The Oncology Nurse

JULY 2016

www.TheOncologyNurse.com

VOL 9, NO 4

How to Assess Quality in the Age of Precision Medicine

CANCER CENTER PROFILE

Putting Patients First at Fairfield Medical Center

Meg Barbor, MPH

F

airfield Medical Center in Lancaster, OH, is a comprehensive cancer care program where medical oncologists, radiation oncologists, surgeons, oncology nurses, and other team members work together to provide an individualized treatment plan for Sandra Black, RN, OCN, CLNC every patient. In addition to chemotherapy, radiation, and surgery, a range of other treatments and ancillary services are offered to patients with cancer, including music therapy, pet therapy, nutritional counseling, yoga, and relaxation.

At Fairfield Medical Center, dedicated oncology nurse navigators provide coordination of all aspects of cancer care to help patients and their families deal with their journey.

The Oncology Nurse-APN/PA talked to Sandra Black, RN, OCN, CLNC, an oncology certified nurse who delivers chemotherapy and ambulatory infusions Continued on page 9

Phoenix, AZ—Even though many patients have profound responses to targeted therapy, they can often develop resistance, and this can happen quickly.

Physicians’ understanding of what it means to treat these patients must evolve as do their tumors and their biology, according to a presentation at the 2016 American Society of Clinical Oncology (ASCO) Quality Care Symposium.

“Precision cancer medicine offers patients a new range of therapies and unprecedented hope,” said Stacy Gray, MD, a thoracic cancer physician at Dana-Farber Cancer Institute and assis-

tant professor of medicine at Harvard Medical School, Boston, MA. “One of the things that’s really interesting and exciting about practicing in precision medicine is that we’re practicing in a rapidly changing landscape.”

Dr Gray elaborated on some of the challenges and opportunities clinicians now face in assessing quality in the age of precision medicine.1

Precision Medicine and Care Quality

A relationship exists between precision medicine and care quality accordContinued on page 14

FDA NEWS

Diagnostic Imaging Agent “Newer” Ovarian Cancer Genes, FDA Approved for Rare Option of Risk-Reducing Neuroendocrine Tumors Salpingo-Oophorectomy ccording to a recent announce- matostatin, a hormone that regulates

A

Cristi Radford, MS, CGC Invitae

T

he ability to analyze multiple genes at the same time has led to the estimate that 20% to 25% of women with ovarian cancer have an inherited mutation in a cancer-predisposing gene.1 Although this association has been noted for a while, until recently there was not enough data available

to determine the lifetime ovarian cancer risk for women with a mutation in some of these genes. Therefore, it was challenging to determine which women with a mutation in a “newer” ovarian cancer risk gene should undergo riskreducing salpingo-oophorectomy (RRSO). In February 2016, new recomContinued on page 18

ment by the US Food and Drug Administration (FDA), Netspot, a radioactive diagnostic agent for positron emission tomography (PET) imaging, has been approved in adult and pediatric patients with somatostatin receptor–positive neuroendocrine tumors.

The agent—gallium Ga-68 dotatate— is a positron-emitting analogue of so­

Continued on page 22

INSIDE 7 Communication Tools Electronic “Facility Board” Provides Easy Look at Patient Status 11 Conference News: NCCN The Benefits of the Triage and the COME HOME Model 15 Immunotherapy Immunotherapy: Separating Facts from Fiction

© 2016 Green Hill Healthcare Communications, LLC

the endocrine system. Neuroendocrine tumors have receptors for this hormone, and gallium Ga-68 dotatate works by binding to them.

This FDA approval was based on 3 studies evaluating the safety and efficacy of Netspot, all of which confirmed the usefulness of Ga-68 dotatate images in locating neuroendocrine tumors.

17 Sexual Health NCCN Survivorship Guidelines Update Management of Sexual Dysfunction 19 Palliative Care Panel Addresses Palliative Care Needs, Emphasizes Team Approach 20 Interview with the Innovators Prevention Is the Key to Bone Health in Patients with Prostate Cancer

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In the July issue of The Oncology Nurse-APN/PA, we feature the Fairfield Medical Center from Lancaster, OH. They have a comprehensive cancer program where medical oncologists, radiation oncologists, surgeons, oncology nurses, and other team members work together to provide an individualized treatment plan for every patient (see the cover).

Another featured article this month is the Genetic CounselBeth Faiman, PhD, APRN-BC, AOCN ing column by Cristi Radford, Editor-in-Chief MS, CGC. In her article, she talks about novel ovarian cancer genes as well as risk-reducing salpingo-oophorectomy. For more information about these genes, see “‘Newer’ Ovarian Cancer Genes, Option of Risk-Reducing Salpingo-Oophorectomy,” on the cover.

Don’t forget to read about the lastest research presented at conferences in our conference news section. This month, we continue to cover news from the 2016 American Society of Clinical Oncology (ASCO) Quality Care Symposium, bringing you the latest from the Oncology Nursing Society 41st Annual Congress, as well as data from the 2016 Community Oncology Conference.

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 Rd, Suite 202A, Cranbury, NJ 08512. Copyright © 2016 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.

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In addition, we share a technology update on CancerLinQ, the big data cancer database from ASCO. “We have to create a platform that will accept data from different systems to enable interoperability across many sources,” explained Robert S. Miller, MD, a medical oncologist and Vice President, ASCO Quality and Guidelines, and Medical Director of CancerLinQ (see page 18). We also report on an electronic “facility board,” a communication tool that was created to easily look at patient status and improve communication (see page 7). The board led to more clinical interventions for abnormal vital signs, a reduction in falls among high-risk patients, and more ordering of specialty beds.

This issue also includes articles on a variety of treatments and conditions, including immunotherapy, head and neck cancer, sexual health, palliative care, and side effect management. In particular, the article about immunotherapy provides information about separating facts from fiction (see page 15). “Cancer is inherently robust. We’ve learned this over decades and decades of failure; we’ve seen it become resistant, and patients die. And this has not changed, ultimately, even though some patients do well,” according to the researcher.

In this issue’s reader poll (see below), we ask about your confidence level explaining genomic information to patients.

Please visit our website, TheOncologyNurse.com, and let us know whether this is something you are comfortable doing.

We hope you enjoy this issue, and as always, we look forward to your feedback. n

ASSOCIATION & CONGRESS DIVISION Association Director Patrice Melluso

Meeting & Event Planner Linda Mezzacappa

Senior Account Executive George Fuller

Project Manager

READER POLL Are you confident explaining genomic information to patients? o Yes o No Physicians’ understanding of how to treat patients who develop resistance to target therapy must evolve alongside their patients’ tumors and changing biology.

“Precision cancer medicine offers patients a new range of therapies and unprecedented hope,” according to Stacy Gray, MD, at the 2016 American Society of Clinical Oncology Annual Meeting. In her presentation, she discusses some of the challenges and opportunities clinicians now face in assessing

quality in the age of precision medicine (see “How to Assess Quality in the Age of Precision Medicine,” on the cover). Data suggest that up to 25% of providers are not confident in their knowledge about genomics, their ability to explain genomic concepts to patients, and their ability to make treatment recommendations based on genomic information. Visit us online, and share your insight on precision cancer medicine at the bedside by taking our poll.

Rachael Baranoski

Senior Project Coordinator Gretchen Dann

Project Administrator Sara Mohamed

Go to www.TheOncologyNurse.com to answer the question.

EDITORIAL BOARD EDITOR-IN-CHIEF

Beth Faiman,

PhD, APRN-BC, AOCN

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Cassandra J. Hammond,

RN, MSN, CRNP Quintiles, Inc Sharpsburg, MD

Catherine Bishop,

Shannon Hazen,

Johns Hopkins Kimmel Cancer Center/Sibley Infusion Washington, DC

BD Medical Surgical Systems Charlotte, NC

DNP, NP, AOCNP

Deena Damsky Dell,

RN, BSN, OCN

Taline Khoukaz, MSN, ACNP-C

RN-BC, MSN, AOCN, LNC

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

Wendye DiSalvo,

Sandra E. Kurtin,

Fox Chase Cancer Center Philadelphia, PA

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 Dallas, TX

Sharon S. Gentry, RN, MSN, CBCN

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

RN, MS, AOCN, ANP-C

University of Arizona Cancer Center Tucson, AZ

Ann McNeill,

RN, MSN, NP-C, OCN

Melinda G. Oberleitner,

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

Jayshree Shah,

Pharmacy John F. Aforismo,

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

RN, APN-C, AOCNP, MSN

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Gary Shelton,

DNP, MSN, NP, ANP-BC, AOCNP

NYU Perlmutter Cancer Center New York, NY

Lori Stover, RN, BSN

Western Pennsylvania Cancer Institute Pittsburgh, PA

Joseph D. Tariman, PhD, ANP-BC

DePaul University Chicago, IL

Kena C. Miller,

Jacqueline Marie Toia,

Roswell Park Cancer Institute Buffalo, NY

RN, MS, DNP

Northwestern University Myeloma Program Chicago, IL

Patricia Molinelli,

Connie Visovsky,

Somerset Medical Center Somerville, NJ

University of South Florida College of Nursing Tampa, FL

Ellen A. Neylon,

Jeanne Westphal,

MS, RN, APN-C, AOCNS

MSN, FNP-BC, CCRP, OCN

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

PhD, RN, AOCN

RN, DNS

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

RN, MSN, FNP

Rita Wickham,

PhD, RN, ACNP-BC

RN

Meeker Memorial Hospital Litchfield, MN

BSc Pharm, RPh, FASCP

Drug Knowledge LLC Wethersfield, CT

Nutrition Karen Connelly, RD, CSO

Somerset Medical Center Somerville, NJ

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

Genetic Counseling Cristi Radford, MS, CGC

Invitae Atlanta, GA

Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS

BelHealth Investment Partners

CONFERENCE NEWS

Molecular Profiling Is Vital in Patients with Metastatic Cancer Meg Barbor, MPH

Orlando, FL—Physicians need to advocate for molecular profiling, according to Howard “Skip” Burris III, MD. “I do think, in treating our metastatic patients, it’s going to be as good as the next PET/CT [positron emission tomography/computed tomography] scan, and it’s certainly going to be more important than the follow-up PET/CT scan that you get when the patient develops resistance or progression,” he said at the 2016 Community Oncology Conference.

But the problem is cost, he added. “I think among the list of things we have to advocate for in community oncology is how molecular profiling is going to be paid for, but the cost of this needs to be determined,” said Dr Burris. “I think the simple problem is, they’ll pay for a test when you get an answer, but in this setting the test provides a lot of potential answers, but no definitive answer, which makes it very hard.”

What Test Do I Order?

In addition to the cost, other challenges involved in molecular profiling include determining what type of test to order and knowing which technology is needed for comprehensive tissue testing, interpreting the tests and what the results might mean, determining when to rebiopsy, and getting enough tissue and prioritizing the use of that tissue.

Alterations can occur within a chromosome or across 2 chromosomes, “so

there’s a variety of opportunities for drug development, but it becomes all the more important to know what you’re actually treating in a patient,” said Dr Burris, President of Clinical Operations and Chief Medical Officer at Sarah Cannon Research Institute.

Somatic and germline mutations are important to consider as well, as more and more germline mutational abnormalities are being discovered in patients with metastatic cancer.

“We’ve got to find the right therapy for the right patient at the right time, and I think biopsy, identification, profiling… all of these are going to be very key.”

—Howard Burris III, MD “But there’s a lot of competition in this space, and we’re going to see the best emerge,” said Dr Burris.

Routine single-marker molecular tests, such as immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescence in situ hybridization (FISH), have been used for decades and will continue to play an important role in cancer diagnosis. A

multigene “hot spot” test can identify prespecified mutations occurring in very limited areas of genes of interest, but could fail to detect all classes of genomic alterations.

According to Dr Burris, a comprehensive genomic profiling approach, which tests all of the known clinically relevant cancer genes for all classes of alterations, will provide the most inclusive answer.

“I think the temptation is to get the single-marker molecular test,” he said.

“But what we really want to know, if cost isn’t an issue, is the complete genetic profile, or what the patient had at the beginning and what they have acquired. I think that’s going to be the key for us in taking care of these patients.”

He warned that a new biopsy might be needed before profiling, as a patient’s tumor may change over time depending on treatments and can acquire therapy-specific resistance mutations, so the molecular status of an historical sample may not reflect the patient’s current disease status.

More Liquid Biopsy on the Horizon

Although tissue-based assays are still the “gold standard,” according to Dr Burris, liquid biopsy—a new noninvasive technique that can detect disease biomarkers in blood, urine, and other body fluids—is going to be key in the near future. “Many of your patients

don’t have disease accessible to biopsy, so liquid biopsy is where it’s heading,” he said.

It seems that highly specific tests are more sensitive than broad-based tests and could be adopted much quicker (eg, Droplet Digital PCR–based tests are more sensitive than tests based on next-generation sequencing), he said, but currently there are biologic challenges to be addressed (eg, heterogeneity, localization, not all clonal events are cancer). In addition, 42% of patients shed no detectable circulating tumor DNA into the bloodstream, which Dr Burris called “a little discouraging.”

