ONA March/April 2016 by Haymarket Media

ONCOLOGY NURSE ADVISOR â&#x20AC;¢ MARCH/APRIL 2016

March/April 2016

www.OncologyNurseAdvisor.com A F O R U M F O R P H YS I C I A N A S S I S TA N T S

FEATURE

IMMUNOTHERAPY A Call for Greater Skin Cancer Surveillance in SOTRs

FEATURE

A Unique Activity-based Patient Support Group

RADIATION & YOUR PATIENT

Activating the Immune System to Fight Cancer: CAR T-cell Therapy Harvested T-cells are genetically transduced to create CTL019 cells

Radiotherapy-specific SCPs

COMMUNICATION CHALLENGES

Coping With Anorexia/Cachexia

ISSUES IN CANCER SURVIVORSHIP

An Alternative Sedation Method for Glioma Resection

THE TOTAL PATIENT

Meditation Benefits for Patients and Clinicians VOLUME 7, NUMBER 2

FROM CANCERCARE

HIV and Cancer: A Dual Diagnosis

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PUBLISHING STAFF Editor Joyce Pagán editor.ona@haymarketmedia.com Senior digital content editor Rick Maffei Oncology writer Jason Hoffman, PharmD, RPh Contributing writer Bette Weinstein Kaplan Group art director, Haymarket Medical Jennifer Dvoretz

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Oncology Nurse Advisor (ISSN 2154-350X), March/April 2016, Volume 7, Number 2. Published 6 times annually by Haymarket Media Inc, 114 West 26th Street, 4th Floor, New York, NY 10001. Oncology Nurse Advisor is available for single copy purchases at the following rates. Price per copy: USA $20; Foreign $30. To order call (800) 558-1703. For advertising sales, call (646) 638-6000 (M-F, 9am-5pm, ET). Postmaster: Send changes of address to Oncology Nurse Advisor, P.O. Box 316, Congers, NY 10920. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publisher.

EDITORIAL BOARD Ann J. Brady, MSN, RN-BC Huntington Cancer Center Pasadena, California Jiajoyce R. Conway, DNP, CRNP, AOCNP Cancer Care Associates of York York, Pennsylvania Marianne Davies, DNP, ACNP, AOCNP Smilow Cancer Center @ Yale New Haven New Haven, Connecticut Frank dela Rama, RN, MS, AOCNS Palo Alto Medical Foundation Palo Alto, California Donald R. Fleming, MD Cancer Care Center, Davis Memorial Hospital Elkins, West Virginia Susanne Menon, NP, OCN Center for Gynecologic Oncology Massachusetts General Hospital Cancer Center Boston, Massachusetts Leah A. Scaramuzzo, MSN, RN-BC, AOCN Billings Clinic, Inpatient Cancer Care Billings, Montana Lisa A. Thompson, PharmD, BCOP Kaiser Permanente Colorado Rosemarie A. Tucci, RN, MSN, AOCN Lankenau Hospital Wynnewood, Pennsylvania

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CONTENTS

March/April 2016

IN THE NEWS • Diﬀerent Opioids Provide Similar Pain Control • Sleep Disturbance Is a Common Challenge for Patients With Cancer • Breast Tomosynthesis May Have Potential as Primary Screening Modality • More Than One-quarter of Breast Cancer Survivors Experience Severe Fatigue • NSCLC: Atezolizumab Improves Survival vs Docetaxel • PPB Regimen Feasible as Initial Therapy for Fit Patients With NSCLC … and more

NAVIGATOR NOTES Enhancing Nurses’ Roles Improves Patient Care

Joyce Pagán

44 22

FEATURES A Review of Chimeric Antigen Receptor T-cell Therapy Holly McConville, RN, BSN; Megan Harvey, RN, BSN

A Call for Greater Skin Cancer Surveillance Among SOTRs John Schieszer, MA

The Art of Coping: Creating an Activity-based Support Group Claire Grainger-Valvano, LCSW, OSW-C

48 FIND US ON

Continues on page 8

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STAT CONSULT Alectinib (Alecensa) Alectinib is an anaplastic lymphoma kinase (ALK) inhibitor indicated for the treatment of patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib.

CONTENTS

March/April 2016

33 STAT CONSULT • Elotuzumab (Empliciti) • Uridine triacetate (Vistogard) 37 RADIATION & YOUR PATIENT Radiotherapy-specific SCPs Improve Care Planning Bryant Furlow

COMMUNICATION CHALLENGES Coping With Anorexia/Cachexia Ann J. Brady, MSN, RN-BC

ISSUES IN CANCER SURVIVORSHIP Hypnosedation: An Alternative Sedation Method for Patients Undergoing Glioma Resection Bette Weinstein Kaplan

44 THE TOTAL PATIENT Oncologist Finds the Benefits of Meditation for Himself, Then Shares It With His Patients Bette Weinstein Kaplan

46 FROM CANCERCARE HIV: Coping With a Challenging Concomitant Diagnosis David Horne, LMSW

ASK A PHARMACIST Managing Drug-related Bone Pain Lisa A. Thompson, PharmD, BCOP

PATIENT EDUCATION: FACT SHEET Cigar Smoking and Cancer Cigars usually differ from cigarettes in size and in the type of tobacco used. This fact sheet examines links between cigar smoking and cancer risk.

PATIENT EDUCATION: FACT SHEET Surgery to Reduce the Risk of Breast Cancer This fact sheet examines the potential pros and cons of surgery as a means to reduce breast cancer risk, presented in a question-and-answer format.

PUBLISHERS’ ALLIANCE: AME PUBLISHING Hyperthermic Intraperitoneal Chemotherapy for Epithelial Ovarian Cancers: Is There a Role? This research examines the use of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of ovarian cancer Journal of Gastrointestinal Oncology

PUBLISHERS’ ALLIANCE: MOFFITT Should Vital Signs Be Routinely Obtained Prior to Intravenous Chemotherapy? Results From a 2-Center Study This research sought to explore whether routine checking of vital signs prior to administration of intravenous chemotherapy is associated with fewer complications, particularly hospitalizations and emergency department (ED) visits. Cancer Control

ON THE

WEB

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IN THE NEWS Different Opioids Provide Similar Pain Control Oral morphine, oxycodone, transdermal fentanyl, and buprenorphine provided similar pain control, response rates, and safety profiles in patients with cancer pain, a study published in the journal Annals of Oncology has shown.1 Although guidelines tend to consider morphine and morphine-like opioids comparable and interchangeable in the treatment of chronic pain, individual responses can vary. Therefore, researchers sought to compare the analgesic efficacy, changes of therapy, and safety profile over time of 4 strong opioids. For the multicenter, phase 4 trial, researchers enrolled 520 oncologic patients with moderate to severe pain requiring World Health Organization (WHO) step 3 opioids. Participants were randomly assigned to receive oral morphine, oxycodone, transdermal fentanyl, or buprenorphine for 28 days. At each visit, investigators recorded patients’ pain intensity, therapy modifications, and adverse drug reactions. Results showed that worst and average pain intensity decreased over the 4-week period with no significant differences between the 4 groups. Researchers found that the nonresponse rate ranged from 11.5% in the morphine group to 14.4% with buprenorphine. The study also demonstrated that each group needed increases in the daily dose, ranging from 32.7% with morphine to 121.2% with transdermal fentanyl. The rate of adjuvant analgesic use ranged from 68.9% with morphine to 81.6% with oxycodone, and the rate of drug switches ranged from 12% with oxycodone to 22.1% with morphine. The rate of treatment discontinuation ranged from 14.5% with fentanyl to 27% with morphine. In terms of safety, adverse drug events were similar between the 4 drugs, except morphine was significantly associated with greater neurotoxicity. REFERENCE 1. Corli O, Floriani I, Roberto A, et al. Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase

Eye Motor Skills Damaged in Survivors of Childhood Cancer Chemotherapy agents commonly used to treat childhood cancer impair eyesight in a way that indicates an impact on the central nervous system (CNS). The damage occurs to the patient’s ability to follow moving objects with the eye (eye motor skills). CNS damage linked This study compared 23 survivors of to chemotherapy childhood cancer, currently age 20 to 30 years, with 25 healthy people of the same age. Among the survivors, most of them had experienced visual disorders,

headaches, and dizziness. The degree of the problem appeared to be related to the degree to which the eye motor skills had been affected, suggesting chemotherapy-associated damage to the CNS. Cisplatin, methotrexate, and ifosfamide, which these survivors had received as treatment, are known to cross the blood-brain barrier and thus damage the nervous system. This study examined the effects on eye motor skills and the resulting consequences. An average of 15 years had passed since the patients underwent cancer treatment. Age at the time of treatment seemed to have an important role, as the youngest patients at their time of treatment were most affected. The researchers argue that the medicines in question need to continue to be used, despite their risks, because curing cancer

TOP: © MEDICIMAGE / SCIENCE SOURCE; BOTTOM: © THINKSTOCK

4 ‘real life’ trial on the variability of response to opioids [published online ahead of print March 2, 2016]. Ann Oncol. doi:10.1093/annonc/mdw097.

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IN THE NEWS

Read more at http://bit.ly/1RpwvPg.

Experts’ Viewpoint Offers a Salve for Skyrocketing Cancer Drug Prices Oncology drug costs continue to rise, and the financial distress patients experience has led many to call for efforts to reduce oncology drug prices. Viable policy interventions will not be free and will involve tradeoffs, according to commentary from a team of experts. Doctors offer a plan Scott D. Ramsey, MD, PhD, exto cut drug prices pressed concern that regulating the price of cancer drugs could reduce patients’ access to some cancer medications. Ramsey is a physician, cancer researcher, and economist in his role as director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center in Seattle, Washington. Ramsey and 2 colleagues propose 3 policy interventions: (1) give public and private health insurers the ability to negotiate drug prices with manufacturers, (2) give insurers the ability to withhold a product from formularies if a drug’s price does not represent good value, and (3) provide for greater transparency of cancer drug pricing and better information on treatment choices. Read more at http:// bit.ly/1pxa5pG. In the News continues on page 19

LEFT: © SCIENCE SOURCE ; RIGHT: © BSIP / SCIENCE SOURCE

EOL Care Intensity for Patients With MDS May Be Suboptimal

and describes its long-term effects, and describes screening for cancer recurrence or second cancers, advice on healthy living, and support in the community. However, SCPs were not common practice a decade ago, so most of the study participants did not receive one. The researchers found that, even years later, cancer survivors still need health information related to their cancer. A lot of this information can be provided with the current format of the SCP. Furthermore, print is currently the preferred format; however, the study population was an older generation of cancer survivors who are now approximately 65 to 70 years old.

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Continued from page 15

PPB Regimen Feasible as Initial Therapy for Fit Patients With NSCLC Paclitaxel and pemetrexed with bevacizumab (PPB) produced a high response rate as initial therapy in treatment-naïve patients with advanced lung adenocarcinomas. For the phase 2 trial, researchers enrolled 44 patients with untreated, Adenocarcinoma of advanced lung adenocarcinomas the lung (red tissue) with measurable disease. Participants received paclitaxel 90 mg/m2 IV, pemetrexed 500 mg/m2 IV, and bevacizumab 10 mg/kg IV every 14 days for 6 months; followed by pemetrexed and bevacizumab every 14 days until disease progression or unacceptable toxicity. Results showed that 52% achieved a partial response, including 7 of the 16 patients harboring KRAS mutations. Researchers found that the 2-year overall survival rate was 43% and median survival was 17 months. In terms of safety, the most common grade 3 or 4 treatment-related toxicities included elevated ALT, fatigue, leukopenia, anemia, and elevated AST. Five percent of patients experienced grade 3 or 4 edema and pleural effusions each.

These survival and safety findings were comparable to previously reported phase 2 studies that assessed platinumcontaining doublets in combination with bevacizumab. Read more at http://bit.ly/1q0DcBD.

Dietary Glycemic Index Associated With Increased Lung Cancer Risk Consuming a diet with a high glycemic index, a marker of carbohydrate intake, was independently associated with an increased risk for developing lung cancer in non-Hispanic white persons. For the study, researchers assessed the glycemic index and glycemic load of 1905 patients with newly diagnosed lung cancer at MD Anderson Cancer Center and 2413 healthy controls who received care at Kelsey-Seybold Clinics, both in Houston, Texas. Patients who had never smoked with the highest daily glycemic index were 125% more likely to develop lung cancer than never smokers with lowest daily glycemic index. Among those with less than 12 years of education, patients with the highest glycemic index had a 75% higher risk of the disease. Read more at http://bit.ly/21FWoAl.

