ONA July/August 2016

ONCOLOGY NURSE ADVISOR • JULY/AUGUST 2016

July/August 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

NAVIGATOR NOTES

VP Joe Biden Talks to ASCO Attendees About CancerLinQ

IN THE NEWS

Includes Highlights from the 2016 ASCO Annual Meeting

FEATURE

Managing Pain With Opioids and Sedation Monitoring

ONCOLOGY RESEARCH

How Can We Have a Cancer Cure Moonshot If We’re Short of Fuel?

Clinical trials struggle to accrue sufficient study populations. But patients’ perceptions are not the only barriers.

ISSUES IN CANCER SURVIVORSHIP

Aspirin Use Improves Risk for Cholangiocarcinoma

RADIATION & YOUR PATIENT

Sleep Disorders in Patients Receiving Radiation Therapy

FROM CANCERCARE

Concurrent Mental Illness VOLUME 7, NUMBER 4

THE TOTAL PATIENT

The Corporate Angel Network Achieves a Service Milestone

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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), July/August 2016, Volume 7, Number 4. P ­ ublished 6 times annually by Haymarket Media Inc, 275 7th Avenue, 10th 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

July/August 2016

7

IN THE NEWS • Prolonged Breath Holds Improve Targeted Radiation Therapy for Breast Cancer • Analysis Shows Better Integration Needed Between ClinicalTrials. gov and Drugs@FDA • Palbociclib Demonstrates Efficacy in Acute Myeloid Leukemia

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ASCO 2016

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• More Data Needed on Cancer Treatment Costs • Melanoma: Pembrolizumab Better Than Ipilimumab Regardless of PD-L1 Expression

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• Patients Understand Implications of Multiplex Gene Testing for Inherited Cancer Risk • Trastuzumab Biosimilar Comparable to the Monoclonal Antibody for Advanced HER2+ Breast Cancer … and more

39

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NAVIGATOR NOTES VP Biden Talks About the Role of CancerLinQ at ASCO 2016 Jason Hoffman, PharmD, RPh

16

FEATURES How Can We Have a Cancer Cure Moonshot If We’re Short of Fuel?

Bette Weinstein Kaplan

21

41 FIND US ON

Managing Pain With Opioids and Sedation Monitoring Tahitia R. Timmons, MSN, RN-BC, OCN, VA-BC

Continues on page 6

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FIRST REPORT: ASCO 2016

CONTENTS

July/August 2016

Innovations in Thyroid Cancer Treatment Transform Care A review of 3 studies, presented at the 2016 annual meeting of the American Society of Clinical Oncology, discusses advances in immunotherapies for differentiated and medullary thyroid cancers.

Jason Hoffman, PharmD, RPh

VIDEO 23 STAT CONSULT • Atezolizumab (Tecentriq) • Cabozantinib (Cabometyx) 37

39

RADIATION & YOUR PATIENT Assessing for Radiation-Associated Sleep Disorder

44

Bryant Furlow

COMMUNICATION CHALLENGES Yield Here: Waiting for a Miracle

PUBLISHERS’ ALLIANCE: DOVE PRESS

ISSUES IN CANCER SURVIVORSHIP Daily Long-Term Aspirin Use Improves Risk for All Subtypes of Cholangiocarcinoma

A Systematic Review and Meta-analysis of the Risk of Diarrhea Associated with Vandetanib Treatment in Carcinoma Patients Children’s Voices on Experiencing Radiotherapy, Design and Implementation of the Cancer Warrior Exercise Program, and more

Bette Weinstein Kaplan

OncoTargets and Therapy

THE TOTAL PATIENT Corporate Angel Network: 50,000 Flights of Service for Patients With Cancer Bette Weinstein Kaplan

46 FROM CANCERCARE

Treating Patients With Cancer and Concurrent Mental Illness Maryrose Mongelli, LMSW

48

VIDEO Prostate Cancer Screening: Patient Questions Hear what patients should be asking their doctors when discussing a prostate cancer diagnosis.

Ann J. Brady, MSN, RN-BC

41

Administering an Intramuscular Injection Into the Deltoid Muscle Learn how to give an IM injection in the deltoid muscle. For nursing students, new nurses, or other health care professions.

ASK A PHARMACIST Drug, Premed Sequence, and Flushing the IV Line Lisa A. Thompson, PharmD, BCOP

PUBLISHERS’ ALLIANCE: LIBERTAS ACADEMICA The Melanoma MAICare Framework: A Microsimulation Model for the Assessment of Individualized Cancer Care In this research, a microsimulation model framework is used to examine the impact of simultaneously altering curative treatment approaches in different phases of melanoma treatment.

Cancer Informatics

ON THE

WEB

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IN THE NEWS Prolonged Breath Holds Improve Targeted Radiation Therapy for Breast Cancer Patients with breast cancer can be trained to achieve a breath hold lasting more than 5 minutes, allowing for targeted

administration of radiation therapy with a single dose per daily session that can minimize damage to surrounding tissues.

Usually, a beam of radiation therapy takes 2 minutes to administer. Shaped radiation beams from several different angles intersect at the tumor. Since patients breathe during this time, ventilator movement in the chest increases damage to surrounding healthy tissues. Repeated breath holds of approximately 20 seconds can provide a stable target for the radiation beam, but radiation therapy is administered over several doses. This study showed that a single dose of radiation therapy could be administered stably with a single, prolonged breath hold.

“Following on from our preliminary work on healthy subjects, we wanted to see if we could help patients with breast cancer to achieve a breath hold of over 2 minutes to allow a radiotherapy treatment to be delivered in a single breath hold,” explained Michael Parkes, MA, DPhil, senior lecturer in Applied Physiology, School of Sport, Exercise and Rehabilitation Sciences, the University of Birmingham, Birmingham, England.

Researchers safely trained 15 patients receiving radiation therapy for breast cancer on how to maintain a relaxed posture, naturally raise blood oxygen levels, and reduce carbon dioxide levels by preoxygenation and by mechanically induced hypocapnia. Participants held their breaths for an average of 5.3 minutes.

“Being able to hit the cancerous tumor accurately is essential to avoid damage to other areas, including the heart muscle. Having a stable chest that we can target in one dose could be invaluable in protecting the surrounding tissue,” said Parkes.

Antiemetic Improves Length of Stay and Readmissions for DEB TACE Including an antiemetic in the preprocedure medications for patients with liver cancer undergoing drug eluting bead chemoembolization (DEB TACE) can shorten hospital stays and reduce the chance for readmission due to complications. These findings were Managing PES after reported at the World Conference on DEB TACE Interventional Oncology.

DEB TACE is a minimally invasive interventional radiology procedure in which drug-coated beads are used to deliver

chemotherapy locally to restrict the blood supply to a tumor.

A common side effect of DEB TACE is postembolization syndrome (PES), which causes fever, nausea and vomiting, and pain. PES usually occurs within the first 72 hours after DEB TACE; symptoms then begin to subside after 72 hours.

Standard practice is to hospitalize the patient for 1 to 2 days for observation. In this study, researchers investigated whether adding fosaprepitant, an antiemetic, to the medication regimen prior to DEB TACE treatment would allow for the procedure to be performed on an outpatient basis and prevent hospital readmission for PES. Using the patient database from the University of Cincinnati, researchers reviewed all patients with liver cancer who had undergone DEB TACE over a 23-month

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Read more at http://bit.ly/29qmFla.

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IN THE NEWS

Read more at http://bit.ly/29wBUZ3.

Focal Laser Ablation Feasible and Safe for Treatment of Prostate Cancer Laser heat may soon be an option to treat prostate cancer.

Focal laser ablation, which is the precise application of heat via laser to a tumor, has been found both feasible and safe in men with intermediate risk prostate cancer.

The recently published phase 1 study found no serious adverse events or change in urinary or sexual function at 6 months after the procedure. A laser fiber guided by magnetic resonance imaging (MRI) is inserted into the cancerous tumor. The laser is then heated, destroying the cancerous tissue. The technique is known as MRI-guided focal laser ablation.

If MRI-guided focal laser ablation proves effective in further studies, especially using the new MRI-ultrasound fusion machine, the technique could improve treatment options and outcomes for men with prostate cancer, said Leonard Marks, MD, a professor of urology and director of the University of California at Los Angeles Active Surveillance Program. Historically, prostate cancer is treated with surgery and radiation, which can result in serious side effects such as erectile dysfunction and urinary incontinence.

The new fusion-imaging method provides real-time ultrasound that more clearly delineates the tumor. By combining laser ablation with this fusion-imaging technique, the potential of laser ablation grows enormously. However, the researchers noted that comprehensive biopsy follow-up indicated that treatment margins larger than previously thought necessary may be required for complete ablation of the tumor. The laser treatment is not yet US FDA-approved for use in prostate cancer.

Read more at http://bit.ly/29BGLZh.

Biochemical Marker Is a Better Predictor of Adverse Effects in Patients with NSCLC Albumin concentration with an established cutoff point is proven a better predictor of both chemotherapy toxicity and survival in patients with advanced lung cancer.

Patients with advanced cancer frequently experience cancer cachexia Albumin predicts and sarcopenia, which are associated lung cancer survival with poor survival. Predictors of benefit of chemotherapy or factors that predict survival in these patients, however, are not known. Therefore, this study sought to determine the prevalence of these adverse effects, and their relation to chemotoxicity and survival prediction in patients with advanced non-small cell lung cancer (NSCLC) stage IIIB or IV based on international consensus definition and criteria for diagnosis. Secondary goal of the study was a comparison of the biochemical markers CRP, albumin, protein, IL-6, and hemoglobin with time to tumor progression to assess prognostic value or guide treatment.

Researchers recruited 100 patients with advanced lung cancer; 67 participants were male, median age was 64 years.

Anthropometric measurements and biochemical data along with body composition measurements were obtained for each patient before initiating platinum-doublet therapy. CT was used to measure skeletal muscle cross-sectional area at the third lumbar vertebra, and a previously published cutoff point was used to define sarcopenia. Chemotherapy toxicity was assessed after cycle 1 of treatment, with time-to-tumor progression prospectively determined.

Researchers found that cachexia, sarcopenia and time to tumor progression were not predictive of chemotoxicity.

However, albumin concentration with an established cutoff point of 37.5 g/L was predictive of chemotoxicity and survival.

Read more at http://bit.ly/29ljEza.

Analysis Shows Better Integration Needed Between ClinicalTrials.gov and Drugs@FDA Although Drugs@FDA may be useful for validating trial primary outcomes found on ClinicalTrials.gov, it was far less useful for validating secondary outcomes and information about adverse events, including deaths, according to an analysis of data from 100 trials available on both websites.

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period. Their study sample included 113 consecutive procedures performed in 71 patients.

