TON_March2015_Vol8_No2

MARCH 2015

www.TheOncologyNurse.com

VOL 8, NO 2

Cancer Prehabilitation: Important Lessons From a Best Practices Model

CANCER CENTER PROFILE

Stanford Health Care

Julie Silver, MD

O The MED9 team at Stanford Health Care (left to right): Ashley Harmon, NP; Christine Szura Shen, NP; Mary Petrofsky, NP; Carl Kulpa, NP; Lisa Stringer, NP; Megan Harrington, NP; Laura Zitella, NP; Amber Rickner, NP; and Quan Thai, NP. Team members not pictured: Alisa Kearney, NP; Rachel Landgrebe, NP; and Marie Rinaldi, NP.

S

tanford Health Care (SHC) is a large, comprehensive system serving Stanford, California, and the surrounding area. The system comprises a total of 11,225 people, including 7689 employees, 1070 volunteers, 1016 interns and residents, and 1450 faculty physicians.

Stanford University is an academic medical center, and the cancer institute Continued on page 7

CONFERENCE NEWS

Highlights From the World Cutaneous Malignancies Congress

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he Third Annual World Cutaneous Malignancies Congress (WCMC) took place in San Francisco, California, in October 2014. The WCMC is a 2-day congress dedicated to informing, educating, and fostering the exchange of clinically relevant information in the field of cutaneous malignancies on topics in melanoma, basal cell carcinoma (BCC), Merkel cell carcinoma (MCC), and cutaneous T-cell lymphoma (CTCL). Immune-targeted therapies and inhibitors of hedgehog pathway signaling dot the landscape in recent investigations in the treatment of melanoma, BCC, and MCC. The following articles highlight presentations regarding immunotherapies in oncology. For additional highlights from this premier meeting, visit www.cutaneousmalignancies.com.

Malignant Melanoma Interferon remains the adjuvant therapy of choice in patients at high risk for recurrence of malignant melanoma, said Reinhard Dummer, MD.1 A systematic review favored high-dose interferon ver-

sus observation on relapse-free survival but not overall survival (OS) in patients with high-risk resected primary melanoma. Recently, however, relapse-free survival was found to be a surrogate end

n the front lines of the war on cancer, nurses are often the field commanders—in charge of safely navigating patients through treacherous terrain as well as delivering medical treatment that should provide maximal health benefits and minimize adverse effects. Oncology nurses interface with the “new recruits” and help them through many difficult challenges. Nurses are well positioned to see the short- and long-term effects of cancer and its treatment on patients. They see the physical and emotional impair-

ments develop and accumulate over time. And yes, they see the “financial toxicity” that is caused by the disease and health professionals’ attempts to treat it. Oncology nurses are also uniquely positioned to contribute to and/or lead prehabilitation efforts that may reduce the burden of cancer on individuals and society.1 One cancer survivor wrote a blog that included this question in the title: Are we doing too much in oncology backwards?2 In his blog post he said, “I was reviewing my blood work after my recent stem cell Continued on page 8

Malignant Pleural Effusions Linda Schiech, RN, MSN, AOCN, LNC

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atients with a cancer diagnosis endure multiple complications and stresses, particularly when disease progresses. Unfortunately, the treatments themselves can also result in debilitating side effects that further increase their suffering.

One of the disease developments associated with cancer is malignant pleural effusion (MPE), which affects approximately 15% of patients with cancer.1 A pleural effusion is a collection of fluid between the parietal and visceral pleural layers surrounding the lung.2-6 For the most part, when patients are diagnosed

INSIDE 3 Colorectal Cancer Investigational Drug for Cachexia Appears to Improve Survival 6 Empowering Patients and Survivors Getting Active, Staying Active 15 Side Effects Management

Colorectal Cancer Survivors Frequently Report Bowel Dysfunction

Continued on page 13 © 2015 Green Hill Healthcare Communications, LLC

with an MPE, they are in the advanced stages of their disease. MPE is estimated to occur in about 150,000 people with cancer per year in the United States.7 The normal pleural space contains 10 to 20 mL of fluid, which acts as a lubricant, allowing the lungs to move smoothly when the patient is breathing. Each day, approximately 5 L or more of pleural fluid is produced and moves throughout the pleural space.3,8 Pleural effusion occurs when more fluid is produced than is absorbed from the space. Pleural effusions can also arise from other causes besides cancer, such as congestive heart Continued on page 16

19 Clinical Trials

Full Clinical-Trial Data Sharing Moves Closer to Reality

You voted for

The 2014

ONEu Award Find out who won on page 20

Take a bite out of G-CSF acquisition costs Based on wholesale acquisition cost (WAC) of all short-acting G-CSF products as of November 11, 2013. WAC represents published catalogue or list prices and may not represent actual transactional prices. Please contact your supplier for actual prices.

GRANIX® is an option in short-acting G-CSF therapy » A 71% reduction in duration of severe neutropenia vs placebo (1.1 days vs 3.8 days, p<0.0001)1 – Efficacy was evaluated in a multinational, multicenter, randomized, controlled, Phase III study of chemotherapy-naïve patients with high-risk breast cancer receiving doxorubicin (60 mg/m2 IV bolus)/docetaxel (75 mg/m2)1 » The safety of GRANIX was established in 3 Phase III trials, with 680 patients receiving chemotherapy for either breast cancer, lung cancer, or non-Hodgkin lymphoma (NHL)1 » Now offering a new presentation for self-administration

Indication » GRANIX is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Important Safety Information » Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colony-stimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX. » Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. » Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim. » Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis. » Capillary leak syndrome (CLS): CLS can occur in patients receiving hG-CSFs and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. » Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded. » Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain.

Please see brief summary of Full Prescribing Information on adjacent page.

For more information, visit GRANIXhcp.com.

Reference: 1. GRANIX® (tbo-filgrastim) Injection Prescribing Information. North Wales, PA: Teva Pharmaceuticals; 2014.

©2015 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a registered trademark of Teva Pharmaceutical Industries Ltd. All rights reserved. GRX-40582 January 2015.

COLORECTAL CANCER

Investigational Drug for Cachexia Appears to Improve Survival Chase Doyle

R

esults of a phase 3 study of an investigational monoclonal antibody, MABp1 (Xilonix; XBiotech), evaluated for cachexia in metastatic colorectal cancer (CRC), revealed a surprising finding: patients in the experimental arm showed a trend toward increased overall survival (an end point difficult to reach in any treat-

ment-refractory cancer), with pharmacodynamics activity consistent with this result, investigators reported at the 2015 Gastrointestinal Cancers Symposium, held in San Francisco, California.

“Interim survival and quality of life, analyzed at the conclusion of enrollment, showed a 39% shorter median overall survival (2.0 vs 2.8 months) for

BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR GRANIX® (tbo-filgrastim) injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

4 CONTRAINDICATIONS None.

5 WARNINGS AND PRECAUTIONS 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following administration of human granulocyte colony-stimulating factors. In patients who report upper abdominal or shoulder pain after receiving GRANIX, discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture.

5.2 Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) can occur in patients receiving human granulocyte colony-stimulating factors. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. 5.3 Allergic Reactions Serious allergic reactions including anaphylaxis can occur in patients receiving human granulocyte colony-stimulating factors. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.

5.4 Use in Patients with Sickle Cell Disease Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving human granulocyte colony-stimulating factors. Consider the potential risks and benefits prior to the administration of human granulocyte colony-stimulating factors in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis.

5.5 Capillary Leak Syndrome Capillary leak syndrome (CLS) can occur in patients receiving human granulocyte colonystimulating factors and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

5.6 Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor through which GRANIX acts has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic Rupture [see Warnings and Precautions (5.1)] • Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)] • Serious Allergic Reactions [see Warnings and Precautions (5.3)] • Use in Patients with Sickle Cell Disease [see Warnings and Precautions (5.4)] • Capillary Leak Syndrome [see Warnings and Precautions (5.5)] • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.6)] The most common treatment-emergent adverse reaction that occurred at an incidence of at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group was bone pain.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian.

In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-US-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 106/L after nadir was reached.

patients receiving megestrol acetate versus Xilonix and a trend in increased risk of death (hazard ratio, 2.17; P=.17),” noted George A. Fisher, MD, Stanford University School of Medicine, California, the author of the study.

The objective of the open-label, multicenter, phase 3 randomized trial was to evaluate the efficacy and safety of

Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-USapproved filgrastim product).

Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies.

Additional Adverse Reactions Other adverse reactions known to occur following administration of human granulocyte colony-stimulating factors include myalgia, headache, vomiting, Sweet’s syndrome (acute febrile neutrophilic dermatosis), cutaneous vasculitis and thrombocytopenia.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving GRANIX has not been adequately determined.

7 DRUG INTERACTIONS No formal drug interaction studies between GRANIX and other drugs have been performed.

Drugs which may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone-imaging results.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C Risk Summary There are no adequate and well-controlled studies of GRANIX in pregnant women. In animal reproduction studies, treatment of pregnant rabbits with tbo-filgrastim resulted in increased spontaneous abortion and fetal malformations at systemic exposures substantially higher than the human exposure. GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal Data In an embryofetal developmental study, pregnant rabbits were administered subcutaneous doses of tbo-filgrastim during the period of organogenesis at 1, 10 and 100 mcg/kg/day.

Increased abortions were evident in rabbits treated with tbo-filgrastim at 100 mcg/kg/day.

This dose was maternally toxic as demonstrated by reduced body weight. Other embryofetal findings at this dose level consisted of post-implantation loss‚ decrease in mean live litter size and fetal weight, and fetal malformations such as malformed hindlimbs and cleft palate. The dose of 100 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 50-90 times the exposures observed in patients treated with the clinical tbo-filgrastim dose of 5 mcg/kg/day.

8.3 Nursing Mothers It is not known whether tbo-filgrastim is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GRANIX is administered to a nursing woman. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates.

8.4 Pediatric Use The safety and effectiveness of GRANIX in pediatric patients have not been established.

8.5 Geriatric Use Among 677 cancer patients enrolled in clinical trials of GRANIX, a total of 111 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

8.6 Renal Impairment The safety and efficacy of GRANIX have not been studied in patients with moderate or severe renal impairment. No dose adjustment is recommended for patients with mild renal impairment.

8.7 Hepatic Impairment The safety and efficacy of GRANIX have not been studied in patients with hepatic impairment.

10 OVERDOSAGE No case of overdose has been reported. ©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved.

GRANIX is a registered trademark of Teva Pharmaceutical Industries Ltd. Manufactured by: Distributed by: Sicor Biotech UAB Teva Pharmaceuticals USA, Inc. Vilnius, Lithuania North Wales, PA 19454 U.S. License No. 1803 Product of Israel GRX-40581 January 2015 This brief summary is based on TBO-004 GRANIX full Prescribing Information.

MABp1 in CRC complicated with cachexia.

According to an interview with Michael Stecher, MD, medical director at XBiotech, MABp1 is the first drug of its kind—a true human monoclonal antibody that targets interleukin-1αα (IL-1α).

“A true human antibody is different than a fully human antibody,” explained Stecher, “in that it’s cloned directly from a human B cell; it hasn’t been developed in a mouse…. To our knowledge there are no other antibodies in the clinic that have been cloned directly from a human.”

Patients with metastatic CRC who were eligible for this trial had failed 1 cytotoxic line of therapy (either oxaliplatin or irinotecan) and lost greater than 5% of total body weight in the previous 6 months.

“With a cachectic population,” explained Stecher, “we didn’t want to randomize the placebo, so we randomized megestrol. Thus, the trial was Xilonix the antibody (3.75 mg/kg intravenously every 2 weeks) versus megestrol (oral 800 mg daily)—1:1 randomization with a primary end point of overall survival.”

Because platelets support tumor growth and metastasis, increasing platelet numbers in advanced cancer are often prognostic of poor survival.

In patients treated with MABp1, physical and role function did not decline during therapy; however, these functions worsened in those patients receiving megestrol (median change, –13.3 and –16.7, respectively; P=.02 vs MABp1). Furthermore, MABp1 patients had a treatment-related reduction in platelet counts compared with those in the megestrol group (median reduction, –60,000/mm3 vs 10,000/mm3, respectively; P=.03).

According to Fisher, platelet count is a key pharmacodynamic measure. Because platelets support tumor growth and metastasis, increasing platelet numbers in advanced cancer are often prognostic of poor survival. “IL-1α on platelets, which may mediate pro-tumor effects, is a target of antibody therapy,” noted Fisher, although the precise mechanics of the drug remain somewhat of a mystery.

“This may be an effect of IL-1α on the surface of platelets that the antibody’s Continued on page 7

www.TheOncologyNurse.com

MARCH 2015 I VOL 8, NO 2

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EDITORIAL BOARD EDITOR-IN-CHIEF

Beth Faiman,

PhD, APRN-BC, AOCN

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Cassandra J. Hammond, RN, MSN, CRNP

Avid Education Partners, LLC 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-BC, MSN, AOCN, LNC

Fox Chase Cancer Center Philadelphia, PA

Wendye DiSalvo,

DNP, APRN, AOCN Genentech New London, NH

Denice Economou,

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

Somerset Medical Center Somerville, NJ

Taline Khoukaz,

Gary Shelton,

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

Patient Advocacy Peg Ford

NYU Clinical Cancer Center New York, NY

Sandra E. Kurtin,

Lori Stover, RN,

Arizona Cancer Center Tucson, AZ

Western Pennsylvania Cancer Institute Pittsburgh, PA

Ann McNeill,

Joseph D. Tariman,

MSN, ACNP-C

RN, MS, AOCN, ANP-C

RN, MSN, APN

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Millennium Pharmaceuticals, Inc Boston, MA

Dallas, TX

RJ Health Systems International, LLC Wethersfield, CT

BSc Pharm, RPh, FASCP

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

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

Amy Ford, RN,

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

RN, DNS

Nutrition Karen Connelly,

Kena C. Miller,

BSN, OCN

Pharmacy John F. Aforismo,

Jayshree Shah, RN, APN-C, AOCNP, MSN

RN, BSN, OCN

Constance Engelking, RN,

MS, CNS, OCN

Melinda G. Oberleitner,

RN, MSN, ARNP-BC

DNP(c), MSN, NP, ANP-BC, AOCNP

BSN

PhD, ANP-BC DePaul University Chicago, IL

Jacqueline Marie Toia, RN, MS, DNP Northwestern University Myeloma Program Chicago, IL

Ovarian Cancer Alliance of San Diego San Diego, CA

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

Onco360/OncoMed New York, NY

Patricia Molinelli,

Connie Visovsky,

Somerset Medical Center Somerville, NJ

University of South Florida College of Nursing Tampa, FL

MS, RN, APN-C, AOCNS

RD, CSO

PhD, RN, ACNP-BC

Isabell Castellano, RN

Bristol-Myers Squibb Childrenâ&#x20AC;&#x2122;s Hospital Robert Wood Johnson University Hospital New Brunswick, NJ

Jeanne Westphal, RN Sharon S. Gentry,

Ellen A. Neylon,

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

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

RN, MSN, AOCN, CBCN

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MSN, FNP-BC, CCRP, OCN

Rita Wickham,

Meeker Memorial Hospital Litchfield, MN

PhD, RN, AOCN

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

www.TheOncologyNurse.com

FROM THE EDITOR In this issue of The Oncology Nurse-APN/PA, we offer a selection of topics that we hope you will find useful in your daily practice as you care for patients with cancer.

Julie Silver, MD, discusses cancer prehabilitation and notes that nurses are “uniquely positioned to contribute to and/or lead prehabilitation efforts that may reduce the burden of cancer on individBeth Faiman, PhD, APRN-BC, AOCN uals and society.” A growing Editor-in-Chief body of research shows that the concept of prehabilitation is vital to improving outcomes for patients. Dr Silver talks about leading the launch of the STAR Program Prehab, which models best practices and translates current evidence into protocols that can be implemented by hospitals and cancer centers.

