A Phase II Randomized Crossover Study of Liposomal Doxorubicin Versus Weekly Docetaxel in the First-line Treatment of Women With Metastatic Breast Cancer |
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| Authors: | Denise A. Yardley Howard A. Burris David R. Spigel Bobby L. Clark Elizabeth Vazquez Dianna Shipley John Barton Dana Thompson Ignacio Montes F. Anthony Greco John D. Hainsworth |
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| Affiliation: | 1. Sarah Cannon Research Institute, Nashville, TN;2. Tennessee Oncology, Nashville, TN;3. Consultants in Blood Disorder and Cancer, Louisville, KY;1. Department of Oral, Maxillofacial and Facial Plastic Surgery, Ludwigshafen Hospital, Bremserstrasse 79, 67063 Ludwigshafen, Germany;2. Department of Plastic and Reconstructive Surgery, Burn Center, Trauma Center, BG Ludwigshafen, Ludwig-Guttmann-Straße 13, 67071 Ludwigshafen, Germany;1. Department of Radiation Oncology, University of Colorado Hospital, Aurora, CO;2. Department of Statistics, Radiation Therapy Oncology Group, Philadelphia, PA;3. Department of Radiation Oncology, AZ Oncology Services, Scottsdale, AZ;4. Radiation Oncology, Arizona Breast Cancer Specialists, Scottsdale, AZ;5. Department of Surgery, Ochsner Clinic, New Orleans, LA;6. Department of Radiation Oncology, Medical College of Virginia, Richmond, VA;7. Department of Radiation Oncology, Ochsner Baptist Medical Center, New Orleans, LA;8. Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI;9. Radiation Oncology, Michigan HealthCare Professionals/21st Century Oncology, Farmington Hills, MI;10. Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY;11. Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI;12. Department of Radiation Oncology, Ohio State University Medical Center, Columbus, OH;1. Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Cancer Prevention and Control, Epidemiology and Applied Research Branch, 4770 Buford Hwy NE, MS F-76, Atlanta, GA 30341, USA;2. Battelle, Health & Analytics, 1100 Dexter Ave N, Suite 400, Seattle, WA 98109, USA;1. Department of Physiology I, University of Tübingen, Tübingen, Germany;2. Department of Pediatric Surgery and Pediatric Urology, University Children''s Hospital Tübingen, Tübingen, Germany;3. Department of Cardiology & Cardiovascular Medicine, University of Tübingen, Tübingen, Germany;4. Department of Pharmacy, University of Tübingen, Tübingen, Germany |
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| Abstract: | PurposeWe aim to compare the efficacy and toxicity of liposomal doxorubicin and weekly docetaxel as first-line treatments for patients with metastatic breast cancer (MBC).Patients and MethodsPatients who had received no previous chemotherapy for MBC were eligible. Previous hormonal therapy, adjuvant chemotherapy, and radiation therapy were allowed. Patients were randomized to receive liposomal doxorubicin 40 mg/m2 intravenously [I.V.] every 28 days or weekly docetaxel 36 mg/m2 I.V. days 1, 8, and 15, repeated every 28 days. Patients with objective response or stable disease after 2 cycles continued treatment until tumor progression or unacceptable toxicity. At progression, patients were allowed to cross over to the other regimen. The trial was designed to detect a true difference of 10% in response rate with an 80% power.ResultsBetween March 2001 and July 2007, 102 patients were randomized. The 2 groups had similar demographics; 68% of patients had received previous adjuvant chemotherapy. Liposomal doxorubicin and weekly docetaxel produced similar objective response rates (28% vs. 31%), disease control rates (48% vs. 44%), and progression-free survival (6.5 months vs. 5.5 months). Both agents were well tolerated. Both agents produced crossover responses as second-line treatment (liposomal doxorubicin, 35%; weekly docetaxel, 14%).ConclusionLiposomal doxorubicin is well tolerated and has activity similar to weekly docetaxel in the first-line treatment of patients with MBC. |
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