All patients received premedication with dexamethasone and fosaprepitant. Postprocedural antiemetics and painkillers were also prescribed as needed. Discharge medications included antiemetics, analgesics, and an antibiotic. In this study, 108 procedures (96.4%) were successfully performed without the development of PES that required hospital readmission. The investigators report that only 5 patients (4.4%) were admitted to hospital for PES.

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Read more at http://bit.ly/29lJFj4.

Palbociclib Demonstrates Efficacy in Acute Myeloid Leukemia The FLT3 tyrosine kinase is the most frequent mutation found in acute myeloid leukemia (AML), and targeting CDK6 with palbociclib may be an effective strategy. CDK6 is upstream of FLT3, so blocking CDK6 leads to downregulating FLT3.

Prognosis for patients with AML is poor with high mortality despite advances in chemotherapy and hematopoietic stem cell transplantation. Previous efforts sought to treat AML by blocking FLT3 because its mutations are important in the progression of AML. Unfortunately, FLT3 kinase inhibitors have had limited clinical impact. Reponses in patients with FLT3 mutations are transient and resistant clones emerge rapidly.

In this study, Iris Uras, of the University of Veterinary Medicine, Vienna, Austria, and colleagues note that the tumor-promoting factor CDK6 directly regulates and initiates production of FLT3, thus causing AML. “We found a novel therapeutic window that attacks the dependency of a cancer cell on its growth regulator,” explained Uras. The compound, from breast cancer therapy, palbociclib

deprives the cancer cells of nutrients. AML cancer cells carrying the mutation died immediately, but the drug does not affect cells lacking the mutation, indicating high specificity.

An advantage of palbociclib is that it was approved to treat breast cancer in 2015; therefore, clinical studies in patients can be rapidly initiated, as its safety profile is already known.

Combining palbociclib with compounds that block FLT3 kinase activity increases its efficacy.

Read more at http://bit.ly/29wyDJ1.

Palliative Care-Led Support vs Usual Care: No Significant Difference in Impact on Cancer Patients’ Family Members Palliative care–led informational and emotional support meetings do not reduce anxiety or depression symptoms and may increase posttraumatic stress disorder (PTSD) symptoms in family members of patients with chronic critical illness.

Any type of support Family surrogate decision makers is helpful for families for patients with chronic critical illness experience significant psychological distress; therefore, researchers sought to determine if meetings with palliative care clinicians could ease this distress.

The intervention group (130 patients with 184 family surrogate decision makers) were engaged in at least 2 structured family meetings led by palliative care specialists and were given an informational brochure. The control group (126 patients with 181 family surrogate decision makers) was provided with an informational brochure and routine family meetings conducted by ICU teams.

The study was completed by 312 of 365 family surrogate decision makers (mean age, 51 years; 71% female). No significant difference in anxiety and depression symptoms was seen between the surrogate decision makers in the intervention group and those in the control group; however, PTSD was greater in the intervention group.

The researchers conclude that palliative care–led intervention does not reduce anxiety or depression for patients’ families. Their findings also do not support routine or mandatory palliative care–led discussion of goals of care for all families of patients with chronic critical illness.

Read more at http://bit.ly/29qfA44.

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The comparison was funded by the National Library of Medicine and led by Lisa Schwartz, PhD, and Steven Woloshin, PhD, from The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire.

Primary outcomes are the answer to the most important question asked by a trial, and may report whether a new treatment is more effective than existing therapies. Secondary outcomes address other relevant questions related to the study.

All primary outcome measures posted on ClinicalTrials.gov were matched with publically available data from Drugs@ FDA in the study sample and were found to be largely consistent. In contrast, approximately 51% of the secondary outcomes listed on ClinicalTrials.gov were identified on Drugs@FDA. Serious adverse events and deaths for most trials also could not be validated because Drugs@FDA typically only reports such data aggregated across trials.

The researchers suggest better integration between the two sites. Even if all the numbers reported in ClincalTrials. gov were completely accurate, information on the trial design, conduct, or analysis would be incomplete and could affect conclusions about the trial results assessed in Drugs@FDA.

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IN THE NEWS | ASCO 2016

More Data Needed on Cancer Treatment Costs More transparency regarding the costs of various treatment regimens in real time is needed to “choose wisely” for patients, providers, and payers, said Rena M. Conti, PhD. In a presentation on value in cancer care, Dr Conti, associate professor and an economist at the University of Chicago, discussed 3 posters presented at the 2016 annual meeting of the American Society of Clinical Ongology.

The first was a global cost-effectiveness analysis of first-line bevacizumab in metastatic colorectal cancer from the perspective of payers in the United States, United Kingdom, Canada, Australia, and Israel. This study used a Markov model of metastatic colorectal cancer with inputs from efficacy, safety, and quality-of-life data. Quality-of-life data were assumed to be stable. Researchers found that reimbursements vary widely but adding bevacizumab to frontline therapy is consistently not cost-effective across countries.

The second study evaluated regimen-specific costs, including total and out-of-pocket costs, of trastuzumabcontaining and non-trastuzumab–containing regimens among commercially insured patients with breast cancer. This study analyzed MarketScan data collected between 2008 and 2012 from outpatients and inpatients who were 18 months post diagnosis. Results showed that costs vary widely across regimens and out-of-pocket expenses are substantial but do not vary by regimen.

The final study reassessed the cost-effectiveness or cost-utility of regimens previously evaluated in 4 Canadian randomized controlled trials that included a total of 1979 patients with various types of cancer. These studies included erlotinib, cetuximab, and cisplatin — 3 drugs for which genericization has taken place or is expected. The study demonstrated that genericization of costly oncology drugs can significantly improve the cost-effectiveness/cost-utility of cancer therapies; however, it assumes that care conforms to the trial following drug launch and there was no detail on price measures.

Web Application Improves Follow-up in Patients With Advanced Lung Cancer A Web application called Moovcare that guides follow-up improved survival for patients with advanced lung cancer after receiving initial therapy.

Researchers sought to evaluate the impact of a Web-mediated follow-up application on outcomes in patients Self-assessment app with advanced lung cancer. For the improves survival multicenter, phase 3 study, investigators enrolled 133 patients with stage III or IV lung cancer who had completed initial chemotherapy, radiotherapy, or surgery. Patients were randomly assigned 1:1 to receive

standard follow-up care, which included physician visits and CT scans every 3 to 6 months depending on physician discretion, or to use the Web application with the same frequency of physician visits but fewer scheduled CT scans.

Patients used the Web application to self-assess symptoms weekly, and caregivers could enter data on behalf of the patient. The application then analyzed 12 symptoms and reported those results to the patient’s oncologist. The Web application evaluated changes in symptoms and triggered email alerts for the clinician who would then determine adaptations to cancer care, including the initiation of supportive care.

At 1 year, 75% of patients in the Web application arm were still alive compared with 49% of those in the standard follow-up arm (HR, 0.325; 95% CI, 0.157-0.672; P =.0025),

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researchers reported. Median overall survival was 19 months vs 12 months, respectively.

0.41-0.77; P <.001); and, for double vs single ASCT, 0.69 (95% CI, 0.50-0.71; P =.03).

Read more at http://bit.ly/2ajerbX.

Read more at http://bit.ly/29Cxj8l.

Upfront ASCT Preferred Treatment for Younger Patients With Newly Diagnosed Multiple Myeloma

Melanoma: Pembrolizumab Better Than Ipilimumab Regardless of PD-L1 Expression Pembrolizumab provides benefit over ipilimumab in patients with advanced melanoma, regardless of tumor PD-L1 expression status or number of prior therapies, according to results from the KEYNOTE-006 trial.

T he K EY NOT E - 0 0 6 st udy OS improved with enrolled 834 patients, of which 80% pembrolizumab were PD-L1-positive and 18% were PD-L1-negative. Approximately two-thirds were treatmentnaïve and the other third had received 1 line of therapy.

Participants were randomly assigned to receive pembrolizumab 10 mg/kg IV every 2 or 3 weeks, or ipilimumab 3 mg/kg IV every 3 weeks. Pembrolizumab was given for 24 months or until disease progression or unacceptable toxicity, while ipilimumab was given for 4 cycles or until progression or intolerable toxicity.

Results showed that overall survival was improved with pembrolizumab in all subgroups except those who were PD-L1-negative; however, the sample size in that group was small. Researchers found that patients who were treatmentnaïve and had PD-L1-positive tumors benefitted the most from pembrolizumab therapy.

Read more at http://bit.ly/29lHQ5Q.

Patients Understand Implications of Multiplex Gene Testing for Inherited Cancer Risk Multiplex gene testing of diverse patients has found that patients who test positive advise relatives to test, “suggesting that participants understood the implications of test results,” according to results of a planned interim analysis of a prospective trial.

The trial also found that based on test results, few patients reported preventive surgery at the 3-month follow-up and those with genetic variant of uncertain significance had no more distress, regret, or uncertainty than those who tested

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Upfront autologous stem cell transplantation (ASCT) remains the preferred treatment for patients age 65 years or younger with newly diagnosed multiple myeloma.

These findings from the European Myeloma Network, “the largest conducted so far, was designed to primarily compare upfront ASCT vs chemotherapy alone, including bortezomib,” said Michele Cavo, of the Seràgnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy.

The study compared 4 cycles of bortezomib-melphalanprednisone (VMP) vs high-dose melphalan (HDM) and single or double ASCT (if centers applied a tandem ASCO policy) as intensification therapy after bortezomib-cyclophosphamide-dexamethasone induction and peripheral blood stem cell collection. After VMP and HDM, consolidation therapy with bortezomib-lenalidomide-dexamethasone vs no consolidation was planned, followed by lenalidomide maintenance until disease progression or toxicity.

From February 2011 through April 2014, the study enrolled 1510 patients; of these, 1192 were included in the analysis, 497 in the VMP group, and 695 in the ASCT group. At a median follow-up of 26 months, median progression-free survival from first randomization, the primary study end point, was found not reached in patients who received ASCT, compared with 44 months for the VMP arm (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.59-0.90; P =.003). This benefit was retained across predefined patient subgroups, including those with revised ISS stage III (HR, 0.59; 95% CI, 0.560.97; P =.036) and high-risk cytogenetics [t(4;14) ± del(17p) ± del(1p) ± 1q gain] (HR, 0.69; 95% CI, 0.52-0.92; P =.010).

In addition, a “superior rate” of very good partial response or greater was observed among the patients who received ASCT (85.5%) compared with VMP (73.8%; P <.001).

When median progression-free survival was examined by single or double ASCT, it was not reached for either ASCT arm and was significantly longer at 3 years, 73.1% for double ASCT and 63.0% for single ASCT, compared with 57.5% for VMP. The HR for single ASCT was 0.81 (95% CI, 0.65-1.01; P =.06); double ASCT, 0.56 (95% CI,

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IN THE NEWS | ASCO 2016

Read more at http://bit.ly/29Nfk1K.

