Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 4
© 2004 American Society of Clinical Oncology

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Abstract

A multicenter phase III comparison of docetaxel (D) + prednisone (P) and mitoxantrone (MTZ) + P in patients with hormone-refractory prostate cancer (HRPC)

Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Erasmus University, Rotterdam, Netherlands; US Oncology, Raleigh, NC; Orszagos Onkologiai Intezet, Budapest, Hungary; Onkologiczny Klinika Chemotherapii, Lodz, Poland; BC Cancer Agency, Vancouver, BC, Canada; Hopital Europeen Georges Pompidou, Paris, France; Institute Gustave Roussy, Villejuif, France; Queen Elizabeth Hospital, Edgbaston, United Kingdom; Princess Margaret Hospital, Toronto, ON, Canada

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Background: Docetaxel-based regimens have shown encouraging anti-tumor activity in phase II trials in HRPC. This study compared two schedules of D+P to MTZ+P, an accepted standard in HRPC. Methods: Patients (pts) with histologically-proven metastatic HRPC, testosterone <50 ng/ml, adequate hematologic and organ function, clinical and/or biochemical (PSA) progression, and no antiandrogens within 6 wk, were stratified by pain and KPS and randomized to daily prednisone (5mg po bid) plus D (ARM A-75mg/m² q3wk x 10 cycles; ARM B-30mg/m²/wk x 5 of 6 wk x 5 cycles) or MTZ (ARM C-12mg/m² q3wk x 10 cycles). Primary endpoint was survival; secondary endpoints included PSA response (50% decrease for at least 4 wk), pain response, and toxicity. A modified Bonferroni method was used to adjust for multiple comparisons. Results: 1,006 pts were randomized. Median follow up was 20.7 mo. Pts in all arms had similar baseline characteristics. Planned treatment was delivered to 98%, 96% and 99% pts in A, B, and C, respectively. Grade 3/4 toxicities (% pts A, B, C): overall (45.8%, 43.0%, 34.6%), including bone pain (7.8%, 7.3%, 9.9%), infection (5.7%, 5.5%, 4.2%), fatigue (4.5%, 5.5%, 5.1%), and diarrhea (2.1%, 4.8%, 1.2%). The most common laboratory grade 3/4 toxicity was neutropenia (32.0%, 1.5%, 21.7%). Conclusions: The D q3wk +P schedule improved overall survival and increased pain response and PSA response vs MTZ+P. It was well tolerated, but with more grade 3/4 neutropenia than MTZ+P. This is the first phase III study to show a significant survival benefit in HRPC. (Supported by Aventis)

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Abstract presentation from the 2004 ASCO Annual Meeting