was an oral rinse/gargle sample to measure HPV DNA, which is a research test with imperfect sensitivity and specificity, D’Souza explained. Of the 166 patients, 147 were men and 19 were women. Median age was 56 years.

Patients worry about oral HPV transmission and wonder about the risk of cancer for their spouses. The study found that 65% of patients had HPV detected at diagnosis, and 7% still had HPV infection 1 year after cancer treatment. The overall prevalence of HPV infection among partners was 7.2%. The prevalence among the female partners was 5%, which is similar to women in the general population. HPV-16, the subtype responsible for most cases of HPV-OPC, was detected in 54% of patients but only 2.7% of the 88 female partners and none of the 6 male partners. A history of oropharyngeal cancer in partners was uncommon. None was detected in partners in an oral cancer screen. Five (3.4%) of the male patients reported having a partner who developed cervical cancer or precancer; a history of cervical cancer was reported in 1 current partner and 2 previous partners; a history of cervical dysplasia was reported in 2 current partners of HPV-OPC cases. “Men have a higher prevalence of HPV-OPC than women. Maybe they are more likely to get HPV, and there may be some environmental differences. We don’t know how HPV is transmitted. Oral sex most likely transmits it to the mouth, but there is no evidence that saliva transmits it to the genitals,” D’Souza said. Reference

D’Souza G, Gross ND, Pai SI, et al. Oral HPV infection in HPV-positive oropharyngeal cancer cases and their spouses. J Clin Oncol. 2013;31(suppl):Abstract CRA6031. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL.

www.TheOncologyNurse.com

Conference News: ASCO Selumetinib Improves Outcomes in Uveal Melanoma

Selumetinib is an oral MEK inhibitor; MEK is a key component of the mitogen-activated protein kinase (MAPK) pathway. Alterations in GNAQ and GNA11 activate the MAPK pathway, leading to cancer cell proliferation. These mutations are present in about 85% of patients with uveal melanoma and render them susceptible to MEK inhibition. In the study, 98 patients with treatment-naive uveal melanoma were randomized to receive, in a 1:1 ratio, oral temozolomide 150 mg/m2 daily or oral selumetinib 75 mg twice daily for 5 days in a 28-day cycle. If the disease progressed, patients receiving temozolomide were allowed to cross over to selumetinib. During the study, 40 of the 44 patients (90%) in the temozolomide arm with radiographic progression

www.TheOncologyNurse.com

Richard D. Carvajal, MD

crossed over to selumetinib. Both arms were well balanced at baseline for age, sex, performance status, disease stage, and previous therapies. More than 90% had metastatic disease (most having liver metastases), and more than

50% had elevated lactate dehydrogenase levels. GNAQ mutations were present in about 37% of both arms; GNA11 mutations were seen in 50% of the temozolomide arm and 44% of the selumetinib arm; wild-type EXON5 was

Reference

Carvajal RD, Sosman JA, Quevedo F, et al. Phase II study of selumetinib (sel) versus temozolomide (TMZ) in gnaq/Gna11 (Gq/11) mutant (mut) uveal melanoma (UM). J Clin Oncol. 2013;31(suppl):Abstract CRA9003. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL.

Simple Rapid Vinegar Cervical Test Saves Lives in India A simple low-tech intervention delivered by women from the slums in India reduced the rate of death from cervical cancer in that country by about one-third. The intervention, which entails visual inspection of the cervix after a swab of vinegar is applied to it, could prevent an estimated 22,000 deaths from cervical cancer in India annually and close to 73,000 deaths each year in the developing world. “Cervical cancer is the number one cause of cancerrelated death in India and in most parts of the developing world. But in the developed world, the incidence has declined due to screening. There is no cancer screening program in India, and Pap screening is not feasible because of inadequate infrastructure, cost, and other factors,” explained lead author Surendra Shastri, MD, of the Tata Memorial Centre in Mumbai, India. The study included more than 150,000 women, aged 35 to 64 years with no previous history of cancer, from 20 slum clusters in the state of Maharashtra. The women were randomized to receive either screening with visual inspection with vinegar (VIA) to the cervix (n = 75,360) or no screening (n = 76,178). Primary healthcare workers were recruited from the slums and given a 4-week training on VIA to deliver the intervention. The VIA test takes 1 minute for results: after vinegar is applied to the cervix, if white areas appear in or near the transformation zone on the endocervix and/or ectocervix, the test is considered VIA positive; if not, it is VIA negative. Both groups were provided with cancer education and biennial monitoring for cervical cancer; the screening group also had 4 rounds of biennial VIA screening. In both groups, women were referred to the Tata Memorial Hospital for diagnosis and for free treatment if cases of cervical intraepithelial neoplasia or invasive cervical cancer were confirmed. The incidence of cervical cancer was similar in the 2 groups: 26.7 per 100,000 in the screening group and 27.5

Photo by © ASCO/Silas Crews 2013

In the largest randomized study of melanoma of the eye, selumetinib more than doubled progressionfree survival compared with temozolomide.

present in 14% and 19%, respectively. On a waterfall plot, tumor regression was achieved in 50% of the selumetinib group versus 11% of the temozolomide group; 15% and 0%, respectively, had a RECIST response. PFS was 15.9 weeks in the selumetinib arm versus 7 weeks in the temozolomide arm, a difference that was highly significant (P = .0005). Median overall survival was not significantly different at the time of ASCO, 10.8 months versus 9.4 months, respectively. “Selumetinib could be considered a new standard for patients with advanced uveal melanoma and provides a platform for the development of new combination approaches,” Carvajal stated.

Photo by © ASCO/Scott Morgan 2013

Selumetinib achieved tumor shrinkage in half of patients with melanoma of the eye (uveal melanoma) and doubled progression-free survival (PFS) compared with temozolomide in a phase 2 crossover study, making this the first agent to improve clinical outcomes in this relatively rare type of cancer. “This is the largest randomized study of patients with melanoma of the eye, and selumetinib more than doubled progression-free survival compared with temozolomide,” said lead author Richard D. Carvajal, MD, of Memorial Sloan-Kettering Cancer Center in New York City. Temozolomide was selected as the comparator agent for the study. Although the drug is used for cutaneous melanoma, it has no known effect in uveal melanoma. Carvajal said the choice of a comparator drug was challenging because there is no known effective therapy in uveal melanoma. The standard of care is participation in clinical trials, he noted. “The choice of comparator drug was discussed, and we felt that temozolomide was a reasonable choice,” he told listeners at an ASCO press conference. About 2000+ cases of uveal melanoma are diagnosed each year in the United States. Most patients present with early-stage disease, but about 50% develop metastatic disease, with a median survival of 9 to 12 months.

Surendra Shastri, MD

per 100,000 among controls. Thus, VIA screening did not lead to overdiagnosis. Cervical cancer–specific death rates were reduced by 31% with VIA screening (P = .003); these rates were 11.1 per 100,000 in the screening group and 16.2 per 100,000 in controls. There was also a nonsignificant 7% reduction in allcause mortality in the screened group. Shastri and colleagues plan to train primary healthcare workers to provide VIA screening every 24 months to all women between the ages of 35 and 64 years in Maharashtra state. In addition, the Indian government is planning to implement VIA screening throughout the country and to work with other countries in the developing world to offer training resources. Reference

Shastri SS, Mittra I, Mishra G, et al. Effect of visual inspection with acetic acid (VIA) screening by primary health workers on cervical cancer mortality: a cluster randomized controlled trial in Mumbai, India. J Clin Oncol. 2013;31 (suppl):Abstract 2. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL.

JuLY 2013 I VOL 6, NO 6

Conference News: ASCO Modafinil No Help With Fatigue in Lung Cancer A phase 2 study had previously shown that modafinil and placebo significantly relieved fatigue in patients with lung cancer. This lack of signif-

icant differences between treatment groups called into question National Comprehensive Cancer Network (NCCN) recommendations for the

treatment of cancer-associated fatigue. In a recent multicenter double-blind phase 4 trial, 208 patients with lung cancer were randomized to receive, in a 1:1

Being Fit at Age 50 Lowers Cancer Risk Middle-aged men with a high level of cardiovascular fitness have a lower risk of developing and dying of lung or colorectal cancer than do men who are not fit. Improved fitness level also reduces the risk of prostate cancer–related death but not the risk of developing it. As would be expected, men who were more fit had a lower risk of cardiovascular death. The study measured fitness as a marker of future cancer risk. Fitness level is a different measure than body weight or exercise level, explained lead author Susan Lakoski, MD, assistant professor of internal medicine at the University of Vermont in Burlington. “This is the first study to explore fitness as a marker of future cancer risk prognosis. This finding makes clear that patients should be advised that they need to achieve a certain level of fitness, and not just be told that they need to exercise. Unlike exercise behavior, fitness level can be measured objectively in a clinical setting. Previous studies have shown that poor fitness level is associated with increased risk of cardiovascular disease,” she said. She recommended that primary care doctors go beyond a prescription for exercise and advise their patients that being fit lowers their risk of dying of the 3 major cancers that affect men in the United States. The Cooper Center Longitudinal Study, conducted at the Cooper Clinic in Dallas, Texas, enrolled 17,049 men and followed them prospectively. The men had a single cardiovascular fitness assessment as part of a preventive health checkup at a mean age of 50 years. The fitness test involved treadmill walking under conditions of changing speed and elevation. Performance on the test was measured by units of fitness

called metabolic equivalents (METs). Results were divided into 5 quintiles based on fitness performance. Medicare claims were analyzed to identify study participants who had a diagnosis of lung, colorectal, or prostate cancer. At a median follow-up of 20 to 25 years, 2332 men were diagnosed with prostate cancer, 277 with lung cancer, and 276 with colorectal cancer. Cancer deaths numbered 347, and 159 men died of cardiovascular disease (CVD). In an analysis adjusted for smoking, body mass index, age, and other factors, the risk of a diagnosis of lung cancer was reduced by 68% in men with the highest levels of fitness versus those in the lowest quintile; the risk of colorectal cancer was reduced by 38% in the highest versus the lowest quintile for fitness. No impact of fitness was found for development of prostate cancer. Among those who developed cancer, men at the higher levels of fitness had a lower risk of cancer-related death from all 3 cancers, as well as a lower risk of death due to CVD. Lakoski said that even a 1-MET difference reduced the risk of dying of cancer and CVD by 23% and 14%, respectively. Men who had low fitness levels were at increased risk of cancer and CVD regardless of weight. As a result of these findings, Lakoski cautioned that fitness, not weight loss, should be emphasized to reduce risk of cancer and CVD. Reference

