Oncology Nurse Advisor May/June 2015

ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015

www.OncologyNurseAdvisor.com

May/June 2015

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

■ Earn 0.5 contact hours

FREE CONTINUING EDUCATION INSIDE! Treatment of CLL using the principles of shared decision-making, PAGE 18

DIAGNOSTIC TESTS

Liquid biopsies: A new tool for serial monitoring in the clinical setting

CANCER SCREENING

Simulation tool teaches clinical breast examination technique

PATIENT COUNSELING

Overview of NCCN guidelines for smoking cessation

RADIATION & YOUR PATIENT

Palliative radiotherapy

COMMUNICATION CHALLENGES

Confirmation bias

FROM CANCERCARE VOLUME 6, NUMBER 3

Unique challenges for patients with lung cancer

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Circulating tumor cells and circulating tumor DNA entering the blood through vessel epithelium

5/27/15 11:45 AM

DOSAGE AND ADMINISTRATION Do not administer CYRAMZA as an intravenous push or bolus.

Recommended Dose and Schedule The recommended dose of CYRAMZA is 10 mg/kg administered by intravenous infusion over 60 minutes on day 1 of a 21-day cycle prior to docetaxel infusion. Continue CYRAMZA until disease progression or unacceptable toxicity.

Premedication Prior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine H1 antagonist (e.g., diphenhydramine hydrochloride). For patients who have experienced a Grade 1 or 2 infusion reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion.

Dose Modifications Infusion-Related Reactions (IRR) • Reduce the infusion rate of CYRAMZA by 50% for Grade 1 or 2 IRRs. • Permanently discontinue CYRAMZA for Grade 3 or 4 IRRs. Hypertension • Interrupt CYRAMZA for severe hypertension until controlled with medical management.

• Permanently discontinue CYRAMZA for severe hypertension that cannot be controlled with antihypertensive therapy.

Proteinuria • Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Reinitiate treatment at a reduced dose of 8 mg/kg every 3 weeks once the urine protein level returns to <2 g/24 hours. If the protein level ≥2 g/24 hours reoccurs, interrupt CYRAMZA and reduce the dose to 6 mg/kg every 3 weeks once the urine protein level returns to <2 g/24 hours.

• Permanently discontinue CYRAMZA for urine protein level >3 g/24 hours or in the setting of nephrotic syndrome.

Wound Healing Complications • Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed.

Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding • Permanently discontinue CYRAMZA. For toxicities related to docetaxel, refer to the current respective prescribing information.

PATIENT COUNSELING INFORMATION • Hemorrhage: Advise patients that CYRAMZA can cause severe bleeding. Advise patients to contact their health care provider for bleeding or symptoms of bleeding including lightheadedness.

• Arterial thromboembolic events: Advise patients of an increased risk of an arterial thromboembolic event.

• Hypertension: Advise patients to undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms.

• Gastrointestinal perforations: Advise patients to notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain.

• Impaired wound healing: Advise patients that CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo surgery without first discussing this potential risk with their health care provider.

• Pregnancy and fetal harm: Advise females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, and risk to postnatal newborn and infant development and to use effective contraception during CYRAMZA therapy and for at least 3 months following the last dose of CYRAMZA. • Lactation: Advise patients not to breastfeed during CYRAMZA treatment.

• Infertility: Advise females of reproductive potential regarding potential infertility effects of CYRAMZA. Additional information can be found at www.CYRAMZAhcp.com.

ON THE

WEB

FEATURE Counseling cancer patients on effective nutritional practices Patients with GI cancer may struggle to maintain nutritional status; therefore, nurses should be ready to step in with information and interventions.

Leslie Burgess

FROM CANCERCARE Coping with the loss of fertility after cancer The inability to have children as a result of cancer treatment can be a significant loss for patients and their caregivers.

These tips can help nurses guide patients as they learn to cope.

Angelique Caba, LCSW

FIRST REPORT ONS 40th Annual Congress Oncology Nurse Advisor’s First Report team coverage of the 2015 Congress from Orlando, Florida, including synopses of sessions, audio reports from the posters, and video interviews of presenters.

Jason Hoffman, PharmD, RPh; Joyce Pagán; Stephan Cho

STAT CONSULT Dasatinib (Sprycel) A tyrosine kinase inhibitor with several indications for the treatment of Ph+ CML or Ph+ ALL in adults

Erlotinib (Tarceva) A HER1/EGFR tyrosine kinase inhibitor with indications for the treatment of NSCLC in several clinical settings, and in combination with gemcitabine for locally advanced, unresectable, or metastatic pancreatic cancer

ONCOLOGY NURSE ADVISOR VIDEO A Nurse Navigator’s Role Monica Cerda-Juarez, of MD Anderson in Katy, explains how a nurse navigator guides patients from diagnosis, through treatment, and on to survivorship

Understanding Targeted Cancer Therapies Eli Lilly and Company, Indianapolis, IN 46285, USA Copyright © 2015, Eli Lilly and Company. All rights reserved.

RB-L HCP BS 04MAY2015 CYRAMZA® (ramucirumab) injection

Cyramza_HalfV_ONA_May15.pdf.indd 1

An overview of the main types of targeted therapies, their risks and benefits, how they differ from chemotherapy, which are FDA-approved, and how to find clinical trials that are evaluating these novel agents

RB-L HCP BS 04MAY2015

5/27/15 2:15 PM

PUBLISHING STAFF Editor Joyce Pagán editor.ona@haymarketmedia.com Senior digital content editor Rick Maffei Oncology writer Jason Hoffman, PharmD, RPh Contributing writer Bette Weinstein Kaplan Group art director, Haymarket Medical Jennifer Dvoretz Assistant art director Livvie Zurlini Production director Kathleen Millea Grinder Production manager Krassi Varbanov krassi.varbanov@haymarketmedia.com Circulation manager Paul Silver

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Oncology Nurse Advisor (ISSN 2154-350X), May/June 2015, Volume 6, Number 3. P ­ ublished 6 times annually by Haymarket Media Inc, 114 West 26th Street, 4th Floor, New York, NY 10001. Oncology Nurse Advisor is available for single copy purchases at the following rates. Price per copy: USA $20; Foreign $30.

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EDITORIAL BOARD Ann J. Brady, MSN, RN-BC Huntington Cancer Center Pasadena, California Jia Conway, DNP, FNP-BC, AOCNP, NP-C 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 • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 7

CONTENTS

May/June 2015

11

IN THE NEWS • Thyroid cancer risk increases after breast cancer • New therapeutic strategy discovered for ovarian cancer • Study pinpoints genetic cause of increased leukemia risk • Palbociclib shows promise for hormone-resistant breast cancer • Prostate cancer review upends widely held belief on postprostatectomy radiation

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ONCOLOGY NURSE ADVISOR FORUM • Effect of chemotherapy on saliva test results • Use of pharmacokinetics to measure response in CML • Effective use of the prescribing information on drugs

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CONTINUING EDUCATION Treatment of a 49-year-old white male presenting with newly diagnosed CLL using the principles of shared decision-making

11

18

David A. Rizzieri, MD; Heather L. Paradis, MSN, ANP-BC, AOCN

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FEATURES Liquid biopsy: A new tool in the management of NSCLC Kathy Boltz, PhD

30

Simulation tool teaches clinical breast examination technique Bette Weinstein Kaplan

32

37 FIND US ON

Smoking cessation: Helping patients with cancer quit Joyce Pagán

Continues on page 10

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JOIN OUR COMMUNITY Submit a question to an oncology nurse advisor

CONTENTS

May/June 2015

Have a question? Our panel of oncology clinicians is available to answer your questions. Submit questions to editor.ona@HaymarketMedia.com.

Answer the ONA poll question

35

STAT CONSULT Isavuconazonium sulfate (Cresemba)

37

RADIATION & YOUR PATIENT An evolving role emerges for palliative radiotherapy Bryant Furlow

39

COMMUNICATION CHALLENGES Confirmation bias Ann J. Brady, MSN, RN-BC

ONA asks… Answer our poll question and compare your opinions with those of your colleagues on key nursing issues at OncologyNurseAdvisor.com Subscribe to ONA newsletters Stay current with daily news reports and special series from key oncology conferences on our Web site, sign up for our e-newsletters at OncologyNurseAdvisor.com/subscribe.

Earn CE credits

41

ISSUES IN CANCER SURVIVORSHIP Vitamin D and prostate cancer: Higher intake improves active surveillance outcomes Bette Weinstein Kaplan

43

THE TOTAL PATIENT Hospice program provides compassionate end-of-life care in a challenging environment Bette Weinstein Kaplan

45

FROM CANCERCARE Unique challenges confront patients with lung cancer Andrew Chesler, LMSW

48

ASK A PHARMACIST Using a micron fi lter; purity of herbal supplements Lisa A. Thompson, PharmD, BCOP

10 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

Each issue offers one new CE activity co-provided by the Nurse Practitioner Healthcare Foundation. Activities are active for 2 years.

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IN THE NEWS Thyroid cancer risk increases after breast cancer Breast cancer survivors are at increased risk of developing thyroid cancer, especially within 5 years of their breast

New therapeutic strategy discovered for ovarian cancer Researchers have identified a new therapeutic target for ovarian clear cell carcinoma, a particularly aggressive form of ovarian cancer, paving the way for what could be the first effective targeted therapy of its kind for the disease. Ovarian clear cell carcinoma EZH2 inhibition for affects approximately 5% to 10% of clear cell subtype American women with ovarian cancer and approximately 20% of patients in Asia. Although most patients with ovarian cancer initially respond well to standard-care platinum-based chemotherapy, the response

rate among those with the clear cell subtype is typically low and there is currently no effective therapy for these patients.

Researchers at The Wistar Institute’s Gene Expression and Regulation Program began by looking at ARID1A, a chromatin remodeler. When functioning normally, ARID1A makes it possible for chromatin, a cellular structure that holds DNA together in cells, to open up and allow cells to receive commands. This process dictates cell behavior and prevents them from becoming cancerous. ARID1A, however, is mutated in more than 50% of cases of ovarian clear cell carcinoma.

What interested the researchers was the relationship between ARID1A and EZH2, an enzyme that promotes compaction of the DNA. While present in normal cells to maintain a transcriptional balance, an overabundance of EZH2 was associated with the progression of different types of cancer, including

PHOTOS: © ISTOCK

cancer diagnosis, according to a new analysis of a large national database. Until now, the relationship between breast and thyroid cancer has been controversial, largely based on single-institution studies that suggest a possible increase in thyroid cancer incidence after breast cancer.

Using the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) database, researchers at Columbia University (New York City) determined the number of people with a diagnosis of breast and/or thyroid cancer between 1973 and 2011. They found 704,402 patients with only breast cancer, 49,663 patients with only thyroid cancer, and 1,526 patients who developed thyroid cancer after breast cancer.

Compared with patients with breast cancer alone, women who had breast cancer followed by thyroid cancer were younger, on average, at diagnosis of their breast cancer; more likely to have had invasive ductal carcinoma (the most common type of breast cancer); a smaller focus of cancer; and to have received radiation therapy as part of their breast cancer treatment. There was no difference in risk based on whether the breast cancer was hormone receptor positive or had spread to lymph nodes.

Compared with patients who had only thyroid cancer, breast cancer survivors who developed thyroid cancer were more likely to have a more aggressive type of thyroid cancer, but the tumors were smaller in size and fewer patients required additional radioactive iodine treatment. Because thyroid cancer tends to occur at younger ages than breast cancer, survivors who then developed thyroid cancer were older, on average, than those with only thyroid cancer (62 years vs 45 years, respectively). The study findings show that breast cancer survivors developed thyroid cancer at a median of 5 years; therefore, a dedicated thyroid examination every year for the first 5 years after a breast cancer diagnosis, especially for those who received radiation therapy, is recommended.

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 11

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IN THE NEWS

Read more at https://bit.ly/1GmVaU3

Study pinpoints genetic cause of increased leukemia risk Mutation of the gene ETV6 is a newly discovered, heritable genetic cause of acute lymphoblastic leukemia (ALL).

The finding started with a family with an abnormally high rate of ALL. The familial link to abnormal blood dynamics and predisposition to ALL Cause of heritable implied a common genetic denomiALL is discovered nator. Researchers performed whole exome sequencing of family members, then sifted through the data to compare these high-risk genomes with normalrisk genomes. The key difference between healthy genomes and those predisposed to develop ALL was mutation of the gene ETV6, which is involved in blood cell development.

Somatic mutations of the gene have previously been implicated in the development of blood cancers. This study is one of two new reports to show that germline mutation of ETV6 can also cause cancers. Unlike somatic mutation of the gene, the germline mutation appears to puts the patient one important step closer to developing leukemia from the time of birth.

Read more at https://bit.ly/1Kii6pN

Palbociclib shows promise for hormone-resistant breast cancer Palbociclib is well tolerated and extends progression-free survival (PFS) in newly diagnosed, advanced breast cancer, including in patients whose disease has stopped responding to traditional endocrine treatments, according to results of a phase II study. The drug is an investigational oral medication that works by blocking molecules responsible for cancer cell growth, and was recently approved by the FDA for the treatment of metastatic breast cancer in patients just beginning to undergo endocrine therapy.

The phase II trial primarily sought to evaluate disease response and control, while monitoring for the presence

of side effects such as neutropenia. Patients enrolled in the trial had previously undergone several prior chemotherapy and hormonal regimens for metastatic disease. Overall, researchers noted a median PFS of 3.7 months for patients taking the drug. However, patients with hormone receptorpositive (HR+) breast cancer had significantly longer PFS (5.1 months) compared with that of the HR-negative group.

