Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of the prostate.

摘要: Abstract The purpose of this study was to assess the efficacy weekly administration docetaxel as a single agent in patients with hormone-refractory, symptomatic, metastatic prostate cancer respect symptom palliation, tumor response, time progression, and survival. Sixty men progressive that had progressed on at least one hormonal regimen were enrolled multicenter phase II study. Twenty-one percent received prior palliative radiotherapy, 25% chemotherapy for hormone-refractory disease. Patients scheduled receive three 8-week cycles (36 mg/m2 days 1,8, 15, 22, 29, 36) 2-week intervals between cycles. dose could be decreased event toxicity, but no escalation permitted. A ≥50% decrease serum prostate-specific antigen (PSA) levels from baseline stabilization or improvement performance status lasting 2 months longer occurred 24 (41%) patients, whom 16 (27%) ≥80% more. median progression all 5.1 (range, 0.9 18.2 months). estimated who those did not have reduction PSA level stable improved 6.65 4.3 months, respectively. overall survival 9.4 1.6 Treatment toxicity considered acceptable. Single-agent 36 associated response rate 41%, increased survival, minimal myelosuppression cancer.