In The News

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NAVIGATOR NOTES

he American Society of Clinical Oncology recently held its 2016 ASCO Quality Care Symposium, a 2-day event focusing on strategies and methods for measuring and improving the quality and safety of cancer care. In this issue, the editors present some reports from the symposium specific to nurse navigation.

Standardized staffing model ensures efficiencies in outpatient chemotherapy centers Because nursing roles and

responsibilities and appropriate staffing levels were not established for the ambulatory oncology infusion suites across a health care system, whether nurses were working to their highest skill level or performing appropriate activities could not be determined. Furthermore, treatment across the system varied despite similar patient populations at the different sites, introducing unnecessary costs to the system as a whole. This project sought to establish a defined role for the infusion nurse, a target nurse-to-patient ratio, and create efficiencies within the clinical setting. To do this, daily patient volume and hours of operation were compiled for the outpatient sites across the health care system, and an acuity-based ratio tool, an hours per unit (HPU) method using billed charges for technical procedures, and a simple 1:6 nurse-to-patient ratio based on patient volume were used to determine nurse-to-patient ratio; all of which produced similar results. The project team chose a target nurseto-patient ratio of 1:6 as the model, and created a staff template for each site.

Enhancing Nurses’ Roles Improves Patient Care Joyce Pagán

In addition, the team observed workflows to determine potential staffing adjustments. The pilot site was initially staffed with 14 full-time nurses. Through process improvement, clear role delineation was created that maximized the

efficiency of the nursing team; the site now operates with 5 full-time nurses. The adjustments made maximized the efficiency of the nursing team, reduced costs, with no decline or compromise in quality of care or patient safety. Nurse involvement in oral chemo initiation improves patient care Many

of the safeguards for parenteral chemotherapy, including education by an oncology nurse, are not a part of initiating oral chemotherapy. A team of clinicians, nurses, and a pharmacist sought to improve the initiation process for oral chemotherapy at Beth Israel Deaconess Medical Center, using the 2013 American Society of Clinical Oncology/Oncology Nursing Society Standards as its framework. The team’s goal was to implement an intervention of comprehensive nursing education that included administration, safe handling, and side effects by the first follow-up visit as a part of oral chemotherapy initiation, and apply the intervention to at least 50% of patients by February 1, 2016. In the team’s first plan-do-study-act (PDSA) cycle, 10 new prescriptions were written between November 10, 2015, and February 1, 2016. Applying the intervention, 60% of patients were seen by a nurse and all received comprehensive education by their first followup appointment. The team plans to implement a second PDSA cycle, adding a follow-up call from a nurse 1 to 2 weeks after oral chemotherapy initiation. Ongoing assessment of the intervention will include evaluation of the impact of nurse education on patient satisfaction

Obtaining written informed consent improved from 0% to 75%, and documenting patient education improved from 37% to 80%. 20 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2016 • www.OncologyNurseAdvisor.com

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and measure nurse time for education to determine feasibility of expanding the intervention to all oncology clinics. Streamlined process improves informed consent and patient education Oral oncology medications are

self-administered, therefore, appropriate patient education directly impacts adherence to drug regimen. At this community-based medical oncology clinic, implied consent was obtained while providing patient education on side effects, but whether written informed consent was obtained was not documented. This was identified as a patient safety and risk management concern. A first step was to develop a new consent form that meets the American Societ y of Clinical Oncolog y/ Oncology Nursing Society safety standards. Packets including the new consent form and patient education materials were placed in a central location and reminder checklists were placed in examination rooms to prompt clinicians on the new process. Finally, clinicians were in-serviced on the new process, including contacting the nurse to initiate the new prescription and begin patient education before the patient left clinic. Using the plan-do-study-act technique, the intervention was implemented over a 6-month period from April to October 2015. Data were collected on 101 consecutive patients initiated on oral oncology drugs. Results at the end of the initial implementation period indicated obtaining written informed consent improved from 0% to 75%, and documenting patient education improved from 37% to 80%. Health literacy as a measure of ability to self-manage effects of oral therapy Researchers enrolled 125

patients from 10 oncology practices

in the Michigan Oncology Quality Consortium (MOQC) currently taking oral oncolytics to participate in an assessment of patient confidence in self-management of side effects of oral oncolytic agents. The participants were asked to complete an online survey that assessed demographics, clinical information, health literacy (3 items) and patient activation measure (PAM, 13 items). Differences by age, sex, education level, health literacy, and PAM level were examined. The PAM instrument assessed patient self-reported knowledge, skills, and confidence for self-management. In addition, participants were asked to

All patients reported that the video was a helpful addition to written materials. rate their confidence in self-managing fatigue, nausea, and diarrhea on a scale of 0 to 10. Patient demographics included age, 66.2 (SD, 13.6) years; sex, 57.7% were female; mean length of oral oncolytic therapy, 12.9 (SD, 13.8) months; and average number of medications, 5.9 (SD, 3.2). Patient activation levels were high for approximately three-quarters of participants (41.5% level 3 and 32.5% level 4), 8.9% were level 2, and 17.1% were level 1. Confidence in self-management of side effects was higher for nausea and vomiting (85.5% and 88.7%, respectively) than for fatigue (high 79%, moderate 12.1%, low 8.9%); however, 6.5% and 4.8% of patients reported low confidence in managing nausea and vomiting, respectively.

When combined, conf idence in managing each of the 3 symptoms was higher by a statistically significant degree among patients with higher health literacy (P = .001), higher PAM levels (P = .018), and older patients (P = .041). Videos are effective learning tools for patients Patient education is a criti-

cal element in enhancing patient preparedness and survivorship, especially for patients undergoing complex treatments such as hematopoietic stem cell transplantation (HSCT). An essential part of counseling for these patients is diet-related education to prevent infectious complications. Current practice involves clinicians engaging patients in a one-on-one discussion, with printed take-home materials. However, these researchers sought to determine if a video-based teaching tool could strengthen the learning process for patients and their caregivers, particularly older patients. First, focus groups of patients, nurses, physicians, pharmacists, and dietitians were asked semistructured questions about topics and institutional protocols that could be presented in the video. After refinement of content and usability, the video was presented to 10 patients admitted to the hospital for HSCT and their caregivers. The patients were instructed on using the video and given unlimited time to view it. In a feedback survey, all the patients reported that the video was a helpful addition to the written materials provided, and the content was consistent and easy to use. Two patients responded that the video was long but had positive comments on the comprehensiveness of the content, and 1 patient preferred having printed materials during food preparation. However, all the patients asked for the video to be available after discharge. â&#x2013;

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FEATURE | CAR T-cell Therapy

A Review of Chimeric Antigen Receptor T-cell Therapy The authors present an overview of this emerging targeted immunotherapy technique, and nurses’ role in recognizing and managing its toxicities. HOLLY MCCONVILLE, RN, BSN; MEGAN HARVEY, RN, BSN

Leukapheresis

Infusion

T-cell activation/ Lentivirus transfection

Modified T-cell expansion

FIGURE 1. CAR T-cell therapy is initiated with leukapheresis. The harvested T-cells are activated with antibody-coated beads and transfected with a lentivirus engineered to produce CAR expression on the T-cell surface. Modified T-cell expansion continues until quantity of CTL019 cells is sufficient for infusion. Lymphodepleting chemotherapy, administered prior to infusion allows the CTL019 cells to continue expanding after infusion.

he immune system plays an important role in preventing tumor initiation and development. It can prevent tumor development by both protecting a person from infection with oncogenic viruses and through tumor surveillance, by which the immune system targets cells that abnormally express tumor antigens.1 Cancer often develops when tumor cells evade immune surveillance or suppress the immune response, resulting in immune tolerance.2,3 Cell-based immunotherapies that overcome immune tolerance by reprogramming the immune system to make it more targeted and effective at eliminating tumor cells have been developed. One such therapy employs chimeric antigen receptor (CAR) T-cells, which are reprogrammed T-cells that selectively identify tumor cells and target them for destruction. The therapy involves harvesting a patient’s T-cells, genetically reengineering the cells in a laboratory, then infusing the reprogrammed T-cells back into the patient to seek and destroy tumor cells.4,5 In this article, we describe CAR T-cell therapy and the nurse’s role in caring for patients undergoing this therapy, based on our experience treating patients participating in CTL019 clinical studies. CTL019 is a CAR T-cell therapy being evaluated for the treatment of B-cell malignancies. CARS AND T-CELLS CARs are engineered fusion proteins consisting of an extracellular antigen-binding domain

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derived from an antibody and intracellular stimulatory domains. Second-generation CARs include an intracellular costimulatory region to enhance activation. A CAR therefore combines all of the cellular signaling components required to activate a T-cell. To express a CAR on a patient’s T-cells, the T-cells are harvested and genetically modified with a viral vector encoding the CAR.6 Several CAR T-cell therapies have been developed and clinically evaluated with a great deal of investigation directed at tumors that express CD19, a cell surface protein expressed in most B-cell malignancies including acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and most B-cell lymphomas.7,8 CTL019, a CD19-targeted CAR T-cell therapy developed at the University of Pennsylvania, has been in clinical investigations since 2010 and was the first CAR T-cell therapy to be given breakthrough therapy designation status by the US Food and Drug Administration. HOW CAR T-CELL THERAPY WORKS Patients were consented and the risks associated with therapy are described prior to initiating the clinical trial; but given the complexities of the therapy, risks were also discussed throughout the clinical trial. Figure 1 illustrates the CTL019 therapy process.6,9,10 To begin therapy, T-cells are harvested from the patient by leukapheresis, whereby whole blood is removed from the patient, mononuclear cells (including T-cells) are separated, and the remaining blood components are returned to circulation. The patient undergoes clinical examination at least 1 day prior to the apheresis procedure to determine whether the collection can be obtained peripherally or whether the patient will require a central venous catheter. If a central venous catheter is required, it is usually placed the morning of the collection and removed after the procedure. Patients are instructed to inform the apheresis nurse about any symptoms during the procedure. The most common side effect during apheresis is citrate toxicity, which can cause paresthesia, flushed sensation, nausea, and vomiting; it is caused by citrate binding to calcium in the patient’s blood in the apheresis tubing during collection.11 Oral calcium carbonate (TUMS) usually alleviates symptoms associated with citrate toxicity; however, a calcium infusion is occasionally needed. After apheresis, the T-cells are sent to a manufacturing facility at University of Pennsylvania or one designed for Good manufacturing practice-grade production of CTL019

cells. The T-cells are activated on antibody-coated beads then transfected with a lentivirus engineered to incorporate the genetic material encoding the CAR, producing CAR expression on the T-cell surface and the generation of CTL019 cells. The CTL019 cells are allowed to multiply until a quantity sufficient to initiate treatment has developed; this typically takes approximately 3 to 4 weeks. The patient undergoes lymphodepleting chemotherapy prior to infusing the CTL019 cells to facilitate their expansion after infusion. A review of lymphodepleting chemotherapy and its potential side effects is conducted, and patients must recover from all chemotherapy-related toxicities before the CTL019 infusion. Additional pretreatment medications include acetaminophen and diphenhydramine/H1 antihistamines. Steroids, however, are not administered as part of the preinfusion medication regimen. The reprogrammed T cells have the potential to expand postinfusion, generating additional CTL019 cells programmed to hunt CD19-positive tumor cells. This expansion appears to be necessary for the treatment’s antitumor activity. Lympholytic and immunosuppressive agents may diminish CAR T-cell expansion, thereby reducing its antitumor efficacy. Therefore, avoiding these agents is recommended; steroids should also be avoided. Therapeutic or higher doses of steroids should be stopped more than 72 hours prior to

The reprogrammed T cells have the potential to expand postinfusion, generating additional CTL019 cells. infusion of CTL019 cells, as they might affect the CAR T-cell activity. Patients may not receive steroids during and after CTL019 therapy unless they develop severe cytokine release syndrome (CRS) or steroid therapy is clinically indicated. EFFICACY AND SAFETY OF CTL019 THERAPY Results of pilot studies of CTL019 in patients with relapsed/refractory (r/r) ALL conducted at the University of Pennsylvania and the Children’s Hospital of Philadelphia were reported.12-14 Among a cohort of 59 pediatric patients, 55 (93%) achieved complete remission (CR) after treatment with CTL019.14 Other studies examining the use of CD19