Trastuzumab Biosimilar Comparable to the Monoclonal Antibody for Advanced HER2+ Breast Cancer MYL-1401O, a biosimilar trastuzumab antibody, is comparable in efficacy and safety to the anti-HER2 monoclonal antibody trastuzumab as frontline therapy in patients with advanced, HER2-positive breast cancer.

The phase 3 HERITAGE study Molecular model of enrolled 500 patients with centrally trastuzumab confirmed, measurable HER2-positive metastatic breast cancer who had not received prior chemotherapy or trastuzumab for metastatic disease. Participants were randomly assigned 1:1 to receive MYL-1401O or trastuzumab in addition to docetaxel or paclitaxel for at least 8 cycles, followed by trastuzumab alone until disease progression.

Data indicated that the objective response rate at 24 weeks was 69.6% with the biosimilar compared with 64% with trastuzumab. The rates of serious adverse events were 38% and 34%, respectively. The most frequently reported serious adverse event was neutropenia in both arms, and there was no

difference in the incidence of cardiotoxicity in either group.

Of note, 4 treatment-related deaths occurred in each group.

“To our knowledge, this is one of the first clinical trials to show equivalency of a trastuzumab biosimilar to the branded cancer drug,” said Hope S. Rugo, MD, a professor of medicine at the University of California, San Francisco.

Read more at http://bit.ly/2aGrZ3S.

Adjuvant Gemcitabine/Capecitabine: Standard of Care for Resected Pancreatic Cancer Adjuvant gemcitabine plus capecitabine significantly improved overall survival compared with gemcitabine monotherapy in patients with pancreatic ductal adenocarcinoma, according to results of the European Study Group on Pancreatic Cancer (ESPAC)-4 trial.

Calling the combination regimen “the new standard of care for resected pancreatic cancer,” John P. Neoptolemos, MD, PhD, University of Liverpool, Liverpool, United Kingdom, presenting on behalf of ESPAC, said the 5-year survival rate was “superior to previous ESPAC trial arms, including no chemotherapy, chemoradiotherapy, and 5FU/FA.” From January 2008 to September 2014, 722 patients were randomly assigned within 12 weeks of surgery to either 4-week cycles of gemcitabine 1000 mg/m2 on days 1, 8, and 15 for 6 cycles (n = 366) or gemcitabine with oral capecitabine 1660 mg/m2/day for 21 days of a 28-day cycle (n = 364).

Median age was 65 years (range, 37 to 81 years) and 57% were men. Baseline WHO performance status was 0 (42%), 1 (55%), or 2 (3%), and postoperative median CA19-9 was 18.7 kU/L. Median maximum tumor size was 30 mm (range, 0-110); 60% were R1 resections, 80% were node positive, and 39% had poorly differentiated tumor grade.

Results showed that median overall survival for patients treated with gemcitabine plus capecitabine was 28.0 months and 25.5 months for gemcitabine alone. In the safety set, diarrhea was 19% in the gemcitabine/capecitabine arm vs 6% in the gemcitabine alone arm; neutropenia was 38% vs 24%; infections were 3% vs 7% and hand-foot syndrome was 7% vs 0%.

Read more at http://bit.ly/29vt2S6.

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negative, said Allison W. Kurian, MD, MSc, Stanford University Cancer Institute, Stanford, California.

The study opened in August 2014 in cancer genetics clinics at LA County, USC, and Stanford University. Eligible patients were those who met standard testing guidelines or predictive models that estimated 2.5% or greater mutation probability. The validated Multidimensional Impact of Cancer Risk Assessment (MICRA) scale was used to survey patients 3 months after their genetic test, results of which Dr Kurian reported; surveys will also be conducted at 6 months and then annually thereafter.

Of 1000 of the planned 2000 total participants, 11.6% tested positive for a pathogenic mutation, 36.5% had variant of uncertain significance only, and 51.9% tested negative. Median age was 51 years; 82% were female; 40.4% were Hispanic; and 74.3% had a personal history of cancer, primarily breast cancer (37.6%); 25.7% reported no cancer.

Scores of mutation-positive patients differed significantly from those of negative patients and those with variants of uncertain significance for all MICRA components. Scores of patients with variants of uncertain significance did not differ significantly from those of negative patients for any MICRA components.

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NAVIGATOR NOTES

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I

n his address to more than 35,000 oncology professionals at the 2016 annual meeting of the American Society of Clinical Oncology (ASCO), Vice President Joe Biden spoke about his vision for comprehensive data-sharing as part of the Cancer MoonShot initiative, referencing specifically ASCO’s CancerLinQ.1 “Today, oncologists and cancer researchers realize that they can’t [advance cancer progress] alone.…

What’s required today extends beyond any individual or any individual discipline, beyond medicine itself.… It requires somewhat of a change in mindset. It requires a lot more openness: open data, open collaboration and, above all, open minds,” Vice President Biden said.1 CancerLinQ is a data-sharing initiative developed to rapidly improve the quality of care for people with cancer. It connects and analyzes electronic health records to provide data for oncologists to use to make more informed decisions about patient care. CancerLinQ generates usable, searchable, real time information that oncology professionals can retrieve from their computers or mobile devices, giving them the ability to compare actual care they are providing with standard guidelines.2 CancerLinQ can also explore patterns and trends across patient characteristics, which will help to coordinate and improve care. Oncologists can determine the best evidence-based course of care by contrasting their patient’s care against data from similar cases.2 CancerLinQ has completed agreements with 58 oncology practices, comprising 1000 providers under

VP Biden Talks About the Role of CancerLinQ at ASCO 2016 Jason Hoffman, PharmD, RPh

contract in 39 states and the District of Columbia.2 Another critical aspect of the Cancer MoonShot includes creating new approaches to developing and recruiting for clinical trials. To achieve this, ASCO designed the Targeted Agent

and Profiling Utilization Registry (TAPUR) study.3 “As personalized medicine and combination therapy become the norm for cancer treatment, we need new approaches to clinical trials. That was one of the epiphanies,” said Vice President Biden. “The one thing that was completely new to me was how difficult it was to get into a trial; or how to find out where one was being conducted; or if you are conducting one, to find patients who can, in fact, qualify.”1 The study, which has received consent from 49 patients from 37 sites, is designed to assess molecularly targeted cancer agents used outside of indications already approved by the US Food and Drug Administration (FDA), and to collect data on clinical outcomes. TAPUR provides substantial flexibility for both patients and clinical sites to participate by using broad inclusion criteria, allowing physicians to choose the genomic profiling test and blood/tumor sample, and streamlining data collection.3 “TAPUR addresses a critical priority for achieving the promise of precision medicine: identifying existing, effective treatments for cancers based on their genomic profiles,” said ASCO Chief Medical Officer Richard L. Schilsky, MD, FASCO. “Since only [approximately] 5% of adult patients participate in oncology clinical trials, creative approaches like TAPUR, whose study design is grounded in real-world clinical practice, are needed to gather information that will benefit future patients.”3 ■ The references can be found in the online version of this article at http://bit.ly.com/2agC3h2.

“What’s required today extends beyond any individual or any individual discipline, beyond medicine itself....” www.OncologyNurseAdvisor.com • JULY/AUGUST 2016 • ONCOLOGY NURSE ADVISOR 15

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FEATURE | Clinical Trials

How Can We Have a Cancer Cure Moonshot If We’re Short of Fuel?

Cancer research relies on clinical trial participation, but patients — and their physicians — cite various fears and misconceptions as reasons to decline.

BETTE WEINSTEIN KAPLAN

“C

linical research is the rocket fuel for better treatments, more accurate diagnoses, and ultimately, cures,” said José Baselga, MD, PhD, physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York. Yet patients are simply not enrolling in enough clinical trials to fuel cancer research.

WHY PATIENTS SAY “NO”

© THINKSTOCK

Patients’ perceptions are not the only barriers to insufficient patient accrual in clinical trials.

Memorial Sloan Kettering Cancer Center conducted a survey of almost 600 physicians and more than 1500 consumers age 18 to 69 years. Of the consumers who responded, only 35% said they would be likely to enroll in a clinical trial, and as few as 40% of respondents indicated having a positive impression of clinical trial participation.1 Why is this? Survey responses indicated • 34% were concerned they would feel like guinea pigs • 35% did not trust the efficacy of an unproven treatment • 46% were worried about being given a placebo • 48% were concerned that the trial location would be inconvenient • 50% did not know whether medical insurance or Medicare would cover the cost (it usually does) or if they would be responsible for outof-pocket expenses, and • 55% were worried about the safety and side effects of the study medication.1 Continued on page 20

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FEATURE | Clinical Trials

Other researchers found fear of being the subject of an experiment or of being randomized were the most common reasons for not participating.2 Unknown toxicity and side effects of chemotherapy were also cited.2 After discussing their treatment plans with their clinicians, some patients just do not want to veer from the proposed treatment.

PHYSICIAN PERCEPTIONS Physicians surveyed for the MSKCC study agreed with many of the barriers their patients cited. Side effects and safety were cited by 63% of doctors; that same percentage shared their patients’ apprehension about the possibility of receiving a placebo instead of the drug. Fifty-three percent of the responding physicians worried about their patients perceiving themselves as guinea pigs.

More than half of the physicians (56%) admitted that the only time they discussed clinical trials with their patients was late in the course of treatment. Only 32% brought up the possibility of clinical trial enrollment early on. In fact, 28% of participating physicians considered clinical trials to be a treatment of last resort.1 One negative aspect cited by physicians was the timeconsuming process of enrolling patients in trials. Heavily

“[I]t is critical that the cancer community address common myths and misunderstandings.” scheduled clinicians must take extra time to evaluate the trial, enroll the patient, explain the details of the study, and be available to answer ongoing questions. Thus, lack of time is a significant barrier to encouraging patients to enroll.2

criteria for 1 particular trial; however, only 39 agreed to participate — an overall accrual rate of only 14% (39/276).3 The most common reasons patients gave for not participating were they wanted other treatment (34%), the distance from the cancer center was too great (13%), and insurance was denied (8%).3 Eleven percent of patients would not give a reason.

Patients with government-funded insurance tended to enroll in clinical trials more than patients with private insurance.3 CLINICAL TRIAL ADVANTAGES The patient population that enrolls in the most cancer clinical trials has historically been children younger than 15 years, and mortality rates for that age group have been on the decline since the 1970s.2 Now is the time to apply that same successful model to older patients with cancer.

There are a number of valid reasons to pursue the clinical trial course. It is the fastest and most direct route toward the newest treatments for every stage of cancer, often years before they are available to the general public. Those treatments are often offered at reduced cost or even no cost at all.

Paul Sabbatini, MD, deputy physician-in-chief for clinical research at MSKCC, advises, “While concerns regarding clinical trials are understandable, it is critical that the cancer community address common myths and misunderstandings around issues like effectiveness, safety, use of placebo — they’re used in very few studies — and at which point in treatment a trial should be considered.”

