Three-Weekly Docetaxel With Prednisolone for Patients With Hormone-Refractory Metastatic Prostate Cancer: Preliminary Results

Abstract

Background: The aim of this phase II clinical study was to evaluate three-weekly docetaxel plus prednisolone as firstline chemotherapy for treatment of hormone-refractory metastatic prostate cancer (HRMPC). Materials and Methods: Thirty five metastatic HRPC patients were treated with docetaxel 70 mg/m2 on Day 1, every 3 weeks plus oral prednisolone 5 mg twice daily at Clinical Oncology Departments, 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: In 35 patients with metastatic HRPC, 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 12 months. Median time to disease progression was 9 months. Prostate-specific antigen (PSA) declined ≥50% in 9 patients (25.7%). The most common grade 34/ toxicity associated with studied protocol was neutropenia (85.7%). Conclusions: When given with prednisolone, treatment with docetaxel every three weeks lead to improved survival and response rates with accepted tolerability.