Clinical Oncology News - Jan/Feb 2009 - Vol. 4, No. 1

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FDA NEWS

Clinical Oncology News • JANUARY/FEBRUARY 2009

Degarelix Approved for Prostate Cancer

Hypothalamus GnRH

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he FDA has approved degarelix (Ferring Pharmaceuticals), an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of advanced prostate cancer. Potential trade names are still under review with the FDA. Phase III trials showed that degarelix is at least as effective as leuprolide (Lupron Depot, Abbott Laboratories) in sustaining castrate levels or lower of testosterone, and resulted in a statistically significant faster reduction of testosterone. By day 3 of treatment, 96% of patients receiving degarelix achieved castrate levels of testosterone, compared with

Anterior Pituitary Gland

FSH, LH Testis Prostate Gland

Hormonal regulation of the prostate gland Academy GmbH & Co. KG Provided by www.prostatecancerliving.com

see FDA NEWS, page 15 

Copyright © 2009 by McMahon Publishing, New York, NY 10036. All rights reserved. Clinical Oncology News (ISSN 1933-0677) is published monthly ­for $70.00 per year by McMahon Publishing. Postage paid at New York, NY, and at additional mailing offices.

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Advisory Board Bioethics Joseph P. DeMarco, PhD, Professor Emeritus of Philosophy, Department of Philosophy, Cleveland State University, Cleveland, OH Paul J. Ford, PhD, Associate Staff in Bioethics and Neurology, The Cleveland Clinic Foundation; Assistant Professor, Cleveland Clinic Foundation Lerner College of Medicine of Case Western Reserve University, Cleveland, OH

Community Oncology John W. Finnie, MD, Staff Hematologist and Medical Oncologist, David C. Pratt Cancer Center, St. John’s Mercy Medical Center, St. Louis, MO

Hematologic Malignancies Jennifer R. Brown, MD, PhD, Attending Physician, CLL & Lymphoma Program, Dana-Farber Cancer Institute; Assistant Professor of Medicine, Harvard Medical School, Boston, MA Agnes Y.Y. Lee, MSc, MD, Associate Professor, Department of Medicine, McMaster University; Consultant, Thromboembolism Service, Hamilton Health Sciences Henderson General Hospital, Hamilton, Ontario Richard Stone, MD, Clinical Director of the Adult Acute Leukemia Program, Dana-Farber Cancer Institute; Associate Professor of Medicine, Harvard Medical School, Boston, MA

Oncology Nursing Betty Ferrell, RN, PhD, Research Scientist, City of Hope National Medical Center, Duarte, CA

Pharmacy Polly E. Kintzel, PharmD, Clinical Pharmacy Specialist—Oncology, Spectrum Health Hospitals, Grand Rapids, MI Melvin E. Liter, MS, PharmD, Liter Enterprises, Liter Consulting Services, Lexington, KY

Policy and Management Mary Lou Bowers, MBA, President and CEO, Barbara Constable, RN, MBA, Director,

Testosterone

0% receiving leuprolide. By day 14, 99% of patients receiving degarelix achieved castrate levels of testosterone, compared with 18% receiving leuprolide. In the clinical trial, prostate-specific antigen (PSA) levels were also monitored as a secondary end point. PSA levels were reduced by 64% two weeks after administration of degarelix; 85% after one month; 95% after three months; and remained suppressed throughout the one-year period of treatment. These results should be interpreted with caution because of the heterogeneity of the patient population studied. There is no evidence showing that the rapidity of PSA decline is related to a clinical benefit.

Rhonda M. Gold, RN, MSN, Director, The Pritchard Group, LLC, Rockville, MD

Solid Tumors Bone Metastases Allan Lipton, MD, Professor of Medicine and Oncology, Milton S. Hershey Medical Center, Penn State University, Hershey, PA

Breast Cancer Andrew Seidman, MD, Attending Physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center; Associate Professor, Weill Cornell Medical College, New York, NY

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Gynecologic Cancer

Editorial Staff

Maurie Markman, MD, Vice President for Clinical Research, University of Texas M.D. Anderson Cancer Center, Houston, TX

Kate O’Rourke, Editor korourke@mcmahonmed.com

Lung, and Head and Neck Cancers Edward S. Kim, MD, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX

Lung Cancer, Emesis Richard J. Gralla, MD, President, New York Lung Cancer Alliance, New York, NY

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com James Prudden, Group Editorial Director David Bronstein, Editorial Director, Hospital Group Robin B. Weisberg, Manager, Copyediting Services Elizabeth Zhong, Associate Copy Chief Vanessa Atanasio, Contributing Editor Barbara Gormise, Senior Copy Editor

Gastrointestinal Cancer

Infection Control

Edward Chu, MD, Chief, Section of Medical Oncology; Professor of Medicine and Pharmacology; Deputy Director of Clinical Research, Yale Cancer Center, Yale University, New Haven, CT

Susan K. Seo, MD, Director, Antibiotic Management Program, Assistant Member, Memorial Sloan-Kettering Cancer Center, New York, NY

Sales Staff

Symptom Control and Palliative Care

Julianna Dawson, Associate Publication Director jdawson@mcmahonmed.com

William S. Breitbart, MD, Chief, Psychiatry Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY

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Steven D. Passik, PhD, Associate Professor of Psychology in Psychiatry, Weill Cornell Medical College; Associate Attending Psychologist, Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY

Michele McMahon Velle, Creative Director, MAX Graphics

Joseph V. Pergolizzi Jr., MD, Adjunct Assistant Professor, Johns Hopkins University School of Medicine, Baltimore, MD

Martin Barbieri, Production Manager

Cathy Eng, MD, Associate Professor, Department of Gastrointestinal Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX Leonard Saltz, MD, Attending Physician, Memorial Sloan–Kettering Cancer Center; Professor of Medicine, Weill Cornell Medical College, New York, NY

Gastrointestinal Cancer and Sarcoma Ephraim Casper, MD, Associate Chairman, Regional Network, Department of Medicine, Memorial Sloan-Kettering Cancer Center; Professor of Medicine, Weill Cornell Medical College, New York, NY

General Oncology Michael J. Fisch, MD, MPH, Medical Director, Clinical Community Oncology Program Research Base, Associate Professor of General Oncology and Palliative Care, University of Texas M.D. Anderson Cancer Center, Houston, TX

Genitourinary Cancer Ronald M. Bukowski, MD, Director of Experimental Therapeutics Program, Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, OH

Russell K. Portenoy, MD, Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, NY Charles F. von Gunten, MD, PhD, Director of the Center for Palliative Studies, San Diego Hospice and Palliative Care; Medical Director of the Doris A. Howell Service and Associate Clinical Professor of Medicine at the University of California, San Diego, CA

Laura Tendler, Copy Editor

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Art and Production Staff Frank Tagarello, Senior Art Director/ Managing Director, MAX Graphics Dan Radebaugh, Director of Production and Technical Operations

McMahon Publishing Raymond E. McMahon, Publisher & CEO, Managing Partner Van Velle, President, Partner Thomas Ciriacks, Vice President, Medical Education Matthew McMahon, General Manager, Partner Lauren Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

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