Patients may wish to participate in a clinical trial to benefit themselves, or they may choose to be altruistic and help future patients. In any case, now is the time to break down the barriers to clinical trial participation. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

REFERENCES 1. Despite pressing need, survey finds most Americans unlikely to enroll in

OPERATIONAL AND STRUCTURAL BARRIERS An obvious first step for eligibility to participate in a cancer clinical trial is to be undergoing treatment at a cancer clinic where a trial is being conducted. This may not be so easy, as factors such as transportation availability and costs, insurance coverage, and childcare often play a role.

The next barriers are finding a clinical trial applicable to the patient’s type and stage of cancer, then encouraging the patient to participate. In one study at the University of California Davis Cancer Center, clinical trials were available to 91 of 276 patients.3 Seventy-six of whom met eligibility

clinical trials. Memorial Sloan Kettering Cancer Center web site. https:// www.mskcc.org/press-releases/despite-pressing-need-survey-findsmost-americans-unlikely-enroll-clinical-trials. https://www.mskcc.org/ press-releases/despite-pressing-need-survey-finds-most-americansunlikely-enroll-clinical-trials. May 23, 2016. Accessed June 28, 2016.

2. Unger JM, Cook E, Tai E, Bleyer A. The role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;35:185-98. doi:10.14694/EDBK_156686.

3. Lara PN Jr, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19(6):1728-1733.

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FEATURE | Pain Management

Managing Pain With Opioids and Sedation Monitoring Use of opioids in pain management and keeping a close eye on their adverse effects is an important part of cancer care. But there is room for improvement.

TAHITIA R. TIMMONS, MSN, RN-BC, OCN, VA-BC

P

© THINKSTOCK

ain and its management are important issues for patients with cancer. They are a vulnerable population, and their symptom management should be high on clinicians’ list of priorities. But tool development for measuring pain objectively and monitoring for complications needs improvement, and nursing can be at the forefront of this initiative.

More than 60% of patients with advanced stage disease or metastatic cancer will experience pain.1 It is one of the leading reasons patients seek medical treatment, and their pain may be undertreated.2,3 Furthermore, the Institute of Medicine estimates pain costs at $560 billion to $635 billion annually.4 Pain management seeks to ease a patient’s suffering through pharmaceutical and nonpharmaceutical interventions.5 Opioid analgesia is the primary pharmacologic intervention, but its delivery relies on assessing pain via a tool.5 The best tool is a patient’s self-report5; however, this must be coupled with a tool for assessing complications to indicate the effectiveness of the pain management regimen.

ANTICIPATING COMPLICATIONS Pain management is a delicate dance between potential complications and effectiveness of the intervention. And nurses are essential in preventing adverse effects.

Potential side effects and complications from opioid use for pain management are dizziness,

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FEATURE | Pain Management nausea, vomiting, constipation, physical dependence, tolerance, sedation, and respiratory depression.6 Patients should be monitored closely, especially when there are route changes in medication.

One of the most feared unintended complications when managing a patient’s pain is opioid-induced respiratory depression.5 In the clinical setting, this condition is described in terms of decreased respiratory rates (ie, <10 breaths/min). Although respiratory depression is uncommon, it is the most serious of complications and is associated with increased mortality.3 Therefore, monitoring for respiratory depression can be the first step in ensuring patient safety when opioids are delivered.

Appropriate assessment of the depth of sedation decreases the risk of respiratory depression.

becomes clinically significant as easily as a clinician using a sedation scale that checks respiratory rate and level of sedation.

Pigmentation, spot checks, and the process of performing pulse oximetry may lead to a false sense of security.8 Hospitals using capnography, which offers a better measure of respiratory compromise, found nursing staff develop alarm fatigue and have slow response rates.8 Facilities using capnography need to emphasize serial sedation assessments to prevent respiratory depression and sedation during opioid pain management.

MOVING FORWARD The field of pain management has come far, but we still have more work to do. As pain management cases become more complicated and involve multiple agents, we as nurses must remain cognizant of the key role we play in keeping patients safe during pain management therapy. Nurses should become informed users of sedation tools. And we must develop education programs encouraging nurses to incorporate these tools as a standard part of their pain assessment routine. ■

Sedation — a common and often anticipated adverse effect — often precedes respiratory depression. Appropriate assessment of the depth of sedation decreases the risk of clinically significant opioid-induced respiratory depression.

Serial sedation assessments and the use of tools during opioid administration help prevent respiratory depression.7 Only a few validated tools were developed specifically for measuring sedation.7 Many of these tools — the Ramsay Scale, Richmond Agitation-Sedation Scale (RASS), the Riker Sedation-Agitation Scale, and the Aldrete scale — are used in medical-surgical nursing and have been adapted and repurposed. Only one tool exists for measuring opioid-induced sedation: the Pasero Opioid-Induced Sedation Scale (POSS).8 With patient-controlled analgesia (PCA) in particular, using a scale to complete a sedation assessment for patients can be an important step in establishing their baseline to detect any changes. The Institute for Safe Medication Practices emphasized the importance of sedation assessment of patients using PCAs because of deaths associated with opioid use.9 Managing patients’ risk for sedation needs to be continued if and when they are transitioned to a different form of pain management.

Tahitia Timmons is an education coordinator at Cancer Treatment Centers of America, Philadelphia, Pennsylvania.

RELYING ON TECHNOLOGY

8. Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain

REFERENCES 1. van den Beuken-van MH, de Rijke JM, Kessels AG, et al. High prevalence of pain in patients with cancer in a large population-based study in The Netherlands. Pain. 2007;132(3):312-320.

2. American Society of Pain Management Nurses. Pain Management Nursing.

Philadelphia, PA: W.B. Saunders; 2000.

3. Deandrea S, Montanari M, Moja L, Apolone G. Prevalence of undertreatment in cancer pain. A review of published literature. Ann Oncol.

2008;19(12):1985-1991.

4. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; 2011.

5. Pasero C. Pain Assessment and Pharmacologic Management. St. Louis, MO: Elsevier/Mosby; 2011.

6. Benyamin R, Trescot AM, Datta S, et al. Opioid complications and side effects. Pain Physician. 2008;11(2 Suppl);S105-S120.

7. Nisbet A, Mooney-Cotter F. Comparison of selected sedation scales for reporting opioid induced sedation assessment. Pain Manag Nurs.

2009;10(3):154-164.

Nurses can easily place their faith in technology, such as pulse oximetry monitoring and capnography, to prevent adverse events. But their value in this setting is not clear, and, in fact, pulse oximetry is often an inaccurate indicator.8 Oxygen saturation monitoring (PaO2) does not measure ventilation, and cannot recognize respiratory depression before it

Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.

9. Institute for Safe Medication Practices. Safety Issues With PatientControlled Analgesics: Part 1 – How Errors Occur. https://www.ismp.org/ newsletters/acutecare/articles/20030710.asp. Published July 10, 2003.

Accessed June 29, 2016.

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STAT CONSULT

Atezolizumab (Tecentriq) Drug Type

• Programmed death-ligand 1 (PD-L1) blocking antibody

Indications

• Treatment of patients with locally advanced or metastatic urothelial carcinoma who ——Have disease progression during or following platinum-containing chemotherapy ——Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Mechanism of Action

• Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors • This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the antitumor immune response without inducing antibody-dependent cellular cytotoxicity Dosage and Administration

• Dosage: 1200 mg • Administer as an intravenous infusion (immediately once prepared) over 60 minutes every 3 weeks until disease progression or unacceptable toxicity • If infusion is tolerated, all subsequent infusions may be delivered over 30 minutes • Do not administer as an IV push or bolus Dosage Adjustments

• Withhold atezolizumab for any of the following ——AST/ALT 3-5× ULN or total bilirubin 1.5-3× ULN ——Grade 2 or 3 diarrhea or colitis ——Symptomatic hypophysitis, adrenal insufficiency,

hypothyroidism, hyperthyroidism, or grade 3 or 4 hyperglycemia ——Grade 2 ocular inflammatory toxicity ——Grade 2 or 3 pancreatitis, or grade 3 or 4 increases in amylase or lipase levels (>2× ULN) ——Grade 3 or 4 infection ——Grade 2 infusion-related reactions ——Grade 3 rash • Atezolizumab may be resumed in patients whose adverse reactions recover to grade 0 or 1 • Permanently discontinue atezolizumab for any of the following ——Grade 3 or 4 pneumonitis ——AST or ALT >5× ULN or total bilirubin >3× ULN ——Grade 4 diarrhea or colitis ——Grade 4 hypophysitis ——Myasthenic syndrome/myasthenia gravis, GuillainBarré, or meningoencephalitis ——Grade 3 or 4 ocular inflammatory toxicity ——Grade 4 or any grade of recurrent pancreatitis ——Grade 3 or 4 infusion-related reactions ——Grade 4 rash Specific Populations

• Pregnancy ——Advise pregnant women or women of childbearing potential of the potential hazard to a fetus • Nursing mothers ——Because of the potential for serious adverse reactions in a breastfed infant from atezolizumab, advise a lactating woman not to breastfeed during treatment and for 5 months after final dose

www.OncologyNurseAdvisor.com • JULY/AUGUST 2016 • ONCOLOGY NURSE ADVISOR 23

STAT CONSULT • Pediatric ——Not established • Geriatric ——No overall differences in safety and effectiveness were observed between older and younger patients • Renal impairment ——Dosage adjustment not recommended for patients with renal impairment • Hepatic impairment ——Dosage adjustment not recommended for patients with mild hepatic impairment ——Atezolizumab has not been studied in patients with moderate or severe hepatic impairment Boxed Warnings

• Immune-related pancreatitis ——Withhold for moderate or severe, and permanently discontinue for life-threatening pancreatitis, or any grade of recurring pancreatitis • Infection ——Withhold for severe or life-threatening infection • Infusion reaction ——Interrupt or slow the rate of infusion for mild or moderate infusion reactions and discontinue for severe or life-threatening infusion reactions • Embryo-fetal toxicity ——Atezolizumab can cause fetal harm ——Females of reproductive potential should be advised of the potential risk to a fetus and to use effective contraception

• None Contraindications

• None Warnings and Precautions

• Immune-related pneumonitis ——Withhold for moderate, permanently discontinue for severe or life-threatening pneumonitis • Immune-related hepatitis ——Monitor for changes in liver function ——Withhold for moderate, permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation • Immune-related colitis ——Withhold for moderate or severe, permanently discontinue for life-threatening colitis • Immune-related endocrinopathies ——Hypophysitis ■■ Withhold if moderate or severe, permanently discontinue if life-threatening ——Thyroid disorders ■■ Monitor for changes in thyroid function ■■ Withhold for symptomatic thyroid disease ——Adrenal insufficiency ■■ Withhold for symptomatic adrenal insufficiency ——Type 1 diabetes mellitus ■■ Withhold for grade 3 or higher hyperglycemia • Immune-related myasthenic syndrome/myasthenia gravis, Guillain-Barré, or meningoencephalitis ——Permanently discontinue for any grade • Ocular inflammatory toxicity ——Withhold if moderate, permanently discontinue if severe