JP Morgan predicts liquid biopsy will be a $20-billion field in the next 5 years, “but figuring out how to pay for it will be an interesting challenge,” Dr Burris said.

“We’re taking care of the other 99% that can’t get the Dana-Farber or the MD Anderson treatment. They’re being treated in the community, and how we do this is so important,” he said. “We’ve got to find the right therapy for the right patient at the right time, and I think biopsy, identification, profiling…all of these are going to be very key.” n

Reference

Burris HA. The influx of new cancer drugs: clinical, patients care, and operating ramifications. Presented at: 2016 Community Oncology Conference; April 14-15, 2016; Orlando, FL.

COMMUNICATION TOOLS

Electronic “Facility Board” Provides Easy Look at Patient Status Caroline Helwick

San Antonio, TX—An electronic “facility board” situated on a wall in the nurses’ station of a medical/surgical unit led to more clinical interventions for abnormal vital signs, a reduction in falls among high-risk patients, and more ordering of specialty beds, according to nurses from Cancer Treatment Centers of America (CTCA) at Eastern Regional Medical Center in Philadelphia, PA. At the Oncology Nursing Society 41st Annual Congress, Jessica O’Driscoll, BSN, RN, HN-BC, said the facility board serves as a simple visual alert system for the entire treatment team.

“In a perfect world, we would all communicate effectively to meet the needs of each patient at all times. In reality,

a disorganized and hectic day often occurs, leaving room for error. That’s when technology comes in,” she said. “Because of this tool, the nurses Jessica O’Driscoll, on the medical/ BSN, RN, HN-BC surgical floor at CTCA implemented an electronic board to help bridge these communication issues.”

The facility board is a compilation of data downloaded from the patient’s electronic health record. It is situated on a wall at the nurses’ station, where it

is easily visualized for almost instant recognition of problem areas for each patient. Vital signs, along with risk factors for falls and pressure ulcers, are highlighted when they are outside acceptable parameters.

“Clinicians come into the unit and are able to get a quick picture of a patient’s status,” she said.

The electronic board has multiple uses: • Rapid assessment of vital signs, which are frequently monitored postoperatively • Visual display of the patient’s status for discussion during multidisciplinary morning rounds • Review of quality indicators, as a quick reference for the charge nurse • Identification of patients with high

Hendrich scores, for whom a fall risk bundle can be maintained.

Improvements Documented

Improvement in the prompt identification of patient deterioration and risk was analyzed using 2 months of postimplementation data on abnormalities or changes with vital signs, Hendrich scores, and Braden scores.

A survey was also sent to all disciplines to qualitatively measure the value of the board for physicians, physical therapists, pharmacists, and nutritionists. The survey asked, “In your experience, has information from the facility board directly impacted treatment or plan of care for your patient?”

“We determined that the facility Continued on page 8

CONFERENCE NEWS: NCCN

Opioid Prescriptions for Pain Management: Safe Patient, Prescriber, Community Wayne Kuznar

Hollywood, FL—Achieving balance in the appropriate use of opioids to treat cancer pain requires skill and compassion. Strategies for safely and effectively prescribing opioids while reducing the risk of drug misuse and abuse were offered by Judith Paice, PhD, RN, FAAN, at the National Comprehensive Cancer Network 21st Annual Conference.

Best practices for the management of chronic pain is a timely issue, given the recent federal proposal to address prescription opioid abuse and the heroin use epidemic.

“We’ve learned to use opioids a little more judiciously, but the pendulum maybe swung a little bit too far in the direction of using them in people who maybe aren’t the best candidates, or using doses higher than we should,” said Dr Paice, Director, Cancer Pain Program, Division of Hematology/ Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL. “We’re starting to reevaluate…; our goal is truly a balance between analgesia, function, and safety. We need to think of those 3 components when we’re providing good pain control.”

Another way to think of the challenge is the safety of the patient, prescriber,

and community, she said. The concept of no pain for 24 hours a day, 7 days a week is now considered unrealistic.

In addition to understanding the characteristics of the pain, the providers should also assess the effect the pain is having on the patient’s life. Response to interventions for past pain episodes, including the types of adverse effects, is part of this assessment. Comorbid conditions should be considered as well, since these may place the patient at risk for misuse of pain medicines. The patient’s functional goals should also be determined.

Medication choice should match the type of pain. For somatic pain, rely on nonopioids, advised Dr Paice, whereas neuropathic pain may require opioids at higher doses, along with adjuvant analgesics. Visceral pain is less well understood, but opioids and corticosteroids are reasonable choices.

Less well-known adverse effects of opioids include hormonal changes (suppression of testosterone), which may impact libido, fertility, bone health, and fatigue.

“I don’t want to lose track of the fact that we still have people who are undermanaged with pain control,” she said.

Those at risk for undertreatment include infants and children, patients >65

years of age, long-term survivors, cognitively impaired persons, economically disadvantaged patients, and non– English-speaking patients.

The oncology patient can likewise suffer from overtreatment of pain. As with undertreatment, long-term survivors are at risk of overtreatment. Others at similar risk are patients with comorbid mental health conditions (ie, anxiety, depression, sleep disorders). “We need to be very clear with patients that you can’t take these medicines to treat your anxiety…or to help you sleep,” said Dr Paice. Patients with limited financial resources may be at risk of overtreatment with opioids because they have limited access to physical therapy and mental health counseling.

While the long-term benefits of opioid therapy have not been documented, since the duration of most studies has been 12 weeks, adverse effects of longterm opioid use include cognitive difficulties and depression; respiratory depression is also related to opioid use.

An increasing rate of opioid prescriptions correlates with increasing rates of opioid abuse and opioid-related deaths, she pointed out. The differential diagnosis of aberrant drug-taking behavior includes pseudo-addiction, in which the

amount of drug ordered is insufficient, possibly because of insurance limits.

Some patients, however, do have an opioid addiction while others attempt to obtain the drug with criminal intent (diversion). Smoking is a risk factor for addiction as are a personal history of sexual abuse and a family history of substance abuse.

Urine drug-toxicology testing can help discern whether patients are taking the drug as prescribed or are diverting it.

Prescription drug–monitoring programs are available to screen for aberrant behaviors and to verify medication dose and refill dates.

When opioids are no longer beneficial, physicians should provide a strategy to wean the patient off the drug.

A slow downward titration, about a 10% reduction in dose per week, is recommended.

To ensure a safe community, educate patients and their families about safe medication practices, including keeping pain medicines locked away, Dr Paice advised. n

Reference

Paice J. Cancer pain management: strategies for safe and effective opioid prescribing. Presented at: National Comprehensive Cancer Network 21st Annual Conference; March 31-April 2, 2016; Hollywood, FL.

COMMUNICATION TOOLS

Electronic “Facility Board” Provides Easy Look...

The electronic facility board at the nurses’ station serves as a visual alert system for the entire treatment team.

board was impactful,” Ms O’Driscoll reported. “We saw a definite improvement at the end of the second month,

in all 3 areas.” After 2 months of intervention, clinicians intervened for abnormal vital signs in 27% of patients,

Continued from page 7

falls decreased by 33%, and the number of specialty beds ordered (based on Braden score) increased by 32%.

“The increase in the use of specialty beds was ultimately reflected in no pressure ulcers for our inpatient unit,” she added.

The survey also showed that 68% of the multidisciplinary team noticed an improvement in interdepartmental communication.

“We kept collecting data for the next 4 months, and we found some great improvements,” Ms O’Driscoll continued, with 21% of the unit’s patients receiving vital sign interventions, falls decreasing by 50%, and specialty mattress orders increasing by 24%.

score is high, and if so, whether fall precautions are in place,” she said. “We saw a big improvement in this area.”

The “fall risk bundle” includes a yellow bracelet, yellow nonskid socks, yellow blanket, chair alarm, and yellow star placed outside the room of patients considered at increased risk of falls.

To publicize their successes with the facility board, the nurses published an article in the hospital’s newsletter, focusing on the reduction in falls. This brought all stakeholders up to date on the fall risk bundle.

“It was very well received, and we have been able to keep patient falls almost to zero since we started this project,” Ms O’Driscoll said. n

Focus on Fall Prevention

Reference

“Fall prevention was big,” she said.

“As charge nurses look at the board, they can see whether the Hendrich

O’Driscoll J. Utilization of an innovative tool to improve oncology patient outcomes. Presented at: Oncology Nursing Society 41st Annual Congress; April 28May 1, 2016; San Antonio, TX.

CANCER CENTER PROFILE

Putting Patients First... to patients treated at the center. Ms Black was recently featured in a video presentation at the Oncology Nursing Society (ONS) 41st Annual Congress in San Antonio, TX. The video, Heroic Hearts: To Be an Oncology Nurse, The Movie, focuses on the extraordinary role of the oncology nurse in caring for patients living with cancer.

What does your current job at Fairfield Medical Center entail?

Sandra Black (SB): I am a chemotherapy staff nurse delivering chemotherapy and ambulatory infusion therapy to cancer patients treated at our center.

We are a community-based cancer center and provide both inpatient and outpatient treatment. I work with a wonderful multidisciplinary team to provide our full range of services.

My position involves reviewing each patient’s medical history, cancer regimen, treatment cycle, and tolerance of the current therapy. Ensuring that the patient and family are educated about the treatment safety measures, and potential side effects, is very important.

My assessment also includes reviewing lab values, taking vital signs, and monitoring pain control prior to providing ongoing therapy.

What was it like to participate in the video at ONS?

SB: The video was called Heroic Hearts and was produced by Tesaro, an oncology-focused biopharmaceutical company.

The video featured 3 oncology nurses and highlighted their daily tasks and challenges in caring for patients during one of the most difficult times of their lives. I was selected as one of the participants in the video to share my oncology journey, because I am directly involved with managing patients’ fears and concerns regarding cancer treatment.

What are some of the challenges in your job?

SB: My philosophy is to turn challenges into opportunities. One of the biggest challenges is staying competent and current with all the changes in cancer therapies so that I can continue to provide the best care possible to my patients. Fortunately, ever-evolving changes in care are contributing to improved outcomes, making many cancers a chronic disease. As an oncology nurse, I have to be competent, be aware of possible side effects, and address adverse reactions to therapy.

Availability of time to help patients can also be a bit of a challenge, but my team members quickly assist as needed.

Patients can be overwhelmed by all the

Continued from the cover

information they receive. We try to help them with their special needs through the cancer journey.

What are some of the rewards of your job?

SB: My cancer journey has allowed me to share in the lives of so many patients

and families that have endured cancer.

Each time I see one of my survivors, we share a hug in happiness of where we have been. And when those hugs are shared with family members who no longer have their loved one, I am reminded that it is a gift to be part of their journey as well.

I love what I do because I feel I can help people and make a difference. I challenge myself to have the knowledge and expertise to reassure people with cancer. There are many opportunities with oncology nursing. I have worked with hospice, been the nurse at a camp for children with cancer, served Continued on page 10

CONFERENCE NEWS

Palliative Care Specialists Want More Involvement At a 2016 NCCN roundtable, specialists offered helpful phrases for painful discussions Audrey Andrews

Hollywood, FL—When patients hear the phrase palliative care, they sometimes feel their oncology team is “giving up on them,” according to a survey of attendees at the National Comprehensive Cancer Network (NCCN) 21st Annual Conference.

The survey was part of an interactive roundtable discussion on palliative care, moderated by Toby C. Campbell, MD, MSCI, a thoracic medical oncologist and Chief of Palliative Care at the University of Wisconsin Carbone Cancer Center. The panel included several palliative care specialists and a mathematician whose mother died of cancer.

“The words palliative care are threatening to patients if they don’t know what they are.”

—Carri Siedlik, APRN, ACHPN “The words palliative care are threatening to patients if they don’t know what they are,” said Carri Siedlik, APRN, ACHPN, a nurse practitioner in the Palliative Care Program at the University of Nebraska Medical Center’s Fred & Pamela Buffett Cancer Center, in Omaha. “But once patients know what it is, they all want it.”

Panelists agreed that the impression of “giving up” can be a formidable barrier to patients’ acceptance of palliative care services, but one that can be overcome through enhanced communica-

tion. Maria Dans, MD, Director of Palliative Care Services at Siteman Cancer Center, Barnes-Jewish Hospital, in St. Louis, MO, said she proactively addresses the possibility that patients may feel this way. She tells them, “It is not about giving up but changing the fight as the disease progresses and priorities change.”

Dr Campbell uses his patients’ concerns as an opportunity to praise their valiant fight, with phrases such as, “Look at all the work you have been doing and all the chemo you have been through; giving up is not any part of who you are.

This has always been about life, and you are not giving up on life!”

He also suggested digging deeper into their concerns, to discover what is driving the patient to want to live longer. “Get past the first question about not losing hope,” he advised. “There is a lot of interesting stuff the next question down.”

The best time to broach the conversation about palliative care and end of life is at the beginning of the patient’s journey, according to Dr Campbell. “It is much easier to bring that up when you are not facing that decision right now,” he explained. “I bring it up at the beginning and at every progression.

