March/April 2014
www.TheOncologyNurse.com
Vol 7, No 2
The Patient’s Voice
Cancer Center Profile
St. Jude Crosson Comprehensive Practice Makes Not Perfect: Striving After Cancer Cancer Center Carolyn Comeau
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s a 7-year breast cancer survivor, my primary feeling most of the time is awe and gratitude that I’m still here. I can savor life’s small moments and big events, from sipping a piping hot tall dark roast to celebrating my dear friend’s 50th by dancing my youknow-what off! There’s a phenomenon I’ve spoken about with other survivors, however, that also often accompanies survivorship and can at times be vexing. It’s similar to something I’ve dubbed the “What Did You Do to Get Cancer Syndrome” (WDYDGCS),
Sue Lepich, RN, BSN, a breast nurse navigator at the St. Jude Crosson Comprehensive Cancer Center in Fullerton, California, talks to a patient who is receiving a chemotherapy infusion.
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he St. Jude Crosson Comprehensive Cancer Center, located in Fullerton, California, is part of the St. Joseph Health System. The cancer center was established in 1998 and includes the Ann G. Fetters Diagnostic Imaging Center, the Fred A. Jordan Family Radiation Oncology Center, and the Kathryn T. McCarty Breast Center. Using the combined expertise of medical oncologists, radiation therapists, surgeons, and other cancer specialists, the cancer center provides advanced diagnostic procedures and therapies, ongoing clinical trials, and treatments based on the latest breakthroughs in biotherapy, chemotherapy, and immunology. In addition, the center offers a nurse navigator program, a resource library, classes, support groups, Continued on page 22
Alice Goodman
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he 2014 Genitourinary (GU) Cancers Symposium, sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology and held in San Francisco, California, packed a wealth of information into just
2½ days. Presentations focused on prostate, bladder, testicular, kidney, and other less common GU cancers, providing excellent reviews of the state of the art as well as a multitude of news stories related to potential advances. Below is a summary of some highlights from the meeting.
Continued on page 12
Genetic Counseling
Hereditary Melanoma Cristi Radford, MS, CGC Ambry Genetics
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ay 5th is Melanoma Monday, as designated by the American Academy of Dermatology.1 Melanoma is a form of cancer that begins in the melanocytes. It may originate in the skin, eye, or intestines. As most people know, exposure to sunlight and artificial sources of ultraviolet radiation, such as tanning beds, are the main risk factors for cutaneous melanoma.2 In addition to sun exposure, other risk factors include pigmentary characteristics, nevi,
Conference News
Highlights of the 2014 Genitourinary Cancers Symposium
which occurs when one is first diagnosed. My main topic is its sequel, “Perfect Survivor Syndrome,” or PSS, but in order to talk about that, I have to first familiarize you with WDYDGCS. When I was first diagnosed, I received an outpouring of love and support from close friends, family, acquaintances, and strangers alike, but with some, there also came a dose of questioning about how I lived prior to my getting cancer. I was peppered with questions about my precancer lifestyle, some quite personal. “Did you
immunosuppression, family history, and personal history. Similar to all cancers, a proportion of melanoma is due to inherited predisposition. Approximately 10% of cutaneous melanoma cases are attributed to inherited factors.3 There is an inverse correlation between melanoma risk and skin color. Lighter skinned ethnic groups are more likely to develop melanoma than darker skinned ethnic groups. Therefore, clinicians should Continued on page 14
inside Empowering Patients and Survivors. . . . . . . . . . . . . . . . . . . . Living, Loving, and Legacy Perspectives. . . . . . . . . . . . . . . . . Building Trust With Patients
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Side Effects Management. . Understanding FOLFOX Toxicity: Some Subsets Have Higher Risks
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Best Practices. . . . . . . . . . . . . . What Is the Patient’s Experience With HCC?
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Continued on page 8 ©2014 Green Hill Healthcare Communications, LLC
Renal Cancer . . . . . . . . . . . . . . Molecular Therapy Beyond Sorafenib in HCC: New Pathways, Targets Being Explored
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The Whole Patient. . . . . . . . . . The Dynamic Partnership of Music and Medicine
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Through the Eyes of an Advocate . . . . . . . . . . . . . . . . In a Perfect World of Scientific Conferences: Less Stress, Less Strain!
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FIFTH ANNUAL
Y E AR A N N I V E R S A RY
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A N N I V E R S A RY
September 18-21, 2014 Walt Disney World Dolphin Hotel • Orlando, Florida
TO DATE, THE CONFERENCE HAS HAD MORE THAN:
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Expert Speakers
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(only missed your first year). I submit a report
to provide new and motivating presentations. – 2013 Conference Attendee
93%
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93% of 2013 conference attendees said they intended to change their practice as a result of participating in the AONN+ Conference
50 40 30 20
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2011
2012
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“WOW! I am so impressed with the growth of AONN. Lillie, Sharon, and their team are awesome. The speakers were knowledgeable about their subject matter and all the presentations were relevant to my practice. I will use the pearls of wisdom shared by the speakers to my team at
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97% of 2013 conference attendees rated the AONN+ Conference as Above Average or Excellent when compared with other continuing education activities
home. I arrived feeling we have a pretty good program and I am leaving with ideas to share to make it even better!” – Donna Moore Wilson, BSN, RN, CBCN Oncology Nurse Navigator Bon Secours Cancer Institute Richmond, Virginia
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Editorial Board EDITOR-IN-CHIEF
Beth Faiman,
PhD(c), MSN, APRNBC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH
Catherine Bishop, DNP, NP, AOCNP
Shannon Hazen, RN, BSN, OCN Novant Health Presbyterian Cancer Center Charlotte, NC
Patricia Irouer Hughes, RN, MSN,
Melinda Oberleitner, RN,
Karla Wilson,
College of Nursing and Allied Health Professions University of Louisiana Lafayette, LA
City of Hope National Medical Center Duarte, CA
Jayshree Shah, NP
Pharmacy John F. Aforismo,
DNS, APRN, CNS
John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ
Johns Hopkins Kimmel Cancer Center/Sibley Infusion Washington, DC
BSN, OCN
Deena Damsky Dell, MSN, RN-BC,
Taline Khoukaz,
Gary Shelton,
University of Southern California Norris Cancer Center & Hospital Los Angeles, CA
NYU Clinical Cancer Center New York, NY
AOCN, LNC
Fox Chase Cancer Center Philadelphia, PA
Wendy DiSalvo,
DNP, APRN, AOCN Genentech New London, NH
Denice Economou,
RN, MN, CNS, AOCN City of Hope National Medical Center Duarte, CA
Constance Engelking, RN,
MS, CNS, OCN
The CHE Consulting Group, Inc. Mt. Kisco, NY
Amy Ford, RN,
BSN, OCN Biodesix, Inc. Dallas, TX
Piedmont Healthcare Rex, GA
NP, MSN, ACNP-C
MSN, NP, ANP-BC, AOCNP
Sandra E. Kurtin,
Lori Stover, RN,
Arizona Cancer Center Tucson, AZ
Western Pennsylvania Cancer Institute Pittsburgh, PA
Ann McNeill,
Joseph D. Tariman,
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
BSN
PhD, APRN, BC Northwestern University Myeloma Program Chicago, IL
Jacqueline Marie Toia, RN, MS, DNP Northwestern University Myeloma Program Chicago, IL
Pamela Hallquist Viale, RN, MS,
CS, ANP, AOCN Saratoga, CA
RN, MSN, FNP-C, CPON
BSc Pharm, RPh, FASCP RJ Health Systems International, LLC Wethersfield, CT
Nutrition Karen Connelly, RD, CSO
Somerset Medical Center Somerville, NJ
Patient Advocacy Peg Ford
Ovarian Cancer Alliance San Diego, CA
Social Work Carolyn Messner, DSW, MSW, LCSW-R, BCD CancerCare New York, NY
Genetic Counseling Cristi Radford, MS, CGC Ambry Genetics Sarasota, FL
Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS
Onco360/OncoMed New York, NY
Sharon S. Gentry, RN, MSN, AOCN, CBCN
Ellen A. Neylon, MSN, FNP-BC, CCRP, OCN
Novant Health Derrick L. Davis Cancer Center Winston-Salem, NC
Columbia University Medical Center Center for Lymphoid Malignancies New York, NY
Cassandra J. Hammond, RN,
Dolores “Jeff” Nordquist, RN, MS,
Avid Education Partners, LLC Sharpsburg, MD
Mayo Clinic Rochester, MN
MSN, CRNP
www.TheOncologyNurse.com
CS, FNP
Connie Visovsky,
PhD, RN, ACNP-BC University of South Florida College of Nursing Tampa, FL
Rita Wickham,
PhD, RN, AOCN Northern Michigan University Independent Oncology & Palliative Care Consultant Marquette, MI
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
MARCH/APRIL 2014 I VOL 7, NO 2
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From The Editor PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko ppawelko@the-lynx-group.com Group Director, Sales & Marketing
John W. Hennessy jhennessy2@the-lynx-group.com Publisher Russell Hennessy rhennessy@the-lynx-group.com Editorial Director Kristin Siyahian ksiyahian@the-lynx-group.com Managing Editor Kristen Olafson kolafson@the-lynx-group.com Copy Editors Mollie Friedman Peggy Roeske Editorial Assistant Jennifer Brandt Production Manager Cara Nicolini
The Lynx Group President/CEO Brian Tyburski
I
n this issue of The Oncology Nurse-APN/PA (TON), we discuss some of the “personal” situations we may confront as healthcare professionals. Carolyn Comeau talks about how she struggled with trying to be the “perfect patient” and then the “perfect survivor” as she dealt with breast cancer treatment and her life in its aftermath. If some of our patients Beth Faiman, PhD(c), feel this pressure, how can we MSN, APRN-BC, AOCN identify this and help them proEditor-in-Chief cess these emotions? Sue Bond addresses how to be honest, without be a “Debbie Downer,” when treating patients who have incurable metastatic cancer. She states, “Good relationships, especially therapeutic relationships, have to be built on trust and honesty.” This month’s Reader Poll asks if this is a situation you have confronted (see below). Please tell us what you say to patients and how you respond to their concerns. We also present information about the role of music therapy. At the recent Academy of Oncology Nurse &
Chief Operating Officer Pam Rattananont Ferris
Reader Poll
Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore
Do you confront the issue of how “honest” to be with patients about their incurable metastatic cancer?
Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen
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Patient Navigators annual conference, Deforia Lane, PhD, MT-BC, noted “the ubiquity of music” in our lives and presented specific examples about the positive impact of music therapy for patients. When it comes to attending conferences, many of us have become stressed as we juggle travel schedules and getting to all the sessions we want to attend. In her Through the Eyes of an Advocate column, Peg Ford wonders “what [can] be done to ease the toll that attending conferences must take on healthcare providers and researchers, who are already strained with the demands of their important work.” She discusses a recent conference for cancer patient advocates, sponsored by BAG IT, that directly confronted some of the typical stresses and strains felt by many conference attendees. Interestingly enough, the program announcement for the upcoming 2014 ASCO conference describes a “meeting-within-a-meeting” structure, “designed to create a more intimate, symposium-like feel for certain tracks” to increase “both convenience and navigability” for attendees. Please visit our website, www.TheOncologyNurse.com, and tell us what topics you want to see covered in TON. We love to hear from you and we appreciate your feedback. l
o Yes
o No
©iStockphoto.com/Slobodan Vasic
S
ue Bond, in her “Building Trust With Patients” article, discusses the role of honesty when treating patients with incurable metastatic cancer—
placing the discussion in the context of Kübler-Ross’s stages of grief. How do you handle this situation? What if telling the “truth is a downer?”
Go to www.TheOncologyNurse.com to answer the question and add your comments.
The Oncology Nurse-APN/PA®, ISSN 1944-9798 (print); ISSN 1944-9801 (online) is published 6 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2014 by Green Hill Healthcare Communications, LLC. All rights reserved. The Oncology Nurse-APN/PA® logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, The Oncology Nurse-APN/PA®, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: editorial@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues, $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in The Oncology Nurse-APN/PA® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in The Oncology Nurse-APN/PA® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.