Adverse Effects

• Most common (≥15%) ——Abdominal pain ——Back/neck pain ——Constipation ——Decreased appetite ——Diarrhea ——Dyspnea ——Fatigue ——Nausea ——Peripheral edema ——Pyrexia ——Rash ——Urinary tract infection ——Vomiting • Most common grade 3-4 and laboratory abnormalities (≥5%) ——Anemia ——Fatigue ——Hyperglycemia ——Hyponatremia ——Lymphopenia ——Urinary tract infection Drug Interactions

• None What to Tell Your Patient

• Atezolizumab is a prescription medicine used to treat people with a type of bladder cancer called urothelial carcinoma • Tell your nurse or doctor about all of your medical conditions, including

28 ONCOLOGY NURSE ADVISOR • JULY/AUGUST 2016 • www.OncologyNurseAdvisor.com

——Immune system problems, such as Crohn disease, ulcerative colitis, or lupus ——If you have had an organ transplant ——Lung or liver problems ——A condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome ——Currently receiving treatment for an infection • Your nurse will set up an intravenous line to administer your atezolizumab dose into your vein over 30 to 60 minutes • Atezolizumab is usually given every 3 weeks • Your physician will decide how many treatments you need • Your blood will be tested periodically to check for certain potential side effects • If you miss an appointment, call your nurse or doctor as soon as possible to reschedule your appointment.

• Atezolizumab can cause serious side effects, such as ——Hormone gland problems, especially the pituitary, thyroid, and adrenal glands, and pancreas ——Inflammation of the eyes ——Intestinal problems (colitis) ——Liver problems (hepatitis) ——Lung problems (pneumonitis) ——Nervous system problems (neuropathy, meningoencephalitis) ——Severe infections ——Severe infusion reactions • Call or see your nurse or doctor right away if you experience any symptoms related to these problems or if your symptoms get worse • Your nurse or doctor will check you for these potential problems during your treatment with atezolizumab • Your nurse or doctor may give you corticosteroid or hormone replacement medicines

• Your nurse or doctor may delay or completely stop atezolizumab treatment if you have severe side effects • The most common side effects of atezolizumab ——Constipation ——Decreased appetite ——Fever ——Nausea ——Tiredness ——Urinary tract infection • These are not all the possible side effects you may experience.

• Tell your nurse or doctor if you experience any side effect or if a side effect persists or is bothersome • Atezolizumab can cause harm to a fetus when administered to a pregnant woman ——You should use effective contraception during your treatment with atezolizumab and for 5 months after your last dose ——Inhibition of the PD-L1/PD-1 pathway can increase the risk of immune-related rejection of a developing fetus, resulting in miscarriage • Fertility may be impaired in females of reproductive potential while receiving treatment with atezolizumab • Lactating women ——Presence of atezolizumab in human milk, its effect on the breastfed infant, or its effects on milk production are not known; however, you are advised not to breastfeed your infant while during treatment with atezolizumab and for 5 months after the last dose because of the potential for serious adverse reactions in breastfed infants.

Prepared by Jason Hoffman, PharmD, RPh.

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STAT CONSULT

Cabozantinib (Cabometyx) Drug Type

• Kinase inhibitor

Indications

• Treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy Mechanism of Action

• Cabozantinib inhibits tyrosine kinase activity of MET, VEGFR-1, VEGFR-2 and VEGFR-3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2 • These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes, such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment Dosage and Administration

• Dosage: 60 mg • Administer orally once daily until disease progression or unacceptable toxicity • Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking cabozantinib • Do not substitute Cabometyx tablets with Cometriq capsules (used for thyroid cancer) • Instruct patients to not take a missed dose within 12 hours of the next dose • Tablets should be swallowed whole; they should not be crushed • Patients should avoid foods such as grapefruit, grapefruit juice, and nutritional supplements that inhibit cytochrome P450 during cabozantinib treatment Dosage Adjustments

• For adverse reactions ——Withhold cabozantinib for CTCAE grade 4 adverse

reactions, and for grade 3 or intolerable grade 2 adverse reactions that cannot be managed with a dose reduction or supportive care ——Upon resolution/improvement, reduce dose as follows ■■ If previously receiving 60 mg daily, resume treatment at 40 mg daily ■■ If previously receiving 40 mg daily, resume treatment at 20 mg daily ■■ If previously receiving 20 mg daily, resume at 20 mg if tolerated; otherwise, discontinue drug ——Permanently discontinue cabozantinib for any of the following ■■ Development of unmanageable f istula or GI perforation ■■ Severe hemorrhage ■■ Arterial thromboembolic event ■■ Hypertensive crisis or severe hypertension despite optimal medical management ■■ Reversible posterior leukoencephalopathy syndrome • For patients undergoing surgery ——Stop treatment with cabozantinib at least 28 days before scheduled surgery, including dental surgery • In patients with hepatic impairment ——Reduce starting dose of cabozantinib to 40 mg once daily in patients with mild or moderate hepatic impairment Specific Populations

• Pregnancy ——Cabozantinib can cause fetal harm ——Advise pregnant women or women of childbearing potential of the potential hazard to a fetus

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• Nursing mothers ——Because of the potential for serious adverse reactions in a breastfed infant from cabozantinib, lactating women should not breastfeed during treatment and for 4 months after final dose • Pediatric ——Not established • Geriatric ——No overall differences in safety and effectiveness were observed between older and younger patients • Renal impairment ——Dosage adjustment is not required in patients with mild or moderate renal impairment ——There is no experience with cabozantinib in patients with severe renal impairment • Hepatic impairment ——Reduce cabozantinib dose in patients with mild (Child-Pugh score A) or moderate (Child-Pugh score B) hepatic impairment ——Cabozantinib is not recommended for use in patients with severe hepatic impairment Boxed Warnings

• None Contraindications

• None Warnings and Precautions

• Hemorrhage ——Do not administer cabozantinib if recent history of severe hemorrhage • GI perforations and fistulas ——Monitor for symptoms ——Discontinue cabozantinib for fistulas that cannot be adequately managed or perforations • Thrombotic events ——Discontinue cabozantinib for myocardial infarction, cerebral infarction, or other serious arterial thromboembolic events • Hypertension and hypertensive crisis ——Monitor blood pressure regularly ——Discontinue cabozantinib for hypertensive crisis or severe hypertension that cannot be controlled with antihypertensive therapy • Diarrhea ——Cabozantinib may cause severe diarrhea

——Interrupt cabozantinib treatment immediately until diarrhea resolves or decreases to grade 1 ——Recommend standard antidiarrheal treatments • Palmar-plantar erythrodysesthesia syndrome (PPES) ——Interrupt cabozantinib treatment until PPES resolves or decreases to grade 1 • Reversible posterior leukoencephalopathy syndrome ——Discontinue cabozantinib • Embryo-fetal toxicity ——Cabozantinib can cause fetal harm ——Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception Adverse Effects

• Most common (≥25%) ——Constipation ——Decreased appetite ——Diarrhea ——Fatigue ——Hypertension ——Nausea ——PPES ——Weight loss • Most common grade 3-4 and laboratory abnormalities (≥5%) ——Anemia ——Diarrhea ——Fatigue ——GGT increased ——Hypertension ——Hypokalemia ——Hypomagnesemia ——Hyponatremia ——Hypophosphatemia ——Lymphopenia ——PPES Drug Interactions

• Concomitant use of cabozantinib with strong CYP3A4 inhibitors ——Concomitant use increases exposure of cabozantinib compared with use of cabozantinib alone ——Increased cabozantinib exposure may increase risk of exposure-related toxicity ——Reduce daily cabozantinib dose by 20 mg ——Resume dose that was used prior to initiating CYP3A4 inhibitor 2 to 3 days after discontinuation of the strong inhibitor

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STAT CONSULT • Concomitant use of cabozantinib with strong CYP3A4 inducers ——Concomitant use decreases exposure of cabozantinib compared with use of cabozantinib alone ——Reduced cabozantinib exposure may lead to reduced efficacy ——Increase daily cabozantinib dose by 20 mg as tolerated ■■ Daily dose of cabozantinib should not exceed 80 mg ——Resume dose that was used prior to initiating the CYP3A4 inducer 2 to 3 days after discontinuation of the strong inducer What to Tell Your Patient

• Cabozantinib is a prescription medicine used to treat people with advanced kidney cancer who previously received a specific type of therapy • Before taking cabozantinib, tell your nurse or doctor about all of your medical conditions, including ——Any unusual bleeding ——High blood pressure ——Plan to have any surgery, including dental surgery ——Liver problems • Take cabozantinib exactly as your nurse or doctor tells you • Do not take cabozantinib with food • Do not eat for at least 2 hours before and at least 1 hour after taking cabozantinib • Swallow cabozantinib tablets whole with a full 8-oz glass of water • Do not crush cabozantinib tablets • Store cabozantinib at room temperature ——68°F to 77°F (20°C to 25°C) • If you miss a dose ——Take the missed dose as soon as you remember, up to 12 hours before your next dose ——Do not take a missed dose less than 12 hours before your next dose; wait until your next regular scheduled dose • Do not drink grapefruit juice, or eat grapefruit or supplements that contain grapefruit during treatment with cabozantinib

• Tell your nurse or doctor about all the medicines you take, as cabozantinib and certain other medicines may affect each other and cause side effects • Cabozantinib can cause serious side effects, including ——Severe bleeding (hemorrhage) ——A tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula) ——Blood clots, stroke, heart attack, and chest pain ——High blood pressure ——Diarrhea ——A skin problem called hand-foot skin reaction ——Reversible posterior leukoencephalopathy • Your clinician may change your dose, temporarily stop, or permanently stop treatment with cabozantinib if you experience certain side effects • The most common side effects of cabozantinib ——Constipation ——Decreased appetite ——Nausea ——Tiredness ——Vomiting ——Weight loss • This is not a complete list of all the side effects you may experience • Tell your nurse or doctor if you experience any side effect that bothers you or that does not go away • If you are of reproductive potential, be aware that cabozantinib can cause harm to a fetus ——Tell your nurse or doctor if you are pregnant ——You should avoid becoming pregnant while you are receiving cabozantinib ■■ Use an effective contraception during treatment and for 4 months after the final dose • You should not breastfeed your baby while receiving cabozantinib and for 4 months after the final dose because of the potential for serious adverse reactions in a breastfed infant Prepared by Jason Hoffman, PharmD, RPh.