Then, when it is time, it is not a surprise, [and] my patients are more prepared for it.”

Addition of Palliative Care Need Not Weaken the Bond

In the audience survey, attendees at the session also felt patients dislike the idea of adding another physician to their

personal team of providers. As explained

by Sophia Smith, PhD, MSW, Associate Professor of Nursing at Duke University, Durham, NC, patients spend a lot of time, sometimes years, establishing a strong relationship with their oncologists and nurses and do not want this “family” bond to be weakened.

The best time to broach the conversation about palliative care and end of life is at the beginning of the patient’s journey.

Indeed, according to Dr Dans, bringing in a palliative care specialist may actually strengthen the primary relationship. “It may be easier for someone else to start these hard conversations,” she suggested, adding that ideally all members remain in the patient’s inner circle. “No one wants anyone to make an end run around someone they have a relationship with,” she said.

Ms Siedlik acknowledged the delicate balance that’s required. She has made it a point to build and maintain good relationships with many oncologists, since physicians as well as patients could see newcomers as interlopers.

“I am always very ‘consult cautious’ and make sure I have good consult etiquette,” she said, adding that she is trying to avoid being seen as someone who is there “to pull the rug out” from under the patient and treatment team.

Palliative Care Specialists Save Others Time

Referral to palliative care specialists can also benefit the oncology care providers by relieving them of the time-consuming conversations about goals of care and prognosis and of dealing with the aftermath of sometimes troubling news. While oncology providers spend most of their time on the treatment plan and management of symptoms, the panelists indicated that the oft-neglected emotional topics are the ones many patients want to focus on.

Dr Campbell added that when the oncology team acknowledges their time is limited for these critical end-of-life conversations, they should see this as an opportunity to refer patients to palliative care specialists for this service. “Some of these items are the domains of palliative care, and you may be assisted by members of the palliative care team,” he said.

While palliative care has traditionally been offered through inpatient services, he indicated that palliative care services are now moving toward ambulatory or “outreach” settings. Still, when surveyed, the audience indicated that palliative care services are not as available as they would hope. Attendees ranked their number one barrier to providing palliative care services as “having limited or no access to palliative care where I practice.” n

Reference

Campbell T. Palliative care: providing comfort from a patient and provider perspective. Presented at: National Comprehensive Cancer Network 21st Annual Conference; March 31-April 2, 2016; Hollywood, FL.

CANCER CENTER PROFILE

Putting Patients First... on the board of the American Cancer Society, and am a chemotherapy educator of ONS, to name a few of these opportunities.

I also enjoy promoting cancer prevention and detection, and speaking with patients and family members about preventive measures and screening, and self-care.

What inspired you to become an oncology nurse?

SB: [While] living in a rural community, 2 family members developed cancer in 1980. Access to cancer services was limited, diagnosis came too late, and

Continued from page 9

treatment was very debilitating. I decided that I wanted to make a difference in the lives of cancer patients, and with the encouragement of my family members I took a new career direction. I had planned to go to dental hygiene school but I was pulled toward cancer nursing. My goal became to make the experience somehow better for the patients I would encounter.

What are you excited about in the field of oncology right now?

SB: I am excited about the many advances in cancer care. I actively sup-

port research and help patients enroll in clinical trials. These new therapies can make a big difference. Another family member developed lymphoma and failed on traditional therapies. He enrolled in a clinical trial of radio­ immunotherapy that extended his life.

Eventually he did lose his battle with cancer, but without that therapy, he believed he wouldn’t have lived as long as he did.

What advice would you give someone entering the field of oncology nursing?

SB: Follow your heart. If this is a career

you are drawn to, be assured that challenges are also opportunities. Keep learning, and seek certification. Continually reinforce your commitment to credentialing and strive to give the best care to your patients and the facility where you work.

What would you do if you won the lottery?

SB: We love the outdoors, so I would go camping and enjoy nature’s beauty more. I would continue to support cancer care, mission work, and, if time allowed, I would work to improve oncology nursing care in prisons. n

CONFERENCE NEWS: NCCN

The Benefits of Triage and the COME HOME Model Meg Barbor, MPH

Orlando, FL—At the heart of the oncology medical home is triage, according to Barbara McAneny, MD, Chief Executive Officer of New Mexico Cancer Center as well as Innovative Oncology Business Solutions (IOBS), where she also serves as chief medical officer.

IOBS was awarded a $19.76-million grant from the Center for Medicare & Medicaid Innovation to develop a Community Oncology Medical Home (COME HOME) model and implement that model in 7 community oncology practices around the country.

“The COME HOME vision is all centered around triage,” said Dr McAneny at the 2016 Community Oncology Conference.1 “We try to make sure that when patients call in they reach someone who knows something about their disease, the drugs they’re taking, and the side effects, and also about them as a person, so that they can get the care they need.”

The COME HOME Model

According to 2008 data from the North Carolina Disease Event Tracking and Epidemiologic Collection Tool, presented by researchers in the Journal of Clinical Oncology, 63.2% of the 37,760 emergency department (ED) visits by cancer patients in that year resulted in admissions, mostly for control of such symptoms as pain, respiratory problems, and gastrointestinal issues.2 Medical homes, on the other hand, have been shown to reduce inpatient admissions by 15% to 50%, and in just the first year of the COME HOME program, practices saw a 9.5% reduction in inpatient admissions (from 38.28% to 34.63%), she reported.

“What patients value the most is being at home with the people they love, not spending time in the hospital or cancer center,” Dr McAneny stated.

Moreover, hospital admissions are known to create additional financial hardships for patients. “I can’t help the cost of the drugs, but I can keep them out of the hospital,” she added.

COME HOME clinics deliver all outpatient cancer care, and their triage system ensures that patients receive the right care, in the right place, at the right time, by helping them manage the side effects of their cancer and its treatment at the most cost-effective site and at the earliest stage of development.

“We found that if you go to the ER and you’re a cancer patient and you’re skinny and bald, your chances of being admitted are about 2 out of 3 whether you need to be admitted or not,” she said. “So if we can avoid that, we’d like to. We found that we could do a fair

amount of savings for patients, practices, and the entire healthcare system, which is a good thing.”

IOBS created the COME HOME triage system to provide aggressive, standardized symptom management for patients, thereby reducing ED utiliza-

tion and inpatient admissions and costs.

“Patients don’t call up and say, ‘I have squamous cell carcinoma of the tonsil,’ they call and say ‘my throat hurts,’” said Dr McAneny. So when a patient calls in, a first responder focuses on 1 of 38 symptom-specific pathways (eg, pain, nausea

and vomiting, fatigue), utilizing a realtime, web-based decision support system that is already populated with patient demographic data. Then, if the caller is not experiencing a true medical emergency necessitating immediate admission to a hospital, the first responder Continued on page 12

CONFERENCE NEWS

SWOT Meets Wound Care Needs Caroline Helwick

San Antonio, TX—The creation of a dedicated wound ostomy care (WOC) team resulted in an almost complete elimination of pressure ulcers in a 74bed hospital, according to nurses who created it and described the program at the Oncology Nursing Society 41st Annual Congress.

“We have a new sense of awareness of the importance of pressure ulcer prevention,” said Stephanie Terry, BSN, RN, CWOCN, PCCN, HN-BC, who co-created the program with Joe Rudolph, BSN, RN, CWOCN, DWC, of Cancer Treatment Centers of America at Eastern Regional Medical Center in Philadelphia, PA. The 2 certified wound ostomy and continence nurses direct the skin integrity care for all the institution’s inpatients and outpatients.

Oncology patients are at high risk for skin issues. Contributing factors include immobility, poor nutrition, lack of adherence with self-care regimens, change in mental status, and cancer treatment, “which, in addition to slowing or stopping the growth of cancer, can affect a person’s skin, hair, and nails,” she said.

“The year 2013 was eye-opening for us,” said Ms Terry. “Our hospital-acquired pressure ulcer prevalence rate was a shocking 11%! The benchmark really should be zero. We knew we needed to make some changes.”

Pressure ulcers (bedsores) are caused by constant pressure on one area of the body. For patients who are bedridden, an air or water pad that lies on top of the mattress helps prevent them. Special “low-air-loss beds” or “air-fluidized beds” may also help prevent ulcers or keep them from worsening.

“In response to the high-risk oncology patient and our high quarterly preva-

lence rates, the skin wound ostomy team, aka, SWOT, was born,” she said.

Recruitment and Training

Nursing recruitment for the original SWOT was accomplished by flyers, emails, and rounding on the floors, with Ms Terry and Mr Rudolph seeking out nurses who had expressed a special in-

Tracking Outcomes

“We have a new sense of awareness of the importance of pressure ulcer prevention.”

—Stephanie Terry, BSN, RN, CWOCN, PCCN, HN-BC terest in skin, wound, and ostomy care.

Currently, 25 nurses are dedicated to “skin excellence” and have been labeled the “skin champions.”

SWOT agreements were designed to outline expectations and provide team members with a sense of membership.

The Benefits of Triage... places the patient-related calls on a dashboard for the triage nurses. The triage nurses then take the calls from the dashboard and begin the triage assessment.

Standard order sets are already outlined in the system for defined patient groups (eg, patients on chemotherapy with fever are scheduled for same-day appointments and have chemistry and complete blood counts ordered without needing physician sign-off for every patient). “We have schedules that have blanks, and the nurses have the power to fill them,” she added. “They don’t have to ask permission or forgiveness.”

These agreements are aligned with the institution’s incentive program, known as the professional clinical ladder.

Training of the skin champions is conducted through a yearly in-depth educational module, along with monthly meetings to review prevalence rates.

Root-cause analysis creates “mindfulness of how we can improve the care we provide to our patients, and a culture of awareness and safety,” Ms Terry said.

Before implementation of the program, pressure ulcers were tracked through consults with the WOC nurse, but this system lacked transparency.

“At the time, we didn’t have a grip on what was going on in the hospital, and we didn’t have the tools we needed to implement that transparency,” Ms Terry told The Oncology NurseAPN/PA. Today, an electronic variance system has significantly increased transparency; it allows staff to notify the WOC nurses, the quality department, and senior management of all skin integrity issues in both the inpatient and outpatient settings. The system also allows the wound experts to document incidence, which represents daily occurrences and is the best quality measure of the prevention program, she explained.

“With the electronic variance system, we are more proactive and there is lots more transparency,” she noted.

A critical component of the program is Wound Care Wednesday, a proactive assessment of skin integrity for all hospitalized patients that is completed each Wednesday by a skin champion. This nurse also completes a rounding tool that focuses on specific details, including Braden score and the use of proper

interventions for high-risk patients.

The data can be used to identify and address areas of weakness.

Pressure ulcer prevalence is now determined monthly. It includes assessment by 2 nurses (with another nurse recording data), followed by chart review (nutritional status, etc) and debriefing.

Improvements Shown

The SWOT program has had a clear impact on the facility and stakeholders, Ms Terry reported.

The hospital-acquired pressure ulcer prevalence rate decreased from a high of 11% in 2013 to below 1% in 2015, with resulting declines in penalties to the hospital. Skin assessment documentation on admission and during hospitalization has improved. Nursing staff are now more aware of the available skin, wound, and ostomy products, and they report increased satisfaction. SWOT has also served as a model for improvement in other areas, for example, leading to the creation of the Fall and Safety Team.

SWOT has received significant support from senior management, as evidenced by proper staffing ratios that facilitate adequate training of floor nurses.

The team structure continues to improve with the addition of team leaders, she said.

“We continue to set short-term goals,” Ms Terry added, “that will eventually lead to the overall goal of maintaining a hospital-acquired pressure ulcer rate of zero!” n

Reference

Terry S. Evolution of a skin wound ostomy team (SWOT) program to meet the challenges of oncology patients.

Presented at: Oncology Nursing Society 41st Annual Congress; April 28-May 1, 2016; San Antonio, TX.

Continued from page 11

The triage pathways guide the triage nurses by providing better patient management, improving timeliness and coordination of care, ensuring safe and seamless care, and enhancing patient care experiences, she said. A second dashboard is used to follow up on patients and is used only by the triage nurses.

According to Dr McAneny, in a community oncology practice, $10,000 a month supports 1 triage nurse plus all associated infrastructure and triage support for 250 patients on active chemotherapy or 2000 total active patients.

But in a hospital, the same amount of

money supports only approximately 8 ED visits or 1 hospitalization.

After implementation of the COME HOME model, New Mexico Cancer Center experienced a 35.9% drop in the percentage of patients with ED visits, a 43.1% drop in the percentage of patients with inpatient admissions, a 23.8% drop in inpatient days, and a $4784 (22.4%) drop in 6-month total cost of care, she reported. With utilization of the COME HOME model, they estimate a savings of approximately $175,000 per practice, per month.

