December 2010, Vol 3, No 8 by Green Hill Healthcare Communications, LLC

deCeMber 2010

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VOL 3, NO 8

RESEARCH

CANCER CENTER PROFILE

Geisinger Medical Center’s Cancer Institute Joins the NCCCP By Dawn Lagrosa

Preferences of Cancer Patients in Multidisciplinary Clinics By Muhammad Janjua, MD1; D. Lee, RN1; Jamie L. Studts, PhD2; Goetz H. Kloecker, MD, MBA1 1University of Louisville, James Graham Brown Cancer Center, Division of Medical Oncology/Hematology, Louisville, Kentucky 2University of Louisville School of Medicine, University of Kentucky, Markey Cancer Center, Louisville, Kentucky

he diagnosis and treatment of cancer often involves many specialties. The current progress in cancer care has been dependent on the effective interaction of these specialties to facilitate the process in the many multidisciplinary clinics created during the past decade. These clinics help the

patient get the best possible treatment decision in the timeliest fashion. After the decision is made based on review and consensus by the different specialties, the patient gets support to navigate the system. Many of these clinics have nurses working as coordinators, who gather all the medical records, schedule appointContinued on page 18

MODELS OF CARE Mammography technologist Jessica Davis, RT(R) (M), is part of a multidisciplinary breast cancer care team working to improve access to screening, treatment, and research.

his past April, Geisinger Medical Center’s (GMC) Cancer Institute became one of 14 sites added to the National Cancer Institute Community Cancer Centers Program (NCCCP). Joining this national network of community cancer centers offers GMC the opportunity to expand its state-of-the-art cancer care and research in northeast Pennsylvania. GMC is a part of Geisinger Health System (Geisinger), which serves a mostly rural population and has cancer centers in Danville, WilkesBarre, State College, and Hazleton. Geisinger takes pride in its innovative approach to healthcare delivery to this population, which also includes many elderly patients. In addition, a significant portion is underserved because of socioeconomic status and transportation problems. Thanjavur Ravikumar, MD, FACS, director of the Center for Surgical Innovation, and co-chair of the oncology service line at Geisinger’s Cancer Institute, believes that serving this mix of patients marries wells with the NCCCP’s mission of reducing cancer healthcare

Comanagement Offers Long-term Alignment for Physicians and Hospitals By Eileen Koutnik-Fotopoulos

he changing healthcare environment is forcing physicians and hospitals to rethink the delivery of patient care. Structuring partnerships between physicians and hospitals is critical in today’s healthcare climate as more initiatives focus on metrics for quality performance. One effective physician–hospital model built around integration, alignment, and engagement of physicians is comanagement agreements. A growing number of

hospitals are entering into comanagement arrangements with physician groups to manage key service lines, such as cancer. The structure of comanagement agreements varies depending on the duties and scope of the agreement; however, physicians and hospitals are committed to finding strategies to deliver cost-effective healthcare that benefits patients and improves quality across the continuum of care. “Quality and performance in health-

Continued on page 20

Inside Multidisciplinary Tumor Board Case Study Treatment of Metastatic Gastrointestinal Stromal Tumor page 4

Healthcare Design Infusion of Design with Evidence page 8

ESMO Prompt Pain Relief for Compression Fractures Cell Cycle Expression Proﬁle Oﬀers Prognostic Data page 12

Continued on page 16

Oncology Drug Codes Medications Used for the Treatment of Multiple Myeloma and Myelodysplastic Syndromes page 22

Fostering a Dialogue to Improve Patient Care & Outcomes

Submit your cases online today at www.myelomacases.com

REALIGNING REIMBURSEMENT. REWARDING QUALITY CARE.

More than 1,000 leading oncologists agree: Itâ&#x20AC;&#x2122;s time for reimbursement to change. The entire United Network of US Oncology is working to realign reimbursement policies to recognize high-quality care. Join us as we collaborate with like-minded insurers and policymakers, and be a part of the future for community-based oncology. To learn more about the United Network of US Oncology, visit usoncology.com/MCC

Editorial Board EDITOR-IN-CHIEF

Mark J. Krasna, MD St. Joseph Cancer Institute Towson, MD Surgical Oncology

Scott E. Eggener, MD University of Chicago Chicago, IL Surgical Oncology

Arun Kumar, MD

Greg Pilat, MBA

VA Medical Center Huntington, WV Medical Oncology

Advocate Health Care Oak Brook, IL Oncology Administration

Shaji K. Kumar, MD

Cristi Radford, MS, CGC

Mayo Clinic Rochester, MN Hematology-Oncology

Sarasota Memorial Hospital Sarasota, FL Genetic Counseling

Ritu Salani, MD

John F. Aforismo, BSc Pharm, RPh, FASCP

Beth Faiman, RN, MSN, APRN, BC, AOCN

RJ Health Systems International Wethersfield, CT Oncology Pharmacy

Cleveland Clinic Taussig Cancer Institute Mayfield Heights, OH Oncology Nursing

Elizabeth Bilotti, RN, MSN, APNc

Mehra Golshan, MD

Terry Macarol, RT(R)(M)(QM)

John Theuer Cancer Center Hackensack University Medical Center Hackensack, NJ Oncology Nursing

Dana-Farber Cancer Institute Boston, MA Surgical Oncology

Advocate Health Care Oak Brook, IL Radiological Technology

Ohio State University Medical Center Columbus, OH Medical Oncology

Nicole A. Bradshaw, MS, CIC

Patrick A. Grusenmeyer, ScD, FACHE

Patrick Medina, PharmD, BCOP

Andrew Salner, MD

Mountain States Tumor Institute Nampa, ID Oncology Administration

Christiana Care Health System Newark, DE Oncology Administration

Oklahoma University College of Pharmacy Oklahoma City, OK Oncology Pharmacy

Hartford Radiation Oncologists Association Hartford, CT Radiation Oncology

Anna M. Butturini, MD

Marilyn Haas, PhD, CNS, ANP-BC

Patricia Molinelli, MS, RN, APN-C, AOCNS

Timothy G. Tyler, PharmD, FCSHP

CarePartners Asheville, NC Oncology Nursing

Somerset Medical Center Somerville, NJ Oncology Nursing

Comprehensive Cancer Center Desert Regional Medical Center Palm Springs, CA Oncology Pharmacy

Dawn Holcombe, MBA, FACMPE, ACHE

Judy A. Olson, RT(R), RDMS

Gary C. Yee, PharmD, FCCP, BCOP

Children’s Hospital Los Angeles Los Angeles, CA Medical Oncology

Minsig Choi, MD G. V. Montgomery VA Medical Center Jackson, MS Medical Oncology

Steven L. D’Amato, RPh, BCOP Maine Center for Cancer Medicine Scarborough, ME Oncology Pharmacy

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DGH Consulting South Windsor, CT Oncology Administration

Patricia Hughes, RN, MSN, BSN, OCN Piedmont Healthcare Atlanta, GA Oncology Nursing

St. Luke’s Mountain States Tumor Institute Boise, ID Oncology Administration

University of Nebraska Medical Center Omaha, NE Oncology Pharmacy

Nicholas Petrelli, MD

Burt Zweigenhaft, BS

Helen F. Graham Cancer Center Christiana Care Health System Newark, DE Surgical Oncology

BioPharma Partners LLC New York, NY Managed Care

december 2010 I VoL 3, No 8

INTRODUCTION

PUBLISHING STAFF Publisher Philip Pawelko phil@greenhillhc.com Editorial Director Karen Rosenberg karen@greenhillhc.com Managing Editor Dawn Lagrosa dawn@greenhillhc.com Directors, Client Services John W. Hennessy john@greenhillhc.com Cristopher Pires cris@greenhillhc.com Production Manager Marie RS Borrelli Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Andrea Boylston Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732-992-1891 Fax: 732-656-7938

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Journal of Multidisciplinary Cancer Care® (ISSN # 19490321) is published 8 times a year by Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2010 by Green Hill Healthcare Communications, LLC. All rights reserved. Journal of Multidisciplinary Cancer Care® is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, Journal of Multidisciplinary Cancer Care®, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. E-mail: karen@greenhill hc.com YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. The ideas and opinions expressed in Journal of Multidisciplinary Cancer Care® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in Journal of Multidisciplinary Cancer Care® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.

december 2010 I VoL 3, No 8

his past month, we learned the results of the National Lung Screening Trial. This is the first time we have clear data on the benefit of lung cancer screening in high-risk populations—20% fewer lung cancer deaths among trial participants (current and former heavy smokers) screened with low-dose helical computMark J. Krasna, MD ed tomography compared with ST. JOSEPH CANCER chest x-ray. As exciting as these results INSTITUTE are, much remains to be done: Editor-in-Chief the investigators need to comprehensively analyze their data, major clinical societies need to study the results and determine whether guideline changes should be made, and Medicare and other payers need to make coverage decisions regarding their high-risk enrollees. Hopefully, all these aspects will come together and we will see a significant decline in lung cancer deaths in the future. We will need to work together to make this and other improvements in cancer care a reality. Our profile on Geisinger Cancer Institute shows how working together can bring about innovation and discovery. Or as the institute’s chair of the oncology service line, Dr Thanjavur Ravikumar,

CONTENTS

puts it, “We will basically learn from each other.” The multidisciplinary tumor board case study also highlights the benefits of teamwork and integrating new data and guidelines into patient care. The case presented provides insight into how the team from the Oregon Health and Science University Knight Cancer Institute used the National Comprehensive Cancer Network Task Force Report, Update on the Management of Patients with Gastrointestinal Stromal Tumors, in prospectively discussing their patient and his cancer’s genotype. The research by Janjua and colleagues details how this teamwork is viewed by our patients. The patients surveyed believed that healthcare professionals working together provided them with the most comprehensive treatment plan and the most complete explanations of their disease. This research, unfortunately, also sheds light on the lack of data on the improvement of medical outcomes with multidisciplinary care—a limitation that has just been overcome. This November, Gomella and colleagues at Kimmel Cancer Center at Jefferson University in Philadelphia were the first to publish data showing that a multidisciplinary approach to aggressive prostate cancer can improve survival. This 15-year study found that 10-year survival approaches 100% in stage I and II prostate cancer. Again, I hope this issue of Journal of Multidisciplinary Cancer Care benefits your practice and provides ideas on how to move it forward. l

december 2010 • VoL 3, No 8

FEATURE ARTICLES 4 Multidisciplinary Tumor Board Case Study Treatment of metastatic gastrointestinal stromal tumor: a multidisciplinary approach 8 Healthcare Design Infusion of design with evidence 12 Conference News Prompt pain relief for compression fractures with balloon kyphoplasty Cell cycle expression profile offers prognostic data for prostate cancer 17 Lung Cancer Low-dose CT screening found to reduce lung cancer deaths in large study DEPARTMENTS 3 recent FdA Approvals 20 News Note 22 Oncology drug Codes Medications used for the treatment of hematologic cancers

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Recent FDA Approvals Trastuzumab for Her2-positive Metastatic Stomach Cancer The US Food and Drug Administration (FDA) has approved trastuzumab (Herceptin, Roche) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil) for human epidermal growth factor receptor type 2 (HER2)-positive metastatic cancer of the stomach or gastroesophageal junction in patients who have not received prior medicines for their metastatic disease. Approval was based on results of a phase 3 study (ToGA), which showed that patients who received trastuzumab plus chemotherapy had improved overall survival (HR, 0.73; 95% CI, 0.600.91; P = .0038). Median overall survival was 13.5 months for patients on combination therapy compared with 11 months for those on chemotherapy alone. An analysis based on an additional year of follow-up showed the numbers to be slightly lower (HR, 0.80; 95% CI, 0.67-0.97; P = .02; median overall survival, 13.1 vs 11.7 months). IHC and FISH Assays for detection of Her2-positive Metastatic Stomach Cancer The FDA has expanded approval for two diagnostic tests (HercepTest and HER2 FISH pharmDx Kit, Dako) to include patients with metastatic gastric or gastroesophageal junction adenocarcinomas (stomach cancer) in whom trastuzumab is being considered as treatment. HercepTest is an immunohistochemistry (IHC) assay used to identify patients with human epidermal growth factor receptor type 2 (HER2)-positive cancers. HER2 FISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification. Approval was granted in conjunction with the FDA’s approval of trastuzumab in combination with chemotherapy for HER2-positive metastatic cancer of the stomach or gastroesophageal l junction in patients who have not received prior medicines for their metastatic disease. eribulin for Late-stage refractory breast Cancer The FDA has approved eribulin mesylate (Halaven, Eisai) to treat patients with metastatic breast cancer who have received at least two previous chemotherapy regimens for late-stage disease. Approval was based on a single study of 762 patients who were randomized to either treatment with eribulin or another single-agent therapy chosen by their oncologist. Patients had metastatic breast cancer for which they had previous anthracycline- and taxanebased chemotherapy for late-stage disease. Median overall survival was 13.1

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months for patients receiving eribulin compared with 10.6 months for the controls. Eribulin, a synthetic form of a chemotherapeutically active compound derived from sea sponge, is a microtubule inhibitor believed to inhibit cancer cell growth. Side effects reported include

neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, peripheral neuropathy, and constipation. radiofrequency Ablation System for Metastatic Spinal Lesions The FDA has awarded 510(k) clearance to a new platform extension (RFA

system, Dfine) indicated for the palliative treatment of vertebral body lesions where metastatic disease has spread to the spine causing severe pain and discomfort. This system consists of a percutaneous radiofrequency ablation (RFA) device that provides localized tumor necrosis. l

with dedicated Amgen Reimbursement Counselors There is A place you can go for user-friendly online tools and reimbursement forms… …where your coverage questions can be Answered …where online Access to forms is simple …where you can talk to A single Amgen Reimbursement Counselor for all your reimbursement activity

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For insurance verification…prior authorization…patient assistance program information…billing and claims processing support…and appeals support. Amgen Assist™ and Amgen Inc. do not guarantee success in obtaining reimbursement. Third party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by our Amgen Assist™ staff. ©Amgen. All rights reserved. MC48319-B 06/10

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december 2010 I VoL 3, No 8

Multidisciplinary Tumor Board Case Study

Treatment of Metastatic Gastrointestinal Stromal Tumor: A Multidisciplinary Approach By Lindsay C. Overton, MD1,2; Joseph Bubalo, PharmD, BCPS, BCOP2; Anne C. Kratz, RN, BSN, OCN2; Michael C. Heinrich, MD, FACP1,2 1

Division of Hematology and Medical Oncology, Portland VA Medical Center; 2Division of Hematology and Medical Oncology, Oregon Health and Science University Knight Cancer Institute, Portland, Oregon

Case Presentation Chief complaint: Abdominal pain and weight loss for 3 months. History of present illness: A 53-year-old white man with a history of hyperlipidemia treated with atorvastatin originally presented in 2007 to the emergency department with worsening constipation, abdominal pain, and a 20-lb weight loss. Given concerns about diverticular disease or colon cancer, computed tomography (CT) imaging was done that showed a 6-cm small bowel mass with evidence of partial small bowel obstruction. No other masses were visible on CT imaging. The patient underwent surgical resection. Pathology revealed a gastrointestinal stromal tumor (GIST) with spindle cell morphology, dimensions of 6 cm x 4 cm x 3 cm with 12 mitotic figures per 50 high power fields. Given the primary site, tumor size, and mitotic rate, the patient was believed to have an 85% risk of recurrent disease. At the time of his diagnosis, there were no published data regarding adjuvant therapy, and the patient was monitored clinically for recurrence. Three years after resection, the patient presented to his primary care provider with abdominal bloating and fatigue. Laboratory tests revealed worsening iron deficiency anemia. Repeat CT scan showed multiple peritoneal implants; the largest measured 2 cm x 2 cm. A CT-guided biopsy was performed, with pathology consistent with GIST. At that time, mutational testing was performed on the patient’s original surgical tumor specimen, which showed a KIT exon 9 mutation.

