Bicalutamide combination therapy versus castration alone: A combined analysis of historical data

Autor: L. Klotz, Paul F. Schellhammer, K. J. Carroll
Rok vydání: 2004
Předmět:
Zdroj: Journal of Clinical Oncology. 22:4634-4634
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2004.22.90140.4634
Popis: 4634 Background: Meta-analyses of randomized trials using flutamide or nilutamide + castration compared with castration alone in D2 prostate cancer have shown a modest overall survival benefit. No direct comparisons have been undertaken of combination therapy using bicalutamide (‘Casodex’) 50 mg with castration alone; here we combine historical data to try to delineate the likely benefit of bicalutamide in this setting. This methodology has been well accepted in other oncology areas: eg in colon cancer, studies comparing the efficacy of 5-fluorouracil (5-FU) + leucovorin to 5-FU alone, and 5-FU + leucovorin to capecitabine, were integrated on the principle that equivalent groups were being compared in otherwise disparate studies (Stat Med 2003;22:239–64). This analysis resulted in FDA approval for capecitabine based on this approach. Methods: A double-blind, randomized, multicenter trial comparing bicalutamide and flutamide combination therapy (Urology 1997;50:330–6) was combined with the Prostate Cancer ...
Databáze: OpenAIRE