Lakoski SG, Barlow C, Gao A, et al. Cardiorespiratory fitness and risk of cancer incidence and cause-specific mortality following a cancer diagnosis in men: the Cooper Center longitudinal study. J Clin Oncol. 2013;31(suppl):Abstract 1520. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL.

ratio, modafinil or placebo. Modafinil was given at a dose of 100 mg for 14 days, followed by 200 mg for 14 days. Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue survey. A 3-point change in the FACITfatigue score is believed to be clinically significant. At 28 days, patients receiving modafinil had a mean change of 5.28 points on the FACIT-fatigue scale compared with 5.11 points in those receiving placebo, a nonsignificant difference. Most responses were observed at day 14 and sustained through the end of the study, indicating no dose-dependent response. No differences between groups were noted on secondary end points assessed using the Epworth Sleepiness and Hospital Anxiety and Depression scales. Adverse events were also similar between groups. These included headache, nausea/vomiting, and anxiety (symptoms commonly associated with modafinil). The study was presented by Kate Fife, MD, of the NIHR Cambridge Biomedical Research Centre in the United Kingdom. This is the second placebo-controlled study to call into question use of psychostimulants to control cancer-related fatigue. l Reference

Fife K, Spathis A, Dutton SJ, et al. A multicenter, randomized, double-blinded, placebo-controlled trial of modafinil for lung cancer-related fatigue: dose response and patient satisfaction data. J Clin Oncol. 2013;31 (suppl):Abstract 9503. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL.

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!

WebadMay.indd 1

JULY 2013 I VOL 6, NO 6

5/10/13 1:20 PM

www.TheOncologyNurse.com

Cancer Center Profile

Mission SECU Cancer Center Continued from cover counties in western North Carolina. In addition, Mission Health provides prevention and education programs, including free cancer screenings, to the local community. Karen Grogan, RN, MSOM, MHA, OCN, CENP, executive director of cancer services, discusses the services available at the Mission SECU Cancer Center and explains how the nursing staff participated in the design of the new center.

www.TheOncologyNurse.com

er. Maybe consultant work will someday fit into my career plans. l

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

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

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

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

AONNAsize SaveTheDate_31413_Layout 1 6/7/13 12:27 PM Page 1

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

How were your oncology nurses involved in the design and planning of the new cancer center? KG: We established end-user groups that included oncology nurses, patients, physicians, and many others who met regularly with our architects to plan the scope of services and map patient flow to create a patient-centric design. Our focus was on ease of access, efficiencies in care, and creating a healing, supportive environment. What inspired you to enter the field of oncology nursing? KG: Foremost, it was the personal connection an oncology nurse develops with patients while sharing their cancer journey that I found compelling during my adult and pediatric oncology rotations in nursing school. It has been an honor to share treatment successes

Karen Grogan, RN, MSOM, MHA, OCN, CENP

IS NOW

Group Director, Sales & Marketing John W. Hennessy john@greenhillhc.com

How does that translate to better outcomes for your patients? KG: Having our providers and services in one location has greatly improved communication and coordination of care for our patients. Through our multidisciplinary clinics, the time between diagnosis and initiation of treatment has been reduced and our compliance rate with recommended treatments has improved, in large part owing to nurse navigation services.

If you weren’t working in this field, what would you be doing? KG: Oncology nursing has been my life career and will always be what defines me. However, I enjoyed the opportunity to lead the cancer center project with our facility project manag-

Any advice for nurses just entering the field? KG: Nursing has to come from the heart. You have to care and respect each individual’s values and personal decisions. Nursing is physically and

What are you excited about right now in the cancer field? KG: The field of personalized medicine through genomics is very exciting. I anticipate that chemotherapy regimens will look very different over the next 10 years as we better understand how to target specific cell types. What approach does your institution take when treating people with cancer? KG: In November 2011, we opened a 118,000-square-foot outpatient cancer center specifically designed to be patient-centric. Our aim is to get each patient to the desired outcome, without harm, without waste, and with an exceptional experience for the patient and family.

emotionally difficult, but I think it is the most rewarding career imaginable.

and end-of-life experiences with many patients and families over the years of my career.

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

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.

Fourth Annual Navigation

Memphis, Tennessee • The Peabody Memphis

NOVEMBER 15-17, 2013 CONFERENCE CO-CHAIRS Lillie D. Shockney, RN, BS, MAS AONN Program Director University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, Johns Hopkins Clinical Breast Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Department of Surgery and Oncology Associate Professor, JHU School of Medicine Departments of Surgery, Oncology, and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD

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

www.AONNonline.org AONNAsize31413

Scan Here to Register

To use 2D barcodes: Visit the app store to download a QR Code reader for your smartphone lynxcmeAsize_61213

JuLY 2013 I VOL 6, NO 6

Best Practices

NCCN Updates Its Clinical Practice Guidelines Continued from cover of the H. Lee Moffitt Cancer Center, Tampa, Florida. For more extensive tumors, radical surgery is the chief recommendation. Options include wide local excision, laser, radiation therapy, glansectomy, and partial/total penectomy. Penilepreserving surgery maintains function and quality of life in a select cohort with small lesions, where negative margins can be obtained. For bulky disease with positive lymph nodes, neoadjuvant chemotherapy has proven effective. A nomogram is recommended for predicting metastatic lymph node involvement, as it outperforms the conventional clinical risk categories. The NCCN did not recommend dynamic sentinel node biopsy, owing to its low sensitivity and inadequacy in detecting occult inguinal disease. Acute Promyelocytic Leukemia: A Nonchemotherapy Option “For the first time, the NCCN guidelines have taken chemotherapy out of the up-front treatment for acute promyelocytic leukemia (APL),” said Margaret R. O’Donnell, MD, City of Hope Comprehensive Cancer Center, Duarte, California.

Based Regimen) trial, ziv-aflibercept improved overall survival from 12.1 months to 13.5 months (P = .0032) and progression-free survival from 4.7 to 6.9 months (P = .0001).2 This benefit is similar to what is achieved with bevacizumab, though at a higher financial and toxicity cost, Saltz noted. A 12-week regimen exceeds

S:7”

Important Safety Information WARNINGS AND PRECAUTIONS: • Treatment with ISTODAX has been associated with thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, monitor these hematological parameters during treatment with ISTODAX and modify the dose as necessary • Serious and sometimes fatal infections have been reported during treatment and within 30 days after treatment with ISTODAX and the risk of life threatening infections may be higher in patients with a history of extensive or intensive chemotherapy • Electrocardiographic (ECG) changes have been observed with ISTODAX • In patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions should be considered, such as monitoring electrolytes and ECGs at baseline and periodically during treatment • Ensure that potassium and magnesium are within the normal range before administration of ISTODAX • Tumor lysis syndrome has been reported during treatment with ISTODAX. Patients with advanced stage disease and/or high tumor burden should be closely monitored and appropriate precautions taken, and treatment should be instituted as appropriate • ISTODAX may cause fetal harm when administered to a pregnant woman. Advise women to avoid pregnancy while receiving ISTODAX. If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus (Pregnancy Category D) ADVERSE REACTIONS: Peripheral T-Cell Lymphoma The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 3 (N=131) were thrombocytopenia (24%), neutropenia (20%), anemia (11%), asthenia/fatigue (8%), and leukopenia (6%), and in Study 4 (N=47) were neutropenia (47%), leukopenia (45%), thrombocytopenia (36%), anemia (28%), asthenia/fatigue (19%), pyrexia (17%), vomiting (9%), and nausea (6%). Infections were the most common type of serious adverse event reported in Study 3 (N=131) and Study 4 (N=47). In Study 3, 25 patients (19%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections. The most common adverse reactions regardless of causality in Study 3 (N=131) were nausea (59%), asthenia/fatigue (55%), thrombocytopenia (41%), vomiting (39%), diarrhea (36%), and pyrexia (35%), and in Study 4 (N=47) were asthenia/fatigue (77%), nausea (75%),

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

Cutaneous T-Cell Lymphoma The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 1 (N=102) were infections (11%) and asthenia/fatigue (8%), and in Study 2 (N=83) were lymphopenia (37%), infections (33%), neutropenia (27%), leukopenia (22%), anemia (16%), asthenia/fatigue (14%), thrombocytopenia (14%), hypophosphatemia (10%), vomiting (10%), dermatitis/exfoliative dermatitis (8%), hypermagnesemia (8%), hyperuricemia (8%), hypocalcemia (6%), nausea (6%), and pruritus (6%). Infections were the most common type of serious adverse event reported in both Study 1 (N=102) and Study 2 (N=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection. The most common adverse reactions regardless of causality in Study 1 (N=102) were nausea (56%), asthenia/fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%) and in Study 2 (N=83) were nausea (86%), asthenia/fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG ST-T wave changes (63%), neutropenia (57%), lymphopenia (57%), infections (54%), anorexia (54%), vomiting (52%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), leukopenia (46%), dysgeusia (40%), and constipation (39%). S:9.875”

The guidelines for APL were changed as a result of a study by Lo-Coco and colleagues presented at the 2012 American Society of Hematology Annual Meeting, which compared the gold standard for newly diagnosed non– high-risk APL—simultaneous all-trans retinoic acid (ATRA) and chemotherapy (idarubicin)—with the chemotherapy-free combination of ATRA and arsenic trioxide (ATO).1 Complete responses were observed in 97% of patients, but 2-year event-free survival was 97% in the experimental arm versus 87% in controls. For patients with low- or intermediate-risk APL, the guidelines now recommend induction with ATRA plus ATO.