He was started on standard-dose imatinib (400 mg/day), and then after 1 month of treatment, his imatinib dose was increased to 400 mg twice daily. Given the interaction between imatinib and atorvastatin, the patient was changed to pravastatin. In addition, the patient was advised to discontinue use of St. John’s wort. The patient was also treated for iron deficiency anemia. Six months later, repeat CT imaging showed decreased size of all peritoneal masses, the largest now 1.0 cm x 0.8 cm. Medical history: Hyperlipidemia; mild depression treated with St. John’s wort. Surgical history: Tonsillectomy, 1965; small bowel resection, 2007. Family history: Mother: 75 years old with diabetes and hypertension. Father: deceased at age 45 in motor vehicle accident. Paternal uncle: colon cancer at 72. No other family history of cancer. Social history: Patient is divorced with two grown children. He works as a foreman at a construction site. He quit smoking 30 years ago, with a 10 packyear history. He drinks 1 to 2 drinks per week and occasionally smokes marijuana. Medications: Pravastatin, 40 mg by mouth daily; aspirin, 81 mg by mouth daily; daily multivitamin. Allergies: Penicillin causes hives.

Physicians’ perspective of patients who are intolerGastrointestinal stromal ant of imatinib or whose tumor (GIST) is the most disease has progressed on common sarcoma arising in imatinib therapy. A number the abdominal cavity. GIST of other TKIs have been usually arises from the mustested in the third-line or cular wall of the stomach, later clinical setting in but can arise in the small or phase 2 clinical trials. Overlarge intestine (including all, the prognosis for the rectum). In the United patients with metastatic States, there are an estimat- Lindsay C. Overton, MD GIST has markedly imed 4000 to 6000 new cases proved over the past diagnosed annually.1 Before decade, with median sur2000, there was no active vival increasing from an medical treatment for metestimated 1 to 1.5 years to astatic GIST.2 As will be the current 4 to 5 years.3-5 A landmark study by discussed, the introduction Hirota and colleagues in of small-molecule tyrosine 1998 reported that most kinase inhibitors (TKIs) has GISTs (~80%) harbored a revolutionized the treatgain of function mutation ment of GIST. Currently, there are two US Food and Michael C. Heinrich, MD, in the KIT receptor tyrosine kinase (Figure).6 ApproxDrug Administration (FDA)FACP imately 8% of GISTs have approved treatments for advanced GIST: imatinib for first-line an activating mutation of the homolotreatment, and sunitinib for treatment gous platelet-derived growth factor

december 2010 I VoL 3, No 8

Physical examination: General: Overweight man who appears older than stated age, well groomed in no acute distress. Vital signs: Temperature: 98.1°F; heart rate: 93 bpm; blood pressure: 134/86 mm Hg; oxygen saturation: 98% on room air; height: 70 inches; weight: 100 kg. Head, ears, eyes, nose, throat: Pupils equal, round, reactive to light; conjunctiva pale, no sclera icterus; mucous membranes moist. Neck: Soft, supple; no appreciated jugular venous distension; no cervical, supraclavicular or infraclavicular lymphadenopathy. Respiratory: Clear to auscultation bilaterally; no wheezing, rhonchi, or rales. Cardiovascular: Regular rate and rhythm; no murmur, rubs, or gallops noted. Abdomen: Well-healed midline laparotomy scar noted; normoactive bowel sounds; distended abdomen; no fluid wave appreciated; no tenderness to palpation noted. Extremities: Trace bilateral edema to ankles. Laboratory values: White blood cell: 3.2 K/cu mm; hemoglobin: 10.3 g/dL; hematocrit: 30.1%; platelet count: 200K/cu mm; segmented neutrophils: 63%; lymphocytes: 30%; eosinophils: 2%; basophils: 1%; monocytes: 4%; sodium: 144 mmol/L; potassium: 4.1 mmol/L; chloride: 104 mmol/L; carbon dioxide: 26 mmol/L; blood urea nitrogen: 20 mg/dL; creatinine: 1.1 mg/dL; glucose: 95 mg/dL; ferritin: 21 ng/mL

receptor-alpha (PDGFRα) tyrosine kinase.7 Ten to fifteen percent of adult GISTs lack mutations of KIT or PDGFRα and are referred to as wildtype GIST.1 Shortly thereafter, in vitro data demonstrated the potency of the small-molecule kinase inhibitor imatinib (formerly STI-571) against mutant and wild-type KIT kinases.8 These studies led to the hypothesis that imatinib might be active against advanced GIST. In 2000, imatinib was used on a compassionate basis to treat one patient with metastatic GIST.9 Notably, this patient had a remarkable clinical and imaging response to treatment, leading to further testing in phase 2 studies.10,11 In the pivotal phase 2 study (B2222) leading to FDA approval of imatinib for treatment of GIST, 147 patients were treated in a multicenter study, with 82% of patients having partial response or stable disease.10 Similarly, the European Organisation for Research and Treatment of Cancer (EORTC) phase 1/2 study reported an

overall response rate of 68.1%.12 During the phase 2 studies, various imatinib dosing regimens were used, varying from 400 mg daily to 1000 mg daily. Based on these studies, 800 mg total daily dose was established as the maximally tolerated dose. Parallel phase 3 trials were performed to determine the optimal imatinib dose for treatment of metastatic GIST. Both the EORTC/ Italian/Australasian and the Southwest Oncology Group (SWOG)/National Cancer Institute (NCI) Canada studies compared 400 mg/day with 800 mg/day as the target imatinib dose. The results of these studies have been published separately.5,13 Notably, these two studies were intentionally designed to be evaluated in a meta-analysis (known as MetaGIST), involving a total of 1640 patients. The MetaGIST study found a small but significant progression-free survival (PFS) advantage for patients treated in the high-dose arm (hazard ratio [HR], 0.89; P = .04). No difference was observed between the two arms for

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Multidisciplinary Tumor Board Case Study

overall survival (OS; HR, 1.00; P = .97) or objective response.3 Translational studies using tumor samples from these clinical studies have identified tumor genotype as a strong predictor of clinical benefit for patients with metastatic GIST treated with imatinib. Specifically, patients whose tumor harbors a KIT exon 11 mutation (~70% of GIST) have the highest rates of objective response, PFS, and OS compared with patients whose tumors had no kinase mutations (wild-type GIST, approximately 10%-15% of GIST) or GIST with somatic KIT exon 9 mutations (~10% of patients).14 In the SWOG/NCI Canada study, PFS for these three groups was 24.7 months for KIT exon 11–mutant tumors compared with 16.7 months for wild-type GIST and 12.8 months for patients with KIT exon 9–mutant tumors. In terms of the effect on OS, KIT exon 11–mutant GIST patients had a median OS of 60 months compared with 38.4 months for wild-type GIST patients and 49 months for KIT exon 9–mutant GIST patients.15 The effect of tumor genotype and imatinib dose on clinical outcomes also was analyzed in the MetaGIST study. Within patients in KIT exon 9–mutant GIST, PFS was significantly longer for patients treated in the high-dose arm (P = .017). For patients whose tumor had a different genotype, no difference was observed between treatment arms. In terms of OS, there was a trend toward a survival advantage for patients with KIT exon 9– mutant GIST treated with high-dose therapy (P = .15).3 Overall, imatinib has revolutionized the treatment of GIST, as it has for treatment of chronic myeloid leukemia (CML). For most patients, imatinib 400 mg once daily is the optimal dose (Figure). However, in patients with KIT exon 9–mutant tumors, data support a target dose of 400 mg twice daily. These dosing recommendations have recently been incorporated into the National Comprehensive Cancer Network clinical practice guidelines for GIST.16 Based on these guidelines, our patient was started on imatinib 400 mg once daily to assess drug tolerance and then underwent dose escalation to 400 mg twice daily after his first month of therapy. At the time when this patient underwent surgical resection of his primary tumor, there were no data regarding adjuvant therapy with imatinib. Consequently, this patient was monitored for recurrence. However, risk analysis of his tumor (based on size, origin, and mitotic rate) indicated that he had a greater than 85% chance of recurrence.17 It was not until 2009 that data regarding the adjuvant use of imatinib

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were published by DeMatteo and colleagues.18 This study showed that adjuvant therapy with imatinib prolonged PFS after 1 year of therapy. Currently, patients with intermediate- or high-risk resected primary GIST should be considered for treatment with at least 1 year of adjuvant imatinib.16 Notable findings in this patient were iron deficiency and anemia. Iron deficiency is a common finding in GIST patients and usually a consequence of bleeding from the primary tumor. The patient’s anemia is likely due to his iron deficiency, although an element of anemia of chronic disease and/or imatinibinduced myelosuppression also could exist. It is important to recognize and treat iron deficiency in GIST patients, as anemia is a common side effect of imatinib treatment. Patients with metastatic GIST and uncorrected iron deficiency anemia may experience severe anemia and fatigue during imatinib treatment. It is important to recognize that oral iron replacement may not be effective in patients with previous total/subtotal gastrectomy or patients treated with proton pump inhibitors, because an acidic environment is required for iron absorption. Nurse’s perspective The initial visit to an oncologist can be a stressful experience. Hearing about one’s cancer diagnosis, assimilating prognosis, treatment plans, and follow-up care can be emotionally overwhelming. Timing of the first appointment is critical to the start of treatment but the patient

Patients should have easy written access to the clinic phone number to report all side effects and receive reliable phone triage of their symptoms and reported side effects of therapy. —Anne C. Kratz, RN, BSN, OCN may still be in shock. This shock can be lessened by the oncology nurse special-

Imatinib 400 mg/day Imatinib 800 mg/day

Exon 9 (10%) Exon 11 (70%) Exon 13 (2%) Exon 17 (1%) Representation of the KIT protein with the location and approximate frequencies of KIT mutations in GIST. Dosing recommendations based on the site of KIT mutation are shown (green boxes 400 mg once daily, red boxes 400 mg given twice daily).1,2 Dosing recommendations for other tumor genotypes as are as follows: (1) patients with wild-type GIST (no mutation of KIT or PDGFRα) genes should be treated with 400 mg/day of imatinib; (2) patients with mutations of exon 12 or 14 of PDGFRα should be treated with 400 mg/day; (3) patients with mutations of exon 18 of PDGFRα should be considered for treatment with 400 mg twice daily, but expert consultation is advised for this uncommon GIST subtype. references 1. Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28:1247-1253. 2. Demetri GD, von Mehren M, Antonescu CR, et al. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010;8(suppl 2):S1-S41. Figure. Dosing Recommendations for KIT-mutant GIST Based on Tumor Genotype

ist. The oncology nurse should assess the patient and care partner’s learning style and educational needs in order to offer appropriate information related to the disease process and treatment plan. If the treatment plan contains oral targeted cancer treatment such as imatinib, the nurse hopes to instill trust and empower the patient to be an active partner in the treatment of their disease. Patients should have easy written access to the clinic phone number to report all side effects and receive reliable phone triage of their symptoms and reported side effects of therapy. The patient’s imatinib prescription will be written by the physician. An important role of the oncology nurse is to help guide the patient through the maze of insurance authorizations, copays, mail-order pharmacies, and patient-assistance programs. Again, this partnership with the patient instills trust and opens the patient to active participation in his or her care. Medication adherence strategies are very important with imatinib and other oral agents, because the patient is responsible for his or her own therapy. Skipped doses, patient drug holidays, or simple forgetfulness can all result in suboptimal clinical outcomes, such as loss of tumor response and/or decreased duration of response. Although not as well studied in GIST, patient noncompliance during imatinib treatment of CML has been shown to be a common problem. For example, Wu and colleagues estimated average imatinib medication

compliance to be only 79% during a 6year study of 592 patients. Imatinib noncompliance in CML patients is associated with higher overall healthcare costs and less favorable treatment results.19 Health literacy screening at the onset of therapy and ongoing follow-up is necessary to remove any barriers the patient may have to achieving good medication adherence. Nurses can provide practical tools such as calendars, electronic reminders, and enlisting phone calls from family and friends to ensure adherence to the treatment regimen. By enlisting patients as partners, the oncology nurse, in partnership with the oncology pharmacist, hopes to empower them to learn, question, and report side effects. Each patient should have a planned drug supply (these are expensive medications), guidance for managing side effects, a list of which side effects require prompt follow-up, phone numbers to call, and a plan to integrate this medication into everyday life to improve patient quality of life and to maintain lifestyle expectations. A patient taking imatinib may experience myriad side effects or none at all.20 Drug side effects can make a patient feel unsure and vulnerable with continuing the treatment plan. Upfront education about side effects and a partnership between the physician/patient/ nurse/pharmacist to manage these effects empowers the patient to report and comply with side-effect management strategies. Common side effects in Continued on page 6

december 2010 I VoL 3, No 8

Multidisciplinary Tumor Board Case Study Treatment of Metastatic Gastrointestinal Stromal Tumor... continued from page 5 Table

Clinically Significant Inducing or Inhibiting Medications and Probable or Known Natural Productsa

CYP3A4 inducers

CYP3A4 inhibitors

Carbamazepine Dexamethasone Fosphenytoin Nevirapine Oxcarbazepine Phenobarbitol Phenytoin Primidone Rifabutin Rifampin

Amprenavir Atazanavir Clarithromycin Erythromycin Indinavir Itraconazole Ketoconazole Nefazodone Nelfinavir Posaconazole Ritonavir Saquinavir Telithromycin Voriconazole

CYP3A4 inducing supplements Gingko Grape seed extract Guggul Quercetin St. John’s wort

CYP3A4 inhibiting supplements American elder Berberine Bishop’s weed Bitter orange Cat’s claw Devil’s claw Dehydroepiandrosterone Echinacea Eucalyptus oil Feverfew Garlic

German chamomile Goldenseal Goldthread Grapefruit juice Kava kava Pomegranate Red clover Schisandra Star fruit Valerian Wild cherry

Common CYP3A4 substrates Alprazolam Amiodarone Atorvastatin Buspirone Citalopram Cyclosporine Felodipine Lovastatin Simvastatin Sirolimus Tacrolimus Triazolam CYP2C9 Warfarin

This is not a comprehensive listing. Readers are advised to carefully consult additional references when checking for potential drug–drug interactions between imatinib and other medicinal or natural products.

Sources: References 22 and 23.

which the GIST patient receiving imatinib should be counseled on and given management strategies for include gastric irritation with nausea and vomiting and, although rare, gastrointestinal hemorrhage, edema, electrolyte imbalances (especially potassium and magnesium), rashes, alopecia, hepatotoxicity, and liver function test abnormalities. Gastrointestinal side effects can be managed by dosing with food or judicious use of antiemetics, electrolytes with oral supplementation, and edema with salt and fluid management strategies. Rashes often respond to topical corticosteroid or moisturizing creams but should be followed closely as severe bullous reactions (including erythema multiforme and Stevens-Johnson syndrome) have occurred with imatinib. The oncology care team should encourage patients to report side effects and the effectiveness of supportive care interventions to ensure continued adherence to imatinib therapy.20 Imatinib can also cause bone marrow suppression or have adverse effects on liver enzymes. Patients should expect frequent lab draws to monitor blood counts and liver tests. The nurse should be a partner in explaining the blood test results and the meaning of the values to help patients understand this complex assessment tool. As will be discussed, patients should understand that oral targeted therapies may interact with other medications they are taking. Patients should be encouraged to disclose all their prescribed and complementary medications. As partners in therapy, patients should know that becoming pregnant or

december 2010 I VoL 3, No 8

fathering a child while taking imatinib is not advised. Open discussion of sexuality is always encouraged. The management of patients being treated for GIST is complicated and requires a multidisciplinary approach. The role of the nurse is pivotal in patient education, side-effect management, and ongoing patient support.

study in 12 healthy volunteers, those taking St. John’s wort had a 43% reduction in the imatinib area under the curve (AUC) from baseline.24 This magnitude of change could significantly diminish the clinical response in our patient.

