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

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Eisenberger, M. A. Articles by Tannock, I. Search for Related Content PubMed Articles by Eisenberger, M. A. Articles by Tannock, I.

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

4

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)

View larger version (25K): [in this window] [in a new window]

Abstract presentation from the 2004 ASCO Annual Meeting