Weekly Docetaxel And Prednisolone Versus Prednisolone Alone In Androgen-Independent Prostate Cancer: A Randomized Phase II Study

Main Category: Urology / Nephrology
Also Included In: Prostate / Prostate Cancer;  Cancer / Oncology
Article Date: 05 Mar 2007 - 0:00 PDT

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UroToday.com- In 2004 two large randomized clinical trials demonstrated that docetaxel based chemotherapy improved survival in androgen-independent prostate cancer (AICAP). In combination with prednisone, patients had improved quality of life and this is now the standard therapy for AICAP. However, docetaxel chemotherapy is expensive, and in 2002 the Norwegian Urological Cancer Group had started a phase II study comparing docetaxel chemotherapy with prednisolone to prednisolone alone. The primary endpoint was PSA response, however after the publication of the trials showing a survival benefit for docetaxel treated patients in 2004, this study was closed for accrual. Dr. Fossa and associates publish the data in the online version of European Urology and to date this is the only trials comparing these two treatment groups. The combination of docetaxel and prednisolone was superior.

Patients had AICAP, metastatic disease and castrate levels of testosterone. Arm A patients were treated with docetaxel on days 1, 8, 15, 22, and 29 plus prednisolone 5mg twice daily with each cycle lasting 6 weeks. Oral methylprednisolone (32mg) was given one hour prior to each docetaxel infusion. Arm B patients received prednisolone (5mg) twice daily. During the 36-week trial, patients had clinical and laboratory assessment.

A total of 104 and 97 patients were eligible for evaluation at 6 and 12 weeks, respectively. In Arm A, 29 of 54 patients (54%) responded at 6 weeks, compared to 13 of 50 patients (26%) in Arm B. The respective numbers at 12 weeks were 36 of 52 (69%) in Arm A and 16 of 45 patients (35%) in Arm B. By August 2005, 40 patients in Arm A and 38 patients in Arm B had progressed. Median progression-free survival was 11 months in Arm A and 4 months in Arm B. The median overall survival was 27 months in Arm A and 18 months in Arm B.

Treatment of AICAP patients with docetaxel and prednisolone led to improved survival without unacceptable toxicity compared to prednisolone alone. The significant survival improvement suggests that docetaxel is clearly justified even in the context of increased costs.

Fossa SD, Jacobsen AB, Ginman C, Jacobsen IN, Overn S, Iversen JR, Urnes T, Dahl AA, Veenstra M, Sandstad B
Eur Urol 2006;epub

Reviewed by UroToday.com Contributing Editor Christopher P. Evans, MD

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