Those who had previously progressed through at least two rounds of hormonal therapy saw significantly greater benefits, suggesting substantial activity in the setting of acquired endocrine resistance. Though some patients experienced low white blood cell counts or other side effects, symptoms were managed with dose reductions, and improvements in tumor shrinkage and disease control were still noted.

Read more at https://bit.ly/1di2rJE

Prostate cancer review upends widely held belief on postprostatectomy radiation Two new studies have upended the widely held view that it is best to delay radiation treatment as long as possible after prostatectomy to prevent unwanted side effects. The findings inject hard facts into a debate that has long divided the medical community, with many Delaying radiation radiation oncologists preferring adjuhas no benefit vant therapy. Many urologists, however, prefer salvage therapy, which is radiation given after prostatespecific antigen test results suggest it is needed.

The two studies address the lack of facts, in hopes of providing doctors with the information they need to determine the best course of treatment. Adjuvant therapy was not found to increase rates of erectile dysfunction. The researchers conclude that a delayed salvage radiation approach is still reasonable for patients with low-grade disease at low risk of recurrence. But once there is a compelling reason for radiation, delaying it to avoid complications does not seem to have any benefit for the patient.

Read more at https://bit.ly/1Baes97

For full news stories visit OncologyNurseAdvisor.com

LEFT: © SIU BIOMED COM / CUSTOM MEDICAL STOCK PHOTO; RIGHT: © BRYSON BIOMEDICAL ILLUSTRATIONS / CUSTOM MEDICAL STOCK PHOTO

ovarian clear cell carcinoma. This prompted the researchers to explore the utility of EZH2 inhibition as a potential therapeutic means of treating cancer with ARID1A mutation.

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ONCOLOGY NURSE ADVISOR FORUM Our Consultants Ann J. Brady, MSN, RN-BC, symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California.

Jia R. Conway, DNP, CRNP, FNP-C, AOCNP, oncology nurse practitioner at Cancer Care Associates of York in York, Pennsylvania.

Abimbola Farinde, PharmD, MS, BCPP, CGP, LCDC, PM/ PRC, FASCP, FACA, FNAP, Rsci, ARSPharmS, clinical pharmacist specialist, Clear Lake Regional Medical Center, Webster, Texas Donald R. Fleming, MD, hematologist/oncologist, Cancer Care Center, Davis Memorial Hospital, Elkins, West Virginia.

Kerstin L. Lappen, RN, MS, ACNS, ACHPN, clinical nurse specialist, palliative care consult service, Abbott Northwestern Hospital, Allina Health System, Minneapolis, Minnesota.

K. Lynne Quinn, RN, MSN, CRNP, AOCNP, director of oncology, Bryn Mawr Hospital and Bryn Mawr Health Center, Bryn Mawr, Pennsylvania.

Lisa A. Thompson, PharmD, BCOP, clinical pharmacy ­specialist in oncology, Kaiser Permanente, Colorado

Rosemarie A. Tucci, RN, MSN, AOCN, manager for oncology research & data services, Lankenau Hospital, Wynnewood, Pennsylvania

QUESTIONS & ANSWERS EFFECT OF CHEMOTHERAPY ON SALIVA TEST RESULTS A Genecept Assay (Genomind; Chalfront, Pennsylvania) saliva assay is useful to me for complicated psych drug implementation. Many oncology patients take psych meds either before or during treatment. Do medications administered by oncologists for cancer treatment alter alleles affecting saliva, thus rendering the Genomind assay null and void? —Virginia Owens, MSN, FNP, PMHNO This question has generated much discussion within my hospital’s oncologic and psychiatric community. The direct answer to the question is, “No. The chemotherapy will not alter alleles affecting saliva, thus it will not render the assay null and void.”

The bigger questions that we considered were: Will the psychiatric drugs interfere with the chemotherapy? There should be someone making sure that drug-to-drug reactions will not be an issue. And, does this test really identify specific psychiatric disorders or does it identify how patients metabolize certain psychotropic medications, which would affect the response someone would have receiving drug therapy for these disorders? —Rosemarie A. Tucci, RN, MSN, AOCN

USE OF PHARMACOKINETICS TO MEASURE RESPONSE IN CML Tyrosine kinase inhibitor (TKI) compliance is a real problem in the treatment of patients with chronic myeloid leukemia (CML). What data are available concerning inter- and intrapatient variability in the pharmacokinetics of these drugs, and is measurement of their pharmacology possible or valuable in management? —William P. Peters, MD, PhD Chronic myeloid leukemia (CML) represents 5% of leukemia cases. It typically starts with a relatively indolent chronic phase (CP) and goes through a triphasic pattern of chronic followed by accelerated and ending with blastic phases, each more aggressive than the prior phase.

The current first-line treatment for CML is imatinib (Gleevec), nilotinib (Tasigna), and dasatinib (Sprycel). With these very effective medications, progression to the later stages is rarely seen. Treatment outcome is typically such that the longer the patient stays in remission, the less likely they are to later relapse, which is quite unique to the oncology world. Highly effective later-line treatments (ie, bosutinib [Bosulif] and ponatinib [Iclusig]) are now commercially available for patients who do not respond well or who are intolerant and/or resistant to first-line therapy. Based on current guidelines for response milestones, very few patients end up requiring a curative stem cell transplant, as the risk of this procedure is far beyond that of the oral medications.

When imatinib was first introduced, not much recourse was available for those patients who had a less than optimal response. Pharmacokinetics started to become

DO YOU HAVE A QUESTION FOR OUR CONSULTANTS? Send it to editor.ona@haymarketmedia.com.

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 13

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ONCOLOGY NURSE ADVISOR FORUM Pharmacokinetics started to become popular with imatinib when it was the only game in town, and there were some practical methods for assessing response and resistance. popular with imatinib when it was the only game in town, and there were some practical methods for assessing response and resistance to the drug. But the mechanisms behind resistance are quite complex and not simply found in maintaining serum drug levels. The other issue is that there are already established goals to monitor efficacy such as cytogenetic remission within a reasonable timeframe as a significant determinant of outcome. In conclusion, routine pharmacokinetic testing to customize a treatment for CML is likely to remain a noncommercial activity. —Donald R. Fleming, MD

EFFECTIVE USE OF THE PRESCRIBING INFORMATION ON DRUGS How can clinicians other than the oncologist be more informed about the drugs they prescribe? Some drugs can cause cancer, and the clinician does not appear to consider that when prescribing for a patient with cancer. —Name withheld on request All prescription medications have prescribing recommendations or references that clinicians can access. Within the prescribing references, or what is called the “Prescribing Information (PI),” pharmaceutical companies list indications and use, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specifi c populations, overdosage, clinical pharmacology, nonclinical toxicology and clinical studies, how medication is supplied, and patient counseling

information. The nonclinical components of this information often address the carcinogenic potential of the medication.

All clinicians have access to this information when prescribing oral and intravenous oncolytics. For example, the prescribing information for erlotinib (Tarceva) states that carcinogenicity studies were conducted for 2 years with no identified carcinogenic risks discovered at variable dosages of the medication; however, temazolamide (Temodar) was found to be carcinogenic in rats inducing mammary cancers in both males and females at doses 0.13 to 0.63 times the maximum human dose (25-125 mg/m2) when administered orally on 5 consecutive days every 28 days for 6 cycles. Therefore, prescribing clinicians have the necessary information to make them aware of the potential carcinogenic effects of the medications they prescribe to treat malignancies.

The risk-benefit ratio should be weighted when treatment decisions are being determined, and patients legally have to be made aware of these risks when signing informed consent for treatment.

It is the responsibility of the prescribing clinician to know the risk of secondary malignancies when prescribing medications and the incidence of such risks, and the overall benefit to the client of the medication being prescribed. —Jiajoyce R. Conway, DNP, FNP-BC, AOCNP

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CONTINUING EDUCATION Disclosure of Conflicts of Interest It is the policy of Montefiore Learning Network to ensure balance, independence, objectivity, and scientific rigor in all its educational activities. All faculty participating in our programs are expected to disclose any relationships they may have with commercial companies whose products or services may be mentioned so that participants may evaluate the objectivity of the presentations. In addition, any discussion of off-label, experimental, or investigational use of drugs or devices will be disclosed by the faculty.

Faculty Disclosures: Dr. Rizzieri has indicated he is on the advisory boards for Ariad, Clavis, Millennium, Novartis, and Onyx. He is also on the speakers’ bureau for Ariad, Celgene, GlaxoSmithKline, Incyte, Sanofi-Aventis, Seattle Genetics, and Spectrum. Dr. Rizzieri has further indicated he is a principal investigator for Bristol-Myers Squibb, Cyclacel, Eli Lilly, Micromet, Sunesis, and Supergen. He is also a consultant for CTI and an expert reviewer for Pfizer. Ms. Paradis has indicated she has no relative relationship with industry to disclose relevant to the content within this CME/CE activity.

Course Directors Disclosures: Dr. Rizzieri has indicated he is on the advisory boards for Ariad, Clavis, Millennium, Novartis, and Onyx. He is also on the speakers’ bureau for Ariad, Celgene, GlaxoSmithKline, Incyte, Sanofi-Aventis, Seattle Genetics, and Spectrum. Dr. Rizzieri has further indicated he is a principal investigator for Bristol-Myers Squibb, Cyclacel, Eli Lilly, Micromet, Sunesis, and Supergen. He is also a consultant for CTI and an expert reviewer for Pfizer. Ms. Sakalian has indicated she has no relative relationship with industry to disclose relevant to the content within this CME/CE activity.

Accredited Provider Disclosure: The staff of Duke University Health System Department of Clinical Education & Professional Development and Montefiore Learning Network involved with this activity and any content validation reviewers of this activity have reported no relevant financial relationships with commercial interests.

Publishing Staff Disclosures: Christine Stone, PhD, MBA, and Lori Marrese of Haymarket Medical Education have nothing to disclose with regard to commercial support.

Disclaimer Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

For questions about CE, please call Montefiore Learning Network at 718-904-2139 or e-mail mmclough@ montefiore.org.

EDUCATIONAL OBJECTIVES At the conclusion of this activity, learners should be better able to: • Evaluate patient- and disease-related factors used to diagnose and risk-stratify patients with CLL in order to select appropriate treatment strategies • Apply shared decision-making techniques when treating patients with CLL • Define strategies to monitor and manage patients during “watch and wait” protocols and to identify disease progression

PROGRAM DESCRIPTION Chronic lymphocytic leukemia (CLL) is a slow growing B-cell malignancy that remains incurable. Most patients with CLL relapse or become refractory to treatment. Several newly approved agents have promising clinical activity in CLL, including “difficultto-treat” populations. Educating oncology healthcare professionals about choosing between these new therapeutic options to treat patients with CLL will contribute to the effective management of this condition and could help improve patient outcomes.

FACULTY David A. Rizzieri, MD Professor of Medicine Chief, Section of Hematologic Malignancies Associate Director of Clinical Research Division of Hematologic Malignancies and Cellular Therapy Duke Cancer Institute Duke University Medical Center Durham, NC Heather L. Paradis, MSN, ANP-BC, AOCN Nurse Practitioner Oncology/Hematology Duke University Medical Center Durham, NC CME/CE COURSE DIRECTORS David A. Rizzieri, MD Professor of Medicine Chief, Section of Hematologic Malignancies Associate Director of Clinical Research Division of Hematologic Malignancies and Cellular Therapy Duke Cancer Institute Duke University Medical Center Durham, NC Susan Sakalian, MS-RN, OCN Montefiore Medical Center Bronx, New York ACCREDITATION STATEMENTS This activity has been planned and implemented by the Duke University Health System Department of Clinical Education & Professional Development and Haymarket This activity is jointly supported by a grant from Gilead Sciences, Inc. and Pharmacyclics, Inc.

18 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

Medical Education for the advancement of patient care. The Duke University Health System Department of Clinical Education & Professional Development is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing education for the health care team.

Montefiore Learning Network is an approved provider of continuing nursing education by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.

DESIGNATION STATEMENTS Duke University Health System Department of Clinical Education & Professional Development designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

This enduring activity is awarded 0.50 contact hours. Approval Code: NYP268-11/12-15.

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Treatment of a 49-year-old white male presenting with newly diagnosed CLL using the principles of shared decision-making Clinicians are often at a loss for how to successfully educate and involve patients in their care decisions. This case illustrates the effective use of SDM in clinical practice.

DAVID A. RIZZIERI, MD; HEATHER L. PARADIS, MSN, ANP-BC, AOCN

C

© SPL / SCIENCE SOURCE

hronic lymphocytic leukemia (CLL) is a monoclonal disorder characterized by a progressive accumulation of functionally incompetent lymphocytes and is one of the most common forms of adult leukemia in the United States.1,2 While it is most prevalent in the seventh to ninth decades of life, a significant proportion (11% to 27%) of the newly diagnosed CLL population are under the age of 55 years.2,3 Approximately 25% of patients with CLL have no symptoms at the time of diagnosis and are only diagnosed via a routine blood test; the remaining 75% present with a wide range of physical and laboratory abnormalities (eg, constitutional symptoms, lymphadenopathy, splenomegaly, anemia, and/or bleeding).1 The diagnostic criteria for CLL are detailed in Figure 1.

