Objective: To investigate the use of docetaxel 75 mg/m(2) intravenously every 3 weeks plus prednisone 5 mg orally twice daily in men with metastatic hormone-refractory prostate cancer (HRPC) progressing after first-line mitoxantrone/prednisone (MP), the primary outcome being progression-free survival with prostatic-specific antigen (PSA) and pain response, toxicity and quality of life (QoL) also assessed.
Patients and methods: Thirty patients from four centres were enrolled in the study; all had had previous MP for symptomatic, metastatic HRPC and all had castrate levels of testosterone maintained during therapy.
Results: At enrolment, the median age was 69 years, the mean PSA level was 324 ng/dL, and 86% of patients reported pain. There was a PSA response in 57% of the men and a reduction in pain in >60%; the overall QoL was maintained. There were four cases of febrile neutropenia and two treatment-related deaths. The median progression-free and overall survival were 5 and 15 months, respectively.
Conclusion: Docetaxel was associated with high rates of PSA and pain response in this study. Non-haematological toxicity was similar to that during first-line treatment, but rates of febrile neutropenia and toxic death appeared to be slightly higher. In selected patients with progressive metastatic HRPC previously treated with mitoxantrone, docetaxel appears to be a beneficial therapeutic option.