We also feature an article about malignant pleural effusions. Linda Schiech, RN, MSN, AOCN, LNC, writes about treatments for this debilitating adverse event that affects approximately 15% of patients with cancer—usually those who are in the advanced stages of their disease.

She presents information about the diagnosis and various treatment options for this complication.

In this issue, we share highlights of the recent World Cutaneous Malignancies Congress (WCMC) and the Gastrointestinal Cancers Symposium. WCMC presents some of the cutting-edge research in cutaneous malignancies. This information helps us keep current with possible treatment directions in this field. From the Gastrointestinal Cancers Symposium, we share results of a presentation that shows that patients with colorectal cancer who underwent sphincter-preserving surgery or anastomosis are unprepared to deal with their long-term bowel dysfunction. Virginia Sun, RN, PhD, stated, “Evidence-based interventions that are timely and personalized are needed to support positive adjustments to bowel changes following surgery.”

Be sure to read about Laura Zitella, an advanced practice provider (APP)/nurse practitioner at Stanford Health Care who was the first recipient of the APP of the Year Award presented by the APP General Council and the Center for Advanced Practice at Stanford. Also, read the interview with Jessica Engel, DNP, FNP-BC, AOCNP, who received the Oncology Nurse Excellence Award at the recent Academy of Oncology Nurse & Patient Navigators Fifth Annual Conference. Both of these women illustrate the best of our profession! n

PUBLISHING STAFF Vice President/Group Publisher Russell Hennessy rhennessy@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Director, Client Services Dave Dempsey ddempsey@the-lynx-group.com Editorial Director Kristin Siyahian ksiyahian@the-lynx-group.com Managing Editor Kristen Olafson kolafson@the-lynx-group.com Copyeditors Mollie Friedman Peggy Roeske Production Manager Melissa Lawlor

THE LYNX GROUP President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly

READER POLL Do you talk to your patients about how to best stay physically active? o Yes In her Getting Active, Staying Active article, Angela Long notes “the growing body of scientific evidence demonstrating the importance of physical activity for…optimal quality of life before, during, and after cancer

o No

treatment.” Angela discusses how patients and survivors can best find physical activities that are a match for their “fitness personality.” Do you talk to your patients about being physically active, as patients and survivors?

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

Human Resources Jennine Leale Director, Strategy & Program Development John Welz Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistants Lora LaRocca Wayne Williams Director, Digital Media Anthony Romano Jr Digital Media Specialist Charles Easton IV Web Content Manager Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Mezzacappa Project Manager Deanna Martinez Project Coordinator Rachael Baranoski

The Oncology Nurse-APN/PA®, ISSN 1944-9798 (print); ISSN 1944-9801 (online) is published 6 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright © 2015 by Green Hill Health­care Com­munications, LLC. All rights reserved. The Oncology Nurse-APN/PA® logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

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

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

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MARCH 2015 I VOL 8, NO 2

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EMPOWERING PATIENTS AND SURVIVORS

Getting Active, Staying Active Angela Long

W

e hear more and more from the growing body of scientific evidence demonstrating the importance of physical activity for cancer prevention, cancer survivorship, and optimal quality of life before, during, and after cancer treatment. Physical activity contributes to our health by helping to control our weight, maintaining healthy bones and muscles, and promoting our psychological well-being. Despite proven health benefits and broad awareness of the benefits of physical activity, the results of recent studies suggest that more than 50% of Americans do not engage in enough regular physical activity.

Cancer patients and survivors often face obstacles beyond the average person’s lack of motivation to exercise that often accounts for the general population’s preference to opt out of physical activities.

Treatment-induced side effects such as arthritis, osteoporosis, heart problems, thyroid problems, urinary problems, lymphedema, neuropathy, pain, and fatigue can present significant challenges to cancer

While the obstacles to incorporating physical activity into our lives during and after cancer treatment can be many, research shows that physical activity can help to alleviate many of the side effects of cancer treatment. patients and survivors wishing to embrace physical activity as part of a healthy lifestyle. While the obstacles to incorporating physical activity into our lives during and after cancer treatment can be many, research shows that physical activity can help to alleviate many of the side effects of cancer treatment. The most proven benefits of exercise are reducing fatigue and assisting with energy balance. Thus, physical activity can open the door to an increasingly active lifestyle by increasing our energy, and, along with it, our motivation.

Cancer shows us that, while we can have a lot in common, we are all unique. How we get back onto a path of health and well-being and what that path looks like following cancer will vary from person to person. According to Suzanne Brue, MS, researcher and author of The 8 Colors of Fitness, we all have our own fitness personality, and it can be especially difficult to maintain an exercise regimen if we choose physical activities that are

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of shared accomplishment that developed and was experienced by all during those 3 days of racing and fellowship with survivors and athletes from around the world.

less than compatible with our personalities and interests. Fortunately, there are courses to help individuals identify their fitness personalities so they can build and maintain a physically active lifestyle that suits them.

New research, programs, and organizations are emerging all the time to help cancer survivors overcome obstacles and begin and maintain physically active lifestyles.

Sport for Women Cancer Survivors

Getaways to Get Started

A wonderful way survivors can get a jump start on the thrills and adventures that can come of a physically active life is through organized getaways. Numerous organizations plan a variety of adventures, retreats, camps, and cruises for cancer survivors. All of them are opportunities to reclaim and embrace life in a new and healthy way, while connecting with other survivors striving to do the same.

First Descents offers young adult cancer fighters and survivors a free outdoor adventure experience designed to empower them to climb, paddle, and surf beyond their diagnosis. River Discovery offers cancer survivors of any age the opportunity to enjoy rafting, hiking, swimming, and kayaking down the Idaho River. Epic Experience offers paddleboarding in the summer and snowshoeing and snow cave building in the winter. The goal of these adventure programs is to introduce survivors to experiences that are both physically and emotionally healing.

High adventure is not for everyone. For those looking for a more laid-back and relaxed getaway, there are camps offered by Faces of Courage, the Pink Lemonade Project, or Harmony Hill, to name just a few.

Breast Cancer Wellness Magazine organizes a “Thrivers Cruise” for breast cancer survivors looking to cruise to enticing destinations with other survivors. All of these programs include opportunities to learn about ways to develop and maintain a more physically active lifestyle. Thanks to the founders of these programs and supporters of their missions, most of these getaways are offered at no or low cost to cancer survivors.

Getting Active at the Gym

Thanks to organizations such as LIVE­ STRONG, cancer survivors need only travel as far as their local YMCA to get the jump-start they are looking for to help them become more physically active.

LIVESTRONG has partnered with the YMCA to offer a 12-week, small-group program designed for adult cancer survivors.

The program emphasizes health rather than disease. It is designed to help cancer survivors feel physically and emotionally strong enough to move on to their “new normal.”

The YMCA fitness instructors are trained in the elements of cancer, postrehab exercise, and supportive cancer care. They work with each participant to fit the program to his or her individual needs. The program aims to

Angela Long

assist participants in developing their own physical fitness plan to continue to practice a healthy lifestyle after the program ends.

Breast Cancer Survivors Dragon Boating

In 1996, at the University of British Columbia in Vancouver, Canada, Dr Don McKenzie, a sports medicine professor and an exercise physiologist, conducted an experiment. Dr McKenzie questioned the prevailing idea at that time that women treated for breast cancer should avoid rigorous upper-body exercise for fear of developing lymphedema. He decided to put the ques-

In dragon boat racing, I observed how survivors can realize a strength that comes from working with others toward shared goals of attaining a certain level of physical ability, but dragon boating and competitive paddling are not for everyone. Fortunately, there are many other options for those looking to combine physical activity with social opportunities designed around the shared experience of cancer survivorship and optimal health. For example, Team Survivor is a nonprofit organization with affiliates across the country that promotes all kinds of sport, group exercise, and support programs for women survivors of any type of cancer. Some program offerings at present include walking, running, swimming, tennis, yoga, cycling, golf, Pilates, triathlon training, and dragon boat racing.

Team Survivor programs vary from city to city, but all focus on providing fun, fitness, health education, and peer support.

Just as there is no “one size fits all” prescription for getting physically active, our physical fitness interests and goals can change over time as we progress from cancer patient to cancer survivor and beyond. What is most important is that we not give up on finding

Oncology nurses can play an important role in supporting cancer patients and survivors in their efforts to rebuild a physically active lifestyle. tion to the test, and the seeds of the Pink Dragon Boat Racing movement were sown.

To determine the impact of exercise on breast cancer survivors, Dr McKenzie developed a paddling program in which he had 24 breast cancer volunteers paddle daily for 3 months. After 3 months of strenuous upper-body exercise in the company of other survivors, the women felt not just healthier, but happier. They loved exercising with the support of their fellow paddlers and breast cancer survivors. Over the years, the movement has spread across Canada and to numerous other countries.

I was introduced to this amazing team sport almost 2 years ago, when the IBCPC (International Breast Cancer Paddlers’ Commission) was making plans to hold its international event in my hometown of Sarasota, Florida. Before I knew it, I was captain and founder of Survivors In Sync, a dragon boat paddling team that competed in its most recent event in October 2014.

There are hardly words to describe the sense

those physical activities that best suit our personalities, interests, and physical abilities at any given time. Oncology nurses can play an important role in supporting cancer patients and survivors in their efforts to rebuild a physically active lifestyle, by both educating them about the benefits of physical activity and pointing them to some of the many options that exist to support them in their journeys back to good health. n­

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

BreastInvestigators.com.

For more Physical Activity for Cancer Survivors resources go to http://breast investigators.com/content/physical-activity-­ cancer-survivors.

www.TheOncologyNurse.com

CANCER CENTER PROFILE

Stanford Health Care is designated by the National Cancer Institute as a Center of Excellence.

SHC includes ambulatory clinics and community practices that are collectively referred to as the Stanford Health Care Alliance.

The Oncology Nurse-APN/PA spoke with Laura Zitella, MS, RN, ACNPBC, AOCN, Lead Advanced Practice Provider (APP)/Nurse Practitioner (NP) for Inpatient Hematology/Oncology about her role at SHC and her experience there. Zitella is the first recipient of the APP of the Year Award presented by the APP General Council and the Center for Advanced Practice at Stanford.

Continued from the cover

patient care and the other 50% is administrative and involves managing the clinical operations for our team and ongoing professional development of our staff.

“My goal is to give patients the best experience possible, making sure that in addition to the medical treatment, our team addresses the supportive care needs and emotional needs of our patients.”

What does your job entail as Lead APP for the Inpatient Hematology/Oncology APP team?

Laura Zitella (LZ): I supervise a team of 12 nurse practitioners who care exclusively for cancer patients admitted as inpatients at Stanford Hospital. At Stanford, there are 4 medical teams to care for inpatients with cancer: an oncology resident team, a hematology resident team, a combined/APP bone marrow transplant (BMT) team, and our NP hematology/oncology team.

Our team, called MED9, was created in 2012 in response to the increased volume of hematology/oncology patients. It is the first medical team at Stanford to include only NPs who provide medical care in collaboration with the attending physician. Our team model has been very successful with excellent patient outcomes and high ratings of patient satisfaction and continuity of care. As a result, this year we expanded our team from 8 to 12 nurse practitioners and from 3 to 4 attending physicians to accommodate an increased patient volume.

I developed the structure for our operations, and I interview, hire, orient, and train the staff. Currently, 50% of my time is spent providing

ney, giving them guidance and advice.

I also find mentoring my staff very rewarding, helping them develop new skills and witnessing their transformation into expert clinicians.

—Laura Zitella, MS, RN, ACNP-BC, AOCN

What are the most challenging aspects of your job?

LZ: It turns out that the most challenging aspects are also the most exciting for me. I would say the main challenge is keeping current with all the advances in oncology—implications of genomics and identification of new targets for various cancer types. This involves using my clinical judgment regarding the best treatment for each patient and optimizing supportive care.

My goal is to give patients the best experience possible, making sure that in addition to the medical treatment, our team addresses the supportive care needs and emotional needs of our patients.

What is the most rewarding aspect of your job?

LZ: Developing a relationship with patients. It is an honor to meet each patient and help that person and his/her loved ones through a very difficult jour-

What led you to pursue becoming an oncology APP?

LZ: I always had a strong interest in science and also a strong desire to make a difference in the lives of others.

I knew pretty early on that I wanted to be a nurse practitioner. I have been doing this for 18 years.

Tell me about the award you received. I believe it was the first one awarded at Stanford.

LZ: The award was given to me in 2014 by the Center for Advanced Practice at Stanford. The Center oversees all of the APPs at Stanford, including NPs, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists.

The award was in recognition of my contributions to SHC. The main ones are creating the first APP inpatient team; developing comprehensive onboarding and orientation for all APPs

at SHC; coediting a book with MiKaela Olsen called Hematologic Malignancies in Adults, published in 2013 (the definitive textbook for hematology published by the Oncology Nursing Society); cofounding the Stanford Advanced Practice Council in 2008 with Tracey Mallick, NP; creating a quarterly APP newsletter; obtaining privileges for APPs to order chemotherapy independently according to the attending physician determined treatment plan; coediting the Stanford Oncology Handbook; giving educational presentations at local and national scientific meetings; and creating the annual conference held at Stanford called “Topics in Acute and Ambulatory Care for APPs.”

Has the award changed your life?

LZ: It is one of the biggest honors of my professional career to be recognized by my peers. I am grateful for the opportunities that have been available to me at Stanford, working with such dedicated, compassionate, and accomplished colleagues.

What are your professional goals for the future?

LZ: My main professional focus is the mentoring of new APPs and nurse practitioner students. I have been a volunteer clinical professor at University of California San Francisco School of Nursing since 2003 (Stanford doesn’t have a school of nursing), and I precept students in the clinical setting and present a hematology lecture every year.

I am also excited about another project at SHC. Stanford is in the process of designing a cancer hospital that will optimize the patient experience, and I am part of the core team that is involved in this initiative. Right now we are in the design phase, and we expect the cancer hospital to open by 2022. n

Investigational Drug for Cachexia Appears to Improve Survival Continued from page 3

binding to,” Stecher hypothesized regarding platelet reduction, “or it may be through a reduction in IL-6, which we had seen in previous trials.”

While the reasons behind its success continue to be explored, the most important outcome of the drug could not be denied—the trend toward improved survival between the 2 arms. “In the Xilonix group,” iterated Stecher, “we had a

www.TheOncologyNurse.com

median survival of 2.8 months versus 2 months’ survival in the megestrol arm.

That didn’t reach significance—it was .17—but it’s a very good trend.”

The study enrolled 40 patients between March 2013 and July 2014, at which time it was halted to revise inclusion criteria to reduce screen failures. Investigators are currently using an amended phase 3 protocol to simplify enrollment

for an ongoing study of MABp1 in an advanced CRC population.

“It was a difficult trial to accrue because of the cachexic component,” said Stecher. “Finding colorectal cancer patients who had lost 5% of their total body weight in 6 months was challenging, so we decided to change the criteria.

We’ve changed the protocol to be a traditional third-line protocol, double-blind

placebo-controlled…so the population is going to be totally different. They’re not going to have weight loss.” n

Reference

Fisher GA. A phase III study of Xilonix in refractory colorectal cancer patients with weight loss. J Clin Oncol (ASCO Annual Meeting Abstracts). 2015;33(suppl 3):Abstract 685. Poster presented at: 2015 Gastrointestinal Cancers Symposium; January 15-17, 2015; San Francisco, CA. http://meetinglibrary.asco.org/content/ 140631-158. Accessed January 27, 2015.