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Empowering Patients and Survivors
Living, Loving, and Legacy Angela Long
“At the end of our lives we all ask, ‘Did I live? Did I love? Did I matter?’” Brendon Burchard
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fter a nearly fatal car accident, Brendon Burchard, author of The Charge, said that at that pivotal moment on death’s doorstep, he asked himself 3 questions that to this day help him live life more fully. “Did I live? Did I love? Did I matter?” I’ve never been in a car accident in which my life was endangered, but I did see my life flash before my eyes when I was diagnosed with breast cancer. During my treatment and for quite some time thereafter, I spent many sleepless nights pacing the house asking myself whether I had lived, loved, and made my life matter. I questioned whether I had loved with my whole heart and had let my love be known. Most importantly, I wondered how I would be remembered, or whether I would be remembered at all, by my two children,
who were only 5 and 2 at that time. When we receive a cancer diagnosis, we hope that our diagnosis does not mean we have reached the end of our life, but the shattering news causes us to examine our life with new lenses. Have I Lived? “It is not the things we do in life that we regret on our death bed. It is the things we do not...Find your passion and follow it.” Randy Pausch
I was 35 when I was diagnosed with breast cancer. Despite my young age, I felt some peace when reflecting on my 35 years. I had not done or seen nearly all that I wanted to, but I had traveled and had enjoyed many experiences that I had dreamed of as a child. What I regretted was that I had played it safe. I hadn’t taken risks. I hadn’t dreamed big. I would change that when given my “second chance.”
I stopped sweating the small stuff and started concentrating on the big picture. My friend, and cancer survivor, Jan Brown shares a similar experience. She says that after her cancer diagnosis, “Things that seemed so important became trivial. I learned to just get over myself.” A cancer diagnosis may also teach us to appreciate the moments. We often become more present in our everyday experiences
Angela Long
and soak them in through channels of gratitude we hadn’t known before. Cheryl Stoppiella explained what cancer taught her: “Don’t just stop to smell the roses. Touch them and be sure to pick some to share with your loved ones. Every moment, no matter how insignificant, has a miracle in it.” Have I Loved? “Carve your name on hearts, not tombstones. A legacy is etched into the minds of others and the stories they share about you.” Shannon L. Alder
When it comes to love and relationships, I have to admit my epiphanies did not come all at once. But they came far more quickly once I became more aware of the precious commodity of time. I became acutely focused on spending my time and energy on the relationships that mattered most to me. I began to weed out those relationships that—
Perspectives
Building Trust With Patients Sue Bond, FNP-ANP
M
y kids often call me “Debbie Downer.” I tell them this is not so. I’m realistic, the devil’s advocate looking at everything from all sides, and I’m honest. This, they tell me, is a downer. Perhaps they are right, but that is the way I think—I have never been good at white lies. I feel that if you ask me for my opinion I should give you my opinion, the good, the bad, or the ugly. Now this does not mean I am totally devoid of tact—I have, over the years, learned to temper this honesty with compliments and distraction techniques. Honesty is not always a bad thing: I am also the person who tells you that you have something in your teeth, yanks toilet paper off your foot, or pulls out that skirt, which you somehow tucked into your panty hose, before you leave the restroom. So how does honesty enter in to treating incurable metastatic cancer as it relates to Kübler-Ross’s well-known stages of grief? 1. Denial: We all have experienced those patients who tell you shortly after being stunned by the diagnosis that they are going to beat cancer, that they will be the miracle. Who am I to tell them “No, most likely not.” Who
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am I to take away that glimmer of hope in their eyes? So how do you keep reality in the picture without dousing that light? We all know when the doctors come in and tell our patients that their scans are great that patients believe they have been cured—that their idea of great scans differs from the doctor’s idea of a great scan. There is a big difference between cured and no or little progression. Explaining this difference to our patients is important, and it is part of the fine line between likely reality and their fantasy that many of us walk with them on their journey. 2. Anger: How often do we hear “I never smoked, why do I have cancer?” or the hardest question of all “Why me? It’s not fair.” I honestly don’t know how to answer that question; who does? So I agree with them that it isn’t fair and they aren’t at fault. Our patients know we can’t answer that question, so we should not try; rather, listen to them, sit with them, and care with them. 3. Bargaining: “If I have a positive attitude then I will survive.” “I prayed to God to save me, and I know He will.” These are common statements that lead to hard conversations, and I find that just listening is usually best at this point, but sometimes patients
Sue Bond, FNP-ANP
push for my opinion. I tell them that if it were attitude, or desire, we would not have to look for a cure. If it were strength, or being a good person, we would not have to look for a cure. When patients talk about their faith or strength of prayer, I remind them that we can pray for what we want, but we also pray “Thy will be done,” and often His will is not our will. There is no such thing as not praying enough or hard enough. 4. Depression: Eventually it becomes obvious, even to those with the strongest cases of denial, they are not going to get better; they are not going to get their miracle. This is when we do a lot of hand holding, not only for our patients but also for their loved ones. And this is when I feel that the
trust that has been built with honesty through all of the other steps most benefits the patients. They know they can be open and honest with me; they can be angry, frustrated, scared, and sad. 5. Acceptance: Most of our patients eventually do accept their fate, sometimes before their families. I often try to speak to families together about allowing the patient the freedom to die. I ask them to be honest with each other. Frequently the patient is being brave and fighting for the sake of loved ones, who in turn are being brave and encouraging for the sake of the patient. In reality they all know that it is time to move to the next step but are afraid to be the first to admit it. Sometimes just starting the conversation is all it takes for them to have a frank discussion about what their future and goals should be. Is it the best policy to be honest with our patients? I think so. Good relationships, especially therapeutic relationships, have to be built on trust and honesty. During this time of upheaval, patients need to be able to have something solid they can count on, someone they can trust, someone who will tell them the truth, even if that truth is a downer. l
www.TheOncologyNurse.com
Empowering Patients and Survivors for whatever reason—didn’t matter as much. I instinctively began to tune into the difference between giving my unconditional love versus maintaining unconditional relationships that did not create healthy connections. Cancer compelled me to work to honor my loved ones for who they are, regardless of how I think they should be. I love them warts and all and expect them to love me the same. Though cancer can take its toll on the best of marriages and leave already vulnerable relationships in shambles, my experience was to the contrary. My husband and I have had a strong friendship and bond since first meeting in high school. After battling cancer together, that love and bond only grew stronger. Vicki Tashman, founder of Pink-Link breast cancer support network, also found that her diagnosis strengthened her marriage. She says that she and her husband are “more emotionally intimate” than they were prior to her breast cancer. I believe part of that comes from being vulnerable and allowing ourselves to be honest with all of our emotions. Vicki said, “At the beginning of my journey, he said to me, ‘I can’t wait until you get back to normal.’ I replied, ‘Well, there’s going to be a new normal and I hope you’re on for the ride!’ ” Have I Mattered? “Live today the way you want to be remembered tomorrow.” Dillon Burroughs
When I would look at the faces of my two beautiful children, I knew that my life had mattered. Less certain of the significance my life had outside of being a mom, I made a promise to God that if he got me through, I would use my experience to make a difference in the lives of others. He has held me to it. I know I am not alone in my promise, as there are thousands of scholarships, foundations, nonprofits, and businesses that have emerged from the single seed of such grateful emotion. Leaving a legacy certainly doesn’t mean one needs to start a nonprofit or volunteer the rest of one’s life away. Time and reflection have taught me that our legacy lives within our every day. Sometimes what seems insignificant to us can move mountains for others. Our job, our family, and our daily exchanges with those we encounter are opportunities for us to leave our mark on the world and in the hearts of others. I would not imply that cancer is all about enlightenment. If we are fortunate to have positive revelations about our life and how we want to live after cancer, these revelations are most often entwined with many days, months, and sometimes years of sadness, anxiety, and possibly depression. Through
www.TheOncologyNurse.com
time and healing, with support and a lot of reflection, it is more than possible to gain a new and more positive outlook on life following a cancer diagnosis. As a response to those 3 questions I asked myself after diagnosis, I have vowed to spend the rest of my days living a life of service: first, service to myself in living the life that I dream; second, service
to my loved ones by loving with my whole heart and without condition; and last, service to others by working toward things that matter and make a difference in the biggest and even the smallest ways. If you would like a list of resources surrounding the topics of living, loving, and legacy, email me at angela@breastinvestigators.com.
l
Angela Long is the founder and creator of Breast Investigators. Breast Investigators serves as a comprehensive resource guide to help those affected by breast cancer readily gain access to quality information, care, assistance, and support. Visit www.BreastInvestigators.com.
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WORLD CUTANEOUS MALIGNANCIES CONGRESS
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OCT. 29 - OCT. 31, 2014
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WCMC CONFERENCE CHAIR Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Medical Oncology & Hematology St. Luke’s Cancer Center Bethlehem, PA
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Roy S. Herbst, MD, PhD Ensign Professor of Medicine Professor of Pharmacology Chief of Medical Oncology Director, Thoracic Oncology Research Program Associate Director for Translational Research Yale Cancer Center New Haven, CT WCMC GBC2014Reg_33114
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Conference News Continued from cover
Hormone Therapy Poses Health Risks in Prostate Cancer Patients Men with prostate cancer are often treated with hormone therapy (androgen deprivation therapy [ADT]), but this treatment can have unpleasant and even harmful side effects, including metabolic abnormalities that lead to diabetes mellitus (DM) and cardiovascular disease (CVD). A new study found that with prolonged exposure to ADT ( 2 years), both DM and CVD are more likely to occur in older men and in men with comorbidities than in younger men. This study should reassure younger men diagnosed with prostate cancer who are prescribed ADT, said lead author Alicia K. Morgans, MD, Vanderbilt University School of Medicine, Nashville, Tennessee. However, older men with comorbidities who have a
higher risk may want to select a different treatment option, she added. The study assessed the association between duration of exposure to ADT and development of incident DM or CVD in a prospectively surveyed cohort of 3718 survivors diagnosed with local prostate cancer and enrolled in the Prostate Cancer Outcomes Study at 6 SEER sites. Of these survivors, 3526 were eligible for the study: 2985 for the DM analysis and 3112 for the CVD analysis. Patients were stratified by length of exposure to ADT: no ADT (2033 in the DM analysis and 2112 in the CVD analysis); ADT for <2 years (692 in the DM analysis and 723 in the CVD analysis); or ADT for 2 years (260 and 277, respectively). Development of DM or
CVD was established by patient report in surveys at baseline, 6 months, and 1-, 2-, 5-, and 15-year time points as well as by death certificate diagnoses.
Patients were stratified by length of exposure to ADT.
Older men (>76 years for DM and >74 years for CVD) who were exposed to ADT for 2 years had the highest risk of developing DM and CVD. A multivariate analysis identified greater comor-
bidity burden as being significantly associated with odds of developing DM or CVD versus men with no other comorbidities. Shorter exposure to ADT (<2 years) was not significantly associated with developing either DM or CVD over 15 years of follow-up. The main implication of these findings is that older men with comorbidities who have been taking ADT for 2 years should be monitored for DM and CVD, Morgans said. l Reference
Morgans AK, Fan K-H, Koyama T, et al. Influence of age on incident diabetes (DM) and cardiovascular disease (CVD) among prostate cancer survivors receiving androgen deprivation therapy (ADT). J Clin Oncol. 2014;32(suppl 4). Abstract 31. Presented at: 2014 Genitourinary Cancers Symposium; January 30, 2014; San Francisco, CA.
Immunotherapy with ipilimumab improved progression-free survival (PFS) and prostate-specific antigen response compared with placebo, but improvement in overall survival (OS) failed to reach statistical significance in postdocetaxel metastatic castration-resistant prostate cancer (mCRPC), according to results of a randomized phase 3 trial (CA184-043). Although the failure to significantly improve survival is disappointing, the study provided hints of subsets of patients who might derive greater benefit from ipilimumab: patients with more favorable prognostic factors (ie, no visceral metastasis, lower levels of alkaline phosphatase, and elevated hemoglobin). “Results of this trial support further investigation of ipilimumab in patients with fewer adverse prognostic features than those enrolled in this trial,” said lead author Charles G. Drake, MD, PhD, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland. CA184-043 enrolled 799 patients with mCRPC who had received docetaxel therapy. After being treated with at least 1 dose of bone-directed radiotherapy, patients were randomized in a 1:1 ratio to ipilimumab versus placebo. During the maintenance phase, those in the ipilimumab arm received ipilimumab every 12 weeks, and those in the placebo arm received placebo
Photo by © ASCO/Todd Buchanan 2014.
Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Charles G. Drake, MD, PhD
every 12 weeks. Median OS was 11.2 months for ipilimumab versus 10 months for placebo (hazard ratio [HR] 0.85; 95% confidence interval [CI], 0.72-1.00; P = .0530). The secondary end point of PFS was met, Drake reported. Median PFS was 4 months in the ipilimumab group and 3 months in the placebo group. In a prespecified subset analysis, the presence of visceral metastases appeared to interfere with the treatment effect of ipilimumab. Drake explained that most clinical trials exclude patients with visceral metastases, but this trial did not.
