ONA January/February 2017

ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017

www.OncologyNurseAdvisor.com

January/February 2017

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

Navigation Program Increases Breast Screening Rates

FEATURE

Cold Cap: Reducing ChemotherapyInduced Alopecia

FEATURE

A Review of Kinase Inhibitors for Hematologic Cancers

RADIATION & YOUR PATIENT

Shared Decision Making: New Paradigms in Radiation Oncology

ISSUES IN CANCER SURVIVORSHIP

Resistance Training Improves Posttreatment Outcomes for Breast Cancer Survivors

THE TOTAL PATIENT

VOLUME 8, NUMBER 1

Palliative Care: Quality of Life, Symptom Burden Improved

COMMUNICATION CHALLENGES

Noncompliance: Is That What’s Really Going on With Your Patient?

There are many factors to consider when addressing noncompliance.

The Pharmacology Courses You Need Available now on myCME! Developed by NPACE, one of the nation’s leading providers of nurse practitioner continuing nursing education, these courses will help you meet your state and national certification pharmacology credit requirements in one convenient web-based location.

• Satisfy the new ANCC pharmacotherapeutic requirement • Clinically relevant topics, latest updates, clinical pearls, and tools you can implement immediately • Created by NPs, for NPs

Nurse Practitioner Associates for Continuing Education (NPACE) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. ®

Nurse Practitioner Associates

for Continuing Education

Take a closer look at myCME, the fastest growing online resource for CE pharmacology credits.

Visit myCME.com/pharmacology

PUBLISHING STAFF Editor Joyce Pagán editor.ona@haymarketmedia.com

Publisher Chad Holloway (201) 799-4878 chad.holloway@haymarketmedia.com

EDITORIAL BOARD

Senior digital content editor Rick Maffei

National sales manager Scott Bugni (917) 882-0658 scott.bugni@haymarketmedia.com

Ann J. Brady, MSN, RN-BC Huntington Cancer Center Pasadena, California

Oncology writer Jason Hoffman, PharmD, RPh Contributing writer Bette Weinstein Kaplan Group art director, Haymarket Medical Jennifer Dvoretz Assistant art director Holly Morrison Production editor Kim Daigneau Production director Kathleen Millea Grinder Production manager Brian Wask brian.wask@haymarketmedia.com Circulation manager Paul Silver

Account manager Henry Amato (646) 638-6096 henry.amato@haymarketmedia.com Manager, Multi-channel business development, Haymarket Oncology Marc A. DiBartolomeo (609) 417-0628 marc.dibartolomeo@ haymarketmedia.com Managing editor, Haymarket Oncology Lauren Burke Editorial Director Kathleen Walsh Tulley CEO, Haymarket Media Inc Lee Maniscalco Haymarket Media Inc Sales and Editorial offices 275 7th Avenue, 10th Floor, New York, NY 10001; (646) 638-6000

Subscriptions: www.OncologyNurseAdvisor.com/freesub Reprints: Wright’s Reprints (877) 652-5295 Permissions: www.copyright.com

Oncology Nurse Advisor (ISSN 2154-350X), January/February 2017, Volume 8, Number 1. 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.

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

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 1

CONTENTS

January/February 2017

9

IN THE NEWS • Frailty Classifications Associated With Prognosis Among Older Patients With Cancer • Beach Umbrella Not Enough for Protection From UV Rays • Diarrhea Common But Manageable With Pertuzumab-Containing Regimens • Optimal Timing of Influenza Vaccination in Patients Receiving Chemotherapy • Early Endometrial Cancer Surgery May Reduce Survival • Longer Dosing Interval of Zoledronic Acid May Be Acceptable for Bone Metastases • Alcohol Consumption, Particularly White Wine, Associated With Increased Risk of Melanoma … and more

21

NAVIGATOR NOTES Navigation Program Leads to Increased Screening Rates

9

26

43

Jason Hoffman, PharmD, RPh

22

FEATURES Cold Cap: Reducing a Dreaded Treatment-Related Effect Bette Weinstein Kaplan

26

A Review of Kinase Inhibitors for Hematologic Cancers Debra Hughes, MS

46 FIND US ON

Continues on page 8

linkedin.com/company/oncology-nurse-advisor

plus.google.com/+Oncologynurseadvisor

@ONAcom

OncologyNurseAdvisor.com/app-download

facebook.com/OncologyNurseAdvisor

OncologyNurseAdvisor.com

2 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

You Asked for a Simpler CME Search

We Listened

The All-New myCME Can Help You Find Relevant Courses Faster Than Anyone. > Relevant courses automatically displayed based on your profession, specialties and topics of interest > Extensive array of accredited CME/CE activities in dozens of therapeutic areas > Personal dashboard of bookmarked, in progress and completed activities > New Resources and Trending features keep you updated with personalized medical news and information, along with rankings of the most popular CME/CE activities

Simplify Your CME Search.

Visit myCME.com Today ©2013 Haymarket Media, Inc.

Print ad • R7 • B

ISSUES IN CANCER SURVIVORSHIP Most Common Reason for Prostate Cancer Second Opinions: More Information Researchers surveyed men with prostate cancer to learn which men seek a second opinion and why.

CONTENTS

Bette Weinstein Kaplan

January/February 2017

34 STAT CONSULT • Olaratumab (Lartruvo) • Rucaparib (Rubraca) 38

RADIATION & YOUR PATIENT Shared Decision Making: New Paradigms in Radiation Oncology Bryant Furlow

40

COMMUNICATION CHALLENGES Noncompliance? Look for a Cause Ann J. Brady, MSN, RN-BC

43

ISSUES IN CANCER SURVIVORSHIP Resistance Training Improves Posttreatment Outcomes for Breast Cancer Survivors

FROM CANCERCARE Hypnosis and Its Use in Cancer Treatment A cursory look at hypnosis and where it may be used to offer an alternative and side-effect–free management of several aspects of care.

Talila Marcus, LMSW

PATIENT EDUCATION: FACT SHEETS Pathology Reports This fact sheet examines pathology reports, including tissue collection methods, the way in which tissue samples may be processed, and details typically included in such reports.

Formaldehyde and Cancer Risk This fact sheet reviews the basics related to formaldehyde and how the general population can be exposed to it, and reviews both the potential short- and long-term health effects related to such exposure.

Bette Weinstein Kaplan

PUBLISHERS ALLIANCE: DOVE PRESS 45

THE TOTAL PATIENT Palliative Care Update: Best Improvements in Quality of Life, Symptom Burden Bette Weinstein Kaplan

46 FROM CANCERCARE

Tips for Working With Hispanic Patients and Caregivers

What You Do Not Know Could Hurt You: What Women Wish Their Doctors Had Told Them About Chemotherapy Side Effects on Memory and Response to Alcohol This research examines the incidence of alcohol- and memory-related side effects of chemotherapy in female cancer patients.

Breast Cancer: Basic and Clinical Research

Jennifer Gomera, MSW, LMSW

48

ASK A PHARMACIST Preventing TLS in Patients Receiving Venetoclax Lisa A. Thompson, PharmD, BCOP

ON THE

WEB

8 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

IN THE NEWS Frailty Classifications Associated With Prognosis Among Older Patients With Cancer Researchers have developed frailty classifications of older patients with cancer to aid clinicians in making treatment decisions and selecting geriatric interventions; however, no study has compared frailty classifications or evaluated their performance in predicting outcomes.

To assess agreement among 4 classifications and compare their predictive performance in a large cohort of inpatient and outpatients with various malignancies, investigators prospectively included 1021 patients aged 70 years or older with solid or hematologic cancers who underwent a geriatric assessment in 1 of 2 French teaching hospitals between 2007 and 2012.

Researchers measured frailty using 4 classifications: Balducci, International Society of Geriatric Oncology (SIOG) 1, SIOG2, and a latent class typology. One-year mortality and 6-month unscheduled admissions were used as outcomes.

Results showed that all 4 classifications had good discrimination of 1-year mortality, with discrimination being best with SIOG1 followed by the latent class typology.

Similarly, discrimination was good with all 4 classifications for 6-month unscheduled admissions.

However, researchers found that when patients were classified into 3 (fit, vulnerable, or frail) or 2 categories (fit vs vulnerable or frail and fit or vulnerable vs frail), agreement among the 4 classifications ranged from very poor to good, with agreement being best between SIOG1 and the latent class typology and between SIOG1 and Balducci.

The study also demonstrated that performance of the classifications varied across tumor sites. Discrimination was very good for predicting mortality in patients with prostate and breast cancers and lower for colorectal cancers.

Despite poor to moderate agreement among the 4 frailty classifications of older patients with cancer, all 4 classifications consistently performed well with respect to predicting 1-year overall mortality and 6-month unscheduled admissions in this large cohort of older, treatment-naïve patients.

Rucaparib Monotherapy Approved for Advanced Ovarian Cancer The US FDA has granted accelerated approval to rucaparib (Rubraca) as standalone therapy for patients with advanced ovarian cancer who harbor a deleterious BRCA mutation and have been treated with at least 2 prior lines of chemotherapy.

Approval was based on findings from the 2 single-arm clinical trials that evaluated rucaparib in 106 patients with BRCA-mutant advanced ovarian cancer who had been

treated with 2 or more chemotherapy regimens. Fifty-four percent of patients who received rucaparib achieved an overall response with a median duration of response of 9.2 months.

Clinicians should be aware that rucaparib may increase the risks for developing myelodysplastic syndrome, acute myeloid leukemia, and fetal harm.

The recommended dose and schedule for rucaparib is 600 mg orally twice daily with or without food.

Read more at http://bit.ly/2jJu6Y2.

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 9

© THINKSTOCK

Read more at http://bit.ly/2kjZ3Ba.

IN THE NEWS

Sun-protective behavior impacts skin cancer prevention. Although shade, which works by physically shielding skin, protects against direct harmful UV rays, reflected and indirect UV rays may still reach the skin.

Because there is insufficient clinical Shade is not enough evidence that a beach umbrella alone to protect skin can provide adequate skin protection, researchers sought to directly measure sunburn protection conferred by a standard beach umbrella compared with that offered by sunscreen with a high sun protection factor under actual use conditions.

For the single-center, evaluator-blinded, clinical study, researchers enrolled 81 people with Fitzpatrick skin types I (1%), II (52%), and III (47%) in Lake Lewisville, a lake in north Texas 159 meters above sea level. Participants were randomly assigned to use a beach umbrella alone or only sunscreen with a sun protection factor of 1 while sitting on a sunny beach for 3.5 hours at midday.

Investigators then evaluated each participant for clinical sunburn on all exposed body sites 22 to 24 hours after sun exposure, including the face, back of the neck, upper chest, arms, and legs.

Researchers found that neither the umbrella nor the sunscreen alone completely protected beachgoers from sunburn, suggesting that a combination approach may be necessary.

Read more at http://bit.ly/2jwrzn8.

Obesity Increases Risk for Transformation of MGUS to Multiple Myeloma Multiple myeloma is one of the most common hematologic malignancies in the United States and is frequently preceded

by MGUS, an asymptomatic plasma cell neoplasm involving an excess of M protein.

To investigate the role of obesity in the progression of MGUS to multiple myeloma, researchers analyzed data from 7878 patients with MGUS included in the US Veterans Health Administration database. Of those, 39.8% were overweight, 33.8% were obese, and 64.1% were white.

During a median follow-up of 68 months, 329 (4.2%) patients with MGUS progressed to multiple myeloma, including 72 (3.5%) normal-weight patients, 144 (4.6%)

overweight patients, and 113 (4.3%) obese patients.

After adjusting for multiple variables, researchers found that obese patients had a nearly 2 times higher risk for progressing to multiple myeloma than normal-weight patients (hazard ratio [HR], 1.98; 95% CI, 1.47-2.68). In addition, overweight patients had a 55% increased risk for transforming to multiple myeloma compared with normal-weight patients (HR, 1.55; 95% CI, 1.16-2.06).

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

Ruxolitinib May Improve Symptom Control in Patients With CLL Disease-related symptoms negatively impact the quality of life of patients with CLL not receiving systemic therapy.

Because available therapies are not specifically designed to control disease-related symptoms, researchers sought to evaluate whether ruxolitinib, a JAK2 inhibitor that reduces symptoms in patients with myelofibrosis, would improve disease-related symptoms in patients with CLL. For the open-label, single-arm, phase 2 trial (ClinicalTrials. gov Identifier: NCT02131584), investigators enrolled 41 symptomatic patients with CLL receiving care at MD Anderson Cancer Center in Houston, Texas, who did not require systemic therapy. All participants received ruxolitinib 10 mg orally twice daily.