Pharmacist’s perspective The oncology pharmacist should interact with the patient on a variety of levels to increase medication understanding, safety, and success with imatinib therapy. Notably, careful review of drug–drug interactions between imatinib and other agents is a common and important area of focus for oncology pharmacists. In vivo, imatinib is a strong, competitive inhibitor of CYP3A4 and CYP2C9 and a relatively weak inhibitor of CYP2D6. Imatinib is metabolized primarily by CYP3A4, with minor contributions from CYP1A2, CYP2D6, CYP2C9, and CYP2C19.21 Thus, imatinib is not only affected by CYP3A4 inducers and inhibitors, but it also inhibits the metabolism of other drugs metabolized by CYP3A4. Although many agents are metabolized via the CYP enzyme systems, these interactions are critically important when the affected medication has a narrow therapeutic margin, is metabolically affected to a large degree, or is a critical element of patient care (Table). In this case, our patient was taking St. John’s wort, a dietary supplement sometimes used for managing mild depression and a known potent inducer of multiple enzyme systems. In a drug interaction

Each medication or supplement that a patient is receiving should be reviewed…to look for common CYP substrates.

Other potent inducers (Table) have been shown to affect imatinib to a similar or greater degree and should be avoided when possible. If the inducing agents cannot be avoided, then the dose of imatinib may need to be adjusted upward, but there are no clear guidelines for this situation. Significant CYP3A4 inhibitors (Table) need to be addressed in a similar fashion. For example, ketoconazole has been shown to raise the AUC of imatinib by 40% after a single dose and could greatly increase side effects in patients in whom the interacting agent was not discontinued or replaced with another agent.25 In this case, the St. John’s wort was discontinued, because its clinical benefits were uncertain. The patient also was cautioned to have any additional dietary supplements being contemplated for use reviewed by the team, because there are

multiple agents known to modify CYP activity. With respect to imatinib’s effects on other agents, atorvastatin is a CYP3A4 substrate and imatinib increases the blood levels of a similarly metabolized statin, simvastatin, by 2- to 3.5-fold. This degree of increased drug exposure can significantly increase the risk for side effects, such as myalgias, hepatotoxicity, and rhabdomyolysis.26 In the current case, we substituted pravastatin for atorvastatin. This agent is expected to provide similar antilipid benefits, but is only a minor CYP substrate. It is important for the GIST patient care team, especially the oncology pharmacist, to review each medication or nutritional supplement in the patient’s medication list for potential drug–drug interactions and/or overlapping side effects. Many other medications can be similarly affected, because CYP3A4 is among the most common pathways used for medication metabolism. Medications with narrow therapeutic margins, where small changes in blood level can cause profound physiologic effects, are the most concerning when reviewing for drug interactions. For example, although imatinib inhibition of CYP2C9 is not as significant as its effects on CYP3A4, CYP2C9 is the primary enzyme that metabolizes warfarin. Imatinib treatment can inhibit CYP2C9 sufficiently to decrease warfarin metabolism and cause patients to become excessively anticoagulated and at increased risk for bleeding events. Each medication or supplement that a patient is receiving should be reviewed in a similar manner to look for common CYP substrates (Table) and to assess the risk of interaction or overlapping side effects. Patients should be advised to contact the oncology care team whenever any change in medication profile is considered (including both adding and subtracting medications). Conclusions The introduction of TKIs has revolutionized the treatment of metastatic GIST. However, obtaining optimal treatment results requires a multidisciplinary approach by physicians, oncology nurses, and oncology pharmacists. In particular, patient education to ensure medical compliance, and successfully manage side effects and concomitant medications are critical elements for successful treatment of patients with GIST. Although this review has emphasized first-line treatment of metastatic GIST with imatinib, similar multidisciplinary coordination of care is required when using sunitinib for second-line treatment of metastatic GIST. l

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Multidisciplinary Tumor Board Case Study

disclosures Funding was provided in part by a Merit Review Grant from the Veterans Affairs Administration (MCH) as well as from the GIST Cancer Research Fund (MCH) and the Life Raft Group (MCH). All potential conflicts of interest have been reviewed and managed by Conflict of Interest Committees at the Portland VA Medical Center and the Oregon Health and Science University. references 1. Corless CL, Heinrich MC. Molecular pathobiology of gastrointestinal stromal sarcomas. Annu Rev Pathol. 2008;3:557-586. 2. DeMatteo RP, Heinrich MC, el-Rifai W, Demetri G. Clinical management of gastrointestinal stromal tumors: before and after STI-571. Hum Pathol. 2002;33:466-477. 3. Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28:1247-1253. 4. Blanke CD, Demetri GD, von Mehren M, et al. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008;26:620-625. 5. Verweij J, Casali PG, Zalcberg J, et al. Progressionfree survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004;364: 1127-1134. 6. Hirota S, Isozaki K, Moriyama Y, et al. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science. 1998;279:577-580. 7. Heinrich MC, Corless CL, Duensing A, et al. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003;299:708-710. 8. Heinrich MC, Griffith DJ, Druker BJ, et al. Inhibition of c-kit receptor tyrosine kinase activity by STI 571, a selective tyrosine kinase inhibitor. Blood. 2000;96:925-932. 9. Joensuu H, Roberts PJ, Sarlomo-Rikala M, et al. Effect of the tyrosine kinase inhibitor STI571 in a patient with a metastatic gastrointestinal stromal tumor. N Engl J Med. 2001;344:1052-1056. 10. Demetri GD, von Mehren M, Blanke CD, et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002; 347:472-480. 11. Van Oosterom AT, Judson I, Verweij J, et al. STI571, an active drug in metastatic gastrointestinal stromal tumors (GIST) an EORTC phase I study. Proc Am Soc Clin Oncol. 2001;20(1A):Abstract 2. 12. Van Oosterom AT, Judson I, Verweij J, et al; for the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. Lancet. 2001;358:1421-1423. 13. Blanke CD, Rankin C, Demetri GD, et al. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008;26:626-632. 14. Heinrich MC, Corless CL, Demetri GD, et al. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol. 2003;21:4342-4349. 15. Heinrich MC, Owzar K, Corless CL, et al. Correlation of kinase genotype and clinical outcome in the North American Intergroup Phase III Trial of imatinib mesylate for treatment of advanced gastrointestinal stromal tumor: CALGB 150105 Study by Cancer and Leukemia Group B and Southwest Oncology Group. J Clin Oncol. 2008;26:5360-5367. 16. Demetri GD, von Mehren M, Antonescu CR, et al. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010;8(suppl 2):S1-S41. 17. Miettinen M, Lasota J. Gastrointestinal stromal tumors: pathology and prognosis at different sites. Semin Diagn Pathol. 2006;23:70-83. 18. DeMatteo RP, Ballman KV, Antonescu CR, et al; for the American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised,

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double-blind, placebo-controlled trial. Lancet. 2009; 373:1097-1104. 19. Wu EQ, Johnson S, Beaulieu N, et al. Healthcare resource utilization and costs associated with nonadherence to imatinib treatment in chronic myeloid leukemia patients. Curr Med Res Opin. 2010;26:61-69. 20. Joensuu H, Trent JC, Reichardt P. Practical management of tyrosine kinase inhibitor-associated side effects in GIST. Cancer Treat Rev. May 28, 2010. Epub ahead of print.

21. Peng B, Lloyd P, Schran H. Clinical pharmacokinetics of imatinib. Clin Pharmacokinet. 2005;44:879-894. 22. Lacy CF, Armstrong LL, Goldman MP. Drug Information Handbook. Hudson, OH: Lexi-Comp, Inc; 2010. 23. Therapeutic Research Faculty. Natural Medicines Comprehensive Database. http://naturaldatabase.thera peuticresearch.com/nd/products.aspx?AspxAutoDetect CookieSupport=1. Accessed October 6, 2010. 24. Frye RF, Fitzgerald SM, Lagattuta TF, et al. Effect of St John’s wort on imatinib mesylate pharmacokinetics.

Clin Pharmacol Ther. 2004;76:323-329. 25. Dutreix C, Peng B, Mehring G, et al. Pharmacokinetic interaction between ketoconazole and imatinib mesylate (Glivec) in healthy subjects. Cancer Chemother Pharmacol. 2004;54:290-294. 26. O’Brien SG, Meinhardt P, Bond E, et al. Effects of imatinib mesylate (STI571, Glivec) on the pharmacokinetics of simvastatin, a cytochrome p450 3A4 substrate, in patients with chronic myeloid leukaemia. Br J Cancer. 2003;89:1855-1859.

A Friday Satellite Symposium preceding the 52nd ASH Annual Meeting

Challenging Cases in Multiple Myeloma A Dialogue Between Community and Academic Clinicians to Improve Patient Care and Outcomes December 3, 2010 Rosen Centre Hotel Ballrooms A & B, Orlando, Florida Register online today at www.myelomacases.com/register PROGRAM DESCRIPTION

PROGRAM AGENDA

This continuing medical education symposium will serve as a forum for discussion of current questions and concerns regarding the treatment and management of patients through the multiple myeloma (MM) life cycle. A panel of domestic and international myeloma experts will be joined by representatives from community cancer care facilities and private oncology practices. By thoroughly engaging participants with interactive cases and physician point-counterpoint-style discussions, this symposium will provide evidence-based treatment and management recommendations and address new treatment regimens and management strategies based on recent clinical trials and emerging data. In addition to considering differences in domestic and international care, barriers and/or limitations faced by community cancer centers and private-practice oncologists will be debated.

12:30 -

1:00 PM

Registration and Lunch Service

1:00 -

1:10 PM

Welcome and Introduction Sundar Jagannath, MD - Chair

CASE PRESENTATIONS Each case will be presented by an expert faculty member and discussed by the international and community panel. 1:10 – 1:40 PM

Case 1: Difficult diagnosis G. David Roodman, MD, PhD

1:40 – 2:10 PM

Case 2: Newly diagnosed, stem cell transplant eligible patient Sundar Jagannath, MD

2:10 – 2:40 PM

Case 3: First-line therapy in a non-SCT eligible patient Stefan Knop, MD

2:40 – 3:10 PM

Case 4: Multiple risk factors Jonathan L. Kaufman, MD

3:10 – 3:40 PM

Case 5: Treatment of MM across the life cycle Noopur Raje, MD

3:40 -

3:50 PM

Question & Answer Session

3:50 -

4:00 PM

Closing Remarks Sundar Jagannath, MD

LEARNING OBJECTIVES At the end of this activity participants will be able to: • Apply early management strategies that consider new diagnostic and staging criteria for SMM, MGUS, and MM and new imaging studies in order to improve prognosis for your patients. • Evaluate novel therapeutic regimens as induction therapy for your patients considering an SCT in order to provide the most rapid response and allow the largest amount of stem cell collection, while maintaining safety and tolerance. • Integrate novel agent-based regimens that provide optimal outcomes and a survival benefit into your management strategy for patients ineligible for SCT after appraising emerging data from clinical trials. • Identify patient- and disease-associated factors that impact choice of therapeutic agent and formulate management strategies using a risk-adapted approach to treatment of MM. • Construct optimal treatment regimens based on novel combinations and make informed treatment decisions in order to improve the long-term outlook for myeloma patients across the life cycle of the disease.

TARGET AUDIENCE This activity has been developed for hematologists and medical oncologists, as well as nurses, pharmacists, and other allied health professionals who are interested in meeting the challenges faced when treating patients with multiple myeloma in academic and community settings.

ACCREDITATION INFORMATION Physician Accreditation The University of Cincinnati designates this activity for a maximum of 3 AMA PRA Category 1 Credits ™. The University of Cincinnati is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians should only claim credit commensurate with the extent of their participation in the activity. Registered Nurse Designation Medical Learning Institute, Inc. (MLI) Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 3.0 contact hours. Registered Pharmacy Designation Medical Learning Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 3.0 contact hours (0.3 CEUs) of continuing education credit. The universal activity number for this activity is 0468-9999-10-058-L01-P.

FACULTY CHAIR: Sundar Jagannath, MD Professor, Hematology and Medical Oncology Mount Sinai School of Medicine’s Tisch Cancer Institute Director of the Multiple Myeloma Program, The Mount Sinai Medical Center New York, NY Leon Dragon, MD, FACP Medical Director Kellogg Cancer Center Northshore University HealthSystem Highland Park, IL

Stefan Knop, MD University Hospital Würzburg Würzburg, Germany

Charles M. Farber, MD, PhD Section Chief of Hematology and Oncology Department of Medicine Carol G. Simon Cancer Center, Morristown, NJ Shoba Kankipati, MD Associate Physician EPIC Care East Bay Partners in Cancer Care San Francisco Bay Area, CA Jonathan L. Kaufman, MD Assistant Professor Blood and Marrow Transplantation Department of Hematology and Medical Oncology Emory University School of Medicine Member, Winship Cancer Institute Emory University, Atlanta, GA

Noopur Raje, MD Associate Professor of Medicine Harvard Medical School Director, Center for Multiple Myeloma Massachusetts General Hospital Boston, MA G. David Roodman, MD, PhD Professor of Medicine Vice Chair for Research Department of Medicine Director, Myeloma Program Director, Bone Biology Center University of Pittsburgh Medical Center Pittsburgh, PA Ari Umutyan, MD Redwood Regional Medical Group Hematology and Medical Oncology Napa, CA

ACKNOWLEDGMENT This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

This activity is jointly sponsored by the University of Cincinnati, Medical Learning Institute, Inc., a nonprofit medical accreditation company, and Center of Excellence Media, LLC.

december 2010 I VoL 3, No 8

Healthcare Design

Infusion of design with evidence By Natalie Petzoldt, AIA, LEED AP, EDAC Vice President, Cannon Design, St. Louis, Missouri

esigning healthcare of hospital design, includfacilities today is ing the acoustical impact of much different than carpet, programs to reduce how they were designed infection rates, and design years ago. In the same way, improvements to deter falls designing healthcare faciliand medication errors—all ties for the future also of which not only improves should be unlike those that the patient experience, but currently are being dealso helps hospitals become signed. Facility design is more cost efficient. Natalie Petzoldt, AIA, influenced by many facMost research carried out LEED AP, EDAC tors—ranging from services in the field of evidenceprovided to budget availbased design relates to the able to technology to operations to cul- inpatient environment within the hosture to regionalization. However, the pital. With that said, when it comes to significant factor that should influence cancer care, design must meet the needs all contemporary healthcare design is of the 80% to 90% of care that is delivevidence. ered in the outpatient setting. In addition, the diagnosis and treatment regiWhat is evidence-based design? men for a cancer patient is much The Center for Health Design defines different from that of a “typical” healthevidence-based design (EBD) as “the care patient. A cardiac patient, for process of basing decisions about the instance, is likely to make a handful of built environment on credible research visits to the hospital for diagnosis, treatto achieve the best possible outcomes” ment, and rehabilitation. It is common, (www.healthdesign.org). This is similar however, for the average cancer patient to the evidence-based medicine cur- to make more than 100 visits to the hosrently being applied by clinicians with- pital or cancer center to receive care in the facilities we design. The health- during the first year following diagnosis. care design industry has come a long Because there is limited evidence and way in what is understood about the research that directly relates to the impact of the built environment on design of cancer centers, Cannon patients and staff with regard to their Design has dedicated the past 10 years health and safety. For healthcare, the to researching and studying evidence, goal is to achieve the best possible out- especially as it pertains to infusion cencomes for patients, families, and staff ter design. The goal of evidence-based while improving the process of delivery. design is to identify, hypothesize, impleIn 1984, environment psychologist, ment, gather, and report the data associRoger Ulrich, began the push forward to ated with the research project. To this study how the built environment end, two common questions arise. impacts patients. Ulrich’s initial study • Can infusion center design impact showed how a patient recovering from the emotional well-being of patients? gallbladder surgery—whose hospital • What are patient and family preferroom offered views of nature—used less ences as they relate to infusion envipain medication and had a shorter ronments? length of stay than a patient who could The research included both qualitaonly see a brick wall out the window tive methods (face-to-face or group (Science. 1984;224:420-421). This spurr- interviews) and quantitative methods ed the industry to research many areas (formal surveys and questionnaires).