Multivariate analysis identified the following favorable prognostic factors for OS: age <70 years, alkaline phosphatase <1.5 times the upper limit of normal, hemoglobin >11 g/dL, and absence of visceral metastases. Median OS was 14.4 months with ipilimumab in patients with no visceral metastases versus 5.7 months in the presence of visceral metastases. Drake acknowledged that the trial was underpowered to show an interaction between ipilimumab and visceral metastases, “but the hazard ratio is clearly in the wrong direction.” HR was 1.644 (95% CI, 1.1572.336) and P = .0056. The safety of ipilimumab in this study was similar to the experience with ipilimumab in metastatic melanoma, an indication for which it has received approval from the US Food and Drug Administration. Based on the findings of CA184-043, a separate phase 3 trial of ipilimumab has been launched (CA184-095) in chemotherapy-naive mCRPC patients without visceral metastases. l Reference
Drake CG, Kwon ED, Fizazi K, et al. Results of subset analyses on overall survival (OS) from study CA184-043: ipilimumab (Ipi) versus placebo (Pbo) in post-docetaxel metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2014;32(suppl 4). Abstract 2. Presented at: 2014 Genitourinary Cancers Symposium; January 30, 2014; San Francisco, CA.
have you ever wanted to write an article for TON ? We’re interested in articles about the everyday issues that affect nurses—everything from chemotherapy safe handling to supportive care for patients to challenging cases.
Contact editorial@greenhillhc.com for information. 8
MARCH/APRIL 2014 I VOL 7, NO 2
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Conference News
Choosing Wisely Campaign The American Society of Clinical Oncology (ASCO) is again participating in the American Board of Internal Medicine’s (ABIM) Choosing Wisely campaign designed to streamline healthcare delivery. The announcement stated that ASCO and the ABIM Foundation
hope the campaign will encourage proper use of diagnostic and treatment modalities; avoid overuse or misuse of these interventions; improve patient quality of life and outcomes; stimulate discussions about these subjects between physicians and patients;
and lead to a culture of routine evaluation of cost, value, and benefit of interventions in a critically burdened healthcare system. The new recommendations, announced at the Genitourinary Cancers Symposium, are as follows:
• Do not give patients antiemetics when initiating a chemotherapy regimen with low or moderate potential for causing nausea/vomiting. These drugs are designed for chemotherapy regimens with a high risk of causing nausea/vomiting. • Do not use combination chemotherapy (multiple drugs) for patients with metastatic breast cancer. These patients should receive single-agent therapy, with the exception of those who require a rapid response to relieve tumorrelated symptoms.
The American Society of Clinical Oncology is again participating in the American Board of Internal Medicine’s Choosing Wisely campaign designed to streamline healthcare delivery.
• Avoid use of PET (positron emission tomography) or PET-CT (computed tomography) imaging for routine follow-up care to monitor for recurrence in patients treated with curative intent. PET and PET-CT are used to diagnose, stage, and monitor how well treatment is working. Using these tests to monitor for recurrence does not improve outcomes and therefore is not recommended unless there is high-level evidence that such imaging will change outcome. • Do not perform PSA (prostate-specific antigen) testing for screening asymptomatic men for prostate cancer if they have <10-year life expectancy. • Do not use a targeted therapy designed for use against a specific genetic abnormality unless a patient’s tumor cells have a specific biomarker that predicts an effective response to the targeted therapy. Full details of these recommendations and the Choosing Wisely campaign can be accessed at www.asco.org/topfive. l
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Conference News Continued from page 9
Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma determine whether CN had a survival benefit in the era of newer targeted therapies for mRCC. Patients with synchronous mRCC with a life expectancy of 1 year appear to have a survival benefit if treated with targeted therapy and CN, whereas those with a shorter life expectancy will prob-
ably have no benefit, the study found. “Not all patients with metastatic renal cell carcinoma should undergo cytoreductive nephrectomy. Patients with longer estimated survival may benefit, but those with 4 or more risk factors [as indentified by International Metastatic Renal Cell Carcinoma
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MAY 2013 • VOLUME 6 • NUMBER 2
CONSIDERATIONS in
Multiple Myeloma
™
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ASK THE EXPERTS: Maintenance Settings PUBLISHING STAFF Group Director, Sales & Marketing John W. Hennessy john@greenhillhc.com Editorial Director Susan A. Berry susan@coexm.com Senior Copy Editor BJ Hansen Copy Editors Dana Delibovi Rosemary Hansen Grants/Project Associate Susan Yeager The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Director of Human Resources Blanche Marchitto Associate Editorial Director, Projects Division Terri Moore
LETTER
FROM THE
EDITOR-IN-CHIEF
Over the past decade, significant progress has been made in the management of multiple myeloma, including new standards of care and the development and approval of several novel, effective agents. Despite this progress, more work needs to be done and numerous questions remain regarding the application and interpretation of recent clinical advances. In this sixth annual “Considerations in Multiple Myeloma” newsletter series, we continue to explore unresolved issues related to the management of the disease and new directions in treatment. To ensure an interprofessional perspective, our faculty is comprised of physicians, nurses, and pharmacists from leading cancer institutions, who provide their insight, knowledge, and clinical experience related to the topic at hand. In this second issue, experts from Dana-Farber Cancer Institute answer questions related to the management of patients in the maintenance setting.
to learn more!
Sincerely, Sagar Lonial, MD Professor Vice Chair of Clinical Affairs Department of Hematology and Medical Oncology Winship Cancer Institute Emory University School of Medicine Atlanta, GA
Daniel Y. C. Heng, MD, MPH
The CN group had more favorable-risk patients (63% vs 45% in the no CN group). The analysis of the study was adjusted for this baseline difference, Heng said. In a univariate analysis of overall survival, the CN group lived longer: 20.6 months versus 9.5 months (adjusted hazard ratio: 0.60; 95% confidence interval, 0.52-0.69; P <.0001). A multifactorial analysis adjusted for IMDC criteria found an incremental benefit for CN as survival lengthened but not much benefit for patients with a shorter life expectancy. IMDC poor prognostic factors include Karnofsky performance status <80%, time from diagnosis to treatment of <1 year, and 4 lab tests for anemia, hypercalcemia, neutrophilia, and thrombocytosis. No comparison could be made between CN or no CN in patients with all 6 prognostic factors because of insufficient numbers, but those with 0-3 prognostic factors had a significant survival benefit with CN, Heng said. l
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.
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Discussions in Personalized Treatment for Lymphoma: Do We Have Consensus? CONTRIBUTING FACULTY Chair Stephanie A. Gregory, MD
The Elodia Kehm Chair of Hematology Professor of Medicine Director, Lymphoma Program Rush University Medical Center/Rush University Chicago, IL
Sonali M. Smith, MD
Associate Professor Section of Hematology/Oncology Director, Lymphoma Program The University of Chicago Medical Center Chicago, IL
Mitchell R. Smith, MD, PhD Director of Lymphoid Malignancies Program Taussig Cancer Institute Cleveland Clinic Cleveland, OH
2014 PROSPECTUS
Steve M. Horwitz, MD
Assistant Attending Medical Oncologist Lymphoma, Cutaneous Lymphomas, T-Cell Lymphoma Memorial Sloan-Kettering Cancer Center New York, NY
Supported by an educational grant from Celgene Corporation
This activity is jointly sponsored by Medical Learning Institute Inc and Center of Excellence Media, LLC.
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YEAR ANNIVERSARY
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YEAR ANNIVERSARY
FIFTH ANNUAL
Navigation and Survivorship Conference SEPTEMBER 18-21, 2014 WALT DISNEY WORLD DOLPHIN HOTEL ORLANDO, FLORIDA
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Scan Here to Register To use 2D barcodes: Visit the app store to download a QR Code reader for your smartphone
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MARCH/APRIL 2014 I VOL 7, NO 2
Database Consortium (IMDC) criteria] and limited life expectancy should not have this surgery. Of course there may be exceptions to this rule, but this is an interesting approach to patient selection,” said Daniel Y. C. Heng, MD, MPH, Tom Baker Cancer Centre, University of Calgary, Canada. The retrospective analysis was based on data from consecutive patients treated at 20 international cancer centers with targeted therapy for mRCC (total number: 3245; 2569 treated with CN). After exclusions for patients undergoing CN before metastasis occurred (about 49%), the study was based on 676 patients who did not have nephrectomy and 982 who had CN.
Photo by © ASCO/Todd Buchanan 2014.
Building on the theme of appropriate use of procedures and treatments, a new study suggests that cytoreductive nephrectomy (CN) will not alter survival of patients with metastatic renal cell carcinoma (mRCC) with a short life expectancy (<1 year) and poor prognostic factors. The study was conducted to
Reference
Heng DYC, Rini BI, Beuselinck B, et al. Cytoreductive nephrectomy (CN) in patients with synchronous metastases from renal cell carcinoma: results from the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). J Clin Oncol. 2014;32(suppl 4). Abstract 396. Presented at: 2014 Genitourinary Cancers Symposium; February 1, 2014; San Francisco, CA.
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Conference News
The Cancer Genome Atlas: Bladder Cancer muscle-invasive urothelial bladder carcinoma have actionable mutations that can be targeted in selected populations with either drugs approved by the US Food and Drug Administration or investigational agents. • Epigenetic regulatory genes are frequently altered in this type of bladder cancer, suggesting that there may be a different paradigm for therapeutic intervention. Seventysix percent of tumors had 1 inactivating epigenetic mutation and 41% had 2. More clinical and laboratory research is needed with drugs that target these alterations, such as histone deacetylase inhibitors, DNA methyltransferase inhibitors, and bromodomain inhibitors. These drugs may be useful in subsets of patients, Rosenberg said. Rosenberg and colleagues analyzed DNA from 131 muscle-invasive urothelial bladder cancer tumors and corresponding normal samples (predominantly blood). They determined that bladder cancer was one of the most
highly mutated tumor types, with each tumor possessing an average of 302 exonic mutations, 204 segmental alterations in DNA copy number, and 22 large-scale genomic alterations. Thirtytwo recurrent significantly mutated genes were identified that appear to be involved in bladder cancer pathogenesis. Some of these genetic abnormalities had not been previously reported in bladder cancer or in other cancers included in the TCGA, he said. Three clusters of abnormalities were identified based on an integrated analysis of both mutations and copy number: a genomic amplification cluster; a p16-deleted cluster; and a p53-mutated cluster. “These clusters suggest that there may be different oncogenic mechanisms involved in the development of muscleinvasive bladder cancer, but we don’t know yet whether any of them are clinically relevant,” Rosenberg commented. Between mutation and copy number analysis, potential targets were identified in 69% of the tumors, including 42% with targets in the phosphatidylinosi-
tol-3-OH kinase/AKT/mTOR pathway and 45% with targets in the RTK/ MAPK pathway (including ERBB2). Rosenberg said that this work represents progress in bladder cancer, and carefully designed trials are needed to test therapies directed to these potentially actionable genetic aberrations. l Photo by © ASCO/Todd Buchanan 2014.
The Cancer Genome Atlas (TCGA) project now includes a recently reported comprehensive molecular characterization of muscle-invasive urothelial bladder carcinoma (presented January 31, 2014, at the Genitourinary Cancers Symposium and published simultaneously online in Nature).1,2 The hope is that these genetic discoveries will translate to identification and development of new treatments for bladder cancer. New therapies for bladder cancer represent an unmet need. Over the past decade, kidney and prostate cancer therapy has seen an explosion of novel agents, but no new treatment for bladder cancer has been identified since the 1970s. The TCGA findings on muscle-invasive urothelial bladder cancer were presented by Jonathan Rosenberg, MD, Section Chief of the Non-Prostate Program in the Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City. The 2 major take-home messages of his presentation were: • The majority of patients with
Jonathan Rosenberg, MD
References
1. Rosenberg JE, Kim J, Cherniack A, et al. Somatic genomic alterations in urothelial cancer: results of the Cancer Genome Atlas (TCGA) bladder cancer (BC) analysis. J Clin Oncol. 2014;32(suppl 4). Abstract 285. Presented at: 2014 Genitourinary Cancers Symposium; January 31, 2014; San Francisco, CA. 2. Cancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature. 2014;507(7492):315-322.