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FEATURE | CAR T-cell Therapy CAR T-cells in r/r ALL reported similar efficacy, with CR rates ranging from approximately 70% to 90%.15,16 Other studies on CTL019 and other CD19 CAR T-cell therapies also reported efficacy in treating r/r CLL, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma.17-20 In patients with r/r CLL, reported CR rates for CAR T-cell therapy ranged from 10% to 29%.17,19,20 Among patients with r/r DLBCL and FL who were treated with CTL019, the objective response rate (ORR) was 50% (17% CR) and 100% (43% CR), respectively, at 3 months posttreatment.21 Another study reported an ORR of 63% to 86% (13% to 57% CR) in patients with r/r DLBCL and an ORR of 75% (0% CR) in patients with r/r FL using a CD19 CAR T-cell therapy.22,23 Clinical trials of CAR T-cell therapy for DLBCL and FL used smaller cohorts than the trial described above for ALL; cohorts ranged from 7 to 12 patients in the DLBCL trials, and 4 to 7 patients in the FL trials.21,23 Therefore, although CAR T-cell therapy holds promise as a treatment for these and other non-Hodgkin lymphomas (NHLs), data from more patients are needed before efficacy can be established. CAR T-cells also have potential for long-term persistence, which may protect against subsequent relapse. Long-term persistence seems to be a unique characteristic of CTL019 cells. In the analysis by Maude and colleagues, a 68% probability of detectable CTL019 cells at 6 months after CTL019 therapy was observed, and polymerase chain reaction (PCR)

A common toxicity associated with CTL019 therapy is cytokine release syndrome, a systemic inflammatory event. detected CTL019 cells in some patients at 2 years posttreatment.12 In the updated analysis of 59 pediatric patients with ALL, 6-month and 12-month relapse-free survival were 76% and 55%, respectively.14 CAR T cells also have potential in extramedullary disease and central nervous system (CNS) leukemia. In the seminal report by Maude and colleagues, 2 of 30 patients with ALL, treated with CTL019, had cerebrospinal fluid (CSF) blasts present prior to CTL019 therapy.12 These patients had no detectable CNS leukemia at 6 months, and no CNS relapses were observed.12 CTL019 cells were detected in the CSF of 17 of 19 patients with evaluable samples.12

TABLE 1. Grading System for CTL019-Associated CRS28 Grade 1: Mild Reaction • Treated with supportive care, such as antipyretics, antiemetics Grade 2: Moderate Reaction • Requiring intravenous therapies or parenteral nutrition • Some signs of organ dysfunction related to CRS • Hospitalization for management of CRS-related symptoms including fevers with associated neutropenia Grade 3: More Severe Reaction • Hospitalization required for management of symptoms related to organ dysfunction including grade 4 LFTs or grade 3 creatinine related to CRS • Includes hypotension treated with intravenous fluids or low-dose pressors, coagulopathy requiring FFP or cryoprecipitate, and hypoxia requiring supplemental oxygen Grade 4: Life-threatening Reaction • Complications such as hypotension requiring high-dose pressors, hypoxia requiring mechanical ventilation

POTENTIAL TOXICITIES Cytokine release syndrome Results from CAR T-cell

therapy studies are encouraging; however, the therapy is associated with serious toxicities that may require timely intervention. A common toxicity associated with CTL019 therapy is CRS, a systemic inflammatory event that results from the release of cytokines associated with the proliferation and activation of T-cells.12 These cytokines, including interleukin 6 (IL-6) and interferon-γ, produce systemic symptoms such as fever, nausea, chills, headache, rash, hypotension, and dyspnea when released into the circulation in high levels. CRS is also associated with many immunotherapies, including anti-CD20 monoclonal antibodies (eg, rituximab), bispecific antibodies (eg, blinatumomab), and several T-cell therapies.24 In patients with r/r ALL, mild CRS is typically observed within 4 days after CTL019 infusion; more severe cases usually manifest within 24 hours of treatment with fever. For patients with ALL, severity of CRS correlates with the patient’s baseline disease burden, as those with higher blast counts often experience more severe CRS symptoms. We observed CRS of any grade in 88% of pediatric patients with r/r ALL who were treated with CTL019.14 Other centers also reported CRS in patients with r/r ALL who were treated with CD19 CAR T-cell therapies.15,25-27 CRS manifests in both adult and pediatric patients with ALL with differing severities26,27; therefore, the syndrome is recognized as an expected, mechanism-based adverse effect associated with

24 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2016 • www.OncologyNurseAdvisor.com

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FEATURE | CAR T-cell Therapy the antitumor activity of CD19 CAR T-cells. The effect was also observed in 65% to 90% of patients with CLL who were treated with CD19 CAR T-cells.17-19 Extensive safety data are not yet available for CD19 CAR T-cells therapy in patients with NHL, but in a recent report, 2 of 30 (7%) patients with r/r NHL treated with CTL019 experienced CRS grade 3 or higher.21

Symptoms of TLS include nausea, vomiting, shortness of breath, irregular heartbeat, cloudy urine, lethargy, and joint discomfort. A novel CRS grading system and management algorithm was developed based on the clinical experience of patients with CRS treated at the University of Pennsylvania and Children’s Hospital of Philadelphia ( Table 1).28 Following CTL019 infusion, symptoms such as worsening respiratory distress, increased oxygen requirements, hemodynamic instability despite IV fluids, need for moderate-dose to high-dose vasopressor support, or rapid clinical deterioration require medical intervention. Increased levels of IL-6 have been reported in patients with more severe CRS caused by CAR T-cell therapy; the anti–IL-6 receptor antibody tocilizumab was used in these cases.29 Tocilizumab effectively reversed CRS in patients, and should be readily available for expedited administration to patients treated with CAR T-cells.12,30 If no improvement is seen after administering tocilizumab, additional management might include steroids. This is one of the few times when steroids would be administered to patients receiving CTL019 therapy. Nine of 30 patients with r/r ALL received tocilizumab for severe treatment-related CRS, which resulted in improvement in fever and hypotension.12 In addition, 6 patients also required glucocorticoids.12 Overall, of 97 evaluable patients at our institution, 3 patients were considered to have refractory CRS and died as a result.31 All of them were adults with ALL, and all had significant disease burden and concurrent infections.31 Coordinated nursing care between departments is essential for managing the treatment of patients with CRS. Written instructions given at the time of CTL019 infusion include what symptoms to watch for and who to contact if CRS is suspected. Usually developing a fever is the first symptom, and patients are instructed to call if their fever rises above

100.5°F. Patients must know how to contact a physician outside of normal business hours. A tocilizumab information sheet, and the potential of developing CRS, is reviewed and discussed with the patient at the time of CTL019 infusion. The most important aspect of caring for patients with CRS is education between all departments of the hospital, from the emergency department to the intensive care unit. All departments need to work together so patients are effectively treated throughout the hospitalization. Giving the patient a copy of the clinical trial documents so they are appropriately triaged at the emergency department should CRS occur is beneficial for both clinical staff and the patient. At our institution, the inpatient hospital pharmacy receives a weekly email regarding which patients will receive CTL019 therapy and which patients have recently received treatment to allow the pharmacy to have the necessary drugs, such as tocilizumab, in stock. CTL019 infusion may be administered on an outpatient basis, if deemed appropriate by the treating physician. Macrophage activation syndrome/hemophagocytic lymphohistiocytosis (MAS/HLH) is another potential adverse

event of CAR T-cell therapy. It may occur concurrently with or shortly after CRS. MAS and HLH are generally considered to be overlapping syndromes, can also occur outside of CTL019 therapy, and are characterized by excessive activation of well-differentiated macrophages.32 MAS/HLH associated with CAR T-cell therapy displays characteristic patterns of laboratory test results, including highly elevated ferritin, C-reactive protein, and D-dimer levels.14,17 In a small number of patients, profound hypofibrinogenemia was observed, which may require administering blood products.29 Patients may also develop elevated levels of transaminases and triglycerides; moderate marrow hemophagocytosis may subsequently occur. In severe cases, tocilizumab can effectively treat MAS/HLH, and is typically used for concurrent CRS in the context of CAR T-cell therapy.33 Tumor lysis syndrome (TLS), which occurs when tumor cells lyse and release large amounts of cellular contents into the bloodstream, has also been reported in patients undergoing CAR T-cell therapy, as well as other therapies that cause rapid killing of malignant B cells.9,34 Symptoms of TLS are caused by overwhelmed organ systems and include nausea, vomiting, shortness of breath, irregular heartbeat, cloudy urine, lethargy, and/or joint discomfort.35 TLS is best managed through monitoring and anticipating the syndrome. Monitoring includes testing calcium, potassium, phosphorus, creatinine, and uric acid levels at least 2 to 3 times per week, depending on laboratory test results. The management strategy generally includes fluid hydration, allopurinol, and/or rasburicase.

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Encephalopathy Neurologic toxicity has been described in several studies using CAR T-cell therapy for patients with ALL and NHL.12,16,22,23,30 In Maude and colleagues’ analysis, 13 of 30 patients experienced neurologic adverse events.12 These events ranged from delirium experienced during a high CRS-associated fever to global encephalopathy, which could include aphasia, confusion, and hallucinations. In another study, seizure-like activity in patients with CRS-associated neurologic toxicity was confirmed using electroencephalograms.30 Of the patients in our study who experienced high fevers, many had some degree of delirium, and a few patients experienced delayed encephalopathy independent of high fevers, CRS severity, or prior tocilizumab.12 Symptoms typically lasted 2 to 3 days. Although the pathophysiology of CTL019-associated encephalopathy is not well understood, it may be a result of the cytokine-mediated inflammatory state. However, neurologic toxicity did not appear to correlate with CRS severity, and was not prevented by tocilizumab. A noteworthy finding by Maude and colleagues is that CTL019-modified T-cells were detected in the CSF of 17 of 19 patients with evaluable samples, and only a fraction of these patients experienced encephalopathy.12 When neurologic symptoms manifest after a CTL019 infusion, the patient is examined and appropriate imaging studies are obtained. If clinically indicated, a lumbar

During the consent process for CTL019, patients are made aware they may require IVIG infusions due to B-cell aplasia. puncture may be performed, and the CSF is evaluated for the presence of CTL019 cells, infection, or disease relapse. B-cell aplasia CD19, the cell surface marker that directs CTL019 cells to target tumor cells, is also present on normal, nonmalignant B cells. As a result, CTL019 therapy targets and destroys these normal B cells as well as the leukemic cells, causing B-cell aplasia.36 Other researchers have also reported an association between CD19 CAR T-cell persistence and B-cell aplasia in patients with ALL, DLBCL, and CLL.16,19,23,27 In the most recent analysis of CTL019 in patients with r/r ALL, no serious infections or complications were observed as a result of B-cell aplasia12; however, because B cells produce antibodies, patients receiving CTL019 therapy often require intravenous immunoglobulin (IVIG) replacement therapy,

with administration based on local guidelines. During the consent process for CTL019, patients are made aware they might require IVIG infusions due to B-cell aplasia. IVIG infusions are usually administered in the outpatient setting by an infusion nurse. The side effects are reviewed with the patient prior to IVIG therapy. Patients know to immediately report any symptoms of infection to their physician and to have their immunoglobulin levels routinely checked. In clinical trials in which CAR T-cells persist for a shorter duration, concomitant B-cell aplasia is less of a concern; however, long-term B-cell aplasia may be associated with long-term tumor surveillance. THE POTENTIAL OF CTL019 AND CAR T-CELL THERAPY