Before treatment and at 3 months, researchers assessed symptom control using the Brief Fatigue Inventory (BFI), the CLL module of the MD Anderson Symptom Inventory (MDASI), and symptom-associated interference in daily activities.

Among the 25 treatment-naïve and 16 previously treated patients, results showed that the average percentage change from baseline to month 3 was 44.3% in BFI score (P <.0001), 43.4% in symptom interference score (P <.0001), and 42.1% in MDASI score (P <.0001).

The findings suggest that further evaluation of ruxolitinib for symptom control in this patient population is warranted.

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

Diarrhea Common But Manageable With Pertuzumab-Containing Regimens Pertuzumab targets the extracellular dimerization domains of the human epidermal growth factor receptor 2 protein (HER2), thereby blocking ligand-dependent

10 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

© THINKSTOCK

Beach Umbrella Not Enough for Protection From UV Rays

Optimal Timing of Influenza Vaccination in Patients Receiving Chemotherapy Research evaluating the optimal timing of influenza vaccination for patients receiving chemotherapy is limited; therefore, researchers sought to compare the immunogenicity of an influenza vaccine administered concurrently with chemotherapy with that of a vaccine given within the cytopenic period during 3-week chemotherapy cycles.

For the study, researchers enrolled 97 patients with solid tumors undergoing scheduled 3-week cytotoxic chemotherapy. Of those, 61% had breast cancer and 30% had lung cancer. Participants were randomly assigned to receive the 20142015 seasonal influenza vaccine on day 1 or 11 of the chemotherapy cycle.

Investigators stratified patients by their age and previous influenza vaccination status, and measured antibody responses to influenza vaccine strains H1N1, H3N2, and B before and 21 to 28 days after vaccination.

Results showed that seroprotection rates after vaccination were not significantly different between the day 1 and day 11 groups (strain H1N1, 67% vs 75% [P =.403]; strain H3N2, 77% vs 80% [P =.772]; strain B, 21% vs 27% [P =.472]).

Researchers also found that seroconversion rates and postvaccination geometric mean titers were similar between the 2 groups; however, vaccine-related adverse events occurred significantly more frequently in patients who received the vaccine during the cytopenic period (32% vs 13%; P =.040).

The findings ultimately suggest that influenza vaccination can be performed on the first day of chemotherapy administration or during the cytopenic period.

heterodimerization of HER2 with other HER family members, including EGFR, HER3, and HER4. As such, pertuzumab could result in adverse events similar to those observed with EGFR antagonists, such as diarrhea.

Therefore, researchers sought to determine the incidence and severity of diarrhea observed with pertuzumab in the CLEOPATRA, NeoSphere, and TRYPHAENA trials. For the study, investigators analyzed data from 1443 patients with metastatic breast cancer included in the CLEOPATRA trial and 639 patients with early-stage breast cancer included in the NeoSphere and TRYPHAENA studies.

Results showed that the incidence of all-grade diarrhea across studies was generally greater for pertuzumab-based

treatment, ranging from 28% to 72%. Most cases of diarrhea were grade 1 (21% to 54%) and grade 2 (8% to 37%).

Grade 3 cases of diarrhea ranged from 0% to 12% and 0% of patients reported grade 4 diarrhea.

Investigators also evaluated the incidence of febrile neutropenia concurrent with diarrhea and the effect of pre-existing gastrointestinal comorbidities. They observed no relationship between pre-existing gastrointestinal comorbidities and diarrhea, and overlap between diarrhea and febrile neutropenia was infrequent, ranging from 0% to 11%.

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

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 11

© THINKSTOCK

Read more at http://bit.ly/2jJwT3C.

IN THE NEWS

Cancer registries are valuable epidemiologic tools that can inform cancer prevention policies, early diagnosis, and treatment practices. But cancer registries’ geographic coverage and quality varies dramatically around the world, noted Sujha Subramanian, PhD, of RTI International in Research Triangle Park, North Carolina.

“There is almost 100% coverage in North America, but less than 10% in Central and South America, Asia and Africa,” noted coauthor Florence K. L. Tangka, PhD, of the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia. “These countries are essentially fighting cancer blindfolded as they often can’t know how to best direct their resources.”

There is an urgent need to establish sustainable cancer registries and to ensure high-quality data are recorded in those databases, they reported.

Governments around the world have approved the Non-Communicable Diseases (NCD) Global Monitoring Framework and have committed to reducing cancer and other NCD deaths by 25% in the coming 8 years, the coauthors noted.

Registering a cancer patient’s data can cost as little as $0.01 per patient, the coauthors reported.

Read more at http://bit.ly/2kk16ta.

Early Endometrial Cancer Surgery May Reduce Survival Surgery within 2 weeks or after more than 8 weeks of endometrial cancer diagnosis may worsen survival because of perioperative death and outcomes at low-surgicalvolume centers.

“Delay in surgical treatment was a risk factor for mortality in low-risk cancers only and was likely associated with poor access to specialty care,” reported lead author David Shalowitz, MD, of the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues.

The study authors suggested that treatment for endometrial cancers should begin within 8 weeks of diagnosis but that “referral to an experienced surgeon … should be prioritized over expedited surgery.”

The study team reviewed data for more than 200,000 women with endometrial cancer in the United States, of whom 140,078 had low-risk tumors.

Patients who had surgery in the first 2 weeks after diagnosis had a 14% higher 5-year mortality risk overall compared with patients whose surgeries occurred in the third to fourth week after diagnosis. Among the 68,360 patients with high-risk cancers, the 5-year mortality rate was 20%.

Patients undergoing surgery in the first 2 weeks died more frequently within a month of surgery than the other patients (0.7% vs 0.4%; P <.001). That might suggest that differences in cancer care and not tumor biology likely explain the findings, they suggested.

Read more at http://bit.ly/2k8YCdS.

Alcohol Consumption, Particularly White Wine, Associated With Increased Risk of Melanoma Alcohol consumption is associated with greater incidence of several cancers including in the aerodigestive tract, liver, pancreas, colon, rectum, and breast. In this study, researchers sought to determine whether alcohol increases the risk of melanoma.

The study included Data used in this study were from a 210,252 participants total of 210,252 participants involved with 3 large, prospective cohort studies who were followed for a mean of 18.3 years. Alcohol consumption was determined via review of food-frequency questionnaires.

A standard drink was defined as 12.8 g of alcohol.

Results showed an association between overall alcohol consumption and melanoma, with a 14% increase in risk for each alcoholic drink consumed per day. White wine was associated with a 13% increase in risk for each drink consumed per day. No significant increase in risk was associated with drinking red wine, beer, or liquor.

Furthermore, people who drink 20 g or more of alcohol were 2% more likely to develop melanoma of the head, neck, or extremities, but 73% more likely to develop melanoma of the trunk.

The researchers conclude that melanoma is associated with alcohol consumption; however, they caution that their study did not include nonwhites so these findings cannot be generalized to other racial or ethnic groups. In addition, the study did not account for risk factors such as sun-protection behaviors.

Read more at http://bit.ly/2j5XcPj.

12 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

© THINKSTOCK

Urgent Need for Sustainable Cancer Registries Around the World

IN THE NEWS

Results from the commercial nextgeneration FoundationOne (F1) and Guardant360 (G360) gene sequencing tests vary dramatically for the same cancer patients.

“Our findings indicate that the output from genetic testing can differ A comparison of F1 markedly depending on which test and G360 tests is applied,” the researchers noted.

“Since both the F1 and the G360 tests are performed in thousands of patients with cancer each year, these findings are clinically relevant.”

The F1 test might detect “a much broader range of aberrations than that accommodated by G360 testing,” the authors noted. But their study excluded F1 findings that were beyond the scope of the G360 test, so that cannot explain the reported discordance.

The study included 9 adult patients treated at a University of Washington community oncology practice, seven of whom had stage IV cancers of the breast, pancreas, lung, or salivary gland.

“Differences in timing between the 2 tests may cause discordance; however, 7 of the 8 patients with alterations underwent both tests within a 2.5-month period,” they reported.

Read more at http://bit.ly/2jR1huG.

Longer Dosing Interval of Zoledronic Acid May Be Acceptable for Bone Metastases Zoledronic acid is a third-generation aminobisphosphonate used to lower the incidence of skeletal-related events and pain in patients with metastases to the bone. Although it is approved to be administered every 3 to 4 weeks, the optimal dosing interval for zoledronic acid remains unclear.

Therefore, researchers designed a multicenter, open-label, phase 3 trial (ClinicalTrials.gov Identifier: NCT00869206) to evaluate whether zoledronic acid administered every 12 weeks is noninferior to zoledronic acid given every 4 weeks.

For the study, researchers enrolled 1822 patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma who had at least 1 site of bone involvement.

Participants were randomly assigned 1:1 to receive zoledronic acid intravenously every 4 weeks or 12 weeks for 2 years.

Results showed that 29.5% of patients in the zoledronic acid every 4-week dosing group who completed the study and 28.6% of those in the every 12-week dosing group experienced at least 1 skeletal-related event, defined as a clinical fracture, spinal cord compression, radiation to bone, or surgery involving bone, within 2 years of randomization.

The between-group absolute difference in risk of skeletalrelated events was −0.3% (95% CI, −4 to ∞), below the 7% predefined noninferiority margin threshold (P <.001 for noninferiority).

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

3-Drug Regimen With Ricolinostat Active, Safe in Multiple Myeloma Previous research has demonstrated HDAC inhibition improves the efficacy of proteasome inhibitors in multiple myeloma but adds significant toxicity. Because preclinical models suggest that HDAC6 is responsible for the observed synergy between HDAC inhibitors and proteasome inhibitors, researchers sought to evaluate the safety and preliminary efficacy of the HDAC6-selective inhibitor ricolinostat in combination with standard proteasome inhibitor therapy.

For the multicenter, open-label, phase 1/2 study (ClinicalTrials.gov Identifier: NCT01323751), investigators enrolled 72 patients with relapsed or refractory multiple myeloma who had received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.

Of those, 15 patients received oral ricolinostat monotherapy and 57 patients received ricolinostat in combination with bortezomib and dexamethasone.

Results showed although single-agent ricolinostat therapy was not associated with significant toxicity, no patients achieved a minor or partial response. Six patients had stable disease for a median of 11 weeks.

In the combination cohort, 160 mg daily of ricolinostat was well tolerated, with less severe constitutional, gastrointestinal, and hematologic toxicities compared with reported data on nonselective HDAC inhibitors. The most common treatment-emergent adverse events were thrombocytopenia, anemia, diarrhea, hypertension, fatigue, hyperglycemia, renal insufficiency, nausea, hypophosphatemia, and hyponatremia.

Investigators observed significant gastrointestinal toxicity in patients who were treated with twice daily dosing of ricolinostat.

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 19

© THINKSTOCK

Comparing Popular Commercial Cancer Gene Tests Yield Different Results

IN THE NEWS Drug-Drug Interactions Between Capecitabine and PPIs Reduce Survival in GI Cancers

Various agents, including biologic targeted agents, have been approved for advanced NSCLC over the last decade, but there have been limited data on their use and associated survival and spending. Therefore, researchers sought to use linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data to assess infusion and oral antineoplastic agents prescribed for newly diagnosed advanced-stage NSCLC over a 12-year period.

For the study, researchers analyzed data from 22,163 older patients with newly diagnosed advanced-staged NSCLC who were treated with antineoplastic agents between 2000 and 2011. Investigators estimated the adjusted percentage of patients who received each agent, days while on treatment, survival, and spending in the 12 months after diagnosis.

Results showed a substantial shift in treatment over the study period with rapid adoption of pemetrexed (39.2%), erlotinib (20.3%), and bevacizumab (18.9%). Investigators observed a decline in paclitaxel (38.7%), gemcitabine (17.0%), and vinorelbine (5.7%; all P <.05).

Researchers found that the average total days on therapy increased from 103 days to 108 days, with patients who received bevacizumab, erlotinib, or pemetrexed having the longest average treatment durations. The average treatment duration for patients receiving these agents was approximately 146 days compared with 75 days for those who did not receive these agents.

Investigators observed modest but statistically significant median survival gains of 1.5 months over the 12-year period (P < .001).