“We have to get the patients what

they need, when they need it, and we have to have a system behind it to make sure we can do this properly,” Dr McAneny added. “And when we do that, we can have fewer days in the hospital, which is of value to my patients primarily, and is of huge value as well to whoever is paying the bills.” n

References

1. McAneny B. IOBS triage system overview. Presented at: 2016 Community Oncology Conference; April 1415, 2016; Orlando, FL. 2. Mayer DK, Travers D, Wyss A, et al. Why do patients with cancer visit emergency departments? Results of a 2008 population study in North Carolina. J Clin Oncol.

2011;29:2683-2688.

CONFERENCE NEWS

Significant Roadblocks to Oncology Appointments at NCI Cancer Centers Meg Barbor, MPH

Phoenix, AZ—Newly diagnosed cancer patients face fear and uncertainty regarding their prognosis. Many seek evaluation and treatment from top-tier, comprehensive cancer centers, but recent literature has revealed barriers to access for these patients and their family members.

Geoffrey Hamlyn and colleagues from Duke University and the Duke Cancer Institute in Durham, NC, conducted a study to evaluate this availability and accessibility gap in National Cancer Institute (NCI)-designated cancer centers and presented their results at the 2016 ASCO Quality Care Symposium.

In order to evaluate the obstacles faced by patients and caregivers in attempting to access services at major cancer centers, the investigators used a “mystery shopper” format to contact 40 NCI-designated, comprehensive cancer centers.

Five Duke graduate research assistants simulated calls by a patient’s family member to make an initial consultation appointment, using a standardized script informed by real patient calls to Duke and reflecting a “typical” caller’s knowledge and concern. Each center received 4 calls each on separate dates (160 total), and call order and patient names were randomized. Two calls to each center presented a patient with private insurance, and 2 presented a

patient with Medicaid.

Of 160 calls, 117 (73%) were first answered by electronic prompts or voicemail, rather than a live person.

“The question is whether that customer engagement strategy is really ideal for something as intimate and sensitive as oncology,” said Mr Hamlyn.

Mean call duration was 9.4 minutes, and, on average, callers spent 7.1 minutes speaking to an attendant and 2.4 minutes on hold or being transferred.

Only 19.3% of callers were able to obtain an actual date for a first-available appointment without first registering into the cancer center’s database. Half (51.3%) of the callers were given an estimated date for a next-available appointment, and nearly a third (29.4%) were told that a date for an appointment could not be estimated unless the patient was registered in the cancer center’s database.

Nearly three-quarters of appointment dates (estimated or actual) were more than 1 week away. Specifically, only 1.3% of next-available appointments were within 1 to 2 days, 25.7% were within 3 to 7 days, 57.5% were within 7 to 14 days, and 15% were not available until 2 weeks or later.

“These are really big hurdles,” said Mr Hamlyn. “If we’re calling on behalf of the patient and may not be armed with certain information, this accessibility/availability gap is certainly some-

“The question is whether that customer engagement strategy is really ideal for something as intimate and sensitive as oncology.”

—Geoffrey Hamlyn thing that we need to be aware of. It’s a business concern and a quality concern, and it may inform some potential reevaluation.”

The investigators observed no statistically significant variation in appointment availability according to payer,

with 7 to 14 days to next-available appointment the most common time span for both Medicaid and private insurance, but they did notice some qualitative differences, in particular, a “variation in tone.”

“In many cases, an attendant would be dismissive in some tone or perhaps particularly interested if we indicated that we had privately insured patients, so this is a significant finding in many ways,” said Mr Hamlyn. “I think this is something that could be a real barrier to entry for some people who are calling for patients who are publicly insured.”

“These findings were striking,” said Sandra L. Wong, MD, MS, Professor and Chair in the Department of Surgery at Dartmouth-Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth. “What this means is that there are real barriers to getting into what is perceived as high-quality cancer care.”

“The qualitative feel that callers were treated differently once the payer type was known is concerning,” she added.

“These findings scream at a need to reevaluate our intake processes and address barriers to care.” n

Reference

Hamlyn G, Hutchins K, Johnston A, et al. Accessibility and barriers to oncology appointments at 40 NCI-designated cancer centers. Presented at: ASCO Quality Care Symposium; February 26-27, 2016; Phoenix, AZ. Abstract 55.

Discharge Before Noon: Possible Through Nurse-Led Initiative Caroline Helwick

San Antonio, TX—A nurse-led initiative to discharge patients before noon has paid off at the Mount Sinai Hospital, NY, according to Kathleen Edmondson-Martin, MA, RN, OCN, Clinical Nurse Manager in the hospital’s bone marrow transplant unit.

At the Oncology Nursing Society 41st Annual Congress, Ms EdmondsonMartin described the discharge-beforenoon (DBN) project, in which the treatment team makes every effort to see that oncology inpatients eligible for discharge exit the unit before noon.

DBN is an interdisciplinary initiative that promotes clinically safe and high-quality patient care. Nurses collaborate with the healthcare team to ensure that discharge needs are met.

Ultimately, DBN is a means of reducing

avoidable re­ admissions and hospital length of stay. The project first proved itself in the hematology/oncology and bone marrow transplant units, and is now operating throughout the hospital.

“Overall it’s been a great success,” she said. “The DBN initiative helped to build trust and to foster a collaborative team that became part of the culture of the unit.”

DBN should be a priority for several reasons, according to Ms EdmondsonMartin. It allows patients to arrive home earlier in the day, when they have time to address “daytime-sensitive” issues, such as filling prescriptions.

Problems that are not dealt with until later in the day can lead to readmissions, she pointed out.

DBN improves patient throughput,

keeps patients on scheduled treatment plans, allows those waiting for oncology beds to get them sooner (reducing waiting time in the emergency department), and optimizes the patient experience, she said.

The process requires active problem-solving in “real time,” structured and timely ongoing communication, continuous process improvement, and “a spirit of camaraderie,” according to Ms Edmondson-Martin.

Three questions are key to DBN working for an individual patient: What is the plan of care today? What is the discharge date and time? Who needs to do what to make it happen?

“We have 24/7 ongoing communication that starts with the email I generate after our interdisciplinary rounds every

morning, and we continually update each other on the progress of discharges,” she said. “We discuss patients identified as DBN, and the nurse passes information along in the change-of-shift report.”

Also part of a successful DBN initiative are nursing and physician lead­ ership presence, and the buy-in and contribution of all team members.

“Physicians and nurse practitioners had to see the value of what we were doing,” she said, noting that they had to change their habit of rounding in the morning and discharging in the afternoon.

It is also important to clearly outline the clinical nurse’s role and to have a DBN “escalation tool” that identifies what is necessary for prompt discharge, which nurse is responsible, and “who to Continued on page 14

CONFERENCE NEWS

How to Assess Quality... ing to the 6 domains of healthcare quality outlined by the Institute of Medicine, starting with effective care.2 According to these domains, care should also be patient centered, delivered in a timely fashion, and efficient, creating little waste in the system.

Effectiveness of care could be facilitated through the identification of subpopulations most likely to respond to a given therapy. “We also know that many of our targeted therapies are significantly less toxic than chemotherapy, thus improving safety,” she added.

“In addition, as we understand cancer biology better and we understand an individual patient’s tumor better, we can give them information that’s really tailored to their specific situation.”

There are significant threats to care quality that come with the introduction of precision medicine, such as insufficient data and human error, Dr Gray warned. From a provider perspective, mistakes with human data processing can jeopardize both the effectiveness and the safety of care, and from a patient perspective, these flaws can lead to care that is not patient-centered.

Finally, tests and therapies are extremely expensive, with many targeted therapies costing tens of thousands of dollars per month. Access to care is also an issue, and with the increasing specialization of care, genetic and genomic information, and immunotherapy, care is sometimes more fragmented. Additionally, dealing with genetic and genomic information can raise concerns about discrimination for providers and patients, potentially threatening equity.

Precision Cancer Care at the Bedside

Physicians now face the challenge of understanding genomic information.

Studies are showing that up to 25% of providers are not confident in their knowledge about genomics, their abili-

Continued from the cover

ty to explain genomic concepts to patients, and their ability to make treatment recommendations based on genomic information.

“Interventions targeting physician education are desperately needed,” Dr Gray said.

The question about when to adopt new precision medicine technologies is an important one, she stressed. When mature studies confirm preliminary data, then early adopters of tests or treatments have benefited their patients; however, should the data not be confirmed, then their patients may have been harmed.

“Precision cancer medicine offers patients a new range of therapies and unprecedented hope.”

—Stacy Gray, MD

Patients Are Not Populations

In the practice of precision medicine, patients are divided into groups based on their likelihood of responding to therapies according to biomarkers or genomic information, but biomarkers and genomic tests are not always perfect, she emphasized.

Patients’ test results may differ by assay, and there is not a lot of consistency from test to test, according to Dr Gray. Many trials exclude biomarkernegative patients, but in the case of anti–PD-1/PD-L1 therapies, approximately 15% of patients with PD-L1– negative tumors respond to therapy.

The issue of understudied groups is also extremely important in genomic medicine because of the underrepresentation of racial and ethnic minorities and elderly patients in genomic resource

Discharge Before Noon... bump it up to” if a barrier arises. A review of “near miss” cases is also part of the strategy, as this leads to improvements in the process. “We have noticed common themes for near misses, including scheduling of appointments and delays in transportation and medication deliveries, and have been able to fix those throughout our hospital,” she said.

A spirit of friendly competition also helps. At Mount Sinai, a trophy is awarded once a month to the unit with the most DBNs.

reference databases. Providers must also consider the issue of access—how to obtain access for their patients, and what kind of information patients need.

“We don’t have the adequate workforce to be able to deliver genomic care, and we know that many patients who may stand to benefit from enrollment in clinical trials of targeted agents may not live anywhere close to where those trials are being conducted,” she said. “Access to care is an issue that providers face on a day-to-day basis.”

Clinical Trial Enrollment

Lee Newcomer, MD, MHA, a senior vice president at UnitedHealthcare with strategic responsibility for oncology, genetics, and women’s health, posed a more aggressive approach toward clinical trial enrollment.

“We have an obligation to be stewards, not only on behalf of our patients, but also on behalf of the entire country and its healthcare system,” said Dr Newcomer. “And part of our stewardship is making sure that we put people in clinical trials so we can catch the data very quickly, so that it can fall into the field equally as quickly.”

In particular, he encourages patient clinical trial enrollment. For example, enrolling 100,000 patients in phase 2 trials for actionable genes in 3 years would allow greater patient access to clinical trials and create a database of information about targeted agents.

Provider Considerations of the Patient Experience

Many targeted therapies are extra­ ordinarily expensive. Approximately 25% of patients spend most or all of their savings during cancer treatment, and 10% have out-of-pocket costs in excess of $18,000 a year.

“I think when providers think about precision medicine, they think about what it means for the patient, and one

of the most pressing concerns is financial toxicity,” said Dr Gray. “But one of the movements that has been wonderful in oncology is the awareness of this financial toxicity.”

According to the literature, approximately 50% of oncologists are now considering total cost when making treatment recommendations, and 84% consider out-of-pocket costs when they talk to their patients about treatment recommendations. “I think it’s impor­ tant to remember that, given the efficacy of some of these drugs, they’re impossible to ration at an individual level,” she added. “These are decisions that really can’t be made at an individual doctor-patient level, but need to be made at a policy level.”

In regard to patients’ information needs and preferences, early data suggest that most patients want somatic and germline information. “Oncologists want to honor patients’ preferences when returning results, so we need to build systems that allow them to do that in an effective way,” she said.

“Although there are some threats to quality as we introduce these kinds of tests and treatments into care, personalized medicine really does promise to improve care quality,” said Dr Gray. “I think that in terms of effectiveness, we really need to create a much broader evidence base through more comprehensive research, we need education for patients and providers to address flaws in human data processing, and when we think about cost and access to care, we really need to work in the policy space.” n

References

1. American Society of Clinical Oncology. How do we assess quality in the age of precision medicine? ASCO Quality Care Symposium; February 26-27, 2016; Phoenix, AZ. http://meetinglibrary.asco.org/presentation BySession/9063/5261.

2. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001. www.nap.edu/ books/0309072808/html/. Accessed March 31, 2016.

Continued from page 13

Before implementation of the DBN initiative, the baseline rate of noon discharges was 6% in 2014, which rose to 16% in 2015. After implementation, the average rate in February 2016 was 33%.

“Our DBN rate can go from 0% to 40%, based on the complexity of discharges on the unit, but it hovers around 33%,” she noted.

Avoidable readmission rates were 17.2% in 2014, dropping slightly to 16.9% in 2015. While that seems like a

minor improvement, she noted, “The goal is not to have them be higher, so we are going in the right direction!”

They also saw improvement in patient satisfaction with the DBN process, based on communication, pain management, discharge plan, responsiveness of hospital staff, and care transitions, as measured by Press Ganey scores. Although the scores were not “perfect,” she noted, “we think it’s better to be better than waiting to be perfect. Two steps forward and one step back is still

one step forward…DBN is still a work in progress, and there are still things we can do to improve.”