Although CAR T-cell therapy is not without the potential for serious adverse events, the response rates achieved in patients who had exhausted most other therapies are encouraging, and not often seen in these patient populations. As CAR T-cell therapies continue to be studied, treatment protocols will improve, as will the CAR technology itself. Follow-up remains relatively short and number of patients treated is limited, but the potency of CAR T-cell therapy suggests this treatment strategy will become an important consideration in the management of patients with r/r B-cell malignancies. ■ Acknowledgments Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. The authors thank Matthew Hoelzle, PhD, for his assistance with this manuscript. They also thank Dr David Porter, MD, and Heather DiFilippo, MSN, CRNP from the University of Pennsylvania for their assistance. Holly McConville is nursing supervisor for the Clinical Trials Unit at University of Pennsylvania, Philadelphia. Megan Harvey is a clinical nurse, level III, at the Hospital of the University of Pennsylvania, in Philadelphia. REFERENCES 1. Schreiber RN, Old LJ, Smyth MJ. Cancer immunoediting: integrating immunity’s roles in cancer suppression and promotion. Science. 2011;331(6024):1565-1570. 2. Lu B, Finn OJ. T-cell death and cancer immune tolerance. Cell Death Differ. 2008;15(1):70-79. 3. Duttagupta PA, Boesteanu AC, Katsikis PD. Costimulation signals for memory CD8+ T cells during viral infections. Crit Rev Immunol. 2009;29(6):469-486. 4. Gross G, Waks T, Eshhar Z. Expression of immunoglobulin-T-cell receptor chimeric molecules as functional receptors with antibody-type specificity. Proc Natl Acad Sci U S A. 1989;86(24):10024-10028. References continue on page 28

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FEATURE | CAR T-cell Therapy 5. Eshhar Z, Waks T, Gross G, Schindler DG. Specific activation and targeting of cytotoxic lymphocytes through chimeric single chains consisting of

persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med. 2015;7(303):303ra139.

antibody-binding domains and the gamma or zeta subunits of the immu-

21. Schuster SJ, Svoboda J, Nasta S, et al. Phase IIa trial of chimeric antigen recep-

noglobulin and T-cell receptors. Proc Natl Acad Sci U S A. 1993;90(2):720-724.

tor modified T cells directed against CD19 (CTL019) in patients with relapsed

6. Kalos M, Levine BL, Porter DL, et al. T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci Transl Med. 2011;3(95):95ra73. 7. Scheuermann RH, Racila E. CD19 antigen in leukemia and lymphoma diagnosis and immunotherapy. Leuk Lymphoma. 1995;18(5-6):385-397. 8. Kershaw MH, Westwood JA, Slaney CY, Darcy PK. Clinical application of genetically modified T cells in cancer therapy. Clin Transl Immunol. 2014;3:e16. 9. Porter DL, Levine BL, Kalos M, Bagg A, June CH. Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med.

or refractory CD19+ lymphomas. J Clin Oncol. 2015;33(suppl):Abstract 8516. 22. Kochendoerfer J, Somerville R, Lu L, et al. Anti-CD19 CAR T cells administered after low-dose chemotherapy can induce remissions of chemotherapyrefractory diffuse large B-cell lymphoma. Blood. 2014;124(21): Abstract 550. 23. Kochenderfer JN, Dudley ME, Kassim SH, et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2014;33(6):540-549. 24. Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124(2):188-195.

2011;365(8):725-733. 10. Porter DL, Kalos M, Zheng Z, Levine B, June C. Chimeric antigen receptor therapy for B-cell malignancies. J Cancer. 2011;2:331-332. 11. Davenport A, Tolwani A. Citrate anticoagulation for continuous renal replacement therapy (CRRT) in patients with acute kidney injury admitted to the intensive care unit. NDT Plus. 2009;2(6):439-447. 12. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507-1517.

25. Curran K, Riviere I, Kobos R, et al. Chimeric antigen receptor (CAR) T cells targeting the CD19 antigen for the treatment of pediatric relapsed B cell ALL. Blood. 2014;124(21):Abstract 3716. 26. Turtle C, Sommermeyer D, Berger C, et al. Therapy of B cell malignancies with CD19-specific chimeric antigen receptor-modified T cells of defined subset composition. Blood. 2014;124(21):Abstract 384. 27. Gardner R, Park J, Kelly-Spratt K, et al. T cell products of defined CD4:CD8

13. Grupp S, Maude S, Shaw P, et al. T cells engineered with a chimeric anti-

composition and prescribed levels of CD19CAR/Egfrt transgene expres-

gen receptor (CAR) targeting CD19 (CTL019) have long term persistence

sion mediate regression of acute lymphoblastic leukemia in the setting

and induce durable remissions in children with relapsed, refractory ALL.

of post-allohsct relapse. Blood. 2014;124(21):Abstract 3711. 28. Porter DL, Lacey SF, Hwang W, et al. Cytokine release syndrome (CRS)

Blood. 2014;124(21):Abstract 380. 14. Grupp S, Maude S, Shaw P, et al. Durable remissions in children with relapsed/refractory ALL treated with T cells engineered with a CD19targeted chimeric antigen receptor (CTL019). Blood. 2015;126(23):

after chimeric antigen receptor (CAR) T cell therapy for relapsed/refractory (R/R) CLL. Blood. 2014;124(21):Abstract 1983. 29. Grupp SA, Kalos M, Barrett D, et al. Chimeric antigen receptor-modified T cells for acute lymphoid leukemia. N Engl J Med. 2013;368(16):1509-1518.

Abstract 681. 15. Park J, Riviere I, Wang X, et al. CD19-targeted 19-28z CAR modified autologous T cells induce high rates of complete remission and durable responses in adult patients with relapsed, refractory B-cell ALL. Blood.

30. Davila ML, Riviere I, Wang X, et al. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med. 2014;6(224):224ra25. 31. Frey NV, Levine B, Lacey SF, et al. Refractory cytokine release syn-

2014;124(21):Abstract 382. 16. Lee DW, Kochenderfer JN, Stetler-Stevenson M, et al. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet.

drome in recipients of chimeric antigen receptor (CAR) T cells. Blood. 2014;124(21):Abstract 2296. 32. Ravelli A. Macrophage activation syndrome. Curr Opin Rheumatol. 2002;14(5):548-552.

2014;385(9967):517-528. 17. Porter D, Frey N, Melenhorst J, et al. Randomized, phase II dose optimization study of chimeric antigen receptor modified T cells directed against CD19 (CTL019) in patients with relapsed, refractory CLL. Blood.

33. Maude SL, Barrett D, Teachey DT, Grupp SA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014;20(2):119-122. 34. Kochenderfer JN, Dudley ME, Carpenter RO, et al. Donor-derived CD19-

2014;124(21):Abstract 1982. 18. Brentjens RJ, Rivière I, Park JH, et al. Safety and persistence of adoptively transferred autologous CD19-targeted T cells in patients with relapsed or chemotherapy refractory B-cell leukemias. Blood. 2011;118(18):4817-4828. 19. Park JH, Rivière I, Wang X, et al. Impact of the conditioning chemotherapy on outcomes in adoptive T cell therapy: results from a phase I clinical trial of autologous CD19-targeted T cells for patients with relapsed CLL.

targeted T cells cause regression of malignancy persisting after allogeneic hematopoietic stem cell transplantation. Blood. 2013;122(25):4129-4139. 35. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Non-Hodgkin’s lymphomas. Version 2.2016. http://www.nccn.org/professionals/physician_gls/pdf/ nhl.pdf. Accessed February 25, 2016. 36. June CH, Maus MV, Plesa G, et al. Engineered T cells for cancer therapy.

Blood. 2012;120(21):Abstract 1797. 20. Porter DL, Hwang WT, Frey NV, et al. Chimeric antigen receptor T cells

Cancer Immunol Immunother. 2014;63(9):969-975.

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FEATURE | Skin Cancer Surveillance

A Call for Greater Skin Cancer Surveillance Among SOTRs Solid-organ transplant recipients are at increased risk for several cancers, in particular non-melanoma skin cancer and non-Hodgkin lymphoma. JOHN SCHIESZER, MA

Canadian study suggested that improved strategies may be needed for cancer prevention, screening, and surveillance among solid organ transplant recipients (SOTRs).1 Researchers found that SOTRs may be at very high risk of skin cancer. They looked at 11 061 SOTRs and found that they had a significantly higher risk of cancer death compared with the general population. “We found that transplant recipients were almost 3 times more likely to die of cancer than the general population. We found that for all types of cancer there was at least equivalent or excess mortality in transplant recipients. The excess risk of cancer mortality was highest for non-melanoma skin cancer and non-Hodgkin lymphoma,” said study author Sergio Acuna, MD, of the University of Toronto in Canada. However, he said these cancer types were not responsible for most cancer deaths. Nonmelanoma skin cancer accounted only for 3.3% of the cancer deaths. Most cancer deaths in transplant recipients were related to lung cancer (20.9%), liver malignancy (17.7%), non-Hodgkin lymphoma (15.9%), and colorectal cancer (7.1%). The study suggested that cancer is a leading cause of death in SOTRs and the authors of this study said the cancer incidence rates are expected to increase in the next 10 years as the median age of transplant recipients increases. “We were surprised to see the magnitude of the difference in cancer mortality. Despite the increased incidence of cancer in transplant

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FEATURE | Skin Cancer Surveillance recipients and reports of worse cancer outcomes in this population, we were expecting a smaller excess in the risk of cancer mortality given the multiple competing causes of death in this population,” said study co-author Nancy Baxter, MD, PhD, a professor in the Department of Surgery at St. Michael’s Hospital in Toronto, Canada. “It was also quite surprising to see that the risk of cancer mortality was higher than that of the general population in older transplant recipients and that the risk of cancer death was not restricted to long-term survivors, indicating that the burden of cancer mortality was substantial even early after transplantation.” For this investigation, Baxter and colleagues examined data from patients who underwent solid organ transplantation in Ontario, Canada, between 1991 and 2010. The analysis was conducted between November 2013 and February 2015. Mortality rates were examined by using data from the Canadian Organ Replacement Register, the Ontario Cancer Registry, and the Office of the Registrar General of Ontario death database. The investigators identified 6516 kidney recipients, 2606 liver recipients, 929 heart recipients, and 705 lung transplantation recipients. The median age was 49 (37 to 58) years, and 36% were female (n = 4004). The study showed there were 3068 deaths and 20% (n = 603) were cancer-related. Cancer mortality rates for SOTRs were found to be significantly elevated compared with the Ontario population with a standardized mortality ratio (SMR) of 2.84. In addition, the study showed that the risk remained elevated when patients with pretransplant malignant neoplasms (n = 1124) were excluded (SMR: 1.93). Interestingly, the study showed that the increased risk was irrespective of transplanted organ. “More research is needed to understand why these differences in cancer mortality exist between transplant and nontransplant patients. Moreover, strategies for targeted cancer screening and to improve the outcomes of transplant recipients who develop cancer, specifically related to the management of immunosuppression during cancer treatment, are also needed,” Acuna reported. The study showed that SOTRs were at increased risk of nonHodgkin lymphoma mortality. However, researchers found that cardiothoracic recipients had the highest risk and there were several differences in site-specific risk of cancer mortality. The researchers found that liver transplant recipients were at increased risk of dying from posttransplant de novo liver cancers. They also found that only kidney recipients were at increased risk of mortality from leukemia, melanoma, colorectal, oral cavity/pharynx, and prostate cancer. The investigators noted that a tailored approach to cancer screening may be required for SOTRs. Kidney recipients

should be especially cautioned to take all available steps to prevent skin cancer. “Screening can really help for preventing poor outcomes of skin malignancies,” Baxter explained. “Oncologists should be aware that these patients are not only at increased risk of developing skin malignancies, but also at increased risk of dying of cancer.” Acuna said it is important that clinicians involved in the care of transplant recipients follow the current recommendations for cancer screenings in SOTRs. Clinicians should start cancer screenings early after transplantation and have a high level of suspicion to identify malignancies at earlier stages.

Immune suppression strategies are improving and this may also affect cancer risk among SOTRs in the coming years. In addition, clinicians involved in the care of transplant recipients should counsel them to take every possible precaution to reduce their cancer risk, including limiting sun exposure, quitting smoking, reducing alcohol consumption, improving their diet, and increasing their physical activity. Medical oncologist Khaled Tolba, MD, who is an assistant professor at Oregon Health & Science University, in Portland, said this is a very important study because it demonstrated specific types of cancer that may pose a greater risk in SOTRs. He said immune suppression strategies are improving and this may also affect cancer risk among SOTRs in the coming years. “The immune suppression will expose the patient to several viral infections and some of them might be oncogenic and lead to skin cancer or other solid tumors. In a normal person, the viral infection will get cleared but that is not the case with solid organ transplant recipients,” Tolba said. “This is definitely a concern and it is has been known for a long time. However, we are learning more about the immune suppression and we might be able to better manipulate it to prevent the problem posed by viral infections.” ■ REFERENCE 1. Acuna SA, Fernandes KA, Daly C, et al. Cancer mortality among recipients of solid-organ transplantation in Ontario, Canada [published online ahead of print January 7, 2016]. JAMA Oncol. doi:10.1001/ jamaoncol.2015.5137.