Weight Gain on Hormone Therapy Younger, thinner, nondiabetic men were more likely to gain weight on androgen deprivation therapy (ADT) than older men with comorbidities. “This is a new finding. We always thought that older, sicker prostate cancer patients were more likely to gain weight on hormonal therapy, but this study shows something different. At present, we don’t have an explanation for this, but our working theory is that younger men have higher baseline levels of testosterone than older, obese, and diabetic men and the magnitude of testosterone decline on hormone therapy might explain the weight gain,” said lead author Daniel Seible, MD, Dana-Farber Cancer Institute,
Boston, Massachusetts. The retrospective study assessed weight change among 118 men with nonmetastatic prostate cancer assigned to ADT. The primary end point was weight change 1 year after initiation of ADT. The secondary aim was to identify factors associated with weight gain. Overall, a significant weight gain was found 1 year after starting ADT (P = .0005). Three main risk factors associated with weight gain were: • Younger age: gain of 5.98 lb for men younger than age 65 versus 1.3 lb for men older than age 65 • Body mass index (BMI) <30: 4.36 lb gained for
those with BMI <30 versus 0.22 lb for men with BMI 30 • Nondiabetic status: 3.43 lb gained versus 0.57 lb for diabetic men Another finding was that the more risk factors a patient had at baseline, the greater the weight gain. In this study, the authors did not measure baseline testosterone levels of subjects, Seible said. l Reference
Seible DM, Gu X, Hyatt A, et al. Identifying men at greatest risk of weight gain from androgen deprivation therapy. J Clin Oncol. 2014;32 (suppl 4). Abstract 80. Presented at: 2014 Genitourinary Cancers Symposium; January 30, 2014; San Francisco, CA.
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The Patient’s Voice
Practice Makes Not Perfect: Striving After Cancer Continued from cover eat much (fill in your ingestible villain of choice: meat, sugar, carbohydrates, dairy, processed foods, coffee) before your diagnosis?” “What about exercise?” they’d ask quizzically, proceeding to whether the water I drank was filtered properly, if I had a microwave, if I thought positively at least 90% of the time, or if I wore the color purple too much (well, maybe the purple part is a bit of an exaggeration, but it certainly felt like it got to that level of minute detail). It was when a woman approached me one day and quietly said, “You know, don’t you, that mammograms are what give you breast cancer?” that I (figuratively at least) threw my arms up in the air and decided I’d need to make the decisions that were best for me, from that point on. I’m well aware of how loaded with controversy the previous paragraph is. I don’t intend to start a debate or foster dispute. These are solely my views, and I don’t pretend to speak for all breast cancer survivors. I just write this in the hope that it puts some readers’ minds at ease—that they forgive themselves more easily for the harsh judgments we make about everything we do and don’t do after diagnosis.
concern for me. Everyone feels helpless when someone they love gets diagnosed; that is why casseroles were invented! I bring up the “What Did You Do to Get Cancer Syndrome” because its sequel, after I finished my course of treatment, was “How Do I Become the Perfect Cancer Survivor?” This practice had less to do with people advising me than with my having a raging internal debate with myself about the best practices for living optimally post cancer. To tell the truth, I spent many hours devising in my mind a rather rigid “Perfect Survivor’s Plan,” or PSP, that was impossible to live up to. It went something like this: 1. E at some type of “ideal” diet. 2. Don’t get stressed. Retain the aura of Buddha, despite the fact that your kid has a fever, your car needs new tires, and you have an imminent work deadline. 3. Attract positivity by being 100% positive 100% of the time. Whatever you do, don’t focus on the school principal’s curt email response to your fantastic fundraising idea, the fact that your property taxes are way too high, and whether or not you should dye your hair.
I feel that our culture is a bit obsessed with control, and if you throw cancer into the mix, it really gets interesting.
As for the answers to those questions, the fact is I’d been a vegetarian for 15 years of my adult life; paid attention to nutrition and ate a balanced diet; wasn’t officially a jock, but was certainly active every day; and as for my attitude, I’ve been described by some as not only energetic but even the dreaded “perky!” I realized at some point that I’d probably committed this same faux pas, at least inwardly, with people before, so I’m not guiltless. The conclusion I’ve come to is that most people (including me) are downright terrified when confronted with the C-word. And why not? It’s the stuff of scary statistics and stories, and the word is usually accompanied by sobering phrases like “valiantly fighting,” “enduring lots of treatment,” and the worst one, to me, “succumbed to cancer.” I got to the point where this line of conversation annoyed the bejesus out of me, but then I realized it came from a place of fear—a how-do-I-make-absolutely-certain-I-don’t-get-cancer kind of fear. And I couldn’t blame them. I realized these inquiries also came out of love and
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4. Engage in a grueling workout regimen, often. The more punishing, the better. 5. Concentrate on each and every thing that could be a carcinogen: imbalanced pH in your body, nitrites in processed meats, free radicals, and the ever-popular Carcinogens That Aren’t Always Apparent (radon, pesticide residue on my celery, and second-hand smoke). And then there’s the newly discovered danger in all things yellow—now I can worry about the rubber gloves I use to do the dishes, countless sippy cups my kids’ lips touched, and our current shower curtain! Below are my admittedly slightly tongue-in-cheek, but ultimately much more realistic responses to the list above, created after many conversations with other survivors and following my own sleep-challenged nights: 1. Life’s not worth living if I’m eating only black beans and kale. Nothing against black beans and kale—I just think food is a sensual pleasure and have decided that “everything in
moderation” is a rule I can actually live with. 2. I’m a cancer survivor—I get stressed! But I try to see the myriad strategies I can use to assuage my worry: meditation, walking the dog, a soothing bath, positive visualization, getting lost in a novel. The practical advantages of these prescriptions? They don’t cost a thing. 3. I am a human being with an expansive range of human emotions, and the range includes times of being blue, anxious, and frustrated, as well as content, peaceful, and jovial. I’ve decided that it’s not a good idea for me to try to mold my feelings around a hard-to-attain, idealistic model. Feelings are not only completely unique—they ought not to be judged. That’s not to say I don’t think there’s a time and place for aids like antidepressants. I don’t think we should “bootstrap it” through the cancer journey and what follows, but our emotions represent an inherently well-designed and functional continuum. 4. I will go to the Y and use the rowing machine and take Zumba classes because I also happen to enjoy those things. I will walk my dog. I may dance when I cook dinner. I will even wear a pedometer and try to reach 10,000 steps. 5. In the words of the hit song from Frozen, I’ve “let it go.” It’s not that I live in a world where I’m oblivious to risk; rather, I try to keep my worries in perspective, so that I can indeed become more Buddha-like (see #2 of the first list!). Cancer helped me figure out why I get so aggravated with conspiracy theorists. I’ve always thought I have enough to worry about without wondering if UFOs are government funded! Now, I really can differentiate what’s worth my fretting and what is unproductive agonizing. I feel that our culture is a bit obsessed with control, and if you throw cancer into the mix, it really gets interesting. Perhaps it’s our strong Judeo-Christian tradition in the United States, but the belief seems to persist that if we live a certain way, we get a guaranteed, favorable outcome. One of the hardest parts about cancer for me is that it’s so randomly cruel. It’s not just jerks who get cancer, and sometimes that’s how I feel it should go. Rather, it’s often wonderful, loving, smart, funny, community-minded people. It’s one thing to know something intellectually and another thing to know it emotionally. For me, cancer made me cross over the bridge into the land of knowing things emotionally, and I’m grateful. This helped me in the process of finding a happy medium
when it came to defining my personal best practices for cancer survivorship. Despite what might seem a glib, dark humor on my part, my cancer journey intensified the level of gray I decided I could live with. By this I mean I became less sure of things, and more willing to consider the fact that there are even fewer absolute answers in life than I thought.
Every person I’ve met who has coped with cancer has a very special perspective.
There is a loss of innocence that comes along with a cancer diagnosis, but there’s an undeniably enriching awakening too. Many of us are awakened to truly reassess our lives during and after treatment (from relationships, to jobs, to where we live), to reconnect with things we forgot we loved (painting, gardening, or chess), and to ask hard questions about what we’ve been doing with our time and how we really want to spend it henceforth. Our “no pain, no gain” culture can stifle this kind of prioritization. I’ve heard from more than a few survivors that their journey helped them prioritize, but quick! Every person I’ve met who has coped with cancer has a very special perspective, and I relish hearing their list of how to live their best postdiagnosis life. Well-known developmental psychologist Bruno Bettelheim’s book A Good Enough Parent posited that parents shouldn’t strive for perfection, not only because it’s impossible but also because children would never develop resilience. I reckon that cancer patients and survivors uniformly believe they’ve developed enough resilience, but it’s undeniable that no one’s life escapes significant adversity. As we face it, we adjust our rules for living— both the simple (What should I eat?) and the more complex (With whom should I spend my time?). Every new person I meet has lessons to teach me, and I, hopefully, can offer some as well. Each day illuminates varying levels of my success with Carolyn’s Rules of Survivorship, but cancer has also taught me to be more forgiving to my most outspoken critic: myself. Armed with my list, each day I start anew, but now I remember to cut myself some everlovin’ slack. That’s the simplest, most deconstructed form of my “survivor-osophy” that I try my best to carry with me. l
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Multiple Myeloma
Benefit Shown for Pomalidomide 4 mg Daily on Intermittent Schedule Caroline Helwick
T
he optimal dosing of pomalidomide in the treatment of multiple myeloma has not been established. Yale University investigators compared continuous and intermittent dosing regimens, and while the intermittent schedule was associated with more toxicity, they concluded that it is preferable, said Kartik Sehgal, MD, a postdoctoral fellow at Yale University School of Medicine, who reported the study at the 2013 American Society of Hematology Annual Meeting. “Both continuous and intermittent dosing regimens of pomalidomide with dexamethasone have remarkable clinical activity in heavily pretreated, relapsed/ refractory multiple myeloma patients,” Sehgal said. “Our objective was to determine the optimal dosing strategy for patients who relapse after treatment with standard regimens. These 2 dosing regimens have been evaluated in clinical trials but not compared head to head.” The investigators found that while the intermittent regimen was asso-
ciated with more grade 3/4 adverse events (AEs)—probably due to a higher dose of pomalidomide—it led to greater maximal reduction in tumorassociated immunoglobulin. The intermittent schedule, therefore, is being used in his clinic, Sehgal said. Details of the Comparison The single-center randomized phase 2 trial involved 39 patients with myeloma, all of whom were resistant to lenalidomide; approximately 80% were also resistant to bortezomib, and 80% were resistant to both agents. About two-thirds of the group had abnormal molecular cytogenetic profiles. The continuous dosing group received pomalidomide 2 mg/d on days 1 to 28 of a 28-day cycle, while the intermittent group received pomalidomide 4 mg/d on days 1 to 21 of a 28-day cycle. All patients received dexamethasone 40 mg/wk on days 1, 8, 15, and 22, beginning with cycle 2, until disease progression. “The question is whether we should give a higher or lower dose of pomalid-
Table
Clinical Efficacy of 2 Pomalidomide Dosing Regimens Continuous Dosing (2 mg/d, 28/28 d) (n = 19)
Intermittent High-Dose (4 mg/d, 21/28 d) (n = 20)
Response rate, n (%) ORR VGPR PR
4 (21) 2 (11) 2 (11)
9 (45) 2 (10) 7 (35)
Stable disease
10 (53)
9 (45)
19 (49)
Progressive disease
5 (26)
2 (10)
7 (18)
28
54
Outcome
Maximum reduction in disease, mean %
omide, but at the same time we want to decrease adverse events, so we give a higher dose but with 1 week off, which lessens side effects,” Sehgal said.
Lung Cancer In 2010, Dr Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), chose the 6 original health priorities that he would call “winnable battles.” Tobacco use was one of them. As reported in the CDC’s tobacco overview materials, tobacco use is responsible for 443,000 deaths in the United States each year, including 128,900 deaths attributed to lung cancer.1 Here we will consider some specific lung cancer statistics.