ed only a 1.5-month overall survival benefit,” he noted. When added to FOLFIRI (fluorouracil/leucovorin/ irinotecan) as a second-line treatment in the VELOUR (Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With B:8.75” Metastatic Colorectal T:8.125”of an OxaliplatinCancer After Failure

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

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

New Agents in Colorectal Cancer Two new agents recently approved for metastatic colorectal cancer are now Cosmos Communications

Cosmos Communications C M Y K

JULY 2013 I VOL 6, NO 6

24303a M

25298a

K03.01.13 133

1 js 9

js www.TheOncologyNurse.com 06.28.13 133 9

T:10.875”

Two new agents recently approved for metastatic colorectal cancer are now included in the NCCN guidelines—zivaflibercept and regorafenib.

included in the NCCN guidelines— ziv-aflibercept and regorafenib—though their overall benefit is relatively minor, Leonard Saltz, MD, of Memorial SloanKettering Cancer Center, New York, acknowledged. “We had hoped ziv-aflibercept would be the next step forward, but in the registration study it provid-

Best Practices $30,000, while a course of bevacizumab costs less than $14,000. “This cost difference was a deal breaker for our physicians at Sloan-Kettering. We decided there is no need for ziv-aflibercept at this time,” he added. In the updated guidelines, ziv-aflibercept is acceptable when added to FOLFIRI or irinotecan, but should not be used as a single agent, in combination with FOLFIRI after failure of

FOLFIRI/bevacizumab, or added to a failed regimen. Bevacizumab was also added as an option after first progression, in combination with FOLFIRI, irinotecan, FOLFOX (fluorouracil/ leucovorin/ oxaliplatin), or CapeOx (capecitabine/ oxaliplatin). Regorafenib was added to the guidelines as a treatment option after first, second, or third progression, depending on previous lines of therapy, based

on the 1.4-month survival advantage seen in the CORRECT (Regorafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer) trial.3 Giant Cell Tumor of the Bone New treatment pathways for giant cell tumor of bone (GCTB) and chordoma debuted in the updated version of the guidelines for bone cancer. These are rare neoplasms; therefore, clini-

cians lack familiarity with them. While GCTB is considered a benign disease, it carries a 2% risk for metastasis. Intralesional excision with the use of a high-speed burr is advised over more extensive surgery that requires skeletal reconstruction. While recurrence is not uncommon, the use of adjuvant therapy, either thermal or chemical, ameliorates this risk. In patients with unresectable Continued on page 14

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

RECHARGE THE POSSIBILITIES

www.istodax.com Please see Important Safety Information on adjacent page. Please see Brief Summary of full Prescribing Information on following pages.

Cosmos Communications

www.TheOncologyNurse.com

25298a

06.28.13

133

js 9

JuLY 2013 I VOL 6, NO 6

Best Practices

NCCN Updates Its Clinical Practice Guidelines Continued from page 13 or recurrent disease, denosumab can help restore the skeletal architecture and allow a joint-conserving procedure or avoidance of surgery altogether. For localized disease, excision is recommended; if resection carries unacceptable morbidity or the tumor is unresectable,

treatment with serial embolization, denosumab, interferon, pegylated interferon, and/or radiotherapy can be used. For metastatic disease, surgery is indicated if feasible. The recommended workup includes history, physical examination, cross-sectional imaging of the primary

site, chest imaging, and biopsy, with optional bone scan. New Agents in Multiple Myeloma “We have wonderful new agents, at least a lot more potent than prior-generation drugs,” said Kenneth C. Anderson,

Only

ISTODAX® (romidepsin) for injection For intravenous infusion only The following is a brief summary only; see full prescribing information for complete product information. 1 INDICATIONS AND USAGE ISTODAX is indicated for: • Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. • Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated. 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information The recommended dose of romidepsin is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8 and 15 of a 28-day cycle. Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the drug. 2.2 Dose Modification Nonhematologic toxicities except alopecia • Grade 2 or 3 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline, then therapy may be restarted at 14 mg/m2. If Grade 3 toxicity recurs, treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2. • Grade 4 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2. • Romidepsin should be discontinued if Grade 3 or 4 toxicities recur after dose reduction. Hematologic toxicities • Grade 3 or 4 neutropenia or thrombocytopenia: Treatment with romidepsin should be delayed until the specific cytopenia returns to ANC ≥1.5×109/L and/or platelet count ≥75×109/L or baseline, then therapy may be restarted at 14 mg/m2. • Grade 4 febrile (≥38.5°C) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with romidepsin should be delayed until the specific cytopenia returns to ≤Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m2. 2.3 Instructions for Preparation and Intravenous Administration ISTODAX should be handled in a manner consistent with recommended safe procedures for handling cytotoxic drugs. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Hematologic Treatment with ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, these hematological parameters should be monitored during treatment with ISTODAX, and the dose should be modified, as necessary [See Dosage and Administration (2.2) and Adverse Reactions (6)]. 5.2 Infection Serious and sometimes fatal infections, including pneumonia and sepsis, have been reported in clinical trials with ISTODAX. These can occur during treatment and within 30 days after treatment, and the risk of life threatening infections may be higher in patients with a history of extensive or intensive chemotherapy [See Adverse Reactions (6)]. 5.3 Electrocardiographic Changes Several treatment-emergent morphological changes in ECGs (including T-wave and ST-segment changes) have been reported in clinical studies. The clinical significance of these changes is unknown [See Adverse Reactions (6)]. In patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions should be considered, such as the monitoring of electrolytes and ECGs at baseline and periodically during treatment. Potassium and magnesium should be within the normal range before administration of ISTODAX [See Adverse Reactions (6)]. 5.4 Tumor Lysis Syndrome Tumor lysis syndrome (TLS) has been reported to occur in 1% of patients with tumor stage CTCL and 2% of patients with Stage III/IV PTCL. Patients

MD, of Dana-Farber Cancer Institute, Boston, Massachusetts. The approval of the second-generation proteasome inhibitor carfilzomib led to its recent inclusion in the guidelines for transplant candidates, in combination with lenalidomide/dexamethasone. This triplet

with advanced stage disease and/or high tumor burden should be closely monitored, appropriate precautions should be taken, and treatment should be instituted as appropriate. 5.5 Use in Pregnancy There are no adequate and well-controlled studies of ISTODAX in pregnant women. However, based on its mechanism of action and findings in animals, ISTODAX may cause fetal harm when administered to a pregnant woman. In an animal reproductive study, romidepsin was embryocidal and resulted in adverse effects on the developing fetus at exposures below those in patients at the recommended dose of 14 mg/m2/week. If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus [See Use in Specific Populations (8.1)]. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Cutaneous T-Cell Lymphoma The safety of ISTODAX was evaluated in 185 patients with CTCL in 2 single arm clinical studies in which patients received a starting dose of 14 mg/m2. The mean duration of treatment in these studies was 5.6 months (range: <1 to 83.4 months).

Common Adverse Reactions Table 1 summarizes the most frequent adverse reactions (> 20%) regardless of causality using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 3.0). Due to methodological differences between the studies, the AE data are presented separately for Study 1 and Study 2. Adverse reactions are ranked by their incidence in Study 1. Laboratory abnormalities commonly reported (> 20%) as adverse reactions are included in Table 1. Table 1. Adverse Reactions Occurring in >20% of Patients in Either CTCL Study (N=185) Study 1 Study 2 (n=102) (n=83) Grade 3 Grade 3 Adverse Reactions n (%) All or 4 All or 4 Any adverse reaction 99 (97) 36 (35) 83 (100) 68 (82) Nausea 57 (56) 3 (3) 71 (86) 5 (6) Asthenia/Fatigue 54 (53) 8 (8) 64 (77) 12 (14) Infections 47 (46) 11 (11) 45 (54) 27 (33) Vomiting 35 (34) 1 (<1) 43 (52) 8 (10) Anorexia 23 (23) 1 (<1) 45 (54) 3 (4) Hypomagnesemia 22 (22) 1 (<1) 23 (28) 0 Diarrhea 20 (20) 1 (<1) 22 (27) 1 (1) Pyrexia 20 (20) 4 (4) 19 (23) 1 (1) Anemia 19 (19) 3 (3) 60 (72) 13 (16) Thrombocytopenia 17 (17) 0 54 (65) 12 (14) Dysgeusia 15 (15) 0 33 (40) 0 Constipation 12 (12) 2 (2) 32 (39) 1 (1) Neutropenia 11 (11) 4 (4) 47 (57) 22 (27) Hypotension 7 (7) 3 (3) 19 (23) 3 (4) Pruritus 7 (7) 0 26 (31) 5 (6) Hypokalemia 6 (6) 0 17 (20) 2 (2) Dermatitis/Exfoliative dermatitis 4 (4) 1 (<1) 22 (27) 7 (8) Hypocalcemia 4 (4) 0 43 (52) 5 (6) Leukopenia 4 (4) 0 38 (46) 18 (22) Lymphopenia 4 (4) 0 47 (57) 31 (37) Alanine aminotransferase increased 3 (3) 0 18 (22) 2 (2) Aspartate aminotransferase increased 3 (3) 0 23 (28) 3 (4) Hypoalbuminemia 3 (3) 1 (<1) 40 (48) 3 (4) Electrocardiogram ST-T wave changes 2 (2) 0 52 (63) 0 Hyperglycemia 2 (2) 2 (2) 42 (51) 1 (1) Hyponatremia 1 (<1) 1 (<1) 17 (20) 2 (2) Hypermagnesemia 0 0 22 (27) 7 (8) Hypophosphatemia 0 0 22 (27) 8 (10) Hyperuricemia 0 0 27 (33) 7 (8)

Cosmos Communications K

JULY 2013 I VOL 6, NO 6

25298a_pi

1 js 9

06.28.13 133 www.TheOncologyNurse.com

Best Practices joins a growing list of regimens that greatly increase response rates, he said. For relapsed/refractory disease, the updated guidelines also include carfilzomib as a preferred salvage therapy option, as well as the new immunomodulating drug pomalidomide plus low-dose dexamethasone. Other recommended regimens now also include

bortezomib/vorinostat and lenalidomide/bendamustine/dexamethasone. Updates in Non-Hodgkin Lymphoma The growing use of lenalidomide in non-Hodgkin lymphoma is reflected in the updated guidelines. New to the guidelines for the second-line treatment