MARCH 2015 I VOL 8, NO 2

7

BEST PRACTICES

Cancer Prehabilitation: Important Lessons From a Best Practices Model Continued from the cover

Julie Silver, MD

transplant and noticed that my hemoglobin and red blood cells had dropped 47% from my normal health to their lowest values two weeks after my transplant. I then checked what altitude a 50% drop in oxygen would correspond to. A 50% drop in oxygen represents an altitude of over 19,000 feet. Mt. Everest south base camp is 16,700 feet.” The survivor continued, “It would be irresponsible to send someone to Mt. Everest base camp without training them first, but it is common practice in oncology to physically challenge patients in a similar manner without training them for the difficulty to come. Instead, we nurse patients through the treatment challenge, cheer them when they are finished, then send them off to physical therapy to address injuries.” Then, in bold and italics for emphasis, he admonished, “This is not a success story, this is poor survivorship planning.”

Lillie D. Shockney, RN, BS, MAS, a University Distinguished Service associate professor of breast cancer at Johns Hopkins University School of Medicine and director of the Johns Hopkins Cancer Survivorship Program, is a big proponent of evidence-based prehabilitation care. Lillie, who is also the program director and cofounder of the Academy of Oncology Nurse & Patient Navigators (AONN+), says, “We need to focus on survivorship care beginning at the time of diagnosis. Our institution embraced this concept some time ago. It works. Patients value it. The oncology specialists have seen its benefit to their patients. Survivorship care needs to begin at the moment of diagnosis. Prehab is part of that process of implementing survivorship care early on.”

Important Lessons From a Best Practices Prehabilitation Model

In 2013, my colleague and I published the first-ever review on cancer

8

MARCH 2015 I VOL 8, NO 2

prehabilitation.3 In this journal article, we highlighted the growing body of research in the field that supports making changes in clinical care delivery, now.

At the editor’s request, we included a list of the search terms we used because, unfortunately, “prehab” and “prehabilitation” are the least likely terms to be found in the scientific literature. Terms such as “prophylactic cancer rehabilitation” or “preoperative cancer rehabilitation” are much more common. Consequently, it’s easy to underestimate the evidence base.

About a year or so before the cancer prehabilitation review article was published, I led the launch of STAR Program Prehab in the United States—a best practices model that translates the current evidence base into protocols that hospitals and cancer centers can implement. As the evidence base grows, the ability to provide more guidance increases. STAR Program Prehab is a multimodal model that involves 5 key components of prehabilitation care, including general and targeted exercise, nutrition, stress reduction, and smoking cessation (Figure 1).

In the past year, we’ve seen exponential growth in implementation that is probably due to multiple factors, including recently released research studies

and reviews, clinicians becoming more familiar with the concept of prehabilitation, and patients wanting these services. Over the past 3 years, we’ve learned a lot about what works and what doesn’t, to anticipate the barriers and effectively overcome them. Listed next are some of the most important lessons gleaned from implementing cancer prehabilitation services.

Lesson #1: Take the time to define cancer prehabilitation for your entire team.

One of the key lessons we’ve learned is that a lot of healthcare professionals believe they are already delivering cancer prehabilitation services, when what they are offering is “usual care” preoperative preparations or “usual care with education” (Figure 2). Prehabilitation is defined as “[A] process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment and includes physical and psychological assessments that establish a baseline functional level, identify impairments, and provide interventions that promote physical and psychological health to reduce the incidence and/or severity of future impairments.” 4 By definition, prehabilitation is time

Figure 1 STAR Program Prehabilitation Model of Care

Stress reduction

Nutrition

General exercise

Smoking cessation

Targeted exercise

Survivor

Acute cancer treatment

The STAR Program utilizes a multimodal prehabilitation model that includes 5 distinct components in the protocols.

Reproduced from the STAR Program and used with permission from McKesson Corporation and/or one of its subsidiaries. Copyright © 2015. All Rights Reserved.

based, and requires documented assessments and interventions that demonstrate specific outcomes. Therefore, it is data driven. It is imperative that the entire healthcare team understands the definition or there will be people who believe that prehab is “whatever is done prior to surgery or the start of other cancer treatments.” This inaccurate and overly simplistic view of cancer prehabilitation—which is medical treatment—results in poor implementation and suboptimal patient outcomes.

Lesson #2: Engage an oncology physician champion.

Ron Ponchak, PT, MBA, is the director of rehabilitation at Lahey Hospital and Medical Center in Massachusetts. Ron knows firsthand that an engaged oncology physician can make all the difference. He advises, “You need a champion and a few key people who are really engaged, and those people are the drivers of your program.” At Lahey, Ron works closely with Andrea McKee, MD, a radiation oncologist specializing in lung cancer. Dr McKee says, “Prehab is part of patient-centered care. One of the first things patients ask me during our initial visit together is, ‘What can I do to help myself?’ Patients already intuitively understand that prehab will benefit them. It has taken the medical community a little bit longer to catch on. [At Lahey] our team is very excited to offer pulmonary prehab. Everyone is completely engaged and eager to work together for the benefit of our thoracic oncology patients.”

Lesson #3: Arm your champions with the information they need to convey to colleagues how to overcome the 2 biggest barriers: time and money.

With regard to time, there are 2 approaches—one is to avoid delays in starting cancer treatment and the other is to accept delays if they can be justified by the benefit-versus-risk assessment.

This is something that individual oncologists must decide on a case-by-case basis. For example, in some patients with lung cancer who have comorbidities, surgery to resect the cancer may carry considerable risk. Dr Timothy Sherwood, a thoracic surgeon at Mary Washington Healthcare in Virginia, says he is not overly concerned about delays and sends all of his “mid-risk” and “high-risk” patients with lung cancer to prehab for 4 to 8 weeks. He explains that there are already built-in www.TheOncologyNurse.com

BEST PRACTICES before or the week they started radiation.” To do this, Matt recognized that the speech therapist needed to be embedded in the radiation department. He reports that the start of speech therapy changed from 57 days to −6 days— meaning that, on average, patients now see the speech therapist 6 days prior to the start of radiation treatment rather than 57 days after treatment has started (Figure 3). Matt knew that to get the oncologists on board, he needed to show them data. He says, “Once we set

the goal, it’s been much better.”

The second commonly stated barrier that your champions will need to address with colleagues is money. Usually this takes one of two forms—either that prehabilitation won’t be covered by third-party payers or that patients will incur additional co-pays that become a financial burden to them. Co-pays and other expenses for prehabilitation can usually be justified when one considers the often overwhelming financial difficulties of patients who, after treatment,

High

Figure 2 Cancer Prehabilitation Versus Usual Care and Education

Quality of Cancer Care

Usual Care + Prehabilitation Assessments & Interventions

Usual Care + Education

Usual Care • No baseline established • No specific interventions to improve physical & psychological health prior to acute cancer treatment

Low

delays with staging and that, regardless, he wants his patients to safely get through the surgery. He says, “I would rather have them get through surgery safely than have a horrific postoperative outcome.”

Delays may be due to the need for further diagnostic testing or to patients getting second or even third opinions.

Sharon Gentry, RN, MSN, a breast nurse navigator at Novant Health Derrick L. Davis Cancer Center in North Carolina, says, “There is usually a ‘hurry up and wait’ time as oncology patients undergo biopsies and scans to establish the stage of their disease prior to treatment planning. This is a perfect time to engage the patient, physically and emotionally, to become active against their disease.” Dr McKee at Lahey concurs: “I am not concerned that treatment will be delayed by prehab. The program is designed to gently encourage and build the reserve of our patients prior to surgery or treatment, not run them into the ground.”

Dr Sherwood and his team have shown not only that they are able to get their patients safely through surgery, but that some of the survivors are actually healthier after cancer treatment than they were at diagnosis.5 Beth Ann Palmento is one of Dr Sherwood’s former patients who had this experience. When her lung cancer was diagnosed at age 74 years in February 2013, she was offered the choice of either palliative radiation therapy or lung cancer prehabilitation followed by surgical resection to potentially cure her disease. Beth Ann wanted to have surgery. “I knew the radiation option meant I wouldn’t have a very long life. When Dr Sherwood delayed the surgery, I understood he had a reason for doing it. He told me in the beginning that I wasn’t ready for surgery.”

After several weeks of prehabilitation, Beth Ann went into surgery with more confidence than she would have had without it. “I think it helped a lot. After my surgery, my husband had to slow me down, because I felt so good.”

Of course, delays aren’t always appropriate or even necessary. Matt LeBlanc, RN, BSN, is an oncology rehabilitation nurse navigator at Anne Arundel Medical Center in Maryland. He heard from colleagues, “We don’t have time for patients to do prehabilitation, because we are doing such a great job and getting them into acute cancer treatment right away.” Matt calculated the time from diagnosis for head and neck cancer patients to see a speech-language pathologist: 57 days. He knew that starting targeted swallowing exercises and offering other prehabilitation interventions would likely improve patients’ outcomes.6 Matt says, “We set a goal that all head and neck patients would see the speech therapist either the week

Low

• No baseline established • Specific interventions to improve physical & psychological health prior to acute cancer treatment are variable with poor control and no baseline to compare results

• Baseline established with physical & psychological assessments • Specific interventions employed to improve physical & psychological health above baseline prior to acute cancer treatment

Ability to Assess & Potentially Improve Physical & Psychological Outcomes

High

Reproduced from the STAR Program and used with permission from McKesson Corporation and/or one of its subsidiaries. Copyright © 2015. All Rights Reserved.

Figure 3 Prehabilitation Improves the Time Frame to Begin Speech Therapy

Speech therapy consult -­Usual Care Speech therapy consult -­Prehabilitation

Average difference in time to speech therapy consult = 63 days

Days

-­‐6 0

57 Radiation treatment beings

At Anne Arundel Medical Center, embedding a speech-language pathologist in the radiation department significantly improved the time for an initial consultation.

Reproduced from the STAR Program and used with permission from McKesson Corporation and/or one of its subsidiaries. Copyright © 2015. All Rights Reserved.

develop significant physical impairments requiring many rehabilitation visits, lost time from work, and sometimes permanent disability. It is less expensive for the patient and society to prevent or reduce physical impairments from the start.

With regard to third-party payer coverage, a lot of confusion exists among healthcare professionals, because there is no “prehabilitation” reimbursement code. As with all medical care, the delivery of these services, as well as the coding and billing with appropriate documentation, is essential for reimbursement. Lori McKitrick, MA, CCC/ SLP, MBA, the senior director of program management for the STAR Program, says, “We are working with our programs to implement a multimodal and interdisciplinary reimbursable model for cancer prehabilitation. To date, the majority of services have been covered, as long as there is proper documentation and coding.”

Lesson #4: Include Nurses and Rehabilitation Professionals on the Prehabilitation Team

Nurses are a critical part of offering successful cancer prehabilitation services.7 The STAR Program actively engages oncology nurses.8 Lori Mc­ Kitrick explains, “The STAR Program sees all patient care as interdisciplinary.

The nurse and/or navigator is a key driver in the patient’s course of treatment.” Lillie Shockney agrees: “As more and more people become diagnosed with cancer and fewer oncology specialists exist to take care of them, the role of nurses, nurse navigators, and other healthcare professionals will increase. We need to make sure rehab medicine specialists are part of that healthcare team.”

Although the STAR Program has begun to implement best practices prehabilitation protocols, there is still much work to be done. Messina Corder, RN, BSN, MBA, is the manager of the Mary Washington Healthcare Regional Cancer Center administration department. Despite their early success with physical outcomes and a downward trend for hospital length of stay in their prehabilitation patients with lung cancer, she says, “Prehab is underutilized in general and in our institution. It has taken our STAR Program’s continued physician education, networking, and evidence of positive patient outcomes to build a network of trust and understanding about prehab.” Sharon Gentry believes that prehabilitation services will become the standard of care and says, “Think of prehab as a phase in population management—a way to make the patient remain an active member of society and possibly a stronger, healthier member.” n Continued on page 14

www.TheOncologyNurse.com

MARCH 2015 I VOL 8, NO 2

9

For patients with bone metastases from solid tumors

Prevent bone complications longer In a prespecified integrated analysis of 3 pivotal trials (N = 5,723),

8.2

XGEVA® was proven to delay the median time to first bone complication by

months longer vs zoledronic acid1

XGEVA® is a convenient 120 mg subcutaneous injection administered once every 4 weeks.2

Bone complications, or skeletal-related events (SREs), are defined as radiation to bone, pathologic fracture, surgery to bone, and spinal cord compression.2,3 Median Time to First Bone Complication1 27.7

months

Data from a prespecified integrated analysis of three international, phase 3, double-blind, double-dummy, active-controlled trials comparing XGEVA® with zoledronic acid for the prevention of bone complications in patients with bone metastases from solid tumors or multiple myeloma.1

XGEVA VA® 120 mg Q4W (n = 2,862) VA

19.5

months

zoledronic acid 4 mg Q4W (n = 2,861) 1 YEAR

HR* = 0.83 (95% CI: 0.76-0.90)

2 YEARS

P < 0.001

†

IMPORTANT SAFETY INFORMATION Hypocalcemia • Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when XGEVA® is administered with other drugs that can also lower calcium levels. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

• An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation.

Monitor calcium levels and calcium and vitamin D intake.

Hypersensitivity • XGEVA® is contraindicated in patients with known clinically significant hypersensitivity to XGEVA®, including anaphylaxis that has been reported with use of XGEVA®.

Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue XGEVA® therapy permanently.

*Hazard ratio (HR) is defined as the increase or decrease in likelihood of an event of interest (in this case a bone complication) for one group relative to that in a comparator group.

P value for superiority.

†

Drug Products with Same Active Ingredient • Patients receiving XGEVA® should not take Prolia® (denosumab).

Osteonecrosis of the Jaw • Osteonecrosis of the jaw (ONJ) can occur in patients receiving XGEVA®, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with osseous metastasis, the incidence of ONJ was higher with longer duration of exposure.

• Perform an oral examination and appropriate preventive dentistry prior to the initiation of XGEVA® and periodically during XGEVA® therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with XGEVA®.

• Patients who are suspected of having or who develop ONJ while on XGEVA® should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture • Atypical femoral fracture has been reported with XGEVA®.

These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

XGEVA® is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

XGEVA® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

• RANK Ligand (RANKL) is produced by bone cells in the skeleton and is a key mediator of bone resorption4 • RANKL production is increased at sites of bone metastases, and stimulates osteoclasts to destroy bone4 • XGEVA® acts precisely to bind RANKL and inhibits osteoclast formation, function, and survival2 • Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA®2

Learn more at XGEVA.com

• Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of XGEVA® therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Embryo-Fetal Toxicity • XGEVA® can cause fetal harm when administered to a pregnant woman. Based on findings in animals, XGEVA® is expected to result in adverse reproductive effects.

©2014 Amgen Inc. All rights reserved. 04/14 80218-R1-V1

• Advise females of reproductive potential to use highly effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®. Apprise the patient of the potential hazard to a fetus if XGEVA® is used during pregnancy or if the patient becomes pregnant while patients are exposed to XGEVA®.

Adverse Reactions • The most common adverse reactions in patients receiving XGEVA® with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia.

Please see brief summary of Prescribing Information on the following page.

REFERENCES: 1. Lipton A, Fizazi K, Stopeck AT, et al. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials.