“I think we have demonstrated that successful, sustainable improvements are possible,” Ms Edmondson-Martin commented, “and this is a win-win initiative.” n

Reference

Edmondson-Martin K. A nurse-led clinical quality initiative that improves patient experience. Presented at: Oncology Nursing Society 41st Annual Congress; April 28-May 1, 2016; San Antonio, TX.

IMMUNOTHERAPY

Immunotherapy: Separating Facts from Fiction Meg Barbor, MPH

Scottsdale, AZ—Response is a poor outcome measure of immunotherapy, according to Tanguy Seiwert, MD, who addressed this and other concerning issues in immunotherapy at the 2016 Multidisciplinary Head and Neck Cancer Symposium.

“The impact of immunotherapy, at least for PD-1 [programmed death-1] checkpoint blockade, is primarily on survival,” he said. “Response rate likely significantly underestimates its benefit, and based on what we’ve seen in other cancer types, the impact will probably be more pronounced in overall survival than in progression-free survival, given that response is not that reliable.”

According to Dr Seiwert, Associate Director of the Head and Neck Cancer Program at the University of Chicago, IL, much overall survival benefit is likely derived from patients with minor shrinkage and prolonged disease stabilization, and response is only moderately correlated with benefit of immunotherapy. “We see patients who have rapidly growing disease, and then suddenly the disease is stable,” he said. “So it can clearly modify the disease dynamic.”

In a keynote address at the symposium, Dr Seiwert offered some immunotherapy “pearls” based on his experience from treating a substantial number of patients with immunotherapy.

A Sustainable Response

Pseudoprogression is rare. “I estimate that 95% of imagery-based progression of disease is real disease,” he said. “Keeping patients on an ineffective agent for a prolonged period of time, if their disease is progressing, is potentially harmful.”

The biologic half-life of a PD-1 or its ligand (PD-L1) inhibitor is months, he added. “So if you stop the agent, you will probably still see the benefit, if such a benefit should actually occur. But in my experience, stopping the treatment and going to something like a cytotoxic agent instead is better.”

According to Dr Seiwert, unlike anticytotoxic T-lymphocyte antigen 4, the use of immune-related response criteria is of unclear benefit for PD-1/PD-L1.

“Dynamic of response is also impor­ tant,” he said. Most responses to immunotherapy occur relatively early, but delayed responses do occur. “The majority of patients who have a response seem to have a sustainable response—not forever—but it seems to be more stable than what we see with other agents,” he said.

For a faster response, he recommends the use of chemotherapy.

Immune-Related Side Effects

According to Dr Seiwert, PD-1/ PD-L1 agents are exceptionally welltolerated, even in older patients and patients with poor performance, and particularly when compared with chemoradiation, chemotherapy, and radiation and surgery. The most common adverse events are mild fatigue, hypothyroidism, and itchy skin. There are severe adverse events, such as pneumonitis and colitis, but they are rare, and, if recognized early, they are treatable.

So intensive screenings for symptoms of pneumonitis and colitis are imperative.

“Why are we so afraid?” Dr Seiwert asked. “We treat patients with some of the most toxic treatments [available], we make patients sick as hell with

said. “And when to discontinue treatment may need to be individualized.”

A Long Way to Go

“The impact of immunotherapy, at least for PD-1 checkpoint blockade, is primarily on survival.”

—Tanguy Seiwert, MD chemoradiation, and yet we’re so afraid of immune-related side effects? That seems very strange.”

“These side effects may actually even be a biomarker for benefit,” he continued. “What we want to do is break tolerance. We should treat more, and we shouldn’t be as afraid as we were, and I think as we learn more about these agents we might get more comfortable.”

In terms of cure and treatment duration, these questions are clearly unanswered. “I think the depth of responses really may matter. If you have a very deep response, these may be patients who have long-term survival and benefit, and maybe the disease never comes back,” he

“There are a lot of challenges ahead,” Dr Seiwert stated. “We’ve taken a big step in the right direction, but we have a long way to go.”

“Cancer is inherently robust,” he said. “We’ve learned this over decades and decades of failure; we’ve seen it become resistant, and patients die. And this has not changed, ultimately, even though some patients do well.”

Fifty percent to 75% of patients with head and neck cancer do not derive benefit from anti–PD-1 agents. “So there we have patients who are constitutively resistant to immuno-oncology,” he stated. And a large fraction of patients who do respond may ultimately develop acquired resistance.

According to Dr Seiwert, immunotherapy is broadly active across human papillomavirus–positive and –negative cancers, including nasopharyngeal cancers, so it is an agent that can potentially be used very broadly. Additionally, responses to immunotherapy seem to be more durable, and “maybe for some patients, even for very advanced disease, we may be able to eradicate their disease completely,” he said.

“I think this is the point in time for a call to action,” Dr Seiwert added. “We should move forward, because we actually have something that works; we just need to do better.” n

Reference

Seiwert T. Immunotherapy for head and neck cancer.

Presented at: Multidisciplinary Head and Neck Cancer Symposium; February 18-20, 2016; Scottsdale, AZ.

Patient Tip: 5 Steps to Quit Smoking Cigarette smoking is associated with a wide variety of adverse health effects.1 In fact, >480,000 people die each year in the United States because of cigarette smoking. It is linked to cancer, cardiovascular and respiratory diseases, and other increased health risks.

The following tips are ways that you and your patients can quit smoking2:

1.

3.

2.

4.

Recognize an Oncoming Flare As a first step to quitting smoking, write down why you want to do it (eg, is it to improve your health, or so that you can be with your loved ones long-term?). Identifying why you really want to quit will motivate you to stop smoking.

Talk to Your Healthcare Professional Once you have decided that you want to quit smoking, talk to your physician or a trusted healthcare professional and identify a method for quitting that will work best for you.

Don’t Smoke Any Cigarettes When you start your smoking cessation program, quit smoking cigarettes altogether. Each cigarette you smoke damages your lungs, blood vessels, and cells throughout your body.

Don’t Give In Quitting smoking takes time and commitment. Be prepared to experience feelings of nicotine withdrawal, and find coping mechanisms to handle symptoms such as bad moods and the desire to smoke.

5.

Focus on the Benefits Remember, taking steps to quit smoking is great news. It is the single most important step you can take to protect your health, and the health of your family.

References

1. Centers for Disease Control and Prevention. Health effects of cigarette smoking. www.cdc.gov/tobacco/data_statistics/fact_sheets/ health_effects/effects_cig_smoking/#cancer. Updated March 17, 2016. Accessed June 22, 2016.

2. Centers for Disease Control and Prevention. Quit smoking. www. cdc.gov/tobacco/quit_smoking/how_to_quit/quit_tips/index.htm. Updated March 17, 2016. Accessed June 22, 2016.

HEAD & NECK CANCER

Dental Oncology Is Vital to Head and Neck Cancer Care Caroline Helwick

San Antonio, TX—Proper attention to dental care for patients with head and neck cancer can mean the difference between a good functional outcome and a poor one, according to a dental oncologist and nurse who described dental oncology at the Oncology Nursing Society 41st Annual Congress.

The topic was discussed by Maureen Sullivan, DDS, Chief of the Department of Dentistry, Oral Oncology & Maxillofacial Prosthetics at Erie County Medical Center in Buffalo, NY, and Colleen Palay, BSN, RN, an oncology nurse navigator at University Hospitals Seidman Cancer Center in Cleveland, OH. The discipline of dental oncology encompasses general dentistry, oral medicine, oral pathology, and maxillofacial prosthetics for patients with cancer.

“It is critical to have a dentist involved at the time of diagnosis,” Dr Sullivan said. “The dental oncologist can play an integral role before, during, and after antineoplastic treatments, and offers the best chance of functional as well as esthetic outcomes.”

The role nurses play is also critical, said Ms Palay. “They educate patients and their families, and they are in a position to advocate for the patient to obtain the necessary care,” she said.

“Getting the patients to see a dentist before treatment is something that will help with the side effects due to the cancer and the treatment, and will improve quality of life long term.”

“We need to treat our dentists as members of the multidisciplinary team,” she emphasized. With nurses, dentists, and surgeons collaborating, she said, “we can help prevent things such as crowning a tooth only to have the surgeon extract it.”

Presurgical Considerations

Optimal timing can be a challenge, especially when the dental oncologist is not on site at the treating facility, Ms Palay said.

The challenge for nurses is to find a dentist at the time of diagnosis. “You call dentists. Take cookies to the dental school. See what you can make happen,” she said.

Ideally, patients are evaluated for dentition upon a diagnosis of head and neck cancer. The dental oncologist then communicates to the surgeon his or her recommendations for optimal

oral and prosthetic rehabilitation.

The evaluation includes a comprehensive clinical and radiographic assessment of the patient’s oral and dental status and existing prosthetics (dentures, etc). At this time, patients should also be educated about acute and late-stage adverse effects of upcoming treatments, and should be taught proper dental hygiene,

“The dental oncologist can play an integral role before, during, and after antineoplastic treatments, and offers the best chance of functional as well as esthetic outcomes.”

—Maureen Sullivan, DDS Importantly, all dental pathosis is evaluated for and eliminated at the time of surgery and before chemoradiation. Management of dental problems is much more difficult after treatment, which creates its own set of problems, Dr Sullivan emphasized.

“With the patient asleep [during biopsy], we can get aggressive dentistry done in a hurry so there is sufficient healing prior to resection and chemotherapy and radiation,” she said, noting that she extracts all “hopeless teeth” at that time. Upfront, there is also better access to the oral cavity.

Common Secondary Effects of Radiotherapy

The adverse effects of radiotherapy

are well known to nurses. Dr Sullivan offered her recommendations for management.

Mucositis occurs as a result of permanent damage to DNA, and there is still no effective means of treatment or prevention. Patients can try baking soda rinses, systemic analgesics and local anesthetics, antifungal medications, and fluoride rinses and toothpaste (dry mouth formula).

“The most important thing we do in our center is anticipate mucositis, and give virtually all patients a PEG [percutaneous endoscopic gastrostomy tube],” she said. “And we babysit these patients, and see them through radiotherapy. We alert the head and neck nurses if they are not doing well.”

Xerostomia is lifelong, but with intensity-modulated radiotherapy some saliva can return, though it will not be quite normal. Amifostine, a salivary gland protectant, has shown modest benefit but is expensive, has adverse effects, and must be given 20 minutes prior to radiotherapy. For hyposalivation, she recommended salivary substitutes, regular hydration, and systemic sialagogues, which include pilocarpine and cevimeline.

Dry mouth creates a highly cariogenic oral environment, which is another reason Dr Sullivan emphasized “dealing with teeth before and not after treatment.”

She creates customized acrylic trays that are filled with prescription fluoride and worn by the patient 5 minutes a day, and advises patients to brush with PreviDent 5000 Plus toothpaste for 12 months. “It’s worth its weight in gold,” she commented.

In patients with complex crowns and bridges or difficult dentition, and in those receiving high-dose chemotherapy, clinicians should “look beyond the surface for opportunistic infections.”

For infection prevention, mucin-based salivary substitutes may help restore normal oral flora but systemic antifungals and antivirals are favored, especially for patients who do not adhere to oral care regimens.

“I encourage you to investigate these, but I tell my patients there is no substitute for a toothbrush,” Dr Sullivan said.

limited oral opening—or trismus— greatly restrict dental care. Prevention involves range-of-motion therapy after surgery and use of dynamic devices.

Osteoradionecrosis is a dreaded, often disfiguring adverse effect of radiation that involves delayed healing of the jawbone and sometimes fracture and extraoral fistulae. The primary approach is preventive, including the elimination of existing infection. For treatment, conservative measures are often sufficient: palliation, antibiotics, meticulous oral hygiene, and removal of necrotic bone with simple surgery.

With neck dissection, however, more extreme measures such as hyperbaric oxygen therapy, removal of teeth, and more radical treatment of necrosis followed by reconstruction may be required, Dr Sullivan indicated.

Severe Effects

Palay C, Sullivan M. Dental oncology. Presented at: Oncology Nursing Society 41st Annual Congress; April 28-May 1, 2016; San Antonio, TX.

Scar contracture and fibrosis causing

Advocating for Patients

As a nurse navigator, Ms Palay deals daily with patients needing dental care, and she shared her observations.

The nurse’s role, she said, is also to align the patient with the dentist, ideally several weeks before beginning treatment. This can be challenging, she acknowledged. It may even be difficult to locate dentists willing to see these patients, who often cannot pay for services. Unfortunately, insurance coverage for dental care is usually inadequate, she pointed out.

A quick initial evaluation, however, is something nurses can handle (ie, assessing dentition and function and getting the patient’s dental history). After surgery, nurses teach and reinforce good dental hygiene, including brushing, flossing, and the use of fluoride and mouthwashes. She would not recommend, for the first-time flosser, to start this practice immediately after treatment, when the mucosa is fragile. She suggested that patients delay getting dentures for 6 months after treatment.

