The Canadian Uro-Oncology Group multicentre phase II study of docetaxel administered every 3 weeks with prednisone in men with metastatic hormone-refractory prostate cancer progressing after mitoxantrone/prednisone.

Abstract

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. 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. 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. 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.