Prognosis varies greatly and is heavily impacted by cytogenetics and other molecular features.5 CLL risk stratification includes the use of various prognostic biomarkers (eg, basic

Increased lymphocytes (blue) and reduced erythrocytes (red) and other blood components, indicative of chronic lymphocytic leukemia, seen on colored scanning electron micrograph

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CONTINUING EDUCATION | Using the principles of shared decision-making FIGURE 1. Diagnostic Criteria for CLL4 At least 5,000 B-lymphocytes/µL in the peripheral blood

CLL cells must be clonal as confirmed by flow cytometry B-lymphocytes must display a characteristic immunophenotype: coexpression of T-cell antigen CD5, B-cell surface antigens CD19, CD20, CD23, with CD20 and CD79b levels low compared to normal B-cells

Per the National Cancer Institute Working Group and iwCLL guidelines.

laboratory measures, tumor proliferation time, cytogenetic status), age, and performance status, in addition to clinical staging.6,7 The goal of CLL treatment is to maintain the best quality of life and treat only when patients become symptomatic, as some patients live for decades with no need for treatment.8 Treatment options for CLL range from periodic observation with treatment of complications to a variety of therapies (eg, steroids, alkylating agents, purine analogues, combination chemotherapy, monoclonal antibodies, small molecule inhibitors, and transplant options).5,9,10 When choosing a treatment regimen, it’s important for healthcare professionals (HCPs) to consider a balance of efficacy and tolerability and/or safety, factoring in considerations including the patient’s performance status, existing comorbidities, and comparative toxicity profiles of recommended treatment regimens.11 Treatment options should also be discussed with the patient and shared decision-making (SDM) employed.12,13 SDM has been defined as “an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve informed preferences.”14 SDM takes into account, among other factors, a patient’s needs and the patient’s family’s needs, values, and preferences and aids in the achievement of patient-centered care. Effective physician-patient communication, SDM, and patient-centered care can impact patient satisfaction, which may in turn correlate with clinical outcomes, as well as treatment costs.12,15 Unfortunately, studies have shown that patient preferences are often ignored when it comes to therapy choice.12,14

Despite growing attention to patient-centered care and the importance of SDM, a lack of clear guidance on how to accomplish SDM in routine practice remains. Elwyn et al have proposed that HCPs can provide information and support the decision-making process in such a way as to empower patients to act independently and make their own choices regarding treatment. This can be achieved through the 3-part model depicted in Figure 2.14 We’ll explore each of these steps more in-depth throughout the rest of this piece.

INTRODUCING RICHARD F Richard F was diagnosed with CLL at age 49 years in September 2010. His notable past medical history included coronary artery disease, including a bypass surgery in 2004, hypertension, and elevated cholesterol. For these conditions, he was currently receiving the following medications: rosuvastatin, candesartan cilexetil, nebivolol, and baby aspirin. Richard’s father died from acute leukemia at age 60 years, which is noteworthy in that approximately 5% of patients with CLL report a family history of leukemia in population-based samples.1 The age at which Richard was diagnosed is also noteworthy in that he was relatively young at diagnosis. Diagnosis at ≤55 years old is associated with a shorter time to treatment compared with those diagnosed at age >55 years.3 While those diagnosed with CLL at ≤55 years have longer overall survival compared with those diagnosed with CLL at age >55 years, this population still has significantly shorter survival compared with an age- and sex-matched normal population.3 Richard had no symptoms at diagnosis, with his disease coming to light during a routine blood test. Recall that this is not uncommon, as approximately 25% of patients with CLL have no FIGURE 2. Three-Step Model for SDM in Clinical Practice14 Choice Talk

A planning step whereby the HCP conveys to the patient that reasonable options exist

Option Talk

HCP provides more detailed information about options

Decision Talk

HCP supports the patient as he or she considers preferences and decides what is best

20 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

FIGURE 3. Choice Talk Step in the SDM Model14

Choice Talk

• Step back – What to do next?

• Offer choice – Explain that you’ll provide good information about how treatments differ • Justify choice – Emphasize the importance of respecting individual preferences and the role of uncertainty • Check reaction – Be sure patient is comfortable • Defer closure – Explain you are happy to share your views, but that you’d like to describe the options in greater detail

symptoms at the time of diagnosis and are similarly only diagnosed via a routine blood test.1 RICHARD’S DISEASE FINDINGS Diagnostic testing determined that Richard had a white blood cell (WBC) count of 19,000/mm3, 60% of which were lymphocytes. Two repeat blood exams showed persistent leukocytosis. A flow cytometry immunophenotypic report showed CD5+, monoclonal B-cells (23% of the white cells) with small cell size and a phenotype characteristic of CLL. The monoclonal B-cells were characterized as CD19+, dim but 100% expression of CD20+, and CD23+, which is a characteristic CLL immunophenotype.4 However, no CD38 expression was detected, a characteristic CLL immunophenotype that predicts a poor prognosis.4 Molecular cytogenetic testing revealed that Richard harbored the 13q deletion (del[13q]), a commonly occurring mutation with an incidence of approximately 55% in CLL.16 Alone, del(13q) confers a favorable prognosis.5,6 However, Richard also harbored the 11q deletion (del[11q]), the second-most commonly occurring chromosomal change behind del(13q), occurring in approximately 18% of CLL patients, and a poor prognostic indicator.16 The mutational status of noteworthy genes was also evaluated for Richard. These findings included an unmutated immunoglobulin variable region heavy chain (IgVH) gene, which correlates with an inferior outcome in CLL, including a less indolent clinical course and shorter survival.4,8 Richard’s 70-kDa ζ-associated protein (ZAP-70) results were considered borderline, with ZAP-70 expression of 20% or more typically predicting a poor outcome.6 Finally, a deletion in the ataxia telangiectasia mutated (ATM) gene was detected. ATM gene alterations are present at diagnosis

in approximately 25% of individuals with CLL and are associated with a shorter treatment-free interval.17 INITIAL TREATMENT APPROACH

Richard visited with multiple HCPs to gain information about CLL and to gain a consensus on what the best initial approach was for him and his disease. He also obtained literature from professional societies as well as other information gathered from online research, specifically looking at clinical trials and emerging treatments. All the HCPs Richard visited recommended a “watch and wait” approach for him, whereby he would be monitored without therapy.4 He was also informed that some of his prognostic indicators were not favorable, and that his platelet counts could drop enough that treatment would be warranted. Providing information such as what is described here is encompassed during the “choice talk” step of the SDM model proposed

by Elwyn et al, whereby the patient is informed that reasonable choices exist (Figure 3).14 Per the National Cancer Institute Working Group and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines and the National Comprehensive Cancer Network (NCCN), it is generally recommended that newly diagnosed patients with asymptomatic early-stage disease are monitored via the “watch and wait” approach without therapy unless they have evidence of disease progression.4,6,8 This approach allows most patients to maintain the best quality of life and only receive treatment when they become symptomatic, an approach bolstered by the findings that early intervention with standard chemotherapy is not associated with a survival benefit.8 Richard was monitored under a “watch and wait” protocol from the time of his diagnosis in September 2010 through FIGURE 4. Notable Events Occurring During Richard’s “Watch and Wait” Period Spring 2012

Spring 2013

Fall 2013

• First HCP • CT scan notes • Intermittent swelling in discussion about groin area, for which lymphadenopathy in a potential number of locations Richard took prednisone treatment if as needed • MRI confirms lymphadenopathy and platelets fall • HCP advises treatment if below 50,000 small nodes, mild platelets fall below 80,000 cells/µL splenomegaly cells/µL • HCP restaged at that • New node + existing time to Rai stage 2, nodes now in neck region, though it should be node in groin larger, but noted that because the no cervical adenopathy, spleen was not axillary adenopathy, or palpable, he was supraclavicular actually stage 1 adenopathy

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 21

CONTINUING EDUCATION | Using the principles of shared decision-making February 2014. Typically, during “watch and wait,” a patient is monitored approximately once every 3 months for disease progression and to measure lymphocyte doubling time.8 Notable events that occurred during Richard’s “watch and wait” period are outlined in Figure 4.

DISEASE PROGRESSION AND FIRST-LINE TREATMENT

Most guidelines and disease-expert oncologists stipulate initiating treatment only when there is evidence of progressive or symptomatic disease.1,4,6 Richard’s disease began to show signs of progression beginning in January 2014, with symptoms such as increased fatigue, thrombocytopenia (platelets at 78,000 cells/µL), increased adenopathy, and vertigo that required a trip to the emergency department and was successfully treated with meclizine. A PET scan was also performed, the results of which were consistent with diffuse CLL. The next month, Richard visited with 2 different HCPs, who diverged in opinion regarding whether to continue “watch and wait” or initiate therapy. The HCP who recommended initiating therapy was concerned that Richard’s platelet counts would continue to drop so low that fludarabine + cyclosporine + rituximab (FCR) would no longer be an option. Richard went back to the HCP who recommended further “watch and wait” and asked about available treatment options if they continued to “watch and wait” but his platelet counts dropped too low for FCR. The only available treatment that was suggested to Richard would most likely not be covered by insurance and could potentially cost him $15,000/month. Thus, due to the financial implication of the therapy, it was not an option for him.

This time period in Richard’s disease course highlights the FIGURE 5. Option Talk Step in the SDM Model14

Option Talk

• Check knowledge – Ensure accurate knowledge of options and associated benefits and harms • List options – Provide a clear list of options • Describe options – Describe options in practical terms, generate dialogue, and explore preferences; be clear about the pros and cons of different options • Provide patient decision support – Provide tools that make options visible (eg, Issues Cards, Decision Boards, Options Grids) • Summarize – List the options again and ask the patient to “teach back” the information to ensure good understanding

need for the “option talk” step of the SDM model, whereby the patient is provided more detailed information about options and their associated risks and benefits (Figure 5).14 At this point, Richard had 2 HCPs in disagreement about what was best for him. He performed a good deal of research into clinical trials, treatments that were considered standard within the field, etc. At the time, he was not eligible for clinical trials involving the new small molecule inhibitors ibrutinib or idelalisib. Richard reviewed literature on FCR and was impressed by its efficacy, and ultimately decided that initiating FCR once every 28 days would be best for him. FCR is a recommended first-line therapy for CLL patients aged <70 years.5 He understood that his fatigue might worsen and his platelet counts could be affected by FCR treatment. His goal was remission with hopes that he would buy a few years until he could try a novel small agent (eg, ibrutinib, idelalisib). His HCP communicated the schedule, as well as the usual and potential adverse effects

Despite growing attention to patientcentered care and the importance of SDM, a lack of clear guidance on how to accomplish it in practice remains. associated with FCR. Prophylactic medicines were also prescribed to reduce risk of tumor lysis syndrome, a rare but possible adverse event following therapy with a purine analogue-based regimen, such as FCR, and included: the antiviral valacyclovir, the antibiotic sulfamethoxazole/trimethoprim, and the uric acid-lowering agent allopurinol.4,18,19 This time period brings us to the final step of the SDM model, the “decision talk,” whereby the HCP supports the patient as they consider preferences and ultimately decide together what is best for the patient (Figure 6).14 Richard received FCR from February 2014 through July 2014. He tolerated his first cycle well, but did experience fatigue, especially after the first few days of treatment.

By mid-March, all his nodes were virtually resolved and his platelet counts were stable at 110,000 cells/µL. However, hypogammaglobulinemia, or low levels of immunoglobulins, was noted, which is associated with an increased susceptibility to infection. As a result, the neutrophil-boosting agent pegfilgrastim was prescribed.18 In April, he was hospitalized with a 101°F fever with chills and dysuria resulting from a multidrug resistant urinary tract infection that 2 rounds of oral antibiotics had failed

22 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR PB

to resolve. Ultimately, intravenous antibiotics resolved the infection. As a result of this hospitalization, the FCR dose was reduced. Richard also suffered from mucositis from the FCR treatment, and was treated with magic mouthwash, a solution used to treat mouth sores caused by some forms of chemotherapy and radiation therapy. By June 2014, a PET scan showed a significant response to the FCR treatment, with his platelets mostly stable but slightly low at 80,000 cells/µL. In July, Richard received his sixth and presumably final cycle of FCR therapy, with the plan to continue to monitor his disease off-therapy.

As of this writing, Richard is still experiencing fatigue despite his normal red blood cell count, though he still has a slightly low platelet count (~100,000 cells/µL). He feels that the fatigue is gradually getting better, and he resumed working full-time. His lymph nodes are no longer swollen, overall he “feels good,” and he is very happy with his current state. Looking to the future, Richard’s goal for second-line treatment, when it becomes necessary, is to maintain a good quality of life, and he is hopeful that he’ll be able to use a small molecular inhibitor at that time.

SUMMARY Richard demonstrated some “difficult-to-treat” CLL characteristics (ie, del[11q], unmutated IgVH, borderline ZAP-70, ATM deletion, young age at diagnosis; comorbidities of heart and metabolic disease). After a period of “watch and wait,” he responded well to traditional first-line chemoimmunotherapy. Richard is currently doing very well and is very happy with his current condition and level of disease control.

Richard’s case highlights the value of SDM as part of patient-centered care in the treatment of CLL. Optimal treatment outcomes for B-cell malignancies such as CLL rely

Understanding the value of the SDM model as it relates to formulation of treatment plans is an essential part of being an educated clinician. on the assumption of several factors, including proper adherence to the prescribed regimen to induce, and hopefully maintain, tumor responses.20 For the latter, hematologists/ oncologists take into account a patient’s performance status, existing comorbidities, and comparative toxicity profiles of recommended treatments to find a regimen that delivers a

FIGURE 6. Decision Talk Step in the SDM Model14

Decision Talk

• Focus on preferences – Guide patient to focus on preferences • Elicit a preference – Be ready with a back-up plan by offering more time or being willing to provide further guidance if requested • Moving to a decision – Check for the need to either defer or make a decision • Offer review – Review and arrive at closure

balance of efficacy and toxicity.21 However, another aspect that may affect patient adherence to a prescribed regimen may often be ignored: the individual needs, values, and preferences of the patient as well as the patient’s family.