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RADIATION & YOUR PATIENT

© THINKSTOCK

S

Assessing for RadiationAssociated Sleep Disorder Bryant Furlow Sleep disturbances are associated with cancer stage, being more common among patients with advanced disease, and can impact patient well-being in several domains, including anxiety, physical weakness (asthenia), and pain management, according to a new study of patients undergoing radiation therapy. The role of radiation therapy in sleep disturbance is poorly understood, but cranial irradiation is a well-established risk factor for sleep problems, including somnolence syndrome. Oncology nurses and radiation oncology team members should ask patients if they are experiencing sleep problems, and patients for whom sleep disorders are suspected should be referred for sleep medicine studies, diagnosis, and treatment.

leep disturbances are common among patients with medical conditions,1-9 and patients with cancer are at least twice as likely to suffer insomnia as the general population.4,5 Up to 88% of cancer patients experience sleep problems such as insomnia, hypersomnia, and sleep apnea, compared with 15% of the general population ( Table 1).4,5 Such sleep disturbances can have an important impact on patients’ well-being in several domains, including memory and cognitive function, immune function, depression, anxiety, and quality of waking-life.1-5 Several factors appear associated with sleep disturbances in cancer such as circulating hormone levels, pain, tumor-associated symptoms (such as pain, fever, and shortness of breath), seizure disorders, chemotherapy agents, alcohol consumption, and use of opioids and other sedatives or hypnotics.1-5 Sleep disorders may also predate cancer diagnosis; however, few studies have focused on the effects of preexisting sleep dysfunctions on cancer and its treatment and outcomes.

The exact nature of the relationships between postdiagnosis sleep problems and associated factors, including the molecular pathways involved, in patients with cancer remain poorly understood.

RADIATION-ASSOCIATED SLEEP DISORDERS

The role of radiation therapy in sleep disturbance is complex and likely varies depending on cancer type, radiation target fields, treatment history, and patient factors (eg, age).1,3,4,8 Cranial irradiation can disrupt sleepwake cycles and hormone regulation of wakefulness and sleep onset.4 Both adults and children with acute

lymphocytic leukemia undergoing cranial irradiation frequently experience somnolence syndrome (SS) up to 6 weeks post radiation–therapy; SS affects up to 50% of children who receive more than 18 Gy cranial irradiation at dose fractions of 1.5 to 2 Gy.5 Among patients with head and neck cancers, accelerated radiation therapy fractionation appears to be associated with postradiation recovery from sleep disturbance (as well as nausea, vomiting, and diarrhea).2 A recent cross-sectional study employing cancer patient’s self-rated sleep questionnaire responses found that sleep problems are frequent among patients arriving at the radiation oncology department before radiation therapy is initiated, and that risk factors include cancer stage and prior chemotherapy.1 Study participants with prior

Ask patients about their sleep habits and report need for sleep assessment. chemotherapy reported significantly elevated rates of hypersomnia prior to radiation therapy.1 Not surprisingly, radiation therapy patients with sleep disorders were also found to be taking higher levels of hypnotic (sleeping) medications.1 One recently published study found that, among patients undergoing radiation therapy for prostate cancer, interleukin-6 (IL-6) levels increased throughout radiation treatment as predicted — but IL-6 was not significantly associated with sleep problems or patient fatigue.3 Continued on page 38

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RADIATION & YOUR PATIENT TABLE 1. Sleep Disorders in Patients with Cancer5 Circadian rhythm disorders Disorders of the sleep-wake cycle Hypersomnias Disorders of excessive sleep Insomnias Disorders initiating or maintaining sleep state Parasomnias Dysfunctions associated with sleep, sleep stages, or partial arousals from sleep Sleep apnea Sleep-related breathing disorders Somnolence syndrome Extreme daytime drowsiness and hypersomnia, frequently seen in adult and pediatric patients with acute lymphocytic leukemia

SLEEP MANAGEMENT

When sleep disturbance is suspected, sleep medicine referrals for polysomnography (studies in which brain waves, eye and body movements, and blood oxygen levels are recorded during sleep) should be made to allow diagnosis and possible treatment to ameliorate or mitigate the impacts on patients before, during, and following cancer treatments.5 Patients must be assessed for sleep problems in a timely fashion to take advantage of such resources. But surprisingly, patients with cancer rarely mention sleep problems to their cancer care team unless they are asked specifically about their sleep patterns.4 Treatment options vary, depending on patient age, comorbidities (including psychiatric diagnoses such as bipolar disorder), and the exact nature of sleep disorder(s). Some sleep medications involve the same neuronal receptors (eg, serotonin receptors) as

do some psychiatric medications prescribed to treat depression or bipolar disorder.10 Particularly among older patients, manag ing sleep d isorders w ith medications can increase the risk of polypharmacy-associated drugdrug interactions and side effects. 5 Communication and coordination between a patient’s sleep-medicine physician and cancer care team are important. Changes in weight and fat stores can importantly affect appropriate sleep-medication dosing schedules.5 Therefore, nonpharmacologic management strategies such as physical exercise and cognitive-behavioral therapy for insomnia (CBT-I) with sleep-hygiene practices (eg, maintaining a dark and quiet sleep environment, fixed bedtime) are preferred first-line treatments for patients with cancer experiencing sleep disorders.5 Tobacco smoking cessation and avoiding alcohol or caffeine consumption late in the day, especially 4 to 6 hours before bedtime, can also help alleviate insomnia.5 Given the frequency and potentially serious impact of sleep disorders on patients with cancer, more research is needed to clarify the roles of tumor biology and cancer treatment with radiation, chemotherapy, and hormone therapy. Oncology nurses should ask patients about their sleep habits and report needed referrals for sleep assessments. ■

2. Nyqvist J, Fransson P, Laurell G, et al.

Bryant Furlow is a medical journalist based in Albuquerque, New Mexico.

9. Costa AR, Fontes F, Pereira S, Gonçalves

Differences in health related quality of life in the randomized ARTSCAN study; accelerated vs. conventional radiotherapy for head and neck cancer. A five year follow up. Radiother Oncol. 2016;118(2):335-341. doi:10.1016/ j.radonc.2015.12.024.

3. Holliday EB, Dieckmann NF, McDonald TL, Hung AY, Thomas CR Jr, Wood LJ. Relationship between fatigue, sleep quality and inflammatory cytokines during external beam radiation therapy for prostate cancer: a prospective study. Radiother Oncol.

2016;118(1):105-111. doi:10.1016/j.radonc.

2015.12.015.

4. DeIsigne J. Managing sleep disorders in cancer patients. OncoLog. 2013;58(2). https:// www2.mdanderson.org/depts/oncolog/ articles/pf/13/2-feb/2-13-2-pf.html. Accessed June 27, 2016.

5. Sleep disorders (PDQ®)—Health professional version. National Cancer Institute web site. http://www.cancer.gov/ about-cancer/treatment/side-effects/sleepdisorders-hp-pdq#section/_23. Accessed June 27, 2016.

6. Langford DJ, Lee K, Miaskowski C. Sleep disturbance interventions in oncology patients and family caregivers: a comprehensive review and meta-analysis.

Sleep Med Rev. 2012;16(5):397-414.

7. Kamath J, Prpich G, Jillani S. Sleep disturbances in patients with medical conditions.

Psychiatr Clin North Am. 2015;38(4):825-841. doi:10.1016/j.psc.2015.07.011.

8. Olson K. Sleep-related disturbances among adolescents with cancer: a systematic review.

Sleep Med. 2014;15(5):496-501. doi:10.1016/ j.sleep.2014.01.006.

M, Azevedo A, Lunet N. Impact of breast cancer treatments on sleep disturbances - a

REFERENCES 1. López E, de la Torre-Luque A, Lazo A, Álvarez J, Buela-Casal G. Assessment of sleep distur-

systematic review. Breast. 2014;23(6):697-709. doi:10.1016/j.breast.2014.09.003.

10. Harvey AG, Soehner AM, Buysse DJ. Bipolar

bances in patients with cancer: cross-sec-

disorder. In: Kryger MH, Roth T, Dement

tional study in a radiotherapy department.

WC, eds. Principles and Practice of Sleep

Eur J Oncol Nurs. 2016;20:71-76. doi:10.1016/

Medicine. 6th ed. Philadelphia, PA: Elsevier;

j.ejon.2014.12.008.

2017:1363-1369.

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COMMUNICATION CHALLENGES

Yield Here: Waiting for a Miracle

© THINKSTOCK

Ann J. Brady, MSN, RN-BC

If hope is not based in reality, patients and their loved ones may miss the opportunity to hope for what is achievable.

W

hat does someone have to do to make a miracle occur? Is hoping for a miracle enough? Is there a certain number or quality of prayers that need to be said? Or, a certain amount of time that has to pass?

CLINICAL SETTING These may sound like questions related to faith, but we encounter patients and family members who disavow religion and yet hope and wait for a miracle. What is our role as health care providers in addressing a spiritual issue that impacts health care decisions?

Sometimes in the face of what seems obvious — a patient with poor performance status who is unable to undergo additional chemotherapy, a weak and cachectic patient, or someone with widespread disease that has spread in spite of treatment — we hear the same rationale for continuing to refuse any discussion of Goals of Care: “We are praying for a miracle.”

This is one of the most perplexing statements. Such a declaration is a conversation stopper, one that blocks continued discussion or counterpoint. It makes me uncomfortable, and puts me immediately on the defensive because the idea of waiting for a miracle implies that if a patient or family accepts the patient’s condition, that is tantamount to giving up not just the physical fight, but the spiritual one.

From there, I can infer that any effort to explain the reality of the situation therefore reflects on me as someone who is pushing them to give up, somewhat violating their autonomy.

In a situation such as this, my goal is to open and facilitate discussion. Yet I am left feeling like the bearer of bad news and someone who dismisses their beliefs. Instead of creating an atmosphere of understanding, I feel like I am promoting a loss of faith. Many of us, myself included, incorrectly believe if we can just figure out the “right” explanation, patients and families will understand we are not negating their desire for a miracle but are trying to prepare them for what will likely happen.

DISCUSSION

The challenge becomes keeping hope based in reality. If hope is not based in reality, patients and their loved ones may miss the opportunity to hope for what is achievable: the birth of a grandchild, a family reunion, a wedding. But how do I do that?

There is no easy answer. But I got some new insight into the dynamics while driving the other day.

I was listening to the radio in the car. As I drove, the road narrowed from 2 lanes

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COMMUNICATION CHALLENGES

Insight into the different meanings of yield has allowed me to stop and consider what my goal for a conversation with a patient is.

to 1 and a sign on the side of the road said, “Yield.” I glanced over my shoulder, knowing I had to be aware of other cars on the road.