PILOT STUDY Drill Deeper on Patient Environment 59%

1. Temperature control

54%

2. Light control 3. Visibility from staff

48%

4. Reading light

37%

5. Quiet environment (no TV)

15%

6. Privacy from staff

50%

100%

Figure 1. Survey question: “What control would an infusion patient most want?”

december 2010 I VoL 3, No 8

Phase 1 of the research study gathered data through patient focus groups, interviews, and questionnaires. Phase 2 of the study included postoccupancy evaluation (POE), where the research team evaluates and assesses behavior within the new spaces. The POE included interviews, questionnaires, and observation by trained researchers. For those who chose to participate in this study, questionnaires were distributed to patients and their guests at the beginning of their infusion treatment, and collected at the end of the treatment session. Results were analyzed by both doctoral researchers and registered healthcare architects who focused on analyzing the impact of the environment on behavior.

The most prominent factors influencing the design of infusion centers appear to be desire for control, varying levels of privacy, and accommodations for the patients’ guests.

The research included locations across the United States. The participants in this multiple-phase study represent both community-based cancer centers and National Cancer Institute (NCI)-designated Comprehensive Cancer Centers. All patient respondents were adults, with most aged 50 years and older. The mix of patient respondents included a broad spectrum of cancer types; however, most were women. Patients receiving chemotherapy or infusion sessions spend many hours in a recliner or bed within an infusion center. Treatment times can last as long as 8 hours or more. Based on results, the most prominent factors influencing the design of infusion centers appear to be desire for control, varying levels of privacy, and accommodations for the patients’ guests. desire for choice and control A patient at Todd Cancer Institute, Los Angeles, California, stated during a focus group session, “Sense of control is important because cancer takes away your control.” During the research study, specific questions were asked to understand what types of control are desired

by patients. One of the questions on the patient survey asks, “What control would an infusion patient most want?” The patient was able to select multiple options from a list or write in their own answer. Many of the results related to controlling light, sound, and entertainment (Figure 1). As measured by patient survey results, temperature control was the most important criteria, mainly due to the fact that infusion patients are pumped with fluids that are cooler than the body temperature. At many centers, after a patient is positioned in the station, one of the first things a nurse will do is bring the patient a warm blanket. Infusion centers should consider other ways to allow patients to have individual control over the temperature of their environment. Usually this is done through the building heating, ventilating, and air conditioning system, although many manufacturers are currently installing heated seats within the recliners—an absolute patient favorite. desire for privacy Recent evidence from research regarding the inpatient environment shows that there are advantages to private inpatient rooms. In 2006, the American Institute of Architects Guidelines for Design and Construction of Health Care Facilities introduced the recommendation for private patient rooms to address safety, noise, and privacy issues in adult PILOT STUDY Phase 2

Sometimes 28% Private 50% Share 22%

n = 161 Location summary Banner Health, Phoenix, Arizona Case Western, Cleveland, Ohio Northwestern, Chicago, Illinois

Figure 2. Survey question: “What type of room do you desire?”

acute care hospitals. These include a quieter room that encourages a more satisfying sleep; a reduction in infection rates; Continued on page 10

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“After my balloon kyphoplasty, I’m walking pain-free again.” Tom Callaghan experienced debilitating pain due to spinal fractures caused by multiple myeloma. He underwent a minimally invasive procedure, Balloon Kyphoplasty, to treat the spinal fractures.

KYPHON® Balloon Kyphoplasty

To learn more about Balloon Kyphoplasty, visit our website at www.kyphon.com.

The complication rate with KYPHON® Balloon Kyphoplasty has been demonstrated to be low. As with all surgical procedures, there are risks associated with the procedure, including serious complications, and though rare, some of which can be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product. © 2009 Medtronic Spine LLC. All Rights Reserved. 16003611_001 rev 1

Healthcare Design Infusion of design... continued from page 8

Figure 3. Semiprivate treatment environment at the Melvin & Bren Simon Cancer Center at Indiana University.

and an overall improvement in patient satisfaction—reducing patient stays. Some might suggest that the desire for privacy translates directly to the outpatient cancer center environment, although there was no research in this regard. Our research study probed extensively at the topic of private infusion spaces. Based on results from the patient surveys, we found that private patient rooms are desired by some, but not by all (Figure 2). Private patient rooms in an infusion center are desirable to certain patients who are seriously ill—those who receive several guests, in addition to the occasional child who accompanies a mother into treatment. Other patients desire an open treatment environment which provides camaraderie, support, and a more social atmosphere. At the Simon Cancer Center, Indianapolis, Indiana, one patient wanted “an environment that encourages more patient interaction,” and another noted, “when you spend a lot of time together with other patients, friendships are formed.” Our research also indicates that the

PILOT STUDY

desire for private treatment rooms varies depending on the institution and the patient population. For example, results from a large NCI-designated cancer center in the Midwest showed that 65% of patients surveyed prefer a private room. In contrast, when the same research was conducted at a large community-based cancer center in the Southwest, only 27% of patients preferred a private room. Before making program and design decisions for a new infusion center, facility planners should conduct the appropriate research to understand the characteristics unique to their patient population (Figure 3). Based on the findings indicating that not all patients desire private treatment rooms, we further researched how many patients could be accommodated comfortably in an open treatment area. The patient questionnaire asked, “If I am receiving infusion in an open area, what is the ‘right number’ of patients to be put together?” Most patients preferred between two and five (Figure 4). We gathered more qualitative data regarding this topic during patient focus groups and interviews. A significant number of patients also stated that two chairs per room were not desirable, as they may not want to have a person with them during their entire treatment session. Therefore, not only are “semiprivate” rooms not typically desired by patients; but large group settings are not preferred either. As one patient at Banner Health noted, “Don’t put us in a big fish bowl!” which is defined as a larger space with patient recliners facing one another. Another important finding is that patients prefer visibility by the staff, rather than privacy from staff. This finding is consistent with similar results gathered from nurses who want to be able to see the patients’ faces in case of a reaction to the medications.

7 to 10 6%

Phase 1 A: 2 to 3 B: 3 to 5 C: 5 to 7

5 to 7 19%

2 to 3 39%

D: 7 to 10 E: More than 10

Location summary Todd Cancer Center, Los Angeles, California Siteman Cancer Center, St. Louis, Missouri Karmanos Cancer Institute, Detroit, Michigan Cancer Care of Maine, Bangor, Maine

3 to 5 36%

Figure 4. Survey question: “If I am receiving infusion in an open area, what is the ‘right number’ of patients to be put together?”

december 2010 I VoL 3, No 8

Survey of Infusion Patients Drill Deeper on Patient Amenities 90%

1. A guest chair 53%

2. Access to food/drink 3. Coat hangers

34%

4. Wireless Internet

26%

5. Blanket or pillow

25%

50%

100%

Figure 5. Survey question: “What amenities would you like to have in an infusion (chemotherapy) treatment area?”

desire for companions/guests As our research shows, the amenity infusion patients most desire is, surprisingly, not technology such as television or a computer, but rather ample space for a guest chair (Figure 5). These results are resoundingly consistent at all cancer centers. This simple amenity provides some of the highest satisfaction for patients and their families. When patients are interviewed or offer additional comments on a questionnaire, they often reference the guest chair and how important it is. Part of the design phase for a facility is to choose the furnishings. For an infusion center, a major focus is placed on the patient recliner that patients often use for hours receiving only one treatment. Therefore, patients are the best individuals to test the recliners. They can determine whether the specific recliner’s levers, arms, and/or mechanics are too challenging for use. Based on our research and interviews, the guest chair may be just as important. At an infusion center that recently opened, one of the comments we heard repeatedly during the POE was that the guest chairs should be as comfortable as the patient recliners. Don’t forget that the family members are often there for the same length of time as the patient. A guest chair sitting beside the patient recliner is a basic provision for an infusion center. This idea of providing space for the family can be taken even one step further. Often, if a family member wants to make a phone call, read a book, or perhaps nap, their only options are to either use the guest chair provided or return to the waiting room outside the treatment area. Recently, infusion centers have found that providing a “family lounge” space within the infusion area, or between several treatment pods, provides a great amenity for the patient and their family. This idea of the “living room” was implemented at the Simon Cancer Center where recliners were located around a fireplace. The recliners can be used by patients who desire to move around, but are more often used by family mem-

Figure 6. “Living room” space for patients and their guests at the Melvin & Bren Simon Cancer Center at Indiana University.

bers who want to nap, read the newspaper, or socialize with others (Figure 6). Summary When designing an infusion center, the challenge for the whole team of architects, engineers, clinicians, nurses, and hospital leadership is how do we apply evidence to design the best patient care environment. As one patient noted, “You don’t want to be there, but you have to.” Can we design an infusion center that makes it more desirable for people to want to be there? There is evidence that says we can. l

News Note bundled Payments begin UnitedHealthcare has begun its bundled-payment approach in five oncology practices. This approach will pay physicians a lump sum for each patient’s total course of chemotherapy for breast, lung, and colon cancer. The bundled sum is based on regimens chosen by the oncologists in the program plus a case management fee. l

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Chronic Lymphocytic Leukemia The Essentials of Patient Care LOG ON TODAY TO PARTICIPATE www.coexm.com/ace02.asp Release Date: April 29, 2010 Expiration Date: April 28, 2011

TARGET AUDIENCE This activity is intended for hematologists, oncologists and others who are involved with the care of patients with Chronic Lymphocytic Leukemia (CLL).

STATEMENT OF NEED CLL is the most common type of leukemia in the United States, with over 15,000 new cases per year, characterized by the accumulation of monoclonal B cells in the bone marrow, peripheral blood, and lymphoid tissue. Primarily a disease of the elderly, the median survival for CLL varies substantially: many patients survive more than 10 years after diagnosis, but a subset of symptomatic patients have shorter life expectancies—in the range of 1.5 to 6 years. The clinical/research body of knowledge in CLL is rapidly changing and represents a challenge for the whole treatment team.

FACULTY Neil E. Kay, MD Professor Department of Medicine Mayo Clinic Rochester, Minnesota

Michael Keating, MD Course Chair Professor of Medicine Deputy Department Chairman Department of Leukemia M.D. Anderson Cancer Center Houston, Texas

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • List the essential steps in diagnosis and treatment planning of the CLL patient • Select CLL treatment regimens based on patient characteristics • Define data supporting the benefit/risk ratio of upfront, relapsed, and refractory CLL setting • Define strategies to manage fludarabine-resistant CLL • Describe emerging therapies in CLL

This activity is supported by an educational grant from Genentech BioOncology and Biogen Idec.

This activity has been approved for 1.5 AMA PRA Category 1 Credits™. For further information and to participate, please go to: www.coexm.com/ace02.asp

In collaboration with

Conference News ESMO

The following articles are based on presentations at the 35th European Society for Medical Oncology Congress held in Milan, Italy, October 8-12, 2010.

Prompt Pain relief for Compression Fractures with balloon Kyphoplasty By Caroline Helwick

MILAN—Painful vertebral compression fractures can be promptly and effectively treated with balloon kyphoplasty, an international study showed. The Cancer Patient Fracture Evaluation (CAFE) study was the first to randomize cancer patients with vertebral compression fractures to balloon kyphoplasty or standard nonsurgical treatment (controls). The results were reported by Leonard Bastian, MD, of the Klinikum Leverkusen in Leverkusen, Germany. “We found that we can reduce pain immediately in these patients,” Bastian said at a press conference. “Cancer patients with vertebral compression fractures having balloon kyphoplasty have a superior outcome.” Balloon kyphoplasty involves a 1-cm incision into the fractured vertebra through which a balloon is inserted and inflated to restore the shape and height

of the vertebra. The balloon is then deflated and removed, and quick-setting bone cement is injected into the vertebral body to maintain the shape. The study population included 134 patients with three or fewer vertebral compression fractures who were randomized to kyphoplasty (n = 70) or nonsurgical management (n = 64), mainly physical therapy, analgesics, and sometimes braces and bed rest. Patients were followed for 1 year. After 1 month, the Roland-Morris Disability Questionnaire score dropped by 8.3 points in the kyphoplasty group but increased slightly by 0.1 point in the nonsurgical group. After just 1 week, the kyphoplasty group reported significant improvements in back pain, with a change in the numerical rating scale of -3.8 points, compared with virtually no change in the control group, and they used less analgesia.

The difference between the groups in the two pain measurements was highly significant (P <.0001), Bastian noted.