Attention to these issues forms the core of patient-centered care and can be achieved through implementation of SDM.22-26 The benefits of effective communication between clinicians and their patients with cancer are far‐reaching.27 Clinicians achieve greater diagnostic accuracy and patients who are actively engaged in decision making around their care are more adherent to therapeutic regimens and more satisfied with their care.28,29 Understanding the value of the SDM model as it relates to successful formulation of personalized treatment plans for patients with CLL is an essential part of being an educated clinician.

A NURSING PERSPECTIVE ON MANAGING PATIENTS WITH CLL

CLL is a monoclonal disorder of the lymphocytes and, as mentioned, is one of the most common forms of leukemia.

The specific criteria for diagnosis and symptoms can range from none to early satiety due to splenomegaly, anemia, and thrombocytopenia due to autoimmune processes or marrow overcrowding.2 Since patients can live for years with CLL, the goal of therapy is to treat only when needed and for symptom relief.30 Therefore, patients in clinic with CLL range from those being monitored to those actively receiving therapy. The therapy can vary from multiagent intravenous therapy to oral therapy.

In this case, Richard was diagnosed at a younger-thanaverage age for CLL. A common occurrence, his CLL was diagnosed based on routine labs that showed an elevated white count with lymphocytosis.2 Patients like this usually do not need therapy initially and can be monitored, as was the case with Richard. This is an important time for patients to feel comfortable and able to communicate

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 23

CONTINUING EDUCATION | Using the principles of shared decision-making with their care team. The patient has been told that they have a form of cancer and are going to be watched and not treated. This can be very difficult for patients to accept and understand. A great deal of education and reassurance are needed initially. Over time, the patient becomes comfortable with this approach. During the “watch and wait” period, the patient is usually seen every 3 months

There is usually ongoing discussion at these visits about treatments and what options there are for when they are needed. and assessed for disease progression.4 This includes looking at his or her counts—specifically the white count and the lymphocyte doubling time, which gives some indication of how quickly the disease is progressing. The hemoglobin and platelets are observed for decline and physical exam is performed to measure lymphadenopathy and splenomegaly. There is usually ongoing discussion at these visits about treatments and what options there are for when they are needed.

Richard had tests to discover prognostic markers, which help to give some indication as to prognosis. In his case, he had the favorable marker of 13q deletion but also had an 11q deletion, which is a poor prognostic marker. In CLL, the poor prognostic markers carry more weight than the good, so the 11q deletion “trumps” the 13q deletion. He also had another poor risk marker with an unmutated immunoglobulin variable region heavy chain (IgVh) gene.6 These markers indicate he is likely to need therapy sooner and have shorter time between treatments than patients with favorable markers who may never require treatment.

It is helpful to realize that he will likely need treatment, but as was the case in his situation, he was able to go several years before it was needed.

As Richard’s platelet counts began to drop and he had increasing and new lymph nodes, he began to consider his treatment options. As was seen in his case, there is not always a

consensus on when to start therapy. It varies between providers and also should be influenced by what is best for the patient since there is not an exact time when intervention is needed.

Richard acknowledged that he had concerns regarding when to initiate therapy; therapy should be initiated before the counts are too low or the patient is too symptomatic.

FCR has been the standard of care for first-line therapy in CLL patients under age 70 years.5 This may change as newer agents become available, however, at the time for Richard, FCR was appropriate therapy. He received medication to prevent tumor lysis, as well as antiviral therapy and PCP prophylaxis. Due to the immunosuppressive nature of f ludarabine, it is important to provide antiviral and bacterial prophylaxis.31 Management of side effects is important with any therapy to improve patient compliance and quality of life. Fatigue can be a major component, as it was with Richard, and nurses can assist by providing education and recommendations for fatigue management.32 Once they have completed a first-line therapy, CLL patients return to a “watch and wait” period. Hopefully, for most patients this is an extended period of time. With patients who have poorer risk factors, this time is likely to be less, but with new small molecule inhibitors becoming available, it is hoped that their course will improve.5 These agents are rapidly becoming standard second-line therapies and are under investigation in clinical trials for frontline therapy.

Nurses will need to be familiar with how they are given and what side effects to expect to help educate patients.33,34 ■ David Rizzieri is professor of Medicine, chief, Section of Hematologic Malignancies, associate director of Clinical Research Division of Hematologic Malignancies and Cellular Therapy, at Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina.

Heather Paradis is a nurse practitioner in Oncology/Hematology, Duke University Medical Center.

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2. Facts spring 2014. Leukemia & Lymphoma Society. Revised April 2014. http://www.lls.org/content/nationalcontent/resourcecenter/ freeeducationmaterials/generalcancer/pdf/facts.pdf. Accessed November 24, 2014.

TO TAKE THE POST-TEST FOR THIS CE ACTIVITY

and apply for 0.5 contact hours, please go to myCME.com/CLLCase2

3. Parikh SA, Rabe KG, Kay NE, et al. Chronic lymphocytic leukemia in young (≤ 55 years) patients: a comprehensive analysis of prognostic factors and outcomes. Haematologica. 2014;99(1):140-147.

4. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the

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International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute–Working Group 1996 guidelines. Blood.

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19. Fludara (fludarabine phosphate). Prescribing Information. Montville, NJ: Berlex; 2003.

20. Hohneker J, Shah‐Mehta S, Brandt PS. Perspectives on adherence and

5. National Cancer Institute at the National Institutes of Health. Chronic lymphocytic leukemia treatment (PDQ®). Last modified April 2014. http://www.cancer.gov/cancertopics/pdq/treatment/CLL/health professional. Accessed November 24, 2014.

persistence with oral medications for cancer treatment. J Oncol Pract.

2011;7:65‐67.

21. Lonial S. Presentation and risk stratification—improving prognosis for patients with multiple myeloma. Cancer Treat Rev. 2010;36 Suppl 2:S12‐S17.

6. The NCCN Clinical Practice Guidelines in Oncology: Non-Hodgkin’s Lymphomas. (Version 4.2014). http://www.nccn.org. Accessed November 24, 2014.

22. Lee EO, Emanuel EJ. Shared decision-making to improve care and reduce costs. N Engl J Med. 2013;368:6‐8.

23. Barry MJ, Edgman‐Levitan S. Shared decision-making – the pinnacle of

7. Shanafelt TD, Jenkins G, Call TG, et al. Validation of a new prognostic index for patients with chronic lymphocytic leukemia. Cancer.

2009;115:363-372.

patient‐centered care. N Engl J Med. 2012;366:780‐781.

24. Paget L, Han P, Nedza S, et al. Patient‐clinician communication: basic principles and expectations. Institute of Medicine, 2011.

8. Gribben JG. Chronic lymphocytic leukemia: planning for an aging population. Expert Rev Anticancer Ther. 2010;10(9):1389-1394.

9. Imbruvica (ibrutinib). Prescribing Information. Sunnyvale, CA: Pharmacyclics, Inc.; 2014.

25. Michalopoulou G, Falzarano P, Arfken C, Rosenberg D. Physicians’ cultural competency as perceived by African American patients.

J Natl Med Assoc. 2009;101:893‐899.

26. Stacey D, Bennett CL, Barry MJ, et al. Decision aids for people facing

10. Zydelig (idelalisib). Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; 2014.

health treatment or screening decisions. Cochrane Database Syst Rev. 2011;10:CD001431.

11. Lonial S. Presentation and risk stratification—improving prognosis for patients with multiple myeloma. Cancer Treat Rev. 2010;36(suppl 2):S12-S17.

12. Lee EO, Emanuel EJ. Shared decision making to improve care and reduce costs. N Engl J Med. 2013;368:6-8.

27. Prouty CD, Mazor KM, Greene SM, et al. Providers’ perceptions of communication breakdowns in cancer care. J Gen Intern Med. 2014;29(8):1122-1130.

28. Bonvicini KA, Perlin MP, Bylund CL, et al. Impact of communication train-

13. Paget L, Han P, Nedza S, et al. Patient-clinician communication: basic principles and expectations. Institute of Medicine, 2011. http://www. iom.edu/~/media/Files/Perspectives-Files/2012/Discussion-Papers/ VSRT-Patient%20Clinician.pdf. Accessed October 30, 2013.

14. Elwyn G, Frosch D, Thomson R, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361-1367.

15. Michalopoulou G, Falzarano P, Arfken C, Rosenberg D. Physicians’ cultural competency as perceived by African American patients. J Natl Med Assoc. 2009;101:893-899.

ing on physician expression of empathy in patient encounters. Patient Educ Couns. 2009;75:3-10.

29. Haskard KB, Williams SM, DiMatteo MR, et al. Physician and patient communication training in primary care: effects on participation and satisfaction. Health Psychol. 2008;27:513-522.

30. Gribben JG. Chronic lymphocytic leukemia: planning for an aging population. Expert Rev Anticancer Ther. 2010;10(9):1389-1394.

31. Moran M, Browning M, Buckby E. Nursing guidelines for managing infection in patients with chronic lymphocytic leukemia. Clin J Oncol

16. Döhner H, Stilgenbauer S, Benner A, et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med. 2000;343:1910-1916.

17. Guarini A, Marinelli M, Tavolaro S, et al. ATM gene alterations in chronic lymphocytic leukemia patients induce a distinct gene expression profile and predict disease progression. Haematologica. 2012;97(1):47-55.

18. MedlinePlus Medical Dictionary. http://www.nlm.nih.gov/medlineplus/ mplusdictionary.html. Accessed November 25, 2014.

Nurs. 2007;11:914-924.

32. Elphee EE. Caring for patients with chronic lymphocytic leukemia.

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33. Hartigan K. Patient education: the cornerstone of successful oral chemotherapy treatment. Clin J Oncol Nurs. 2003;7(suppl 6):21-24.

34. Winkeljohn D. Adherence to oral cancer therapies: nursing interventions. Clin J Oncol Nurs. 2010;4:461-466.

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FEATURE | Liquid biopsy

Liquid biopsy: A new tool in the management of NSCLC This developing technology allows serial monitoring to better gauge response to treatment and prognosis for patients with non-small cell lung cancer.

KATHY BOLTZ, PHD

ctDNA

Liquid biopsies, an emerging technology that uses blood samples can provide valuable information that allows oncologists to provide precision medicine.

This article reports on a presentation by Matthew Krebs, MD, PhD, at the European Lung Cancer Conference, in Geneva, Switzerland. Krebs discussed the development of liquid biopsy, and its use in the management of non-small cell lung cancer.

L Circulating Tumor Cells

© JENNIFER E. FAIRMAN, CMI, FAMI

Tumor

Liquid biopsies use measurements of levels of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in blood samples to monitor treatment response.

iquid biopsy is a developing technology that offers a way to monitor tumor clonal evolution that facilitates precision medicine. Matthew Krebs, MD, PhD, of the Institute of Cancer Sciences at The University of Manchester in the United Kingdom described the development of both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) for liquid biopsies. His session covered the promises and pitfalls of using liquid biopsy in the management of non-small cell lung cancer (NSCLC) at the European Lung Cancer Conference in Geneva, Switzerland.

Krebs explained that although serial biopsies offer valuable information, they are not practical.

So, the development of liquid biopsies offers a promising alternative. Liquid biopsies, using blood samples, allow serial monitoring of patients.

CIRCULATING TUMOR CELLS Currently, the only validated system for CTCs is the CellTracks system. However, for NSCLC, its big drawback is that it is completely dependent on epithelial markers, and these particular

26 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

FEATURE | Liquid biopsy markers are present in only approximately 15% of patients with NSCLC. Other systems to track CTCs are in development, but none are yet validated, Krebs stated.

The level of CTCs and their change after treatment offer prognostic information on patients. The number of CTCs is a strong indicator for overall survival—more CTCs predicts worse overall survival. Krebs explained that CTCs can detect ALK-gene rearrangement and expression, though measuring ALK in CTCs is technically challenging and not currently practical outside of dedicated research laboratories.

New technologies allow for single-cell analysis of CTCs. These are helpful in addressing questions on if the heterogeneity of CTCs ref lects tumor heterogeneity, if different populations of cells have unique driver mutations, and which CTCs survive and result in metastases.

CTCs are an excellent research tool. They allow the assessment of morphology, protein expression, and genetic aberrations all in the same cells. The downsides include the lack of validation

ctDNA provides information on actionable aberrations that allow a relevant trial to be selected. and qualification for most technologies and the wide variations in CTC definitions and technologies. It is difficult to reproduce assays across multiple sites, which limits the routine clinical use of CTCs. Also, CTC technology is expensive.

CIRCULATING TUMOR DNA Technologies to assess ctDNA have progressed very rapidly in recent years. Its sensitivity is now down to 1% to 2% with the scorpion amplification refractory mutation assay (SARMS).

Krebs shared the example of determining EGFR mutation status by ctDNA in the phase IV study of gefitinib in EGFRpositive advanced NSCLC.1 This assay, compared with tumor block and plasma with the SARMS assay, had a concordance of 94.3%, sensitivity of 66%, and specificity of 100%.1 In cases where tumor material is not available, liquid biopsy assayed by ctDNA to determine EGFR mutation status can allow patients with EGFR mutation to start gefitinib.