•T he American Cancer Society estimates that there will be approximately 224,210 new cases of lung cancer in the United States in 2014.2
•O f the 2 major types of lung cancer, non– small cell lung cancer is diagnosed in 7 of 8 lung cancer patients, and small cell lung cancer is found in 1 of 8 patients.5
•A mong risk factors for developing lung cancer, cigarette smoking is number 1. Of the more than 7000 chemicals in tobacco smoke, at least 70 are known carcinogens, and smoking causes more than 90% of lung cancers in the United States. The second leading cause is exposure to radon gas, which causes about 20,000 cases of lung cancer annually.3
• I n the Annual Report to the Nation on the Status of Cancer, covering the years 19752010, the National Cancer Institute included a special feature on comorbidities among cancer patients. Reporting on patients with lung, colorectal, breast (female), and prostate cancer, who were age 66 years and older and were Medicare beneficiaries, data show that 30% had a least 1 comorbidity. However, among those with lung cancer, at least 1 comorbidity was found in 52.9% of patients. Diabetes, chronic obstructive pulmonary disease, congestive heart failure, and cerebrovascular disease were the most common comorbidities.6
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P = .18
P = .02
Total (N = 39)
13 (33) 4 (10) 9 (23)
41
bbreviations: ORR, objective response rate; PR, partial response; VGPR, very good A partial response.
Noteworthy Numbers
•A lthough lung cancer accounts for only 14% of all new cancer diagnoses, it is responsible for 27% of all cancer deaths, more than colorectal, breast, pancreatic, and prostate cancers combined. It is the leading cause of cancer death among all ethnicities regardless of gender, and is responsible for almost 2 times as many deaths in women as breast cancer and almost 3 times as many deaths in men as prostate cancer.4
Difference Between Arms
Sources 1. www.cdc.gov/winnablebattles/Tobacco/. 2. www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-celllung-cancer-key-statistics. 3. www.cdc.gov/cancer/lung/basic_info/risk_factors.htm. 4. http://events.lungevity.org/site/PageServer?pagename=v2_AboutLungCancer. 5. www.cancer.gov/cancertopics/wyntk/lung/page4. 6. www.cancer.gov/newscenter/newsfromnci/2013/ReportNationDec2013Release.
Outcomes With the 2 Regimens The intermittent/higher-dose arm had numerically higher response rates, but the difference was not statistically significant. What was significant, however, was the difference in maximum reduction in disease, Sehgal reported (Table). Median progression-free survival was similar, 4.4 months with continuous dosing and 5.1 months with intermittent dosing (P = .56). Median overall survival was the same, 17.7 months, in each arm. “Despite a greater decrease in maximum reduction of disease with the intermittent dose, we did not see a difference in progression-free or overall survival,” he noted. He said pomalidomide was “pretty well tolerated” but there was a significant increase in pomalidomide-related grade 3/4 AEs with the higher, intermittent dose. Serious drug-related AEs were observed in 8 patients (40%) in the intermittent arm versus 5 patients (26%) in the continuous arm (P = .5), and drug-related grade 3/4 AEs were observed in 18 patients (90%) in the intermittent arm versus 10 patients (53%) with continuous dosing (P = .013). “We recommend going with the higher, intermittent dosing,” Sehgal told The Oncology Nurse-APN/PA. “This leads to a greater reduction in disease, and this probably gives the patient a better chance for a good outcome. Although there is the possibility of more grade 3 and 4 toxicity, in our experience the side effects are manageable.” Reference
Sehgal K, Kocoglu MH, Deng Y, et al. Comparison of intermittent and continuous dosing regimens of pomalidomide in relapsed/refractory myeloma: results of a phase II randomized trial. Poster presented at: 2013 American Society of Hematology Annual Meeting; December 8, 2013; New Orleans, LA. Abstract 3205.
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Genetic Counseling
Hereditary Melanoma Continued from cover
Cristi Radford, MS, CGC
be more concerned about a possible genetic link when a melanoma is present in an individual of darker skin. Additionally,
individuals with multiple nevi and/or atypical nevi are at an increased risk of melanoma, as are individuals who have undergone organ transplants. The associated risk with organ transplants is hypothesized to be due to the effects of immunosuppressive therapy. A family history of melanoma, personal history of melanoma, and/or a personal history of nonmelanoma skin cancer are also risk factors for melanoma.2 Hereditary melanoma is defined as 3 or more diagnoses in a family.3 The main gene associated with inherited cutaneous melanoma is CDKN2A, cyclin-dependent kinase inhibitor 2A. It controls the passage of cells through the cell cycle allowing for repair of DNA damage prior to cellular replication. Mutations
in the CDKN2A gene are estimated to account for 20% to 40% of familial melanoma cases.4 This gene encodes 2 proteins: p16 and p14. Thus, it is also often referred to as p16. Further, variants in the MC1R gene have been associated with CDKN2A penetrance. The reported lifetime risk of developing melanoma varies widely across the literature, ranging from 28% to 91% by age 80. Risk also varies based on geographic location. The average age of diagnosis for the first melanoma is 39 years. In addition to being at increased risk for melanoma, individuals with a mutation in CDKN2A are also at increased lifetime risk for pancreatic cancer, ranging from 11% to 17%.5 CDK4, cyclin-dependent kinase 4, is also an important part of the cell cycle
and is in the same signaling pathway as CDKN2A. As with CDKN2A, the average age of diagnosis of the first melanoma is 39 years, individuals are prone to multiple melanomas, and they are more likely to have atypical nevi. Mutations in CDK4 are thought to be rare, as few families have been reported in the literature. However, analysis of the CDK4 gene has not been common practice and will likely increase with its incorporation on multigene panels. To date, all of these families have had a mutation that affects the ability of CDK4 to bind with CDKN2A. Hereditary melanoma families negative for mutations in CDKN2A should be evaluated for mutations in the CDK4 gene.6 Genetic counseling and possibly CDKN2A/CDK4 testing should
Side Effects Management
Understanding FOLFOX Toxicity: Some Subsets Have Higher Risks Caroline Helwick
S
ubsets of patients with colon cancer may benefit from increased surveillance for toxicities associated with adjuvant FOLFOX (leucovorin, fluorouracil, oxaliplatin) treatment, Canadian researchers suggest, based on their detailed analysis of the toxicity profile of this common regimen and their identification of factors that predict toxicity. They presented their findings at the 2014 Gastrointestinal Cancers Symposium, held January 16-18, in San Francisco, California.
The identification of patients with colon cancer at increased risk for side effects of adjuvant treatment allows clinicians to be more vigilant in preventing and managing these issues.
The identification of patients with colon cancer at increased risk for side effects of adjuvant treatment allows clinicians to be more vigilant in preventing and managing these issues. “This enables the optimal delivery of chemotherapy,” said lead author Gillian Gresham, formerly of the University of Ottawa and now a doctoral candidate at Johns Hopkins University School of Public Health, Baltimore, Maryland. The study sought to identify the key side effects associated with adjuvant FOLFOX in early colon
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cancer, and to look for their associations with clinical and patient-related factors. The study included patients with stage III colon cancer treated at the 5 regional cancer centers of the British Columbia Cancer Agency. The researchers retrospectively reviewed the charts of 475 patients who received adjuvant FOLFOX. Their median age was 62 years, and 55% were male. Renal, Cardiovascular, and Sensory Toxicities Were Common The most common toxicities were abnormal kidney function (61.7%), neuropathy (54.9%), and cardiovascular-related side effects (hypertension, hypotension, thromboembolism, cardiac arrest; 51.4%). Gastrointestinal (GI) toxicities, including nausea, vomiting, and diarrhea, were recorded in 44% of patients. Other common toxicities included anemia (76%), abnormal liver enzymes (61.7%), thrombocytopenia (28%), and neutropenia (27.8%). In a multivariate analysis, renal dysfunction (glomerular filtration rate [GFR] <50) carried a 69% increased risk of any GI toxicity. The risk of significant neutropenia was increased 2- to 3-fold among patients whose time between diagnosis and receipt of adjuvant chemotherapy exceeded 8 weeks; those with poor performance status; those older than 70 years; and patients with low white blood cell count (<6.4 x 109). Interestingly, multiple toxicities were more prevalent among patients who waited more than 8 weeks to initiate adjuvant FOLFOX, Gresham added. “It’s possible that patients who wait longer to initiate adjuvant therapy may already be sicker at baseline,” she said. “Neuropathy was interesting, because abnormal creatinine seemed to be pre-
dictive in both the univariate and multivariate models.” Focus on GI Toxicities The researchers also developed a 5-point scoring system to stratify patients into low- and high-risk groups for GI toxicity, based on baseline clinical factors. Low-risk patients (score 0-2) had a 45% risk for toxicity, whereas high-risk patients (score 3-5) had a 59% risk. In the multivariate model for risk of any GI toxicity, age <70 years carried an odds ratio (OR) of 2.6 (P = .049); GFR <50 had an OR of 1.69 (P = .0038); and delayed time to adjuvant chemotherapy had an OR of 1.79 (P = .0059). Patients received 2 points each for delayed time to adjuvant treatment and poor GFR, and 1 point for advanced age. Gresham said that the scoring system could be useful, but it needs to be validated first. Gresham suggested that considering important baseline characteristics—such as time to adjuvant treatment, advanced age, renal function, and certain laboratory parameters—when recommending adjuvant FOLFOX can be useful in identifying patients who are likely to experience serious side effects. “We think this group of patients may benefit from increased monitoring in order to enable optimal doses of curative chemotherapy to be delivered,” she said. “Our recommendation would be to look for and recognize these characteristics at baseline. Monitor these patients more closely, and treat more proactively.” l Reference
Gresham G, Sidhu J, Malhi N, et al. Predicting toxicities from adjuvant treatment in a population-based cohort of early colon cancer (CC) patients (pts): a strategy to improve use of curative chemotherapy. J Clin Oncol. 2014;32(suppl 3):Abstract 412.
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ers p Genetic Counseling
be offered for individuals with 3 or more relatives on the same side of the family with melanoma, 3 or more primary melanomas in one individual, or individuals with pancreatic cancer and melanoma on the same side of the family.3 In addition to being linked to mutations in CDKN2A and CDK4, melanoma may also be part of other cancer predisposition syndromes. Therefore, it is important to take into account all can-
cers in an individual’s personal and family history when assessing inherited risk. Individuals with xeroderma pigmentosum (XP) have a high risk of developing melanoma, greater than a 2000-fold increase by age 20 with the average first diagnosis occurring around age 22. XP is an autosomal recessive condition characterized by severe ultraviolet light photosensitivity, as well as ocular abnormalities and sometimes neurological manifestations.
In addition to being linked to mutations in CDKN2A and CDK4, melanoma may also be part of other cancer predisposition syndromes.
Individuals have been reported with hundreds of primary skin cancers.7 Werner syndrome is also an autosomal recessive condition. It is characterized by features of premature aging in the second decade of life and is due to mutations in the WRN gene. It is associated with an increased risk for acral lentiginous melanomas and mucosal melanomas.8 Melanoma has also been reported in hereditary breast and ovarian cancer families, specifically those with BRCA2 mutations,9 Cowden syndrome,10 and Li-Fraumeni syndrome.11 Additionally, BAP1 mutations have been associated with both uveal and cutaneous melanoma.12
Take-Home Messages • Two genes, CDKN2A and CDK4, are associated with hereditary melanoma families. As phenotypic differences are not known, mutations in both genes should be ruled out in at-risk families. • Several other inherited syndromes have been shown to have an increased risk for melanoma. Therefore, when assessing a melanoma survivor for inherited risk, all cancers in his or her personal and family history should be taken into account. l References pantone 188
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Faculty Perspectives
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1. Melanoma Monday®. American Academy of Dermatology website. www.aad.org/spot-skin-cancer/ what-we-do/melanoma-Monday. Accessed March 4, 2014. 2. Melanoma. National Cancer Institute website. www.cancer.gov/cancertopics/types/melanoma. Accessed March 4, 2014. 3. Gabree M, Seidel M. Genetic testing by cancer site: skin. Cancer J. 2012;18(4):372-380. 4. Goldstein AM, Chan M, Harland M, et al. High-risk melanoma susceptibility genes and pancreatic cancer, neural system tumors, and uveal melanoma across GenoMEL. Cancer Res. 2006;66(20):9818-9828. 5. Genetics of skin cancer (PDQ). National Cancer Institute website. www.cancer.gov/cancertopics/pdq/genetics/ s-zkin/HealthProfessional/page4. Accessed March 4, 2014. 6. Puntervoll HE, Yang XR, Vetti HH, et al. Melanoma prone families with CDK4 germline mutation: phenotypic profile and associations with MC1R variants. J Med Genet. 2013;50(4):264-270. 7. Bradford PT, Goldstein AM, Tamura D, et al. Cancer and neurologic degeneration in xeroderma pigmentosum: long term follow-up characterises the role of DNA repair. J Med Genet. 2011;48(3):168-176. 8. Lauper JM, Krause A, Vaughan TL, et al. Spectrum and risk of neoplasia in Werner syndrome: a systematic review. PLoS One. 2013;8(4):e59709. 9. Breast Cancer Linkage Consortium. Cancer risks in BRCA2 mutation carriers. J Natl Cancer Inst. 1999;91(15):1310-1316. 10. Bubien V, Bonnet F, Brouste V, et al. High cumulative risks of cancer in patients with PTEN hamartoma tumour syndrome. J Med Genet. 2013;50(4):255-263. 11. Schneider K, Zelley K, Nichols KE, et al. Li-Fraumeni syndrome. GeneReviews. www.ncbi.nlm.nih.gov/books/ NBK1311/. Accessed March 4, 2014. 12. Murali R, Wiesner T, Scoyler RA. Tumours associated with BAP1 mutations. Pathology. 2013;45(2):116126.