Importantly, approximately 44% of patients received antineoplastic agents in the last 30 days of life throughout the study period, regardless of year of diagnosis. Current guidelines recommend treating patients until evidence of disease progression, after which time patients may live only a few weeks.

Capecitabine is commonly prescribed for gastric cancer, and also has indications for colorectal and breast cancers. Proton pump inhibitors (PPIs) are commonly used to treat heartburn and gastrointestinal bleeding. PPIs are also available as over-theA secondary analysis counter remedies for heartburn and of the TRIO-013 trial gastric acid suppression (eg, Nexium, Prevacid, and Protonix).

In a secondary analysis of TRIO-013 (ClinicalTrials.gov Identifier: NCT00680901), a phase 3 randomized trial with 545 patients with metastatic gastroesophageal cancer (median age, 60 years; 74% [406] men) who received capecitabine and oxaliplatin and were randomized to treatment with or without lapatinib, researchers sought to determine if PPIs impair the efficacy of capecitabine in patients with metastatic gastroesophageal cancer.

For the study, use of proton pump inhibitors was confirmed by review of patients’ medication records. Researchers compared progression-free survival and overall survival among patients who were treated with PPIs vs those who were not.

Multivariate Cox proportional hazards modeling was used to account for younger age (younger than 60 years), Asian ethnicity, female sex, and disease stage (metastatic/advanced).

Of the patients included in this analysis, 229 received PPIs (42.0%) and were evenly distributed between the 2 treatment arms.

Among those who did not receive lapatinib (placebo arm), patients treated with PPIs had worse median progression-free survival (4.2 months vs 5.7 months), overall survival (9.2 months vs 11.3 months), and disease control rate (83% vs 72%) compared with those patients who were not treated with PPIs. Multivariate analysis demonstrated that progression-free survival and overall survival were worse in patients treated with proton pump inhibitors.

Among those patients in the lapatinib (treatment) arm, the effect of PPIs on progression-free survival and overall survival was less; however, overall survival was significantly different in this group on multivariate analysis.

These results demonstrate that because proton pump inhibitors may raise gastric pH levels, use of these drugs has a negative effect on dissolution and absorption of capecitabine; however, their effect on lapatinib is unclear.

Read more at http://bit.ly/2k1kJp2.

Read more at http://bit.ly/2jvqp7m.

Read more at http://bit.ly/2kgC4I1.

Considerable Shifts in NSCLC Treatment With Modest Gains in Survival

20 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

© DR P. MARAZZI / SCIENCE SOURCE

Researchers found that 37% of patients in the combination cohort who received daily ricolinostat at a dose of 160 mg or 240 mg achieved a partial response or better. Among those with bortezomib-refractory disease, the response rate was 14%.

NAVIGATOR NOTES Navigation Program Leads to Increased Screening Rates Jason Hoffman, PharmD, RPh

UConn Health’s patient access department. The navigator would then call UConn Health’s radiology department with the patient to schedule a breast screening.

One to 3 days before the appointment, the navigator calls to remind the patient of the appointment.

Of the 99 patients referred for breast screening, 69.7% were black, 23.2% were Hispanic/Latino, and 6.1% were white. Results showed that 57.6% underwent screening and 75.4% attended the breast screening with no cancelled appointments.

Ms Banks also found that 50.7% of black women, 69.6% of Hispanic/ Latino women, and 83.3% of white women underwent mammography screening, suggesting that additional effort needs to be made to improve screening rates among black and Hispanic women.

Among the 25% who cancelled their first appointment, 17.5% attended the second appointment.

Reasons for failed follow-up included out-of-service phone number; failure to answer phone calls or respond to voicemail message; receipt of breast cancer screening elsewhere due to distance of UConn Health; and receipt of breast cancer screening elsewhere due to familiarity with a different imaging center. ■ REFERENCE

when a patient has not undergone a recent mammography. The navigator would educate the woman on the importance of maintaining breast health and register the patient by calling

1. Banks RM, Stevenson CE. Community breast navigation improves breast cancer screening in Hartford, CT. Poster presented at: 2016 San Antonio Breast Cancer Symposium; December 6-10, 2016; San Antonio, TX.

The community navigator’s primary role was to educate patients, schedule screening, and reschedule missed appointments. www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 21

©THINKSTOCK

A

community breast navigation program in an underser ved area of Connecticut improved mammography screening rates among African American and Latino women.1 “In the United States in 2013, only 37.1% of uninsured women received mammogram screenings compared to 70.4% of insured women,” said Rasha M. Banks, MPH candidate, UConn Health, The Carole and Ray Neag Comprehensive Cancer Center, Farmington, Connecticut. “To combat barriers to access that cause low rates of mammogram screening, UConn Health, in partnership with Susan G. Komen Connecticut and Community Health Services Inc in Hartford, developed the Community Breast Navigation Program (CBNP).”

Through the CBNP, a community breast navigator was embedded in the adult medicine clinic of Community Health Services for approximately 7 months, with the primary roles of providing breast health education, streamlining screening scheduling, and following up with patients to reschedule missed appointments.

The navigator also provided solutions to barriers for patients, including a bus pass or gas card; breast care and breast cancer education; making mammographies and ultrasounds free; being bilingual; scheduling appointments; calling to remind patients of appointments; and rescheduling missed or cancelled appointments.

For the CNBP, a physician or medical assistant would notify the navigator

FEATURE | Chemotherapy-Induced Alopecia

Cold Cap: Reducing a Dreaded Treatment-Related Effect Inducing scalp vasoconstriction is proven to minimize a dreaded side effect of treatment in women receiving chemotherapy for breast cancer.

BETTE WEINSTEIN KAPLAN

© VÈRONIQUE BURGER / SCIENCE SOURCE

A

Scalp cooling systems effectively reduced hair loss in women undergoing chemotherapy for breast cancer.

growing number of women are thrilled to have “hat head” — their hair appearing flattened and unflattering as a result of wearing a hat. The reason for this is the hat they have been wearing is a cold cap, a device that preserves the hair of patients undergoing chemotherapy so after their chemotherapy they actually still have hair to be flattened.

The science of cold caps, or scalp hypothermia, to minimize chemotherapy-induced alopecia (CIA) began more than 2 decades ago in Europe with anecdotal reports on women taking cold showers immediately before and after chemotherapy or wearing shower caps filled with ice cubes during their treatment. The theory is that cooling down the scalp causes vasoconstriction, which limits the amount of chemotherapeutic agent that reaches the hair follicles and slows down hair-cell metabolism so the cells do not absorb the full dose of chemotherapy that does reach the follicles. Therefore, the hair cells are more likely to survive. Scalp hypothermia is equally effective in women and men.

Hope Rugo, MD, professor of medicine and director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, is a leading proponent of scalp hypothermia. Her clinical trial of the DigniCap® (DBA Dignitana Inc; Dallas, Texas) led to recent FDA clearance of the device, the first cleared for scalp cooling in the United States. The study included 122 women with stage I or stage II

22 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

The Pharmacology Courses You Need Available now on myCME! Developed by NPACE, one of the nation’s leading providers of nurse practitioner continuing nursing education, these courses will help you meet your state and national certification pharmacology credit requirements in one convenient web-based location.

• Satisfy the new ANCC pharmacotherapeutic requirement • Clinically relevant topics, latest updates, clinical pearls, and tools you can implement immediately • Created by NPs, for NPs

Nurse Practitioner Associates for Continuing Education (NPACE) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. ®

Nurse Practitioner Associates

for Continuing Education

Take a closer look at myCME, the fastest growing online resource for CE pharmacology credits.

Visit myCME.com/pharmacology

FEATURE | Chemotherapy-Induced Alopecia TABLE 1. Cold Caps and Cooling Systems Manual Cold Caps Arctic Cold Caps

https://arcticcoldcaps.com

ChemoColdCaps

http://chemocoldcaps.com

Elasto-Gel

www.icewraps.com

Penguin Cold Caps

https://penguincoldcaps.com

Wishcaps

http://wishcaps.com

Computerized Cooling Systems Dignicap — Intelligent Scalp Cooling System

www.dignicap.com

Paxman Scalp Cooling System

http://paxmanscalpcooling.com

breast cancer (including nonrandomized control patients).

The DigniCap System prevented hair loss in 70.3% of patients with breast cancer receiving neo/adjuvant chemotherapy, compared to controls where all patients experienced significant hair loss. The most commonly reported side effects were chills, headaches, and discomfort in the neck and shoulders.1 The success of scalp hypothermia depends on several factors: the chemotherapy agent or agents being infused, the type of cap that is used, how well the cap is fitted to the patient’s head during each treatment, how long the patient keeps the cap on each time, and how thick the patient’s hair is. Some reports note that very thick hair insulates the scalp from getting as cold as it needs to be, making the cooling cap less successful at preventing alopecia.2

Once an anthracycline is combined with a taxane such as paclitaxel, docetaxel, or nab-paclitaxel, the success rate [of the cap] declines.

Scalp cooling can be surprisingly effective. For example, the docetaxel (Taxotere) and cyclophosphamide (TC) regimen can cause total alopecia; however, one study demonstrated that cold cap therapy effectively controlled patients’ hair loss.3 Although most of the women reported thinning of their hair after each chemotherapy treatment, the Dean’s alopecia score 3 months after completing chemotherapy was excellent for 65% of patients, good for 25% of patients, and moderate or poor for 10% of patients. In addition, none of the women withdrew from the study due to intolerance of the cold caps.3

Anthracycline-only chemotherapy seems to be the most receptive to scalp hypothermia therapy. Patients receiving doxorubicin, epirubicin, and daunorubicin were pleased with their results. In one study, 92% of patients on anthracyclineonly chemotherapy experienced no hair loss. However, once an anthracycline is combined with a taxane such as paclitaxel, docetaxel, or nab-paclitaxel, the success rate declines. Cold caps used in patients who receive combination chemotherapy with cyclophosphamide seem to be the least effective.4 COLD CAPS AND COOLING SYTEMS Scalp cooling is achieved by wearing a special lined cap designed to fit snug (Table 1). The cap lining is filled with a gel that stays flexible even when frozen. Prior to each chemotherapy session several caps are chilled to between –15°F to –40°F either manually (the patient stores the caps in a cooler filled with dry ice) or mechanically (placed in a mechanical cooler at the infusion center). A home freezer will not bring the caps to the proper temperature; the cold cap process requires using a freezer that can maintain a temperature of –30°C (–22°F).

Some infusion centers have special biomedical freezers that freeze and maintain the caps at the ideal temperature.

Patients bring their caps to the infusion center the day before their treatment and put the caps in the biomedical freezer so they will be ready for the next day’s chemotherapy session.

The caps are worn for approximately 1 hour before and up to 4 hours after each infusion session, depending on the type of chemotherapy administered.5 Manual caps are uncomfortably cold when first placed on the patient’s head. However, the discomfort resolves after several minutes as the scalp becomes numb. Computerized scalp cooling systems offer an advantage for patients in that the caps are at room temperature when the patient puts it on and are then brought down to treatment temperature.

Two currently available computer-controlled scalp cooling units are DigniCap and the Paxman Scalp Cooling System (Paxman Coolers Limited; Huddersfield, England). Both devices were developed in Europe.

The DigniCap is connected to a cooling control unit.

Channels in the cap circulate coolant, while sensors monitor scalp temperature. The system automatically regulates the cap’s temperature throughout the treatment.6 Clinical trials for the Paxman system are underway in the United States. The Paxman system was developed by a family-owned company that had developed a beer cooling system for breweries. Their cold cap prototype was conceived when a family member with breast cancer faced chemotherapy-induced alopecia. Although the cooling product did not work for her, the company continued to

24 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

Patients who plan to use scalp cooling during their chemotherapy sessions should receive additional instructions specific to its use. refine its product. Similar to other cooling systems, each cap is connected to a cooling unit that controls the circulating coolant in the cap for up to 2 patients at a time.7 PATIENT EDUCATION Patients who plan to use scalp cooling during their chemotherapy sessions should receive additional instructions specific to its use. The following discussion points need to be reviewed.

• The technique is not perfect. You will experience some hair loss.

• Scalp cooling is not comfortable, but it is tolerable. The caps must be very cold to be effective. A manual cap is at treatment temperature when you put it on; cooling systems chill the cap after you put it on. Your scalp will become numb from the cold.

• You need to bring someone with you to each chemotherapy session to help you with putting on the cooling cap and with changing the manual caps as the cap temperature rises.