Digital PCR, also known as droplet PCR, further increases the sensitivity of ctDNA to allow the quantification of mutated alleles.2 More than yes or no information, Krebs explained that digital PCR gives quantification and allows

serial monitoring of changes, such as detecting the T790M mutation before clinical progression is evident. Digital PCR gives information about the biology of a patient’s disease.

Two recent studies found that failure to eradicate ctDNA leads to worse overall survival.3,4 Krebs predicted that ctDNA will have a role in the clinic in the future. It provides early information on treatment response. Further, quantifying ctDNA is complementary to imaging. These technologies can be combined.

Whole exome sequencing allows resistance mechanisms to be determined from ctDNA, which offers a new paradigm for studying clonal evolution. The technology can look for clones at baseline in real time and observe their presence and evolution over time.

PROS AND CONS Krebs explained that a big pro for ctDNA is that DNA is easy to extract and the profiling assays are much more amenable to validation and qualification than CTCs. However, different methods for ctDNA analysis are used by different centers. Further, quantification and whole exome sequencing technologies are still in their infancy and have only been reported in small groups of patients. Assays of ctDNA are extremely complex, but are easier to validate than CTCs. Currently, ctDNA is largely a research tool.

Krebs stated that enthusiasm at his institute is so high that all patients are molecularly profiled by ctDNA so they can be considered for phase I clinical trials. The ctDNA provides information on actionable aberrations that allow a relevant trial to be selected. ■ Kathy Boltz is a medical writer based in Phoenix, Arizona.

REFERENCES 1. Douillard JY, Ostoros G, Cobo M, et al. Gefitinib treatment in EGFR mutated caucasian NSCLC: circulating-free tumor DNA as a surrogate for determination of EGFR status. J Thorac Oncol. 2014;9(9):1345-1353.

2. Oxnard GR, Paweletz CP, Kuang Y, et al. Noninvasive detection of response and resistance in EGFR-mutant lung cancer using quantitative next-generation genotyping of cell-free plasma DNA. Clin Cancer Res. 2014;20(6):1698-1705.

3. Tseng JS, Yang TY, Tsai CR, et al. Dynamic plasma EGFR mutation status as a predictor of EGFR-TKI efficacy in patients with EGFR-mutant lung adenocarcinoma. J Thorac Oncol. 2015;10(4):603-610.

4. Mok T, Wu YL, Soo Lee J, et al. Detection and dynamic changes of EGFR mutations from circulating tumor DNA as a predictor of survival outcomes in NSCLC patients treated with first-line intercalated erlotinib and chemotherapy [published online ahead of print March 31, 2015].

Clin Cancer Res. doi:10.1158/1078-0432.CCR-14-2594.

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 29

FEATURE | Sensor-based diagnostics

Simulation tool teaches clinical breast examination technique Sensor technology is used to illustrate the amount of pressure applied in breast palpation, helping clinicians refine their clinical skills for locating a breast mass.

BETTE WEINSTEIN KAPLAN

D

© THINKSTOCK

espite the use of ever-increasingly advanced technology to diagnose breast cancer, the role of the clinical breast examination is as important as ever. To further advance the handson technique, a new sensor-based tool has been designed to improve the technique.

Carla Pugh, MD, PhD, and her group at the University of Wisconsin (UW) Health Clinical Simulation Program are known for innovating the use of simulation-based tools for teaching and evaluating surgical and examination techniques.

They have explored sensor-based techniques for cast placement and removal, for learning ultrasound examination of the thyroid, and for teaching pelvic examinations in the developing world.1-3 Recently, Pugh’s team focused on refining the clinical breast examination. Pugh, a surgeon, is clinical director of the UW Health Clinical Simulation Program and director of patient safety and education at the University of Wisconsin Hospital and Clinics. She is a proponent of using haptic skills in medicine, and to that end she has created a variety of simulative models for teaching clinicians effective manual examination techniques.

HAPTICS In a talk at TedMed 2014, Pugh described haptics as “the art and science of touch.

Knowing how to touch something. Knowing how things are supposed to feel.” It is the ability to discern the difference between what is normal and what is not normal. The tricky

30 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

thing about haptics is that we do not have a sure-fi re way of teaching it; nor do we have a way of measuring it.

Therefore, we have no way of measuring an operator’s competency in the technique, Pugh explained.4 “How could clinicians learn the technique? How can a body of knowledge be mastered when some of its most important aspects cannot be taught in a lecture, read in a book, or even be experienced—such as in an emergency, when situation can change so quickly?”4 CLINICAL BREAST EXAMINATION The current method for training a clinician to perform a clinical breast examination is to have an experienced practitioner observe the trainee palpate the breast. Visual observation, however, does not convey the degree of pressure the trainee is using to palpate the breast and whether

The device creates a map of the trainee’s palpation that shows where the least and the most pressure was applied. it is enough to detect a mass, which is the crucial point of the examination. To this end, Pugh and her team devised a sensor system that registers the amount of force applied.

The device creates a map of the trainee’s palpation that shows blue where the least pressure was applied and red where the most pressure was applied.

The UW group conducted a study in 2013 and 2014 to see how much more accurate the haptic sensor-equipped training device is compared with an examination conducted by an experienced clinician.5 For the project, practicing physicians performed simulated clinical breast examinations exactly the way they would on a symptomatic patient who presents in an office visit. The fictional patient claims to have felt a mass on self-examination but is currently unable to locate the lesion.

FIND US ON

The researchers recruited a total of 553 physician attendees from three annual clinical meetings: the American Society of Breast Surgeons (136 doctors), the American Academy of Family Physicians (236 doctors), and the American College of Obstetricians and Gynecologists (181 doctors). The participants used the Pugh devices specifically developed to teach breast examination techniques. There were four models.

• Model A had a soft, superficial mass measuring 2 cm by 2 cm.

• Model B was the same as model A, except the mass was smaller (2 cm by 1 cm).

• Model C had a hard, 2-cm mass located near the chest wall.

• Model D was the same as model C, except the mass was molded from a soft silicone derivative.

The videos, combined with sensor-map recordings, show successful and unsuccessful techniques for clinical breast exams. The least successful technique was associated with a light palpation (below 10 newtons); that technique placed physicians at significant risk for missing deep-tissue lesions near the chest wall, and in fact, 24.5% did miss them.

This study underscores the potential that sensor technology has for teaching proper technique and thereby extending the lives of patients who might otherwise be lost to breast cancer. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

REFERENCES 1. Maag AL, Laufer S, Kwan C, Cohen ER, Lenhart RL, Stork NC, Halanski MA, Pugh CM. Sensor-based assessment of cast placement and removal.

Stud Health Technol Inform. 2014;196:259-61.

2. Kwan C, Cohen E, Pugh C. Application of a new adaptable thyroid model for ultrasound and hands-on skill assessment. Stud Health Technol Inform. 2014;196:230-2.

3. Kwan C, Cohen E, Salud L, Pugh C. Modification of the pelvic examination simulator for the developing world. Stud Health Technol Inform. 2014;196:222-4.

4. TedMed 2014: Carla Pugh. Available at: http://www.tedmed.com/talks/ show?id=292997. Accessed April 12, 2015 5. Laufer S, Cohen ER, Kwan C, D’Angelo AL, Yudkowsky R, Boulet JR, McGaghie WC, Pugh CM. Sensor technology in assessments of clinical skill. N Engl J Med. 2015 Feb 19;372(8):784-6.

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FEATURE | Smoking cessation guidelines

Smoking cessation: Helping patients with cancer quit The NCCN Clinical Practice Guidelines in Oncology for Smoking Cessation can help you plan a successful quit program for your patients who smoke.

JOYCE PAGÁN

© THINKSTIOCK

H

ealth benefits of smoking cessation are signif icant. Potential benef its include improved treatment outcomes, reduced risk of disease recurrence, and lower risk of secondary cancers. Even after a cancer diagnosis, a patient’s prognosis can be improved if quit attempts are made.

The National Comprehensive Cancer Network (NCCN) presented its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Smoking Cessation at the NCCN 20th Annual Conference: Advancing the Standard of Cancer Care.1 Peter G. Shields, MD, The Ohio State University Comprehensive Cancer Center— Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC—James), served as chair of the NCCN Guidelines Panel for Smoking Cessation. These new guidelines focus on smoking cessation recommendations for patients with cancer. After a cancer diagnosis, patients may be more likely to believe any benefits to quitting smoking have passed. They need to be reassured that it is never too late to quit smoking.

The guidelines recommend a multifaceted approach that includes evidence-based pharmacotherapy, behavior therapy, and close follow-up with retreatment, as needed. It also recognizes that smoking and nicotine addition is a chronic relapsing disorder, and relapse should be expected. Some patients may need to make several attempts before achieving long-term smoking cessation. Nurses should

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be prepared to support and encourage patients who experience a relapse to make another quit attempt.

ASSESSMENT Any member of the health care team (eg, physician, nurse, medical assistant, health educator, other dedicated staff member) can perform the initial evaluation. The discussion of smoking status should be a part of the initial comprehensive patient history and documented in the patient’s health record.

Smoking status can be assessed with two simple questions: Have you ever smoked cigarettes? Do you currently smoke, or have you smoked, cigarettes in the last 30 days?

A current or recent smoker should be asked if they are ready to make a quit attempt in the next 30 days. If yes, the patient’s nicotine dependency should be assessed in terms of how many cigarettes does the patient smoke per day, how soon after waking up does the patient smoke the first cigarette of the day, and does the patient use other types of tobacco or nicotine products.

Some current smokers may have made quit attempts in the past. Prior attempts to quit and why those attempts were unsuccessful, as well as how long the patient was able to maintain abstinence should be included in the health record.

These factors may impact smoking cessation plan and the type of support a patient may need in his or her next quit attempt.

However, some patients may not be ready to make a quit attempt. Nurses should encourage the patient who is not ready to quit to discuss their feelings about quitting in an empathetic manner. The guidelines suggest leaving the conversation as an open-ended discussion by setting a future quit date or considering the use of pharmacotherapy to reduce the number of cigarettes smoked per day with a goal of making a quit attempt in the future.

A former smoker or recent nonsmoker may be at risk for relapse, particularly those whose quit attempt was within the last 30 days. The patient’s risk of relapse is high if he or she experiences frequent or intensive cravings, has increased feelings of stress or depression, lives or works with current smokers, quit less than 1 year ago, is currently using smoking cessation treatment, or uses or abuses drugs such as marijuana, narcotics, and stimulants.

Patients at high risk for relapse may have concerns about their ability to maintain abstinence. Counseling the patient on relapse risk factors and preventive measures may help the patient to recognize the signs of a possible relapse and prepare to deal with the triggers. Helpful strategies may be a short-acting nicotine replacement therapy (NRT) and a referral for behavior therapy.

Smoking status and risk of relapse, even in patients at low risk for relapse, should be re-evaluated regularly at in-person visits or via phone follow-ups. NCCN guidelines recommend continued reinforcement of patient’s success and the importance of maintaining abstinence. Patients who are long-term former smokers and never smokers should have their healthy behaviors supported and be encouraged to remain smoke-free.

TREATMENT The recommended therapies include NRT, pharmacologic therapy (varenicline [Chantix] or bupropion [Zyban]), and behavior therapy. The NCCN guidelines suggest that NRT and pharmacologic therapy can be combined, as needed.1 A combination of NRT and pharmacologic therapy is effective; however, the most effective treatment combined NRT or pharmacologic therapy with behavior therapy or counseling.

Nicotine replacement therapy NRT product forms include gum, inhalers, lozenges, nasal spray, or transdermal patch.2 All of these products can achieve successful smoking cessation when used according to package instructions.

However, patients are more likely to use the gum or transdermal patches correctly than the other forms.

Reported side effects include headache, and nausea and other digestive problems.2 Difficulty falling asleep in the first few days has also been reported. This occurs most often in patients who use the patch, and it usually passes.2 Patients with heart or blood circulation problems can use transdermal patches; however, unhealthy cholesterol (lower HDL) levels caused by smoking will not improve until the patch is discontinued.

NRT may not be safe for pregnant women. Unborn children of women using transdermal patch may have a faster heart rate.2 Pharmacologic therapy Varenicline is a nicotine receptor partial agonist and bupropion is an aminoketone agent.

Both are indicated for use as an aid to smoking cessation treatment.3,4 The treatment plan for both varenicline and bupropion include setting a start date, gradually increasing the dose within the first 7 days, then continuing at the full dose for the duration of the treatment.

Both drugs carry a black box warning about serious neuropsychiatric events, and clinicians are advised to monitor for these symptoms. In addition, they should instruct patients and their caregivers to be alert to neuropsychiatric symptoms and report such symptoms immediately.

Varenicline starting dose is 0.5 mg once daily on days 1 to 3. This is increased to 0.5 mg twice daily on day 4; then increased to 1 mg twice daily for a total of 12 weeks.

For those who successfully quit, an additional 12 weeks

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 33

FEATURE | Smoking cessation guidelines of treatment is recommended to increase the likelihood of long-term abstinence. Varenicline is shown to increase the likelihood of abstinence from smoking for as long as 1 year.

Bupropion starting dose is 150 mg once a day for the first 3 days. The dose is increased to two doses a day, taken at least 8 hours apart, for a total of 300 mg/day on day 4. This dose is continued for 7 to 12 weeks. If the patient successfully quits within this period, nurses should discuss the patient’s readiness to discontinue the drug. Continuing treatment should be based on the relative benefits and risks for the individual patient. If the patient has not successfully quit, bupropion treatment should be discontinued and the smoking cessation plan reassessed.