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Best Practices
What Is the Patient’s Experience With HCC? Caroline Helwick
P
atients with terminal hepatocellular carcinoma (HCC) may be a poorly understood group, according to the findings of quality-of-life research conducted by Lissi Hansen, PhD, RN, of Oregon Health and Science University in Portland, whose special interests are end-of-life issues and ethics. At the 2014 Gastrointestinal Cancers
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Symposium, held January 16-18 in San Francisco, California, Hansen described to The Oncology NurseAPN/PA what she learned from semistructured conversations with HCC patients. “All patients want to tell their stories. They have a voice, and it wants to be heard,” she said. Patients described the disease as very challenging, painful, and filled with
uncertainty, and they reported feeling isolated and even shunned. “The world views HCC differently from most other cancers. Liver cancer is often associated with drug or alcohol abuse, which creates a stigma, although that is no longer the case for a large percentage, who develop HCC as a result of hepatitis B or C they contracted decades ago,” she noted. Obesity
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also is now considered a risk factor. Furthermore, the disease lacks a “spokesperson” (ie, a famous figure who proudly puts a public face on the condition). This heightens the feeling of HCC patients that they are somehow of less value than other cancer patients, she added. HCC is the second-leading cause of cancer-related mortality, and the incidence is rising. Although liver transplant can help patients diagnosed at an early stage, for many patients HCC is incurable, with a duration of survival from diagnosis of only about 1 or 2 years. “Considering the high death rate among people diagnosed with HCC, we know very little about their experiences living with the illness, symptoms, and treatment,” Hansen noted. “I think that to understand the illness experiences of these patients is essential for improving their care. There are very few qualitative studies in the medical literature that examine the patient’s perspective of HCC, and no longitudinal studies toward the end of life.” Studying the Patient Experience The pilot study led by Hansen sought to fill this gap in information and understanding. It followed a prospective, longitudinal descriptive design in which Hansen collected data once a month over a 6-month period from 14 adult patients (11 male, 3 female; mean age 61 years) nearing the end of life. She conducted semistructured interviews at 6 time points, collecting approximately 90 in total. The interview, usually conducted in the patient’s home, included questions about living with HCC, pain and symptom management strategies, treatment decisions, and significant current concerns. The interview data were analyzed using qualitative description. Four Themes Emerged The findings clustered around 4 major themes. Woven throughout each theme were the patients’ experiences across time and their struggles with quality of life and lack of control over how HCC, and the treatment of HCC in particular, were impacting their lives. Theme 1: Illness perceptions. Patient perceptions of HCC covered a broad spectrum, highlighted by a lack of information to prepare them for “the journey ahead,” feelings of isolation, and unrealistic hopes for liver transplant. Theme 2: Uncertainty about treatments over time. Patients treated with
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Best Practices sorafenib (half the group) reported uncertainty with treatment and its efficacy, struggled with symptom management, and questioned or regretted receiving, or not receiving, treatment. Theme 3: Quality of life. Many patients saw quality of life as more important than quantity. Many believed that their quality of life was compromised by the side effects of chemotherapy, and they felt the need to choose between quality and quantity of life. Symptoms impacted daily life. Theme 4: Coping strategies. Patients experienced a range of reactions to their diagnosis and developed their own means of coping, such as denial or finding strength through religion.
Elaborating on these themes, Hansen reported that patients wanted to start treatment as a means of controlling their lives, but often felt the treatment began to control them instead. They struggled with the value of treatment. As one patient said, “I told the oncology nurse, I’m really struggling whether to continue sorafenib or not. I’ve been praying to God to give me guidance in this decision.” Another commented, “I wish I never would have taken sorafenib. If I knew then what I know now….” The side effects of sorafenib— especially skin and gastrointestinal toxicity—were very upsetting to patients. What can nurses do to better care for these patients? “We need to be able to
provide information in a way in which we listen more; we hear more what our patients are saying about their quality of life, their values, their concerns; what’s important to them this week. We need a deeper understanding about what this disease means to them and their lives. We need to help them set their own goals and prioritize these goals. This will help patients and their families feel more in control.” l Lissi Hansen, PhD, RN, of Oregon Health and Science University in Portland, in front of her poster presentation at the 2014 Gastrointestinal Cancers Symposium.
Reference
Hansen L, Vaccaro GM, Rosenkranz SJ, et al. Living with hepatocellular carcinoma from the patient perspective: a longitudinal study. J Clin Oncol. 2014;32(suppl 3). Abstract 373. Presented at: 2014 Gastrointestinal Cancers Symposium; January 16-18, 2014; San Francisco, California.
Renal Cancer
Molecular Therapy Beyond Sorafenib in HCC: New Pathways, Targets Being Explored Wayne Kuznar
Sorafenib remains the only systemic agent to improve survival in advanced HCC.
“While we develop new therapies, a concerted and parallel effort must be made to identify and validate biomarkers of response, resistance, and toxicity to better match patients with safe, effective therapies,” said Zhu, director of liver cancer research at Massachusetts General Hospital, Boston. Surpassing sorafenib may require a combination of antiangiogenic agents with cytotoxic chemotherapy or with other molecularly targeted therapies
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to allow for synergy or additive effects. “Alternatively, it might require moving beyond the antiangiogenesis approach and targeting cell autonomous pathways involved in hepatocarcinogenesis, such as the HGF/c-MET, PI3K/AKT/mTOR, or FGF/FGFR pathways,” he said. Antiangiogenic Strategies Antiangiogenic agents including pazopanib, lenvatinib, axitinib, and ramucirumab are in clinical development for treating HCC. Based on phase 2 data, lenvatinib and ramucirumab have advanced to phase 3 evaluation. Although HCCs are highly vascular tumors with increased levels of vascular endothelial growth factor (VEGF), multiple VEGF receptor (VEGFR) inhibitors have failed to improve OS in HCC. This failure has prompted reconsideration of targeting VEGFR in HCC, said Zhu. Future efforts should focus on developing surrogate and predictive markers to identify patients likely to benefit from antiangiogenic treatment. Antiangiogenics are being combined with chemotherapy (sorafenib plus doxorubicin) in late-stage clinical trials, and with targeted therapies (ie, bevacizumab) in early-phase trials. mTOR Inhibitors mTOR regulates protein translation, angiogenesis, and cell cycle progression in HCC. mTOR inhibitors have been shown to inhibit cell growth and tumor vascularity in HCC cell lines and HCC tumor models. The mTOR inhibitor everolimus failed to extend OS compared with best supportive care in the multi-
center EVOLVE-1 trial of 546 patients with advanced HCC. Nevertheless, the preclinical promise of inhibiting the mTOR pathway has led to the development of other mTOR inhibitors, such as temsirolimus and sirolimus, and CC-223, which is a dual inhibitor of TORC1/ TORC2. Immune-Based Therapy In the realm of immune-based therapy for HCC, “perhaps the most excitement comes from the inhibitors targeting the checkpoint pathway,” said Zhu. A phase 1 trial has been conducted with tremelimumab, a fully human IgG2 monoclonal antibody that blocks cytotoxic CTLA-4 in hepatitis C virus–related HCC. It generated a modest response rate of 17% and a progression-free survival of approximately 6 months in 17 evaluable patients. It also modulated hepatitis C viral load. The PD-1 inhibitor nivolumab is also entering clinical trials. HGF/c-MET Inhibitors The HGF/c-MET pathway has a significant role in promoting angiogenesis, proliferation, and metastasis in HCC. c-MET inhibitors have shown early evidence of modest efficacy. Tivantinib, a selective, non-ATP–competitive inhibitor of c-MET, improved time to progression, particularly in patients with tumors with a high MET signature, compared with placebo in a phase 2 study. The median OS in patients with MET-high tumors was 7.2 months with tivantinib versus 3.8 months with placebo. “If you enrich the right population, you may achieve the clinical benefit,” Zhu noted.
Cabozantinib, a receptor tyrosine kinase inhibitor of c-MET/VEGFR2, is also in phase 3 evaluation in patients in whom sorafenib has failed or could not be tolerated. It demonstrated antitumor activity in a randomized discontinuation phase 2 study, with a median progression-free survival of 4.2 months.
Photo by © ASCO/Todd Buchanan 2014.
M
any molecularly targeted agents that inhibit different pathways of hepatocarcinogenesis are under clinical development, and novel targets are being assessed in hepatocellular carcinoma (HCC). These efforts were described by Andrew X. Zhu, MD, PhD, at the 2014 Gastrointestinal Cancers Symposium. Sorafenib remains the only systemic agent to improve survival in advanced HCC. It improves median overall survival (OS) in HCC, but median survival is still only about 10 months. Unfortunately, multiple more potent or selective antiangiogenic agents have failed to improve on this outcome.
Andrew X. Zhu, MD, PhD
Cancer Stem Cells Novel approaches to targeting cancer stem cells (CSCs) are being explored in multiple cancers, including advanced HCC. Hepatocarcinogenesis and the regulation of CSCs have both been shown to involve the Wnt pathways. OMP-54F28, a fusion protein, targets CSCs, bulk tumor cells, and tumor stromal cells. A phase 1/2 study combining OMP-54F28 and sorafenib for the first-line treatment of advanced HCC is under way. l Reference
Zhu A. Molecular therapies in hepatocellualar carcinoma beyond sorafenib: alternatives to recent phase III trials failures. Presented at: 2014 Gastrointestinal Cancers Symposium; January 17, 2014; San Francisco, CA.
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The Whole Patient
The Dynamic Partnership of Music and Medicine Lisa A. Raedler, PhD, RPh
D
eforia Lane, PhD, MT-BC, delivered the final address of the Fourth Annual Conference of the Academy of Oncology Nurse & Patient Navigators. Lane is the Associate Director of the Seidman Cancer Center, and Director of Music Therapy at University Hospitals of Cleveland, Seidman Cancer Center, and Rainbow Babies & Children’s Hospital. She is also an opera singer and breast cancer survivor. Lane earned her PhD in music education from Case Western Reserve University, and is board certified as a music therapist. She is nationally renowned for developing music therapy programs for diverse populations, including adult and pediatric patients with cancer. She is a spokesperson for the American Cancer Society. In 1994, Lane received honorary membership into the Oncology Nursing Society. Before launching her presentation titled “Music & Medicine: A Dynamic Partnership,” Lane proffered an eloquent “Deforia-devised” definition of oncology nurse navigators: “You are an eclectic group of women and men who have efficiency in their DNA; multitasking skills galore; the ability to navigate physical, social, psychological needs of patients and families; and who balance ever-changing, ever-challenging personalities of a multidisciplinary team.” Lane expressed respect and gratitude for nurse navigators, who “carry the weight of care upon broad shoulders.”
clients improve their health in several domains, including cognitive functioning, motor skills, emotional development, social skills, and quality of life. The music experiences that therapists use to achieve their treatment goals range from free improvisation and singing to listening to, discussing, and moving to music. How Are Music Therapists Trained and Certified? Lane indicated that more than 7000 music therapists are board certified in the United States. They are educated at 1 of 70 colleges and universities with bachelors-, masters-, or doctoral-level music therapy programs. A degree in music therapy requires proficiency in guitar, piano, voice, music theory, music history, reading music, improvisation, as well as varying levels of skill in assessment, documentation, and other counseling and healthcare skills depending on the focus of the particular university’s program. To become board certified, a music therapist must complete a music therapy degree from an accredited American Music Therapy Association (AMTA) program at a college or university, complete a music therapy internship, and pass the board certification examination in music therapy. The credential Music Therapist-Board Certified (MTBC) is granted by the Certification Board for Music Therapists upon successfully passing the board certification examination.
Music therapists—credentialed professionals who have completed an approved music therapy program—customize their approach to each patient as they develop therapeutic relationships.