Eur J Cancer. 2012;48:3082-3092. 2. XGEVA® (denosumab) prescribing information, Amgen. 3. Brodowicz T, O’Byrne K, Manegold C. Bone matters in lung cancer. Ann Oncol. 2012;23:2215-2222. 4. Roodman GD. Mechanisms of bone metastasis. N Engl J Med. 2004;350:1655-1664.

www.XGEVA.com

S:9.5”

Brief Summary: Consult package insert for complete Prescribing Information

Body System GASTROINTESTINAL Nausea Diarrhea GENERAL Fatigue/ Asthenia IN VESTIGATIONS Hypocalcemiab Hypophosphatemiab NEUROLOGICAL Headache RESPIRATORY Dyspnea Cough

Xgeva n = 2841 %

Zoledronic Acid n = 2836 %

31 20

32 19

45

46

18 32

9 20

13

14

21 15

18 15

Adverse reactions reported in at least 10% of patients receiving Xgeva in Trials 1, 2, and 3, and meeting one of the following criteria: • At least 1% greater incidence in Xgeva-treated patients, or • Between-group difference (either direction) of less than 1% and more than 5% greater incidence in patients treated with zoledronic acid compared to placebo (US Prescribing Information for zoledronic acid) b Laboratory-derived and below the central laboratory lower limit of normal [8.3 – 8.5 mg/dL (2.075 – 2.125 mmol/L) for calcium and 2.2 – 2.8 mg/dL (0.71 – 0.9 mmol/L) for phosphorus] Severe Mineral/Electrolyte Abnormalities • Severe hypocalcemia (corrected serum calcium less than 7 mg/dL or less than 1.75 mmol/L) occurred in 3.1% of patients treated with Xgeva and 1.3% of patients treated with zoledronic acid. Of patients who experienced severe hypocalcemia, 33% experienced 2 or more episodes of severe hypocalcemia and 16% experienced 3 or more episodes.

• Severe hypophosphatemia (serum phosphorus less than 2 mg/dL or less than 0.6 mmol/L) occurred in 15.4% of patients treated with Xgeva and 7.4% of patients treated with zoledronic acid.

Osteonecrosis of the Jaw In the primary treatment phases of Trials 1, 2, and 3, ONJ was confirmed in 1.8% of patients in the Xgeva group (median exposure of 12.0 months; range 0.1 – 40.5) and 1.3% of patients in the zoledronic acid group. The trials in patients with breast (Trial 1) or prostate (Trial 3) cancer included an Xgeva open label extension treatment phase where patients were offered Xgeva 120 mg once every 4 weeks (median overall exposure of 14.9 months; range 0.1 – 67.2). The patient-year adjusted incidence of confirmed ONJ was 1.1% during the first year of treatment and 4.1% thereafter. The median time to ONJ was 20.6 months (range: 4 – 53).

Atypical Subtrochanteric and Diaphyseal Fracture Atypical femoral fracture has been reported with Xgeva.

Postmarketing Experience. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post approval use of Xgeva: • Hypocalcemia: Severe symptomatic hypocalcemia, including fatal cases.

• Hypersensitivity, including anaphylactic reactions.

• Musculoskeletal pain, including severe musculoskeletal pain. Positive rechallenge has been reported.

Immunogenicity. As with all therapeutic proteins, there is potential for immunogenicity. Using an electrochemiluminescent bridging immunoassay, less than 1% (7/2758) of patients with osseous metastases treated with denosumab doses ranging from 30 – 180 mg every 4 weeks or every 12 weeks for up to 3 years tested positive for binding antibodies. No patient with positive binding antibodies tested positive for neutralizing antibodies as assessed using a chemiluminescent cell-based in vitro biological assay. There was no evidence of altered pharmacokinetic profile, toxicity profile, or clinical response associated with binding antibody development. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody (including neutralizing antibody) test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies to denosumab with the incidence of antibodies to other products may be misleading.

DRUG INTERACTIONS: No formal drug-drug interaction trials have been conducted with Xgeva. In clinical trials in patients with breast cancer metastatic to bone, Xgeva was administered in combination with standard anticancer treatment. Serum denosumab concentrations at 1 and 3 months and reductions in the bone turnover marker uNTx/Cr (urinary N-terminal telopeptide corrected for creatinine) at 3 months were similar in patients with and without prior intravenous bisphosphonate therapy.

There was no evidence that various anticancer treatments affected denosumab systemic exposure and pharmacodynamic effect. Serum denosumab concentrations at 1 and 3 months were not altered by concomitant chemotherapy and/or hormone therapy. The median reduction in uNTx/Cr from baseline to month 3 was similar between patients receiving concomitant chemotherapy and/or hormone therapy.

USE IN SPECIFIC POPULATIONS: Pregnancy: Category D. Risk Summary: Xgeva can cause fetal harm when administered to a pregnant woman based on findings in animals. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth. There are no adequate and well-controlled studies with Xgeva in pregnant women. Women should be advised not to become pregnant when taking Xgeva. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women who become pregnant during Xgeva treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Clinical Considerations: The effects of Xgeva are likely to be greater during the second and third trimesters of pregnancy. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. If the patient becomes pregnant during Xgeva therapy, consider the risks and benefits in continuing or discontinuing treatment with Xgeva. a

Animal Data: The effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which RANK ligand (RANKL) expression was turned off by gene removal (a “knockout mouse”).

In cynomolgus monkeys dosed subcutaneously with denosumab throughout pregnancy at a pharmacologically active dose, there was increased fetal loss during gestation, stillbirths, and postnatal mortality. Other findings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia and tooth malalignment; and decreased neonatal growth. At birth out to one month of age, infants had measurable blood levels of denosumab (22-621% of maternal levels). Following a recovery period from birth out to 6 months of age, the effects on bone quality and strength returned to normal; there were no adverse effects on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes were present, though small; and minimal to moderate mineralization in multiple tissues was seen in one recovery animal. There was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor.

Maternal mammary gland development was normal. There was no fetal NOAEL (no observable adverse effect level) established for this study because only one dose of 50 mg/kg was evaluated. In RANKL knockout mice, absence of RANKL (the target of denosumab) also caused fetal lymph node agenesis and led to postnatal impairment of dentition and bone growth. Pregnant RANKL knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation.

Nursing Mothers. It is not known whether Xgeva is excreted into human milk.

Measurable concentrations of denosumab were present in the maternal milk of cynomolgus monkeys up to 1 month after the last dose of denosumab (≤ 0.5% milk:serum ratio). Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Xgeva, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Maternal exposure to Xgeva during pregnancy may impair mammary gland development and lactation based on animal studies in pregnant mice lacking the RANK/RANKL signaling pathway that have shown altered maturation of the maternal mammary gland, leading to impaired lactation postpartum. However, in cynomolgus monkeys treated with denosumab throughout pregnancy, maternal mammary gland development was normal, with no impaired lactation. Mammary gland histopathology at 6 months of age was normal in female offspring exposed to denosumab in utero; however, development and lactation have not been fully evaluated.

Pediatric Use. Xgeva is not recommended in pediatric patients. The safety and effectiveness of Xgeva in pediatric patients have not been established. Treatment with Xgeva may impair bone growth in children with open growth plates and may inhibit eruption of dentition. In neonatal rats, inhibition of RANKL (the target of Xgeva therapy) with a construct of osteoprotegerin bound to Fc (OPG-Fc) at doses ≤ 10 mg/kg was associated with inhibition of bone growth and tooth eruption.

Adolescent primates treated with denosumab at doses 5 and 25 times (10 and 50 mg/kg dose) higher than the recommended human dose of 120 mg administered once every 4 weeks, based on body weight (mg/kg), had abnormal growth plates, considered to be consistent with the pharmacological activity of denosumab.

Cynomolgus monkeys exposed in utero to denosumab exhibited bone abnormalities, reduced hematopoiesis, tooth malalignment, decreased neonatal growth, and an absence of axillary, inguinal, mandibular, and mesenteric lymph nodes. Some bone abnormalities recovered once exposure was ceased following birth; however, axillary and inguinal lymph nodes remained absent 6 months post-birth.

Geriatric Use. Of patients who received Xgeva in Trials 1, 2, and 3, 1260 (44%) were 65 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients.

Renal Impairment. Two clinical trials were conducted in patients without cancer and with varying degrees of renal function. In one study, patients (N=55) with varying degrees of renal function (ranging from normal through end-stage renal disease requiring dialysis) received a single 60 mg subcutaneous dose of denosumab. In a second study, patients (N=32) with severe renal dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis) were given two 120 mg subcutaneous doses of denosumab. In both studies, greater risk of developing hypocalcemia was observed with increasing renal impairment, and with inadequate/no calcium supplementation. Hypocalcemia was mild to moderate in severity in 96% of patients.

Monitor calcium levels and, calcium and vitamin D intake.

Females and Males of Reproductive Potential. Contraception Females: Counsel patients on pregnancy planning and prevention. Advise females of reproductive potential to use highly effective contraception during therapy, and for at least 5 months after the last dose of Xgeva. Advise patients to contact their healthcare provider if they become pregnant, or a pregnancy is suspected, during treatment or within 5 months after the last dose of Xgeva. Males: The extent to which denosumab is present in seminal fluid is unknown. There is potential for fetal exposure to denosumab when a male treated with Xgeva has unprotected sexual intercourse with a pregnant partner. Advise males of this potential risk.

OVERDOSAGE: There is no experience with overdosage of Xgeva.

HOW SUPPLIED/STORAGE AND HANDLING: Xgeva is supplied in a singleuse vial. Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 14 days. Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label. Protect Xgeva from direct light and heat. Avoid vigorous shaking of Xgeva.

PATIENT COUNSELING INFORMATION: Advise patients to contact a healthcare professional for any of the following: • Symptoms of a hypersensitivity reaction, including rash, urticaria, pruritus, lip swelling, shortness of breath, hypotension and respiratory tract edema • Symptoms of hypocalcemia, including paresthesias or muscle stiffness, twitching, spasms, or cramps • Symptoms of ONJ, including pain, numbness, swelling of or drainage from the jaw, mouth, or teeth • Persistent pain or slow healing of the mouth or jaw after dental surgery • Symptoms of atypical femoral fracture, including new or unusual thigh, hip, or groin pain • Pregnancy or nursing Advise patients of the need for: • Avoiding therapy with Xgeva if a serious allergic reaction occurred with prior Xgeva or Prolia therapy • Proper oral hygiene and routine dental care • Informing their dentist that they are receiving Xgeva • Avoiding invasive dental procedures during treatment with Xgeva • The use of highly effective contraception during and for at least 5 months after treatment with Xgeva for females of reproductive potential Advise patients that denosumab is also marketed as Prolia®. Patients should inform their healthcare provider if they are taking Prolia.

Amgen Manufacturing Limited, a subsidiary of Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 ©2010-2014 Amgen Inc. All rights reserved.

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INDICATIONS AND USAGE: Bone Metastasis from Solid Tumors. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Important Limitation of Use. Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

DOSAGE AND ADMINISTRATION: Recommended Dosage. The recommended dose of Xgeva is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.

Preparation and Administration. Visually inspect Xgeva for particulate matter and discoloration prior to administration. Xgeva is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter. Prior to administration, Xgeva may be removed from the refrigerator and brought to room temperature (up to 25°C/77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Xgeva in any other way. Use a 27-gauge needle to withdraw and inject the entire contents of the vial. Do not re-enter the vial. Discard vial after single-use or entry.

CONTRAINDICATIONS: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Xgeva.

Hypersensitivity. Xgeva is contraindicated in patients with known clinically significant hypersensitivity to Xgeva.

WARNINGS AND PRECAUTIONS: Drug Products with Same Active Ingredient. Xgeva includes the same active ingredient (denosumab) found in Prolia. Patients receiving Xgeva should not take Prolia.

Hypersensitivity. Clinically significant hypersensitivity including anaphylaxis has been reported with use of Xgeva. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue Xgeva therapy permanently.

Hypocalcemia. Xgeva can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct pre-existing hypocalcemia prior to Xgeva treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when Xgeva is administered with other drugs that can also lower calcium levels. In the postmarketing setting, severe symptomatic hypocalcemia has been reported. Advise patients to contact a healthcare professional for symptoms of hypocalcemia. An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

Osteonecrosis of the Jaw. Osteonecrosis of the jaw (ONJ) can occur in patients receiving Xgeva, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion.

Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials, in patients with osseous metastasis, the incidence of ONJ was higher with longer duration of exposure (see Adverse Reactions). Seventy-nine percent of patients with ONJ had a history of tooth extraction, poor oral hygiene, or use of a dental appliance as a predisposing factor. Perform an oral examination and appropriate preventive dentistry prior to the initiation of Xgeva and periodically during Xgeva therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with Xgeva. Patients who are suspected of having or who develop ONJ while on Xgeva should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture. Atypical femoral fracture has been reported with Xgeva. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During Xgeva treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of Xgeva therapy should be considered, pending a risk/benefit assessment, on an individual basis.

EMBRYO-FETAL TOXICITY: Xgeva can cause fetal harm when administered to a pregnant woman. Based on findings in animals, Xgeva is expected to result in adverse reproductive effects. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent peripheral lymph nodes, abnormal bone growth, and decreased neonatal growth (see Use in Specific Populations). Advise females of reproductive potential to use highly effective contraception during therapy, and for at least 5 months after with the last dose of Xgeva. Apprise the patient of the potential hazard to a fetus if Xgeva is used during pregnancy or if the patient becomes pregnant while patients are exposed to Xgeva. Advise patients to contact their healthcare provider if they become pregnant or a pregnancy is suspected during this time.

ADVERSE REACTIONS: The following adverse reactions are discussed below and elsewhere in the labeling: • Hypocalcemia • Osteonecrosis of the Jaw The most common adverse reactions in patients receiving Xgeva (per-patient incidence greater than or equal to 25%) were fatigue/asthenia, hypophosphatemia, and nausea (see Table 1). The most common serious adverse reaction in patients receiving Xgeva was dyspnea. The most common adverse reactions resulting in discontinuation of Xgeva were osteonecrosis and hypocalcemia.

Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. The safety of Xgeva was evaluated in three randomized, double-blind, double-dummy trials in which a total of 2841 patients with bone metastasis from prostate cancer, breast cancer, or other solid tumors, or lytic bony lesions from multiple myeloma received at least one dose of Xgeva. In Trials 1, 2, and 3, patients were randomized to receive either 120 mg of Xgeva every 4 weeks as a subcutaneous injection or 4 mg (dose adjusted for reduced renal function) of zoledronic acid every 4 weeks by intravenous (IV) infusion. Entry criteria included serum calcium (corrected) from 8 to 11.5 mg/dL (2 to 2.9 mmol/L) and creatinine clearance 30 mL/min or greater. Patients who had received IV bisphosphonates were excluded, as were patients with prior history of ONJ or osteomyelitis of the

jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/ oral surgery, or any planned invasive dental procedure. During the study, serum chemistries including calcium and phosphorus were monitored every 4 weeks.

Calcium and vitamin D supplementation was recommended but not required. The median duration of exposure to Xgeva was 12 months (range: 0.1 – 41) and median duration on-study was 13 months (range: 0.1 – 41). Of patients who received Xgeva, 46% were female. Eighty-five percent were White, 5% Hispanic/Latino, 6% Asian, and 3% Black. The median age was 63 years (range: 18 – 93). Seventy-five percent of patients who received Xgeva received concomitant chemotherapy.

Table 1. Per-patient Incidence of Selecteda Adverse Reactions of Any Severity (Trials 1, 2, and 3)

CONFERENCE NEWS

Highlights From the World Cutaneous Malignancies Congress point for OS in a meta-analysis of 12 adjuvant trials in patients with resectable melanoma.2 Ulceration and stage are predictive of interferon efficacy in melanoma, such that “only patients with ulceration and microscopic [N1] disease are profiting from pegylated interferon alfa-2b,” said Dummer, vice chairman, Department of Dermatology, University Hospital Zürich, Switzerland. Two years of treatment with interferon in the adjuvant setting is warranted, he said.

For high-risk melanoma patients with macrometastases (N1b disease and higher), interferon has a minor impact, but adjuvant ipilimumab after surgery offers an improvement in recurrence-free survival, said Dummer. Specifically, in the EORTC 18071 trial, 3-year recurrence-free survival rates were 46.5% in patients randomized to ipilimumab (10 mg/kg every 3 weeks for 4 doses) versus 34.8% in a placebo group—a 25% relative reduction in risk with ipilimumab. Median recurrence-free survival was 26.1 months in the ipilimumab group and 17.1 months in the placebo group (P=.0013). The impact on recurrence-free survival with ipilimumab was observed in patients with microscopic metastases (33% risk reduction) and with macroscopic metastases (17% risk reduction). About half of the patients discontinued ipilimumab because of side effects, most within the first 16 weeks.