Simultaneously, the program on the radio was about farming in America. Several farmers were interviewed about the challenge of farming in the era of large conglomerate farms. The interview also delved into the variables farmers have to contend with, from weather changes, to water and drought, and the use of modified crops.

One of the people interviewed on the program spoke about the impact of these variables on his crop yield. In this instance, the word yield did not mean to give way but rather had to do with what the farms produced — the quantity and quality.

In the course of just a few short miles, my attention was drawn to the complexity of the English language. Yield is one of those words with more than one meaning.

It is not surprising that nonnative English speakers struggle with the idiosyncrasies of the spoken language.

I had never really considered that the word yield had more than one meaning, yet as I considered the differences between the word’s meanings, I thought of how this may apply to patient/family interactions, especially when they say they are waiting for a miracle.

There are times when I do not want to yield to their viewpoint. I want to hold to what I know, just as a driver can fail to

JOIN THE CONVERSATION • Is an unrealistic idea of hope something you need to talk someone out of, or is it something you can yield to?

ON THE

WEB

Go to http://bit.ly/2a6HmFZ for the online version of this article and share your perspective and experiences on yielding to patients’ and their family members’ acceptance of a clinical situation with your colleagues.

yield for merging cars on the road. Yet, if I yield to the patient’s and/or family’s point of view, even when I disagree, maybe the yield, in this case what the conversation may produce in terms of insight and acceptance on my part, will be a clearer understanding between us and ultimately some resolution to our differences.

Yield — I love the many dimensions of the English language and the nuances inherent in some words. I love the paradox of yield as a verb, to yield, and as a noun, the yield.

We are a solution-based society. Our focus is on what has to be done to accomplish a task. There are times when I realize that the way I think about end of life is no different. I am trying to get a patient and their loved ones to this point of understanding and acceptance, but it is the point of understanding and acceptance that I believe in.

The insight I gained by considering the different meanings of yield has allowed me to stop and consider what my goal for a conversation with a patient and family is.

Is it about opening up and understanding what patients and their loved ones have to say, or is it about trying to convince them of what I know?

When patients and their loved ones state that they are “waiting for a miracle” as a rationale for refusing to address what I see as obvious, is it a place setter for them?

The statement is fraught with complicated responses — how exactly do you dispute a belief? — so much so that it may also serve the purpose of giving them the time to prepare to yield to what is inevitable.

If I follow the logic of yield as a metaphor for complicated interactions, I can think of the car pulled to the side of the road waiting until it is safe to merge into traffic. And, I can think of the variables at play for my patient, those which I may know as little about as I do about crop yield. And I can yield and yield. ■ Ann Brady is the symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California.

40 ONCOLOGY NURSE ADVISOR • JULY/AUGUST 2016 • www.OncologyNurseAdvisor.com

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ISSUES IN CANCER SURVIVORSHIP

© THINKSTOCK

Daily Long-Term Aspirin Use Improves Risk for All Subtypes of Cholangiocarcinoma Bette Weinstein Kaplan

A

spirin use apparently offers protection against bile duct cancer, according to the findings of a recently published study. Bile duct cancer, or cholangiocarcinoma (CCA), is a particularly aggressive and lethal cancer that has been increasing in incidence in the United States.1 Cholangiocarcinoma is classified into 3 subtypes by location: intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA). Each type has diverse genetics and manifestations, requires different management, and patient outcomes are dissimilar. For these reasons, experts consider the subtypes as separate diseases. All 3 subtypes have poor prognosis.

For patients with iCCA or pCCA, in particular, 5-year survival rates after complete resection are 30% to 40%; without surgery, patients live only 12 to 15 months.

DAILY ASPIRIN AND CCA RISK Studies have shown daily aspirin administration has a beneficial effect on the risk for some gastrointestinal cancers. Aspirin has an antiplatelet effect as a result of its action on the COX-1 isozyme. It also has anti-inflammatory action resulting from its COX-2 isozyme inhibition.

Overexpression of COX-2 is a source of inflammation and a factor in the development of several cancer types, including cholangiocarcinoma, which is caused by continuous inflammation. Therefore,

Jonggi Choi, MD, Roongruedee Chaiteerakij, MD, PhD, and Lewis Roberts, MBChB, PhD, of the Mayo Clinic College of Medicine, Rochester, Minnesota, and colleagues undertook a large hospital-based case-control study to evaluate the risk factors for cholangiocarcinoma and the effect of aspirin use on the disease.

For their project, the researchers used data from the Mayo Clinic Biobank and Hepatobiliary Neoplasia registries and from the Rochester Epidemiology Project. The project included a cohort of 2395 patients with cholangiocarcinoma who were seen at the Mayo Clinic from 2000 through 2014 and a control group of 4769 healthy persons matched for sex, age, race, and place of residence. A total of 591 (24.7%) patients with cholangiocarcinoma and 2129 (44.6%) controls were aspirin users. The researchers classified aspirin dose as low-dose aspirin (81-162 mg/ day) or high-dose aspirin (325 mg/ day). Current aspirin use was defined as taking aspirin at least once a week at the index date.

REMARKABLY EFFECTIVE The adjusted odds ratios (AORs) supported the researchers’ conclusion that aspirin users were protected against all 3 subtypes. The team found that patients with any one of the subtypes were almost 60% less likely than controls

to be on aspirin therapy. A statistically significant 3-fold reduction in risk for cholangiocarcinoma was associated with aspirin use. These aspirin-related risk reductions were consistent for all subtypes: 3.4-fold for dCCA, 2.9-fold for iCCA, and 2.9-fold for pCCA. Compared with nonusers, and broken down among the subtypes, the participants who were current aspirin users

Use of high-dose vs low-dose produced a difference among aspirin users. had a 71% lower risk of developing dCCA, a 66% lower risk of developing pCCA, and a 65% lower risk of developing iCCA. Although no difference was seen between those who used aspirin daily and those aspirin users who did not use the drug daily, the protection afforded by aspirin did vary over time. The protective effect of aspirin was stronger among those using the drug for more than 3 years compared with those who had been using it for 3 years or less.

Use of high-dose vs low-dose also produced a difference among aspirin users.

However, no significant difference was

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ISSUES IN CANCER SURVIVORSHIP noted between daily aspirin users when compared with nondaily aspirin users.

The researchers found that different subtypes of cholangiocarcinoma were susceptible to different risk factors. The most common risk factor for cholangiocarcinoma was primary sclerosing cholangitis (PSC). Biliary tract diseases and non-PSC related cirrhosis were the next

most significant risk factors, followed by hepatitis B, diabetes, and smoking.

The Mayo Clinic team is planning another study to validate aspirin for the prevention of cholangiocarcinoma.

They plan to initiate a case-control trial comparing aspirin use among controls with PSC without CCA and patients with PSC and CCA. ■

Download the

Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

REFERENCE 1. Choi J, Ghoz HM, Peerphatdit T, et al. Risk factors for cholangiocarcinoma: aspirin-use and the risk of cholangiocarcinoma. Hepatology.

2016 Apr 26. doi:10.1002/hep.28529. [Epub ahead of print]

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Write for ONA! Oncology Nurse Advisor offers clinical updates and evidence-based guidance to the oncology nurse community and includes regular coverage of topics such as the safe handling and administration of chemotherapy drugs, side effect management, new developments in specific cancers, palliative care, communication with patients and family, and cancer survivorship.

We welcome contributions from readers in the following categories: Oncology Nurse Advisor Forum: Answers to clinical questions and advice for clinical problems. Readers may submit questions and requests for advice that are 50 to 100 words long. The author should include full name and degrees, name of institution or practice, and city and state.

Feature article: Oncology Nurse Advisor welcomes feature articles on the administration and handling of chemotherapy drugs; side-effect management; communication with patients, families, and colleagues; whatâ&#x20AC;&#x2122;s new in the treatment of specific cancers or cancer-related conditions; survivorship issues; patient navigation; and other topics of interest to oncology nurses. Manuscripts should be 1200 to 2000 words long and should include a brief reference list.

Reflections: These are brief, reflective essays on a topic related to oncology practice or narratives recounting a meaningful experience with a patient. Manuscripts should be 800 to 1200 words long.

Case Study: This department focuses on clinical cases of interest to oncology nurses. Manuscripts should be written in the standard case-followed-by-discussion format and should be 1500 to 2000 words long. A brief reference list may accompany the discussion section. Please include a list of 3 to 5 take-home points (teaching points) for the reader. The PDF template in our Author Guidelines is an easy, step-by-step guide for writing up your Case Study.

Ask a Pharmacist: In this department, our oncology pharmacist answers readersâ&#x20AC;&#x2122; drug-related questions. Questions should be 50 to 100 words. The author should include full name and degrees, name of institution or practice, and city and state.

See our author guidelines, available at www.OncologyNurseAdvisor.com, for more details.

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THE TOTAL PATIENT Corporate Angel Network: 50,000 Flights of Service for Patients With Cancer Bette Weinstein Kaplan

T

here really are angels among us.

They are caring. They fly, but they do not fit the preconceived notion of an angel. These angels are the more than 500 major corporations that comprise the Corporate Angel Network (CAN). CAN is a network of Fortune 500 companies — many in the top 100 — that give empty seats on their corporate jets to patients with cancer, bone marrow donors, and bone marrow recipients who need a ride to a distant treatment destination. Best of all: patients fly free.

A MILESTONE FLIGHT The Corporate Angel Network recently flew its 50,000th cancer patient flight, taking a rambunctious 18-month-old boy, Baron Yerby, and his parents back to their home in Atlanta after his treatment at Memorial Sloan Kettering Cancer Center (MSKCC), in New York, New York. For the milestone flight, the family flew on an aircraft owned by NCR, a corporation based in Atlanta.

At age 3 months, Baron’s parents noticed an odd glow in his right eye.

They soon learned he had retinoblastoma. Baron did well after treatment in Atlanta; however, he experienced a relapse and new tumors appeared in his left eye. At that point, all treatment options had been exhausted except one: a procedure in which a high dose

of chemotherapy would be delivered directly into the ophthalmic artery. But MSKCC is one of only a few facilities in the world that perfected using intraarterial chemosurgery to treat this rare malignancy. It is a procedure that the little boy must undergo monthly at the cancer center. He is only able to do so because of the Corporate Angel Network.

Patients can consider treatment options beyond those at their local hospital.

A VILLAGE OF VOLUNTEERS Founded in 1981 by pilot and business owner Leonard M. Greene, licensed commercial pilot Priscilla H. Blum, and business owner Jay N. Weinberg, Corporate Angel Network is the only charitable organization in the United States whose sole mission is to arrange free travel on corporate jets for patients with cancer going to and from treatment centers. At its headquarters in White Plains, New York, 6 employees and 50 part-time volunteers work with patients, physicians, corporate flight departments, and leading cancer centers to arrange more than 2500 patient

flights per year. That breaks down to 225 to 250 patient flights each month.