What Is Music Therapy? Lane introduced nurse navigators to what she termed “a most magnificent profession”: music therapy. Music therapy is the clinical- and evidence-based use of music interventions to accomplish specific patient goals. Music therapists—credentialed professionals who have completed an approved music therapy program—customize their approach to each patient as they develop therapeutic relationships. They help
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The Impact of Music Therapy Lane is enthused about the ubiquity of music. “It is a part of our culture. It is a part of our ethnicity. For many of us, it is a part of our celebrations. It is everywhere!” By asking the audience to participate by clapping and singing, Lane demonstrated just how relevant music is to mood and physiologic functioning. “Music, with its rhythms, can lower blood pressure, heart rate, and respiration rate…This beautiful thing
called music can literally adjust your behavior. It can stimulate past memory…People who cannot talk can sing.” Using the example of a woman with metastatic breast cancer, Lane described how music therapists assess patients, formulate treatment goals and concrete intervention plans, and then collect data regarding patient outcomes. With a music therapist’s help, Lane’s hypothetical breast cancer patient—who is also a mother and wife and who feels depressed and anxious— learns to write a song for her daughter, including lyrics and rhythms. Music therapists collect and document data about how long the patient engages, her attitude, her degree of involvement in the song-writing activity, her ambulation, and pain scale ratings. Clinical outcomes associated with music therapy can be significant. Lane stated, “This is a magnificent time to be a music therapist.” Her highlighted examples included former US Representative Gabrielle Giffords, who was critically injured by a gunshot wound to the head. “[Ms Giffords’s] music therapist used a neurologic music therapy technique, called melodic intonation therapy, to address her speech.” The therapeutic effects of music have already been investigated in a variety of clinical scenarios and healthcare settings. “There is a great deal that we know about how we respond to music. We take evidence-based studies and theories, and use them to help our patients,” according to Lane. Examples of the effects of music therapy were illustrated in a series of video recordings of stroke victims who were unable to ambulate effectively. Lane explained that rhythmic auditory stimulation, a neurologic music therapy technique, can help such patients as they undergo rehabilitation. One of the patients, a young man who suffered a stroke, is very unsteady at the onset of the video. His physical therapist works with him, while the music therapist simply watches from a distance. The video shows the patient’s faltering gait and his lack of arm swing. Later in the session, this patient’s music therapist uses rhythmic auditory stimulation—a simple metronome ticking, no music. When the metronome is on, the patient walks more comfortably, his arms swing in a coordinated manner, and he is steady. Lane explained that clinical research shows that hospitalized patients who walk, “IV poles and all,” while listening to live music of the genre they prefer, walk farther and perform more exercise repetitions. “They are
propelled by the music, which synchronizes the body.” Music Therapy in Palliative Care Patients Shifting her focus to the cancer arena, Lane recalled a randomized controlled study of music therapy and its effects on chronic pain in hospitalized patients. This study randomized 200 palliative care patients to standard care alone, which included medical and nursing care plus scheduled analgesics, or standard care plus music therapy. The study objective was to reduce the amount of pain that patients experienced as measured by validated pain scale ratings. Patients in the experimental group met with a music therapist who conducted a single 20-minute music therapy intervention that was directed at lowering pain. The intervention included guided imagery, followed by live slow-tempo harp music. (The goal of guided imagery is to employ mental images, as well as effective breathing and relaxation techniques, to minimize pain.) Lane noted that the researchers used standardized pain assessments preand postintervention, including use of a 0 to 10 numeric rating scale (NRS). The research to which Lane referred was recently published by Kathy Jo Gutgsell, PhD, the music therapist who played at the bedside of all patients in the experimental group (J Pain Symptom Manage. 2013;45:822-831). This study demonstrated that both the music therapy and control groups showed significant declines in pain using the NRS from pre- to posttest (mean change of 1.94 for music therapy and 0.56 for control). However, a significantly greater change (P <.0001) was seen in the music therapy group. Gutgsell and colleagues concluded that, based on these data, “palliative care clinicians may confidently refer trained music therapists to treat pain in this vulnerable population.” Music Therapy and Preventive Medicine Shifting to the role of music in facilitating community-level relationships and outreach, Lane recalled statistics related to the higher rate of mortality associated with breast cancer in African American women. “When given an opportunity to speak with women of color who were 60 years and over using music therapy, I said ‘yes!’ I did not have a clue how I was going to do it, but I said yes.” Lane and colleagues, both of whom were also breast cancer survivors, created Project Temple, an outreach pro-
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The Whole Patient gram in which music therapists visited churches, inner city apartment buildings, and senior citizen homes to talk about breast cancer screening through use of a musical skit. “[In the skit,] we talked about [cancer and cancer screening] as though we were sitting around a kitchen table. We sang the songs that helped us through our journey…We
called it ‘Sing, Sister, Sing.’ And each of us gave our personal testimony, if you will, at the end [of the skit].” Lane smiled as she recalled Project Temple participants. She noted that many were initially very skeptical (“I’ll listen to this, but...”), ultimately asking her and her colleagues, “Can you put your finger right here? Do you think
PMMP O
that is cancer? I’ve had that for a couple of months.” She laughed, “Are those 44DDs? I have stroked many a breast!” Project Temple was a real success: Lane described that participants loosened up, sang along, and asked many questions. They also agreed to free mammograms and were able to have the procedure conducted in the mobile
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van that accompanied the actors. In all, Lane estimated that she and her colleagues have reached more than 3000 women. “It was wonderful!” “Communicating From the Heart” Lane concluded her presentation by singing a poignant spiritual that was taught to her by her mother. “To me, the most beautiful part of using music with people is communicating from the heart and giving them a voice.”
Lane and colleagues created Project Temple, an outreach program in which music therapists visited churches, inner city apartment buildings, and senior citizen homes to talk about breast cancer screening through use of a musical skit.
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Lillie Shockney, RN, BS, MAS, the program chair, agreed. “We may see hundreds or even thousands of cancer patients, but that patient only sees one of us. That patient will remember you forever. If you did the right thing, as an advocate and a navigator…that patient will remember it forever.” To learn more about music therapy and to find a certified music therapist, visit www.musictherapy.org. l
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Leukemia
Raising the Bar: 4 Drugs for CLL Alice Goodman
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everal new drugs for the treatment of chronic lymphocytic leukemia (CLL) are considered major advances: 2 have been approved and 2 are under review by the US Food and Drug Administration (FDA). At the recent Chemotherapy Foundation Symposium, experts discussed ibrutinib, idelalisib, ofatumumab, and obinutuzumab.1,2 “Ibrutinib and idelalisib are 2 potent BCR [B-cell receptor] pathway inhibitors that are highly effective in both untreated and treated CLL,” stated Morton Coleman, MD, Weill Cornell Medical Center, New York City. Idelalisib is a phosphatidylinositol 3kinase (PI3K) inhibitor that achieves dramatic nodal responses in patients with CLL; but along with nodal shrinkage, white blood cell counts rise when treatment is first initiated. In one study, the nodal response rate was 81%, while the overall response rate (ORR) was 72% due to lymphocytosis. Median progression-free survival (PFS) was 17 months, and overall survival is not yet reached in heavily treated poor-prognosis patients with CLL. Idelalisib has been studied in combination with rituximab as well as with bendamustine. Both combinations achieved about a 90% response in the lymph nodes, with a concomitant rise in lymphocyte count, although less so than when idelalisib is used as a single agent. A study of idelalisib plus rituximab as frontline therapy in 64 patients with CLL achieved an ORR of 97%. Partial response rate was 67% in patients with p53 abnormalities. The major adverse effect was grade 3 diarrhea in 15 patients (23%).3 A pivotal study of idelalisib is now
ongoing in the United States and the drug is under review by the FDA. The same response pattern—a robust lymph node response with increased lymphocytosis—is seen with the Bruton’s tyrosine kinase inhibitor ibrutinib. This drug is also under review by the FDA. A phase 1b/2 study included 116 patients with CLL/small lymphocytic leukemia treated with ibrutinib monotherapy; some were relapsed/refractory and some were treatment naive. The best ORR was 84% in treatment-naive patients and 88% in relapsed/refractory patients. At 26 months, 96% of treatment-naive patients are still part of the study and PFS was 75% for the relapsed/refractory patients. These outcomes were observed in patients with
ment was observed among patients with pretreatment cytopenias.4 A pivotal study of ibrutinib is planned. Ofatumumab and Obinutuzumab “Both ofatumumab and obinutuzumab [anti-CD20 monoclonal antibodies] have a great future and an important place in the treatment of CLL,” said Kanti Rai, MD, Hofstra North ShoreLIJ School of Medicine, Hempstead, New York. Rituximab was the first anti-CD20 antibody to be approved a number of years ago for the treatment of hematologic malignancies. Ofatumumab was approved in the past few years, and approval was granted to obinutuzumab in November 2013.
Several new drugs for the treatment of chronic lymphocytic leukemia are considered major advances: 2 have been approved and 2 are under review by the US Food and Drug Administration.
poor-prognosis cytogenetics, including deletions in 17p and 11q.1,4 “These are amazing results,” Coleman said. Grade 3 and 4 adverse events included pneumonia and diarrhea, but the diarrhea is less intense than with idelalisib, Coleman noted. Ibrutinib and ofatumumab were combined in a phase 2 trial, in which the ORR was 100%. Sustained improve-
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Ofatumumab has good activity in CLL as a single agent and in combination with other drugs. Recent studies show that ofatumumab can replace rituximab in the fludarabine/cyclophosphamide/rituximab regimen for patients with CLL. A phase 2 trial confirmed comparable high activity and safety of the O-FC (ofatumumab/fludarabine/cyclophosphamide) regimen as frontline
treatment of previously untreated CLL. Investigators are moving forward with this regimen using the 1000-mg dose of ofatumumab. Idelalisib in combination with ofatumumab versus idelalisib alone is in phase 1/2 testing. The combination of ofatuzumab and lenalidomide has been extremely effective as frontline therapy for CLL, Rai said. The pivotal trial of obinutuzumab plus chlorambucil showed superiority of this combination versus rituximab plus chlorambucil. The ORR was 75% with obinutuzumab/chlorambucil versus 65.9% with rituximab/chlorambucil. Complete response was achieved in 22% versus 8%, respectively; and median PFS was 23 months versus 16 months (P <.0001). Neutropenia was reported in 34% versus 25%, respectively, and grade 3 to 5 adverse events in 67% versus 48%. “Ofatumumab and obinutuzumab have each demonstrated good activity in CLL as single agents. Now ongoing trials are showing that combinations with each of these drugs are extremely promising,” Rai said. l References
1. Coleman M. Ibrutinib and idelalisib in CLL. Presented at: 2013 Chemotherapy Foundation Symposium; November 6, 2013; New York, NY. http://chemotherapyfoundationsymposium.org/ CMS/2013archives/110613_008_coleman. 2. Rai K. Anti-CD20 monoclonal antibodies in therapy of CLL: obinutuzumab and ofatumumab. Presented at: 2013 Chemotherapy Foundation Symposium; November 6, 2013; New York, NY. http://chemotherapyfoundationsymposium.org/ CMS/2013archives/110613_009_rai. 3. O’Brien SM, Lamanna N, Kipps T, et al. A phase II study of the selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor idelalisib (GS-1101) in combination with rituximab (R) in treatment-naive patients (pts) 65 years with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). J Clin Oncol. 2013;31(15 suppl):Abstract 7005. 4. Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32-42.