“All the balloon kyphoplasty patients reported sustained improvements throughout the 12-month period of the study.” —Leonard Bastian, MD Patients receiving balloon kyphoplasty reported significantly fewer days with limited activity—6.2 days fewer per 2 weeks (P <.0001)—and greater improvements in quality of life as mea-

sured by an eight-point advantage in the SF-36 score (P <.0001). Crossover to kyphoplasty was allowed after 1 month, and the 38 patients who did so experienced similar benefits with regard to back pain relief, activity level, and quality of life. “All the balloon kyphoplasty patients reported sustained improvements throughout the 12-month period of the study,” Bastian said. Adverse events were similar except for the occurrence of one intraoperative non–Q-wave myocardial infarction that resolved in the kyphoplasty group and a cement leakage to the disc and adjacent fracture 1 day later in another patient. The indication for this procedure is virtually any painful vertebral compression fracture or multiple fractures. Bones that have been highly compromised due to metastases, however, may not be amenable to kyphoplasty. l

Cell Cycle expression Profile Offers Prognostic data for Prostate Cancer By Dawn Lagrosa

MILAN—A newly derived genetic expression signature can be used to help determine the choice of therapy for men with clinically localized prostate cancer, especially those with a Gleason score of 6, according to researchers. This signature provides oncologists with more data regarding patients’ likelihood of survival at 10 years, opening the options of active surveillance for those with “favorable” signatures and for more aggressive treatment for those with “unfavorable” signatures. In the most recently presented of three studies on the cell cycle progression (CCP) score, Jack Cuzick, PhD, head of the Centre for Epidemiology, Mathematics, and Statistics, Wolfson Institute of Preventive Medicine, London, United Kingdom, and his colleagues used the CCP score (a genetic signature of the RNA expression profile of 31 genes related to CCP) to assign a prognostic designation to 337 paraffin sections from men with clinically local-

december 2010 I VoL 3, No 8

ized prostate cancer diagnosed by transurethral resection between 1990 and 1996. Pathology samples were restricted to men who had received only conservative treatment, were under the age of 76 years at time of pathological diagnosis, and had baseline prostatespecific antigen (PSA) measurement. Using univariate analysis, the researchers found the CCP score to be significantly associated with prostate cancer death (λ2 = 92.7; Idf, P <10-21). The hazard ratio for death from prostate cancer was 2.92 (95% confidence interval, 2.38-3.57) for a one-unit increase in CCP score (~1 standard deviation change in distribution, range -1.8 to 4). Multivariate analyses showed the CCP score to be the dominant variable (λ2 = 42.2, P <10-10), compared with Gleason score (λ2 = 7.2), baseline PSA (λ2 = 29.3), and all other prognostic factors. They found no apparent differences in the hazard ratio for CCP across Gleason scores or baseline PSA levels as

well as no significant interactions with other risk factors. The researchers noted that this represents a predictor for dying from prostate cancer within 10 years, and this predictor allowed them to identify 32% of the cohort with a 10-year risk of dying from prostate of less than 5%. In a press release issued after the presentation: Myriad Genetics clarified this benefit, “Twenty-five percent (25%) of the prostate cancer patients had a favorable PROLARIS [the trade name of the molecular diagnostic product] score and showed a 98.5% chance of surviving their disease over a 10-year period.… In contrast, prostate cancer patients who received an unfavorable PROLARIS score showed only a 42.4% chance of surviving their disease over a 10-year period.” This new study builds on two studies announced earlier this year. At the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Sym-

posium in March, Gregory P. Swanson, MD, Departments of Radiation Oncology and Urology, The University of Texas Health Science Center at San Antonio, and his colleagues presented a poster detailing the development and validation of the genetic expression signature to define the risk of disease recurrence after radical prostatectomy. Then, in an abstract published in conjunction with the European Organisation for Research and Treatment of Cancer-National Cancer InstituteASCO annual meeting on Molecular Markers in Cancer this past October, Steve Stone, PhD, Vice President of Cancer Genomics, Myriad Genetics, Salt Lake City, Utah, and colleagues demonstrated that the genetic expression signature is prognostic in prostate cancer patients both at diagnosis and after prostatectomy. In both settings, the genetic expression signature provided data to help differentiate aggressive from indolent disease. l www.jomcc.com

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Totect® Kit (dexrazoxane) for injection is for intravenous infusion only. Totect is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

First and only FDA approved treatment for anthracycline extravasation. Supplied as a convenient and accessible complete three day treatment kit for single patient use, which should be proactively stocked on-site and infused as soon as possible and within 6 hours of an anthracycline extravasation. Demonstrates 98% overall efficacy based on two biopsy-confirmed clinical trials1,2 in reducing or avoiding surgical intervention (i.e., surgical debridement, plastic surgery and their related costs), thereby reducing postponement of a patient’s chemotherapy treatments and the avoidance of long-term consequences. Cited in nursing guidelines.3,4 Extravasation management is now a chemotherapy administration safety standard.5

For more information, call 866-478-8274 or visit our website at www.totect.com To order Totect®, contact one of our authorized distributors. ASD Healthcare Cardinal Specialty McKesson/OTN Oncology Supply US Oncology (800) 746-6273 (866) 677-4844 (800) 482-6700 (800) 633-7555 (888) 987-6679 1

Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane). Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550. 2 Totect® package insert. 3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009. 4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009. 5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658. © 2010 Topotarget USA. All rights reserved. TOT0111/7-10 Totect and its logo mark are registered trademarks of Topotarget A/S Image is copyright © Photo Researchers, Inc.

Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: Totect is a cytotoxic drug. Vial contents must be mixed and diluted before use. Totect should not be mixed or administered with any other drug during the infusion. Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasation. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day. The Totect dose should be reduced 50% for patients with creatinine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the affected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administration. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.3-5 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water. Contraindications: None. Warnings and Precautions: Myelosuppression: treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Use in Pregnancy: Pregnancy Category D. Totect can cause fetal harm when administered to a pregnant woman. There is no adequate information about the use of Totect in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Adverse reactions: The most common adverse reactions (≥ 16%) are nausea, pyrexia, injection site pain and vomiting.

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Drug Interactions: No drug interactions have been identified. Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treatment with topical DMSO decreases the efficacy of systemic dexrazoxane. Use in Specific Populations: Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. Renal Impairment: Reduce the Totect dose by 50% In patients with creatinine clearance values <40 mL/min. Pediatric Use: The safety and effectiveness of Totect in pediatric patients have not been established. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Overdosage: There are no data on overdosage. There is no known antidote for dexrazoxane. Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of dexrazoxane has not been investigated. Nevertheless, a study by the National Cancer Institute has reported that long term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused significant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Thus, dexrazoxane is mutagenic and clastogenic. The possible adverse effects of Totect on the fertility of humans and experimental animals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (about half the human dose on a mg/m2 basis).

Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Hameln Pharmaceuticals GmbH 31789 Hameln Germany

Manufactured for: Topotarget A/S Fruebjergvej 3 DK-2100 Copenhagen Denmark

Models of Care Comanagement Offers Long-term Alignment... continued from cover care is now being measured more closely,” said Steven Elliott, MHA, a partner with Cenergy, LLC, who presented “Program Excellence: Physician CoManagement in Cancer Care” at the 2010 American College of Oncology Administrators Oncology Update: Positioning for Success conference. “There is a tremendous focus on the federal and state level to elevate the quality of care.” In business since 2004, Cenergy is a healthcare advisory firm employing a team of experienced professionals who have extensive background in all facets of the healthcare market. The company’s focus is physician–hospital alignment and service-line development 50%

with strength in helping their clients improve the quality and financial performance of patient care. The comanagement model Elliott defined comanagement (also referred to as shared management) as a quality-focused physician–hospital alignment strategy (Figure 1). Cenergy’s unique approach includes a 1-year contractual agreement between physician practices and a hospital to: •Work collaboratively to manage a specific service line • Achieve improvements in quality and efficiency of operational departments • Provide a forum for strategic development of the service line.

50%

Medical oncology Radiation oncology Surgical oncology

Cancer institute Hospital Comanagement executive team Base management fee + Quality bonus

Cancer services

Program operation team

Hospital and physician groups sign 1-year management services agreement to work together to manage a specific service line. Most management fees are tied to the accomplishment of predefined indicators related to improving quality and program performance. Figure 1. Defining Comanagement: Organizational Structure

Compensation is based on quality metrics and program performance improvements, noted Elliott. Most management fees are tied to the accomplishment of predefined indicators related to enhancing quality and program performance. The indicators are established at the first meeting of the comanagement executive team. A comanagement arrangement typically divides physician compensation into two categories (Figures 2 and 3). The total management fee is based on a percentage of net revenues from the previous 12 months and is broken out in both a fixed and variable component. • Fixed management compensation is paid monthly in a stipend to each practice based on participating physicians. The fee has to be consistent with the fair market value of the time and efforts of the participating physicians. Compensation is based on a defined set of management duties to oversee the service line through both formal and informal meetings. • Variable compensation is allocated equally to a set of predetermined quality and performance indicators. This variable compensation is distributed based on the achievement of predefined targets by indicator. “Compensation is set in stone and does not change over the course of the agreement,” he explained. Furthermore, after the contract begins, no other physicians or healthcare systems can participate. Meets legal requirements The comanagement model meets all current state and federal regulations, according to Elliott. The Stark and Anti-Kickback laws are two of the regulations that impact physician–hospital alignment compensation. The Stark law, also referred to as the physician selfreferral statute, prohibits a physician from referring patients to an entity for a

designated health service, if the physician or a member of his or her immediate family has a financial relationship with the entity, unless an exception applies. The federal Anti-Kickback law prohibits the knowing and willful offer, solicitation, payment, or receipt of anything of value to influence the referral of federal healthcare program business, including Medicare or Medicaid. benefits of comanagement The comanagement approach benefits patients, physicians, and hospitals. Under this model, physicians and hospitals are working together to improve quality of patient care and the patient experience (Figure 4). “With the advent of the Internet and 24-hour access to healthcare information, patients are more technology savvy today, particularly cancer patients,” said Elliott. “They have become masters at finding where they can get the best care.” Many healthcare experts agree that oncology service lines may be appropriate for comanagement arrangements. In cancer care, the inpatient and outpatient service lines are broad, allowing for more benchmarks to measure metrics for quality and performance. The comanagement method also is advantageous for physicians and hospitals, noted Elliott. Advantages include: • Providing flexibility to hospitals and physicians for future collaborative initiatives • Initiating physician–hospital alignment and collaboration • Creating a mechanism for physicians to play an active role in managing a service line • Improving communication between the physician and the hospital • Increasing physician involvement in the management and strategic direction of the service line • Improving clinical outcomes and patient satisfaction

Percent of program net revenue Fixed management fee Management fee Variable compensation Fixed compensation – 20% to 30% (Hours paid monthly in a stipend to each practice based on participating physicians)

Figure 2. Defining Comanagement: Physician Compensation

december 2010 I VoL 3, No 8

Dashboard management

Executive board participation

Operating teams participation

Day-to-day operations oversight

Quality2 threshold

Operational1 efficency incentives

New program development

Budgetary1 objectives 1

Variable compensation – 70% to 80% (Paid by indicator to each participating physician on each program operation team)

Ad hoc committee work

Quality of service incentives

Subject to legal and regulatory limitations. Payment of ANY incentive compensation is dependent on meeting a quality threshold.

Figure 3. Defining Comanagement: Physician Compensation

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Models of Care

• Increasing productivity of the physician by improving operational efficiencies • Improving coordination and efficiency of service-line management and operations • Allowing physicians to participate with no upfront investment • Being easily unwound if it does not meet the intended results. Although the benefits outweigh the drawbacks, they do exist. Elliott said disadvantages of the model include the participants’ lack of familiarity with the management concept, the requirement of active participation by the physicians and not being a passive investment, and a management fee based on percentage of net revenues may not be enough to interest some specialists. Models for success Cenergy has implemented more than 50 comanagement agreements. Elliott highlighted two cancer-focused comanagement agreements the company has implemented during his presentation. One example was a healthcare system searching for a mechanism to improve both outcomes and performance of the program; the solution was a comanagement arrangement. Now in its fourth year, the system’s management team consists of two hospitals, along with medical, surgical, and radiation oncologists. The 12-member comanagement executive team includes six physicians

and six hospital representatives. The team established six program operation teams with 18 physicians and identified 18 indicators. In its first year, the group reached 16 of 18 indicators for an 89% success rate. Under the comanagement model, the hospitals and physicians saw major improvement in patient management and took steps toward a tumor-site approach to care. The other example Elliott described highlighted a 400-bed hospital with a very disjointed program that wanted to improve its clinical care model to enhance efficiency of cancer care and deliver a new emphasis on a coordinated patient experience. Now in its third year with a management team, the comanagement model involves inpatient and outpatient programs among six practices: one radiation oncologist, three medical oncologists, and two surgical oncologists. The nine-member comanagement executive team includes six physicians and three hospital representatives. The group established four program operations teams with 14 physicians and identified 12 indicators. In the first year of the agreement, the group hit 11 of 12 indicators for a 92% success rate. The physician–hospital alignment approach resulted in significant improvements in operating room turnover, hospital length of stay, and patient management. The length of time for comanagement agreements to become operational varies,

Physician Management role in total program environment Compensation for quality performance Specific focus areas for joint activities Alignment for the future

Hospital Organized physician input into management of service Preparation for pay-for-performance compensation method Combined focus on specified areas Pathway to multiservice organization, employment, etc

Bottom Line: Physicians and hospitals are working together to improve the quality of patient care and the patient experience

Figure 4. Defining Comanagement: Benefits of the Arrangement

said Elliott. Cenergy’s timeframe is 90 to 120 days, and nearly 90% have gone on to a second year of the agreement. Within 6 months, physicians and hospitals can start to see positive results in the established indicators. “Nine months is when you see a lot of movement with the indicators,” he said. Whereas the indicators change each year, the indicators met in the previous year are maintained in the next year of the contract. “You always like to see a crossover in maintaining that level of performance,” he said. Future of comanagement models The comanagement model is gaining in popularity as more physicians and hospitals look for alternatives to bolster

efficiency and quality of care. As healthcare reform gets under way and greater levels of physician–hospital integration are encouraged, the industry may see more growth in comanagement agreements. This approach to care is successful when physicians and hospitals work as a team to reach established goals. Healthcare experts agree the model is beneficial to both parties because of its feasibility, efficiency, and versatility. Hospitals see better patient care, improved financial performance, and physician loyalty. Physicians are given opportunities to provide valuable input in the overall direction, design, and management of a core clinical program and receive compensation for achievements that improve patient care. l

LUNG CANCER

Low-dose CT Screening Found to reduce Lung Cancer deaths in Large Study By Karen Rosenberg

large National Cancer Institute (NCI)-sponsored study has shown for the first time that a screening method can reduce deaths from lung cancer by detecting cancers at relatively early stages. The National Lung Screening Trial (NLST), a randomized national trial involving more than 53,000 current and former heavy smokers aged 55 to 74 years, compared the effects of two screening methods for lung cancer— low-dose helical computed tomography (CT) and standard chest radiography— on lung cancer mortality. Results showed a highly significant 20% reduction in lung cancer deaths among trial participants screened with low-dose helical CT. “Lung cancer is the leading cause of cancer mortality in the United States

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and throughout the world, so a validated approach that can reduce lung cancer mortality by even 20% has the potential to spare very significant numbers of people from the ravages of this disease,” said NCI director Harold Varmus, MD. NLST participants were required to have a smoking history of at least 30 pack-years and were either current or former smokers without signs, symptoms, or history of lung cancer at enrollment. Participants were randomly assigned to receive three annual screens with either low-dose helical CT (often referred to as spiral CT) or standard chest radiography. Screening was done at enrollment and at the end of their first and second years on the trial, and participants were then followed for up to another 5 years.