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FEATURE | Activity-based Support Group

The Art of Coping: Creating an Activity-based Support Group The simple childhood pleasure of a coloring book and crayons provides the foundation for a unique support group for patients with cancer. CLAIRE GRAINGER-VALVANO, LCSW, OSW-C

any of us can travel back to our childhood and recollect gathering our crayons and harnessing their power to create fantastic works of art on paper, placemats, chairs, or walls. Coloring not only fostered our imagination, but helped us develop our skills in following directions, self-soothing, and expressing our feelings. Recent studies propose that the crayons we put away in our youth, in an effort to be perceived as “grown up,” may in fact help us as adults as a form of relaxation. Interestingly, as children and adolescents, we tend to let go of the very things that could have kept us calm and soothed us as we aged rather than forgetting how to relax and getting caught up in the whirlwind of life. Recent studies, articles, and television segments piqued my interest on coloring as a relaxation tool. As part of CancerCare’s goal to develop effective programs targeted to people with cancer and their loved ones, I saw the activity as an opportunity to create an innovative group program to reduce stress and enhance coping skills for our clients. Nancy A. Curry, BA, and Tim Kasser, PhD, in their article “Can Coloring Mandalas Reduce Anxiety?” detailed their fascinating study in which 84 undergraduate students were randomly assigned to 1 of 3 group coloring projects.1 The projects were a mandala, a geometric pattern, or freeform coloring on a blank piece of paper.1 Results indicated a greater reduction in anxiety among those participants who colored geometric

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FEATURE | Activity-based Support Group patterns or mandalas. Those participants who colored free form had no significant reduction in anxiety. The authors hypothesized that coloring a pattern takes a certain amount of focus and thought. That focus and thought, which is not used in free-pattern coloring, allows the artist to get caught up in the creation, and in some respect, remove them from life’s general anxiety.1 A DIFFERENT KIND OF SUPPORT PROGRAM Aided by my supervisor, a strong proponent of a varied group curriculum, CancerCare launched its Meditative Mandala support group as a 4-week trial of weekly 90-minute sessions. Although the program name specified mandalas, group members were given the option of coloring a mandala or another type of pattern. Group sessions included a 15-minute tutorial of a positive psychology technique members might employ in their lives. Setting the stage for relaxation included playing background music, such as music from The Cistercian Monks of Stift Heiligenkreuz or classical genres. Members stated the contemplative music enhanced the group experience, as they tapped into their inner artist and began to awaken the right side of their brain.

The approach allowed our clients an opportunity to join a group that was not focused on cancer, but rather [on] living. The group comprised of 6 women, all of whom were in active treatment for cancer or had completed treatment within the past year. Most cancer support groups tend to delve into sharing names, backgrounds, and cancer stories with each other. In this group, however, members were allowed to share just as much as they felt comfortable with. This, initially for some, meant simply stating her name. As the group progressed, there was much quiet chatting and sharing of stories, personal coping techniques, and hope, and what the concept means to them. There is no want for glorious coloring books. From flowers to animals to mandalas to inspirational quotes, the world is one’s oyster in terms of finding that perfectly themed coloring book. The group participants found that colored pencils tended to work best. They are thinner and do not have ink that runs, but be sure to have a great sharpener on hand.

We know that groups can be a most positive experience, but groups are also work; participants need to make a personal decision to come to the sessions, get involved with the other participants, and make the group personally important to make them effective. This group’s members did so, some postponing time away to support self, others, and to promote the strength of the group foundation. Each session built on the previous week’s meeting, and missing a session is to weaken a link. The group unfolded in such a way that members would reflect on previous weeks and whether a coping technique learned within group was helpful and how they employed it in their lives. BENEFITS ABOUND Admittedly, I find relaxing difficult, but I noted that our sessions would fly by, as I along with my members would get caught up in the poetic solitude of creating our artwork. The finished works were frame worthy, and no two were alike in terms of colors or technique used, even if the pieces were created by the same participant/artist. In regard to group members’ feedback, one participant reported, “Everyone knew why we were at the group, but we didn’t have to talk about the cancer, and we got to talk about positive things in our lives.” The participants noticed a strong camaraderie develop within the group, and that the coloring provided an escape from the rush of the day and promoted relaxation. The approach allowed our clients an opportunity to join a group that was not focused on cancer, but rather living, laughing, sharing while enjoying a meditative activity. Another poignant comment from a participant was, “It allowed me to not think of having cancer for a bit.” All the participants discussed wanting to take their blood pressure before and after each session, which was not possible as I am not certified in this area, but they noted feeling that their blood pressure had probably dropped and felt a great serenity and less anxiety. The participants felt the program was too short and should be extended to 8 weeks. Perhaps it’s time for you to step back into that crayon box, and try coloring for yourself, and your patients. Chances are your newfound inner calm will have a ripple effect in your life. ■ Claire Grainger-Valvano is Healing Hearts Program Coordinator at CancerCare. REFERENCE 1. Curry N, Kasser T. Can coloring mandalas reduce anxiety? J Am Art Ther Assoc. 2005;22(2):81-85.

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The approach allowed our clients an opportunity to join a group that was not focus on cancer, but rather [on] living. The group comprised of 6 women, all of whom were in active treatment for cancer or had completed treatment within the past year. Most cancer support groups tend to delve into sharing names, backgrounds, and cancer stories with each other. In this group, however, members were allowed to share just as much as they felt comfortable with. This, initially for some, meant simply stating her name. As the group progressed, there was much quiet chatting and sharing of stories, personal coping techniques, and hope, and what the concept means to them. There is no want for glorious coloring books. From flowers to animals to mandalas to inspirational quotes, the world is one’s oyster in terms of finding that perfectly themed coloring book. The group participants found that colored pencils tended to work best. They are thinner and do not have ink that runs, but be sure to have a great sharpener on hand.

32 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2016 • www.OncologyNurseAdvisor.com

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STAT CONSULT Elotuzumab (Empliciti) Drug Type

• Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7)-directed immunostimulatory antibody

Indications

• Treatment of patients with multiple myeloma who have received 1 to 3 prior therapies, in combination with lenalidomide and dexamethasone Mechanism of Action

• Elotuzumab is a humanized IgG1 monoclonal antibody that specifically targets the SLAMF7 protein • SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities and on natural killer cells, plasma cells, and at lower levels, on specific immune cell subsets of differentiated cells within hematopoietic lineage • Elotuzumab directly activates natural killer cells through both SLAMF7 pathway and Fc receptors Dosage and Administration

• 10 mg/kg intravenously • Administer every week for first two 28-day cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity • On days that empliciti is administered, give dexamethasone 28 mg orally 3 to 24 hours prior plus 8 mg intravenously 45 to 90 minutes prior ——Also give dexamethasone 40 mg orally on days 8 and 22 of cycle 3 and all subsequent cycles • Give lenalidomide 25 mg orally on days 1 to 21 • Infusion rate: Initiate elotuzumab infusion at a rate of 0.5 mL/minute ——Increase infusion rate in a stepwise fashion ■■ Cycle 1, dose 1 »» 0 to 30 min: 0.5 mL/min »» 30 to 60 min: 1 mL/min

»» 60 min or more: 2 mL/min Cycle 1, dose 2 »» 0 to 30 min: 1 mL/min »» 30 min or more: 2 mL/min ■■ Cycle 1, doses 3 and 4 and all subsequent cycles »» 2 mL/min ——Adjust infusion rate following a grade 2 or higher infusion reaction ——Infusion rate may be increased to a maximum of 5 mL/min in patients who have received 4 cycles of treatment • Premedication ——Administer 45 to 90 minutes prior to elotuzumab infusion ■■ Diphenhydramine 25-50 mg PO or IV or equivalent H1 blocker ■■ Ranitidine 50 mg IV or 150 mg PO or equivalent H2 blocker ■■ Acetaminophen 650-1000 mg orally ■■

Dosage Adjustments

• If dose of 1 drug in the regimen is delayed, interrupted, or discontinued, treatment with the other drugs may continue as scheduled ——But if dexamethasone is delayed or discontinued, decision to administer elotuzumab is based on clinical judgment (ie, risk of hypersensitivity) • If grade 2 or higher infusion reaction occurs, interrupt infusion and institute appropriate medical and supportive measures ——Upon resolution to grade 1 or lower, restart elotuzumab at 0.5 mL/min and gradually increase

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STAT CONSULT at a rate of 0.5 mL/min every 30 min as tolerated to rate at which infusion reaction occurred ——Resume the escalation regimen if there is no recurrence of infusion reaction • In patients who experience an infusion reaction, monitor vital signs every 30 minutes for 2 hours after end of elotuzumab infusion ——If infusion reaction recurs, stop elotuzumab infusion and do not restart on that day ——Severe infusion reactions may require permanent discontinuation of elotuzumab therapy and emergency treatment Specific Populations

• Pregnancy ——Not established for elotuzumab ——Lenalidomide is contraindicated for use in pregnancy • Nursing mothers ——Breastfeeding is not recommended • Pediatric ——Not established • Geriatric ——No overall differences in safety of effectiveness were observed between geriatric patients and younger patients Boxed Warnings and Contraindications

• None Warnings and Precautions

• Infusion reactions ——Premedication is required ——Interrupt elotuzumab for grade 2 or higher infusion reactions and permanently discontinue for severe infusion reaction • Infections ——Monitor for fever and other signs of infection ——Treat promptly • Hepatotoxicity ——Monitor liver function and stop elotuzumab if hepatotoxicity is suspected • Inference with determination of complete response ——Elotuzumab can interfere with assays used to monitor M-protein ——This interference can impact the determination of complete response • Second primary malignancies ——Higher incidence of second primary malignancies were observed in a controlled clinical trial of patients with multiple myeloma receiving elotuzumab

Adverse Effects

• Most common adverse reactions in combination with lenalidomide and dexamethasone (>10%): ——Cataracts, constipation, cough, diarrhea, decreased appetite, fatigue, headache, lymphopenia, nasopharyngitis, oropharyngeal pain, pain in extremities, peripheral neuropathy, pneumonia, pyrexia, upper respiratory tract infection, vomiting, weight loss Drug Interactions

• None What to Tell Your Patient

• Elotuzumab is a prescription medicine used to treat multiple myeloma in combination with medicines lenalidomide and dexamethasone • Elotuzumab is only for people who have received 1 to 3 prior treatments for their disease • Tell your nurse or doctor about all of your medical conditions, including if you have an infection • Tell your nurse or doctor about all the medicines you take • Pregnancy, nursing mothers, and if you plan to conceive a child ——Pregnancy is not recommended because elotuzumab is administered with lenalidomide, which may cause embryo-fetal harm and is contraindicated for use in pregnancy. ■■ All patients must agree to the REMS program instructions for lenalidomide, which has specific requirements about contraception, pregnancy testing, blood donation, and sperm donation. ——Tell your doctor or nurse right away if you think you may be pregnant or become pregnant during treatment ——Breastfeeding is not recommended because elotuzumab is administered with lenalidomide/dexamethasone. • Elotuzumab is administered by IV infusion into your vein • Your treatment schedule is divided into cycles that are 28 days (4 weeks) long ——A cycle includes the number of days you receive treatment and the days of rest between treatments. • Elotuzumab, in combination with lenalidomide and dexamethasone, is usually given as follows: ——Cycles 1 and 2, you will receive elotuzumab 1 time every week ——Cycles 3 and up, you will receive elotuzumab 1 time every 2 weeks • Your doctor will decide how many treatments you will receive Continued on page 36

34 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2016 • www.OncologyNurseAdvisor.com

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STAT CONSULT Uridine triacetate (Vistogard) Drug Type

• Pyrimidine analog

Indications

• Emergency treatment of adult and pediatric patients — Following a fluorouracil (5-FU) or capecitabine overdose regardless of presence of symptoms — Exhibit early onset, severe, or life-threatening toxicity affecting the cardiac or central nervous system, and/ or early onset, unusually severe adverse reactions (eg, gastrointestinal toxicity and/or neutropenia) within 96 hours following end of 5-FU or capecitabine administration

• • • • •

Limitations of Use

• Not recommended for nonemergent treatment of adverse reactions associated with 5-FU or capecitabine because it may diminish eﬃcacy of these drugs • Safety and eﬃcacy of uridine triacetate initiated more than 96 hours following the end of 5-FU or capecitabine administration have not been established Mechanism of Action