Both varenicline and bupropion are classified as Pregnancy Category C. Pregnant smokers should be encouraged to use educational and behavioral interventions as first-line smoking cessation therapy. For patients who are nursing, a decision on whether to discontinue treatment or discontinue nursing should be made. No overall differences in safety or effectiveness were reported between older and younger patients with either drug. However, older patients are more likely to have renal impairment and would be at risk for toxic reactions with either drug. Caution in dosing for these patients is recommended.

Safety and efficacy of varenicline in combination with other smoking cessation therapies has not been established.

A high rate of discontinuation due to adverse events was

Nurses and patients should keep in mind that a successful quit may not be achieved on the first attempt. reported as a result of coadministration of varenicline and transdermal nicotine.3 Bupropion is described as compatible for use with a nicotine transdermal system.4 Behavior therapy NCCN guidelines suggest that pharmacotherapy is most effective when combined with behavior therapy. Although even brief advice can improve the success of a quit attempt, the NCCN guidelines recommend using more intensive therapy involving multiple counseling sessions and supportive print and online materials.

Behavior therapy should be tailored to the individual patient, taking into account nicotine dependence and previous quit attempts. Benefits of behavior therapy are that strategies for coping with nicotine withdrawal, identifying smoking triggers, coping with stressful or difficult situations, and avoiding high-risk situations can be provided for patients.

Patients who are unwilling to quit should receive motivational counseling. An empathetic approach to exploring the smoker’s feelings, beliefs, ideas, and values toward smoking cessation can lead to changing their willingness to quit. NCCN guidelines recommend following four general principles: express empathy, develop discrepancy, roll with resistance, and support self-efficacy.

MANAGING RELAPSE Smoking relapse and brief slips are common among persons attempting to quit. The potential for relapse should be discussed with the patient. If a relapse occurs, nurses should be prepared to provide guidance and support. Patients should be encouraged to continue making a quit attempt. Importantly, patients should understand that achieving long-term cessation may take more than one quit attempt. Slips are not necessarily an indication to try an alternative method, but an assessment of why the attempt was not successful should be made.

CONCLUSION Smoking cessation has many benefits for patients, even after a cancer diagnosis. However, smoking and nicotine are addictive.

Nurses and patients should keep in mind that a successful quit may not be achieved on the first attempt. A high incidence of depression, anxiety, and stress is typical in the patient with cancer, and all of these are also common causes of relapse. However, stopping smoking can improve response to treatment, reduce risk of cancer recurrence, and reduce risk of secondary cancers.

NCCN guidelines for smoking cessation in patients with cancer can help clinicians in aiding their patients to achieve long-term smoking cessation. The guidelines recommend a multifaceted approach that includes evidence-based pharmacotherapy, behavior therapy, and close follow-up with retreatment as needed. It is never too late to encourage your patients to stop smoking cigarettes. ■ Joyce Pagán is the editor of Oncology Nurse Advisor.

REFERENCES 1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines).

Smoking Cessation. Version 1.2015. http://www.nccn.org/professionals/ physician_gls/pdf/smoking.pdf. Accessed May 22, 2015.

2. Nicotine replacement therapy. MedlinePlus web site. http://www.nlm. nih.gov/medlineplus/ency/article/007438.htm. Accessed May 22, 2015.

3. Chantix [package insert]. New York, NY: Pfizer Labs; 2015. http://labeling. pfizer.com/ShowLabeling.aspx?id=557. Accessed May 22, 2015.

4. Zyban [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2014. https://www.gsksource.com/gskprm/htdocs/documents/ZYBANPI-MG.PDF. Accessed May 22, 2015.

34 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

STAT CONSULT Isavuconazonium sulfate (Cresemba) Drug type

• Azole antifungal Indications

• Treatment of invasive aspergillosis • Treatment of invasive mucormycosis

Mechanisms of action

• Isavuconazonium sulfate is the prodrug of isavuconazole, an azole antifungal • Isavuconazole inhibits synthesis of ergosterol, a key component of the fungal cell membrane • Accumulation of methylated sterol precursors and depletion of ergosterol weaken membrane structure and function of fungal cells • Has activity against Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, and Mucorales such as Rhizopus oryzae and Mucormycetes species Dosage and administration

• Loading dose ——372 mg every 8 hours for six doses • Maintenance dose ——372 mg once daily starting 12-24 hours after the last loading dose • If administered orally, give two capsules; if administered intravenously, give one reconstituted vial • Isavuconazonium sulfate for injection must be administered through an in-line filter over a minimum of 1 hour • Take with or without food

• Pediatric ——Not established • Geriatric ——No dose adjustment of isavuconazonium sulfate is needed in elderly patients • Renal impairment ——No dose adjustment is needed in patients with mild, moderate, or severe renal impairment, including those with end-stage renal disease • Hepatic impairment ——No dose adjustment necessary in patients with mild or moderate hepatic impairment ——Should only be used in patients with severe impairment when benefits outweigh risks Contraindications

• Hypersensitivity to isavuconazonium sulfate • Coadministration with strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir • Coadministration with strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John’s wort, or long acting barbiturates • Use in patients with familial short QT syndrome

Specific populations

Cautions

• Pregnancy ——Pregnancy Category C ——May cause harm to the fetus • Nursing mothers ——Mothers should not breastfeed while taking this drug

• Hepatic adverse drug reactions ——Serious hepatic reactions have been reported ——Evaluate liver-related laboratory tests at the start and during course of isavuconazonium sulfate therapy Continues on page 36

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STAT CONSULT • Infusion-related reactions were reported during intravenous administration of isavuconazonium sulfate ——Discontinue infusion if these reactions occur • Hypersensitivity reactions ——Serious hypersensitivity and severe skin reactions, such as anaphylaxis or Stevens-Johnson syndrome, have been reported during treatment with other azole antifungal agents ——Discontinue isavuconazonium sulfate for exfoliative cutaneous reactions • Embryo-Fetal Toxicity ——Do not administer to pregnant women unless the benefit to the mother outweighs the risk to the fetus ——Inform pregnant patients of the hazard • Drug Interactions ——Review patient’s concomitant medications ——Several drugs may significantly alter isavuconazole concentrations • Drug Particulates ——Intravenous formulation may form insoluble particulates following reconstitution ——Administer isavuconazonium sulfate through inline filter Adverse effects

• Most common adverse reactions ——Back pain ——Constipation ——Cough ——Diarrhea ——Dyspnea ——Elevated liver chemistry tests ——Headache ——Hypokalemia ——Most common adverse reactions ——Nausea ——Peripheral edema ——Vomiting Drug interactions

• CYP3A4 inhibitors or inducers may alter the plasma concentrations of isavuconazole • Appropriate therapeutic drug monitoring and dose adjustment of immunosuppressants (ie, tacrolimus, sirolimus, and cyclosporine) may be necessary when co-administered with isavuconazonium sulfate • Drugs with a narrow therapeutic window that are P-gp substrates, such as digoxin, may require dose adjustment when administered concomitantly with isavuconazonium sulfate

What to tell your patient

• Isavuconazole is used to treat adults with certain types of fungal infections in the blood or body called aspergillosis and mucormycosis • This medication can be taken as capsules or administered intravenously • Do not take this medication if you are allergic to any of its ingredients, have familial short QT syndrome, or are taking any of the following medications ——Ketoconazole, high-dose ritonavir, rifampin, carbamazepine, St. John’s wort, long-acting barbiturates • Tell your nurse or doctor if you have any of these conditions ——An abnormal heart rate or rhythm ——Liver problems ——Ever had an allergic reaction to other antifungal medications ——Any other medical conditions • Isavuconazole capsules can be taken with or without food • You should swallow the capsule whole • Tell your nurse or doctor if you are pregnant or plan to become pregnant ——This medication should be used during pregnancy only if the potential benefit to the mother outweighs the risks to the fetus.

——If you become pregnant while taking this medication, tell your doctor • You should not breastfeed your baby while taking this medication.

• Isavuconazole may cause ——Changes in the level of a liver enzyme in your blood ——Constipation ——Cough ——Diarrhea ——Drug interactions with cyclosporine, sirolimus, or tacrolimus ——Headache ——Infusion reactions ——Liver problems ——Low potassium ——Nausea ——Severe allergic and skin reactions ——Shortness of breath ——Swelling of arms or legs ——Vomiting • Call your doctor or nurse if you experience any of these side effects, or any other side effects.

Prepared by Jason Hoffman, PharmD, RPh.

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RADIATION & YOUR PATIENT including explicitly informing the patient that the goal of palliative radiotherapy is to reduce symptoms, rather than curing his or her cancer.

©THINKSTOCK

P An evolving role emerges for palliative radiotherapy Bryant Furlow Palliative radiotherapy is a centerpiece of supportive cancer care, offering an effective tool in the management of pain and other symptoms associated with primary or metastatic tumors. As the number of cancer patients climbs with the aging of the Baby Boom generation, and as survival times improve among cancer patients, palliative radiotherapy will represent an increasingly important component of radiation oncology procedures. With advances in diagnostic imaging and conformal radiotherapy, palliative radiotherapy is evolving; outcomes can be quickly predicted and tumors can now be targeted to prevent symptoms before they emerge. The increasing complexity of palliative planning will require more communication and coordination among members of the cancer care team, and with patients,

alliative radiotherapy regimens afford patients rapid and potentially durable relief from pain and other neurologic symptoms, obstructions, and bleeding associated with incurable primary and metastatic tumors, with an emphasis on minimizing potential side effects.1-3 It is a cost-effective and relatively convenient treatment for relieving pain and other symptoms associated with metastatic tumors in bone, brain, and spinal tissues, for example. Palliative radiotherapy is a mainstay for palliation of bone metastases, which are the single most common cause of cancer pain that is frequently severe or intolerable.4 Although outcomes vary for different patients, the overall benefits of palliative radiotherapy are clear, and include improved quality of life (including lower rates of clinical depression) and even prolonged survival but not cure. 3,5,6 Palliative radiotherapy can help control or delay the growth of a tumor and thereby help manage or avoid quality-oflife-degrading symptoms, including pathologic bone fractures caused by metastatic tumor growth. Indications for palliative radiotherapy include pain associated with bone, brain, or visceral metastatic tumors, advanced primary tumor growth in any location, and tumor-associated spinal cord compression; brain tumor-associated neurologic symptoms such as memory and other cognitive impairments, seizures, headaches, motor-control deficits, and fatigue; symptoms of tumorassociated spinal cord compression;

tumor-associated bleeding; or cough or shortness of breath associated with tumor obstruction of airways or esophagus.1,4 Biliary and pancreatic duct obstructions may also be treated with palliative radiotherapy.1 With advances in conformal irradiation modalities and improved diagnostic imaging techniques, palliative radiotherapy is evolving from regimens that offer short-term relief from pain and other symptoms, to prevention or delayed onset of incurable tumors’ impacts to quality of life.1 With increased numbers of cancer diagnoses among aging Baby Boomers and improved survival times, growing numbers of patients will undergo palliative radiotherapy in the coming years. Most radiotherapy centers do not operate dedicated palliative radiation oncology programs, but some cancer centers have developed

Growing numbers of patients will undergo palliative radiotherapy. palliative radiotherapy teams or rapidpalliation radiation clinics to address this facet of supportive cancer care.2,3 These models of care require coordinated multidisciplinary patient management, including communication between palliative and radiotherapy care teams.1,2,7 PALLIATION MODELS Shorter, more conformal radiotherapy regimens have emerged in the research literature as preferred palliative

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 37

RADIATION & YOUR PATIENT approaches because they minimize the potential toxicity, and travel and scheduling burdens, imposed on patients by longer regimens.2 Unfortunately, however, a recent retrospective study of the National Cancer Database found that single-fraction palliative radiotherapy is still significantly underutilized in current clinical practice.8 Intensity-modulated radiotherapy (IMRT) and stereotactic radiotherapy (SRT) allow delivery of higher doses of radiation to target tumors while minimizing irradiation of healthy, nontarget tissues, reducing side effects while improving the potential for local tumor control.2 Radiosurgery has also emerged as an important advance for palliating metastatic brain tumors, whereas body SRT is proving valuable for palliating metastatic tumors in the spine.3,9 Fractionated whole-brain radiotherapy is still in widespread use for brain metastases, but single-fraction stereotactic radiosurgery techniques such as Gamma Knife appear to offer lower neurocognitive impairment rates and good local tumor control rates (exceeding 80% and 90%, respectively, for lung and breast cancer metastases).9 Radiosurgery is highly conformal, irradiating very little nontarget tumor tissue in the brain and, unlike wholebrain radiotherapy, allows repeated treatments when tumors emerge elsewhere in the brain.9 For small metastatic brain tumors (those smaller than 8 cc), there is excellent evidence that Gamma Knife is as effective as traditional surgical removal of brain metastases.9 Imaging may also help with early assessments of palliative radiation’s efficacy, and subsequent treatment planning. For example, a recent study found that post-palliative radiotherapy maximal standardized uptake value (SUVmax) on FDG-positron emission tomography (FDG-PET) imaging of

bone-metastatic lung cancer predicts both the severity of patient’s postintervention pain and local tumor control rates.10

3. Lutz S, Jones J, Chow E. Role of radiation therapy in palliative care of the patient with cancer. J Clin Oncol. 2014;32(26):2913-2919. doi:10.1200/jco.2014.55.1143.

4. Lutz S, Berk L, Chang E, et al; American

CONCLUSION

Society for Radiation Oncology (ASTRO).