• You will feel chilly. You should dress in warm clothes and bring a blanket.

• Baby your hair. Do not shampoo for 3 days before and 3 days after each chemotherapy session. In addition, avoid using hot rollers, curling irons, and products that use alcohol or peroxide; and do not color, tug at, or blow dry your hair for at least 3 months after completing your last course of chemotherapy.

• Scalp cooling will lengthen your time at the infusion center to most of the day. The cold cap is worn at treatment temperature for approximately 1 hour prior to beginning each chemotherapy session, and you keep it on for as long as 4 hours after completing your infusion, depending on the cooling method.

• Your health insurance plan may not cover scalp cooling.

Patients who cannot afford scalp cooling may qualify for a subsidy from organizations that advocate use of the technique.

FIND US ON

ADVOCATES FOR COLD CAPS The Rapunzel Project Founded by 2 breast cancer survivors,

the Rapunzel Project spreads the word about scalp cooling. It serves as an information resource, a clearinghouse to match up patients with scalp cooling centers and financial aid, and also donates biomedical freezers to hospitals for freezing and storing cold caps.8 HairToStay Scalp cooling can cost upwards of $1000 per

patient, approximately the same as a custom-made wig.

Insurance may not pay for it; however, HairToStay, a national nonprofit organization dedicated to providing financial support to patients who cannot afford scalp cooling, can help.

According to Executive Director Bethany Hornthal, some patients refuse chemotherapy for fear of losing their hair.

HairToStay, which is sustained by donations, is also focused on educating and supporting patients with cancer, networking to salons, and expanding awareness of scalp cooling in the United States.9 ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

REFERENCES 1. Rugo HS, Klein P, Melin SA, et al. Clinical performance of the DigniCap System, a scalp hypothermia system, in preventing chemotherapy induced alopecia. J Clin Oncol. 2015;33(suppl):Abstr 9518.

2. Cold caps (scalp hypothermia). American Cancer Society web site. http:// www.cancer.org/treatment/treatmentsandsideeffects/physicalsideeffects/chemotherapyeffects/cold-caps. Accessed January 27, 2017.

3. Cigler T, Isseroff D, Fiederlein B, et al. Efficacy of scalp cooling in preventing chemotherapy-induced alopecia in breast cancer patients receiving adjuvant docetaxel and cyclophosphamide chemotherapy. Clin Breast Cancer. 2015;15(5):332-4.

4. Komen MM, Smorenburg CH, van den Hurk CJ, Nortier JW. Factors influencing the effectiveness of scalp cooling in the prevention of chemotherapy-induced alopecia. Oncologist. 2013;18(7):885-891.

5. Cold caps. Breastcancer.org web site. http://www.breastcancer.org/tips/ hair_skin_nails/cold-caps. Accessed January 27, 2017.

6. DigniCap. https://www.dignicap.com. Accessed January 27, 2017 7. Paxman. http://paxmanscalpcooling.com. Accessed January 27, 2017..

8. The Rapunzel Project. http://www.rapunzelproject.org. Accessed January 27, 2017.

9. HairToStay. http://www.hairtostay.org. Accessed January 27, 2017.

linkedin.com/company/oncology-nurse-advisor

plus.google.com/+Oncologynurseadvisor

@ONAcom

OncologyNurseAdvisor.com/app-download

facebook.com/OncologyNurseAdvisor

OncologyNurseAdvisor.com

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 25

FEATURE | Hematologic Cancer

A Review of Kinase Inhibitors for Hematologic Cancers Ibrutinib, idelalisib, ponatinib, and ruxolitinib are each associated with a variety of potential adverse effects and oncology nurses must be aware.

DEBRA HUGHES, MS

T

© ROB COLVIN

here have been 32 oral kinase inhibitors approved since 2001, 4 of which — ibrutinib, idelalisib, ponatinib, and ruxolitinib — are indicated for use in patients with hematologic cancers.1-4 These agents, all approved between 2011 and 2014, are indicated for several types of leukemias and lymphomas.

With the use of oral kinase inhibitors nurses must be aware of unique adverse effects associated with these drugs. Each agent has a different indication and recommended dose, and 2 have specific guidelines for administration ( Table 1).

OVERVIEW Ibrutinib, idelalisib, and ponatinib all can cause fetal harm,1-3 while ruxolitinib “should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”4 Women should avoid becoming pregnant while taking ibrutinib, idelalisib, and ponatinib,1-3 and those who have received ibrutinib and idelalisib should also wait 1 month after their last dose before attempting a pregnancy.1-2 Men taking ibrutinib should be cautioned against fathering a child while on therapy and for 1 month after their last dose.1 Co-administration of ibrutinib should be avoided with strong and moderate CYP3A inhibitors and strong CYP3A inducers.

Specifically, patients should be warned not to drink grapefruit juice, or eat grapefruit or Seville oranges (often used in marmalades), as these products may increase ibrutinib levels. If 26 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

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.

ONA_Write for Us.indd 1

5/18/16 11:49 AM

FEATURE | Hematologic Cancer TABLE 1. Kinase Inhibitors for Hematologic Cancers: Indication, Recommended Dose, and Administration1-4 Generic (Trade Name)

Indication

Recommended Dose

Administration

Ibrutinib (Imbruvica)

• MCL, at least 1 prior therapy • CLL/SLL • CLL/SLL with 17p deletion • Waldenström macroglobulinemia

• MCL: 560 mg orally once daily • CLL/SLL and Waldenström macroglobulinemia: 420 mg orally once daily

• Take with a glass of water • Do not open, break, or chew the capsules

Idelalisib (Zydelig)

• Relapsed CLL, in combination with rituximab, when rituximab alone would be considered ­appropriate therapy due to other comorbidities • Relapsed follicular B-cell NHL, at least 2 prior systemic therapies • Relapsed SLL, at least 2 prior systemic therapies

150 mg orally twice daily

With a low-fat meal

Ponatinib (Iclusig)

• T315I-positive CML (CP, AP, or BP), or Ph+ ALL • CML (CP, AP, BP) or Ph+ ALL, if no other TKI therapy is indicated

• 45 mg orally, once daily • Hepatic impairment: 30 mg orally once daily • Modify or interrupt dosing for hematologic and nonhematologic toxicity

Take with or without food

Ruxolitinib (Jakafi)

• Intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and postessential thrombocythemia myelofibrosis • Polycythemia vera, with inadequate response to or intolerant of hydroxyurea

• Myelofibrosis: Starting dose based on platelet count ŪŪ>200 × 109/L, 20 mg orally twice daily ŪŪ100 × 109/L to 200 × 109/L, 15 mg orally twice daily ŪŪ50 × 109/L to <100 × 109/L, 5 mg orally twice daily • Monitor complete blood counts every 2 to 4 weeks until doses are stabilized, then as clinically indicated • Monitor or interrupt dosing for thrombocytopenia • Polycythemia vera: Starting dose 10 mg orally twice daily

Key: AP, accelerated phase; BP, blast phase; CLL/SLL, chronic lymphocytic leukemia/small lymphocytic lymphoma; CML, chronic myeloid leukemia; CP, chronic phase; MCL, mantle cell lymphoma; NHL, non-Hodgkin lymphoma; Ph+ ALL, Philadelphia chromosome-positive acute lymphoblastic leukemia; TKI, tyrosine kinase inhibitor.

a moderate CYP3A inhibitor must be used, the dose of ibrutinib should be reduced. Use of ibrutinib should be avoided in patients with moderate or severe baseline hepatic impairment, based on Child-Pugh criteria; if used in those with mild impairment the dose should be reduced.1 Idelalisib is contraindicated in patients with history of serious allergic reactions, including anaphylaxis and toxic epidermal necrolysis. Coadministration of strong CYP3A inducers should be avoided with idelalisib, as should CYP3A substrates. Mothers who are nursing should discontinue either idelalisib or nursing.2 Concurrent use of ponatinib should be avoided with strong CYP3A inhibitors and inducers. If co-administration of a strong CYP3A inhibitor cannot be avoided, the dose of ponatinib should be reduced.3 Ruxolitinib should be avoided with fluconazole doses greater than 200 mg. With strong CYP3A4 inhibitors or fluconazole, ruxolitinib dose should be reduced, interrupted, or discontinued, as recommended. In patients with renal and/or hepatic impairment, the starting dose of ruxolitinib should be reduced or treatment should be avoided. Nursing mothers should discontinue nursing or

ruxolitinib, taking into account the importance of the drug to their specific treatment plan.4 BLACK BOX WARNINGS For 2 of the agents — idelalisib and ponatinib — the most important side effects are those outlined in their respective black box warnings.2,3 Idelalisib The black box on idelalisib prescribing information warns of fatal and serious toxicities including hepatic toxicity, severe diarrhea, colitis, pneumonitis, and intestinal perforation.2 To avoid hepatotoxicity that may require a liver transplant or result in death, patients treated with idelalisib should have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) monitored every 2 weeks for the first 3 months of treatment, every 4 weeks for the next 3 months, then every 1 to 3 months after that. If the ALT or AST rises above 3 times the upper limit of normal (ULN), monitor patients weekly for liver toxicity until the laboratory values are resolved. If the ALT or AST is greater than 5 times the ULN, idelalisib should be withheld and ALT, AST, and total bilirubin should be monitored weekly until the abnormality

28 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

is resolved. Idelalisib should be discontinued in patients who have recurrent hepatotoxicity and other drugs that may cause liver toxicity should not be administered concurrently.2 Patients should be monitored for development of severe diarrhea or colitis, with idelalisib interrupted and then reduced or discontinued.2 Those with pulmonary symptoms such as cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic examination, or a decline in oxygen saturation of more than 5% should be evaluated for pneumonitis. If pneumonitis is suspected, idelalisib should be interrupted until the etiology of the pulmonary symptoms can be determined. If pneumonitis is believed to be caused by idelalisib, discontinue the agent and administer corticosteroids.2 Treatment with idelalisib has resulted in serious and fatal intestinal perforation. In some patients, moderate to severe diarrhea has accompanied the perforation. If a patient has intestinal perforation, idelalisib should be permanently discontinued. Advise patients to report any new or worsening abdominal pain, chills, fever, nausea, or vomiting.2 Ponatinib The black box on ponatinib prescribing information warns of vascular occlusion, heart failure, and hepatotoxicity.3 Within 2 weeks of treatment initiation, ponatinib can cause life-threatening and fatal vascular occlusion at dose levels as low as 15 mg per day, including in patients with and without cardiovascular risk factors and in those age 50 years or younger. Median time to a first event is 5 months.

Recurrent or multisite vascular occlusion have also been observed, with events more frequent with increasing age and in patients with a prior history of ischemia, hypertension, diabetes, or hyperlipidemia.3 Some patients have required cerebrovascular, coronary, and peripheral arterial revascularization procedures due to vascular occlusion. Patients suspected of developing arterial thrombotic events should interrupt or stop use of ponatinib, with a benefit-risk consideration used to guide the decision of whether to restart treatment. Among those who develop serious venous thromboembolism, consider dose modification or ponatinib discontinuation.3 In clinical trials, fatal and serious heart failure of left ventricular dysfunction occurred in patients treated with ponatinib; therefore, patients should be monitored for signs or symptoms consistent with heart failure and treated as clinically indicated, which may include interruption or discontinuation of ponatinib in those who develop serious heart failure.3 Patients treated with ponatinib may show elevated levels of ALT, AST, or both, reflecting hepatotoxicity. For that

reason, liver function tests should be monitored at baseline and then at least monthly, or as clinically indicated, with the dose of ponatinib interrupted, reduced, or discontinued, as clinically indicated.3 ADVERSE EFFECTS FOR SPECIFIC ORGAN SYSTEMS In addition to the black box warnings for idelalisib and ponatinib, the “warnings and precautions” section of the prescribing information for these 4 kinase inhibitors includes adverse effects for specific organ systems including cardiovascular, dermatologic, endocrine and metabolic, hematologic, hepatic, ocular, pulmonary, and renal systems.

Cardiovascular Patients who receive ibrutinib should be monitored periodically for atrial fibrillation (AF); if AF persists, follow dose modification guidelines and consider risks and benefits of treatment. Those who develop arrhythmic symptoms or new onset dyspnea should undergo electrocardiography.1 Clinicians should advise patients receiving ponatinib to report signs and symptoms of slow heart rate, such as fainting, dizziness, or chest pain, as well as rapid heart rate (palpitations or dizziness); if these symptoms occur, ponatinib treatment should be interrupted and the patient should be evaluated.3

If significant worsening, labile, or treatment-resistant hypertension occurs, interrupt ponatinib and evaluate for renal artery stenosis.