Serious Adverse Reactions Infections were the most common type of SAE reported in both studies with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection. Serious adverse reactions reported in > 2% of patients in Study 1 were sepsis and pyrexia (3%). In Study 2, serious adverse reactions in > 2% of patients were fatigue (7%), supraventricular arrhythmia, central line infection, neutropenia (6%), hypotension, hyperuricemia, edema (5%), ventricular arrhythmia, thrombocytopenia, nausea, leukopenia, dehydration, pyrexia, aspartate aminotransferase increased, sepsis, catheter related infection, hypophosphatemia and dyspnea (4%). Most deaths were due to disease progression. In Study 1, there were two deaths due to cardiopulmonary failure and acute renal failure. In Study 2, there were six deaths due to infection (4), myocardial ischemia, and acute respiratory distress syndrome. Discontinuations Discontinuation due to an adverse event occurred in 21% of patients in Study 1 and 11% in Study 2. Discontinuations occurring in at least 2% of patients in either study included infection, fatigue, dyspnea, QT prolongation, and hypomagnesmia. Peripheral T-Cell Lymphoma The safety of ISTODAX was evaluated in 178 patients with PTCL in a sponsor-conducted pivotal study (Study 3) and a secondary NCI-sponsored study (Study 4) in which patients received a starting dose of 14 mg/m2. The mean duration of treatment and number of cycles in these studies were 5.6 months and 6 cycles. Common Adverse Reactions Table 2 summarizes the most frequent adverse reactions (≥ 10%) regardless of causality, using the NCI-CTCAE, Version 3.0. The AE data are presented separately for Study 3 and Study 4. Laboratory abnormalities commonly reported (≥ 10%) as adverse reactions are included in Table 2. Table 2. Adverse Reactions Occurring in ≥10% of Patients with PTCL in Study 3 and Corresponding Incidence in Study 4 (N=178) Study 3 Study 4 (N=131) (N=47) Grade 3 Grade 3 Adverse Reactions n (%) All or 4 All or 4 Any adverse reactions 127 (97) 86 (66) 47 (100) 40 (85) Gastrointestinal disorders Nausea 77 (59) 3 (2) 35 (75) 3 (6) Vomiting 51 (39) 6 (5) 19 (40) 4 (9) Diarrhea 47 (36) 3 (2) 17 (36) 1 (2) Constipation 39 (30) 1 (<1) 19 (40) 1 (2) Abdominal pain 18 (14) 3 (2) 6 (13) 1 (2) Stomatitis 13 (10) 0 3 (6) 0 General disorders and administration site conditions Asthenia/Fatigue 72 (55) 11 (8) 36 (77) 9 (19) Pyrexia 46 (35) 7 (5) 22 (47) 8 (17) Chills 14 (11) 1 (<1) 8 (17) 0 Edema peripheral 13 (10) 1 (<1) 3 (6) 0 Blood and lymphatic system disorders Thrombocytopenia 53 (41) 32 (24) 34 (72) 17 (36) Neutropenia 39 (30) 26 (20) 31 (66) 22 (47) Anemia 32 (24) 14 (11) 29 (62) 13 (28) Leukopenia 16 (12) 8 (6) 26 (55) 21 (45) Metabolism and nutrition disorders Anorexia 37 (28) 2 (2) 21 (45) 1 (2) Hypokalemia 14 (11) 3 (2) 8 (17) 1 (2) Nervous system disorders Dysgeusia 27 (21) 0 13 (28) 0 Headache 19 (15) 0 16 (34) 1 (2) Respiratory, thoracic and mediastinal disorders Cough 23 (18) 0 10 (21) 0 Dyspnea 17 (13) 3 (2) 10 (21) 2 (4) Investigations Weight decreased 13 (10) 0 7 (15) 0 Cardiac disorders Tachycardia 13 (10) 0 0 0

of stage I-II disease is lenalidomide with or without rituximab. For chronic lymphocytic leukemia, first-line therapy now includes lenalidomide (continuous or intermittent dosing) as a treatment option, and bendamustine with or without rituximab. For relapsed/refractory disease, lenalidomide with or without rituximab is a treatment option.

Continued on page 16

Serious Adverse Reactions Infections were the most common type of SAE reported. In Study 3, 25 patients (19%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections. Serious adverse reactions reported in ≥ 2% of patients in Study 3 were pyrexia (7%), pneumonia, sepsis, vomiting (5%), cellulitis, deep vein thrombosis, (4%), febrile neutropenia, abdominal pain (3%), chest pain, neutropenia, pulmonary embolism, dyspnea, and dehydration (2%). In Study 4, serious adverse reactions in ≥ 2 patients were pyrexia (17%), aspartate aminotransferase increased, hypotension (13%), anemia, thrombocytopenia, alanine aminotransferase increased (11%), infection, dehydration, dyspnea (9%), lymphopenia, neutropenia, hyperbilirubinemia, hypocalcemia, hypoxia (6%), febrile neutropenia, leukopenia, ventricular arrhythmia, vomiting, hypersensitivity, catheter related infection, hyperuricemia, hypoalbuminemia, syncope, pneumonitis, packed red blood cell transfusion, and platelet transfusion (4%). Deaths due to all causes within 30 days of the last dose of ISTODAX occurred in 7% of patients in Study 3 and 17% of patients in Study 4. In Study 3, there were 5 deaths unrelated to disease progression that were due to infections, including multi-organ failure/sepsis, pneumonia, septic shock, candida sepsis, and sepsis/cardiogenic shock. In Study 4, there were 3 deaths unrelated to disease progression that were due to sepsis, aspartate aminotransferase elevation in the setting of Epstein Barr virus reactivation, and death of unknown cause. Discontinuations Discontinuation due to an adverse event occurred in 19% of patients in Study 3 and in 28% of patients in Study 4. In Study 3, thrombocytopenia and pneumonia were the only events leading to treatment discontinuation in at least 2% of patients. In Study 4, events leading to treatment discontinuation in ≥ 2 patients were thrombocytopenia (11%), anemia, infection, and alanine aminotransferase increased (4%). 6.2 Postmarketing Experience No additional safety signals have been observed from postmarketing experience. 7 DRUG INTERACTIONS 7.1 Coumadin or Coumadin Derivatives Prolongation of PT and elevation of INR were observed in a patient receiving ISTODAX concomitantly with warfarin. Although the interaction potential between ISTODAX and Coumadin® (a registered trademark of BristolMyers Squibb Pharma Company) or Coumadin derivatives has not been formally studied, physicians should carefully monitor PT and INR in patients concurrently administered ISTODAX and Coumadin or Coumadin derivatives [See Clinical Pharmacology (12.3)]. 7.2 Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes Romidepsin is metabolized by CYP3A4. Although there are no formal drug interaction studies for ISTODAX, strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase concentrations of romidepsin. Therefore, co-administration with strong CYP3A4 inhibitors should be avoided if possible. Caution should be exercised with concomitant use of moderate CYP3A4 inhibitors. Co-administration of potent CYP3A4 inducers (e.g., dexamethasone, carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital) may decrease concentrations of romidepsin and should be avoided if possible. Patients should also refrain from taking St. John’s Wort. 7.3 Drugs that Inhibit Drug Transport Systems Romidepsin is a substrate of the efflux transporter P-glycoprotein (P-gp, ABCB1). If ISTODAX is administered with drugs that inhibit P-gp, increased concentrations of romidepsin are likely, and caution should be exercised. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category D [See Warnings and Precautions (5.5)]. There are no adequate and well-controlled studies of ISTODAX in pregnant women. However, based on its mechanism of action and findings in animals, ISTODAX may cause fetal harm when administered to a pregnant woman. In an animal reproductive study, romidepsin was embryocidal and resulted in adverse effects on the developing fetus at exposures below those in patients at the recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus. Romidepsin was administered intravenously to rats during the period of organogenesis at doses of 0.1, 0.2, or 0.5 mg/kg/day. Substantial resorption or post-implantation loss was observed at the high-dose of 0.5 mg/kg/day, a maternally toxic dose. Adverse embryo-fetal effects were Cosmos Communications

www.TheOncologyNurse.com

New TKIs in Thyroid Cancer With the availability of 2 new tyrosine kinase inhibitors (TKIs), “these are exciting times in thyroid cancer,” said Robert I. Haddad, MD, of Harvard Medical School and the Dana-Farber Cancer Institute, Boston, Massachusetts. The TKIs now offer an

25298a_pi

06.28.13

133

js 9

JuLY 2013 I VOL 6, NO 6

Best Practices

NCCN Updates Its Clinical Practice Guidelines Continued from page 15 option after patients become refractory to radioactive iodine. In advanced or metastatic medullary thyroid cancer, cabozantinib and vandetanib have more than doubled progression-free survival. The guidelines now list both drugs as category

1 treatments for unresectable disease that is symptomatic or asymptomatic and structurally progressive. While not approved by the US Food and Drug Administration for thyroid cancer, other small molecule TKIs (sorafenib, sunitinib) can be considered.