• Uridine triacetate is an acetylated pro-drug of uridine • Following oral administration, uridine triacetate is converted to uridine in the circulation, which competitively inhibits cell damage and cell death caused by fluorouracil Dosage and Administration

• Dosage — Adults: 10 g (1 packet) PO every 6 hours for 20 doses — Pediatric: 6.2 g/m2 of body surface area (not to exceed 10 g/dose) PO every 6 hours for 20 doses • Administer without regard to meals • Administer as soon as possible after an overdose or early

•

onset toxicity within 96 hours following end of 5-FU or capecitabine administration Administer full course of 20 doses as directed Mix each dose with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt and ingest within 30 minutes; do not chew granules Patient should drink at least 4 ounces of water If a patient vomits within 2 hours of dose, initiate another complete dose as soon as possible after vomiting episode; administer next dose at regularly scheduled time If a patient misses a dose, administer that dose as soon as possible; administer next dose at regularly scheduled time Administer via a nasogastric tube (NG tube) or gastrostomy tube (G-tube) when necessary (eg, severe mucositis or coma) — Prepare approximately 4 fluid ounces (about 100 mL) of a food starch-based thickening product in water and stir briskly until the thickener has dissolved — Crush contents of 1 full 10-gram packet of granules to a fine powder. — Add crushed granules to reconstituted thickener product ■ For pediatric patients receiving less than 10 grams, prepare mixture at a ratio of no greater than 1 g/10 mL of reconstituted food starch-based thickening product and mix thoroughly — After administration using NG tube or G-Tube, flush tube with water

Specific Populations

• Pregnancy — Not established • Nursing mothers — Developmental and health benefits of breastfeeding

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STAT CONSULT should be considered along with mother’s clinical need for uridine triacetate and any potential adverse effects on the breastfed infant from uridine triacetate or from underlying maternal condition • Pediatric ——Not established • Geriatric ——Not established Boxed Warnings, Contraindications, Cautions

• None Adverse Effects

• Most common adverse reactions (>2%; N=135) ——Vomiting (10%) ——Nausea (5%) ——Diarrhea (3%) Drug Interactions

• Uridine triacetate is a weak substrate for P-glycoprotein, and therefore may interact with known P-glycoprotein substrates, such as digoxin

Stat Consult | Elotuzumab (Empliciti) Continued from page 34

• If you miss any appointments, call your nurse or doctor as soon as possible • Elotuzumab may cause serious side effects ——Infusion reactions ■■ Your nurse will give you medicines before each infusion of elotuzumab to help reduce the risk of an infusion reaction ■■ Infusion reactions can happen during your infusion or within 24 hours after your infusion ■■ If you have an infusion reaction during treatment, your nurse will slow or stop your infusion and treat your reaction ——Risk of new cancers ■■ Ask your nurse or doctor any questions you may have about the risk of developing new cancers while on this medication ——Your doctor or nurse will check for the development of new cancers during your treatment • Infections ——Tell your nurse or doctor right away if you have fever,

What to Tell Your Patient

• You are taking this drug because you are experiencing an overdose of your anticancer treatment (fluorouracil or capecitabine) • You must take all 20 doses, even if you feel well • Uridine triacetate should be taken mixed in 3 to 4 ounces of a soft food such as applesauce, pudding, or yogurt • Oral granules are orange-flavored • Uridine triacetate granules should not be chewed • Drink at least 4 ounces of water • If you vomit within 2 hours of taking a dose of uridine triacetate, take another complete dose as soon as possible after vomiting ——Take the next dose at the regularly scheduled time • If you miss a dose at the scheduled time, take that dose of uridine triacetate as soon as possible ——Take the next dose at the regularly scheduled time • The most common adverse reactions associated with uridine triacetate ——Diarrhea, nausea, and vomiting Prepared by Jason Hoffman, PharmD, RPh.

flu-like symptoms, cough, shortness of breath, painful skin rash, or burning with urination • Liver problems ——You will need to have blood tests done to monitor your liver function during treatment ——Tell your nurse or doctor if you experience any signs or symptoms of liver problems, such as tiredness, weakness, loss of appetite, yellowing of your skin or eyes, color changes in your stool, constipation, or abdominal swelling • Most common side effects of elotuzumab ——Constipation; cough; decreased appetite; diarrhea; fatigue; fever; numbness, weakness, tingling, or burning pain in your arms or legs; pneumonia; sore throat or runny nose; upper respiratory tract infection • These are not all of the possible side effects of elotuzumab ——For more information, ask your nurse, doctor, or pharmacist • Tell your nurse or doctor about any side effects you experience Prepared by Jason Hoffman, PharmD, RPh.

36 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2016 • www.OncologyNurseAdvisor.com

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RADIATION & YOUR PATIENT share information. The American Society for Radiation Oncology (ASTRO) recently published a new template to help streamline and standardize long-term SCPs for patients who have undergone radiation therapy.

W Radiotherapyspecific SCPs Improve Care Planning Bryant Furlow Cancer survivorship care plans (SCPs) are designed to help clinicians and patients coordinate and communicate about post cancer treatment health care needs, providing a record of the care a patient received, their disease characteristics, and follow-up plans that integrate available evidence-based standards of care, including surveillance and monitoring of potential late effects of treatment. Barriers to SCP implementation include competing time demands, cost and a lack of reimbursement, and a paucity of guidelines and systems to streamline the SCP process. To date, oncology nurses frequently piece together survivorship templates and plans with information from systems and records that are not always designed to

ith advances in cancer care, the American Cancer Society (ACS) predicts that 37% of patients with cancer will survive 5 years or longer over the next 10 years. As a result of improved survival rates and the aging of baby boomers into ages of high cancer incidence, the US population of cancer survivors is expected to approach 19 million people by 2024.1 The American Society of Clinical Oncology (ASCO), ACS, and other bodies have begun to release survivorship care plan (SCP) development tools, including generic and cancertype-specific guidelines and templates. However, few such tools specifically detail the survivorship issues and needs of patients who have undergone radiation therapy as part of their cancer treatment. This has frequently fallen to oncology nurses to create templates addressing these needs, piecing together information from disparate sources. But the American Society for Radiation Oncolog y (ASTRO) recently published a new SCP template to help streamline and standardize long-term care planning for radiation therapy patients, to help close this gap and facilitate completion of SCPs that summarize patient treatment history and needs for future care.2 The ASTRO template includes information about late effects of radiation exposure, as well as general and contact information on preventive, supportive, financial, and nutrition-counseling services.2 Approximately 60% of patients with cancer undergo radiation therapy

as part of their care, notes Ronald Chen, MD, MPH, an associate professor in the Department of Radiation Oncology at the University of North Carolina at Chapel Hill and lead author on the paper presenting the new SCP template. The American College of Surgeons Commission on Cancer (CoC) mandates that as of January 1, 2015, cancer centers were providing SCPs to 10% of eligible patients upon completion of curative-intent cancer treatment.1 By January 1, 2017, half of all eligible patients—and by January 1, 2019, all eligible patients—must receive SCPs upon completion of curative-intent cancer treatment, in order for cancer centers to maintain accreditation.1 But a March 2014 survey of ASTRO members indicates that although “almost all providers follow their patients after treatment,” only 53% are aware of the CoC’s SCP accreditation requirements benchmark for 2015.1

Three key barriers: cost, duplication of efforts, and lack of guidelines. Only 40% of radiation therapy programs surveyed are completing SCPs for curative patients, the survey found, and fewer than 20% provide SCPs to patients undergoing palliative care.1 Components of information included in SCPs are frequently provided to patients after radiation therapy, the survey found, such as summaries of treatment, contact information for providers and ancillary services, or a summary of further tests, side effects, preventive and

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RADIATION & YOUR PATIENT health-promoting behaviors, and surveillance recommendations, but typically, less than 60% of patients receive such information.1 And while 91% of SCPs that are completed are provided to patients, only 22% are provided to their primary care providers.1 The survey identified 3 key barriers to SCP implementation: cost, duplication of SCP efforts provided by multiple cancer care providers, and a lack of consensus or professional guidelines.1 Existing SCP templates are frequently deemed to be poorly suited for radiation therapy follow-up.1 Other barriers to SCP implementation include reimbursement issues and patient adherence.1 One-quarter of survey respondents also identified “unclear benefits” as a barrier to SCP implementation, reflecting the scare available evidence base for how SCPs affect patient outcomes. Respondents reported that incorporating survivorship care planning into electronic medical records would be useful.1 But to date, the vast majority of respondents (79%) report using internally developed SCP outlines. This situation means that patients will not likely receive equivalent survivorship care advice and information.1 The new ASTRO template should help change that situation, and help practices meet CoC accreditation benchmarks. It was designed to streamline preparation of patient-focused long-term survivor care following radiotherapy.2 “The ASTRO template is designed to foster better coordination of

FIND US ON

posttreatment care for cancer survivors, including greater clarity in the dialogue between radiation oncologists and primary care physicians for issues such as less-common side effects that may appear well after treatment is completed,” explained ASTRO Chairman Bruce D. Minsky, MD, FASTRO. “This 2-page template facilitates consistency in SCPs across the discipline and also reduces the time and effort required by providers to complete each

This will reduce the burden of creating two documents for each patient. individual plan,” Chen added. “The field of radiation oncology has a long tradition of creating treatment summaries for each patient, even before the Institute of Medicine recommended survivorship care plans in 2006. This radiation-oncology specific template will serve a dual purpose as both a traditional radiation oncology treatment summary and a plan for survivorship that meets CoC requirements.” This will reduce the burden of creating 2 documents for each patient, Chen said. The treatment-summary component of the ASTRO template outlines survivors’ diagnosis and disease-stage data; treatment details including site, radiation dose, and fraction schedules delivered; and contact information

for the radiation therapy providers.2 The follow-up care plan component includes anticipated radiation-associated side effects and potential late effects, expected course of recovery, possible functional and social impairments, prevention recommendations, including behavioral goals; additional cancer information and sources for more information; and referrals to supportive and ancillary care providers.2 A third page includes additional technical details of radiotherapy that are typically included in treatment summaries.2 In the future, disease-specific templates may be promulgated as well, Chen and his coauthors reported. 2 These “will include more granular details regarding expected toxicities and follow-up care recommendations,” and coordination with electronic medical record system vendors to “facilitate autocreation of SCP documents … to further reduce the burden of creating SCPs,” they reported.2 ■ Bryant Furlow is a medical journalist based in Albuquerque, New Mexico. REFERENCES 1. Koontz BF, Benda R, De Los Santos J, et al. US radiation oncology practice patterns for post-treatment survivor care. Pract Radiat Oncol. 2016;6(1):50-56. doi:10.1016/j. prro.2015.10.002. 2. Chen RC, Hoﬀman KE, Sher DJ, et al. Development of a standard survivorship care plan template for radiation oncologists. Pract Radiat Oncol. 2016;6(1):57-65. doi:10.1016/j. prro.2015.10.001.

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38 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2016 • www.OncologyNurseAdvisor.com

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COMMUNICATION CHALLENGES

Coping With Anorexia/Cachexia

Ann J. Brady, MSN, RN-BC

Anyone who takes care of oncology patients has faced this issue. Families/ caregivers approach the dilemma in a variety of ways.

he has to eat or she’ll starve to death. If he would eat he could get stronger and keep fighting. She is giving up. I fix the food he asks for but then he only takes a few bites. He won’t even try. There has to be something we can do; it isn’t natural not to eat. Can’t we make her eat? If he doesn’t eat he is going to die. It’s like suicide. It’s like we are killing him. How do you respond to family members focused on their loved one’s loss of appetite? What do you say when asked how to make a patient eat more? Anyone who has taken care of oncology patients has faced this issue. Families/caregivers may approach the dilemma in a variety of ways—with hypervigilance, frustration, anxiety, even anger—but the point they make is the same: eating means life, and by extension, not eating means death. We must eat to stay alive.