As of October 20, 2010, 354 participants in the CT arm of the study had died of lung cancer compared with 442 of those in the chest radiography group. The Data and Safety Monitoring Board concluded that this 20.3% reduction in lung cancer mortality met the standard for statistical significance. “The fact that low-dose helical CT provides a decided benefit is a result that will have implications for the screening and management of lung cancer for many years to come,” said Christine Berg, MD, NLST, project officer for the Lung Screening Study at NCI. An ancillary finding was that allcause mortality was 7% lower in participants screened with low-dose helical CT than in those screened with chest radiography. Further analysis will be required to fully elucidate the

reason for this difference. The investigators do not recommend helical CT screening for all smokers, pointing out that it has several possible disadvantages, including the cumulative effects of radiation from multiple CT scans; false-positive results leading to further tests and procedures with possible complications, and costs and anxiety related to the screening process itself. They note too that the population enrolled in this study was a highly motivated and primarily urban group that was screened at major medical centers, and the results may not accurately predict the effects of recommending low-dose helical CT scanning for other populations. Further information about the NLST can be found at www.cancer.gov/news center/qa/2002/nlstqaQA. l

december 2010 I VoL 3, No 8

Research Preferences of Cancer Patients... continued from cover Abstract Purpose: The aim of the study was to investigate patients’ expectations and preferences for services offered at two academic multidisciplinary oncology clinics, especially in regard to the patients’ attitudes about clinical trials. Patients and Methods: Participants included individuals referred to either the gastrointestinal or the thoracic multimodality oncology clinics. Surveys were administered to patients at the time of first clinic visit and/or disease progression. The seven-question survey ments, educate the patients, and find help for many of the social and economic burdens that a diagnosis and treatment of cancer brings. Two approaches can be used to organize patient visits in multidisciplinary clinics. Either all patients are seen by all specialties or the facility has parallel clinics where only certain patients see two or more specialists at one time. Some cancers demand by their very nature one or the other approach. Most patients with head and neck cancer , for instance, would benefit by the “see all specialties” approach, whereas patients with melanoma benefit more by the “parallel clinic” approach. A mainstay of any multidisciplinary clinic is a multidisciplinary conference. These conferences may also differ and discuss either all patients or only patients for whom the plan of treatment

was designed as a self-directed questionnaire and each item used response options that ranged on an ordinate scale from not at all important (1) to extremely important (7). Results: Ninety-three patients were surveyed at the gastrointestinal and thoracic multimodality clinics. The patients’ most preferred items were “to have everything explained,” followed by “to be discussed at the multidisciplinary conference.” Of the seven items, the opportunity to participate in clinical trials ranked

needs further consensus. The multidisciplinary clinic would appear to be an ideal setting for patient accrual to clinical trials. Its interdisciplinary organization facilitates design and completion of clinical and translational trials to which each specialty can enroll eligible patients. The increasing use of multidisciplinary clinics has, however, not increased the number of patients enrolled. Nationwide, the number of cancer patients participating in such trials is very small compared with the pool of eligible candidates. In fact, it is estimated that persistently less than 3% of cancer patients receive treatments in clinical trial investigations.1,2 Although patients generally accept the need for clinical trials, many patients hold negative views of clinical trial research, including the randomiza-

Table 1 Means and Standard Deviations of Importance Ratings by Group

Importance parameters

Combined, initial (n = 68)

Thoracic, initial (n = 43)

Gastrointestinal, initial (n = 25)

Thoracic, recurrence/ progression (n = 25)

Doctors

5.66 ± 1.62

5.58 ± 1.67

5.79 ± 1.56

4.96 ± 1.81

Treatment

5.56 ± 1.58

5.46 ± 1.64

5.71 ± 1.52

5.64 ± 1.52

Explanation

6.91 ± 0.34

6.90 ± 0.30

6.92 ± 0.40

6.79 ± 0.51

Appointment

5.90 ± 1.54

6.28 ± 1.28

5.24 ± 1.74

5.75 ± 1.42

Conference

6.56 ± 1.11

6.60 ± 1.03

6.48 ± 1.26

6.52 ± 0.87

Help

5.42 ± 2.05

5.38 ± 2.06

5.48 ± 2.08

5.96 ± 1.59

Trials

4.80 ± 1.92

4.71 ± 2.05

4.96 ± 1.69

5.40 ± 1.73

Patients’ Preferences in the Multidisciplinary Clinic 7 6 5 4 3 2 1 0

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Figure. Score of Patient Importance by Category

december 2010 I VoL 3, No 8

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lowest. There was no difference between ratings by participants in the two clinics. However, patients with recurrent or progressive cancers reported a slightly higher interest in clinical trials, but still ranked trial entry lower than most other services offered. Conclusion: Patients valued complete explanations far more than they valued access to clinical trials. This preference is important in structuring multidisciplinary clinics and should be emphasized when accruing patients to clinical trials.

tion process.2 Other factors that have been previously identified as barriers to enrollment include a patient’s desire for a treatment different from that offered in a clinical trial, difficulties related to geographic distance from the cancer center where the trial was offered, physician bias, financial constraints, and practical limitations.2 Given the complexity of the response regarding entry into or avoidance of a clinical trial, it seems expedient to try and isolate a few of the major variables to learn more about this phenomenon. Patients and methods Study participants included individuals who were referred to two multidisciplinary oncology clinics (gastrointestinal [GI] and thoracic oncology). Both clinics are staffed by a coordinator, medical oncologist, interventional pulmonologist (only thoracic clinic), surgical oncologist, thoracic surgeon (only thoracic clinic), radiation oncologist, psychologist, social worker, and oncology nurses. The survey was administered to participants during their first visit or at the time of disease progression. The self-report survey was designed specifically for this study and includes seven items that tap specific aspects of providing cancer care in a multidisciplinary team setting: • Efficiency (seeing all doctors on the same day) • University-based care • Communication (opportunity to have diagnosis and treatment explained thoroughly) • Expediency (having first appointment within 10 days) • Multidisciplinary case discussion (having case discussed during multidisciplinary case conference) • Care coordination (access to professional assistance regarding transportation and medical costs) • Access to clinical trials. Each item was rated using a scale that ranged from 1 (not at all important) to 7 (extremely important). In addition to the importance items, background information was collected regarding patient age, gender, the clinic in which they were being seen, and whether they were

being seen for an initial evaluation or following recurrence/progressive disease. The analysis plan primarily involved calculating descriptive statistics to depict mean levels of importance for each of the seven items. Additional analyses (t-tests) explored differences in ratings comparing patients from the two clinics as well as comparing participants seen following their initial cancer diagnosis and individuals seen for recurrent or progressive cancer. results Participants included 43 patients who received initial care in the thoracic multidisciplinary oncology clinic and 25 patients who received initial care in the GI multidisciplinary oncology clinic for a total sample of 68 participants who were seen following their initial cancer diagnosis. An additional 25 responses were collected in the thoracic oncology clinic from participants who experienced a recurrence or progressive disease. Overall, the average age of the 68 patients seen after initial diagnosis was 59.2 ± 9.47 years, and the two clinic groups did not differ significantly based on age. Participants were equally represented by 37 (54%) men and 31 (46%) women, with no difference between the clinic groups based on gender. With regard to the 25 thoracic participants who provided data following recurrence or progression, the average age was 62.5 ± 8.47 years, and the group consisted of 14 (56%) women and 11 (44%) men. Table 1 shows means and standard deviations for the importance ratings across four groups: combined clinics (thoracic and GI) following initial cancer diagnosis, thoracic clinic following initial cancer diagnosis, GI clinic following initial cancer diagnosis, and the thoracic clinic after recurrence/progress. The Figure illustrates the relative preference for each category. In total, 93 patients were surveyed. Ratings were highest for receiving a thorough explanation (6.91 ± 0.34) and for having their case discussed during the multidisciplinary case conference (6.56 ± 1.11). Mean ratings for other factors ranged from 5.42 to 5.90, with

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Research

the exception of access to clinical trials participation, which was rated the lowest (4.80 ± 1.92). Another approach to analyzing the data explored the percent of participants who rated each item as a 7 (extremely important). Results revealed a similar pattern, with more than 90% of individuals rating a thorough explanation as extremely important. The next highest rating (75%) was associated with multidisciplinary conference discussion. Although access to clinical trials remained the least likely to be rated a 7, this item was extremely important to 30% of participants. Analyses were also conducted to explore potential differences between the clinics. Participants in each clinic responded similarly (Table 1). Analyses exploring gender differences on importance ratings failed to identify any significant differences. There was no difference between the GI and thoracic multimodality clinic patients. Patients with recurring or progressive cancers showed a slightly higher interest in clinical trials, but still ranked trials below most other services. To explore the relationship between participant age and importance ratings, a series of Pearson correlations were conducted using the same four groups described previously. There were relatively few statistically significant correlations between age and importance ratings (Table 2). However, a couple of significant results were identified. For one, higher importance ratings for the opportunity to receive assistance regarding travel and financial support were reported by younger individuals, an effect that was largely driven by individuals from the thoracic clinic. In addition, younger age was moderately associated with higher importance ratings for clinical trials access in the combined clinic group, but again, this relationship was largely driven by participants from the thoracic clinic. Other moderate relationships were identified between younger age and more importance of a multidisciplinary case conference among thoracic clinic participants, and younger participants provided higher importance ratings for a thorough explanation by individuals from the GI clinic. discussion The main objective of this survey was to evaluate patient preferences when attending multimodality clinics. Patients placed the most value on understanding their disease and its treatment as well as having their case reviewed in a multidisciplinary conference. There are a number of roles for doctor and patient in medical decision making. These have been conceptual-

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ized as a spectrum with paternalism at one end, at the extreme of which the doctor makes decisions on behalf of the passive patient based on clinical expertise and without considering the patient’s preferences. At the other end is informed decision making, in which the doctor fully informs the patient, detailing all treatment options and their implications and transferring technical expertise so that the patient can make a decision alone based on his or her treatment preferences.3 To help understand the importance of doctor and patient roles in decision making, it helps to look at a study by Hack and colleagues. Their investigation indicated that not all women with breast cancer who receive chemotherapy experienced the same associated degree of distress and decrement in quality of life; it was only those women who received chemotherapy and reported having played a passive role in treatment decision making who were significantly more likely to have reported distress at 12 weeks following adjuvant treatment.4 It is possible that the passive decision style is imposed on the patient by factors associated with the medical context (such as the communication style of the health professional) that serve to erode a patient’s perceived ability to contribute effectively to decisions, thereby raising the level of distress. Despite general support for clinical trials, actual accrual in clinical trials remains low and does not appear to be consistent with public sentiments. Most patients consider research trials to benefit society by improving medical knowledge.5,6 There is a discrepancy between how individuals respond to general statements concerning the value and benefit of clinical trials and how they respond when making personal choices. For example, in a study by Cassileth and colleagues, more than half of the respondents chose “getting the best medical care” as the reason for considering clinical trial participation, yet they indicated that the treatment recommended by their physician would be superior to that provided in a clinical trial.5 In a recent study, female patients voiced positive attitudes toward clinical trials to enhance knowledge, but declined personal enrollment out of mistrust in doctors’ and the industry’s self-regulation.7 Mistrust in the healthcare system and the fear of being misinformed was also found as the reason for African Americans declining trial participation.8 Mills and colleagues, in a systematic review, recognized several specific patient-identified barriers to trial recruitment, including the intentions of those doing the research.9 Different ethnic backgrounds, lan-

Table 2 Correlations between Participant Age and Importance Ratings Thoracic, initial (n = 43)

0.05

0.04

0.16

-0.04

Treatment

-0.17

-0.28

0.11

0.06

Importance parameters Doctors

Gastrointestinal, initial (n = 25)

Thoracic, recurrence/ progression (n = 25)

Combined, initial (n = 68)

Explanation

-0.11

-0.04

-0.34

0.08

Appointment

-0.05

-0.23

-0.004

-0.10

Conference

-0.19

-0.30a

-0.07

0.08

Help

-0.28b

-0.34b

-0.15

0.21

Trials

-0.22

-0.30

-0.01

-0.10

P ≤.10. P ≤.05.

guages, historical experiences, and levels of education contribute to mistrust of the motivation of clinical researchers and the risks of experimental treatments.10 History provides several examples of why these concerns are justified.11,12 Loss of control by being uncertain about treatment allocation is a major barrier besides perceived harms, time commitment, loss of income, and lack of transportation.13 A recent metaanalysis confirmed that 40% to 50% of patients express a dislike toward the possibility of placebo use and randomization.9 The possibility of compromising their quality of life, inconvenience to everyday life, and potential side effects from the treatment have also been found to be among the main barriers.14-18 It should not surprise that the sense of uncertainty after being diagnosed with cancer is even more amplified by the complexities of study design or terms such as “randomized” and “placebo.” These may confuse or discourage otherwise eligible candidates from participating. Conclusions The present survey underscores that patients’ priority when attending multidisciplinary clinics is to understand their condition and management. Patients hope that the healthcare professionals working together “in conference” will shed the most light on their disease and treatment plan. Patients do not appreciate the clinical trial as helpful in this regard. Multidisciplinary clinics should, therefore, emphasize to the public and their patients that clinical trials do more than serve society’s understanding of disease. Healthcare providers should provide patients with tools to understand the trial as it relates to them. This includes an informed consent process that explains the study in detail, research personnel in addition to regular clinical healthcare workers, and a formal audit process. Cancer centers have to do a bet-

ter job in explaining to patients that clinical trials are in their best interest. l references 1. Benson AB 3rd, Pregler JP, Bean JA, et al. Oncologists’ reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study. J Clin Oncol. 1991;9:2067-2075. 2. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA.2004;291:2720-2726. 3. Street RL Jr, Gordon HS, Ward MM, et al. Patient participation in medical consultations: why some patients are more involved than others. Med Care. 2005;43:960-969. 4. Hack TF, Pickles T, Ruether JD, et al. Predictors of distress and quality of life in patients undergoing cancer therapy: impact of treatment type and decisional role. Psychooncology. 2009 Jun 25. Epub ahead of print. 5. Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. Attitudes toward clinical trials among patients and the public. JAMA.1982;248:968-970. 6. Trauth JM, Musa D, Siminoff L, et al. Public attitudes regarding willingness to participate in medical research studies. J Health Soc Policy. 2000;12:23-43. 7. Madsen SM, Holm S, Riis P. Attitudes towards clinical research among cancer trial participants and nonparticipants: an interview study using a grounded theory approach. J Med Ethics. 2007;33:234-240. 8. Kennedy BM, Burnett MF. Clinical research trials: factors that influence and hinder participation. J Cult Divers. 2007;14:141-147. 9. Mills EJ, Seely D, Rachlis B, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 2006;7:141-148. 10. Ellington L, Wahab S, Sahami Martin S, et al. Factors that influence Spanish- and English-speaking participants’ decision to enroll in cancer randomized clinical trials. Psychooncology.2006;15:273-284. 11. Ernst E. 50 years ago: the Nuremberg Doctors’ Tribunal. Part 4: Nazi medicine’s relevance today. Wien Med Wochenschr. 1997;147:70-71. 12. Ioannidis JP, Evans SJ, Gotzsche PC, et al; for the CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med.2004;141:781-788. 13. Ford JG, Howerton MW, Lai GY, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008;112:228-242. 14. Ellis PM, Butow PN, Tattersall MH. Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Ann Oncol. 2002;13:1414-1423. 15. Kemeny MM, Peterson BL, Kornblith AB, et al. Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol. 2003;21:2268-2275. 16. Solomon MJ, Pager CK, Young JM, et al. Patient entry into randomized controlled trials of colorectal cancer treatment: factors influencing participation. Surgery. 2003;133:608-613. 17. Ellis PM, Butow PN, Tattersall MH, et al. Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol. 2001;19:3554-3561. 18. Garcea G, Lloyd T, Steward WP, et al. Differences in attitudes between patients with primary colorectal cancer and patients with secondary colorectal cancer: is it reflected in their willingness to participate in drug trials? Eur J Cancer Care (Engl). 2005;14:166-170.

december 2010 I VoL 3, No 8

Cancer Center Profile Geisinger Medical Center’s Cancer Institute Joins the NCCCP... continued from cover

Thanjavur Ravikumar, MD, FACS, performs surgery in Geisinger's Center for Surgical Innovation.