Hypertension has been reported in patients treated with ibrutinib and ponatinib.1,3 After treatment initiation with ibrutinib, patients should be monitored for new onset hypertension or hypertension not adequately controlled.

As appropriate, existing antihypertension medications should be adjusted or initiated.1 Among those treated with ponatinib, urgent clinical intervention may be required for hypertension associated with confusion, headache, chest pain, or shortness of breath. Blood pressure elevations should be monitored and managed during treatment with ponatinib, with hypertension treated to normalize blood pressure. If hypertension is not medically controlled, ponatinib should be interrupted and the dose should be reduced or discontinued. If significant worsening, labile, or treatment-resistant hypertension occurs, interrupt ponatinib treatment and evaluate the patient for renal artery stenosis.3 Dermatologic In a study of idelalisib in combination with rituximab and bendamustine, 1 case of toxic epidermal

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 29

FEATURE | Hematologic Cancer necrolysis occurred. Other severe or life-threatening cutaneous reactions reported in patients treated with idelalisib are dermatitis exfoliative, rash (erythematous, generalized, macular, maculopapular, papular, pruritic, exfoliative), and skin disorder. Patients should be monitored for development of severe cutaneous reactions and idelalisib should be discontinued if it occurs.2 Nonmelanoma skin cancers have been reported in patients treated with ruxolitinib. These have included basal cell, squamous cell, and Merkel cell carcinoma, necessitating periodic skin examinations.4

Serious bacterial, mycobacterial, fungal, and viral infections have occurred in patients treated with ruxolitinib.

Endocrine and Metabolic Increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, have been associated with ruxolitinib treatment. Clinicians should assess lipid levels approximately 8 to 12 weeks from treatment initiation and monitor and treat patients according to clinical guidelines if hyperlipidemia occurs.4 Hematologic Serious bleeding events, including fatalities, have occurred in patients treated with ibrutinib and ponatinib.1,3 Patients receiving antiplatelet or anticoagulant therapies should be monitored for signs of bleeding because ibrutinib may increase the risk of hemorrhage in this population. Depending on the type of surgery and risk of bleeding, ibrutinib may be withheld for at least 3 to 7 days both before and after surgery.1 The most commonly reported serious bleeding events in patients administered ponatinib were cerebral and gastrointestinal hemorrhage; the majority of hemorrhagic events occurred in those with grade 4 thrombocytopenia. In those with serious or severe hemorrhage, ponatinib treatment should be interrupted and the patient should be evaluated.3 Treatment with ibrutinib, ponatinib, and ruxolitinib can cause neutropenia, thrombocytopenia, and anemia.1,3,4 In those treated with ibrutinib, clinicians should monitor complete blood counts monthly.1 For patients who receive ponatinib, complete blood counts should be monitored every 2 weeks for 3 months and then monthly for as long as clinically indicated. Ponatinib dose should be interrupted if the absolute neutrophil count (ANC) is less than 1000/mm3 or thrombocytopenia is less than 50,000/mm3 and the dose was reduced

TABLE 2. Most Common Adverse Reactions In Patients With B-cell Malignancies1-4 Ibrutinib (Incidence ≥20%) • Anemia • Bruising • Diarrhea • Fatigue • Hemorrhage • Musculoskeletal pain

• Nausea • Neutropenia • Pyrexia • Rash • Thrombocytopenia

Idelalisib (Incidence ≥20%) • Abdominal pain • Chills • Cough • Diarrhea • Fatigue

• Nausea • Pneumonia • Pyrexia • Rash

Ponatinib (Incidence ≥20%) Hematologic • Anemia • Leucopenia • Lymphopenia Nonhematologic • Abdominal pain • Arthralgia • Constipation • Dry skin • Fatigue

• Neutropenia • Thrombocytopenia

• Headache • Hypertension • Nausea • Pyrexia • Rash

Ruxolitinib (Incidence >20%) Hematologic • Anemia Nonhematologic (>10%) • Bruising • Dizziness

• Thrombocytopenia • Headache

as recommended.3 For thrombocytopenia, ruxolitinib dose may be reduced or interrupted; platelet transfusions may be necessary, whereas for anemia, patients may require blood transfusions and/or dose modifications. In clinical trials, severe neutropenia, defined as ANC less than 0.5 × 109/L, was generally reversible if ruxolitinib was withheld until the patient recovered. In all patients, a pretreatment complete blood count should be performed prior to ruxolitinib initiation, with complete blood counts monitored every 2 to 4 weeks until doses are stabilized, then as clinically indicated.4 Idelalisib is primarily associated with neutropenia; therefore, monitor blood counts at least every 2 weeks for the first 3 months of therapy and at least weekly in patients with neutrophil counts less than 1.0 Gi/L.2 Ocular In patients treated with ponatinib, serious ocular toxicities leading to blurred vision or blindness have been

30 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

reported. Conduct comprehensive eye examinations at baseline and periodically during treatment.3 Renal Tumor lysis syndrome has been reported with ibrutinib and ponatinib. Patients should be closely monitored, including baseline risk, and treated appropriately.1,3 Before initiating treatment with ponatinib, ensure adequate hydration and correct elevated uric acid levels.3 OTHER ADVERSE EFFECTS Most common adverse effects reported by patients taking one of these oral agents are listed in Table 2.

In patients treated with idelalisib, serious allergic reactions, including anaphylaxis, have been reported. If a patient develops such a reaction, discontinue idelalisib permanently and institute appropriate supportive measures.2 Fluid retention — including peripheral edema and peripheral and pericardial effusion — has been observed among patients treated with ponatinib. Monitor patients and interrupt, reduce, or discontinue the dose of ponatinib as clinically indicated if fluid retention occurs.3 Ponatinib is also associated with peripheral and cranial neuropathy, with one-third of patients developing this symptom during the first month of treatment. If hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, or neuropathic pain or weakness occur, the clinician should consider interrupting ponatinib and evaluating the patient for suspicion of neuropathy.3 Pancreatitis has been reported with ponatinib; serum lipase levels should be checked every 2 weeks for the first 2 months and then monthly thereafter. Additional serum lipase monitoring may be considered for patients with a history of pancreatitis or alcohol abuse, in which case dose interruption or reduction may be required. If lipase elevations are accompanied by abdominal symptoms, interrupt ponatinib and evaluate patients for pancreatitis. Ponatinib should not be restarted until patient symptoms have completely resolved and lipase levels are less than 1.5 times ULN.3 Ibrutinib has been associated with second primary malignancies, including skin cancers and other carcinomas.1 Compromised wound healing has been reported in patients receiving ponatinib; therefore, the agent should be interrupted at least 1 week prior to major surgery and

FIND US ON

resumed only when wound healing has been judged to be adequate.3 Serious bacterial, mycobacterial, fungal, and viral infections have occurred in patients treated with ruxolitinib. It is important for clinicians to assess patients for signs and symptoms of infection and treat them accordingly. Active serious infections should be resolved prior to ruxolitinib treatment initiation.4 Ruxolitinib is associated with tuberculosis infection, progressive multifocal leukoencephalopathy (PML), and increased hepatitis B viral load. Clinicians should evaluate patients and assess for risk factors, then monitor and treat as clinically indicated.4 Fatal and nonfatal infections have occurred in patients treated with ibrutinib, including cases of progressive PML. Patients should be evaluated for fever and infections and treated as indicated.

CONCLUSIONS Despite the effectiveness of oral kinase inhibitors, patients with hematologic cancers who receive treatment with one of these agents are at risk for adverse events, some of which can be serious and/or fatal. Nurses need to be aware of the signs and symptoms of adverse effects and initial steps to take in managing these events. In addition, the need to alert their oncology team about potential adverse effects cannot be overstated to patients. ■ Debra Hughes is a medical writer based in Lusby, Maryland.

REFERENCES 1. Imbruvica® [package insert]. Sunnyvale, CA: Pharmacyclics LLC; 2016. http://www.accessdata.fda.gov/drugsatfda_docslabel/2015 /205552s002lbl.pdf. Accessed January 27, 2017.

2. Zydelig® [package insert]. Foster City, CA: Gilead Sciences, Inc; 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206545lbl .pdf. Accessed January 27, 2017.

3. Iclusig® [package insert]. Cambridge, MA: ARIAD Pharmaceuticals, Inc; 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/ 203469lbl.pdf. Accessed January 27, 2017.

4. Jakafi™ [package insert]. Wilmington, DE: Incyte Corporation; 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl .pdf. Accessed January 27, 2016.

linkedin.com/company/oncology-nurse-advisor

plus.google.com/+Oncologynurseadvisor

@ONAcom

OncologyNurseAdvisor.com/app-download

facebook.com/OncologyNurseAdvisor

OncologyNurseAdvisor.com

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 31

June 15 - 17, 2017 â&#x20AC;¢ Austin, TX

Are You a Nurse Navigator or Care Coordinator?

JUNE

15 JUNE

16 JUNE

17

Earn Up To

12 CNEs in Just

3 DAYS BROUGHT TO YOU BY:

Join Us at the ONA Navigation Summit!

You can look forward to: • Hearing daily keynote lectures conducted by experts in the field • Participating in case-focused sessions on specific cancer types • Networking with your colleagues from around the country

Make your plans!

Visit us at ONANavigationSummit.com to find all the information you'll need, including: • A complete list of sessions and speakers • Travel information • A justification letter for your supervisor/ institution

SAVE

$50

REGISTER TODAY

with promo code

ONAPRINT50

This activity is jointly provided by the Oncology Nursing Society and Haymarket Media.

Target Audience This educational activity is designed to address the needs of nurse navigators, care coordinators, oncology nurses, advanced practice nurses, cancer program administrators, and cancer service line directors involved in the management of people with cancer.

Continuing Nursing Education ONS is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

The Oncology Nursing Society is providing contact hours for this program and maintains responsibility for adherence to ANCC criteria.

For more information about the accreditation of this program, please contact the Oncology Nursing Society at 1-866-257-4ONS or help@ons.org.

Stay up to date with program announcements and insights.

@ONCNAVSUM

linkedin.com/company/ ona-navigation-summit

STAT CONSULT Olaratumab (Lartruvo) Drug Type

• Platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody

Indications

• Treatment of adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery Mechanism of Action

• Olaratumab is a human IgG1 antibody that binds PDGFR-α • PDGFR-α is a receptor tyrosine kinase expressed on cells of mesenchymal origin • Signaling through this receptor plays a role in cell growth, chemotaxis, and mesenchymal stem cell differentiation • The receptor has also been detected on some tumor and stromal cells, including sarcomas, where signaling can contribute to cancer cell proliferation, metastasis, and maintenance of the tumor microenvironment Dosage and Administration

• Dosage: 15 mg/kg • Administer intravenously over 60 minutes on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity • For the first 8 cycles, administer olaratumab with doxorubicin • Premedicate with diphenhydramine and dexamethasone intravenously prior to olaratumab administration on day 1 of cycle 1 • Visually inspect the diluted solution for particulate matter and discoloration prior to administration ——If particulate matter or discolorations are identified, discard the solution

• Flush line with 0.9% sodium chloride injection at end of infusion Dose Adjustments

• Infusion-related reactions ——Permanently discontinue olaratumab for grade 3 to 4 infusion-related reactions ——Interrupt infusion of olaratumab for grade 1 to 2 infusion-related reactions ■■ After resolution, resume olaratumab infusion at 50% of initial infusion rate • Neutropenia ——For neutropenic fever/infection or grade 4 neutropenia lasting longer than 1 week, discontinue olaratumab administration until ANC ≥1000 cells/μL and then permanently reduce dose to 12 mg/kg Specific Populations

• Pregnancy ——Can cause fetal harm • Advise pregnant women of potential risk to fetus • Nursing mothers ——Advise women to discontinue breastfeeding during treatment with olaratumab and for 3 months following last dose • Pediatric ——Not established • Geriatric ——Clinical studies did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients

34 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

• Renal impairment ——No adjustments necessary • Hepatic impairment ——No adjustments necessary • Patients of reproductive potential ——Females ■■ Use effective contraception during treatment and for 3 months after last dose ——Males ■■ May impair male fertility Boxed Warnings/Contraindications