To qualify for a ride with CAN, a passenger must be a cancer patient (or bone marrow donor or recipient) traveling for treatment, a consultation, or a check-up at a recognized treatment center registered with the National Cancer Institute or the American College of Surgeons. In addition, the patient should be able to walk up the steps of a corporate aircraft without assistance and not require oxygen, an IV, or onboard medical personnel.

As passengers on a routine business flight, CAN passengers are advised to wear clothing appropriate for business travel. A patient may bring an adult companion if a second seat is available.

Two adults can accompany a passenger younger than 21 years.

The Corporate Angel Network could not exist without their volunteers. These dedicated people interact with patients and their families; pilots, dispatchers, and secretaries; corporate flight schedulers; charter companies; doctors, nurses, and social workers; private car services; corporate communications departments; and members of the media. They enter flight schedules into the database and schedule flights; help arrange ground transportation; research and contact new partner corporations; help generate press coverage; and place pro bono advertisements.

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CONNECTING WITH PASSENGERS Patients hear about the Corporate Angel Network through word of mouth from other patients and families who flew on a CAN-arranged fl ight and from nurses, social workers, and other staff members at their treatment facilities.

The patients register with the Corporate Angel Network within 3 weeks of their appointment at a cancer treatment destination. Corporate Angel Network checks with the physician to confirm that the patient is well enough to f ly. A week before the patient’s appointment a volunteer creates a flight request. Corporate schedules are available only a week in advance, so there is no point in looking for a flight before then. At that time the volunteer on the case begins looking for a corporate

flight that matches the requested travel route. Patients are instructed to make arrangements on a commercial flight as a backup in case no corporate flights are available.

Because of the Corporate Angel Network, patients with cancer can consider treatment options beyond those offered at their local hospital, traveling to a facility hundreds or even thousands of miles away that offers more advanced therapy. They can also take advantage of participating in clinical trials conducted at medical centers in other parts of the country.

Additional benefits include avoiding the potential dangers of extended delays, long lines, crowded planes, and possibly sick passengers in commercial airports, an especially critical advantage for patients with immune deficiencies

or chemotherapy-related restrictions who need to limit their exposure.

Importantly, this life-giving service is offered free of charge, easing some of the financial stress for patients so they can focus on their recovery. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

How to Contact the Corporate Angel Network Phone: 914-328-1313 Fax: 914-328-3938 Email: info@corpangelnetwork.org www.corpangelnetwork.org

Let us answer your questions!

E-mail us at editor.ona@haymarketmedia.com with your general questions for our expert Advisor Forum and your drug-related questions for Ask a Pharmacist!

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FROM

C

© THINKSTOCK

ancer is a pandemic. Given new advances in cancer detection, increased screening, and a growing aged population, the next 20 years will see a significant increase in cancer diagnoses, affecting approximately 70% of the world’s population.1 Moreover, cancer does not discriminate, often affecting vulnerable populations. This article addresses the barriers to treatment for cancer patients with concurrent serious and persistent mental illness (SMI).

The Substance Abuse and Mental Health Services Administration defines serious mental illness as a mental, behavioral, or emotional disorder in a person 18 years or older diagnosable over a period of 1 year that impairs one’s ability to function on a personal level and a societal level, as well as substantially inhibiting major life activities, such as schizophrenia, bipolar disorder, and major depressive disorder.2 IMPACT ON DECISION MAKING Patients with SMI often experience stigma related to their illness, frequently causing them to isolate themselves from systems they perceive as exclusionary, including but not limited to the medical community. Therefore, cancer often goes undiagnosed in such patients, until later stages or when metastasis occurs. Moreover, once a patient with SMI receives a cancer diagnosis, there are significant barriers to receiving adequate treatment, such as the patient’s understanding of the diagnosis, commitment to treatment, psychotropic drug interactions with

Treating Patients With Cancer and Concurrent Mental Illness Maryrose Mongelli, LMSW

isolated, have poor memory recall, and a lack of education 3; these circumstances affect the patient’s ability to understand the depth of a cancer diagnosis and the treatment protocol.

These barriers fundamentally affect the SMI patient’s ability to adhere to prescribed cancer treatment (eg, attending chemotherapy appointments, making lifestyle changes as suggested by the treating physician), which may significantly impact the mortality rate within this vulnerable population.

This is not to say that a person with SMI and a concurrent cancer diagnosis does not have the capacity to make informed medical decisions about their treatment. In fact, with proper psychoeducation and adherence to psychiatric medication protocol, patients with SMI can make informed decisions about their cancer care.3 The SMI patient’s level of functioning prior to the cancer diagnosis should be a good baseline indicator of the patient’s ability to make informed medical decisions.

CHALLENGES TO COMMUNICATON

specific chemotherapy treatments, and the treating physicians’ frustration.

Serious mental illness diagnoses can affect a person’s cognitive and executive functioning, and as such, the lack of understanding of a cancer diagnosis may act as a barrier to treatment.

Patients with SMI are often socially

Oftentimes patients with SMI are stereotyped as being “difficult” or “noncompliant” by health care professionals.

This can interfere with the level of care a patient with SMI receives, eg, cancer symptoms may be overlooked as symptoms related to the patient’s SMI, an oncologist’s reluctance to recommend a clinical trial for a patient with SMI because they are perceived as noncompliant.4 Health care professionals may experience frustration and even anger with the SMI cancer

SMI patients’ level of functioning prior to the cancer diagnosis is a good baseline indicator of their ability to make medical decisions.

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patients because of their lack of follow through, self-neglect, and specific behavioral idiosyncracies related to their SMI diagnosis.3 This may be compounded by the nature of the SMI, as the patient may already be reluctant to discuss his or her symptomology, depending on the level of SMI symptom control. Although antipsychotic medication alleviates positive symptoms (hallucinations and delusions) of psychotic disorders such as schizophrenia, the negative (flat and blunted affect) and cognitive symptoms may persist. Moreover, the level of control of the SMI may significantly affect the outcome of the patient’s care.3 CONCLUSIONS

Improving cancer care for patients with concurrent SMI diagnoses entails an understanding of the SMI diagnosis, and collaboration with other members of the interdisciplinary team, such as psychiatrists, social workers, primary care physicans, and also family members. Family members can provide accurate patient history information that may not otherwise be available to the clinicians for various reasons.

Psychiatrists and social workers have the unique ability to create an alliance with the patient and aid the patient in understanding the cancer diagnosis and treatment, and monitor their reactions to treatment or other members of the interdisciplinary team. They can also provide psychoeducation about cancer and the prescribed treatment, and case management services. Communication among interdisciplinary team members is key. Oncologists, although they are medical practitioners, may not possess expertise relating to their patient’s SMI; therefore, consultation with the mental health care team can enable the oncologist to focus on the quality of the patient’s cancer care, thereby optimizing outcomes for the patient.4 Earlier consultation with the patient’s mental health team will also provide the oncologist with a better understanding of the patient’s SMI, further enhancing the care provided by the clinician.

Our role as health care professionals, social service providers, and mental health practitioners is not only to assess, diagnose, and provide treatment, but also to provide a safe environment for

the patient during a trying time where they feel the most vulnerable. This is certainly true with the SMI population. Having an SMI should not be a barrier to receiving the best and most up-to-date cancer treatment. ■ Maryrose Mongelli is an oncology social worker with CancerCare.

REFERENCES 1. Millman J, Galway K, Santin O, Reid J. Cancer and serious mental illness— patient, caregiver and professions perspectives: study protocol. J Adv Nurs. 2016;72(1): 217-226.

2. Mental and substance use disorders.

Substance Abuse and Mental Health Services Administration (SAMHSA) Web site. http:// www.samhsa.gov/disorders. Last updated March 8, 2016. Accessed June 24, 2016.

3. Cole M, Padmanabhan A. Breast cancer treatment of women with schizophrenia and bipolar disorder from Philadelphia, PA: lessons learned and suggestions for improvement. J Cancer Educ.

2012;27(4):774-779.

4. Irwin KE, Henderson DC, Knight HP, Pirl WF. Cancer care for individuals with schizophrenia. Cancer. 2014;120(3):323-334.

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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.

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ASK A PHARMACIST premedications on a cisplatin regimen. At my previous clinic, however, premeds and hydration were administered before mannitol, which was immediately before cisplatin. Does it make a difference?

© THINKSTOCK

—Name withheld on request

Drug, Premed Sequence, and Flushing the IV Line Chemotherapy agents are sometimes required to be administered in a specific sequence. What factors influence the need to follow a specific sequence?

—Name withheld on request

Cisplatin premedications such as antiemetics should be administered 30 to 60 minutes prior to the chemotherapy drug to allow time for the drug to reach its target site prior to chemotherapy administration.

Mannitol is an osmotic diuretic that increases urine output. It may be used before cisplatin to reduce the nephrotoxic effects of cisplatin. Not all institutions use mannitol for this purpose, and may use other methods such as administering prehydration and posthydration with saline and electrolytes.

The diuretic effects of mannitol begin approximately 15 to 30 minutes after an infusion, and can last for 2 to 8 hours.

Given its duration of action, as long as the premedications are administered sufficiently early, administration sequence relative to mannitol does not seem likely to impact outcomes.

medication from the line is very clear by the bright red color of the drug. But most of our IV medications are colorless, so the need to clear the tubing is not so obvious.

What factors should be considered when calculating an adequate postmedication flush to deliver complete doses of small-volume IV medications? There seems to be a wide range of variability across many practice settings.

—Beverly King, BSN, RN-BC

Administering an IV flush between IV medications is critical to prevent incompatability issues between medications from affecting IV line patency or the integrity of the medications.

The solution used to flush the IV line should be selected bearing in mind the compatibilities of both medications.

For example, some medications are not compatible with D5W, while others are incompatible with normal saline. The volume of the IV flush administered may vary with the brand and make of tubing used, thus institutions may have different standard flush volumes. ■ REFERENCE

Multiple factors can inf luence the sequence of administration for chemotherapy drugs. Based on their mechanism of action, some drug combinations are more effective when given in a specific sequence; in other cases, this may also influence the toxicities of the chemotherapy regimen. Other considerations may be more practical, as in cases where it may be best to follow a certain order due to the risk of infusion reactions with the drugs being administered.

I have worked in 2 infusion clinics.

At my current clinic, hydration and mannitol are administered before

The article “Protocols for concomitant infusions in the same IV line” had a brief mention of using the IVPB method to administer premeds and chemotherapy.1 When infusing a drug such as doxorubicin, the need to flush residual

1. Protocols for concomitant infusions in the same IV line [Oncology Nurse Advisor Forum]. Oncol Nurse Adv. 2014 Mar 17. http:// www.oncologynurseadvisor.com/advisorforum/protocols-for-concomitant-infusionsin-the-same-iv-line/article/338515/. Accessed July 7, 2016.

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

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