Nurses should also be aware of the psychosocial distress that patients can experience posttreatment, if their appearance has been altered. “Social interactions, at least initially, can be distressing,” Ms Palay said. n

Reference

SEXUAL HEALTH

NCCN Survivorship Guidelines Update Management of Sexual Dysfunction Wayne Kuznar

Hollywood, FL—An updated survivorship guideline from the National Comprehensive Cancer Network (NCCN) includes an extensive revision on addressing sexual function in cancer survivors. Version 1.2016 of the survivorship guidelines recommends screening for sexual dysfunction in cancer survivors at regular intervals and offering appropriate assessments, referrals, and interventions based on whether the survivor is ready to have a conversation about sexual function.1 The updated guidance was presented at the NCCN 21st Annual Conference, with presentations focusing on the guidelines for women and for men.2

Female Sexual Health

Michelle Melisko, MD, presented the guideline for women, noting that sexual dysfunction is likely to become more prevalent in young breast cancer survivors with increasing use of ovarian suppression.

A recent study of 83 breast cancer survivors revealed that 77% of all study participants and 60% of sexually active ones qualified for a diagnosis of sexual dysfunction based on the Female Sexual Function Index (FSFI).3 “There is an increasing understanding of the safety and risks associated with hormonal interventions,” said Dr Melisko, Associate Professor of Hematology/Oncology, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center.

With longer courses of aromatase inhibitors being recommended in women with breast cancer, “we will be seeing more vaginal dryness and sexual complaints,” she said.

“There is an increasing understanding of the safety and risks associated with hormonal interventions.”

—Michelle Melisko, MD For women with symptoms of pain with sexual activity, the guideline adds ospemifene, a nonestrogen selective estrogen receptor modulator, to the list of treatment options, which also includes topical vaginal therapies (moisturizers, gels, and lubricants), vaginal dilators, pelvic floor physical therapy, and topical anesthetics. Ospemifene is currently contraindicated in survivors with a history of estrogen-dependent cancers, said Dr Melisko, but can be useful for other cancer survivors. Menopausal hormone replacement therapy may be an option to manage sexual and menopausal symptoms in some patients.

For women with low libido, for the first time the updated guideline mentions the option of using flibanserin, although a footnote declares the lack of data to support its use in cancer survivors.

Early evaluation of erectile dysfunction following recovery from cancer treatment is optimal.

tion, ejaculatory problems, or orgasmic problems if total testosterone measured in the morning is <300 ng/dL. A low-dose oral phosphodiesterase-5 inhibitor is a treatment option for erectile dysfunction. Referral to a specialist is now recommended for more complex erectile dysfunction, he said. Second-line treatment options mentioned in the guideline include intracavernosal injection therapy, penile vacuum devices, and intraurethral suppositories.

Early evaluation of erectile dysfunction following recovery from cancer treatment is optimal because untreated dysfunction may lead to long-lasting problems with erections due to fibrosis of the corporal cavernosa resulting in venous leak, said Dr Narus.

The patient’s comfort level with a discussion of sexual health should first be assessed, however, because men may initially be concerned primarily with their cancer. n

Male Sexual Health

References

Recently, a study found that 4% aqueous lidocaine applied to the vulva reduced pain during intercourse, decreased sexual distress, and improved sexual function,4 said Dr Melisko. Seventeen of 20 patients who completed the study and who had abstained from intercourse resumed comfortable penetration. Microablative CO2 laser improved scores on the FSFI at 12 weeks in 77 postmenopausal women with vaginal dryness, and was later approved by the US Food and Drug Administration, but no data with this method are available in breast cancer patients.

An update on sexual function in male cancer survivors was presented by Joseph B. Narus, DNP, GNP-BC, ANP, Nurse Practitioner, Sexual and Reproduction Program, Memorial Sloan Kettering Cancer Center, New York City.

Eliminated in the workup in the new guideline is hemoglobin A1C testing, lipid screening, and evaluation of creatinine. Testosterone therapy may be indicated in men with erectile dysfunc-

1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Survivorship. Version 1.2016. Fort Washington, PA: NCCN; 2016. www.nccn.org/professionals/physi cian_gls/pdf/survivorship.pdf. Accessed April 25, 2016.

2. Melisko M, Narus J. Sexual function in cancer survivors: updates to the NCCN Guidelines® for survivorship. Presented at: National Comprehensive Cancer Network 21st Annual Conference; March 31-April 2, 2016; Hollywood, FL. 3. Raggio GA, Butryn ML, Arigo D, et al. Prevalence and correlates of sexual morbidity in long-term breast cancer survivors. Psychol Health. 2014;29:632-650.

4. Goetsch MF, Lim JY, Caughey AB. A practical solution for dyspareunia in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2015;33:3394-3400.

CANCER AWARENESS

July Is Sarcoma Awareness Month E. K. Charles

A

lthough it is a rare disorder, approximately 14,000 new cases of sarcoma are diagnosed in the United States each year.1 Approximately 15% of cancer diagnoses among patients aged <20 years are sarcomas.

Patients should be encouraged to understand their disease. Healthcare professionals can provide pamphlets and other resources with general information about the condition, including the 2 main subtypes of sarcomas—bone and soft tissue—as well as information about the specific type of sarcoma the patient may have.

In addition, it is important to identify and educate populations that may be at

higher risk for sarcomas. For example, patients with certain inherited disorders (eg, neurofibromatosis or tuberous sclerosis) may be at higher risk for soft tissue sarcomas.2 Other risk factors for soft tissue sarcomas include past treatment with radiation therapy for certain cancers, exposure to chemicals (eg, thorium dioxide), and long-term lymphedema in the arms and legs.

There are also risk factors for sarcomas of the bone; in a very small number of cases, these sarcomas may be hereditary.3 In other cases, patients with disorders such as Paget disease, or who have been exposed to radiation, may be at higher risk for bone sarcomas. Bone

marrow transplantation and certain injuries have also been associated with higher risk for bone sarcomas.

Patients should also be able to recognize the signs and symptoms of sarcomas. For soft tissue sarcomas, patients may see and/or feel a painless lump under their skin; these often occur on the arm or leg.2 Other soft sarcomas may not have signs or symptoms until they grow to a certain size, such as sarcomas that start in the abdomen. In those cases, pain and trouble breathing may be signs and symptoms for patients to look for. In bone cancer, symptoms may include bone pain, swelling and tenderness near the affected area, bro-

ken bones, as well as fatigue, and unintended weight loss.4 Because other conditions may have similar symptoms, it is important that patients bring these to their healthcare provider’s attention. n

References

1. Sarcoma Alliance. What is sarcoma? http://sarco maalliance.org/what-you-need-to-know/what-is-sarco ma/. Accessed June 22, 2016.

2. National Cancer Institute. Adult soft tissue sarcoma treatment. www.cancer.gov/types/soft-tissue-sarcoma/ patient/adult-soft-tissue-treatment-pdq. Updated May 23, 2016. Accessed June 22, 2016.

3. American Cancer Society. What are the risk factors for bone cancer? www.cancer.org/cancer/bonecancer/ detailedguide/bone-cancer-risk-factors. Updated January 21, 2016. Accessed June 23, 2016.

4. Mayo Clinic. Bone cancer: symptoms and causes. www.mayoclinic.org/diseases-conditions/bone-cancer/ symptoms-causes/dxc-20126419. Published March 17, 2015. Accessed June 23, 2016.

TECHNOLOGY UPDATE

An Update on CancerLinQ—ASCO’s Big Data Cancer Database Meg Barbor, MPH

Why CancerLinQ?

Approximately 1.7 million people are diagnosed with cancer every year in the United States, but only a small percentage of adults with cancer can participate in clinical trials where their data are captured systematically and can be retrieved. The vast majority (97%) of patient data is locked away in unconnected files and servers—formerly paper records but now electronic health rec­ ords (EHRs).

“Therefore these learnings are lost and can’t contribute to the greater knowledge,” said Dr Miller. “And quite

Another phenomenon is the existence of more cancers. Many molecular drivers and many diseases require a data management system that is simply outstripped by our current capacity.

A Learning Health System

Photo by © ASCO/Todd Buchanan

Phoenix, AZ—CancerLinQ (Learning Intelligence Network for Quality) is a powerful database containing a vast amount of usable, searchable, real-world cancer information, created by oncologists, for oncologists, to improve the quality of patient care, according to updates presented at the 2016 American Society of Clinical Oncology (ASCO) Quality Care Symposium.

A national initiative inspired and informed by ASCO, CancerLinQ was designed to contribute to high-quality, personalized cancer care for every patient, by bringing all of the electronic data collected from the everyday care of every patient into one rapid learning network.

“This is ASCO’s big-data health information technology platform to improve cancer care,” said Robert S. Miller, MD, a medical oncologist and Vice President, ASCO Quality and Guidelines, and Medical Director of CancerLinQ.

“We have to create a platform that will accept data from different systems to enable interoperability across many sources.”

—Robert S. Miller, MD frankly, many of our patients think we do a much better job than we currently do in having access to this information.”

There has also been an explosion of knowledge and an increase in the data required for medical decision-making.

“The number of facts per decision required to manage patients in the modern era of genomics and proteomics has gone up, but what of course doesn’t change is human cognitive capacity,” said Dr Miller.

CancerLinQ is defined as a learning health system, where research and practice can inform each other. “Discovery is not just limited to the 3% of patients that are in clinical trials, but in the everyday care experiences that are rendered in clinics everywhere, that are basically locked in these servers,” Dr Miller added.

With this database, ASCO aims to improve provider performance and patient outcomes by providing guidance about the best evidence at the point of care; it does so by incorporating ASCO’s clinical guidelines as well as more than 200 clinical quality measures from ASCO’s Quality Oncology Practice Initiative Program. “The real-world outcomes captured as part of the learning health system will be linked back to the same measures and guidelines and will inform their development,” he stated.

Secondarily, the big data aggregation that is enabled by CancerLinQ will allow for generation of insights and data exploration on a scale not seen by the limitations of EHRs. “Another guiding principle was the fact that we recognize that hospitals and physicians will continue to use different commercial systems,” said Dr Miller “We have to create a platform that will accept data from different systems to enable interoperability

across many sources.”

The web-based clinical user portal is accessed through a browser, allowing the user access to various applications like quality performance indicators, data exploration tools, and a series of customizable and standardized analytic reports.

CancerLinQ also adheres to industry standards through a series of regulatory, administrative, technical, and physical safeguards fully compliant with HIPAA (Health Insurance Portability and Accountability Act) and all appropriate state and federal guidelines.

Practice Integration

“The pace of practice engagement has increased sharply in the US over the past few months,” Dr Miller reported. CancerLinQ now holds more than 250,000 patient records in its system and has participation from more than 2 dozen vanguard practices and more than 600 oncologists across the country, with a strong and growing pipeline of interest. “In the next month or so, we’ll be bringing on 2 large multisite health systems with many tens of thousands of records that will be added to the CancerLinQ database,” he added.

“Basically, the vision has always been that CancerLinQ is positioned squarely as part of the quality portfolio of ASCO,” said Dr Miller. “And most importantly, it is guided by ASCO’s mission to support all physicians, in every community and every setting.” n

Reference

Miller R. CancerLinQ update. Presented at: ASCO Quality Care Symposium; February 26-27, 2016; Phoenix, AZ.

GENETIC COUNSELING

“Newer” Ovarian Cancer Genes... mendations were published suggesting that in addition to genes associated with hereditary breast and ovarian cancer syndrome and Lynch syndrome, women with mutations in BRIP1, RAD51C, and RAD51D should discuss the option of RRSO with their healthcare team.2 The most common form of inherited ovarian cancer is still believed to be due to mutations in the BRCA1 and BRCA2 genes, which are present in 10% to 15% of women with ovarian cancer.1,3,4 The risk for ovarian cancer is up to 54% and

Continued from the cover

The estimated lifetime risk of ovarian cancer to age 80 years for women with a mutation in BRIP1 is 5.8%.

Cristi Radford, MS, CGC

27% with mutations in the BRCA1 and BRCA2 genes, respectively.5-7 Additionally, mutations in genes associated

with Lynch syndrome (ie, MLH1, MSH2, MSH6, PMS2, EPCAM) continue to be shown to be associated with

an increased risk of ovarian cancer with an upper range of 24%; the range varies depending on the gene, with some gene risks being more defined than others.8,9 In comparison, the lifetime risk of developing ovarian cancer in the general population is 1% to 2%. Lifetime risk estimates are important because they are absolute risks. The lifetime risk associated with a mutation can be compared with the general population risk to help a woman and her healthcare team determine if the benefits of RRSO outweigh the risks and side effects associat-

PALLIATIVE CARE

NCCN Panel Addresses Palliative Care Needs, Emphasizes Team Approach Wayne Kuznar

Hollywood, FL—Early intervention utilizing a team approach is important to successful palliative care, agreed a multidisciplinary panel convened at the National Comprehensive Cancer Network (NCCN) 21st Annual Conference.

The multidisciplinary panel offered insight into the value of palliative care in the cancer care continuum, emphasizing the importance of open, continuous dialogue.

The transition from active treatment to palliative care can be challenging, as patients may misperceive palliative care as “giving up,” the panel noted, and palliative care planning is difficult to achieve in the typical time allotted to appointments.