Basal Cell Carcinoma

In the treatment of advanced BCC, the hedgehog pathway is already being targeted with the smoothened inhibitor vismodegib, said Aleksandar Sekulic, MD, PhD, associate professor of dermatology at the Mayo Clinic campus in Scottsdale, Arizona.3 “There are several points in the hedgehog pathway where one can potentially intervene,” he said.

Smoothened is a G-protein–coupled receptor protein encoded by the SMO gene of the hedgehog pathway. Other potential targets in the pathway are at the level of hedgehog binding to patched or downstream of smoothened at the level of the Gli protein. In addition to vismodegib, smoothened inhibitors in development are sonidegib (phase 2), LEQ506 (phase 1), BMS833823 (phase 1/2), TAK-441 (phase 1), IPI-926 (phase 1/2), and PF04449913 (phase 1).

Vismodegib was associated with overall response rates of 30% in metastatic BCC and 43% in locally advanced BCC in the pivotal phase 2 trial.4 Responses with sonidegib in a phase 2 trial were comparable. In Gorlin syndrome, vismodegib significantly reduced the

diameter of existing BCCs, and the number of new BCCs compared with placebo.5 An open-label trial of neoadjuvant vismodegib followed by Mohs surgery was associated with a 31% decrease in the anticipated surgical defect among patients who completed 3 months of treatment; results from a phase 2 placebo-controlled trial are pending. Vismodegib plus radiation therapy is being studied in a phase 2 trial of patients with locally advanced BCC.

In the treatment of advanced BCC, the hedgehog pathway is already being targeted with the smoothened inhibitor vismodegib.

Cutaneous T-Cell Lymphoma

Brentuximab vedotin is a chimeric anti-CD30 monoclonal antibody linked to monomethyl auristatin E, a synthetic antitubulin agent, that is being studied in CD30-positive CTCL. Response rates in the range of 70% were obtained with brentuximab vedotin across the spectrum of baseline CD30 expression in patients with mycosis fungoides (MF) or Sézary syndrome (SS) stage IB to IVB, said Steven Horwitz, MD.6 Lower disease stage predicted better response in this study.

Median CD30max was higher in responders to brentuximab vedotin compared with nonresponders (15.5% vs 3.0%; P=.037), and those with CD30 expression <5% were less likely to respond than those with CD30 expression ≥5% (P<.005).

The CCR4 receptor, present in all stages of CTCL, is another target, said Horwitz, associate attending physician, Memorial Sloan Kettering Cancer Center, New York City. KW-0761 (mogamulizumab) is a monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity compared with conventional antibodies. A phase 1/2 study in patients with previously treated CTCL, including MF and SS, showed good tolerability and an overall response rate of 42%. A phase 3 study is comparing progression-free survival in patients randomized to KW-0761 or vorinostat in patients with relapsed/refractory CTCL. IPI-145 is a potent oral inhibitor of both the PI3K-δ and PI3K-γ isoforms that inhibits malignant B- and T-cell survival. Early evidence suggests single agent activity of IPI-145 in CTCL and

peripheral T-cell lymphoma.7 The anti–PD-L1 monoclonal antibody MPDL3280A targets PD-L1 on antigen-presenting cells or tumor cells and prevents interaction with PD-1 on T cells; it has shown encouraging clinical activity in MF/CTCL. A phase 2 study with the anti–PD-1 monoclonal antibody MK-3745 in CTCL (MF/SS) is opening, said Horwitz.

Histone deacetylase (HDAC) has a role in modulating cellular pathways such as proliferation, apoptosis, migration, and differentiation. Adverse effects limit the use of systemic HDAC inhibitors. SHP-141 is a topically applied HDAC inhibitor that inhibits isoforms 1, 2, 3, and 6. “It is a soft drug that is active in skin and breaks down to inactive metabolites,” he said. In a phase 1b study in early-stage CTCL, SHP-141 applied to index lesions produced a clinical objective response (>50% improvement by the composite assessment of index lesion severity score) in 28%.8

Merkel Cell Carcinoma

Cytotoxic chemotherapy works well early in MCC, but the response is shortlived. MCC may be too aggressive for immunotherapy, but targeted therapies may be Shailender beneficial, said Bhatia, MD Shailender Bhatia, MD.9 Because MCC is a neuroendocrine tumor, there appears to be a role for targeting the somatostatin receptor with a somatostatin analog. A trial of pasireotide in MCC and melanoma is ongoing.

Single-fraction high-grade (8 Gy) radiation therapy has been effective with rapid onset of palliation and minimal toxicity in MCC, said Bhatia, assistant professor of medical oncology, University of Washington, Seattle. Single-fraction high-grade radiation is potentially immunogenic and is convenient for patients who are located far from a radiation facility.

Immune Therapies in Melanoma

In the treatment of advanced melanoma, anti–PD-1 monoclonal antibodies have proven effective as single agents. Pembrolizumab is a humanized high-affinity antibody that exerts dual ligand blockade of PD-1; nivolumab is a fully human monoclonal antibody that is also directed toward PD-1. These anti–PD-1 antibodies represent break-

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throughs in extending survival, said Caroline Robert, MD, PhD.10 They perform similarly in the setting of advanced melanoma, with an objective response rate (ORR) of 32% to 34% and 1-year OS in excess of 60%. “Five years ago, only 25% to 30% of patients were still alive at 1 year,” she said.

In patients with ipilimumab-refractory advanced melanoma, pembrolizumab at 2 or 10 mg/kg was associated with an ORR of 26% and a disease control rate of 50%.

The phase 3 CA209-037 study evaluated nivolumab versus investigator’s choice of chemotherapy (ICC) in 405 patients with advanced melanoma who had progressed despite previous therapies directed against CTLA-4 or BRAF mutation.11 Interim efficacy analysis showed a higher ORR in patients who received nivolumab therapy compared with ICC (32% vs 11%), with 3 complete responses in the nivolumab group. Ninety-five percent in the nivolumab group had ongoing response with a minimum of 24 weeks of follow-up, said Robert, head of dermatology at the Institut Gustave Roussy, Paris. Responses with nivolumab were observed regardless of pretreatment PD-L1 expression status, BRAF mutation status, or prior benefit from anti– CTLA-4 therapy.

The most recent advancement in the treatment of advanced melanoma is combining ipilimumab and nivolumab.

Blocking these pathways represents an immunotherapy strategy that can restore tumor-specific T-cell–mediated immunity. In a phase 1 clinical study, the combination given concurrently was associated with an ORR rate of 40% and survival of 85% at 1 year and 79% at 2 years. Even better 1-year (94%) and 2-year survival (88%) was achieved when they were given sequentially.12 Treatment responses were independent of BRAF mutation status. Almost two-thirds (64%) of patients had grade 3/4 treatment-related adverse events.

Registry Examining Real-World Management of Advanced Basal Cell Carcinoma

The real-world management of advanced BCC is being examined in the RegiSONIC Disease Registry Study, said Jean Y. Tang, MD, PhD.13 The goal of RegiSONIC is to learn how clinicians determine and treat advanced BCC in the real world by evaluating the effectiveness, safety, and use of systemic and local treatments in 3 BCC populations: (1) advanced BCC patients who do not have basal cell nevus syndrome (BCNS) and are naive to treatment with a hedgehog pathway inhibitor; (2) Continued on page 14

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CONFERENCE NEWS

Highlights From the World Cutaneous Malignancies Congress those who were previously enrolled in a trial of the hedgehog pathway inhibitor vismodegib; and (3) patients who have BCNS advanced BCC or who have multiple nonadvanced, hedgehog pathway–naive BCC. “The study represents the largest planned, prospective, observational cohort study of patients with advanced BCC and BCNS,” said Tang, associate professor of dermatology at Stanford University in California. It is attempting to provide real-world data that will inform the medical community and improve the care of patients with advanced BCC. RegiSONIC is a multicenter, prospective, observational cohort study in adult patients with advanced BCC or BCNS and per-protocol follow-up. The determination of advanced BCC is left to the discretion of the study clinician, and treatment, procedures, and clinic visit schedules are left to the clinician’s discretion in accordance with routine practice.

Based on the first 131 locally advanced BCC patients enrolled, locally advanced BCC appears to be determined by using a number of tumor characteristics, including size (74%), extent (61%), and location (62%). Median size of the locally advanced BCC was 20.5 mm at determination, the most frequent location was the nose (19.8%), and the most common histopathology was nodular (58.8%).

The pivotal molecular abnormality in BCC carcinogenesis is inappropriate activation of the hedgehog signaling pathway. “Essentially all BCC tumors have an overactive hedgehog signaling pathway, commonly occurring by mutational inactivation of the tumor suppressor PTCH1 gene,” she said.

Vismodegib is a small-molecule inhibitor of the hedgehog signaling pathway that has been proven effective in the treatment of locally advanced BCC. Significant ORRs with vismodegib are

observed in both locally advanced and metastatic BCCs, and the clinical response to vismodegib in responders frequently occurs in a matter of weeks, said Tang.

Vismodegib appears to be an effective chemopreventive agent for BCC. Tang and colleagues showed prevention of new BCCs in patients with BCNS.14 Other data show that in operable BCC, neoadjuvant vismodegib reduces the surgical defect size by 27% at an average of 4 months of treatment. Patients must be on neoadjuvant treatment for at least 3 months to see this effect, said Tang, and they should be counseled about the significant side effects associated with the drug.

“Essentially all BCC tumors have an overactive hedgehog signaling pathway, commonly occurring by mutational inactivation of the tumor suppressor PTCH1 gene.”

—Jean Y. Tang, MD, PhD Managing Resistance to Hedgehog Inhibitor More than half of patients with advanced BCCs develop resistance to vismodegib. In these patients, the hedgehog pathway becomes reactivated; 50% of resistant BCCs contain mutations in the SMO gene of the hedgehog pathway. Smoothened inhibitors as second-line therapy may be effective when resistance to vismodegib develops, said Tang. Itraconazole reduces hedgehog pathway signaling by 50% in vismodegib-naive tumors, and reduced BCC tumor size by 20% at 1

month of therapy. In the mouse model, “the combination of itraconazole and arsenic trioxide does an even better job of reducing tumor size,” she said. In a small sample of 5 patients, the combination was shown to reduce hedgehog signaling as well.

Immunotherapy Approaches in Merkel Cell Carcinoma

The use of immunotherapy in MCC is rational, given the increased incidence of the disease and the worse prognosis in immunocompromised patients, “suggesting that the immune system is important in controlling the disease,” said Isaac Brownell, MD, PhD.15 In addition, prognosis of MCC is improved with the presence of CD8+ tumor-infiltrating lymphocytes. There are documented cases of spontaneous regression of MCC attributed to an antitumor immune response; responses have been observed with immune-stimulating therapies such as dinitrochlorobenzene, tumor necrosis factor-alpha, and interferon; and 80% of MCC patients express non-self Merkel cell polyomavirus viral antigens. Also, the prognosis of MCC is improved with high titers of MCV VP1.

“Similar observations predicted the immune responsiveness of melanoma,” said Brownell, head, Cutaneous Development and Carcinogenesis Section, Dermatology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.

Active immunotherapy trials for MCC include the following agents: anti–PD-L1, adoptive T cells, interleukin (IL)-12 plasmid in vivo electroporation DNA vaccine, glucopyranosyl lipid adjuvant-stable emulsion, F16-IL2 antibody-cytokine fusion with paclitaxel, and adjuvant ipilimumab for excised MCC. n

References

1. Dummer R. Changing arena of adjuvant therapy in

Continued from page 13 malignant melanoma. Presented at: Third Annual World Cutaneous Malignancies Congress; October 30-31, 2014; San Francisco, CA. 2. Suciu S, Eggermont AM, Lorigan P, et al. relapse-free survival (RFS) as a surrogate endpoint for overall survival (OS) in adjuvant Interferon trials in patients (pts) with resectable Cutaneous melanoma: an individual patient data (IPD) meta-analysis. Presented at: 2014 Congress of the European Society for Medical Oncology; September 26-30, 2014; Madrid, Spain. Abstract 1089PD. 3. Sekulic A. Ongoing clinical studies in BCC. Presented at: Third Annual World Cutaneous Malignancies Congress; October 30-31, 2014; San Francisco, CA. 4. Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171-2179.

5. Tang TY, Mackay-Wiggan JM, Aszterbaum M, et al.

Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med. 2012;366 (23):2180-2188.

6. Horwitz S. New systemic therapies in CTCL: beyond the old paradigms. Presented at: Third Annual World Cutaneous Malignancies Congress; October 30-31, 2014; San Francisco, CA. 7. Horwitz S, Flinn I, Patel MR, et al. Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with relapsed/refractory lymphoma. Presented at: 49th Annual Meeting of the American Society of Clinical Oncology; May 31-June 4, 2013; Chicago, IL. Abstract 8518.

8. Kim YH, Krathen M, Duvic M, et al. A phase 1b study in cutaneous T-cell lymphoma (CTCL) with the novel topically applied skin-restricted histone deacteylase inhibitor (HDAC-i) SHP-141. Presented at: 50th Annual Meeting of the American Society of Clinical Oncology; May 30-June 3, 2014; Chicago, IL. Abstract 8525.

9. Bhatia S. Emerging treatment options in MCC: chemotherapy and alternative approaches for metastatic disease.

Presented at: Third Annual World Cutaneous Malignancies Congress; October 30-31, 2014; San Francisco, CA. 10. Robert C. Anti-PD-1 antibodies ± ipilimumab in melanoma. Presented at: Third Annual World Cutaneous Malignancies Congress; October 30-31, 2014; San Francisco, CA. 11. Weber JS, Minor DR, D’Angelo S, et al. A phase 3 randomized, open-label study of nivolmab (anti-PD-1; BMS-936558; ONO-4538) versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma after prior anti-CTLA-4 therapy. Presented at: 2014 Congress of the European Society for Medical Oncology; September 26-30, 2014; Madrid, Spain. Abstract LBA3_ PR. 12. Kluger H, Sznol M, Callahan M, et al. Survival, response duration, and activity by BRAF mutation (MT) status in a phase 1 trial of nivolumab (anti-PD-1, BMS936558, ONO-4538) and ipilimumab (IPI) concurrent therapy in advanced melanoma (MEL). Presented at: 2014 Congress of the European Society for Medical Oncology; September 26-30, 2014; Madrid, Spain. Abstract 1085O. 13. Tang J. Real-world management of BCC: the RegiSONIC study. Presented at: Third Annual World Cutaneous Malignancies Congress; October 30-31, 2014; San Francisco, CA. 14. Tang JY, Mackay-Wiggan JM, Aszterbaum M, et al.

Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med. 2012;366 (23):2180-2188.

15. Brownell I. Rationale and status of immune targeted therapies for MCC. Presented at: Third Annual World Cutaneous Malignancies Congress; October 30-31, 2014; San Francisco, CA.

Cancer Prehabilitation: Important Lessons From a Best Practices Model Continued from page 9

References

1. Silver JK. Cancer prehabilitation and its role in improving health outcomes and reducing healthcare costs. Semin Oncol Nurs. 2015;31(1):13-30.

2. Workoutcancer.org website. https://workoutcancer. wordpress.com/2014/01/22/regarding-exercise-arewe-doingtoo-­much-in-oncology-backwards-2/. Accessed January 27, 2015.

3. Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options and improve physical and psychological health outcomes. Am J Phys Med Rehab.

2013;92(8):715-727.