disparities. NCCCP cancer centers are directed to increase programs to reach

News Note Americans Need Lung Cancer education Americans lack knowledge about lung cancer—its causes, its symptoms, its death rates— according to a survey released by the National Lung Cancer Partnership. The survey of 1000 adult men and women found that even though lung cancer is the number one cancer killer, it is not a disease that Americans worry about. For example: • 80% of respondents did not know that lung cancer is the number one killer • 83% of female respondents and 75% of male respondents did not know that lung cancer takes more lives than breast and prostate cancer, respectively • Only 12% of respondents knew the symptoms of lung cancer, as well as that radon is the second leading cause of lung cancer • Only 6% of respondents had spoken to their doctor about their risk for lung cancer • 32% of respondents knew that half of lung cancer occurred in patients who had previously quit smoking • 98% of respondents recognized that lung cancer does not just affect people who smoke. l

december 2010 I VoL 3, No 8

the underserved in their communities more effectively, thus improving access to cancer screening, treatment, and research. Community outreach The centerpiece at Geisinger is value-based healthcare delivery, a philosophy evident in its advanced patientcentered medical home program, known as ProvenHealth Navigator. At Geisinger, medical homes are caregivers, such as primary care physicians or nurse case managers, who provide service excellence beyond just seeing patients in an acute-care setting. Their proactive approach to chronic diseases is recognized by the National Committee for Quality Assurance—all 40 facilities distributed throughout Geisinger’s community have been recognized as Level 3, the highest level awarded for the medical home model. This philosophy of managing patients through a disease continuum that is continued into wellness programs—a philosophy that is also practiced by Geisinger’s cancer specialists—parallels the NCCCP’s vision of cancer as a disease continuum, according to Ravikumar. NCCCP cancer centers are tasked with improving the quality of care at community hospitals by promoting datadriven, evidence-based, and coordinated cancer care. In addition, NCCCP cancer centers are working to enhance their cancer survivorship and palliative care services. With a $1.7-million award from the NCCCP, Geisinger hopes to reach these goals. To do so, Geisinger will use its medical home model to reach patients and physicians who are not members of the Geisinger system. “We need to provide the same services to both Geisinger patients and non-Geisinger patients in

the 11 counties that surround us,” said Ravikumar in an interview with the Journal of Multidisciplinary Cancer Care. “Our plan through the NCCCP, our obligation, is to all patients in the counties that we serve.” According to Ravikumar, Geisinger plans to reach out to area physicians who are not participants in the Geisinger system through the Keystone Health Information Exchange (KeyHIE) initiative. This initiative aims to provide healthcare professionals with the timely information they need to provide the best care possible for their patients. Through the initiative’s master patient list, patients’ charts and all medical information that reside at any participating hospital can be accessed through a secure web-based browser. Information technology GMC’s Cancer Institute also has “significant strength in information technology,” noted Ravikumar. This is another area that marries well with the NCCCP’s mission. NCCCP cancer centers are charged with exploring what is needed to adapt or adopt the tools of the NCI’s cancer Bioinformatics Grid (caBIG) as well as to enhance their electronic health record (EHR) networks to support and link cancer patients and researchers nationwide. “What the NCCCP wants to do is connect all the cancer centers in the country through a grid called caBIG. They are trying to bring everyone up to speed. We are already advanced in that area, so perhaps the NCCCP thought that it would be a good thing for centers like ours to lead the way,” said Ravikumar. For the past 8 years, Geisinger has been recognized as one of the nation’s “100 Most Wired Hospitals and Health Systems” by Hospitals & Health Networks (H&HN), the journal of the American Hospital Association. As one of the most digitally advanced healthcare providers in the nation, Geisinger uses information technology to address safety and quality, customer service, business processes, workforce, and public health. research In addition, Geisinger already has a very robust biospecimen initiative through MyCode. Currently, MyCode has 20,000 DNA samples from patients throughout Geisinger. Patients at all levels of health are asked to participate, provide a blood sample, and give consent for its use in research. “If any studies need to be done across the cancer research at the community level, we are well positioned to carry out the mission of the NCCCP,” explained Ravikumar. To help the NCCCP reach its goal of applying NCI

Best Practices for Biospecimen Resources to enable all community cancer centers to contribute to the national biobank, Geisinger is expanding its specimen collection beyond Geisinger-affiliated cancer centers by “helping them retrieve the specimen when they operate on cancer patients,” Ravikumar said. As a member of the Community Clinical Oncology Program, Geisinger already has 11 of the 15 NCCCP clinical trials open at its cancer centers. According to Ravikumar, Geisinger plans to expand those 11 trials and open the additional four trials to patients in its community. Because of its rural patient base, Geisinger will offer trials at multiple sites so, as Ravikumar explains, the patients “do not have to come to us in our main center.” In addition, Geisinger accrues to trials through other oncology groups including the Eastern Cooperative Oncology Group and the North Central Cancer Treatment Group. “Using the NCCCP mechanism, we are going to make these trials available to people in the community through outreach and navigators and transportation service,” explained Ravikumar. “In addition, for clinical trials, we are going to enlist oncologists, radiation doctors, surgeons, and primary care physicians who are not Geisinger physicians and make sure that they have access to NCCCP clinical trials.” Quality care All of this, of course, is about the quality of care delivered. “We have some ideas of how we will use our EHR and our model of ProvenHealth to improve the quality of patient care, so every patient gets the same level of care,” said Ravikumar, a surgeon by profession. This care will continue through the disease continuum and include survivorship and palliative care. This past year, Geisinger has launched the Geisinger accelerated performance program (GAPP) initiative. “One of the central focuses of the GAPP initiative is palliative care, making sure that the patients that we cannot cure we offer palliation as a focus and that we keep their quality of life central to our mission.” GMC’s Cancer Institute will not be resting on its laurels. By becoming an NCCCP cancer center, Geisinger hopes to improve on its delivery of innovation and discovery and to enhance its diffusion of research and technology to positively influence cancer care today and tomorrow. Ravikumar looks forward to working with the other physician directors at the other sites. “We belong to the club. We may have one model. Others may other models. We will basically learn from each other,” Rauikumar stated. l

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Presents the Third Annual Curriculum for

CONSIDERATIONS IN MULTIPLE MYELOMA A Newsletter Series for Cancer Care Professionals Center of Excellence Media, along with Editor-in-Chief Sagar Lonial, MD, of Emory University, are pleased to offer your multidisciplinary cancer team this series of newsletters focusing on the challenges of treating patients with multiple myeloma.

SAGAR LONIAL, MD Associate Professor of Hematology and Oncology Emory University School of Medicine

★ Earn Continuing Education Credits ★ 8-part newsletter series

CASE STUDY DISCUSSIONS: • Front-line therapy

• Non-Transplant Patients

• Maintenance Settings

• Cytogenetics

• Transplant Settings

• Side Effect Management

• Retreatment Settings

• Bone Health

Each newsletter will feature: • Contributions from thought-leading physicians, nurses, and pharmacists

• Continuing Education credits available to physicians, nurses, and pharmacists

PARTICIPATE TODAY at www.COEXM.com For complete learning objectives and accreditation information, please refer to each activity.

Target Audience These activities were developed for physicians, nurses, and pharmacists.

These activities are jointly sponsored by

These activities are supported by an educational grant from Millennium Pharmaceuticals, Inc.

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Hematologic Cancers The following sections will assist healthcare professionals and payers by providing appropriate coding, billing, and reimbursement information associated with the management of multiple myeloma or myelodysplastic syndromes.

Multiple Myeloma Multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies).

The following sections include: • Associated ICD-9-CM codes used for the classification of multiple myeloma or myelodysplastic syndromes • Drugs that have been FDA-approved in the treatment of multiple myeloma or myelodysplastic syndromes • Drugs that are Compendia listed for off-label use for breast cancer based on clinical studies that suggest beneficial use in some cases. Please note: if a check mark appears in the FDA column it will NOT appear in the compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions • Current Code Price (AWP-based pricing) • Most recent ASP plus 6% (Medicare allowable), if applicable • Possible CPT® Administration Codes for each medication

generic (Brand) name

HCPCS code: code description

J9017: injection, arsenic trioxide, 1 mg J8499b: prescription drug, oral, non-chemotherapeutic, not otherwise specified betamethasone J0702: injection, acetate and betamethasone acetate betamethasone 3 mg, and sodium phosphate betamethasone sodium (Celestone Soluspan) phosphate 3 mg bortezomib J9041: injection, (Velcade) bortezomib, 0.1 mg carmustine J9050: injection, (BiCNU) carmustine, 100 mg cisplatin J9060: cisplatin, powder (Platinol AQ) or solution, per 10 mg cisplatin J9062: cisplatin, (Platinol AQ) 50 mg cortisone acetate J8499b: prescription drug, (Cortone) oral, non-chemotherapeutic, not otherwise specified cyclophosphamide J8530: cyclophosphamide, (Cytoxan) oral, 25 mg cyclophosphamide J9070: cyclophosphamide, (Cytoxan) 100 mg (all 100-mg NDCs inactive; 500-mg NDCs used to calculate code price)

Associated ICD-9-CM Codes Used for Multiple Myeloma 203 Multiple myeloma and immunoproliferative neoplasms The following fifth-digit subclassification is for use with category 203: 0 without mention of having achieved remission >Failed remission< 1 in remission 2 in relapse 203.0 Multiple myeloma Kahler’s disease Myelomatosis excludes: solitary myeloma (238.6) 203.1 Plasma cell leukemia Plasmacytic leukemia 203.8 Other immunoproliferative neoplasms

FDAapproved for multiple myeloma

arsenic trioxide (Trisenox) betamethasone (Celestone)

Compendia listed off-label use for multiple myelomaa

Current code price (AWP-based pricing), effective 11/1/10

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

CPT ® administration codes

✓

$47.51

$37.25

✓

NDC level pricing $8.00

NDC level pricing $6.24

✓

$46.66

$39.29

✓

$205.69

$175.88

✓

$4.33

$1.50

96409, 96413, 96415

✓

$21.66

$7.49

96409, 96413, 96415

✓

NDC level pricing $2.09

NDC level pricing $0.83

✓

$10.57

$5.96

✓

96413, 96415 N/A

11900, 11901, 20600, 20605, 20610, 96372

96409 96413, 96415

N/A

N/A 96409, 96413, 96415

Continued on page 24

december 2010 I VoL 3, No 8

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 22

FDAapproved for multiple myeloma

generic (Brand) name cyclophosphamide (Cytoxan)

HCPCS code: code description J9080: cyclophosphamide, 200 mg (all 100-mg NDCs inactive; 500-mg NDCs used to calculate code price) cyclophosphamide J9090: cyclophosphamide, (Cytoxan) 500 mg cyclophosphamide J9091: cyclophosphamide, (Cytoxan) 1 gram cyclophosphamide J9092: cyclophosphamide, (Cytoxan) 2 grams daunorubicin J9151: injection, (DaunoXome) daunorubicin citrate, liposomal formulation, 10 mg dexamethasone J8540: dexamethasone, (Decadron) oral, 0.25 mg dexamethasone J1100: injection, (Decadron) dexamethasone sodium phosphate, 1 mg doxorubicin J9000: injection, (Adriamycin) doxorubicin hydrochloride, 10 mg doxorubicin liposomal J9001: injection, (Doxil) doxorubicin hydrochloride, all lipid formulations, 10 mg epirubicin J9178: injection, (Ellence) epirubicin HCl, 2 mg etoposide J8560: etoposide, oral, (Vepesid) 50 mg etoposide J9181: injection, (Etopophos, Toposar) etoposide, 10 mg hydrocortisone J8499b: prescription drug, (Cortef) oral, non-chemotherapeutic, not otherwise specified hydrocortisone J1720: injection, (Solu-Cortef) hydrocortisone sodium succinate, up to 100 mg ifosfamide J9208: injection, (Ifex) ifosfamide, 1 gram interferon alfa-2b J9214: injection, interferon, (Intron-A) alfa-2b, recombinant, 1 million units interferon alfa-n3 J9215: injection, interferon, (Alferon-N) alfa-n3, (human leukocyte derived), 250,000 international units lomustine J8999b: prescription drug, (CeeNU) oral, chemotherapeutic, not otherwise specified lomustine S0178: lomustine, (CeeNU) oral, 10 mg melphalan (Alkeran) melphalan (Alkeran)

J8600: melphalan, oral, 2 mg J9245: injection, melphalan hydrochloride, 50 mg

december 2010 I VoL 3, No 8

Compendia listed off-label use for multiple myelomaa

✓

Current code price (AWP-based pricing), effective 11/1/10 $21.15

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10 $11.92

CPT ® administration codes 96409, 96413, 96415

✓

$52.87

$29.79

96409, 96413, 96415

✓

$95.21

$59.59

96409, 96413, 96415

✓

$171.35

$119.18

96409, 96413, 96415

✓

$68.00

$57.66

96413

✓

$0.09

$0.37

N/A

✓

$0.15

$0.09

✓

$13.20

$3.04

$613.03

$486.80

✓

$5.38

$1.80

✓

$57.33

$28.48

✓

$0.53

$0.55

✓

NDC level pricing $2.33

NDC level pricing $3.42

✓

$42.00

$34.15

96413, 96415

✓

$21.90

$16.06

96372, 96401

✓

$25.09

None reported

11900, 11901

✓

NDC level pricing $10.59

NDC level pricing S0178 not payable by Medicare $4.80

✓

$5.68

✓

$1,922.50

$1,401.83

11900, 11901, 20600, 20605, 20610, 96372, 96374 96409 96413

96409, 96413 N/A 96413, 96415 N/A

96365, 96366, 96372, 96374

N/A

N/A 96409, 96413

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

methylprednisolone (Depo-Medrol)

J1020: injection, methylprednisolone acetate, 20 mg J1030: injection, methylprednisolone acetate, 40 mg J1040: injection, methylprednisolone acetate, 80 mg J2920: injection, methylprednisolone sodium succinate, up to 40 mg J2930: injection, methylprednisolone sodium succinate, up to 125 mg J9265: injection, paclitaxel, 30 mg J3590b: unclassified biologics

methylprednisolone (Depo-Medrol) methylprednisolone (Depo-Medrol) methylprednisolone (Solu-Medrol) methylprednisolone (Solu-Medrol) paclitaxel (Onxol, Taxol) peginterferon alfa-2b (Peg-Intron)

FDAapproved for multiple myeloma

Compendia listed off-label use for multiple myelomaa

Current code price (AWP-based pricing), effective 11/1/10

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

CPT ® administration codes

✓

$3.78

$2.48

11900, 11901, 20600, 20605, 20610, 96372

✓

$5.22

$4.72

11900, 11901, 20600, 20605, 20610, 96372

✓

$9.52

$8.59

11900, 11901, 20600, 20605, 20610, 96372

✓

$2.36

$1.81

96365, 96366, 96372, 96374

✓

$4.15

$2.54

96365, 96366, 96372, 96374

✓

$15.54

$7.45

96413, 96415

✓

S0148: injection, pegylated interferon alfa-2b, 10 micrograms prednisolone J7510: prednisolone, (Prelone, Millipred) oral, per 5 mg prednisone J7506: prednisone, (Orasone, Deltasone) oral, per 5 mg procarbazine J8999b: prescription drug, (Matulane) oral, chemotherapeutic, not otherwise specified procarbazine S0182: procarbazine HCl, (Matulane) oral, 50 mg

✓

NDC level pricing $116.77

✓

$0.59

NDC level pricing S0148 not payable by Medicare $0.02

✓

$0.04

N/A

✓

teniposide (Vumon) thalidomide (Thalomid)

✓

$376.55

NDC level pricing S0182 not payable by Medicare $323.66

N/A

✓

NDC level pricing $55.68

✓

NDC level pricing $1,348.55

NDC level pricing $1,090.84

96413

✓

$5.83

$3.98

96409

✓

$11.66

$7.96

96409

✓

$29.15

$19.90

96409

$263.39

$223.10

peginterferon alfa-2b (Peg-Intron)

topotecan (Hycamtin) vinCRIStine (Vincasar PFS) vinCRIStine (Vincasar PFS) vinCRIStine (Vincasar PFS) zoledronic acid (Zometa)