The roundtable opened with a personal anecdote by Shirin Malekpour, PhD, Family Member Advocate, University of Wisconsin-Madison, who described her mother’s experience with palliative care after being diagnosed with stage III ovarian cancer. “Her medical team was underprepared for our needs in palliative care issues,” she said.

“We were never offered palliative care or any of the other resources but chemotherapy…here’s another surgery, and so forth.”

If not for her husband, who worked as a hematologist at the same hospital and knew of the resources available, palliative care would have gone unnoticed.

Through this avenue, Dr Malekpour was able to connect with Toby C. Campbell, MD, MSCI, and his team at the University of Wisconsin Carbone Cancer Center, who worked with Dr Malekpour’s family to identify her

mother’s priorities and end-of-life values. (Dr Campbell served as the moderator of the NCCN panel.)

“We were never offered palliative care or any of the other resources but chemotherapy…here’s another surgery, and so forth.”

—Shirin Malekpour, PhD

The Practice of Palliative Care

Dr Campbell advised that palliative care be practiced on 3 levels: • Primary—the type provided by clinicians who do not often practice palliative care, such as primary care providers • Secondary—the routine circumstances in treating seriously ill patients; this type is integral to everyday practice in oncology • Tertiary—referral to palliative care services.

Sophia Smith, PhD, MSW, Associate Professor of Nursing at Duke University, Durham, NC, described work at the Duke Cancer Institute around the issue of palliative care. Duke is developing and testing a program called Four Conversations. “It’s an educational curriculum around shared decision making,” she said. A 2-year study of the program is being funded by NCCN and Pfizer, Inc.

The 4 conversations are between the patient and provider, the patient and his/her loved ones, the patient and spirit, and the patient and him/herself. The program provides online content and offers group-facilitated meetings led by a social worker who is trained in the curriculum. “Patients are able to get together with their peers in a confidential online format,” said Dr Smith. The program has evolved from a 1-on-1 format to an online format to make it more accessible and cost-effective. The Four Conversations program was developed specifically for patients with metastatic

Whereas oncologists talk about physical symptoms, palliative care providers tend to talk about emotional and psychological symptoms, issues that may be considered part of advanced care planning. breast cancer who are receiving end-oflife care, with the purpose of maximizing quality of life and improving relationships with providers, family members, and loved ones. As part of the program, patients are taught mind–body exercises and relaxation training. They are also encouraged to complete advance directives.

“We found that only 15% of our patients who died within the past 2 years had documented directives,” she said.

Integrating Palliative Care

A barrier to palliative care planning is a current shortage of palliative care specialists, as clinics are only now building palliative care programs. The traditional model of referral “hasn’t worked particularly well,” said Dr Campbell, with no-show rates of about 50%, making scheduling difficult. “The next move has been toward integrated, or embedded, palliative care,” which places palliative care providers with oncology providers, he said. Home-based palliative care may be the next generation of palliative care, he believes.

“The team approach to [palliative] care is not a substitution, it’s an addition” to care already being provided in a clinic, said Maria Dans, MD, Director of Palliative Care Services at the Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, MO. Whereas oncologists talk about physical symptoms, palliative care providers tend to talk about emotional and psychological symptoms, issues that may be considered part of advanced care planning, said Dr Campbell. “You can reassure yourselves that your patients won’t be spending time going over the same stuff that they’ve already been over,” he said. n

Reference

Campbell T. Palliative care: providing comfort from a patient and provider perspective. Presented at: National Comprehensive Cancer Network 21st Annual Conference; March 31-April 2, 2016; Hollywood, FL.

GENETIC COUNSELING ed with the procedure.

Recently published data have provided some clarification of risks for mutations in PALB2, BRIP1, RAD51C, and RAD51D. Current data associated with PALB2 fail to support a high risk of ovarian cancer.10-13 However, it is important to keep in mind that an individual with a mutation in PALB2 and a strong family history of ovarian cancer may still be a candidate for RRSO based on family history and not her PALB2 mutation status. The estimated lifetime risk of ovarian cancer to age 80 years for women with a mutation in BRIP1 is 5.8%; in RAD51C, 9%; and in RAD51D, 10%.11,14,15 These lifetime risk

estimates are at least triple those of the general population and, according to the most recent National Comprehensive Cancer Network Genetic/Familial High-Risk Assessment: Breast and Ovarian cancer guidelines, RRSO should be considered.2 n

References

1. Walsh T, Casadei S, Lee MK, et al. Mutations in 12 genes for inherited ovarian, fallopian tube, and peritoneal carcinoma identified by massively parallel sequencing. Proc Natl Acad Sci U S A. 2011;108:18032-18037.

2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 1.2016. www.nccn.org/professionals/ physician_gls/PDF/genetics_screening.pdf. Accessed April 4, 2016.

3. Song H, Cicek MS, Dicks E, et al. The contribution of deleterious germline mutations in BRCA1, BRCA2 and the mismatch repair genes to ovarian cancer in the population. Hum Mol Genet. 2014;23:4703-4709.

4. Pal T, Permuth-Wey J, Betts JA, et al. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases. Cancer. 2005;104:2807-2816.

5. Ford D, Easton DF, Bishop DT, et al. Risks of cancer in BRCA1-mutation carriers. Breast Cancer Linkage Consortium. Lancet. 1994;343:692-695.

6. Ford D, Easton DF, Stratton M, et al. Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families. The Breast Cancer Linkage Consortium. Am J Hum Genet. 1998; 62:676-689.

7. Antoniou AC, Pharoah PD, Narod S, et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet. 2003;72:1117-1130.

8. Bonadona V, Bonaïti B, Olschwang S, et al. Cancer risks associated with germline mutations in MLH1, MSH2, and MSH6 genes in Lynch syndrome. JAMA. 2011;305:2304-2310.

9. Goodenberger ML, Thomas BC, Riegert-Johnson D, et al. PMS2 monoallelic mutation carriers: the known unknown. Genet Med. 2016;18:13-19.

10. Norquist BM, Harrell MI, Brady MF, et al. Inherited mutations in women with ovarian carcinoma. JAMA Oncol. 2016;2:482-490.

11. Ramus SJ, Song H, Dicks E, et al. Germline mutations in the BRIP1, BARD1, PALB2, and NBN genes in women with ovarian cancer. J Natl Cancer Inst. 2015 Aug 27. Epub ahead of print.

12. Kanchi KL, Johnson KJ, Lu C, et al. Integrated analysis of germline and somatic variants in ovarian cancer. Nat Commun. 2014;5:3156.

13. Antoniou AC, Casadei S, Heikkinen T, et al.

Breast-cancer risk in families with mutations in PALB2.

N Engl J Med. 2014;371:497-506.

14. Loveday C, Turnbull C, Ramsay E, et al. Germline mutations in RAD51D confer susceptibility to ovarian cancer. Nat Genet. 2011;43:879-882.

15. Song H, Dicks E, Ramus SJ, et al. Contribution of germline mutations in the RAD51B, RAD51C, and RAD51D genes to ovarian cancer in the population. J Clin Oncol. 2015;33:2901-2907.

INTERVIEW WITH THE INNOVATORS

Prevention Is the Key to Bone Health in Patients with Prostate Cancer An interview with The Urology Group, Cincinnati, OH In this interview, members of The Urology Group discussed the importance of bone health in patients with prostate cancer, including details about the guidelines they use, the impact of prevention, as well as the different therapies they use in their practice.

How common are skeletalrelated events (SREs) in patients with prostate cancer undergoing hormonal ablation therapy?

Diana Shafer (DS): In our practice, and since we started the Bone Health Program, we have seen <5% of SREs. The norm in skeletal-related issues among patients on androgen deprivation therapy (ADT) for 4 years is approximately ≤20%.

We know that too often bone health is ignored in urological practices. We like to be on the forefront of technological and pharmaceutical treatments for our patients. We think bone health is extremely important. It goes hand-inhand with treating prostate cancer, so we like to be proactive in preventing SREs, and, hopefully, lead the way for our colleagues across the nation to take bone health more seriously in their practices.

Angela Hunter (AH): When we do encounter SREs in our practice, it is usually after the patient has already sustained and been treated for one, and they are just letting us know about it at their next visit.

Have you noticed any difference in the occurrence of SREs before and after you instituted monitoring treatment with prophylaxis?

AH: We started performing dual-energy x-ray absorptiometry (DXA) scans in patients with prostate cancer >10 years ago. We have been on the forefront of this for quite a while. I think that is why the SRE percentages that we see are low compared with the national norm. Although we do not have the statistics from 10 years ago, our numbers gradually started coming down from when we started that protocol back then.

How do SREs impact quality of life and survival of your patients?

Pamela Skurkay (PS): Pain in particular is a significant issue for our patients, and we try to be proactive in preventing any kind of incidents associated with skeletal fractures. Studies have shown

Diana Shafer, Pamela Skurkay, and Angela Hunter

that, when patients have a major fracture in their hip or spine, their life expectancies decrease significantly. By preventing those fractures, we can keep our patients active, and, hopefully, increase their life spans.

DS: It is very important for patients to continue their active lifestyle; they want to continue playing tennis or golf.

I had a patient who was concerned be-

If a DXA scan has not been done, we order it, and if results are low (T-score, <2.5), then we give patients denosumab (Prolia; Amgen Inc, Thousand Oaks, CA) to begin protecting their bones.

We also make a point to educate our patients on the dental issues associated with Prolia when they start treatment, and make sure they are seeing a dentist regularly.

“We provide patients with educational packets when they first start ADT, which includes information on bone health, the link to a website where they can sign up and get more information, and talk to other people who may have questions that they had not thought of.”

—Diana Shafer, BSN, CURN, CPC-I cause he could no longer empty a 30-lb bag of salt into his water softener—he needed his son-in-law to come to his house to do it for him. These issues are important to patients and impacts their self-image.

AH: We try to make sure that we keep their bones as healthy as possible so that they can continue their daily living activities. They don’t feel the same if they have to rely on somebody else to do something that they are used to doing themselves.

How and when do you screen for bone health in these patients?

DS: We monitor patients as soon as they start ADT. We look at their chart and make sure that they have had a DXA scan in the past 2 years.

Patients whose disease has metastasized are given Xgeva (denosumab; Amgen Inc, Thousand Oaks, CA) instead of Prolia. The nuance in treatment here is that Prolia is given to patients without bone metastases to increase bone mass in men at high risk for fracture who are receiving ADT for nonmetastatic prostate cancer, whereas Xgeva is given to patients who have bone metastases to prevent SREs. AH: In patients whose disease has metastasized, bone scans are usually conducted twice a year. We would conduct DXA scans more often, but Medicare only allows us to do a DXA scan once every 2 years on these patients.

We also make sure that patients are taking calcium and vitamin D supplements, and that their calcium levels don’t get low. We check calcium levels

on a regular basis if they are taking Prolia to make sure that their calcium is staying at a good, normal level. We also urge patients to stop smoking—it is always a good thing to do, no matter what.

We provide patients with educational packets when they first start ADT, which includes information on bone health, the link to a website where they can sign up and get more information, and talk to other people who may have questions that they had not thought of.

PS: The educational packet also includes suggestions for light, weight-bearing exercises to help improve their bone mass. It also recommends getting enough sleep, and offers other general advice on things that would be helpful for bone therapy.

DS: It also addresses weight management. If the patient is overweight, we recommend that they try to lose some weight because that will decrease their risk for a fracture.

How often should bone health screenings occur?

PS: We perform DXA scans in patients with prostate cancer undergoing hormone ablation every 2 years, according to Medicare guidelines. Patients undergoing hormone suppression therapy receive annual bone scans, whereas patients with metastatic cancer of the bones get scans every 6 months.

AH: X-rays and magnetic resonance imaging are performed sooner (ie, between regularly scheduled scans), if the patient develops bone pain, becomes symptomatic, or if something else changes.

What guidelines do you follow to treat and prevent SREs or fractures in patients with prostate cancer?

AH: We follow the American Urological Association’s guidelines, as well as those of the National Comprehensive Cancer Network. Our physicians usually form a committee, where they discuss those guidelines, and then, as a group, come up with a practice that they think best fits the patient population here in the Cincinnati, OH, area.

New healthcare providers and nurses are educated about these guidelines when they start with The Urology Group, so that all of our patients receive the same standard of care.

PS: When patients come in for their first visit, they will receive a packet that includes supplements such as calcium and vitamin D; educational literature,

INTERVIEW WITH THE INNOVATORS such as mild and light weight-bearing exercises; and weight management information if they are overweight. Most of our treatment relies on preventive therapy.

(once a month) and whether patients are prescribed bisphosphonate infusions or Xgeva subcutaneous injection depends on the patients’ condition and their insurance.

What treatment approach do you take in patients with prostate cancer who have a history of low-trauma fracture?

Do most of your patients with prostate cancer have Medicare insurance?

PS: The physician may choose to use bisphosphonate infusions or Xgeva injections in patients with a history of low-trauma fracture.