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4. Silver JK, Baima J, Mayer RS. Impairment-driven cancer rehabilitation: an essential component of quality care and survivorship. CA Cancer J Clin.

2013;63(5):295-317.

5. Hunt E, VanderWijst K, Stokes B, et al. Prehabilitation improves the physical functioning of a newly diagnosed lung cancer patient before and after surgery to allow for a safe surgical resection and decreased hospital length of stay: a case report. J Oncol Navigation Survivorship. 2014;5(4):­­34-35.

6. Kotz T, Federman AD, Kao J, et al. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized

trial. Arch Otolaryngol Head Neck Surg.

2012;138(4):376-382.

7. Knowlton SE, Silver AJ, Silver JK, et al. Can nurses provide assessments and interventions for prehabilitation? A survey study of cancer rehabilitation service line coordinators. J Oncol Navigation Survivorship.

2014;5(4):44.

8. Silver AJ, Knowlton SE, Silver JK, et al. Cancer rehabilitation service line directors perceive navigators as having high value on multidisciplinary rehabilitation teams and identify 3 key barriers to improving their value. J Oncol Navigation Survivorship.

2014;5(4):43.

Julie Silver, MD, is an associate professor at Harvard Medical School and a founder of Oncology Rehab Partners (www.Oncology RehabPartners.com), which developed the STAR Program, a service-line model for high-quality cancer prehabilitation and rehabilitation care that has been adopted by more than 200 hospitals and cancer centers and is now available at hundreds of sites throughout the United States.

www.TheOncologyNurse.com

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Colorectal Cancer Survivors Frequently Report Bowel Dysfunction Chase Doyle

A

ccording to a recent assessment of bowel dysfunction– related needs, the hardships for colorectal cancer (CRC) survivors continue long after leaving the operating room, and survivors desire more information and strategies to help cope with unexpected changes to their bowel patterns, researchers said at the 2015 Gastrointestinal Cancers Symposium held in San Francisco, California.

“Many colorectal cancer survivors struggle with unpredictable bowel function continually for the rest of their lives” said Virginia Sun, RN, PhD, Division of Nursing Research and Education, Department of Population Sciences at City of Hope, Duarte, California. “And many never find any set of management strategies” to help them with this situation.

The study included 37 CRC survivors who were within 1 to 3 months after sphincter-preserving surgery or anastomosis to complete questionnaires on bowel function, fecal incontinence, and bowel dysfunction needs.

To further explore unmet needs, the study randomly selected 6 of these participants for personal interviews. The sample was taken from a single National Cancer Institute–designated comprehensive cancer center.

According to Sun, the mean number of daily bowel movements reported was 5.5 (range 2-10), and many survivors reported problems with incomplete fecal evacuation and the ability to control gas.

“I was pretty much restricted to the home area…for almost a month after the operation,” shared one of the survivors interviewed for this assessment.

“You are always thinking about it, at work especially,” said another survivor.

“I am always on guard or on edge because of that.”

Given the severity of complications detailed, it should come as no surprise that lower quality-of-life scores were observed for the impact of fecal incontinence on lifestyle and coping behavior. Yet, many survivors reported feeling uninformed and unprepared to face these common changes.

“I think it would have been better if they just came out and said, ‘hey, the reality is…you’re going to have an accident,’” said one of the patients surveyed. “I think they have a general idea that it is going to affect 99% [of survivors], and they should come straight out and say it.”

www.TheOncologyNurse.com

Echoed another survivor: “They should give you a heads up ahead of time.…If you are going home from the hospital and they tell you this last min-

ute, I don’t think that is very helpful because you are already being bombarded by other information.”

Despite the prevailing side effect of

bowel dysfunction, Sun observed that surgery remains one of the most common and effective treatments for CRC. However, the troubling fact remains Continued on page 19

Innovations in Oncology Management A newsletter series for oncology practice administrators, administrative staff, advanced practice clinicians, and oncology pharmacists.

The series will provide concise, up-to-date information on current issues that are impacting the business of oncology.

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Topics include: Part 1: Patient Support Services Part 2: Oral Parity Legislation Part 3: Emerging Payment and Delivery Models Part 4: Working Collaboratively with Local Payers TO VIEW THE SERIES ONLINE PLEASE LOG ON TO:

InnovationsInOncologyManagement.com anagement.com Supported by funding from Celgene Corporation and Celgene Patient Support. Manufacturer did not influence content.

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Malignant Pleural Effusions failure, cirrhosis of the liver, tuberculosis, or with a pulmonary embolism, or after open heart surgery. This article will deal only with MPE. Localized causes of fluid buildup in the pleural space tend to be from either the tumor itself causing increased permeability of the membranes or other causes related to obstruction. For example, the tumor may obstruct veins or lymph drainage pathways, allowing fluid to accumulate in the space; main stem bronchus tumors may obstruct the bronchus, causing atelectasis and an effusion from reduced pleural pressure; obstruction from pneumonia can cause an effusion; and finally a tumor may obstruct the thoracic ducts, producing a chyle effusion.9 These are the presumed reasons fluid is unable to flow through the pleural space as it normally would and remains trapped there.

Many malignancies can lead to the development of lung disease or lung metastasis, which could lead to MPE; however, the most common malignancies are adenocarcinoma of the lung, metastatic breast cancer, ovarian cancer, advanced lymphoma, and mesothelioma.3,8,10-13 Patients who have developed an MPE often present with sudden severe shortness of breath, with or without chest pain, and also a dry cough, all ultimately affecting their quality of life.14

Diagnosis

Confirming a pleural effusion, let alone an MPE, can occasionally prove challenging. As mentioned above, many different medical conditions can cause a pleural effusion; thus, validating that the excess fluid in the pleural space is from a malignant cause can be a little more difficult. On physical exam, the patient will have decreased breath sounds on the affected side and there will be dullness over the affected side to percussion.12 A lateral decubitus chest x-ray, or more particularly a computed tomography (CT) scan of the chest, is necessary to confirm an increased volume of fluid in the space. On x-ray, effusions could demonstrate a meniscus sign, which appears concave at the top of the effusion.8 Thoracic ultrasound will more than likely demonstrate excess fluid buildup in the pleural space, and this method is useful should the clinician need to remove some of the fluid for diagnostic testing. Ultrasound is also useful in diagnosing small effusions, detecting thickening of the pleura or diaphragm, or when patients can only be in a recumbent position, such as those in critical condition.12 Next, a sample of the fluid should be obtained to determine if the fluid is an exudate or a transudate. In a hallmark

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Continued from the cover

article regarding transudates and exudates, Richard Light and colleagues distinguished between the two by defining a transudate as happening for mechanical reasons that prevent the fluid being reabsorbed, and an exudate as happening when some other disease is influencing the pleural surface, such as inflammation or a malignancy.15

diagnosing an MPE, with radiologyguided biopsy via CT scan the best way to obtain a suitable specimen with the least morbidity to the patient.12 Clinicians can also obtain a pleural biopsy in the OR when performing one of the surgical procedures mentioned below.

Once the type of effusion is diagnosed, a local treatment, such as pleurodesis or

Patients who have developed an MPE often present with sudden severe shortness of breath, with or without chest pain, and also a dry cough, all ultimately affecting their quality of life.

A sample of at least 50 mL of fluid should be obtained for testing. If the pleural effusion is transudative, usually indicating that the cause of the effusion is systemic (such as one of the benign conditions listed above), the condition itself should be treated systemically to reduce further development of pleural effusions. If the effusion is exudative, however, it is generally from a more local cause and therefore the treatment should be local as well. The “Light criteria,” developed by Richard Light, are what most clinicians use to differentiate between transudative and exudative effusions.9 A patient will need to meet one or more of the following lab values to be diagnosed with an exudative effusion: • Protein level >0.5 in either the pleural fluid or serum • Lactose dehydrogenase (LDH) level >0.6 in either the pleural fluid or serum • Pleural fluid LDH level more than two-thirds the upper limit of normal for serum LDH9 Other tests can also be performed to differentiate an exudate in the pleural fluid: cell count and differential; glucose; pH; cytology; and cultures for bacteria, mycobacteria, and fungus in the fluid as well. As noted by Light, cytology of pleural fluid is one of the quickest ways to determine an MPE, with an approximate 60% diagnostic accuracy.8,9,11 Pleural fluid that is grossly bloody is often a sign of malignancy if trauma has been ruled out. Tumor markers of pleural fluid have been analyzed but have shown little promise in detecting MPE. Markers CA 15-3 and CYFRA 21-1 are probably the best, but they are not sensitive or specific enough to really help.10 Testing the fluid for sensitizing epidermal growth factor receptor mutations is one of the newer exams, and it may assist in determining which drugs will have a more favorable response on the tumor.8,16,17 Pleural biopsy is probably the final approach for

a pleural catheter, can be initiated as described later in this article.

It is important to consider that patients diagnosed with MPE generally have only 3 to 12 months to live, as it is a metastatic process that occurs close to the end of a patient’s life.1,12-14,18 Patients with breast and ovarian cancer or lymphoma may receive systemic treatment (chemotherapy) to treat their disease, which may help in treating the MPE. Patients with lung cancer or mesothelioma may also receive chemotherapy, but the benefit is limited, so clinicians must determine the benefits versus the risks for these patients.10,18 A good deal of research has been conducted regarding administration of certain types of systemic chemotherapeutic agents while the patient still has fluid in the pleural space. Research on metho-

A chest x-ray should always follow a thoracentesis so that the clinician can determine if the fluid was successfully removed from the space and the patient has not developed a pneumothorax during the procedure. trexate has determined that, given its structure and pharmacokinetics, this drug is best administered when the pleural space is empty in order to decrease toxicity to the patient. Recently, studies were conducted with pemetrexed, since its structure and some pharmacokinetics are similar to those of methotrexate and because this drug is often used in the treatment of non–

small cell lung cancer and mesothelioma. Researchers and clinicians have not really reached a consensus regarding pemetrexed; some clinicians feel it is necessary to drain the pleural effusion before the patient receives pemetrexed, and others feel it is safe to give the pemetrexed even if the effusion has not been drained.19 Anecdotally, clinicians prefer that the effusion be drained prior to any treatment. Since systemic treatment may take time to show any value, local treatments to relieve symptoms may have to be utilized in the interim.

Nurses can assist during this early diagnosis phase by reassuring the patient, completing a thorough examination, and providing oxygen for comfort for the patient’s shortness of breath and antianxiety medications as needed. The nurse should encourage the patient to take rest periods to conserve energy and to eat small meals of high-caloric foods to increase energy.6 The nurse can also educate the patient regarding diagnostic testing and the methods that might be used to reduce the MPE.

Therapeutic Options for Treating Malignant Pleural Effusion

Medical Thoracentesis Medical thoracentesis is a temporary measure that entails placing a catheter into the pleural space under ultrasound guidance to obtain fluid specimens (diagnostic thoracentesis) or to drain the space of fluid to provide symptom relief (therapeutic thoracentesis). Because of the obstructive or osmotic reasons mentioned previously that prevent the fluid from exiting the space, along with the fact that fluid continues to be produced in the space, fluid will reaccumulate without a more permanent therapeutic procedure.11,13,18,20 To prevent patient discomfort and reexpansion pulmonary edema, fluid should be removed slowly and should not exceed 1500 to 2000 mL at a time. Reexpansion pulmonary edema occurs in less than 0.5% of cases in which too much fluid is removed too fast, causing the affected lung on that side to reexpand too rapidly. In the absence of pleural pressure monitoring, which is often not used in these cases, the clinician should pay attention to the patient and any complaints of chest pain during the procedure.3,11,20 Medical thoracentesis can be performed by medical doctors, pulmonologists, and/or radiologists. It is best completed under ultrasound guidance, but the spot can be marked via ultrasound to enable the thoracentesis to be performed at a later time; however, studies show that there is a greater risk of pneumothorax when the procedure is perwww.TheOncologyNurse.com

SIDE EFFECTS MANAGEMENT formed in this manner. A chest x-ray should always follow a thoracentesis so that the clinician can determine if the fluid was successfully removed from the space and the patient has not developed a pneumothorax during the procedure.11 The patient should be instructed to report any sudden chest pain or shortness of breath to his or her clinician and monitored for signs and symptoms of chest pain, shortness of breath, hypotension, and infection. Because this procedure can be performed on an outpatient basis, patients will need to be educated on the signs and symptoms of any issues and whom to contact should a problem develop.

Thoracentesis can be performed more than once on a patient. If it is determined that a patient has a small, slowly reaccummulating effusion, the clinician may decide that thoracentesis is the therapeutic option of choice to control the patient’s MPE. Ideally, it will need to be done only a few times. The clinician may decide to use thoracentesis to control an actively dying patient’s MPE to avoid a more invasive procedure.

Another complication of thoracentesis, especially when repeated on a regular basis, is fluid loculation, where adhesions and scar tissue form as a result of

Thoracic surgeons sometimes perform an extrapleural pneumonectomy, involving resection of the lung, pleura, diaphragm, and pericardium, which works because it essentially removes the pleural space. the repeated procedures. In this situation, fluid is compartmentalized into smaller areas and all of the fluid cannot be removed with just 1 procedure.3,11,20 Tissue plasminogen activator (TPA) has been used to try to break apart these adhesions, with moderately good results; however, the scar tissue may reform at a future time.3,20 Placing a chest tube into the pleural space can assist the clinician in draining the effusion. The most common chest tube for this purpose is called a pigtail catheter, a 10-14 French, silicone catheter placed under fluoroscopic guidance.

This type of procedure is usually performed on critically ill or palliative patients, who cannot undergo a more invasive procedure. The catheter itself

can be connected to a closed chest drainage system or to a bag that has a one-way valve. Fluid can be drained from the space as needed without causing too much difficulty for the patient, and it provides symptom management for shortness of breath.21,22 Patients should be monitored for pneumothorax post procedure. Patients with this type of catheter can be cared for at home by hospice or palliative care nurses, who can monitor them for tube dislodgement and infection. Larger-bore chest tubes are rarely used for this procedure, mostly due to discomfort for the patient and the complicated drainage systems needed.

Surgical Procedures Thoracic surgeons sometimes perform an extrapleural pneumonectomy, involving resection of the lung, pleura, diaphragm, and pericardium, which works because it essentially removes the pleural space. This surgery, which is generally reserved for patients with mesothelioma, has high morbidity with a long recovery time and large prolonged air leaks. For optimal outcomes, patients must be in fairly decent shape prior to this surgery, but because many of them are close to the end of their life, they most likely would not be a candidate for this procedure. Compared with pleurectomy, which might also assist in eliminating the pleural space, the extrapleural pneumonectomy has the best outcomes.12,13,20,23 Another procedure that eliminates the pleural space is pleurodesis.10,12,13 The first clinician to perform this procedure, which was described in the Journal of Thoracic Surgery in 1935, was Norman Bethune, a thoracic surgeon from Montreal, Canada. Bethune and several other surgeons knew that causing scar tissue to form in the pleural space would assist in the removal of the space. In their research, they tried many tactics, including packing the space, stitching the lung to the parietal pleura, mechanical irritation, heat, elastic bands, tape, and finally products such as gases, and dusting the pleura with talc powder.

They found the most beneficial method to be iodized talc powder, blown in with a blower under thoracoscopy.24 The modern-day version of this procedure is video-assisted thoracoscopic surgery (VATS) pleurodesis via insufflation or talc poudrage, in which a patient is taken to the operating room under general anesthesia and any adhesions or scars are broken up via thoracoscope, biopsies are taken if needed, and talc is applied to all surfaces using a specialized atomizer to blow it into all areas. All this results in chemical pleurodesis, where scar tissue causes the two surfaces of the parietal and visceral pleural layers to adhere together. Then

a chest tube is placed for drainage. The patient is usually kept in the hospital overnight for monitoring, including vital signs and drainage from the chest tube, as well as chest x-ray to rule out pneumothorax. Pleurodesis has been shown to be about 78% effective, with few patients experiencing failure or re-effusion. Following this procedure, about 5% to 9% of patients develop adult respiratory distress syndrome (ARDS), which is assumed to be related to the size of the talc particles used during the procedure—larger talc particles (>15 μm) being better for the patient.3,8,11,12,25

Nurses can be helpful during the decision to use a tunneled pleural catheter for treatment by first educating the patient regarding the catheter placement process.