• None Cautions

• Infusion-related reactions ——Monitor for signs and symptoms during and following infusion ——Discontinue olaratumab for grade 3 to 4 infusionrelated reactions • Embryo-fetal toxicity ——Olaratumab can cause fetal harm ——Advise females of potential risk to fetus and to use effective contraception during treatment with olaratumab and for 3 months after last dose Adverse Effects

• Most common adverse reactions in patients with soft tissue sarcoma are ——Abdominal pain ——Alopecia ——Anxiety ——Decreased appetite ——Diarrhea ——Dry eyes ——Fatigue ——Headache ——Infusion-related reactions ——Mucositis ——Musculoskeletal pain ——Nausea ——Neuropathy ——Vomiting • Most common laboratory abnormalities in patients with soft tissue sarcoma are ——Hyperglycemia ——Hypokalemia

——Hypomagnesemia ——Hypophosphatemia ——Increased alkaline phosphatase ——Increased aPTT ——Lymphopenia ——Neutropenia ——Thrombocytopenia Drug Interactions

• No known drug-drug interactions • No clinically relevant changes in exposure of either olaratumab or doxorubicin were observed when olaratumab 15 mg/kg and doxorubicin 75 mg/m2 were co-administered in patients with solid tumors What to Tell Your Patient

• Olaratumab is a medicine used to treat your soft tissue sarcoma • You will receive olaratumab intravenously as directed by your physician • Your physician will decide how many doses of olaratumab you will receive • You will also receive another intravenous drug called doxorubicin • Before receiving olaratumab, tell your clinician if you ——Have other medical conditions ——Are pregnant or plan to become pregnant ——Are breastfeeding or plan to breastfeed • Tell your clinician about all medications you take, including over-the-counter medications and vitamins • Report any signs or symptoms of infusion reactions • Treatment with olaratumab poses a potential risk to a fetus ——If you are a female of reproductive potential, use effective contraception during treatment with olaratumab and for 2 months after last dose ——Inform your clinician of a known or suspected pregnancy • Do not breastfeed during treatment with olaratumab and for 3 months after last dose • Olaratumab may cause: abdominal pain, alopecia, anxiety, decreased appetite, diarrhea, dry eyes, fatigue, headache, infusion-related reactions, mucositis, musculoskeletal pain, nausea, neuropathy, and/or vomiting • Tell your nurse or doctor if you have any side effect that bothers you or that does not go away. ■ Prepared by Jason Hoffman, PharmD, RPh.

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 35

STAT CONSULT Rucaparib (Rubraca) Drug Type

• Poly (ADP-ribose) polymerase (PARP) inhibitor

Indications

• Treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated with advanced ovarian cancer who have been treated with 2 or more chemotherapies

• Recommended dose reductions (if starting dose is 600 mg twice daily) are as follows — First dose reduction: 500 mg twice daily — Second dose reduction: 400 mg twice daily — Third dose reduction: 300 mg twice daily

Mechanism of Action

Specific Populations

• Rucaparib is an inhibitor of PARP enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair • In vitro studies have shown that rucaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death • Increased rucaparib-induced cytotoxicity was observed in tumor cell lines with deficiencies in BRCA1/2 and other DNA repair genes

• Pregnancy — Can cause fetal harm — Advise pregnant women of potential risk to a fetus • Nursing mothers — Advise women to discontinue breastfeeding during treatment with rucaparib and for 2 weeks after final dose • Females of reproductive potential — Use effective contraception during treatment and for 6 months after final dose — Pregnancy testing prior to initiating treatment is recommended • Pediatric — Safety and efficacy of rucaparib not established in pediatric patients • Geriatric — No overall differences in safety observed between older and younger patients — Insufficient number of patients to detect differences in efficacy between older and younger patients • Renal impairment — No adjustments recommended for mild to moderate renal impairment — No adjustments recommended for severe impairment or dialysis patients due to lack of data

Dosage and Administration

• Dosage: 600 mg twice daily • Administer orally with or without food • Continue treatment until disease progression or unacceptable toxicity • If patient misses a dose, instruct patient to take next dose at its scheduled time • Vomited doses should not be replaced Dose Adjustments

• To manage adverse reactions, consider interruption of treatment or dose reduction

36 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

• Hepatic impairment ——No adjustments recommended for mild hepatic impairment ——No adjustments recommended for moderate to severe impairment due to lack of data Boxed Warnings/Contraindications

• None Cautions

• Embryo-fetal Toxicity ——Rucaparib can cause fetal harm ——Advise females of reproductive potential of the potential risk to fetus and to use effective contraception during treatment with rucaparib and for 6 months after final dose • Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) ——MDS/AML occurred in patients exposed to rucaparib, including 1 fatal event of AML ——Monitor patients for hematologic toxicity at baseline and monthly thereafter ——Discontinue rucaparib if MDS/AML is confirmed • Most common adverse reactions in patients with ovarian cancer are abdominal pain, anemia, constipation, decreased appetite, diarrhea, dysgeusia, dyspnea, fatigue, nausea, thrombocytopenia, and vomiting.

• Most common laboratory abnormalities in patients with ovarian cancer are decreased hemoglobin, decreased lymphocytes, decreased neutrophils, decreased platelets, increased ALT, increased AST, increased cholesterol, and increased creatinine.

Drug Interactions

• No known drug-drug interactions What to Tell Your Patient

• Rucaparib is a prescription medicine taken by mouth used to treat your advanced ovarian cancer after receiving 2 or more prior chemotherapy medicines for your cancer • Rucaparib is only for patients who have certain BRCA gene mutations • Before receiving rucaparib, tell your clinician if you have other medical conditions, are pregnant or plan to become pregnant, and/or are breastfeeding or plan to breastfeed • Tell your clinician about all medications you take, including over-the-counter medications and vitamins

• Take rucaparib exactly as your clinician tells you • Your physician may temporarily stop treatment with rucaparib or change your dose if you have side effects • Do not change your dose or stop taking rucaparib unless your clinician tells you to • Take rucaparib 2 times a day with or without food, separating each dose by approximately 12 hours • If you miss a dose, take your next dose at your usual scheduled time • If you vomit after taking a dose, do not take an extra dose • Rucaparib may cause serious side effects including bone marrow problems (myelodysplastic syndrome) or a type of blood cancer called acute myeloid leukemia • Your clinician will obtain blood samples for tests to check your blood cell counts before treatment with rucaparib, once a month during treatment, and weekly if you have low blood cell counts for a long time • If you develop MDS or AML, your clinician will stop treatment with rucaparib • Treatment with rucaparib poses a potential risk to a fetus ——If you are able to become pregnant, use effective contraception during treatment with rucaparib and for 6 months after last dose ——Your clinician may do a pregnancy test before you start treatment with rucaparib ——Tell your nurse or doctor of a known or suspected pregnancy • Do not breastfeed during treatment with rucaparib and for 2 weeks after your last dose • Avoid spending time in sunlight • Rucaparib can make your skin sensitive to the sun (photosensitivity) and make you sunburn more easily during treatment with rucaparib • You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight • Rucaparib may cause anemia, changes in how food tastes, changes in liver or kidney function, constipation, decreased appetite, diarrhea, fatigue, increased cholesterol levels, low blood cell counts, shortness of breath, stomach-area pain, nausea, and/or vomiting.

• Tell your clinician if you have any side effect that bothers you or that does not go away. ■ Prepared by Jason Hoffman, PharmD, RPh.

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 37

© THINKSTOCK

RADIATION & YOUR PATIENT

Shared Decision Making: New Paradigms in Radiation Oncology Bryant Furlow A recent paper on the future of radiation oncology reports on the trend toward a greater role for shared decision making and patientreported outcomes, such as the interrelated benchmarks of patient satisfaction, engagement, and treatment-plan adherence.1

F

ully achieving the potential of personalized or patient-centered radiation oncology will require not only technological advances but also evolutions in conceptual approaches, workflow, and the use of decision aids that facilitate shared decision making with patients, argue the authors of a new paper on the future of the field.

Implementing patient-centered care will require an expansion of outcome measures to encompass not only objective clinical end points such as tumor control, clinician-reported adverse events, and overall survival, but also patient-reported and patient-centered outcomes, such as the interrelated benchmarks of patient satisfaction, engagement, and treatment-plan adherence, argue the authors of a new paper on the future of radiation oncology.1 “Evaluations that investigate the safety and efficacy of treatments are increasingly soliciting participation from patients within a model of shared decision making [SDM] that improves patients’ knowledge, satisfaction, physical and emotional well-being, and trust in providers,” wrote lead author Abigail T. Berman, MD, MSCE, of the Department of Radiation Oncology at the University of Pennsylvania in Philadelphia, and coauthors.

Recording patient-reported outcomes (PROs) is a fundamental component of shared decision making in cancer care and quickly becoming a routine component of patient–clinician communication, they noted. Patientreported outcomes will likely prove most useful, at least initially, in that setting. In research settings, patientreported outcomes have long been treated as supplementary or exploratory end points — like afterthoughts, in some cases.

But PROs have real prognostic and clinical value. Quality of life (QoL), for example, “significantly predicts outcomes, including local control and survival,” the authors noted.1 Patient-reported outcomes for QoL, subjective assessments of radiotoxicities and other adverse events, and similar parameters might therefore soon move from being secondary to primary end

points in some clinical trials, displacing “the time-honored physician-reported events,” the team predicted. “[T]hey can not only support highquality, high-value patient care but also enhance recruitment to clinical oncology trials, both of which are challenging to achieve in today’s relatively resource-strapped environment,” they argued.

Radiation oncology is well suited to lead the way in patient-centered care; radiotherapy planning and delivery are inherently “personalized” to each patient to maximize treatment efficacy while minimizing irradiation of healthy, nontarget tissues, thereby minimizing harm. And that has led to the development of important technological advances such as contoured and intensity-modulated radiotherapy.

Embedding DAs into patients’ electronic health records will be a crucial step.

Personalized radiotherapy “will be greatly enhanced with SDM and PROs in the clinical and research setting; at the same time, the field is also fortunately rife with other aspects of ‘personalized’ [radiotherapy]: molecular genomics that may allow [radiotherapy] dose escalation or de-escalation, including current successful ongoing de-escalation efforts in human papillomavirus–positive head and neck cancer,” Dr Berman’s team wrote.1 But nontechnical advances “are equally if not perhaps more important to patient satisfaction, engagement, compliance, and ultimately outcomes,” Dr Berman and colleagues wrote.

38 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

Shared decision making “with or without the use of clinical decision aids (DAs), holds the promise of providing the degree of personalization and patient-centered care for patients in their journey toward discovering the most appropriate radiation treatment plan, including whether radiation is at all appropriate or the modality used.”

A CRUCIAL STEP IN PATIENTCENTERED RADIATION ONCOLOGY

Conceptually, actively involving patients in decision making about radiotherapy will take 4 key steps.1 These are the scaffolds of any SDM-based approach to radiotherapy: • Identify steps in the treatment decision-making process.

• Adopt a “dynamic view” of treatment planning that acknowledges that early decision-making steps might be revisited as the interaction with a patient progresses toward a final plan.

• Find approaches to shared decision making that “lie between the three predominant models” of paternalistic, shared, and informed decision making.

• Recognize practical applications.

That framework accommodates a wide range of operational definitions for SDM.1,2 Further, the “Informed Medical Decisions Foundation defines 6 steps of shared decision making, but the steps are broadly defined,” Dr Berman and her colleagues noted. These steps are: • Invite the patient to participate in decision making.

• Present options.

• Inform patients about the goals, risks, and potential benefits of each option.

• Assist patients in matching options to their personal “goals and concerns” for treatment and their lives.

• “Facilitate deliberation and decision making” and implementation.