Patients should be prepared ahead of treatment with clear descriptions of the radiotherapy modalities, fractionation schedule, goals, and potential complications or side effects involved in their treatment plans. Prior to, during, and following palliative radiotherapy, patients should be monitored for pain, breathing problems, nausea, and other symptoms. 2 Importantly, patients and their families should be explicitly told that the intent of palliative radiotherapy is to reduce a patient’s symptom burden, not to cure cancer; while this may seem obvious to clinicians, patients frequently misunderstand any intervention to have a curative goal.2 Patients should also be prepared for the fact that there may come a point at which palliative radiotherapy will offer no additional benefits and may be stopped. A recently published study found that among patients with breast, colorectal, and prostate cancer, palliative radiotherapy correlates with palliative chemotherapy, even in the last 2 weeks of life, “when treatment may cause increased treatment burden without improved quality of life.”11 ■

Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. Int J Radiat Oncol Biol Phys. 2011;79(4):965-976. doi:10.1016/j.ijrobp.2010.11.026.

5. Temel JS, Greer JA, Muzikansky A, et al.

Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363(8):733-742. doi:10.1056/ NEJMoa1000678.

6. Stavas MJ, Arneson KO, Ning MS, et al.

The refusal of palliative radiation in metastatic non-small-cell lung cancer and its prognostic implications [published online ahead of print January 13, 2015].

J Pain Symptom Manage. doi:10.1016/j. jpainsymman.2014.11.298.

7. Economou D. Palliative care needs of cancer survivors. Semin Oncol Nurs. 2014;30(4):262267. doi:10.1016/j.soncn.2014.08.008.

8. Rutter CE, Yu JB, Wilson LD, Park HS. Assessment of national practice for palliative radiation therapy for bone metastases suggests marked underutilization of singlefraction regimens in the United States. Int J Radiat Oncol Biol Phys. 2015;91(3):548-555. doi:10.1016/j.ijrobp.2014.10.045.

9. Lippitz B, Lindquist C, Paddick I, et al.

Stereotactic radiosurgery in the treatment of brain metastases: the current evidence. Cancer Treat Rev. 2014;40(1):48-59. doi:10.1016/j.ctrv.2013.05.002.

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

10. Zhao F, Ding G, Huang W, et al. FDG-PET predicts pain response and local control in palliative radiotherapy with or without systemic

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treatment in patients with bone metastasis

1. Sharma S, Hertan L, Jones J. Palliative radio-

from non-small-cell lung cancer [published

therapy: current status and future directions.

Semin Oncol. 2014;41(6):751-763. doi:10.1053/j. seminoncol.2014.09.021.

2. McMenamin E, Ross N, Jones J. Palliative

online ahead of print February 2, 2015]. Clin Lung Cancer. doi:10.1016/j.cllc.2015.01.005.

11. Kress MA, Jensen RE, Tsai HT, et al. Radiation therapy at the end of life: a population-

radiotherapy and oncology nursing. Semin

based study examining palliative treat-

Oncol Nurs. 2014;30(4):242-252. doi:10.1016/j.

ment intensity. Radiat Oncol. 2015;10(1):15.

soncn.2014.08.006.

doi:10.1186/s13014-014-0305-4.

38 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

COMMUNICATION CHALLENGES

Confirmation bias

©THINKSTOCK

Ann J. Brady, MSN, RN-BC

Nothing that had happened so far fit her idea of what lung cancer should look like, therefore, it could not be correct.

C

onfirmation bias is the tendency to search for, interpret, or recall information in a way that confirms one’s beliefs or hypotheses.1 In this age of racial unrest in Ferguson, New York, and Madison, all three locations recently in the news, I have read several newspaper editorials discussing the role of confirmation bias in what has happened. I was unfamiliar with the term but one editorial did an especially good job of explaining its meaning.

This column is understandably not a venue for discussing politics or profiling; however, when I read about confirmation bias I immediately thought of how the concept has an interesting application to patient education.

CASE I was discussing the overall goals of symptom management with my patient, Nancy, and her husband Mark before the start of radiation therapy. Nancy had a long history of smoking and was recently told she had an

advanced lung cancer. Surprisingly her main symptom was not shortness of breath or a persistent cough. Instead, it was a nagging pain in her lower back that she believed came from lifting a box a few weeks earlier.

After several weeks of resting her back, anti-inflammatory meds, and regular use of a heating pad with no improvement in her pain, she went to her primary doctor.

Two days later she was sitting in a medical oncologist’s office listening as she was told of her new diagnosis of lung cancer, and a few days after her initial diagnosis, she was having a consult for radiation therapy. That was when I first met her. Before she came in, I happened to run into her medical oncologist and he shook his head when he told me about her saying to him, “I don’t know how you can say I have lung cancer. I don’t feel sick. I strained my back, that’s all.” It was perhaps a classic case of denial, yet it was more than that: nothing that had happened so far fit her idea of what lung cancer should look like, therefore, it could not be correct.

Many of us working in oncology are familiar with denial. It is a reaction that causes a great deal of consternation for us caregivers.

It does not fit into a factually based account of a patient’s illness. It causes a paradoxical comfort and discomfort when we encounter it. Comfortable because we easily recognize it and uncomfortable because it is always a challenge to work with patients we believe are in denial. Though it is not a measurable symptom, it is a word that is easily tossed around. “Nancy is in denial.” Or, “The family in room 652 has a bad case of denial.

They keep asking when their mother is going to get better.” Or, a classic patient statement, “Once I get chemo, I’m going to be fine

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 39

COMMUNICATION CHALLENGES

Denial can coexist with hope. The road forward does not have to be a straight line; instead it can be like a game of hopscotch.

again.” But our willingness to label denial can lull us into thinking we know something about a patient that we do not truly know.

It can keep us from looking at what else is causing the reaction. We can have our own confirmation bias, taking patient or family behavior or statements as affirmation that what we are seeing is, in fact, denial. We somehow feel qualified to identify denial.

But should we?

How do we handle patients like Nancy and her husband Mark? In the clear face of a diagnosis of lung cancer, she clung to what she knew. In her mind, lung cancer manifested itself differently than how she presented. A diagnosis of lung cancer, in her mind, meant shortness of breath, a nagging cough, something more debilitating than her symptom of a sore back. Her confirmation bias kept her from seeing what we saw.

Nancy agreed to treatment, so on some level she accepted her diagnosis. Yet the oncologist and I were both disturbed at her resistance to accepting that after years of smoking, and in spite of her lack of symptoms, she did in fact have lung cancer. Was it enough if she agreed to treatment even while she held on to her skepticism? If we gave her more information about her cancer, would that lessen her denial? And the most difficult question of all is what the denial did for her.

Was it protective? Reactive? A product of true misinformation? And finally, as we tried to convert her to understand the diagnosis, were we actually confirming her bias?

JOIN THE CONVERSATION • Caring for patients who seem to be in denial is not uncommon.

How do you structure your care for a patient in denial?

• Is denial something you think you need to “fix”?

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WEB

Go to OncologyNurseAdvisor.com/challenges-denial to share how you manage interacting with patients who are in denial with your colleagues.

DISCUSSION This experience put me in mind of how we care for someone with an altered mental status. We instruct families to deal with the incessant questions of a confused patient by reorienting them. We tell them not to argue, to nod sympathetically as they tell them they are not in a hotel somewhere but that they are in the hospital. Yet denial in someone who is altered is more acceptable to us than someone clear-eyed and otherwise cognizant. How do we bridge the gap? How do we make it more comfortable all around? I’ll start by saying there is no clear path, nor is there a clear destination.

Denial can coexist with hope. The road forward does not have to be a straight line; instead it can be like a game of hopscotch.

A patient may jump forward to accepting treatment, back to disbelief, sideways as they pause to consider chemo or radiation.

In other words, there are many roads to the same destination. Many times we think as nurses and caregivers that we must keep our patients from taking any detours. Yet the opposite may be true. What we need to do is follow the detour the patient takes us on. We don’t have to force them into understanding their diagnosis the way we do. The communication challenge in this situation is to walk along beside our patients while supporting them and allowing them the room they need. It may sound like a cliché, but it is also sound, empathic care to go to where the patient is. Even if it isn’t where we think they should be.

Nancy finished her radiation and chemo without ever fully acknowledging her diagnosis. After all, as she said, “It just doesn’t feel like cancer.” ■ Ann Brady is the symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California REFERENCE 1. Nickerson RS. Confirmation bias: A ubiquitous phenomenon in many guises. Rev Gen Psychol.

1998;2(2):175-220.

40 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com

ISSUES IN CANCER SURVIVORSHIP

© THINKSTOCK

Vitamin D and prostate cancer: Higher intake improves active surveillance outcomes Bette Weinstein Kaplan

P

rostate cancer will affect 1 in 6 men. However, the disease will be fatal in only 1 in 36, due to its potential for slow growth.1 Urologists often monitor the slower, low-risk cases to determine which will evolve into more significant and aggressive disease. Instead of treating the disease in low-risk patients, they practice active surveillance. In an interview with Oncology Nurse Advisor, Bruce W. Hollis, PhD, professor of Pediatrics, Biochemistry, and Molecular Biology, and director of Pediatric Nutritional Sciences at the Medical University of South Carolina, explained, “The cure—meaning surgery or radiation— is probably worse than the disease, so they wait a year and then do another biopsy to see where the patient stands.”

THE PERFECT MODEL FOR RESEARCH

Prostate cancer’s characteristic latency makes it the perfect model for longitudinal research, and that is exactly what Hollis and his group conducted over an extended period of time. Their pilot study evaluated the effects of enhancing vitamin D status and the subsequent related changes in prostate cancer tumor progression in a significant number of subjects over 1 year. A secondary objective was to compare prostate gland changes from a molecular standpoint before and after

treatment with vitamin D3 for a period of 2 months for men who had chosen surgery over active surveillance. They presented their results at a meeting of the American Chemical Society in March 2015.2 THE STUDY The active surveillance arm of the study included 132 participants; mean age was 65.5 years. These men demonstrated a significant reduction of disease, as assessed via year-to-year prostate biopsy, compared with historical controls. However, prostatespecific antigen (PSA) levels showed no difference by treatment. Men who elected to undergo prostatectomy 2 months after biopsy and were treated with vitamin D3, demonstrated biochemical and molecular changes consistent with a decrease in inflammatory processes compared with men who did not receive vitamin D3.

After 1 year, more than half of the participants in the active surveillance group demonstrated improvement on the vitamin D regimen, as shown by a decreased number of positive cores at repeat biopsy. The group concluded that men with low-risk prostate cancer who are undergoing active surveillance might derive benef it from taking 4,000 IU of vitamin D3 per day, without experiencing side effects from the treatment.

A randomized trial is currently underway to further explore these observations. Hollis said that vitamin D is now widely used in the urology service at the Medical University of South Carolina, demonstrating how the studies have impacted clinical practice.

FINDING SIGNIFICANT TO BLACKS The researcher explained that the results are of particular importance to Black men for a number of reasons.

Compared with white men, Blacks have a higher incidence of prostate cancer. Comparatively, their disease is more aggressive, which leads to higher

“Vitamin D is not really a vitamin. It’s a prehormone that’s made in your body.” mortality rates. Hollis noted that Black men also exhibit a high prevalence for vitamin D deficiency.

“My colleagues and I think a lack of vitamin D is one of the reasons for health disparities among Black populations. This population has chronically low levels of vitamin D, and they suffer inappropriately from

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 41

ISSUES IN CANCER SURVIVORSHIP

many diseases because of it,” explained Hollis. “It’s a hard thing to prove, but if you look at the Physicians’ Health Study and you look at the Black physicians in there, it appears as though just being Black is a risk to your health. This community is more susceptible to cancers in general, to more aggressive cancers in particular, to more overall diseases—and no one knows why. It’s not because of a lack of medical treatment, because compared

The general population should get at least 4,000 IU of vitamin D daily. to others in the Physicians’ Health Study the Black physicians get at least the same or better medical care.”

Vitam in D enhances immune function, Hollis explains. Vitamin D has been studied in the treatment of breast cancer and colon cancer in addition to prostate cancer. He explained that one of the ways it probably acts is by reducing infl ammation, since it is known to

be an anti-inflammatory agent. For example, it lowers C-reactive protein (CRP). Breast cancer, colon cancer, and especially prostate cancer are linked to inf lammatory processes.

Vitamin D also causes cancer cells to enter into an apoptotic cascade.

RDA SHOULD BE 10× MORE Although the federal government recommends a daily amount of 400 IU of vitamin D, Hollis says, “That’s barely enough for an infant, let alone a full-grown person. Vitamin D is not really a vitamin. It’s a prehormone that’s made in your body. You just need sun exposure to start the cycle.

It’s a steroid hormone, like estrogen or testosterone. You can make 10,000 to 20,000 IU of vitamin D in 1 day of total body sun exposure. People in sun-enriched environments make a lot of vitamin D, and its level in their blood is quite high.2 “Different systems in the body require different amounts of vitamin D to reach a threshold. If you’re talking about bone disease, then you need very little vitamin D to make it right. And that’s where the problem lies, because everything is based on the small amount it takes for bone health and not the amount

it takes for all these other systems.

All the randomized studies have been based on skeletal trials; they have not been trials to prevent or treat cancer, autoimmune diseases, or inflammatory processes. What we get in our diets is usually enough to keep us from getting bone disease, but it’s not enough to keep us from getting these other diseases.”