Eating is linked to physical health but also to emotional health. We enjoy taking meals together; we celebrate major events with food: births, weddings, holidays, and other milestones. We prepare food for those we love. In Maslow’s hierarchy of needs, the bottom of the pyramid is physiologic needs of which eating is a significant part. Our relationship with eating is complex and only more so when someone has a terminal illness. That a lack of eating causes alarm is not surprising. The question about poor food intake may occur at any time during the course of treatment but there are 2 significant transition points when the focus escalates: during active treatment when the incidence of nausea and anorexia is first encountered and at end of life (EOL) when the patient no longer has an appetite. Communication and education at these junctures is critical to avoid additional suffering for the patient and family. CASE Frank had colon cancer and had started his third round of chemo. His nausea was fairly well controlled with antiemetics but his appetite was poor. His wife was concerned that he was not eating enough. During his check-up with his med/onc, she said, “It doesn’t matter what I fix, he won’t eat.” Frank protested, “Nothing tastes good.” I wanted to address the concerns of Frank’s wife while honoring his autonomy, but what was the best way to do that? It’s easy to jump right into problem solving, but before introducing any nutritional education I needed to understand her concern. It may seem obvious that she was worried that not eating meant he would not be able to tolerate his treatment. But concerns usually have

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COMMUNICATION CHALLENGES

Lack of appetite is not unusual in cancer and normalizing this can reduce the stress associated with not eating.

many layers and “drilling down” (gently) revealed a lot. His wife prided herself on her cooking, telling me, “I’m a really good cook.” Frank nodded in agreement. And there was more; she considered his cancer diagnosis as something they were fighting together. Her part was taking care of him by fixing the foods he liked. While she had little control over the rest of his treatment, preparing good and nutritious food was something she could be in charge of. His difficulty eating negated her contribution to his care. It was important to remind her of why cancer patients lose their appetite. Treatment itself can cause nausea, and nausea impacts our desire to eat. I asked her to remember the last time she had a stomach flu. What would her response have been if someone tried to coax her into eating? DISCUSSION When a patient like Frank has trouble eating, the stakes are ratcheted higher because his family equates his poor appetite to giving up. Nutritional education is one strategy, but first we must assess a patient like Frank’s current situation in order to tailor the content of our teaching. Lack of appetite is not unusual in cancer and normalizing this can reduce the stress associated with not eating. An essential step is to rule out obstacles to poor appetite. Was he taking his antiemetics correctly? Often “as needed” nausea meds are interpreted by lay persons as “don’t take unless you are vomiting.” Poor appetite can

JOIN THE CONVERSATION • How do you respond to family members focused on their loved one’s loss of appetite? • What do you say when asked how to make a patient eat more?

ON THE

WEB

Go to http://bit.ly/1ZpCXfB for the online version of this article and share your experiences in helping patients’ families cope with cancer-related anorexia and cachexia in their loved ones with your colleagues.

be linked to low grade/ongoing nausea, what a patient may describe as queasiness or no interest in eating. Frank said, “Nothing sounds good to eat.” Constipation may also contribute to nausea so assessment and education regarding a good bowel regimen is important. Once an assessment is completed we can initiate an educational discussion such as: Utilizing strategies for making eating more appealing Small frequent meals should

be offered with a larger amount in the morning—this is different than our cultural tendency to have the larger meal in the evening. Mornings are when the patient will better tolerate food. Food should be served on a small plate since a large plate of food can be overwhelming to someone who already has a poor appetite. Even before they start to eat, seeing a large amount of food may be so daunting it negatively impacts the desire to eat. Have families be cautious about serving foods with a strong aroma or ones that create a strong aroma when being prepared, even if those are foods the patient has preferred in the past. Taste changes because of disease and/or chemo. Have the family keep a log of food intake and be certain the physician knows how much the patient is eating. Appetite stimulants may be useful.1 Create an environment conducive to eating Think of how the ambience of a

restaurant enhances our eating experience. Remind them of this. Can Frank’s wife create an atmosphere that encourages eating? Cheerleading as a strategy for promoting eating almost always back fires. “You can do it!” as a large plate is placed in front of him creates tension, which does not promote eating. Remember his body is saying no to food. When a patient reaches end of life the loss of appetite is intrinsically linked to that phase of disease. Anorexia at this stage is linked to disease rather than treatment. It is natural not to want to eat at end of life. Studies show that people at EOL are not thirsty or hungry because the disease itself causes a lack of appetite. The patient dies from the disease, not from withholding food. Families

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need to be reminded of this again and again since it goes against our natural inclinations. Encourage the family to continue to offer food. Treat eating like taking medicine; eat even if no appetite but never to the point of discomfort or emesis. CASE How do we reconcile the gap between supporting the patient and family and allowing the patient the room to refuse food? By the time a patient is close to dying both the patient and family are worn out. But hope remains, and “if only” thinking continues. All of the treatment options may be exhausted yet the family may think, “if only he would eat, everything would be okay.” Rescue thinking. Hope in the presence of despair. Cindy’s latest scan showed that her disease had progressed. She was tired and had no appetite. Even small amounts of food nauseated her. But she continued to try eating because not eating was an unacceptable option to her sister who was taking care of her. With the best of intentions, she badgered Cindy relentlessly about eating. Worse yet, she was angry that Cindy did not eat enough. Friends took the sister’s side, also well intentioned; they refused to allow Cindy to give up, which is what not eating represented. Cindy was angry, too. “They

are abusing me by trying to force me to eat.” Hearing Cindy describe her actions as abuse resonated with her sister. “I’m so sorry,” she said, “I just want to help you.” DISCUSSION It was important to remind her that Cindy was capable of making her own choices. No one needed to take over for her. Like Frank’s wife, Cindy’s sister felt helpless because neither could change the progression of disease. They are not medically trained, but they know how to prepare food! The communication challenge was to listen, clarify, support, and advocate for the patient even when it was contrary to the wishes of their loved ones. The questions we encounter as oncology nurses are varied, but sometimes the most difficult ones to answer are the ones patients and families think they know the most about. Eating is one of those. ■ Ann Brady is the symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California. REFERENCE 1. Jatoi A. Anorexia and cachexia. CancerNetwork Web site. http://www.cancernetwork.com/cancermanagement/anorexia-and-cachexia. Published June 1, 2015. Accessed February 26, 2016

The challenge was to listen, clarify, support, and advocate for the patient even when it was contrary to the wishes of their loved ones.

Do you have a story you want to share? Oncology Nurse Advisor welcomes narrative essays from oncology nurses for Reflections, our narrative medicine blog. Write 800 to 1,200 words about a patient or life experience that was meaningful to you or a perspective on oncology patient care, and email the manuscript to editor.ona@haymarketmedia.com.

www.OncologyNurseAdvisor.com • MARCH/APRIL 2016 • ONCOLOGY NURSE ADVISOR 41

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Hypnosedation: An Alternative Sedation Method for Patients Undergoing Glioma Resection Bette Weinstein Kaplan

he awake craniotomy is a wellaccepted surgical technique for resection of low-grade gliomas (LGGs).1 The procedure, which utilizes intraoperative electric stimulation, is able to preserve the functional integrity of structures surrounding the tumor. This asleep-awake-asleep (AAA) surgical method is associated with low rates of swelling, seizures, severe permanent deficits, and mortality. The patient, placed in a lateral decubitus position, is asleep for the often stressful surgical opening, then awakened to cooperate with the surgeon during the procedure, then asleep for the surgical closing. The AAA technique works well for surgery on LGGs, which often affect young adults. However, the technique has its limitations. In surgery on high-grade gliomas (HGGs), the lateral decubitus position can lead to difficulties with airway management in older patients, who are more likely to develop HGGs.1 An alternative to the AAA craniotomy is the fully awake procedure, which is performed without any sedation. Obviously, there are no anestheticrelated airway limitations with this technique. Another advantage is that no time is needed to wake up the patient, which can take from 10 to 40 minutes, for the patient-participation phase of the operation. However, some patients report intraoperative pain (20% to 44%),

considerable discomfort (20% to 29%), anxiety (29%), and fear (14%) with the fully awake method.1 A recent study explored a novel method for reducing the perioperative discomfort and trauma associated with fully awake craniotomy, while maintaining its excellent oncologic and functional results.

Hypnosis seemed to ameliorate the unpleasantness of surgical events. HYPNOSEDATION TECHNIQUE Ilyess Zemmoura, MD, PhD, of the CHRU de Tours, Bretonneau Hospital, in France, and his team recently offered the option of hypnosis as sedation (hypnosedation) to all patients at their medical center who were scheduled to undergo awake craniotomy for LGG resection. They also offered the novel alternative to 2 patients scheduled for HGG resection. Forty-three operations using hypnosedation were performed on 37 patients, ranging in age from 18 to 67 years, between May 2011 and April 2015. Six of the patients underwent repeat procedures for tumor regrowth during the study. Of the 37 patients, 5 had prior

surgery under general anesthesia, and 3 had undergone the AAA technique.1 For patients undergoing hypnosedation, preparation begins 1 month before surgery. Each patient is admitted to hospital for 1 day to undergo a complete neuropsychological assessment and functional magnetic resonance imaging (fMRI). While in hospital, the patients meet with the anesthesiologist, who is also the hypnotist, and discuss their hobbies and habits. The anesthesiologist also conducts a brief hypnosis session to introduce patients to the technique. As part of the introductory session, patients learn how to create an imaginary safe place where they could feel protected and secure during surgery. Once in the operating room, the anesthesiologist places the patient in a hypnotic trance, enhancing the trance during the more unpleasant and painful stages of surgery with instructions and storytelling imagery. He uses objective trance symptoms, such as the eye-roll sign, to evaluate the effectiveness of the hypnosis, and utilizes his knowledge of the patient’s hobbies and habits to personalize the storytelling. The technique did not work on all the patients. Six patients could not be induced into a hypnotic trance in the first few minutes, and their procedures were immediately and successfully converted to the AAA method. Continued on page 45

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Oncologist Finds the Benefits of Meditation for Himself, Then Shares It With His Patients Bette Weinstein Kaplan

ernando J. Camacho, MD, is a typically busy oncologist. He is the director of Community Oncology and the medical director of Integrative Oncology at Montefiore Einstein Center for Cancer Care, and clinical assistant professor in the Department of Medicine (Oncology) at Albert Einstein College of Medicine, both in New York City. Since he works at one of the country’s premier cancer facilities, Dr Camacho has a full armamentarium of medications and modalities available to him for treating his patients, including one he uses on himself: meditation. Dr Camacho is more than happy to share the benefits of meditation with his patients—and anyone else who would like to learn. He teaches the practice at both hospital locations.

MEDITATION CANDIDATES Dr Camacho does not recommend meditation for all of his patients, only those he feels would derive the most benefit from it. He will suggest meditation to someone who is unusually anxious or having difficulty dealing with the disease or its complications. The timing has to be right. He says that learning meditation is probably not ideal for patients while they are in the middle of active therapy, since they are busy with chemotherapy or radiation treatments and resting when they can. The patients who come to

his meditation sessions are usually survivors or patients with cancer who are doing well on their current treatment regimens. He notes that men typically do not go for help as much as women. Although he does have male patients in his classes, the breakdown is 20% men to 80% women. Participants range in age from 40 years to almost 80 years. THE SESSIONS Dr Camacho introduces his class participants to meditation by telling them, “This is a tool you can use to relieve some of your suffering.” He explains that the tool is free and readily available, and the only thing it requires is the patients themselves, and they can use the tool to help with all aspects of life. Each class is approximately an hour long. Dr Camacho spends part of each session talking with the patients, explaining how they can express their feelings. Although anxious people who are coping with cancer have difficulty concentrating, he teaches them to find a way to sit still for a while. Dr Camacho is right in there with them, helping them to calm down, explaining how the technique works and will empower them to take care of themselves and their health. He demonstrates some basic mindfulness breathing exercises and teaches them about walking meditation. Dr

Camacho explains how this is something they can readily do … they do not have wait until they are in a particular setting, nor must they be sitting to meditate. He assures his patients they can simply be very aware of the world, which is a type of meditation in itself. Once the technique is learned, some patients use meditation to achieve pain relief and some find it helps with anxiety. Dr Camacho says he has many patients who suffer from anxiety that is not necessarily related to their cancer, but related to their life and their fami-

The tool is free and readily available; the only thing it requires is the patients. lies. He is very aware that everything cancer patients experience is much more stressful because they are coping with the disease. WHY MEDITATION? Dr Camacho explains that, as an oncologist, witnessing the distress his patients experienced affected him, and he became significantly run down. At times, his patients’ agony would

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immobilize him so he was unable to function effectively. At that point, he began looking for coping techniques that “could help me deal with all the

“Because I found meditation so helpful, I thought to share it.” pain and suffering that life provides.” He explained he had been brought up with mostly Christian Western traditions, and although he liked them, he wanted to experience the philosophies