Pleurodesis can also be performed “at the bedside” via a chest tube placed into the pleural space and attached to a collection chamber. Once all fluid has been drained from the space, irritants are introduced through the chest tube to cause scar tissue to form. Many products have been tried over the years: bleomycin, doxycycline, tetracycline, and betadine, to name a few. Studies again have shown that talc achieves the best results. To make the process easier, the talc is made into a slurry and injected into the space via the chest tube, which is then clamped for several hours.

In the past, clinicians would have the patient change position throughout the time the talc was in the space to attempt to get the slurry on all of the surfaces; however, research has found this to be unnecessary. Generally, after several hours the tube will be unclamped and allowed to drain for about 24 hours, at which time it is removed. Talc slurry studies have shown this procedure to be about 71% effective.3,8,11,12,25 After performing a Cochrane review, researchers determined that talc inserted via slurry or insufflation techniques proved to be the best of any of the substances tried.26 Pleurodesis seems to show best results and not demonstrate future failure if apposition is maintained between the visceral and parietal pleural surfaces when the sclerosing agent is being placed in the space to stimulate inflammation and future fibrosis. This information could assist clinicians in determining the course of treatment for a patient, as oftentimes after an MPE is

drained for the first time, the lung does not adequately reexpand to allow for pleurodesis.27,28 A tunneled pleural catheter (TPC) is a 15.5 French, silicone catheter with a cuff placed into the pleural space.

These catheters can be placed by thoracic surgeons, radiologists, and, more recently, interventional pulmonologists, as an outpatient procedure done under moderate sedation and local anesthetic. The catheter has a one-way valve at the end to prevent pleural fluid from exiting and air from entering the space.10-12,17 A postprocedure chest x-ray should confirm placement of the catheter, the fluid amount in the space after drainage, and the absence of pneumothorax. Patients and/or family members are taught to drain the catheter of a prescribed amount of fluid a prescribed number of times per week using vacuum bottles provided by the company. Some insurance policies cover visiting nurses to assist patients with this procedure. This method of treating an MPE allows patients to care for themselves at home. It immediately relieves the symptom of shortness of breath and can be used even if there is no apposition between the visceral and parietal pleural surfaces. Spontaneous pleurodesis can occur with these catheters. Because they are a foreign object in the presumably mostly empty space, and because the patient is on a routine drainage schedule, the catheter is constantly physically irritating the surface of the lining and causing inflammation, resulting, hopefully, in spontaneous pleurodesis, which occurs in about 50% of patients with a TPC after approximately 2 months’ time. The chances of a spontaneous pleurodesis occurring are better if there is apposition between the 2 layers; however, clinicians prefer the TPC method, even if the fluid is loculated or there is a trapped lung, because it achieves symptomatic relief of the effusion.12,17,29 Nurses can be helpful during the decision to use a TPC for treatment by first educating the patient regarding the catheter placement process. Nurses are also heavily involved in educating both the patient and the caregiver regarding management of the TPC as well as setting up visiting nurses to assist and getting supplies for drainage of the catheter for the patient.

Education should include possible complications. Catheters are a foreign object and can be a site of infection.

Although draining the catheter and changing the dressing are done under sterile conditions, patients still need to know signs and symptoms of infection to report. TPCs can become clogged with fibrin by-products at the site of the one-way valve. TPA has been used to break up fibrin, and patients need to be Continued on page 18

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Malignant Pleural Effusions educated when to call the clinician. If spontaneous pleurodesis occurs, then catheters can be removed as the effusion amount decreases. There have been reports of catheters fracturing during removal, so clinicians must be aware of how to handle this situation.

There have also been reports of seeding of the cancer along the catheter, and some clinicians continue with chemotherapy in the hope of preventing this occurrence.3,17,30 A few other methods for treating MPE are either older and not used much, or are very new and still being studied. One older technique is pleuroperitoneal shunt. In this technique, a catheter is placed into the pleural space with a one-way valve and a pump connected to a catheter that goes to the peritoneal space. The patient is taught to press on the pump several times a day, and this shunts the pleural fluid into the peritoneal space. Because of the high occlusion rate with these catheters and the likelihood of infection, clinicians seldom use this method.3,10,11,17 A newer technique still being studied is placement of a port (similar to a venous access port). The patient and caregiver would be taught to access the port with a Huber needle and drain the effusion into a vacuum bottle. The idea is very similar to a TPC, only there is nothing on the outside of the body until the port is accessed for drainage, and the same issues that cause problems for TPC could occur with these ports.31 Another new technique is cytoreductive surgery and hyperthermic intrathoracic chemotherapy (HITHOC) perfusion, similar to a technique used for intraperitoneal tumors. A study was completed in Germany in 2012 with 16 patients—8 patients with mesothelioma and 8 patients with pleural thymoma. After cytoreductive pleural surgery, the patients were perfused with heated chemotherapy into the pleural space.

The surgical procedure and the chemo-

Continued from page 17

therapy went well, with no real leakage of chemotherapy into other areas, as happens in some intraperitoneal cases, probably because of fewer anastomoses in the pleural area. Overall, the thymoma patients did better than the mesothelioma patients, probably due to their better prognosis.32

Future Directions

Clinicians are frustrated that treatment for patients with MPE has changed little since 1935. Ultimately, one would hope the goal would be to cure the patient of his or her pleural metastasis, but in the meantime, clinicians should be cognizant of the fact that most of these patients are close to the end of their life and they need a treatment that deals with their symptoms, does not require as much hospitalization, and is the most cost-effective.

Many research studies have been conducted to determine the best means of treating MPE, ie, either talc pleurodesis or TPC. Other studies have examined the cost of VATS talc pleurodesis versus TPC and have found that VATS is more expensive due to the cost of the operating room, anesthesia, at least 1 or 2 days of in-hospital recovery time, and normal postoperative complications, such as air leakage, pain, etc, which could keep the patient in the hospital longer than planned. TPC, on the other hand, is an outpatient procedure with minimal anesthesia, and patients can return home to care for themselves and their catheter after proper education. TPC does have “hidden” costs, however, such as visiting nurses and supplies for draining the catheter 3 to 4 times per week.33-35 Another trend is to pay more attention to patient outcomes and quality of life. Several research studies reviewed patients’ quality of life based on the type of MPE treatment. These studies found that patients were more satisfied when they had a TPC; their symptoms were

relieved and they were able to care for the catheter at home, increasing their quality of life. Research is also looking at the outcomes of relieving shortness of breath, pain, and other symptoms and how those outcomes for patients are being met.14,17,36 The information reviewed implies there will be new technology, surgeries, chemotherapy, and/or biotherapy drugs developed to assist in treating malignant pleural effusions. Oncology nurses will pay close attention to the research and learn to work with any new procedures that will help their patients. However, for now, clinicians need to treat patients with individualized therapy that relieves their symptoms and allows them to enjoy their remaining life in a quality manner. n

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2013;19(7):320, 322-325.

2. Walker SJ, Bryden G. Managing pleural effusions.

Clin J Oncol Nurs. 2010;14(1):59-64.

3. Thomas JM, Musani AI. Malignant pleural effusions: a review. Clin Chest Med. 2013;34:459-471.

4. Myatt R. Diagnosis and management of patients with pleural effusions. Nurs Stand. 2014;28(41):51-58.

5. Stark P. Imaging of pleural effusions in adults. UpTo Date website. www.uptodate.com. Updated January 7, 2014. Accessed December 9, 2014.

6. Held-Warmkessel J, Schiech L. Caring for a patient with malignant pleural effusion. Nursing. 2008;38(11): 43-47.

7. Light RW. Pleural Diseases. 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2007.

8. Zarogoulidis K, Zarogoulidis P, Darwiche K, et al.

Malignant pleural effusion and algorithm management.

J Thorac Dis. 2013;5(suppl 4):S413-S419.

9. Light RW. Pleural effusions. Med Clin North Am. 2011;95(6):1055-1070.

10. Kaifi JT, Toth JW, Gusani NJ, et al. Multidisciplinary management of malignant pleural effusion. J Surg Oncol. 2012;105(7):731-738.

11. Uzbeck MH, Almeida FA, Sarkiss MG, et al. Management of malignant pleural effusions. Adv Ther.

2010;27(6):334-347.

12. Kastelik JA. Management of malignant pleural effusion. Lung. 2013;191(2):165-175.

13. Muduly DK, Deo SVS, Subi TS, et al. An update in the management of malignant pleural effusion. Indian J Palliat Care. 2011;17(2):98-103.

14. Lorenzo MJ, Modesto M, Pérez J, et al. Quality-­oflife assessment in malignant pleural effusion treated with indwelling pleural catheter: a prospective study.

Palliat Med. 2014;28(4):326-334.

15. Light RW, MacGregor MI, Luchsinger PC, et al.

Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972;77(4):507-513.

16. Smits AJ, Kummer JA, Hinrichs JW, et al. EGFR and KRAS mutations in lung carcinoma in the Dutch population: increased EGFR mutation frequency in malignant pleural effusion of lung adenocarcinoma. Cell Oncol (Dordr). 2012;35(3):189-196.

17. Thomas R, Francis R, Davies HE, et al. Interventional therapies for malignant pleural effusions: the present and the future. Respirology. 2014;19(6):809-822.

18. Nam HS. Malignant pleural effusion: medical approaches for diagnosis and management. Tuberc Respir Dis (Seoul). 2014;76(5):211-217.

19. Dickgreber NJ, Sorensen JB, Paz-Ares LG, et al. Pemetrexed safety and pharmacokinetics in patients with thirdspace fluid. Clin Cancer Res. 2010;16(10):2872-2880.

20. Heffner JE. Management of malignant pleural effusions. UpToDate website. www.uptodate.com. Updated December 16, 2013. Accessed January 25, 2015.

21. Tsai WK, Chen W, Lee JC, et al. Pigtail catheters vs large-bore chest tubes for management of second­ary spontaneous pneumothoraces in adults. Am J Emerg Med. 2006;24(7):­795-800.

22. Jain S, Deoskar RB, Barthwal MS, et al. Study of pigtail catheters for tube thoracostomy. MJAFI. 2005; 62(1):40-41.

23. Ried M, Hofmann HS. The treatment of pleural carcinosis with malignant pleural effusion. Dtsch Arztebl Int. 2013;110(18):313-318.

24. Bethune N. Pleural poudrage: a new technic for the deliberate production of pleural adhesions as a preliminary to lobectomy. J Thorac Surg. 1935;4:251-261.

25. Dresler CM, Olak J, Herndon JE 2nd, et al. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest. 2005;­127(3):909-915.

26. Xia H, Wang XJ, Zhou Q, et al. Efficacy and safety of talc pleurodesis for malignant pleural effusion: a meta-analysis. PLoS One. 2014;9(1):e87060.

27. MacEachern P, Tremblay A. Pleural controversy: pleurodesis versus indwelling pleural catheters for malignant effusions. Respirology. 2011;16(5):747-754.

28. Myers R, Michaud G. Tunneled pleural catheters: an update for 2013. Clin Chest Med. 2013;34(1):73-80.

29. Putnam JB Jr, Light RW, Rodriguez RM, et al. A randomized comparison of indwelling pleural catheter and doxycycline pleurodesis in the management of malignant pleural effusions. Cancer. 1999;86(10):1992-1999.

30. Nasim F, Folch E, Majid A. Tunneled pleural catheter dysfunction: case report and review of complications.

J Bronchology Interv Pulmonol. 2012;19(2):149-152.

31. Kriegel I, Daniel C, Falcou MC, et al. Use of a subcutaneous implantable pleural port in the management of recurrent malignant pleurisy: five-year experience based on 168 subcutaneous implantable pleural ports. J Palliat Med. 2011;14(7):829-834.

32. Ried M, Potzger T, Braune N, et al. Cytoreductive surgery and hyperthermic intrathoracic chemotherapy perfusion for malignant pleural tumours: perioperative management and clinical experience. Eur J Cardiothorac Surg. 2013;43(4):801-807.

33. Boshuizen RC, Onderwater S, Burgers SJA, et al.

The use of indwelling pleural catheters for the management of malignant pleural effusion—direct costs in a Dutch hospital. Respiration. 2013;86(3):224-228.

34. Fysh ET, Waterer GW, Kendall PA, et al. Indwelling pleural catheters reduce inpatient days over pleurodesis for malignant pleural effusion. Chest. 2012; 142(2):394-400.

35. Puri V, Pyrdeck TL, Crabtree TD, et al. Treatment of malignant pleural effusion: a cost-effective analysis.

Ann Thorac Surg. 2012;94(2):374-380.

36. Sabur NF, Chee A, Stather DR, et al. The impact of tunneled pleural catheters on the quality of life of patients with malignant pleural effusions. Respiration.

2013;85(1):36-42.

TAKE ACTION: GET YOUR CANCER CENTER PROFILED!

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

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

Contact editorial@greenhillhc.com for information.

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MARCH 2015 I VOL 8, NO 2

www.TheOncologyNurse.com

CLINICAL TRIALS

Full Clinical-Trial Data Sharing Moves Closer to Reality Rosemary Frei, MSc

A

January 14, 2015, report published by the Institute of Medicine (IOM)1 walks a fine line between the competing clinical-datasharing comfort zones of pharmaceutical companies, physician associations, patient groups, and other advocacy organizations.

The 249-page report lays out 4 recommendations for increased clinical-trial data sharing. These include suggesting a maximum 18-month lag between study completion and sharing of all the data—with some exceptions for trials being used to support a regulatory application—and no more than 6 months between study publication and sharing of the analytic data set. The other recommendations are for clinical-trial stakeholders to “foster a culture in which data sharing is the expected norm,” to “mitigate the risks and enhance the benefits of sharing sensitive clinical trial data,” and to create a framework for addressing all the challenges associated with data sharing.

“While individual stakeholders can take steps to foster clinical trial data sharing, a broad range of stakeholders must act together to build an ecosystem in which responsible data sharing is expected, flourishes and continuously improves,” concluded report-committee chair Bernard Lo, MD, of the Greenwall Foundation, New York, in a summary of the report published in JAMA.2 The Oncology Nurse-APN/PA contacted Richard L. Schilsky, MD, Chief Medical Officer of the American Society of Clinical Oncologists (ASCO), for his view of the report. He said it responds to all of the concerns ASCO president Clifford Hudis, MD, expressed in a March 2014 comment to

tor-in-chief of the New England Journal of Medicine and the chief medical officer of Johnson & Johnson.

The goal of AllTrials is to have all past and present clinical trials by both industry and nonindustry researchers registered and to have their full methods and summary results reported, without exceptions. GlaxoSmithKline (GSK) officials agreed to do so 2 years ago,5 and they have been true to their word. No other pharmaceutical companies have followed in GSK’s footsteps,

Trevor Butterworth

the report committee.3 “ASCO has long recognized that increasing the availability of clinical trial data is in the public interest. We encouraged the committee to recommend harmonizing international rules on data sharing and ensuring that the framework developed is broadly applicable to all clinical trials,” said Schilsky in an email. “We support the report’s recommendations and urge the report’s sponsors to swiftly convene a group to begin developing the infrastructure and policies that will foster responsible data sharing.”

However, members of a group called AllTrials point out on their website4 that—other than the suggested timeframes for sharing data from trials that have been completed and/or published—there are no other hard timelines, actionable steps, or proposed penalties for noncompliance laid out by the report’s authors, which include the edi-

“The IOM report is a huge step forward for medicine….Their affirming of the value of trial registration and data sharing is a recognition that the historical moment has changed—that transparency is the new intellectual currency.”