Shared decision m a k ing DA s and coding schemes, such as the Decision Analysis System for Oncology (for SDM with patients with early-stage breast cancer), OPTION, and the Decision Support Analysis Tool, have been proposed and are in development.1,3,4 Such decision aids, while not yet in wide clinical use, can be invaluable in ensuring high-quality SDM approaches to radiation oncology, the authors argued.1 They can be presented as handbooks or video tutorials, or interactive online guides.1 “Clear hallmarks of a DA include a detailed, personalized discussion of treatment options within the context of a patient’s specific demographics, diseaserelated features, and personal beliefs,” allowing an explicit articulation of the patient’s goals, values, and concerns.1 Barriers to implementation of decision aids and shared decision making include staffing limitations, implementation’s time demands, reimbursement, and system-level tools and infrastructure. Ultimately, embedding decision aids into patients’ electronic health records (EHRs) will be a crucial step toward routine implementation and clinical utilization. It will require coordination with software vendors, championing of the effort by opinion leaders and departmental decision makers, and either reimbursement incentives or “peer pressure” within the department, Dr Berman and colleagues wrote.1 Shared decision making can also facilitate patient participation in clinical trials, such as those that have established that stereotactic body radiotherapy (SBRT) is a viable alternative to surgery for patients with stage I

non-small cell lung cancer who are ineligible for surgery, with excellent safety and tumor control rates.1 SDM approaches are also improving accrual to studies of SBRT’s value for patients who are candidates for surgery.1 “The success of each of these trials will provide meaningful insights into the value of SDM during recruitment to difficult randomized trials,” Dr Berman and colleagues noted.1 Radiation oncology will become more “highly specialized and based on integrating the whole person and his or her molecular fingerprint,” including facets of the patient that only he or she can communicate to the cancer care team, predicted Dr Berman’s team. ■ Bryant Furlow is a medical journalist based in Albuquerque, New Mexico.

REFERENCES 1. Berman AT, Rosenthal SA, Moghanaki D, Woodhouse KD, Movsas B, Vapiwala N. Focusing on the “person” in personalized medicine: the future of patient-centered care in radiation oncology. J Am Coll Radiol.

2016;13(12ptB):1571-1578.

2. Fredrichs W, Hahlweg P, Müller E, Adis C, Scholl I. Shared decision-making in oncology — a qualitative analysis of healthcare providers’ views on current practice. PLoS One. 2016;11(3):e0149789.

3. Savelberg W, Moser A, Smidt M, Boersma L, Haekens C, van der Weijden T. Protocol for a pre-implementation and post-implementation study on shared decision-making in the surgical treatment of women with early-stage breast cancer. BMJ Open.

2015;5(3):e007698.

4. Brown R, Butow P, Juraskova I, et al. Sharing decisions in breast cancer care: development of the Decision Analysis System for Oncology (DAS-O) to identify shared decision making during treatment consultations. Health Expect. 2011;14(1):29-37.

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 39

COMMUNICATION CHALLENGES

Noncompliance? Look for a Cause

PHOTO ILLUSTRATION: J. DVORETZ

Ann J. Brady, MSN, RN-BC

A surprising cause was revealed by an oncology team’s investigation into what at first seemed to be typical noncompliance by a patient.

“I

’m just not sure I really need to do all of this. The chemo is so hard and now radiation, too. I need to think about it.” Jill said.

She shook hands with our radiation oncologist as she left. Jill was warm but aloof at the same time, as if she were dismissing everything the doctor told her but was too polite to say she thought it was all hogwash.

“Thank you for taking time with me,” she added. This was only our first encounter with her, but her parting comment matched our prediction that she would not return. She must not understand how serious it is.

Everyone was surprised when she came back for a SIM to set up her treatment plan.

She fit the profile of a patient in denial, not unusual in cancer treatment. We’ve seen many patients like her before. And we know we cannot force people to be treated. She is in denial.

Then, in spite of going through treatment planning, a kind of commitment in itself,

she failed to show up for her first treatment.

When we called to check in, she said, “Oh, I guess I just got the days mixed up.” She is not taking this seriously.

Not only did she seem to not understand, she was also a bit flaky. That was the updated version our team used to explain her behavior. She is kind of flaky.

She made it in for her first 5 treatments, floating in late, joking with our other radiation oncology patients. Her treatment was on track and all appeared to be going well. But in her second week she missed 2 treatments in a row, then a few more the following week, saying it was because she was exhausted from chemo. The radiation oncologist told her the number of missed treatments was going to impact the effectiveness of her treatment. Her response demonstrated true concern, again all very appropriate. “I see. I’ll be sure not to miss anymore.” She was very convincing and everyone believed her sincerity even while we wondered if she would continue her radiation. Maybe she gets it now.

The thing was there was a difference between how things seemed to be with her and how they actually were. One red flag is just one flag, but several flags demand attention. We talked amongst ourselves: her nurse navigator, physician, symptom management nurse, rad/onc nurse. All of us had begun to wonder the same thing: Was there more than noncompliance going on?

In hindsight, with all the puzzle pieces laid out in front of us, I wonder how we missed it.

But a couple of things kept us from putting it together. It started with our presumption that Jill’s noncompliance was a given. It was because of her quirky personality, her flaky and free-spirit attitude, she didn’t want to

40 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

accept the seriousness of her diagnosis. But it was her ability to seem like she had it together that truly fooled us. She recognized people, asked questions about her treatment plan, joked with others. She did things that made it seem like the reason she missed treatment was explainable.

But our explanations on her behalf piled up too, until they were so high we could not ignore them: she was in denial, she was depressed, she was overwhelmed, she was alone and trying to manage everything herself. She is noncompliant.

Our presumptions and explanations made sense until the day she showed up disheveled and out of sorts. Then those presumptions and explanations no longer made sense. Turned out the actual cause of her noncompliance was brain metastases. Although brain mets are not uncommon with some cancers, it was not expected with hers. Because of the brain mets she lacked capacity. Her lack of capacity meant that even though she seemed to be fully functional, she was not.

DISCUSSION Capacity is an often misunderstood term.

Many confuse it with competency. Competency is a legal definition while capacity

is, literally, an in-the-moment assessment.

The four components of assessing capacity are based on ability: • The ability to make a choice about treatment • The ability to understand relevant information • The ability to appreciate the situation and its consequences, and • The ability to reason.1 Much like informed consent, there is not a legal burden of proof, just an assessment of a person’s ability to understand the consequences of accepting or rejecting treatment.

Rejecting treatment itself is not deemed a lack of capacity, though it is often confused as such.

Not every issue of noncompliance is related to capacity; indeed many are not.

But thinking of noncompliance “outside” the box was a critical element to consider.

Noncompliance is often linked to denial.

Surmising that denial leads to noncompliance, as if both denial and noncompliance are their own diagnosis, is easy.

Reading through many history and physicals (H&Ps) on patients will reveal a comment under Impressions: “pt in denial or non

Not every issue of noncompliance is related to capacity.

But thinking “outside” the box was a critical element to consider.

MYTHS ABOUT DECISION-MAKING CAPACITY1 • Decision-making capacity and legal competency are the same.

• Patients who have not been given relevant and consistent

• Cognitive impairment equals lack of decision-making capacity.

information about their treatment lack decision-making

• Lack of decision-making capacity is a permanent condition.

capacity.

• Patients with certain psychiatric disorders lack decision-

• Lack of decision-making capacity can be presumed when patients go against medical advice.

• There is no need to assess decision-making capacity unless patients go against medical advice.

• Decision-making capacity is an “all or nothing” phenomenon.

making capacity.

• Patients who are involuntarily committed lack decisionmaking capacity.

• Only mental health experts can assess decision-making capacity.

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 41

COMMUNICATION CHALLENGES compliant.” As if, once identified, noncompliance does not require further investigation.

It cannot be identified the way high blood pressure or diabetes is. Once those are identified the symptoms are addressed. But when noncompliance is identified the rationale behind it may be ignored; indeed, when we cannot make sense of noncompliance we may stop there. All is over and done once it is labeled. Often that is exactly what happens.

Noncompliance is an easy explanation when a patient does not follow our very carefully researched treatment plans, does not keep appointments, questions or disregards instructions—easier still if it is first attributed to a case of denial. Of course, we conclude, the reason they do not follow our instructions must be because of noncompliance.

But what if a patient’s noncompliance is instead a symptom of something else?

The communication challenge in this example was about the subtext of what a patient says and does. What else may be going on? Anytime we think a patient is noncompliant or in denial, the next thought we have should be “why?” It may be what we think it is—straight-out denial or a patient wants to do things their own way. Or it could be something else, something off our radar, something that requires a little more digging.

Jill did finish her treatment. After a brief hospitalization her family, who she had kept at bay, stepped forward and helped her with decisions and her care at home. She had managed to seem like she was holding together in her interaction with them.

Noncompliance is not always what it seems. ■ Ann Brady is the symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California.

REFERENCE 1. Ganzini L, Volicer L, Nelson W, Fox E, Arthur Derse. Ten Myths About Decision-Making Capacity.

A Report by the National Ethics Committee of the

Do you have a story you want to share?

Oncology Nurse Advisor welcomes narrative essays from oncology nurses for Reflections, our narrative medicine blog.

Connect with your colleagues by sharing an original article that expresses your take on the important topics and issues that you face in your day-to-day role as an oncology nursing professional.

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.

Veterans Health Administration. Washington, DC: US Department of Veterans Affairs; 2002.

42 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

ISSUES IN CANCER SURVIVORSHIP

© ISTOCK

Resistance Training Improves Posttreatment Outcomes for Breast Cancer Survivors Bette Weinstein Kaplan

S

urvivors of breast cancer often suffer in multiple ways from their disease, its treatment, and the side effects of both. An especially cruel consequence is the adverse effects that have the potential to further change a woman’s body, leading to chronic pain, disability, and even death.

The altered body composition and decreased bone mineral density (BMD) that follows cancer may result in osteopenia and osteoporosis. The greater potential for hip and vertebral fractures bring an increased risk of mortality.

New research is finding that resistance training may help.

IMPACT OF CANCER TREATMENT ON BMD

In a multicenter review of the effects of resistance training in breast cancer, researchers focused on its potential for maintaining bone density.1 Bone mineral density, they noted, is at risk from a number of assaults. For example, chemotherapy adversely affects the size of the osteoids, which reduces bone formation and bone density.

Chemotherapy also results in permanent ovarian failure, which has an adverse effect on bone formation as well. And, aromatase inhibitors (AIs) deplete estrogen production. Bone density measurements obtained from the hip and spine of postmenopausal patients with breast cancer revealed a

significantly greater loss of bone density in these patients compared with breast cancer patients who did not receive adjuvant chemotherapy.

Up to 80% of women with breast cancer experience bone loss caused by their cancer treatment. Bone loss occurs much quicker in women with breast cancer compared with those without breast cancer. Similarly, among women with osteoporosis, those with cancer have a higher rate of falls and their risk of fractures is 5 times higher compared with those who do not have cancer.1 PRESERVING BONE DENSITY Pharmacologic management of bone density loss often causes other problems for breast cancer survivors who may already be unhappy with the polypharmacy approach. Bisphosphonates, for example, can cause osteonecrosis of the jaw, joint pain, back pain, abdominal pain, nausea, diarrhea, and renal toxicity. Patient adherence is low; fewer than 50% of patients adhere to their medication routine. Patients do not want more side effects, thus they hesitate to seek pharmacologic options.1 A low-impact exercise such as walking is popular; easy to do; requires no special clothing, gym membership, or equipment; but it does not improve bone density. In fact, studies have shown that although a walking program might help maintain bone density, patients

participating in a walking program actually may experience a loss of bone at specific sites.1 Resistance training, however, demonstrates positive results on bone density in healthy women.

Few studies have evaluated the effect of resistance training in women with breast cancer; therefore, the researchers conducted a review of the literature to determine whether this form of exercise could help breast cancer survivors maintain bone density. The focus was kept on maintenance in breast cancer survivors because the loss of bone density is so accelerated that just reducing the diminution is significant.1

Few studies have evaluated resistance training in women with breast cancer.

Study findings demonstrate that resistance training can reduce or overcome some of the adverse effects of breast cancer treatment as well as maintain bone density. However, although resistance training has none of the side effects of medication, some precautions are warranted before initiating a resistance training program.

The program should begin during treatment, when bone density losses

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 43

ISSUES IN CANCER SURVIVORSHIP start to occur, and continue through completion of treatment. Additional higher-impact exercise might be necessary to further maintain or even build bone density. Such a program could reduce the risk of fractures and a lifetime of complications, or worse.

A recent meta-analysis of the effects of resistance training in women with or at risk for breast cancer-related lymphedema determined that at least 1 in 5 breast cancer survivors develop arm lymphedema. 2 These patients have often been told to avoid strenuous, repetitive exercise to minimize their risk of developing lymphedema or worsening an existing case of the adverse effect. Some patients misunderstand the recommendation and adopt

a sedentary lifestyle, which can be a significant contributing factor to the development of lymphedema.2 A study involving 27 breast cancer survivors, average age 64 years, assessed the effects of an upper body resistance training intervention on lymphedema.