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

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

8.3 Nursing Mothers It is not known whether romidepsin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and effectiveness of ISTODAX in pediatric patients has not been established. 8.5 Geriatric Use Of the approximately 300 patients with CTCL or PTCL in trials, about 25% were > 65 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out. 8.6 Hepatic Impairment No dedicated hepatic impairment study for ISTODAX has been conducted. Mild hepatic impairment does not alter pharmacokinetics of romidepsin based on a population pharmacokinetic analysis. Patients with moderate and severe hepatic impairment should be treated with caution [See Clinical Pharmacology (12.3)]

16 HOW SUPPLIED/STORAGE AND HANDLING Keep out of reach of children. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-4 [See References (15)]. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling. 17.1 Instructions • Nausea and Vomiting Nausea and vomiting are common following treatment with ISTODAX. Prophylactic antiemetics are recommended to be used in all patients. Advise patients to report these symptoms so that appropriate treatment can be instituted [See Adverse Reactions (6)]. • Low Blood Counts Patients should be informed that treatment with ISTODAX can cause low blood counts and that frequent monitoring of hematologic parameters is required. Patients should be instructed to report fever or other signs of infection, significant fatigue, shortness of breath, or bleeding [See Warnings and Precautions (5.1)]. • Infections Patients should be informed that infections may occur during treatment with ISTODAX. Patients should be instructed to report fever, cough, shortness of breath with or without chest pain, burning on urination, flu-like symptoms, muscle aches, or worsening skin problems [See Warnings and Precautions (5.2]. • Tumor Lysis Syndrome Patients at risk of tumor lysis syndrome (i.e, those with advanced stage disease and/or high tumor burden) should be monitored closely for TLS and appropriate measures taken if symptoms are observed [See Warnings and Precautions (5.4)]. • Use in Pregnancy If pregnancy occurs during treatment with ISTODAX, female patients should be advised to seek immediate medical advice and counseling. [See Warnings and Precautions (5.5)]. • Patients should be instructed to read the patient insert carefully.

8.7 Renal Impairment No dedicated renal impairment study for ISTODAX has been conducted. Based upon the population pharmacokinetic analysis, renal impairment is not expected to significantly influence drug exposure. The effect of end-stage renal disease on romidepsin pharmacokinetics has not been studied. Thus, patients with end-stage renal disease should be treated with caution [See Clinical Pharmacology (12.3)] 10 OVERDOSAGE No specific information is available on the treatment of overdosage of ISTODAX. Toxicities in a single-dose study in rats or dogs, at intravenous romidepsin doses up to 2.2 fold the recommended human dose based on the body surface area, included irregular respiration, irregular heart beat, staggering gait, tremor, and tonic convulsions. In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., clinical monitoring and supportive therapy, if required. There is no known antidote for ISTODAX and it is not known if ISTODAX is dialyzable. 12 CLINICAL PHARMACOLOGY 12.2 Pharmacodynamics Cardiac Electrophysiology The effect of romidepsin on the heart-rate corrected QTc/QTcF was evaluated in 26 subjects with advanced malignancies given romidepsin at doses of 14 mg/m2 as a 4-hour intravenous infusion, and at doses of 8, 10 or 12 mg/m2 as a 1–hour infusion. Patients received premedications with antiemetics. No large changes in the mean QTc interval (> 20 milliseconds) from baseline based on Fridericia correction method were detected in the trial. Small increase in mean QT interval (< 10 milliseconds) and mean QT interval increase between 10 to 20 milliseconds cannot be excluded because of the limitations in the trial design. Romidepsin was associated with a delayed concentration-dependent increase in heart rate in patients with advanced cancer with a maximum mean increase in heart rate of 20 beats per minute occurring at the 6 hour time point after start of romidepsin infusion for patients receiving 14 mg/m2 as a 4-hour infusion. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with romidepsin. Romidepsin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Romidepsin was not clastogenic in an in vivo rat bone marrow micronucleus assay when tested to the maximum tolerated dose (MTD) of 1 mg/kg in males and 3 mg/kg in females (6 and 18 mg/m2 in males and females, respectively). These doses were up to 1.3-fold the recommended human dose, based on body surface area.

New Drugs Exploit Androgen Pathway in Prostate Cancer Two new drugs for prostate cancer take advantage of the persistence of androgen receptor expression, even in castration-resistant prostate cancer. Abiraterone acetate, an androgen syn-

Manufactured for: Celgene Corporation Summit, NJ 07901 Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146

Melanoma: Thin Lesions Can Forgo SLNB A substantial change to the melanoma guidelines pertains to the indication for sentinel lymph node biopsy (SLNB), which the panel concluded is not warranted for thin lesions, ie, those ≤ 0.75 mm. SLNB may be considered when conventional risk factors accompany these very thin lesions. Otherwise, patients with thin lesions undergo wide excision, those with lesions 0.76 to 1.0 mm should be considered for SLNB, and those with lesions >1 mm require SLNB. The change has the potential to affect as much as 75% of patients in the average practice. l

References

Baxter Oncology GmbH Halle/Westfalen, Germany

1. Lo-Coco F, Avvisati G, Orlando SM, et al. ATRA and arsenic trioxide (ATO) versus ATRA and idarubicin (AIDA) for newly diagnosed, non high-risk acute promyelocytic leukemia (APL): results of the phase III, prospective, randomized, Intergroup APL0406 study by the Italian-German Cooperative Groups Gimema-SALAMLSG. Blood. 2012;120:Abstract 6. 2. Van Cutsem E, Tabernero J, Lakomy R, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012;30(28):3499-3506. 3. Grothey A, Van Cutsem E, Sobrero A, et al; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):303-312.

Cosmos Communications

JULY 2013 I VOL 6, NO 6

In advanced or metastatic medullary thyroid cancer, cabozantinib and vandetanib have more than doubled progression-free survival.

For information about the inaugural NCCN Guidelines on Survivorship, see the April issue of The Oncology Nurse-APN/PA.

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

thesis inhibitor, and enzalutamide, an antiandrogen, have changed the treatment landscape, said Philip W. Kantoff, MD, of the Dana-Farber Cancer Institute/Brigham & Women’s Hospital, Boston, Massachusetts. The guidelines include abiraterone/ prednisone as a category 1 recommendation in both the pre- and postchemotherapy settings, and enzalutamide as a category 2A recommendation for docetaxel-naive men and a category 1 recommendation postchemotherapy. “These drugs have a clinically meaningful impact on survival,” Kantoff said.

25298a_pi

06.28.13

133

js 9

www.TheOncologyNurse.com

FDA Approval Process

FDA Expected to Approve Surrogate End Point... Continued from cover end point that predicts clinical benefit; accelerated approval would require subsequent confirmation in a clinical trial. For neoadjuvant breast cancer, this end point would likely be pathologic complete response (pCR) rate. The achievement of a pCR has been associated with superior outcomes in multiple studies, but the correlation needs further validation, said Tatiana M. Prowell, MD, medical officer for the Breast Oncology Group at the FDA, and assistant professor at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. While pCR will most likely be the surrogate end point, other outcomes have been studied in patients with breast cancer, including tumor response on imaging, measurement of the tumor proliferation marker Ki-67, preoperative endocrine prognostic index (PEPI), and residual cancer burden after treatment. Faster Approval of Drugs to Most Benefit High-Risk Patients The traditional drug approval process averages 10 to 15 years. The goal of accelerated approval is to provide early access to effective drugs and to provide incentives for developing drugs for particular breast cancer subtypes with unmet needs. Under the new approval process, a single trial or a short-duration trial would be appropriate for accelerated approval and a simultaneous longer trial would be conducted to support “regular” approval, according to speakers at the “Pushing the Limits of Upfront Care and Drug Development: Neoadjuvant Opportunities in Breast Cancer” session. The use of pCR to support accelerated approval is appropriate “for highly promising drugs and high-risk patient populations,” Prowell maintained. Session Chair Angela DeMichele, MD, of the Abramson Cancer Center of the University of Pennsylvania, Philadelphia, noted there is a “fertile environment” for new drug development in the neoadjuvant breast cancer treatment setting, as the many benefits of neoadjuvant therapy are now established. Moving clinical trials from the adjuvant to the neoadjuvant setting can yield important information about the drugs that are under evaluation, such as the ability of pharmacodynamic markers to provide in vivo evidence of biologic effects. But most importantly, they should identify active agents faster, which serves patients, DeMichele said. She emphasized that surrogate markers must be robust, ie, reproducible and standardized, and their correlation with the true end point (such as

www.TheOncologyNurse.com

overall survival) must be more than a DeMichele also proposed that pCR simple “correlation.” In this case, pCR may not be a valid surrogate end point must be strictly defined as the elimi- for every breast cancer. While it may be nation of all invasive and noninvasive appropriate for human epidermal growth disease in the breast and lymph nodes, factor receptor 2 (HER2)-positive, trirather than a “looser” definition. Its ple-negative, and highly proliferative relationship with the final end point estrogen receptor (ER)-positive disease, can be assured only through long-term it may not be a good surrogate for VBCC0112_VBMAsize_Layout 1 2/15/12 2 follow-up of patients, she added.3:28 PM Pagelow-proliferation ER-positive tumors.

At present, she believes Ki-67 is the best surrogate for the latter, though it is not perfect. Better surrogates are needed for this subset, she said. l Reference

DeMichele A. Pushing the limits of upfront care and drug development: neoadjuvant opportunities in breast cancer. Presented at: 2013 Annual Meeting of the American Society of Clinical Oncology; June 1, 2013; Chicago, IL. Education Session.

VISIT THE NEW ONLINE RESOURCE FOR NURSES AND THE ENTIRE MULTIPLE MYELOMA CARE TEAM

“Quality care is everyone’s business.” Beth Faiman, PhD(c), MSN, APRN-BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Value-BasedCare IN Myeloma

™

RESOURCE CENTER FOR PAYERS, PROVIDERS, AND THE ENTIRE CANCER CARE TEAM

Value-Based Care in Myeloma delivers exclusive interviews and perspectives related to cost, quality, and access issues. Special sections for VA-based clinicians, advanced practice nurses, and pharmacists will also focus on the unique challenges in the management of multiple myeloma.

JuLY 2013 I VOL 6, NO 6

Best Practices

Tobacco Use Often Falls Through the Cracks in Oncology Practices By Alice Goodman

ome people are so addicted to tobacco that a diagnosis of cancer is not enough to make them quit smoking. Patients with cancer who continue to smoke increase their chances of compromising the effects of treatment, of having worse adverse effects from treatment, and of developing a second cancer or clinically evident cardiovascular disease. Despite this problem, many cancer centers and oncology practices have not devoted resources to addressing tobacco use. To bridge the gap between the need for tobacco use intervention and services delivered, a panel of the American Association for Cancer Research (AACR) issued a policy statement, Assessing Tobacco Use by Cancer Patients and Facilitating Cessation, during the organization’s annual meeting.

In a survey of NCIdesignated cancer centers, only 38% of those responding documented smoking status as a vital sign, and less than 50% of these centers had dedicated personnel for tobacco cessation.