Patients taking bisphosphonates come to the office once a month for an intravenous (IV) infusion of Zometa (zoledronic acid; Novartis Pharmaceuticals Corporation). They will usually have blood drawn 2 weeks prior to the infusion to check creatinine levels. Bisphosphonate dosage is adjusted if creatinine levels are too high (>1.5 mg), or if the level rises by >0.5 mg within 1 month following their latest infusion.

Patients taking Xgeva also come to the office once a month for a subcutaneous injection to the abdomen or thigh.

During the first visit, patients stay a half hour so that they can be monitored for side effects after the injection; if they tolerated the injection, we will proceed with treatment. The office visits, which last ≤15 minutes, entail talking to the patient, getting their vital signs (while the medication is warming to room temperature), administering the shot, and then they are out the door.

Patients seem to prefer getting the subcutaneous injection than the IV infusion. One of the reasons is that patients can sometimes experience nausea if the bisphosphonates infusion runs too fast; therefore, they usually have to stay for 20 to 30 minutes.

What side effects have you observed following a Xgeva injection?

PS: The side effects patients experience with bisphosphonate infusions and Xgeva injections are similar.

Patients have reported mild, flulike symptoms, fatigue, low-grade temperature, and occasionally chills, for 24 to 48 hours after treatment. Patients may be switched to a different category of medications if they report more extensive side effects, such as those lasting >48 hours, or if they have severe symptoms (eg, severe pain). We advise patients to contact us right away if these side effects occur.

How are antiresorptive agents used in patients with prostate cancer?

PS: Antiresorptive agents are usually initiated as soon as any bone metastases are identified. They are given regularly

PS: At The Urology Group, we have a lot of patients with prostate cancer who are not of Medicare age; they may be younger. We have patients who are in their 40s or 50s.

It is really important for these patients to be able to maintain a normal lifestyle; it really affects their self-image a lot when they can’t perform their normal daily activities. I’m not just talking about waking up and getting dressed in the morning—they like to golf, or have an active lifestyle, play with their grandchildren, lift things that they could normally lift without worrying about getting a fracture. It is more important to the younger men than it is to the older men.

As Diana mentioned earlier, we had a patient who said that he could no longer lift 30-lb bags of salt to fill his water softener, and had to have his sonin-law come over and do it for him—it was embarrassing for him that he couldn’t even do that normal activity, which he used to do so easily.

AH: It’s not just about a 30-lb bag of salt—it’s also about their kids, and their grandkids. They can’t pick them up, love them, and hold them like they want.

Have there been any issues with patients not being able to afford their therapy?

PS: With the private payers, there have sometimes been issues with extremely large copays for patients, but there are foundations available that offer assistance to patients so that they can get the medications they prefer.

DS: The foundations also help Medicare patients with their copays, or their 20%, depending on whether they have health maintenance organization (HMO) Medicare or traditional Medicare.

Is there a difference in patient adherence to therapy among antiresorptive agents?

PS: I feel that there is a difference in patient adherence. Most of our patients prefer to get a subcutaneous injection in their abdomen or thigh, because they can be in and out of the office in 15 minutes, whereas getting an IV infusion takes 20 to 30 minutes, or more.

In addition, patients getting IV therapy also have to get a blood test within 2 weeks of their infusion versus the injection, which doesn’t require follow-up blood work.

DS: I, too, have seen that a lot of pa-

tients prefer the subcutaneous injection versus the infusion, just because it’s only 1 shot and it’s less invasive.

Do your patients share their views on the advantages of one medication over another?

PS: We find that a lot of our patients have researched their medication or treatments on the Internet. They actually come in to us fairly well-educated, and ask us some pretty good questions.

My patients much prefer the subcutaneous injection versus IV infusion.

We have also had several patients who were needle-phobic. A little shot in the belly is easier for them to tolerate than going through an IV infusion.

AH: It seems like, in today’s modern world, everybody wants convenience, and for things to be quick and easy. The quicker it is for the patient, the happier the patient.

DS: A lot of offices don’t have the setup to administer IV bisphosphonates, so they would have to come here to have that done. That would be an inconvenience to a lot of them, when they could go right down the street from their house and get both their shots at 1 time, during 1 visit.

Do you allow patients taking Xgeva to self-administer the injections at home?

PS: We do not allow patients to self-administer Xgeva; all the injections are administered by a nurse in the office.

Some patients, however, administer their own testosterone injections at home, and we do teach them how to do that. We also have patients who have erectile dysfunction who are taught how to administer their own penile injections with medication.

as well as my patients. You really get attached to them. I worked specifically with one of our advanced prostate cancer physicians, so I got to see their patients on a monthly basis. You really get to know the patients, and they get to know you. It’s a comfortable feeling for both parties because the patient feels comfortable enough to tell you something that they may not tell somebody else.

How do you envision the future evolution of management of bone health in patients with advanced prostate cancer?

DS: I think with technology and all the different medications that are being researched now, the bone health of our future patients can only get better from this point forward.

PS: It’s all about preventive therapy.

AH: With everybody having access to the Internet, not only can we provide them with information, but patients have the opportunity to go online and research even more information.

Knowledge is power, and I think that the more knowledge we have, the more powerful the person. Chances of preventing bone health issues in the future can only get better. n Pamela Skurkay BSN, RN, CPAN, CURN, is certified perianesthesia nurse since 1986 and certified urology nurse since 2009, clinical manager for Physician Office, Bladder Control center, CyberKnife Suite and Outpatient Pharmacy; Angela K. Hunter, BSN, Advance Prostate Cancer Coordinator; and Diana Shafer, BSN, CURN, CPC-I, Manager of Compliance and Electronic Medical Records.

Does your practice allow the nurse navigator to help patients with prostate cancer with their medication choices and financial issues, or do you do that?

DS: Angela Hunter, LPN, is our advanced prostate cancer coordinator.

It’s her job to watch our prostate cancer population, and move them to physicians who will get them the appropriate treatment as soon as they possibly can.

We have a team of precertified specialists who precertify these types of medications, and apply to the foundations to help patients with their financial copays.

AH: I’m still getting my feet wet. I’ve been on the clinical side, and now I work on the backside, and to be honest, I like both. I like the patient care, but I also like what I’m doing now, too. I really miss the staff I used to work with,

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SIDE EFFECTS MANAGEMENT

Functional Impairments of Head and Neck Lymphedema Meg Barbor, MPH

Scottsdale, AZ—Head and neck lymphedema (HNL) is a common but underrecognized and poorly managed complication of treatment for head and neck cancer, but its accompanying functional impairments can be improved with targeted therapy, according to Jan S. Lewin, PhD. “Everybody recognizes that there’s a huge cosmetic component, but I think far fewer recognize the significance of the functional consequences,” said Dr Lewin at the 2016 Multidisciplinary Head and Neck Cancer Symposium.

Up to 75% of treated head and neck cancer patients will develop HNL. There is currently no standard method of assessment for the condition, and the data surrounding it remain sparse.

“External presentation of HNL is what we’re most familiar with,” said Dr Lewin, a professor in the Department of Head and Neck Surgery and Section Chief of Speech Pathology and Audiology at The University of Texas MD Anderson Cancer Center in Houston.

It involves overtly visible edema of the neck, face, oral cavity, and supraclavicular region and is typically characterized by a “double chin.” It ranges from soft and reversible edema to hard, pitting, irreversible edema.

The other type of HNL is internal, and it is a chronic edema of the larynx and pharynx. “This is a challenging type of lymphedema, because it’s invisible to peripheral examination,” she said. “The problem is we can’t physically assess or treat it because we can’t palpate it.”

Significant Functional, Emotional, and Psychosocial Impact

HNL affects respiration and communication, particularly when present in the laryngeal region. In the oral phase, patients with HNL experience difficulty with mastication and transit, food spillage, and drooling, and in the pharyngeal phase, a narrowing of the pharynx can cause difficulty with the transit of food. “And when lymphedema is present in the submental region, patients can experience difficulty performing the strategies and exercises that have been shown to be so beneficial in assisting with swallowing problems,” Dr Lewin added.

Patients with HNL can also experience significant difficulty with reading, writing, and walking, as well as general discomfort, depression, frustration, and embarrassment.

What Works and What Doesn’t

According to Dr Lewin, diuretics provide only temporary relief; debulking and/or liposuction of the head and neck flaps offer no long-term benefit; elevation of the head is not effective; and most people do not tolerate compression pumps.

“And in our experience to date, we see very little benefit to relief of internal HNL from external compression,” she noted.

“What does work is complete decongestive therapy (CDT),” she said. CDT combines 4 different areas of treatment:

gentle massage that helps with manual lymph drainage, compression bandaging and the use of garments to help mitigate swelling, skin care (when needed), and remedial exercises, particularly swallowing exercises, that are practiced when patients are wearing these garments or Kinesio Tape.

The CDT program involves an intensive phase employed for 2 to 4 weeks

“The measurement and management of internal HNL must be a priority if we are going to improve related swallowing dysfunction.”

—Jan S. Lewin, PhD at a frequency of 3 to 5 days per week, a maintenance phase consisting of daily home therapy for 1 to 3 months, and a home program performed by the patient or their significant other.

MD Anderson Retrospective Cohort

Dr Lewin and her colleagues at MD Anderson recently published a retrospective cohort study characterizing their experience with more than 1200 patients with lymphedema, and they have just begun analyzing the patients who have returned for follow-up.

Tumor sites and surgery type in the

study cohort varied, and all patients received a CDT home management protocol, with or without formal outpatient treatment. Of 1202 total patients, 83% complained of cosmetic problems, but more than one-third (37%) also complained of functional problems, and, of those, more than two-thirds (68%) complained of swallowing problems.

“I want to emphasize that the majority of these patients are doing this therapy at home,” Dr Lewin said. “But even if patients do this therapy at home, initial results show 60% are improving and sustaining improvement.”

“What predicted our outcomes was really exercise adherence,” she added.

“The good news is, if patients even partially did what we asked them to do, they had a significant improvement over those who did not adhere to the therapy protocol.” Physical outcomes at last follow-up (median, 6 months) show 70% overall improvement, she reported.

According to Dr Lewin, future investigations must distinguish important variables associated with durable response in order to help minimize lymphatic damage and establish new methods of treatment for refractory HNL. “The measurement and management of internal HNL must be a priority if we are going to improve related swallowing dysfunction,” she stated. n

Reference

Lewin JS. Role of lymphedema therapy. Presented at: Multidisciplinary Head and Neck Cancer Symposium; February 18-20, 2016; Scottsdale, AZ.

FDA NEWS Diagnostic Imaging Agent FDA Approved...Continued from the cover

Netspot is supplied as a sterile, single-dose kit, for preparation of a Ga-68 dotatate intravenous injection; serious adverse reactions have not been identified with use of this agent.

US Food and Drug Administration. FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors. www.fda.gov/NewsEvents/Newsroom/PressAn nouncements/ucm504524.htm. Published June 1, 2016.

Accessed June 22, 2016.

Diagnostic Blood Test FDA Approved for NSCLC Gene Mutation

The Cobas EGFR (epidermal growth factor receptor) Mutation Test v2 is the first blood-based genetic test approved by the FDA for detecting EGFR gene mutation in patients with non–small-

cell lung cancer (NSCLC). This test is a companion diagnostic for erlotinib (Tarceva; Astellas Pharma US, Inc, and Genentech, Inc).

“Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients,” explained Alberto Gutierrez, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, FDA Center for Devices and Radiological Health, Silver Spring, MD, in a press release by the organization.

The test can detect the presence of specific NSCLC mutations in patients’ blood samples, and help select those who may benefit from treatment with erlotinib. A tumor biopsy should be performed to determine whether mutations are present if they are not detected in the blood, the FDA noted.

The efficacy of the Cobas EGFR Mutation Test v2 was evaluated among patients in a clinical trial whose tumor biopsies were previously confirmed as positive for the EGFR exon 19 deletion or L858R mutations.

US Food and Drug Administration. FDA approves first blood test to detect gene mutation associated with nonsmall cell lung cancer. www.fda.gov/NewsEvents/News room/PressAnnouncements/ucm504488.htm. Published June 1, 2016. Accessed June 22, 2016.

Axumin FDA Approved for Recurrent Prostate Cancer

With prostate cancer the second leading cause of cancer-related death among US men, accurate staging is paramount in improving management and outcome among patients with suspected cancer recurrence after their primary treatment.

In a recent announcement, the FDA has stated its approval of axumin, an injectable radioactive agent. Axumin is indicated for PET imaging in men with suspected cancer recurrence, based on elevated prostate-specific antigen levels following prior treatment.

This approval was based on data from 2 studies that evaluated the safety and efficacy of axumin for imaging prostate cancer in patients with recurrent disease. The most commonly reported side effects among patients receiving axumin were pain and redness at the injection site, and a metallic taste in the mouth. n US Food and Drug Administration. FDA approves new diagnostic imaging agent to detect recurrent prostate cancer. www.fda.gov/NewsEvents/Newsroom/PressAn nouncements/ucm503920.htm. Published May 27, 2016. Accessed June 22, 2016.