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A N N IV E R S A RY
FIFTH ANNUAL
Navigation and Survivorship Conference September 18-21, 2014 • Walt Disney World Dolphin Hotel • Orlando, FL
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Through the Eyes of an Advocate
In a Perfect World of Scientific Conferences: Less Stress, Less Strain! Peg Ford
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onferences: What can be said about them? They are absolutely necessary for challenges, progress, and outcomes that will contribute to better evidence-based treatment for patients. One major issue, however, is the number of hours required to attend; the days are packed with sessions starting early and running nonstop well into the evening. When travel time and the possible crossing of time zones are considered, the impact on attendees is troublesome to me. How can an exhausted individual retain much from a session requiring concentration and focus? As a layperson, I was astonished at the pace maintained by healthcare professionals, which I wrote about previously (see “The Pace of Medicine” in the February 2013 issue of The Oncology Nurse-APN/PA). I wondered what could be done to ease the toll that attending conferences must take on healthcare providers and researchers, who are already strained with the demands of their important work. Although I attempted to avoid overloading my own schedule before and certainly during these conferences, I observed the understandably tired faces in the audiences—as well as the constant responding to texts, calls, and emails (you know the program). How much can participants learn or recall from these sessions? In the exhibit hall at the American Association for Cancer Research conference in 2013, an individual placed a flyer in my hand and said, “Perhaps this might be of interest to you as an advocate?” We had not discussed my observations in any way in our conversation, so as I glanced down at the flyer, I was taken aback by its content. Over the years, I have learned to pay attention when coincidences happen in my life, and here was an excellent example: ESCAPE, a program of BAG IT Encouraging and Sustaining Cancer Advocacy Programs and Efforts
Cancer Advocacy Leadership Conference Sunday, August 18 – Thursday, August 22, 2013 Tucson, Arizona ESCAPE brings together cancer advocates from around the country to: • network with other community advocates, both novice and veteran • learn skills to improve their organizations and efforts
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• learn new ways to prevent burnout • experience the integration of mind, body and spirit for balanced living The agenda includes plenary sessions, interactive workshops, and informal neworking groups. This is a small conference by design and a limited number of spaces are available. Yes, most details read like the typical conference design, but several items caught my attention: burnout; integration of mind, body, and spirit for balanced living; and the location of the conference, Miraval Resort, Tucson, Arizona (one of Oprah’s favorite things!). BAG IT (http://bagit4u.org/), the sponsoring organization, and Sherri Romanoski, its founder and president, who was the visionary of the ESCAPE program, celebrated the organization’s 10th anniversary last year. Created “by survivors for survivors,” BAG IT was established to fill a need in the community to provide immediate quality resources to those newly diagnosed with any type of cancer. Members designed a bag to hold helpful, informative publications and a personal navigation binder to assist people during their treatment journey and beyond. The organization has grown to serve the entire state of Arizona, reaching over 45,000 people to date. Surgery, radiology, and oncology offices; hospitals; clinics; and tribal health and resource centers distribute the bags across the state. The collaborative effort between BAG IT and healthcare providers has resulted in a system change in patient education. I felt lucky to be selected to attend, and Sherri’s letter to me showed the depth of her understanding of the stress of modern-day living and the demands of the pace of medicine and advocacy efforts. She wrote: “We invite you to participate fully in both ESCAPE programming and the activities offered by Miraval. It’s an opportunity to explore personal growth, valuable networks, and stimulating ideas. Being a cancer advocate is hard work. Some days, it’s downright exhausting, frustrating, and overwhelming [though I think this describes how our healthcare providers and researchers must feel on a more regular basis]. We designed ESCAPE to help you learn new techniques to strengthen your programs or efforts, meet others you can reconnect with later, and offer an opportunity to rejuvenate your body, mind and spirit. We believe it is a unique program for
unique individuals.” I and 24 other cancer patient advocates from across the country were pampered with tender loving care at Miraval. We were provided ample time to book Miraval activities around the ESCAPE schedule, which was organized in a comfortable flow. Most mornings were kept open to allow each advocate to take personal time. This schedule seemed to support the conference sessions going well into the evenings without the participants feeling any strain. The wonderful transformation of each of the advocates during the conference bears witness to the effectiveness of the ESCAPE program! You might start thinking that this was just an escape from the daily grind, but sessions presented during the conference were about strategic planning, fundraising, attracting volunteers, and legislative actions and included keynote addresses such as Resilience, Optimism and Hope in Cancer Survivorship; Deep Roots: Strong Trees; and Putting Down the Masks: Triggers, Truths and Authenticity. Remarkably, cell phone use was not allowed during the sessions or workshops. Everyone was relaxed, attentive, and alert in the sessions, which struck me immediately. In addition, cell phone use was allowed in only a few public areas of the resort and in private rooms. For those attending scientific conferences at which the sessions start at 8:00 AM and go through full days and well into the evening, the pace never lessens. While it is extremely rewarding to participate and represent the patient community, the energy expended can certainly take its toll on most people, especially cancer survivors. Having the gift of ESCAPE was a blessing, and I cannot thank BAG IT and Sherri enough for their vision and the sponsors—Eisai, Miraval, Genentech, and Ventana Medical Systems—for supporting the health and welfare of patient advocates who work tirelessly across this country. What they accomplished with the creation of ESCAPE might become a template for the medical and scientific communities. Their members would benefit greatly from such an amazing experience. Not only did I feel more rested and refreshed, while there I also felt more alert and more able to participate, learn, and benefit from the terrific working sessions! Could this be an answer to my question as to how to support not only the advocacy community but healthcare providers and researchers as well? Could this be a dynamic paradigm shift regarding how conferences could be designed to better support individuals on all levels, enhanc-
ing the health as well as the education of attendees? Could my writing this article plant some seeds in the minds of the medical and scientific communities for a new form of conference scheduling? Although it is true that not all conferences can happen at resorts, perhaps incorporating some aspects of this conference into other conferences could enhance the experience, reduce the strain on individuals who are already operating at a hectic pace and under heavy demands, and provide a better environment for active participation. Aspects that might be replicated include maintaining cell phone–free zones during sessions; extending the conference a day or two to afford more free time for attendees to get pampered or just relax (if supported, individuals might be willing to take personal days from work to have the extra time at the conference); eliminating the feeling of guilt for those who do not keep up with the existing pace and wish to take some downtime.
Peg Ford
Shortly after arriving home, I received the official notices that I had been nominated and selected to become a member of the Guidelines International Network (G-I-N; www.g-i-n.net) North America (NA) Steering Committee and to be a Patient Advocate for the National Cancer Institute (NCI) Ovarian Task Force. How better prepared and energized I am to participate in these important additional opportunities. This is an exciting time for guidelines development and implementation around the world, and G-I-N NA is at the center of the action. And it is such an honor to represent the patient community for NCI! If you know of a cancer patient advocate who would benefit from attending this year’s ESCAPE program, please refer her or him to BAG IT’s website for more information and an application for this year’s program (http://bagit4u.org/). l
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Cancer Center Profile
St. Jude Crosson Comprehensive Cancer Center Continued from cover What is your biggest reward? TC: The appreciation and gratitude I get from patients and their families make my job worthwhile. The other day I got a card from a recently deceased patient’s husband that read: “The care you provided made her battle with cancer much easier and she appreciated it so much. I appreciate your kindness and help during a difficult time.”
spiritual care, retreats, and distress screening and management to help patients and their families cope with the challenges of diagnosis and treatment—going beyond the physical aspects of cancer and focusing on emotional health as well. The Oncology Nurse-APN/PA spoke with TraciLyn Clark, RN, BSN, OCN, about her role as a GI/GYN oncology nurse navigator at the St. Jude Crosson Comprehensive Cancer Center.
Please describe your responsibilities as GI/GYN Nurse Navigator. TraciLyn Clark (TC): Once I meet the patient via staff referral or self-referral, I become a support for that patient here at the cancer center. I coordinate with surgeons, oncologists, and the hospital staff to develop a treatment plan in discussions with the patient, not at the patient. All treatment options and plans are discussed thoroughly with patients to ensure that we meet their specific and unique needs. Patients can call me any time with questions or with concerns. For example, if a patient had a radiology exam ordered but it was not scheduled, that patient could call me and I would follow up to make sure an appointment for that test was scheduled. We provide patient education, help patients gather information to make treatment decisions, help them improve communication with their medical team, increase understanding, help them understand the tests and procedures they will undergo, and, overall,
TraciLyn Clark, RN, BSN, OCN
The nurse navigator team at St. Jude Crosson Comprehensive Cancer Center (left to right): Gianna Laiola, RN, MSN, OCN—GU Navigator; Sue Lepich, RN, BSN—Breast Navigator (seated in front); TraciLyn Clark, RN, BSN, OCN—GI/ GYN Navigator; Lea Powell, RN, MSN, OCN—Executive Director, Oncology Services; and Shannon Lindop, RN, BSN, OCN—Lung/Head and Neck Navigator.
provide support, encouragement, and friendship for patients. Whenever a patient says he or she feels confident in the plan of care and understands the diagnosis, I know I’ve done my job well. I frequently connect patients to our relaxation class, spiritual care, and our social worker. Hearing that the anxiety level has gone down and that he or she is enjoying life and time with family during care is also an indicator of a job well done. As a navigator, I also facilitate the transition to survivorship, often including a referral to our STAR (Survivorship Training and Rehabilitation) certified oncology program.
What is the approach to care at your center? TC: St. Jude’s belief is that excellent care extends beyond good medicine. We focus equally on medical excellence and on compassionate care for the patient’s mind, body, and spirit. St. Joseph’s was originally founded by the Sisters of St. Joseph of Orange with the mission to extend the ministry of Jesus. Together, with the Sisters, we fulfill that mission to extend the healing ministry of Jesus, and the values of dignity, excellence, service, and justice are our guiding principles. We are a Catholic hospital, and all religions and beliefs are welcome.
How does this approach to care translate to better outcomes? TC: Understanding improves compliance. Developing a treatment plan with the patient improves compliance. Also, the dual emphasis on good outcomes and survival rates as well as caring for the patient holistically (mind/ body/spirit) improves outcomes. These intangibles are critical to improved quality of life. We offer patients spiritual care, healing touch, support groups, and retreats to support them psychologically and spiritually. What is the biggest challenge of your job? TC: In general, compassion fatigue is the major challenge for me and probably for all oncology nurses. I get to know my patients very well and treat them as family members. In the course of a day, often I am there when patients get very bad news. It is a challenge to remain positive and not become emotionally drained by the bad news. Fortunately, part of our training here involves stress reduction and relaxation, with an emphasis on maintaining personal boundaries and having a personal life. We have workshops on destressing and leaving work behind. This allows us to get recharged and bring our best selves to our work.
What led you to your current career? TC: I was in nursing school but was finding it difficult and not what I expected. Then my mother was diagnosed with breast cancer, and she was very unhappy with the care she was receiving. She said, “Traci, you have to finish nursing school, because good nurses can make all the difference.” So I did, and fortunately I got a good externship in oncology and then a placement in oncology at Sharp Memorial Hospital in San Diego. I knew then that I wanted to stay and become an oncology-certified nurse. I received an excellent mentorship and enjoyed taking care of patients. However, I had to learn the hard way to take care of myself as well and to find the “sweet spot” between patient care and personal needs. I now take care of myself, and that includes massages, hikes, and entertainment. What advice would you give to a new oncology nurse? TC: Learn to take care of yourself first. Be careful about choosing mental and emotional health over making money. A happy nurse provides better care than someone who is burned out. What would you be doing if you weren’t an oncology nurse navigator? TC: I also work as a bridal consultant. This is fun for me, and it is a way to save money for a trip to Europe with my husband. I could have taken a second nursing job on weekends, but I wanted to experience a different part of the circle of life. l
Take action: get YOUR cancer center profiled! We are looking to interview oncology nurses from cancer centers around the country. It’s an easy process—a short phone interview and you need to submit some photos.
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Who Will Be the ONE? The Oncology Nurse Excellence Award Winner
The Oncology Nurse-APN/PA 速 (TON) is pleased to announce the 2014 ONE (Oncology Nurse Excellence) Award. This annual award recognizes an oncology nurse for outstanding contribution to oncology nursing practice, patient care, or education in 2014. The 4 leading nominees will be profiled online and in the August issues of TON and the Journal of Oncology Navigation & Survivorship 速 (JONS ). Readers will have an opportunity to nominate an individual online through June 2, 2014, and the winner will be announced at the Fifth Annual Academy of Oncology Nurse & Patient Navigators (AONN+) Conference, September 18-21, 2014, in Orlando, Florida, and profiled in the December issues of TON and JONS. The winner will also receive a plaque recognizing their contribution to oncology nursing, as well as a donation made to the charity of their choice in their name.
Nominate a nurse at
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Now enrolling
Investigating ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Phase II Open-Label Study of the Efficacy and Safety of ABT-199 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion N=100
ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use under investigation in this trial. Primary Endpoint
Secondary Endpoints
• Overall response rate
• • • • • • • •
Complete remission rate Partial remission rate Duration of response Progression-free survival Time to progression Overall survival Percentage of patients who move on to stem-cell transplant Safety and tolerability of ABT-199
Key Inclusion Criteria • Adult patients ≥18 years of age • Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria (relapsed/refractory after receiving ≥1 prior line of therapy and 17p deletion) • ECOG performance score of ≤2 • Adequate bone marrow function • Adequate coagulation, renal, and hepatic function, per laboratory reference range
NCT#01889186 Reference: ClinicalTrials.gov.
@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.
To learn more about this study, please visit www.ClinicalTrials.gov.