Project1_Layout 1 5/9/13 3:03 PM Page 1

A separate survey revealed that while 90% of oncologists who respond-

Fourth Annual Navigation and

November 15-17, 2013 • The Peabo PRELIMINARY AGENDA* FRIDAY, NOVEMBER 15 12:00 pm - 12:30 pm Welcome • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 12:30 pm - 2:00 pm PRE-CONFERENCE WORKSHOPS Basic Navigation Track • Tricia Strusowski, MS, RN • Nicole Messier, RN, BSN OR Advanced Navigation Track • Elaine Sein, RN, BSN, OCN, CBCN • Danelle Johnston, RN, MSN, OCN, CBCN 2:00 pm - 2:45 pm BREAK IN THE EXHIBIT HALL 2:45 pm - 3:30 pm General Session 1: Top 10 Best Practices • Moderators – Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 3:30 pm - 5:00 pm Administrator’s Track • Mandi Pratt-Chapman, MA • Michele O’Brien, MSN, ACNS-BC, RN, BA OR

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

JULY 2013 I VOL 6, NO 6

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

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

Nurse practitioners and physician assistants are in an excellent position to provide assessment of tobacco use and evidence-based interventions. The AACR hopes that the new policy statement will be a wake-up call for oncology practices to address this significant issue. The back story is that recent surveys and studies showed that a sizable proportion of oncology practices do not routinely address tobacco use and that tobacco use is not documented at baseline and follow-up in many clinical trials, even though it is a confounding factor for treatment. In a survey of National Cancer Institute (NCI)–designated cancer centers, only 38% of those responding documented smoking status as a vital sign, and less than 50% of these centers had dedicated personnel for tobacco cessation. By contrast, 78% of the same centers have dedicated nutrition personnel.

ed believed that tobacco use affects cancer outcomes and that tobacco ces-

sation should be included as standard of care, only 40% of these oncologists provided routine assistance for smoking cessation. Moreover, less than 10% of oncologists had specific training in smoking cessation while only 33% of lung cancer specialists considered themselves adequately trained in smoking cessation.

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

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

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

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

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

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

www.TheOncologyNurse.com

Best Practices Recently, a review of 155 NCI Cooperative Group studies revealed that only 29% of registered trials assessed tobacco use at enrollment. Less than 5% of these trials included follow-up on subsequent tobacco use status. Smoking is among the most difficult addictions to treat. Studies suggest that although about 50% of smokers try to

Although about 50% of smokers try to quit, only about 4% to 7% are successful in doing so without evidence-based intervention. quit, only about 4% to 7% are successful in doing so without evidence-based intervention.

Tobacco use is the major risk factor for lung cancer, but it is also implicated in 18 other types of cancer. “A frequent

Survivorship Conference

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

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

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

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

CONFERENCE OVERVIEW

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

TARGET AUDIENCE

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

CONTINUING EDUCATION INFORMATION

Learning Objectives Upon completion of this activity, the participant will be able to: • Discuss the evolution of the role of navigation in healthcare. • Assess strategies for navigating diverse patient populations by cancer type and environmental factors. • Define methods for providing patient support and guidance in the age of personalized cancer care. • Evaluate best practices regarding survivorship and psychosocial care.

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

Liz Danielson, MHA

Danelle Johnston, RN, MSN, OCN, CBCN

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

Laurie Mathis, RN, CBCN, OCN

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

SPONSORS

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

COMMERCIAL SUPPORT ACKNOWLEDGMENT

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

REGISTERED NURSE DESIGNATION

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

2013 CONFERENCE REGISTRATION

www.aonnonline.org /conference

Concrete Steps AACR’s policy statement endorses a number of recommendations to remedy this treatment gap, making oncology practices responsible for providing assessment and intervention for patients who continue to smoke and recent quitters. The following points are included in the recommendations: • R epeated documentation of tobacco use in all patients with cancer, so that the confounding effects of smoking on treatment, disease progression, and comorbidities can be tracked in clinical trials, starting at registration and continuing through follow-up • Tobacco use should also be documented in all clinical care settings. Universal standardized measurement of tobacco use and exposure is required to be able to make cross-center comparisons and compile a meaningful database • Researchers and healthcare quality and accreditation bodies should incorporate evidence-based criteria • Healthcare systems, payers, and funding bodies should provide reimbursement for tobacco use interventions along with incentives for developing and delivering them The Affordable Care Act (ACA), which will be in effect in 2014, provides for reimbursement for smoking cessation interventions by insurance plans, but this will vary by state and be evidence based. In some states, tobacco use interventions are reimbursable if offered by nurse practitioners and physician assistants. Electronic medical records, also part of the ACA, will track smoking status. l Reference

L-AONN-13_Ksize 50813

www.TheOncologyNurse.com

assumption is that once cancer develops, it is fruitless to stop smoking. This is not true!” said Roy Herbst, MD, chair of the panel that produced the AACR policy statement and chief of medical oncology at Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut. Evidence-based approaches to tobacco use cessation include pharmacotherapy and nicotine chewing gum, as well as the 5A approach to smoking cessation: ask about smoking status, advise people to quit, assess interest in quitting, assist with pharmacotherapy and counseling, and arrange follow-up. However, many healthcare providers do not utilize these approaches.

Herbst RS. Reducing tobacco-related cancers incidence and mortality. Presented at: American Association for Cancer Research 2013 Annual Meeting; April 9, 2013; Washington, DC.

JuLY 2013 I VOL 6, NO 6

Faces at the ONS 38th Annual Congress

A View From the Floor The Oncology Nursing Society (ONS) 38th Annual Congress was held in Washington, DC, on April 25-28, 2013. The Oncology Nurse-APN/PA (TON) was thereâ&#x20AC;Ś

Deborah K. Mayer, PhD, RN, AOCN, FAAN, associate professor at UNC-Chapel Hill School of Nursing, delivers a talk on survivorship plans to a crowded audience at the ONS booth on the exhibit floor. There were not enough seats, so people sat on the floor.

Joanne Ebner, RN, BSN, Anne Arundel Medical Center at the DeCesaris Cancer Institute (left), and Judith Smith, MSN, RN, AOCN, Division of Cancer Prevention at the National Cancer Institute (right), jointly presided over the session Cancer Screening Guidelines: Clarity and Controversy.

Deb Ross, BSN, RN, OCN, Mercy Cancer Centers, Toledo, Ohio, presented a poster on establishing a survivorship program in a community-based oncology program (Poster 191).

Jena Buchanan, from Cary, North Carolina, visits the Academy of Oncology Nurse Navigators (AONN) booth to claim her raffle prizeâ&#x20AC;&#x201D; a book authored by AONN Program Director Lillie Shockney.

Michelle Rhiner, RN-BC, MSN, GNP-BC, ACHPN (left), and Neha Parikh, MS, a researcher at INSYS Therapeutics in Chandler, Arizona, collaborated on a poster about patient satisfaction with fentanyl oral spray (Poster 197).

JULY 2013 I VOL 6, NO 6

Joann McNally, RN, of the North Virginia ONS chapter takes charge of the booth for the 6 host ONS chapters. ONS attendees dropped off soaps, shampoos, lotions, and cosmetics for donation to homeless shelters in the Washington, DC, area.

www.TheOncologyNurse.com

ach year, the ONS Foundation offers scholarships for nurses who are planning to attend an ONS conference, as well as for those pursuing their bachelor’s, master’s, or doctoral degree; completing important research; or providing extraordinary care in a specialty of oncology nursing. Below are photos of 2 recipients of awards for travel to the ONS 38th Annual Congress.

Catching up with former colleagues, Lorraine K. McEvoy, DNP, MSN, RN, OCN (left), now at Memorial Sloan-Kettering Cancer Center in Baltimore, Maryland, greets Diane Kramek, RN (middle), and Belinda Hecht, RN (right), both of St. Joseph’s Hospital in Paterson, New Jersey. Lorraine was Diane’s mentor at St. Joseph’s, then Diane trained Belinda. Nursing was a second career for both Diane and Linda.

Irene Misik, an oncology nurse, traveled from Nairobi, Kenya, on an ONS Foundation Scholarship to attend the ONS 38th Annual Congress. Irene works in an 8-bed chemotherapy center, which is a private facility providing expensive care. When asked about her experience thus far, she said: “I came for the education and it is wonderful. I also visited Georgetown Medical Center and was blown away. I am going to learn from the best at this meeting and bring it back to my center.” Katie McCreath, from St. Joseph, Missouri, visits the Academy of Oncology Nurse Navigators (AONN) booth to claim her raffle prize—a book authored by AONN Program Director Lillie Shockney.

Cynthia Mauldin, RN, hails from the Home Care Network in King of Prussia, Pennsylvania. Cynthia is one of this year’s ONS Foundation Scholarship recipients, and reports that the meeting is quite interesting and rewarding. Congratulations to Denise Musser, of Rochester, Minnesota, the winner of our iPad giveaway.

www.TheOncologyNurse.com

JuLY 2013 I VOL 6, NO 6

Conference News: NCCN

The Changing Oncology Landscape: Evolution or Revolution? By Audrey Andrews

Panelists at the NCCN roundtable discussion.

anelists at the 2013 Annual Conference of the National Comprehensive Cancer Network (NCCN) view the oncology world as rapidly changing, and the impact of this—for better or for worse—will be felt by healthcare providers, payers, and patients alike. “Certainly, this landscape is shifting beneath our feet,” said Clifford Goodman, PhD, senior vice president and principal of the Lewin Group, a healthcare consulting firm based in Falls Church, Virginia, who moderated the panel discussion. “There are tectonic forces, and these are unsteady times,” he said.

the workplace with a higher risk profile or more advanced disease. Susan A. Higgins, MD, MS, associate director of the Department of Therapeutic Radiology Residency Training Program at Yale Cancer Center, New Haven, Connecticut, added that in her practice at Yale, she is seeing stage IV cervical cancer (a “third-world country disease”) among her underprivileged patients. In contrast, her affluent patients are moving into concierge practices. While the Affordable Care Act will “ballast the very bottom,” Higgins said, high copays for everyone else means “the bottom of the middle class is falling down.”