A healthy blood level of vitamin D should be 50 to 70 ng/mL. Hollis concludes that to maintain this level, the general population should get at least 4,000 IU of vitamin D daily. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

REFERENCES 1. Marshall DT, Savage SJ, Garrett-Mayer E, et al. Vitamin D3 supplementation at 4000 international units per day for one year results in a decrease of positive cores at repeat biopsy in subjects with low-risk prostate cancer under active surveillance. J Clin Endocrinol Metab.

2012;97(7):2315-2324.

2. Hollis BW. Vitamin D in the prevention and

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treatment of cancer. Talk presented at: American Chemical Society 249th National Meeting & Exposition; March 22-26, 2015; Denver, CO.

THE TOTAL PATIENT

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Hospice program provides compassionate end-of-life care in a challenging environment Bette Weinstein Kaplan

T

hat the US prison system is filled beyond capacity is a wellknown fact. What may not be so well known is that an increasingly large number of prisoners are chronically ill, elderly, or aging. According to Jamie Fellner, writing in Human Rights Watch, the number of incarcerated men and women older than 65 years has more than doubled since 2007, from 15,500 to 31,854 in 2013.1 Although there was actually a reduction in the general federal and state penitentiary population, the number of incarcerated elderly keeps rising disproportionately.

Fellner writes, “US prisons increasingly resemble high-security nursing homes, as the number of aging inmates continues to soar … Many of these prisoners will be into their 70s, 80s, or even older before they have finished their sentences; some are serving life without parole.”1 MORE CASES OF CANCER

Compared with the community at large, there is more illness among a prison population, in a place where it is difficult to be ill. According to a recent report, prisoners have more infectious and chronic illnesses than the general population.2 There are more patients with more aggressive malignancies than seen outside. Studies have shown that the most common cancer among prison inmates is lung cancer,

attributable to the degree of smoking among inmates.3 Those prisoners who develop the disease are young and have an especially poor prognosis.4 However, not only male prisoners suffer more from cancer; incidence of cervical cancer is higher among incarcerated women than in the general population.5 In addition, there are more substance-related illnesses among prisoners, more psychiatric illnesses, and higher rates of dementia as well. As a

A vital part of the program is a peer-care model that trains inmates. result, health facilities in correctional institutions throughout the country must address the need for hospice and end-of-life care.2 The Louisiana State Penitentiary Prison Hospice Program is a long-running model of care that offers an effective solution. The facility, located in Angola, Louisiana, houses more than 5,000 male prisoners in various degrees of incarceration from minimum to super-maximum custody. The Louisiana correctional system has some of the country’s strictest

sentencing laws; many of its prisoners are serving life sentences and therefore growing old in prison.

INCORPORATING THE ESSENTIAL ELEMENTS OF HOSPICE

Founded in 1998, the hospice program has cared for more than 227 patients.

Two nurses (director and coordinator), physicians, a social worker, and several chaplains of different faiths staff the program. A vital part of the program is a peer-care model that trains inmate volunteers to deliver hands-on care to hospice patients. The success of this system relies on five key elements: patient-centered care, an inmate volunteer model, safety and security, shared values, and teamwork.2 Patient-centered care Although all clinicians are familiar with this standard, it has a different meaning when defining end-of-life care in a prison hospice situation. The definition comprises four central concepts that are self-explanatory: offer unconditional care, be responsive, form real relationships, and know your patient.2 Inmate volunteer model Highly trained inmate volunteers provide end-of-life care to their peers. They are assigned a case from admission on, offering a unique connection to the patient while supplementing the nurse by handling nonclinical bedside needs.

Continues on page 44

www.OncologyNurseAdvisor.com • MAY/JUNE 2015 • ONCOLOGY NURSE ADVISOR 43

THE TOTAL PATIENT These peer volunteers, who receive education in hospice care, clinical psychology, and spirituality, often apprentice with more experienced volunteers and mentors. They also speak at conferences and on radio. The volunteers take their roles seriously, as one explained: “That’s the whole point of not dying alone, knowing that somebody is there, that have to do that role [sic].’’2 Safety and security Although this is a hospice, it is still a prison. There are considerations regarding the safety of staff and volunteers, as well as the volunteers’ motives. Boundaries created by policies, procedures, and protocol must be maintained without becoming actual barriers to the functioning of the hospice. Of course, the safety of the patients, who are often bedridden, is a major concern as they are helpless and defenseless.2 Shared values Caring for a gravely ill person can be thankless and stressful in the best of circumstances; giving that level of care to someone who may have committed heinous crimes can be a very difficult task. This might

be impossible if the caregiver was without empathy and compassion, but the prison hospice encourages the volunteers to “do the right things for the right reasons” and be part of their community of caring. Each individual in that community commands respect, including the dying patient.2 Teamwork All the hospice program pa r t icipa nt s work together to achieve the goals of the program.

The interdisciplinary team includes physicians, nurses, social workers, and chaplains. The volunteers also work in a highly organized team. They hold team meetings with the hospice coordinator to discuss the program and patient care. They communicate with one another off the unit as well, ensuring continuity of care.2 The hospice program at Louisiana State Penitentiary is just one prison hospice program, and it is a very successful one. Unfortunately, given the state of our prison population, the necessity of creating many such programs throughout the US correctional system needs to be addressed stat. ■

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

REFERENCES 1. Fellner J. Dispatches: Ever more US prisoners growing old behind bars. Human Rights Watch web site. http://www.hrw.org/ news/2015/02/09/dispatches-ever-moreus-prisoners-growing-old-behind-bars.

Published February 9, 2015. Accessed April 17, 2015.

2. Cloyes KG, Rosenkranz SJ, Berry PH, et al.

Essential elements of an effective prison hospice program [published online ahead of print March 2, 2015]. Am J Hosp Palliat Care.

3. Binswanger IA, Carson EA, Krueger PM, et al.

Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis.

BMJ. 2014;349:g4542.

4. Carbonnaux M, Fossard G, Amzallag E, et al. Earlier onset and poor prognosis of lung cancer in imprisoned patients. Oncology.

2013;85(6):370-377.

5. Binswanger IA, Mueller S, Clark CB, Cropsey KL. Risk factors for cervical cancer in criminal justice settings. J Womens Health (Larchmt).

2011;20(12):1839-1845.

FROM

©THINKSTOCK

A

cancer diagnosis is diffi cult news to hear, but the news that a patient has lung cancer can be especially daunting. Stark statistics illustrate that more people die of lung cancers than any other cancer, with the disease killing three times more men than prostate cancer does each year, and more women than breast and ovarian cancers combined.

All cancer patients commonly suffer from a variety of psychosocial factors or deficits such as fear, anxiety, and financial stress; however, patients with lung cancer may suffer particularly acute loss of hope and stigmatization.

High levels of psychosocial stress can cause mental and/or physical health problems that can lead to a poorer quality of life for patients with lung cancer than for a patient managing a different disease at the same stage.

One factor often responsible for poorer outcomes for patients with lung cancer is that patients may experience strong feelings of stigmatization, as cigarette smoking is the cause of a majority of lung cancer cases. Of the approximately 157,000 people who die of lung cancer each year, 90% of the deaths among men and 80% of deaths among women are caused by smoking.1 Public awareness of the danger of smoking often leads to the misguided idea that patients with lung cancer brought their cancer on themselves.

As evidence of this, there are no standard rehabilitation protocols for patients who have had a lung removed, a deficit in care that one

FIND US ON

Unique challenges confront patients with lung cancer Andrew Chesler, LMSW

leading lung cancer expert (Mark D. Kris, MD, Memorial Sloan Kettering Cancer Center, personal communication, March 2015) surmises is due to discrimination against lung cancer patients.2 Psychosocial stresses, such as discrimination, may have a significant negative impact on the quality of life and daily living for patients, families, and caregivers.3 Patients with lung cancer may have smoked as a

way to cope with stress in the past, so helping them fi nd other ways to manage stress is important given that they will no longer have the option to continue smoking. Patients may be directed to the National Cancer Institute (NCI) toll-free Quitline, which can connect callers to their state’s services to get help quitting smoking (1-800-QUIT-NOW).

Most lung cancers are not diagnosed until the cancer has progressed to stage 4, so it is generally more helpful for patients to focus on being hopeful rather than on the details of the typical prognosis and statistics on outcomes and mortality that may be found on the Internet. Instead of looking only at long-term prospects or a return to full health as yardsticks for measuring treatment success, remind the patient to look for ways to live life as fully as possible.

Living in the moment can help control anxiety and feelings of despair.

Thinking about what can be accomplished or lived in the next few minutes or hours, such as an upcoming visit from a relative or friend, shifts thoughts to a pleasurable event rather than the frightening unknown of the more distant future.

Patients can be reminded that their loved ones draw strength from them, too, and that every moment that the patient spends with a spouse, sibling, child, or grandchild is valuable and a potential source of joy not only for them but also for their loved ones. In other words, there is always important sharing to be done, both from and

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FROM to the patient, even if a patient with lung cancer feels that he or she is in a diminished state.

Realistic planning can bolster hope and dignity. Thinking about how to help others, whether through offering support to other patients or helping loved ones plan for life without the

Determining a patient’s stress level will likely be helpful early in treatment. patient is meaningful, important work.

Putting one’s affairs in order, making sure a will is in place, may bring peace of mind. Support groups, relaxation training, antidepression or antianxiety medication, and individual or family counseling may be helpful.

Determining a patient’s stress level will likely be helpful early in treatment, or even at the time of diagnosis.

Mental health specialists—a social worker, psychologist, psychiatrist, or clergy—are often readily available in hospitals.

There are also several organizations that offer help and sources of information about treatment, financial support, and counseling for both patients and caregivers. A list of support groups in the United States is available from the Lung Cancer Alliance (www. lungcanceralliance.org). Lungcancer. org, a program of CancerCare, is a nonprofit organization that provides free, professional support including counseling, support groups, financial assistance, educational workshops, and publications to anyone coping with lung cancer. Navigatelungcancer.org offers guidance to patients and families with new diagnoses; for patients and families seeking information about

medical issues, the NCI website (www. cancer.gov/cancertopics/types/lung) is a good resource, with a dictionary of cancer terms, government publications, and help with finding clinical trials.

Patients who are searching for nontechnical books about dealing with the psychological effects of cancer would do well to read The Human Side of Cancer,

by Jimmie Holland and Sheldon Lewis, or Help Me Live, by Lori Hope. ■ Andrew Chesler is an oncology social worker at CancerCare.

REFERENCES 1. Lung cancer statistics. Centers for Disease Control and Prevention Web site. http:// www.cdc.gov/cancer/lung/statistics/.

Accessed April 3, 2015.

2. Adler NE, Page AEK, eds. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. Washington, DC: National Academies Press; 2008. http://www.ncbi.nlm.nih.gov/ books/NBK4011/?report. Accessed April 3, 2015.

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ASK A PHARMACIST

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care, and removes bacteria. There are not currently filters that remove viruses.

Not all IV medications should be administered through a filter, and others may require filters of a specific size.

The molecules of some medications may be too large to pass through a filter, or may otherwise bind to the filter and be removed. Thus, it is important to consult your institution’s policies for details on which medications require a filter.

Using a micron filter; purity of herbal supplements Why do some drugs need a micron filter? What is it filtering out? What harm could be caused by not using a filter?

—P. Manfresca, BSN

Filters for intravenous (IV) medication administration are used to remove contaminants from IV products. This filtration is intended to filter out particulate matter, bacteria, and air emboli, protecting the patient from phlebitis due to particulates or infection due to bacteria.

Filters are used with the IV administration of many medications. These filters may be contained within an IV line (in-line filter), and are available in a variety of sizes. A 5-micron filter removes large particles that may have been introduced during product preparation, such as glass particles from glass ampules. The 0.22-micron filter is one of the smallest used in patient

In the last few months, there has been much talk in the media regarding the purity of herbal supplements. How should one advise patients interested in using these products?

—Lisa A. Thompson, PharmD, BCOP

Herbal supplements are not closely regulated by the FDA due to the 1994 Dietary Supplement Health and Education Act. As a result of this, herbal products are not routinely tested for safety, efficacy, purity, or to verify that they contain the ingredients stated on the label.

A 2013 study showed that one-third of herbal products tested using DNA barcoding contained plants or other contaminants not listed on the label.1 Only 2 of 12 companies in this study had products without any contaminants or unlabeled substitutions or fillers. More recently, the New York State attorney general’s office tested herbal supplements sold at four major US retailers and found

that 4 of 5 supplements tested using DNA barcoding did not contain the herbs listed on their labels.2 Representatives from the supplement industry have argued against using this method of testing to verify ingredients; however as of this writing, results from alternate methods of testing performed by the industry have not yet been reported.

When speaking with patients about these products, it is important to advise patients of the potential risks of taking herbal supplements, such as potential interactions with their chemotherapy, their cancer, or other medications.

Patients should review all supplements with a health care provider before taking them during cancer treatment. The United States Pharmacopeia (USP) is an independent group that verifies that herbal supplement ingredients are present in stated amounts, so patients who wish to take these products should consider purchasing products with the USP seal on their labeling. ■ REFERENCES 1. Newmaster SG, Grguric M, Shanmughanandhan D, et al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Medicine.

2013;11:222.

2. O’Connor A. New York attorney general targets supplements at major retailers. New York Times. February 3, 2015. http://well. blogs.nytimes.com/2015/02/03/new-yorkattorney-general-targets-supplements-atmajor-retailers/?_r=0. Accessed April 2, 2015.

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

48 ONCOLOGY NURSE ADVISOR • MAY/JUNE 2015 • www.OncologyNurseAdvisor.com