BACKGROUND AND OBJECTIVES: Since previous studies have indicated there are improvements in overall survival, the aim of this phase II clinical study was to evaluate docetaxel every three weeks plus prednisone as first-line chemotherapy for treatment of hormone-refractory metastatic prostate cancer (HRMPC). METHODS: Thirty-five metastatic HRPC patients were treated with docetaxel 70 mg/m2 every 3 weeks plus oral prednisolone 5 mg twice daily at the clinical oncology departments of Tanta, Mansoura and Menofia university hospitals during the period from June 2006 to December 2008. The primary endpoint was assessment of the overall tumor response rate. Secondary endpoints were assessment of PSA response rate, overall survival rate, and the time-to-disease progression. RESULTS: The median number of cycles administered was 6 cycles. Partial response was observed in 15 patients (42.9%) with evaluable measurable disease. Median survival from protocol entry was 15 months. Median time- to-disease progression was 10 months. Prostate-specific antigen (PSA) declined ≥50% in 9 patients (25.7%). The most common grade 3/4 toxicity associated with studied protocol was neutropenia (85.7%). CONCLUSIONS: When given with prednisone, treatment with docetaxel every three weeks does not improve survival, so the benefit of docetaxel-based therapy is not clear this high risk and poor prognostic group of patients.
BACKGROUND AND OBJECTIVES: Since previous studies have indicated there are improvements in overall survival, the aim of this phase II clinical study was to evaluate docetaxel every three weeks plus prednisone as first-line chemotherapy for treatment of hormone-refractory metastatic prostate cancer (HRMPC). METHODS: Thirty-five metastatic HRPC patients were treated with docetaxel 70 mg/m2 every 3 weeks plus oral prednisolone 5 mg twice daily at the clinical oncology departments of Tanta, Mansoura and Menofia university hospitals during the period from June 2006 to December 2008. The primary endpoint was assessment of the overall tumor response rate. Secondary endpoints were assessment of PSA response rate, overall survival rate, and the time-to-disease progression. RESULTS: The median number of cycles administered was 6 cycles. Partial response was observed in 15 patients (42.9%) with evaluable measurable disease. Median survival from protocol entry was 15 months. Median time- to-disease progression was 10 months. Prostate-specific antigen (PSA) declined ≥50% in 9 patients (25.7%). The most common grade 3/4 toxicity associated with studied protocol was neutropenia (85.7%). CONCLUSIONS: When given with prednisone, treatment with docetaxel every three weeks does not improve survival, so the benefit of docetaxel-based therapy is not clear this high risk and poor prognostic group of patients.