Coverage Continuum The population in the United States is not getting any healthier, despite broadening access to care and efforts to eliminate disparities, the panelists agreed. This is largely because the socioeconomic gap is widening and healthcare is becoming less affordable, especially to the middle class. “In 3 years, the person who makes an average US salary will have to spend 50% of it to cover his out-of-pocket expenses and healthcare premium,” Lee N. Newcomer, MD, senior vice president of UnitedHealth Group, Minneapolis, Minnesota, pointed out. John Fox, MD, MHA, senior medical director of Priority Health, Grand Rapids, Michigan, further predicted, “In the future, there will be healthcare exchanges and subsidies for low-income persons, but the middle class may be squeezed. Their out-of-pocket costs could be up to $6000 for an individual or $12,000 for a family. Even Medicare and Medicaid will experience more cost-sharing. This is a new disparity.” One result of this is a population of persons who bypass preventive care and screening, and thus enter or reenter

The population in the US is not getting any healthier, despite broadening access to care and efforts to eliminate disparities....This is largely because the socioeconomic gap is widening and healthcare is becoming less affordable, especially to the middle class.

JULY 2013 I VOL 6, NO 6

Roy Beveridge, MD, chief medical officer of McKesson Specialty Health, predicted that healthcare reform will increase coverage for previously uninsured persons, “but it is going to create other types of problems for how we care for them.” Newcomer predicted it will broaden access to care but not affect the escalating cost of care. “Access may not be worth much if people cannot afford the deductible,” he pointed out. Involving the Patient Greater attention must be paid to early integration of palliative care, both for quality-of-life reasons and as a way to reduce the cost of end-of-life care. Fox suggested that before cancer outcomes

can be improved, oncology stakeholders need to determine “which outcomes are most valuable.” At Priority Health, he said, they are “those that are most valuable to our patients,” and this is not necessarily longer life expectancy. The patient’s list of priorities must be front and center of clinical decision-making, and any treatment should be consistent with them. “The only way to know this is to ask the patient,” Fox said. Beveridge saw other obstacles to the successful integration of palliative care or end-of-life care: the lack of manpower to effectively deliver it, and the

fact that patients often fail to grasp its meaning. “Patients don’t want to make their caregivers unhappy. We have found in interviews that many will accept a third or fourth line of futile therapy because they don’t want to let their doctors down. Interestingly, physicians say they are giving futile therapy because they don’t want to let their patients down,” he said. Newcomer called this a “philosophical barrier.” “Americans still think death is an option,” he said. “We have a whole culture that says it is wrong to stop [treatment],” and this impedes a full and open exchange about prognosis. “When you throw in the family and cultural dynamic, you almost need the Department of State as a negotiator,”

Beveridge added. “We have found that it is frequently better to have a nurse practitioner or social worker introduce the topic, because we as physicians are not trained to do this, and we don’t do it particularly well.” Tools to help initiate these discussions are becoming available, including the American Board of Internal Medicine Foundation’s Choosing Wisely program, which includes American Society of Clinical Oncology’s “Top Five” list of common, costly procedures in oncology that are not supported by evidence and that should be questioned. Some practices in the UnitedHealth network are asking patients to complete the Choosing Wisely form on hospital admission. “These practices are achieving much more patient-oriented outcomes, far fewer days in the ICU [intensive care unit], and more deaths at home, because they are having this discussion,” Newcomer reported. He said that he recently used the Choosing Wisely tool with his own parents and was surprised at what he learned. “I changed my viewpoint about their end-of-life care. This can be done,” Newcomer said. “It doesn’t require an army of palliative care specialists but a cultural commitment.” Some employers are beginning to see the value of palliative care and have expanded benefits accordingly. Some are even subsidizing advanced care directives and living wills. “At Pitney Bowes, we provide incentives for this,” offered John J. Mahoney, MD, MPH, consultant to Pitney Bowes. How “Big Data” May Personalize Medicine “Big data” will revolutionalize cancer care, panelists predicted. The power of tools like Watson is already being realized, said Marty Kohn, MD, MS, of IBM. Watson is a computer learning system that self-corrects and self-improves with little human input. “Watson can read and comprehend thousands of articles in a few seconds,” according to Kohn. Watson’s future role in therapeutic decision-making can be demonstrated in a joint venture between Memorial Sloan-Kettering Cancer Center and WellPoint. Watson is being taught to understand the critical attributes of a cancer patient’s history, to consult the literature and evidence-based guidelines, and to come up with treatment recommendations. But big data and tools like Watson do far more than accumulate information, Kohn pointed out. They draw from

www.TheOncologyNurse.com

Conference News: NCCN multiple pathways to create a basis for making personalized decisions that are more likely to have value. It is not just â&#x20AC;&#x153;lots of dataâ&#x20AC;? but data that encompass volume, velocity, variety, and variability. More real-world than Watson was the example given by Newcomer, who noted that UnitedHealth Group has access to a decadeâ&#x20AC;&#x2122;s worth of information on 70 to 80 million people that can be integrated with state tumor registries and insurance claims data to create longitudinal records for individuals. This will be used to profile chemotherapy regimens and their progression-free survival rates, he said. He expects this registry to be a more realistic picture than is gained from clinical trial data and to be useful to third-party payers in determining coverage. Among the panelists, Andrew von Eschenbach, MD, president of Samaritan Health Initiatives, Montgomery, Texas, and adjunct professor at M.D. Anderson Cancer Center, Houston, Texas, was particularly enthusiastic. â&#x20AC;&#x153;Big data is the most critically important thing we could be talking about,â&#x20AC;? he said. â&#x20AC;&#x153;If we have any hope of improving outcomes, itâ&#x20AC;&#x2122;s in the big data.â&#x20AC;? The capturing of big data will revolutionize basic research and allow for modeling in silico cellular processes, biological processes, and multiple oncologic pathways. In clinical research, big data will allow for more sophisticated analyses that will â&#x20AC;&#x153;move us from information to real knowledge,â&#x20AC;? von Eschenbach predicted. â&#x20AC;&#x153;Then, with physician engagement and interpretation, we get to wisdom,â&#x20AC;? he said, which should lead to the ultimate goal of giving the right treatment to the right patient for the right reason. â&#x20AC;&#x153;That is the difference between rational medicine and rationed medicine.â&#x20AC;? Others on the panel were more cautious. â&#x20AC;&#x153;The trick is not to acquire data alone,â&#x20AC;? according to Beveridge, but to assure that the integrity of the data is strong. Fox emphasized that data should not be used â&#x20AC;&#x153;in a vacuum,â&#x20AC;? but in the context of patient preferences, which may include no active intervention. â&#x20AC;&#x153;We think about how to improve overall survival, but the challenge is for us to think differently. Overall survival is not the sine qua non of cancer care.â&#x20AC;? How to Brave the New World: The Evolving Ecosystem The future of cancer care requires a reformed â&#x20AC;&#x153;ecosystem,â&#x20AC;? in the words of Goodman. This means the integration of components in a multidisciplinary approach and a competitive collaboration to problem solving. The evolving ecosystem is no longer centered on individual excellence but rather on interoperable performance.

www.TheOncologyNurse.com

â&#x20AC;&#x153;We were trained to play golf. The â&#x20AC;&#x153;61 separate phenomenal cancer cengame has switched to basketball,â&#x20AC;? von ters, but 61 playing together like a Eschenbach said. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s about interoper- well-orchestrated team.â&#x20AC;? ability [and] how to work together so â&#x20AC;&#x153;As we look toward a brave new that I canâ&#x20AC;&#x2122;t be as good as I need to be world in oncology, itâ&#x20AC;&#x2122;s tempting to without Lee Newcomer.â&#x20AC;? look at all the high-tech stuff we have Goodman noted that von for discovering the next cure, but in Eschenbach once headed up the this roundtable we saw that in order to National Cancer Institute: â&#x20AC;&#x153;many get to the next level, we canâ&#x20AC;&#x2122;t forget competing cancer institutions doing that we have disparities in care that research.â&#x20AC;? The ideal scenario, von drag the system down,â&#x20AC;? Goodman conEschenbach said, would not have been cluded. CCC Asize_revised_052313_TON0210 6/5/13 9:30 AM Page 2 â&#x20AC;&#x153;We need to hold up that part

of our at-risk population at the same time we advance the cutting edge with big data and reorganizing the cancer ecosystem. Our current incentives and disincentives are not providing for optimal care.â&#x20AC;? l Reference

Goodman C, Beveridge R, Fox J, et al. The changing oncology landscape: evolution or revolution? Presented at: 2013 Annual Conference of the National Comprehensive Cancer Network; March 15, 2013; Hollywood, FL. Roundtable discussion.