Q2017: injection, teniposide, 50 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J9350: injection, topotecan, 4 mg J9370: vincristine sulfate, 1 mg J9375: vincristine sulfate, 2 mg J9380: vincristine sulfate, 5 mg J3487: injection, zoledronic acid (Zometa), 1 mg

✓

96372

N/A

96413, 96415 N/A

96365, 96374

Continued on page 26 www.jomcc.com

december 2010 I VoL 3, No 8

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 25

Associated ICD-9-CM Codes Used for Myelodysplastic Syndromes

Myelodysplastic Syndromes Myelodysplastic syndromes are a group of diseases in which the bone marrow does not make enough healthy blood cells.

generic (Brand) name

HCPCS code: code description

amifostine (Ethyol) arsenic trioxide (Trisenox) azacitidine (Vidaza) clofarabine (Clolar) cytarabine (Cytosar-U) cytarabine (Cytosar-U) darbepoetin alfa (Aranesp)

J0207: injection, amifostine, 500 mg J9017: injection, arsenic trioxide, 1 mg J9025: injection, azacitidine, 1 mg J9027: injection, clofarabine, 1 mg J9100: injection, cytarabine, 100 mg J9110: injection, cytarabine, 500 mg J0881: injection, darbepoetin alfa, 1 microgram (non-ESRD use) J0882: injection, darbepoetin alfa, 1 microgram (for ESRD on dialysis) J0894: injection, decitabine, 1 mg J0885: injection, epoetin alfa (for non-ESRD use), 1000 units J0886: injection, epoetin alfa 1000 units (for ESRD on dialysis; renal dialysis facilities and hospitals must use code Q4081, effective 1/1/07) Q4081: injection, epoetin alfa, 100 units (for ESRD on dialysis; for renal dialysis facilities and hospital use)

darbepoetin alfa (Aranesp) decitabine (Dacogen) epoetin alfa (Procrit, Epogen) epoetin alfa (Procrit, Epogen)

epoetin alfa (Procrit, Epogen)

238 Neoplasm of uncertain behavior of other and unspecified sites and tissues 238.7 Other lymphatic and hematopoietic tissues excludes: acute myelogenous leukemia (205.0) chronic myelomonocytic leukemia (205.1) myelosclerosis, not otherwise specified (289.89) myelosis: not otherwise specified (205.9) megakaryocytic (207.2) 238.72 Low-grade myelodysplastic syndrome lesions Refractory anemia (RA) Refractory anemia with ringed sideroblasts (RARS) Refractory cytopenia with multilineage dysplasia (RCMD) Refractory cytopenia with multilineage dysplasia and ringed sideroblasts (RCMD-RS) 238.73 High-grade myelodysplastic syndrome lesions Refractory anemia with excess blasts-1 (RAEB-1) Refractory anemia with excess blasts-2 (RAEB-2) 238.74 Myelodysplastic syndrome with 5q deletion 5q minus syndrome, not otherwise specified excludes: constitutional 5q deletion (758.39) high-grade myelodysplastic syndrome with 5q deletion (238.73) 238.75 Myelodysplastic syndrome, unspecified

FDAapproved for myelodysplastic syndromes

Compendia listed off-label use for myelodysplastic syndromesa

Current code price (AWP-based pricing), effective 11/1/10

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

CPT ® administration codes

✓

$564.95

$318.66

✓

$47.51

$37.25

$6.03

$5.13

✓

$135.00

$115.41

✓

$1.25

$1.98

✓

$10.20

$3.67

✓

$6.44

$2.90

96409, 96413, 96415, 96450 96409, 96413, 96415, 96450 96372, 96374

✓

$6.44

$2.90

96372, 96374

$35.50

$30.74

96413, 96415

✓

$15.34

$9.68

96372, 96374

✓

$15.34

$9.68

96372, 96374

✓

$1.53

$0.97

96372, 96374

✓

96374 96413, 96415 96401, 96409, 96413 96413, 96415

Continued on page 28

december 2010 I VoL 3, No 8

www.jomcc.com

CONTINUING EDUCATION CREDITS Current activities at www.COEXM.com include:

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 26

generic (Brand) name

HCPCS code: code description

etoposide (Vepesid) etoposide (Toposar, Etopophos) filgrastim (Neupogen) filgrastim (Neupogen) fludarabine (Fludara) imatinib (Gleevec)

J8560: etoposide, oral, 50 mg J9181: injection, etoposide, 10 mg J1440: injection, filgrastim (G-CSF), 300 micrograms J1441: injection, filgrastim (G-CSF), 480 micrograms J9185: injection, fludarabine phosphate, 50 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0088: imatinib, 100 mg

imatinib (Gleevec) lenalidomide (Revlimid) lymphocyte immune globulin (Atagam) lymphocyte immune globulin (Thymoglobulin) sargramostim (Leukine) thalidomide (Thalomid) topotecan (Hycamtin)

FDAapproved for myelodysplastic syndromes

J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J7504: lymphocyte immune globulin, antithymocyte globulin, equine, parenteral, 250 mg J7511: lymphocyte immune globulin, antithymocyte globulin, rabbit, parenteral, 25 mg J2820: injection, sargramostim (GM-CSF), 50 micrograms J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J9350: injection, topotecan, 4 mg

Compendia listed off-label use for myelodysplastic syndromesa

Current code price (AWP-based pricing), effective 11/1/10

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

✓

$57.33

$28.48

✓

$0.53

$0.55

✓

$283.02

$233.43

✓

$450.66

$366.81

✓

$285.16

$139.57

NDC level pricing $48.56

CPT ® administration codes N/A 96413, 96415 96365, 96366, 96369, 96370, 96372, 96374 96365, 96366, 96369, 96370, 96372, 96374 96413

✓

NDC level pricing $643.21

NDC level pricing S0088: not payable by Medicare NDC level pricing $496.95

96365, 96366

✓

$636.48

$417.51

96365, 96366

✓

$44.64

$23.88

✓

NDC level pricing $1,348.55

NDC level pricing $1,090.84

✓

N/A

96365, 96366, 96372 N/A

96413

Compendia references available upon request. When billing a non-classified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J8999 for CeeNU) in Column 24D and the drug name, strength, and National Drug Code (NDC) in Box 19 to ensure appropriate reimbursement.

References HCPCS Level II Expert, 2010 • Current Procedural Terminology (CPT®), 2010 (CPT® copyright © 2010 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1 & 2, 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 4, 4th Quarter 2010 • FDA-approved indication (from product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare & Medicaid Services), Medicare Allowable 4th Quarter 2010 (effective dates: 10/1/10-12/31/10). Prices listed herein are effective as of November 1, 2010. ASP indicates average sales price; AWP, average wholesale price; CMS, Centers for Medicare & Medicaid Services; CPT, Current Procedural Terminology; FDA, US Food and Drug Administration; ESRD, end-stage renal disease; G-CSF, granulocyte colony-stimulating factor; GM-CSF, granulocyte-macrophage colony-stimulating factor; HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code.

This information was supplied by:

PO BOX 290616, Wethersfield, CT 06109 T: (860) 563-1223 • F: (860) 563-1650 www.RJHealthSystems.com

december 2010 I VoL 3, No 8

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value-focused www.ValueBasedCancer.com www.ValueBasedCancer.com

New NewTools ToolsArriving ArrivingtotoMeasure Measureand and NCCN NCCNRoundtable: Roundtable:Clinical Clinicaland and Manage Economic ManageChemotherapy ChemotherapyCare Care EconomicIssues IssuesImpacting Impacting Business, Cancer Business,clinical clinicalconcerns concernsnow nowconnected connectedinin CancerCare CareDelivery Delivery value-focused value-focusedapproach approach ByBy Daniel Denvir Daniel Denvir

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Baltimore, MD—A long-held business Baltimore, MD—A long-held business truism is is that “if“if you can’t measure it, it, truism that you can’t measure you it.”it.” The application youcan’t can’tmanage manage The application ofofthis thisbelief beliefto tothetheoncology oncologysetting setting was demonstrated at a session of the was demonstrated at a session of the Association AssociationofofCommunity CommunityCancer Cancer Cen ters’ 36th Annual National Cen ters’(ACCC) (ACCC) 36th Annual National Meeting. Kimberly Bergstrom, PharmD, Meeting. Kimberly Bergstrom, PharmD, chief clinical officer for McKesson chief clinical officer for McKesson Specialty Care Solutions, told attendees Specialty Care Solutions, told attendees ofof thethe growing importance of of developing growing importance developing and andusing usingstandardized standardizedchemotherapy chemotherapy treatment regimens, and of of thethe tools that treatment regimens, and tools that

cost control

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“Collision “Collisioncourse” course”ininsight sight cancan benchmark performance andand foster benchmark performance foster compliance with treatment guidelines. Dr DrGoodman Audrey Andrews Goodman compliance with treatment guidelines. By By Audrey Andrews Public and private payers areare movalluded to atolevel Public and private payers movalluded a level ingingto tocontrol exploding healthcare thatthat of frustration control exploding healthcare Hollywood, Hollywood,FL—Clinical FL—Clinicalpractice practice of frustration never been costs, told attendees, issued by by thethe National costs,DrDrBergstrom Bergstrom told attendees, guidelines guidelines issued National hashas never been and control in in cancer andbecause becauseincreased increasedcost cost control Comprehensive ComprehensiveCancer CancerNetwork Network higher higher cancer was areare followed by by conscien“Too many wasinevitable, inevitable,it itis isin inproviders’ providers’ (NCCN) (NCCN) followed conscien- care. care. “Too many interest to to getget a seat at at thethe table. tious oncologists in in their everyday areare stillstill interest a seat table. tious oncologists their everyday patients patients “It“It is is anan important topic, because areare developed young. WeWe important topic, because practice, practice,butbutthey they developed dying dying young. this is one of of those things, if we don’t on on clinical efficacy andand without innovations andand a cure,” he said. this is one those things, if we don’t based based clinical efficacy without need need innovations a cure,” he said. getget a handle on it, it’s going to happen regard to costs. At a roundtable held But the inadequacy of current treatof current treata handle on it, it’s going to happen regard to costs. At a roundtable held But the inadequacy to to us,” sheshe said. “People and groups NCCN’s 15th Annual for for cancer is no the the main us,” said. “People and groups during duringthethe NCCN’s 15th Annual ments ments cancer is longer no longer main Equally challenging, he sugand organizations areare going to to start and organizations going start Conference, Conference, moderator moderator Clifford Clifford problem. problem. Equally challenging, he sugdictating how we provide cancer care, Goodman, PhD, Senior Vice President gested, is finding a means to pay for dictating how we provide cancer care, Goodman, PhD, Senior Vice President gested, is finding a means to pay for and wewe can’t letlet that happen.” at The Lewin Group, predicted, “The ever-costlier carecare thatthat threatens to to and can’t that happen.” at The Lewin Group, predicted, “The thethe ever-costlier threatens appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 guidelines is on a collision course As society struggles to find soluAs society struggles to find soluguidelines is on a collision course with the financial nonsustainability of tions, “the ground is shaking beneath with the financial nonsustainability of tions, “the ground is shaking beneath the healthcare system.” us,” Dr Goodman commented. the healthcare system.” us,” Dr Goodman commented.

Value-Based Value-BasedCancer CancerCare Care will willbebeatatthe theASCO ASCOAnnual Annual Meeting, June 4-8, in Chicago. Meeting, June 4-8, in Chicago.

Continued on page 19 Continued on page 19

Please visit usus atat booth 18121 Please visit booth 18121

SEER-Medicare SEER-MedicareDatabase DatabaseAnalysis Analysis Confirms Expensive Prostate Confirms Expensive Prostate Breast BreastCancer CancerSurvival SurvivalImproves, Improves, Cancers CancersGaining GainingSupremacy Supremacy Photo by © ASCO/Todd Buchanan 2009 Photo by © ASCO/Todd Buchanan 2009

Thanks ThankstotoNew NewTherapies Therapies

efficacy

cost effectiveness

But remains to to Butcost-effectiveness cost-effectivenessofofthis thismove move remains bebedetermined determined

Breast Cancer Conference (EBCC7). Breast Cancer Conference (EBCC7). This improvement, the researchers By Rosemary Frei, MSc This improvement, the researchers By Rosemary Frei, MSc Barcelona—Survival for patients with suggest, is due to increased use of The 2010 Genitourinary Cancers Barcelona—Survival for patients with suggest, is due to rise increased use of San Francisco, CA—The popularity of The 2010 Progress Genitourinary Cancers metastatic breast cancer has improved anthracyclines and the of targeted Symposium: in Multi San Francisco, CA—The metastatic breast has improved anthracyclines and the rise of targeted minimally Symposium: Progresswas in held Multidramatically in the cancer last 20 years, espe- therapies. Management invasive radical popularity prostatec- of disciplinary minimally radical prostatec- March dramatically in the last 20 years,with espe- “There therapies. disciplinary Management cially in the subgroup of patients is no doubt that trastuzu- tomy 5-7 in San Francisco. Allwas ses-held (MIRP),invasive intensity-modulated tomy (MIRP), intensity-modulated cially in the subgroup of patients with “There is no doubt that trastuzu March 5-7 in San Francisco. All HER2-positive tumors, according to mab (Herceptin), which targets the radiation therapy (IMRT), and of sions emphasized a multidisciplinarysesradiation therapy (IMRT), and of approach HER2-positive mab gene, (Herceptin), which important targets the brachytherapy sions emphasized a multidisciplinary research presentedtumors, at the 7thaccording European to HER2 is the most to care; a number of them combined with IMRT research presented at the 7th European HER2 gene, is the most important forbrachytherapy approach to cost care;and a number of them brought out the value issues prostate cancercombined started towith take IMRT off Continued on page 27 for 2002, prostate cancer started analysis to take off associated broughtwith out the cost for andgenitourivalue issues Continued on page 27 after caring a new database after 2002, a new database analysis associated with caring for genitourinary cancers. has confirmed. hasthe confirmed. nary cancers. At American Society of Clinical At the American Society of Can Clinical Oncology’s 2010 Genitourinary - and Women’s Hospital, Harvard Oncology’s 2010Paul Genitourinary Can- Medical and Women’s Hospital, Harvard School, Boston, and his cocers Symposium, L. Nguyen, cerspresented Symposium, Nguyen, Medical School, his coMD, the Paul resultsL. of his investigators foundBoston, MIRP and jumped investigators found MIRP jumped MD, analysis presentedof the team’s dataresults from of thehis from 1.5% of radical prostatectomies team’s analysis of dataand from from of 28.7% radicalinprostatectomies Surveillance, Epidemiology Endthe (RPs) in 1.5% 2002 to 2005. They Surveillance, Epidemiology and End also(RPs) in 2002 28.7% in 2005. They Results (SEER)-Medicare database. found that to IMRT soared from also found that IMRT treatments soared from Results (SEER)-Medicare Dr Nguyen, director of database. Prostate 8.7% of external radiation Dr Nguyen, director of Prostate for 8.7% of external radiation treatments prostate cancer to 81.7%. In addiBrachytherapy, Dana-Farber/Brigham Brachytherapy, Dana-Farber/Brigham for prostate cancer to 81.7%. In 24 addiContinued on page

By Colin Gittens By Colin Gittens

targeted therapies

Continued on page 24

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