The results showed that breast cancer patients who had or who were at risk for lymphedema can safely perform moderate-intensity upper body resistance exercises during and after treatment.2

osteoporosis, and higher risk of hip and vertebral fractures. Resistance training can improve long-term outcomes for these patients. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

REFERENCES 1. Artese A, Simonavice E, Panton LB. The benefits of resistance training in breast cancer survivors: a focus on maintaining bone density. Expert Rev Qual Life Cancer Care.

CONCLUSION

After surviving their cancer, breast cancer survivors may continue to feel the effects of their disease and its treatment. For many survivors, loss of bone density can lead to osteopenia,

2016;1(3);239–248.

2. Simonavice E, Kim JS, Panton LB. Effects of resistance exercise in women with or at risk for breast cancer-related lymphedema.

Support Care Cancer. 2016 Aug 11. doi: 10.1007/s00520-016-3374-0.

Visit OncologyNurseAdvisor.com • Browse oncology nursing news • Read in-depth articles authored by nursing professionals • Review full patient tools, including clinical fact sheets • Gain easy access to an extensive range of oncology drug information • Stay up-to-date by registering to receive our e-newsletters

44 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

THE TOTAL PATIENT

© THINKSTOCK

Palliative Care Update: Best Improvements in Quality of Life, Symptom Burden Bette Weinstein Kaplan

W

e f i r st w rote about palliative care in 2010 when we quoted the Center to Advance Palliative Care: “Today, 53% of hospitals with 50 or more beds have a [palliative care] program.”1 Now, 6 years later, 90% of larger hospitals have palliative care programs.2 The consensus and proof that early adoption of palliative care benefits patients — often as soon as they receive a diagnosis — is a major factor in this growth.

Palliative care can reduce patient suffering and improve the quality of life for patients and caregivers alike. Yet, although the advantages have been demonstrated throughout all stages of illness, sometimes seriously ill patients who could benefit are unable to access palliative care services early enough— or at all. And there is still the misconception that palliative and hospice care are linked and only useful as part of an end-of-life intervention.

Previous randomized clinical trials have shown that palliative care can improve symptom burden, quality of life, and even survival.3 But a newly published review of recent randomized clinical trials sought to update these findings.3 IMPACT ON PATIENT CARE The researchers searched MEDLINE, EMBASE, CINAHL, and Cochrane Library’s CENTRAL through July

2016. They identified 43 trials involving 12,731 patients (mean age 67 years) and 2479 caregivers. Seventy percent of the trials took place in the United States.

Thirty trials involved patients with cancer, and 14 trials involved patients with heart failure — the 2 diseases that require palliative care most frequently.

One-third of the trials took place in ambulatory facilities, while 41% were home-based and 25% were inpatient.

The investigators performed a metaanalysis to evaluate at least 1 of 9 patientlevel outcomes: quality of life, symptom burden, mood, survival, advance care planning, site of death, resource utilization, health care expenditures, and satisfaction with care. Of these, only quality of life and symptom burden showed statistically significant improvement as a result of palliative care. However, some improvement in advance care planning, resource utilization, and satisfaction with care on the parts of both patient and caregiver was reported. According to this analysis, palliative care did not improve survival, but no trials showed palliative care as being responsible for a decrease in survival.

benefitted from palliative care for patients. Of those that did, the reviewers found that there were different types of trials delivering varying kinds of care. And the researchers brought up another point: the changing nature of a terminal illness is reflected in the constantly evolving levels of care the patient requires as his or her condition worsens.

PHILOSOPHY OF CARE The researchers noted that they reviewed “palliative care as a philosophy of care” because the preexisting trials did not offer sufficient data to go into detail about specific models of palliative care.3 There were a number of other limitations, including the reviewers not being able to distinguish between palliative care interventions that were given early in the course of treatment and those that were offered at the end of life. ■ REFERENCES 1. Kaplan BW. Hospice versus palliative care: understanding the distinction. Oncol Nurse Advis. 2010;1(1):42-43. http://bit.ly/2jMwi2O. Accessed December 12, 2016.

2. Malani PN, Widera E. The promise of palliative care translating clinical trials to clinical care.

EFFECT ON CAREGIVERS

In terms of the relationship between palliative care and caregivers, the results were mixed for a number of reasons.

Several of the studies reviewed did not specifically address how caregivers

JAMA. 2016;316(20):2090-2091.

3. Kavalieratos D, Corbelli J, Zhang D, et al.

Association between palliative care and patient and caregiver outcomes: a systematic review and meta-analysis.

JAMA. 2016;316(20):2104-2114.

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 45

FROM

© THINKSTOCK

H

earing the words “You have cancer” is diff icult enough to grasp.

Hearing those words in a language you do not understand or can barely comprehend is even more difficult. Oncology clinicians strive to find the right way to communicate with a patient about a cancer diagnosis, and the task is equally trying for clinicians when the patient is from a different culture or speaks a different language.

Native culture should be kept in mind when communicating with Hispanic patients. For example, family is a very significant part of the Latino culture. Extended family members are commonly involved in the patient’s medical care, and ensuring they feel involved and included is vital. Your care discussions should address the patient as well as any family members who may be with them.

Palos suggests that seeking out the head of the family may ultimately help the patient with medical decision making.1 This person is usually an elder or someone whose opinion is highly respected and valued.

Religion plays an important role; therefore, the clinician may consider suggesting that the patient visit or revisit his or her faith. “Spirituality and religious coping are salient factors in maintaining health and longevity, in well-being during chronic and terminal illnesses, in recovery from traumatic stress, and in positive coping during bereavement,” stated Brady and colleagues.2 Identifying the role religion or faith plays in a patient’s

Tips for Working With Hispanic Patients and Caregivers Jennifer Gomera, MSW, LMSW

Use of an interpreter instead of a family member is helpful as medical jargon can be lost in translation. A family member may have difficulty processing the medical information given to them while also processing their own emotions about the information being provided.

The patient and family should have contact information for a bilingual person who can further assist them should they have a question, concern, or emergency.

A cancer diagnosis can raise many questions and concerns, particularly regarding culturally shared myths and misinformation associated with cancer.

The following myths can influence medical decision making for a patient: • Cancer can spread if a biopsy or surgery is performed.

• Pain is part of treatment and cannot be relieved.

• Taking medication for pain will prolong treatment and make the cancer spread.

• Cancer is contagious.

• Your attitude and beliefs can help you beat cancer.

life may be essential to their medical decision making.

Practical ways to ensure communication with the patient is optimal, including making sure all documentation and instructions are provided in the patient’s primary language.

Understanding these myths and being able to openly discuss them with the patient can go a long way toward providing security and comfort, as well as building a trusting nurse-patient relationship.

A wide range of complementary and alternative medicines (CAM) may be used by Hispanic patients, including several that may be unfamiliar to oncology clinicians.3 Asking

Because of the role of family, your care discussions should address the patient as well as any family members who may be with them.

46 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com

Hispanic patients about their use of CAM products is vital; however, you should foster a comfortable relationship with patients so they can feel at ease with being honest about their use of CAM therapies.

Understanding the rationale, motivations, and history of Hispanics’ use of CAM will enhance the cultural competence of oncology clinicians and help address these patients’ medical needs. 3 Patients should not feel as if they are being judged for using these products, as CAM use may tie into their religious beliefs or practices

or may be part of a tradition handed down by an important figure in their family or community.

No one ever wants to hear those fateful words. But if they must be said, we should, as professionals, do our best to facilitate the experience and make it as easy a transition as we possibly can. Cultural competence is a way to show sensitivity and create a positive, encouraging relationship with the patient for the journey that is to follow.

REFERENCES 1. Palos GR. Hispanic/Latino individuals and families affected by cancer: outreach, screening, and assessment. In: Christ G, Messner C, Behar L, eds. Handbook of Oncology Social Work: Psychosocial Care for People with Cancer. New York, NY: Oxford University Press; 2015:302.

2. Brady MJ, Peterman AH, Fitchett G, Mo M, Cella D. A case for including spirituality in quality of life measurement in oncology.

Psychooncology. 1999;8(5):417-428.

3. Ortiz BI, Shields KM, Clauson KA, Clay PG. Complementary and alternative medicine use

Jennifer Gomera is an oncology social worker with CancerCare.

among Hispanics in the United States. Ann Pharmacother. 2007;41(6):994-1004.

Oncology Nurse Advisor Newsletters keep you involved in all the action on OncologyNurseAdvisor.com Stay up-to-date with oncology-specific news Learn from your colleagues’ questions or participate in polls Read disease-specific features and stories Know when there’s something new Read the latest of our popular columns

How can you get all this delivered to your inbox? Sign up by selecting the Editor’s Choice and ONA Online Email Newsletters at OncologyNurseAdvisor.com/newsletters.

SIGN UP NOW BEFORE YOU MISS OUR NEXT MAILING!

www.OncologyNurseAdvisor.com • JANUARY/FEBRUARY 2017 • ONCOLOGY NURSE ADVISOR 47

ASK A PHARMACIST

©THINKSTOCK

Patients at medium and high risk for TLS should receive IV hydration.

Preventing TLS in Patients Receiving Venetoclax What precautions should be taken to prevent tumor lysis syndrome (TLS) in patients receiving venetoclax (Venclexta)?

—Name withheld upon request

Venetoclax is an oral medication used to treat chronic lymphocytic leukemia (CLL). The drug inhibits the BCL2 protein, which results in apoptosis of the CLL cells. Due to its rapid effects, treatment management at initiation of venetoclax should include hydration, monitoring, and ramp-up dosing based on the patient’s risk for developing TLS. Ramp-up dosing was used when high rates of TLS were seen in patients on a clinical trial after receiving venetoclax.1 Use of ramp-up dosing and other strategies described below dramatically reduced the risk of TLS in subsequent patients.

The ramp-up titration is as follows.

This can be adjusted on the basis of patient tolerance of therapy.

• 20 mg daily for the first week • 50 mg daily for the second week • 100 mg daily for the third week • 200 mg daily for the fourth week • 400 mg daily thereafter.

Risk stratification for TLS is based on tumor volume.

• Low risk All lymph nodes less than 5 cm in size and absolute lymphocyte count (ALC) less than 25 × 109.

• Medium risk Any lymph node 5 to 10 cm or ALC 25 × 109 or greater.

• High risk Any lymph node 10 cm or larger or any lymph node 5 cm or larger and ALC 25 × 109 or greater.

All patients should receive hydration at each dose increase based on their TLS risk level. Patients at low risk should receive 1.5 to 2 L orally; patients at medium risk, at least 1.5 to 2 L orally, and may require additional IV hydration; patients at high risk, 1.5 to 2 L orally with additional IV hydration at 150 to 200 mL/hour as tolerated.

All patients should be started on allopurinol 2 to 3 days prior to initiating venetoclax, and this should be continued until at least 3 to 7 days after the ramp-up titration has been completed. Rasburicase may be required in patients at high risk of TLS with elevated uric acid levels at baseline.

All patients receiving venetoclax

require monitoring with each dose increase via laboratory tests conducted at the following intervals.

• Low risk Predose at each dose increase; 6 to 8 hours and 24 hours after the first 20 mg and 50 mg doses • Medium risk If the patient has good renal function, use the same schedule as for low risk. Patients with impaired renal function may require hospitalization and additional monitoring.

• High risk Patients should be hospitalized for the initial 20 mg and 50 mg doses. Laboratory monitoring should be conducted predose, 4 hours, 8 hours, 12 hours, and 24 hours after the initial 20 mg and 50 mg doses. If clinically appropriate, these patients may be managed as outpatients for subsequent increases.

If TLS occurs, standard TLS management strategies should be employed and the next day’s venetoclax dose should be held. If TLS-associated laboratory changes resolve within 48 hours, continue at the current dose level. If TLS laboratory changes take more than 48 hours to resolve or if clinical symptoms are experienced, resume venetoclax at a reduced dose after TLS resolution. ■

REFERENCE 1. Roberts AW, Davids MS, Pagel JM, et al.

Targeting BCL2 with venetoclax in relapsed chronic lymphocytic leukemia. N Engl J Med. 2015;374(4):311-322.

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

48 ONCOLOGY NURSE ADVISOR • JANUARY/FEBRUARY 2017 • www.OncologyNurseAdvisor.com