Survivorship Continued from page 42

Patients completed 4 questionnaires to evaluate their surgical experience: the Cohen Perceived Stress Scale and the Posttraumatic Stress Disorder Checklist Scale provided psychological assessment; the Peritraumatic Dissociative Experience Questionnaire and a questionnaire designed specifically for this study evaluated patients’ subjective hypnosis experience.1 EFFECTS OF HYPNOSIS Vibration felt during the burr hole procedure and removal of the bone flap are the most negatively reported stages of the procedure. Hypnosis seemed to ameliorate the unpleasantness of these and other surgical events. For example, administering local anesthetics during opening and closing is the most painful part of the surgery, yet few patients even mentioned it. Patients may be

of some of the Eastern religions as well. He began to read more, and eventually explored Buddhist traditions that taught him meditation. It changed his life; made him a better listener and a better person. Dr Camacho explained, “Our minds are very busy, always taking us to different places to which we don’t necessarily want to go. The whole point of meditation is to get you to concentrate on one thing. As a result, I find that I care for my patients just as much now, but I’m able to put it into the context of what the world is and not let it take over my thinking. So, because I found meditation so helpful and it was so soothing to me, I thought I needed to share it with people around me. That’s why I started these classes.”

experiencing a diminution of pain as the hypnotic trance intensifies. Interestingly, although some patients’ postprocedure rating scales indicated they experienced high stress levels, the patients reported that they found the hypnosis to be a positive experi-

Patients reported that they found the hypnosis to be a positive experience. ence. Even the 1 patient whose evaluation score indicated posttraumatic stress disorder following the procedure reported his experience with hypnosis as positive, and he continues to use the technique in his everyday life. The success of hypnosis was more about patients’ motivation and less

INTEGRATIVE ONCOLOGY PROGRAM

As a result of the successful meditation program, Dr Camacho and psychologist Alyson Moadel, PhD, developed the Integrative Oncology Program, bringing together modalities such as meditation, yoga, Reiki, Tai Chi, music and art therapy, acupuncture, and physical therapy. Because data on the anxiety relief patients with cancer achieve with meditation are sparse, the Integrative Oncology Program is currently initiating studies on the subject. Their next step is to identify which patients would be helped by a specific modality. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

about how hypnotizable a patient was, and all but 2 patients said that if they needed another awake craniotomy, they would choose hypnosedation. The neurosurgical team concluded, however, that hypnosedation in LGG resection is not a replacement for the AAA method, which they consider to be the gold standard. Hypnosedation requires too great an investment in preparation and commitment for the team and the patient, but suggest that it can be an alternative to fully awake surgery for older patients. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey. REFERENCES 1. Zemmoura I, Fournier E, El-Hage W, Jolly V, Destrieux C, Velut S. Hypnosis for awake surgery of low-grade gliomas: description of the method and psychological assessment. Neurosurgery. 2016;78(1):53-61. doi:10.1227/ NEU.0000000000000993

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FROM

IDS-associated cancers— lung, head and neck, liver, and ana l cancers— are becoming more common in people who are HIV-positive. This means that oncology professionals are seeing more people with both HIV/ AIDS and a type of cancer that, until recently, has not been associated with HIV/AIDS the way that AIDSdefining cancers (eg, Kaposi sarcoma, non-Hod g k i n ly mphom a, a nd invasive cervical cancer) have been.1 Statistically, people with an HIV diagnosis are 25 times more likely to develop anal cancer, 5 times more likely to develop liver cancer, 3 times more likely to develop lung cancer, and at least 10 times more likely to develop Hodgkin lymphoma than people not infected with the HIV virus.2 From a medical perspective, a dual diagnosis of cancer and HIV complicates treatment for both diseases. Potential drug interactions, compounded side effects, and chemotherapy’s tendency to negatively impact CD4 count or HIV-1 viral load, can all complicate treatment.3 STIGMATIZED DISEASE From a psychosocial perspective, a dual diagnosis of HIV/AIDS and cancer can increase a patient’s difficulty in coping. The unique factor that HIV brings to the patient’s dual diagnosis, more than heart disease, COPD, diabetes, or other types of illness, is stigma. Stigma is social disapproval that segregates individual people and groups into categories rejected by society. Individual or social reactions to

HIV: Coping With A Challenging Concomitant Diagnosis David Horne, LMSW

Kaposi’s sarcoma metastasis to the visceral pleura of the lungs in a patient with AIDS, seen on colored CT scans

someone who is a member of a stigmatized group range from subtle to overt. At the more extreme end of the spectrum, social stigma manifests as prejudice, discrimination, or even violence. Living in a society that

categorizes a person as morally or physically defective can have significant impact on quality of life for patients presenting with dual HIV/AIDs and cancer diagnoses. Cancer itself is not without stigma. Anyone working at a treatment center has seen how uncomfortable the diagnosis can make people. Above and beyond the uneasiness that serious illness elicits from many people, otherwise well-intentioned friends and family members may be overwhelmed with anxiety or feelings of inadequacy. Not knowing what to say or how to help, would-be caregivers may avoid the person with cancer without being aware of what they are doing or why. SUPPORT MAY BE LACKING A dual HIV/AIDS and cancer diagnosis compounds the stigma associated with one or both diseases, thereby increasing a patient’s difficulty in coping. This happens, in part, because people with HIV/AIDS receive less social support, largely due to the association with homosexuality and IV drug use. Studies show diagnoses associated with deviant, socially unacceptable behavior tend to elicit negative reactions (anger and/or blaming) instead of positive social reactions (pity, admiration, offers of help).4 Therefore, stigma is more than a general sense of not being welcome. If we look, for example, at the critical emotional and practical support that many cancer patients find in their religious communities, whether in the form of a structured support program or, as occurs more often, in the form of informal support such as rides, meals,

The unique factor that HIV brings to the patient’s dual diagnosis, more than heart disease or other types of illness, is stigma. 46 ONCOLOGY NURSE ADVISOR • MARCH/APRIL 2016 • www.OncologyNurseAdvisor.com

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friendly visiting, we see how important this support is to our patients. However, someone with an HIV/AIDS diagnosis, particularly those who are gay, lesbian, or transgendered, may not be welcome in a traditional religious community. That critical support, then, is not available. Coping is more difficult. A similar dynamic may be evident in traditional family groups. The patient may not have access to support from a traditional family that has disowned the patient for deviant, embarrassing behavior. A patient with an HIV/AIDS diagnosis may need to conceal aspects of identity, behavior, or diagnosis, if that is possible let alone desirable, to access support that is more readily available to people without a stigmatizing illness. SOCIAL PERCEPTIONS

A cancer diagnosis may reactivate memories regarding their HIV diagnosis.

The bottom line is that people with a dual HIV/AIDS and cancer diagnosis are more likely to suffer the effects of social rejection and internalized shame that result in diminished available social, emotional, medical, and financial support, than patients with simply a cancer diagnosis. ■ David Horne is an oncology social worker with CancerCare. REFERENCES 1. Highleyman L. People with HIV are at higher risk of several types of cancer, large study finds. NAM aidsmap Web site.

nosis may affect how they experience and respond to their current cancer diagnosis, which can in turn limit the person’s access to necessary social and emotional support.

http://www.aidsmap.com/People-withHIV-are-at-higher-risk-of-several-types-ofcancer-large-study-finds/page/3004717/. Published October 7, 2015. Accessed February 5, 2016. 2. National Cancer Institute. HIV infection

Further evidence of the difference between HIV/AIDS and cancer can be found in the type of roles that are commonly attributed or available to patients with each diagnosis. Consider cancer survivor, an archetype that entails enthusiastic social approval and support. Cancer survivors are often presented in the media as heroes, who through their positive outlook and high capacity for coping become role models for the rest of society. There’s no equivalent heroic mantle bestowed as frequently or celebrated as often or widely in the media for people coping with HIV/ AIDS. They continue to be labeled simply as HIV positive.5

FIND US ON

Even for people who today appear to enjoy every benefit of social validation, a cancer diagnosis can activate unresolved trauma surrounding a previous HIV diagnosis. The fear, shame and sense of social rejection that may have been the context of their HIV diag-

WHAT YOU SHOULD EXPECT What does this mean in the hospital or treatment room? As with any other patient, care should be taken to examine any assumptions you may have made about the patient or their experience. Keep in mind that the patient is likely to suffer increased stress due to perceived and actual social isolation and lack of support. In addition, the patient may have a history of coping with a terrifying disease even before their cancer diagnosis, and that the cancer diagnosis may reactivate traumatic memories and unresolved feelings regarding their original HIV diagnosis, even if that was decades prior.

and cancer risk. National Cancer Institute Web site. http://www.cancer.gov/aboutcancer/causes-prevention/risk/infectiousagents/hiv-fact-sheet. Accessed March 18, 2016. 3. Barbaro G, Barbarini G. HIV infection and cancer in the era of highly active antiretroviral therapy (Review). Oncol Rep. 2007;17(5):1121-1126. 4. Schwarzer R, Weiner B. Stigma controllability and coping as predictors of emotions and social support. J Soc Pers Relat. 1991;8(1):133-140. 5. Fife BL, Wright ER. The dimensionality of stigma: a comparison of its impact on the self of persons with HIV/AIDS and cancer. J Health Soc Behav. 2000;41(1):50-67.

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ASK A PHARMACIST

White blood cells

Managing Drug-related Bone pain We sometimes use loratadine (Claritin) to treat bone pain in patients receiving white blood cell growth factors. How does this work? —Name withheld on request

White blood cell growth factors are used in the prevention and treatment of febrile neutropenia in patients receiving myelosuppressive chemotherapy. They may also be used for mobilization of stem cells prior to autologous hematopoietic stem cell transplant, and in other indications to prevent adverse outcomes due to neutropenia. Reported rates of bone pain with these medications are: • fi lgrastim (Neupogen) and its biosimilar filgrastim-sndz (Zarxio), 11% to 30%; • pegfilgrastim (Neulasta), 25% to 45%; and • sargramostim (Leukine), 21%.1 The rates of bone pain vary between agents, and may be associated with

higher doses such as those used for stem cell mobilization (eg, fi lgrastim 10 mcg/kg). Bone pain may also be more common in patients who are younger or are receiving taxanes (eg, paclitaxel [Taxol]).2 Bone pain from white blood cell growth factors involves multiple factors, including inflammation and histamine release. Although the exact mechanism of this pain is not well understood, one potential mechanism is that histamine may cause bone marrow edema and result in pain. Treatment options for bone pain caused by white blood cell growth factors include antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids for severe pain. There is relatively limited clinical data studying the use of loratadine and other antihistamines for bone pain in this setting. There are some case reports on the use of loratadine, astemizole (no longer available in the United States), and hydroxyzine (Atarax) to manage bone pain due to white blood cell growth factors. In the report on the use of loratadine, a patient with severe bone pain thought to be due to pegfilgrastim took loratadine 10 mg daily starting the day prior to chemotherapy through 5 days following chemotherapy. This patient experienced a resolution in her pain and was able to continue receiving pegfi lgrastim with her chemotherapy. Loratadine may be preferred over older antihistamines such as hydroxyzine,

as it is associated with less sedation and fewer anticholinergic side effects (eg, dry mouth), although these may still occur in some patients. Patients receiving loratadine for bone pain due to white blood cell growth factors should be educated about potential adverse effects of loratadine, and counseled to report pain that is not well controlled. ■ REFERENCE 1. Micromedex Healthcare Series. Greenwood Village, CO: Thomson Micromedex. 2. Romeo C, Li Q, Copeland L. Severe pegfilgrastim-induced bone pain completely alleviated with loratadine: a case report. J Oncol Pharm Pract. 2015,21(4):301-304.

2016 DRUG TAKE-BACK DAY The 11th National Prescription Drug Take-Back Day is scheduled for April 30, 2016. At these events patients can turn in prescription medications, including controlled substances such as opioids, for safe and secure disposal. These events are sponsored by the Drug Enforcement Agency (DEA) and thus far have collected more than 5.5 million tons of drugs. Not all sites may be able to take back chemotherapy, so patients are advised to go to www.deadiversion.usdoj. gov/drug_disposal/takeback/ for details, and to find a take-back site in their community.

Lisa A. Thompson, PharmD, BCOP Clinical Pharmacy Specialist in Oncology Kaiser Permanente, Colorado

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