—Trevor Butterworth

although Johnson & Johnson last year gave data from all of its drug trials to Yale University researchers.6 Most companies are opting instead to comply with the much more lax data-sharing regulations from the European Federation of Pharmaceutical Industry Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhMRA).

The leaders of AllTrials know, however, that poking giants can be tricky, and hence they are opting for a softer sell.

“The IOM report is a huge step forward for medicine. And one has to accept that institutional change is often slow,” said Trevor Butterworth, in a conversation with The Oncology NurseAPN/PA. Butterworth heads Sense About Science USA, which is championing the AllTrials initiative in the United States. “Their affirming of the value of trial registration and data sharing is a recognition that the historical moment has changed—that transparency is the new intellectual currency. And the goal of AllTrials is to persuade all pharma companies to do what GSK did.” n

References

1. Institute of Medicine (IOM) Committee on Strategies for Responsible Sharing of Clinical Trial Data. IOM website. https://www.iom.edu/Reports/2015/SharingClinical-Trial-Data.aspx. Published January 14, 2015.

Accessed February 2, 2015.

2. Lo B. Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA. Published online January 16, 2015. Accessed February 2, 2015.

3. ASCO comments on IOM discussion framework for clinical trial data sharing. American Society of Clinical Oncology (ASCO). www.asco.org/asco-comments-iomdiscussion-framework-clinical-trial-data-sharing. Published March 26, 2014, Accessed February 2, 2015.

4. America’s Institute of Medicine says sharing data from clinical trials should “become the norm.” AllTrials. www. alltrials.net/news/americas-institute-of-medicine-sayssharing-data-from-clinical-trials-should-become-thenorm/. Published January 14, 2015. Accessed February 2, 2015.

5. GSK announces support for AllTrials campaign for clinical data transparency [news release]. London, UK. GlaxoSmithKline plc; February 2013. www.gsk.com/ en-gb/media/press-releases/2013/gsk-announcessupport-for-alltrials-campaign-for-clinical-data-transpar ency/. Accessed February 2, 2015.

6. Johnson & Johnson gives clinical trial data to researchers: a “game changer.” AllTrials. www.alltrials.net/ news/johnson-johnson-gives-clinical-trial-data-toresearchers-a-game-changer/. Published January 30, 2014. Accessed February 2, 2015.

SIDE EFFECTS MANAGEMENT

Colorectal Cancer Survivors Frequently Report Bowel Dysfunction Continued from page 15

that there are few evidence-based protocols to support positive adjustments to changes in bowel function.

Survivors desired more information on managing bowel function in an emergency as well as what type of food helps with bowel function, and they also wished for the opportunity to talk to others who share the same experience.

www.TheOncologyNurse.com

“They could have said, ‘you are going to have to dash to the bathroom, but we will have diapers or something for you.’ I [wish they] had a process of helping you get through that,” revealed another patient.

Of those surveyed, 39% preferred information on bowel dysfunction to be given before surgery, while 50% desired

information prior to discharge. The majority of survivors (63%) asked to participate in a bowel rehabilitation/ support program following surgery.

“Evidence-based interventions that are timely and personalized are needed to support positive adjustments to bowel changes following surgery,” concluded Sun. “Survivors need more in-

formation on managing bowel function.” n

Reference

Sun V, Smith DD, Lai LL, et al. Bowel dysfunctionrelated needs assessment in colorectal cancer survivors.

J Clin Oncol (ASCO Annual Meeting Abstracts).

2015;33(suppl 3):Abstract 715. Poster presented at: 2015 Gastrointestinal Cancers Symposium; January 15-17, 2015; San Francisco, CA. http://meetinglibrary.asco.org/ content/140160-158. Accessed February 2, 2015.

MARCH 2015 I VOL 8, NO 2

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ONCOLOGY NURSE EXCELLENCE AWARD

Jessica Engel Named ONE Award Winner at AONN+ Conference

A

t the Academy of Oncology Nurse & Patient Navigators (AONN+) Fifth Annual Conference, held in Orlando, FL, in September, one nurse was recognized by her peers for her commitment to the profession. Jessica Engel, DNP, FNP-BC, AOCNP, nurse practitioner and research assistant at the Marshfield Clinic in Stevens Point, WI, was the recipient of the 2014 Oncology Nurse Excellence (ONE) Award.

Nominated by Adedayo Onitilo, MD, PhD, MSCR, FACP, a physician and colleague at the clinic, Dr Engel is also an instructor in the doctorate of nursing practice (DNP) program at the University of Wisconsin in Oshkosh and Eau Claire. In addition, she has been actively involved in research for the past 8 years, serving as primary investigator, coinvestigator, and project manager, and producing more than 35 peer-reviewed publications. In making the nomination, Dr Onitilo cited Dr Engel’s role as a clinician, educator, and researcher.

“Dr Engel consistently receives excellent patient satisfaction reviews and goes to great lengths to ensure optimal care for her patients,” Dr Onitilo wrote.

“She demonstrates her commitment to education as a professor, and her accomplishments in the field of oncology research set her apart.”

Following is an interview with Dr Engel.

Q: How long have you been a nurse?

Jessica Engel (JE): I have been a nurse in one form or another for a number of years. I graduated nursing school with my bachelor’s degree, and began working as an oncology nurse while I completed a master’s program to become a nurse practitioner. I then continued as a nurse practitioner in a hematology/oncology clinic and hospital setting. I moved to the Marshfield Clinic in Central Wisconsin, and I have worked in Stevens Point at the cancer center for the past 9 years. I went back to school and earned my DNP in 2013.

I came to nursing actually just at an appropriate time for me. Having always had an interest in science, I had earned a bachelor’s degree in biology. As I was beginning medical school, I learned about the job of nurse practitioner, and that seemed to be a much better fit for me, for what I wanted to accomplish for myself and for how I wanted to be able to take care of patients.

Q: What role do you think nurses have in clinical research and education? What impact does this have on patient care?

Lillie D. Shockney, RN, BS, MAS (left), and Sharon Gentry, RN, MSN, AOCN, CBCN (right), present the ONE Award to Jessica Engel, DNP, FNP-BC, AOCNP, at the Fifth Annual AONN+ Conference in Orlando, FL.

Q: What inspired you to become a nurse practitioner, and what path brought you to the position you are in now?

JE: My intention was always to do something in the science field. I considered engineering or something in math and science. But about a year and a half into college, when I was 19, I was diagnosed with Hodgkin lymphoma. That diagnosis helped turn me toward the medical field, something I had not considered before.

the right thing for me to do was redirect my focus toward a career where I would be able to use my experiences as a patient as well as gain the knowledge as a healthcare provider to be able to help others as I was.

Q: What inspires you and motivates you each day?

JE: I really try to have a sense of purpose with all the work that I do. Most days that sense of purpose involves helping and supporting others, such as

I find it most rewarding to have the opportunity to be helpful in real and useful ways and to provide support to the patients and people who I work with.

I really respected the doctors, nurses, and other people who cared for me, especially the knowledge they had about the process of diagnosis, treatment options, and the science behind all of that information. Early on in my experience with Hodgkin lymphoma, though, I began to understand that the importance of considering the emotional and interpersonal impact of a new cancer diagnosis can be just as important as understanding the science of oncology.

Patients are trying to understand their diagnosis and how it has, and will, impact the other parts of their life, and at times they might be unsure how to relate to or explain how they feel to the people who are trying to care for them.

As I considered that, and my newfound interest in the medical field, it seemed

providing guidance for our patients to be the best that they can be or helping my coworkers do the best job they can so that they in turn can then provide better patient care and better services to our community.

Another strong motivator for me is the ability to contribute to patient care, staff development, physician practice, research projects, and nursing student education. In my teaching role, I like being able to teach nursing students to do a good job, and with the research work that I do, especially with publications, I like to be able to put knowledge and information out there for others to use. Those things are really important to me—to be able to come to work each day and know my time is worthwhile in those ways.

JE: As nurses often do not have the opportunity to conduct research independently, I think it is very important to understand that there is great value in becoming part of a research team; it allows nurses to see opportunities and make contributions they might not otherwise have been able to make. Nurses can contribute to a research team in a number of ways, such as the development of concepts and study ideas, or to assist with writing protocols and grant applications, participate with the implementation and conduct of studies, as well as be part of analysis and manuscript writing. By being part of a research team, a nurse is able to use the talents they have as well as learn more about the process of conducting studies overall. Nurses can participate in research in a number of other ways, such as a peer reviewer or by reviewing grant applications for larger funding groups.

With respect to nurses’ role in education, there are many opportunities that span the spectrum from nurses as learners, to nurses as teachers. Nurses can be classroom or clinical instructors. They can be preceptors. Nurses can develop continuing medical education programs, or can write articles for journals that would address areas helpful to educate the nurse readers. In this economic climate, where finances are tight and people are not always able to travel, online programs provide excellent opportunities for nurses seeking additional education. It is important for nurses to take the initiative and try to find educational opportunities that are cost-effective and time-effective. I would encourage nurses to always look for ways to build their knowledge base in their area of specialty, whether that is by obtaining relevant certification or advancing their formal education.

Q: What do you find most rewarding about the work that you do?

JE: I find it most rewarding to have the opportunity to be helpful in real and useful ways and to provide support to the patients and people who I work with. It is very rewarding to know that patients might learn new information; maybe I talked with them or saw them or did some kind of workup, and they have an understanding about their question or condition that they did not Continued on page 22

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3RD ANNUAL

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FIRST ISSUE IN A 5-PART SERIES

A 5-part series The publishers of The Oncology Nurse-APN/PA are proud to present our 3rd annual Conquering the Cancer Care Continuum™ series.

THIRD ANNUAL

Conquering the Cancer Care Continuum Conquering Cancer Carthe i e Cont in SECoN

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ONCOLOGY NURSE EXCELLENCE AWARD

Jessica Engel Named ONE Award Winner at AONN+ Conference Continued from page 20

have before. In oncology you do not always deliver good news, but you can always try to make things understandable.

You can always try to find something that can make the situation a little bit better, or a little more acceptable.

Working with colleagues in the clinic or in my research group, knowing that I support their interests, care, and work so that they are able to do a better job is very rewarding to me. I have learned that each bit of knowledge gained or each accomplishment builds on that before it, and each can be a stepping stone toward future opportunities. However, maybe the most important to me, is that I know I am fortunate that I find happiness in what I do. It is not just my job; being an oncology nurse practitioner and researcher is how I choose to live my life. I hope that some of my happiness, interest, and enthusiasm for my work are things that I am always able to share with others.

Q: What do you feel are the benefits of being a member of AONN+?

JE: What I have and will benefit from the most are the resources, sup-

port, and sense of community. I went to the annual meeting this past year and felt like I really belonged as part of that group. AONN+ has a strong focus on education and quality of care, as well as communicating the importance of certification and job definition. Developing and maintaining standards is very important for the field as a whole.

Those are benefits that the organization provides not just to its members, but also to hiring organizations or the medical care community so that there are standards for nursing and navigation jobs. That makes it easier for more roles to be developed and for more people to be hired into those positions.

Q: How did you feel when you learned that you were nominated for the ONE Award? How did you feel when you won?

JE: Everybody has good days and not-so-great days, and the day I found out about the nomination, it had started off as one of those days that was a little too busy and a little too sad, and I could tell that it was going to be a harder day to get through.

When the email notification came about the nomination, though, all of that just vanished. I read the email a couple of times and realized what it meant. I had not been aware that I was being nominated, so it was a complete surprise. It felt very good that even as

Be persistent, be creative, and be open to opportunities, because you never know what is going to come up next. challenging as it gets, people really do appreciate your work. It was a nice reminder that day, and on many days since, that what I do is important and helpful to others. Reading the descriptions of the other nominees also made me think that this is a group of wonderful nurses, and I was so happy to be considered part of that group.

At the meeting, when the number of members was described, the impact of

Noteworthy Numbers Ovarian Cancer

In 1962, President John F. Kennedy challenged Americans to go to the moon within a decade. Apollo 11 accomplished that goal 7 years later. In 2012, inspired by that challenge, the University of Texas MD Anderson Cancer Center launched the Moon Shots Program. This ambitious plan aims to convert scientific discoveries into clinical advances quickly to improve survival rates for several of the deadliest cancers including ovarian cancer, which is our focus this month.1 •O ne in 72 women will develop symptoms of ovarian cancer are ovarian cancer in her lifetime. nonspecific and screening is Ovarian cancer is the 11th most problematic. Some studies common cancer and the 5th indicate that routine use of leading cause of death due to transvaginal sonography (TVS) cancer in women. It is the as a screening device is not number 1 cause of death due to effective.4 However, since 1987, 2 researchers affiliated with the gynecologic cancers.

• There are 21,980 new ovarian University of Kentucky Markey cancer cases diagnosed in the Cancer Center have conducted United States annually. More free TVS screenings for ovarian than 15,500 of those diagnosed cancer. More than 43,000 will have the high-grade serous participants have received more subtype, which causes nearly than 255,000 free TVS screens 90% of ovarian cancer deaths.3 in this program, which delivers • Early detection is vital to over 1000 screens each month. surviving ovarian cancer, but At least 86 malignancies have only 20% of ovarian cancers are been discovered.5,6 4 • The total National Cancer Institute found at an early stage.

Diagnosis is difficult because research budget for fiscal year

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2013 was $4.79 billion, down from an average of $5.8 billion for the years 2010 through 2012. Of the 2013 budget, $100.6 million was spent on ovarian cancer research.7 Sources

1. www.mdanderson.org/newsroom/ news-releases/2014/year-two-moonshots-program.html.

2. www.ovariancancer.org.

3. www.cancermoonshots.org/cancer-­ types/ovarian/.

4. www.cancer.org/cancer/ovariancancer/­ detailedguide/ovarian-cancerdetection.

5. http://ovarianscreening.info/.

6. www.kentucky.com/2013/10/22/­ 2889633_researchers-touteffectiveness.html?rh=1.

7. www.cancer.gov/researchandfunding/ snapshots/ovarian.

how many people who were part of the organization, and, therefore, how many received the email with our pictures and brief biographies really hit me as I was sitting in the audience. I actually felt a little shy at that moment as well as excited that I and my work had been considered by so many. When my name was announced, I said a silent thank you, meant especially to those who sent in the nomination, to all the other nurses who were nominated for their work, and to those who had voted. I was very proud and excited as I walked to the stage to accept the award.

Q: What advice can you give to other nurses, nurse navigators, or nurse practitioners, especially those who are just starting out?

JE: My best advice is to find someone who can be a mentor for professional development. Also, never stop learning how to be better as a nurse, as a navigator, as a nurse practitioner, or how to be your best self. Other advice that I would give, as it has served me well, is to always help each other and find ways to share your knowledge and resources. Be kind to your patients and to those who you work with. Be persistent, be creative, and be open to opportunities, because you never know what is going to come up next. Be professional and responsible, and try to become as knowledgeable as you can about your content material and about your field. Pursue education and pursue any certification that you think might be helpful.

Q: Is there anything else you would like to mention that we have not discussed?

JE: I am so very appreciative of being selected for this award, and very much thank AONN+ and the members of the organization for their overall recognition and promotion of quality nursing and improving patient care. I offer my gratitude also to the people who nominated me and to all those who I am fortunate to work with who support me in all the different ways that allow me to keep doing what I do. I also want to thank the award sponsors* for making this possible and for helping to bring such a wonderful group of people together at the annual meeting. n

*ONE Award sponsors include Bristol-Myers Squibb, Celgene, Eisai, Genentech: A Member of the Roche Group, Helsinn, Lilly, Pfizer Oncology, Takeda Oncology, and Teva Oncology.

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