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

2ND ANNUAL

CONQUERING THE CANCER CARE CONTINUUM

â&#x201E;˘

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

A 6-part series

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

IN THIS ISSUE

â&#x201E;˘

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

cancer.1 More than half are living well beyond 5 years ancer is an illness associated with substantial physical, emotional, social, and financial ramafter diagnosis. Women comprise a majority of longifications for affected individuals and their term survivors due to the favorable outcomes with families. In a significant number of cases, the diagnosis breast, cervical, and uterine cancers.2 The number of of cancer is either preceded by a period people living with a history of cancer of gradual, nonspecific symptoms or is projected to grow considerably over discovered by routine screening, and the next 20 years for 2 major reasons. individuals are then thrust into a First, the number of Americans over whirlwind of diagnostic testing, inage 65 is predicted to double between vasive procedures, and complicated the years 2000 and 2030.3 Consetreatments with very little warning or Lea Ann Han quently, as a disease primarily of older sen, Associat e ProfessoPharmD, BCOP adults, cancer will also increase. Secopportunity to assimilate their circumr, Virginia Common stances. Frequently, a multidisciplinary ond, as the effectiveness of cancer wea ersity the number of â&#x201E;˘lth Univ approach to treatment is necessary, retreatments improves, he past deca de has seen a dram quiring patients to engage with numerpatients cured of the disease will inthe utilizatio atic upsu n of spec ous medical teams comprising several crease, andrge an in even larger ialty pha types of Medpercentage rmacies for icare Mo Lea Annther Hansen, apeutic dern different specialties, often in different those for can will be living all longer with mod as â&#x20AC;&#x153;athe disease ization Act defi alities, incl cer. The BCOP PharmD, D drug ned a spec cost of can uding multiple part locations. Many patients have beenabout $125 billi while receiving ialty drug cer care may ceed â&#x20AC;&#x153;linesâ&#x20AC;? of with plan-negotia on in 201 0 rise from etc) over $40 ted prices 0 to (first-line, relatively healthy prior to the cancer lion eventbyand second-line, time. per Themonth.â&#x20AC;? 2 Oth thethere7 bilthat exend of the therapy$20 fine spec er health ialty drug deca plans may de. demand fore are not sophisticated consumerstim ofe,medical overall specialtyserBy that for oncology services is expected to ins different dedrug ly. In gen s are pred acco eral, they unthealthcare icte48% vices. Consequently, it is incumbent on by for 2 of ever crease d toby 2020, while the supply of oncologists high cost, adm are inis y 5 tered by pha increase lars spentransition professionals to be able to facilitate patientsâ&#x20AC;&#x2122; cy dol-by only 14% based on current patterns.4or infusion, t. 1 The purp willrma require spec injection ose is of to this artic ial handlin expand into care in orderealth to minimize their distress the need for a wide varietyor are used D, BCOP lain maxiUniversity le underscore the evolutioThese statistics g, en, Pharm for complex to 80%, Commonw 17% ia cial n Lea Ann Hans ssor, Virgin from of ty dise requ range the pha mize their clinical outcomes. of ens healthspeprofessionals and other support personnel to ire spec ases that rmacy ation Profe regim and the ial monitor Associate on assumption oral medic can func2-4 term serv cology, how ing. In onA scomm Challenges existic beyond the initial diagnosis play ation part e in theand ent d 50%. itin enabling each and every patient to rearoun ever, the getrea system treatm tment of ancer agents would be an avera andwith most com to the agents disp nt scenario forperiod as well.istracan According to National ceive quality all of their needs disc antic cer care that addresses ussence mon the pote to oral ensed by he predomina treatment involved admin se, has been adher andthat ntia a specialty disea lityben macy prov thethe traditionally ofefits (NCI), more million individthroughout continuum of the illness. Patients dellen pha ges highlythan 12cha sever by rider of the of cancer has Cancer Institute the apy the (SPP) are due to system from e. Studies indicate pointhighe targeted of view enous chemother the newer United the States are ar,history fine quality their ability to5: nt.living with the of care based on n untru patie of theofpati agents that prove tion of intrav uals in the py are ent. ly monitored are adminis for cancer thera tered oral nnel who close ly. After adherence rates5 has trained perso in an The Evo a systema Nonadherence view dures took place luti tic reďż˝ďż˝ďż˝ďż˝ďż˝ďż˝ďż˝Green Hill Healthcare 15% to 97%. mes Communications, LLC of the literature, When these proce infuDrugs an on of Spe cialty iated with worse outco one acad group of or in a hospital d emic authors prop been assoc and with oncologistâ&#x20AC;&#x2122;s office Pharmac Specialty e states osed tion of the crit diseas educa Lea of the ical er sive Ann most y descriptors in a numb Hansen r hossion center, exten , highe of a spec There is drug to be 3 cian visitsPha possible. More rmD, BCO , was physi y a ialty ased lack famil : incre stays, P of consens patient and specialty ly comâ&#x20AC;˘ High cost us on therates, longer hospital drug. The ver, an increasing definition (prescription Food andpitalization recently, howe not defined incre of a ased morof one or Dru worsening, and s cost mor than $600 the term. involves the use inistration one-third â&#x20AC;˘ e toDifficult diseasgeAdm per month) Initially mon situation synonym dminmedication has , the6 Approximately ous with ations and self-a delivery, l was virt tedâ&#x20AC;&#x201D; Special biotech tality. labe such as more oral medic teins prod uallcatio pies in the handling y n-rela gy prod all medi uced by reco nolotwo-t hirds uctsof, eith requiring taneous thera ation control ner medic istered subcu mbi strict tem mon to prorespo nan due oclo t DNtaliza perature nal antibod tions are nt. The direct A tech â&#x20AC;&#x201D; Restrict hospi niquesa or ies produce of $100 bilhome environme bridomas, admincost ed and at loca sition d nceâ&#x20AC;&#x201D; tion for med but this acqui dherecell is no long nonawith ular purpose of this ar- or distribut ication prep and sibility for drug 7 ThehyLillietsD. er theannu ion site aration Shockney, ng to the patien en, lion caseally. . The 200 al conceâ&#x20AC;&#x201D;ptsRestricted loca istration is shifti RN,Ann availLea BS, Hans 7 ibe gener MAS P rt network, if tion for med ticle is to descr PharmD, BCO their social suppo ch related totration ication adm than 20 and the resear nt time, moren part 2 of inisďż˝ďż˝ďż˝ence adher tďż˝ďż˝ďż˝ ďż˝Green Hill incidence, risk facfor our Conquer able. At the prese regarding patien serived s are FDA appro es, the treatment. TheHealthcare addition, ing the Cancer to r Com ed. In 1). cance focu e mun review oral medication be Car s is on pain adherence icati will e Continu cancer (Tabl man umprobleminab ly examine ons, LLC rs that treatment of matic imp es of this tumo rov the first-line ent.quencpite used for ements in tors,agem and conse wellsasaresurg to ove Ac- pharmaceu eDes dra-will subsequentility clinic other oral agent al rcome it ical in this series l treatm procent. articl andle a number of die initia tica last to effe ence edu whi l The tory age ctiv adher res we ely, fear in grea or are refrac still have a long er Net-designed to help ices for nts, asizing mon maxim nsive Canc have relapsed way to ly respond t pain. Family mem ing they will the best practcontrol pain Com cess fulprehe National on behalfound s in thego to be sucthat their , cording to the ness their of our greatest fear bers, too, comof all comp outcomes. pati I was tely 25% loved one recentlynewat are admin-ents. in great pain is having to witwork, approxima utes opment pipeli ching a few ch and develof an old, blac ease min- nue.1 the sufferin without a way to oncology resear d Health Organ k-and-w is likely to conti trendmov g. Family asedhite wes ed by the Worl so the ern , incre ie. defin fear beorally the was d A s nâ&#x20AC;&#x2122;s tthe cow istere mem rence a perso se will be the nsibility come boy had respo nt to which a gun inby been shoAdhe final images bers r slination witn ger,sand may not be adWith this shift t n in 2003 as the â&#x20AC;&#x153;exte ing a diet, and/o ess before their izatio as the re torancer attemedic antic loved one they mpted n doc- r, taking medication, follow that requitow Many org possibility that from ially toens dies. for regim rem ove the bul havio ctly, espec his chest, adher oped mea anizations have dev ence to longlet ministered corre the estim ates of anothe sure elr all nde g. Overwou tice guidel ment tools and pra d man a bot cowboy gave repeated dosin to unications, LLC ine Comm tleHill s drink and for hcare of whi Healtskey the purpos chelping pro en a ďż˝ďż˝ďż˝ďż˝ďż˝ knifeďż˝ďż˝Gre e of to bite viders his teet

THE QUERING N O C ANCER CARE C

â&#x20AC;˘ Palliation â&#x20AC;˘ Pain management â&#x20AC;˘ Hospice care â&#x20AC;˘ Treatment planning â&#x20AC;˘ Survivorship care â&#x20AC;˘ Biosimilars in supportive care

NUUM

â&#x201E;˘

Conveni en The Impa ce, Challeng es Patient ct of Specialty , and Cost Con Care Pharmac tainmen ies on t:

TU U M CONTIN

SECOND ISSU Therapy E IN THE 2013 SE RIES SE C O N D AN N UA L

CONQUERING T CANCER CAREHE

er nce to Canc Nonadhere Impact of

CONTI

NUUM

Introduct ion to Onc ology Pa in Manag ement

â&#x201E;˘

between effectively h. Iâ&#x20AC;&#x2122;m age pain asso manwas how peo sure back in the day its treatme ciated with cancer this nt. and quor to numple coped with pain provide you The following arti â&#x20AC;&#x201C; cles hard to bite b them and someth limation asso with a wealth of info ing on. This is rfar from idea Today all and guidel ciated with these tools ines. The hospital env patients who ent l. y also pro that though er a mote tful care be an inpatie ironment, whether sure that nt it taken to enLillie D. Sho all their doctor, unit or a clinic visit be ckney, RN, cancer pat of us address with with BS, MAS our ients the pain measure are asked to complet exp pai e n eriencing of whethe ment tool that provide a and implem they are to relieve r the s some exp ent ways it. Pain gree. Patien y are presently in ression pain physical end time, psychologi steals away social what to circ ts have trouble, how , and to what decal le tually absent urance and can mak well-being, and pain was bad (a happy face or a ever, interpreting e quality of very sad face and adequa for some patients. life vircause they in the morning but ) if their Accurate te treatme too not so bad asse ment nee doctor. Fur k a pain pill befo now bed to be prio nt for effective pain ssment re thermore, the cancer man rities for is this info coming to see the viewed by all of us wor agefield. any rma king in I feel confide and sometim one during their visi tion actually rent you t? Sometim es it is not provoking will find the . es it is, Certainly and contain se will assist ing valuable articles thought cer patient one of the greatest fear you information s is the fear s well as dev in reassessing you of pain and expressed by canr current pati that eloping mo suffering and future pati re effectiv ents as ent e the fectively man s have quality of life ways to help your by having aged. Q pain efÂŠ 2013 Gre en Hill Hea lthcare Com munications, LLC

TO VIEW THE SERIES ONLINE PLEASE LOG ON TO:

www.TheOncologyNurse.com TON A-SIZE CCC_060413

JuLY 2013 I VOL 6, NO 6

Standard definition is obsolete. Why use SD vein illumination?

the

ONLY HD vein illumination. VeinViewer

VeinViewer

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.

Visit

www.veinviewer.com