Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: A final report of CALGB 9780

Purpose: To investigate the combination of docetaxel, estramustine (EM), an d low-dose hydrocortisone in men with hormone-refractory prostate cancer (H RPC). Patients and Methods: Combinations of EM with other antimitotic agents such as docetaxel are synergistic in vitro and show significant clinical activi ty in patients with HRPC. We studied intravenous administration of docetaxe l 70 mg/m(2), oral estramustine, and low-dose daily hydrocortisone in men w ith HRPC who demonstrated progression after initial hormone therapy. Results: Of the 47 men enrolled onto this multicenter cooperative group stu dy, 46 were assessable for response and/or toxicity. In the 24 patients wit h measurable disease, there were three complete and nine partial responses for a measurable disease response rate of 50% (12 of 24 patients; 95% confi dence interval [CI], 27% to 73%. In the 44 patients in whom pretreatment pr ostate-specific antigen (PSA) was elevated, 30 (68%) had a 50% or greater d ecrease, and 25 (57%) had a 75% or greater decrease in PSA. The combined me asurable disease and biochemical response rate in all 46 assessable patient s was 54% (three complete responses, 22 partial responses, 95% CI, 37% to 7 1%). The predominant toxicity was neutropenia, with 26% of patients having grade 3 and 30% having grade 4 granulocytopenia; there were no episodes of febrile neutropenia. Other common but mild adverse effects included malaise /fatigue, peripheral edema, and hyperglycemia, The incidence of thromboembo lic events during therapy was 9%. With a median follow-up of 17 months, the median survival was 20 months. The median time to disease progression was 8 months for all patients, and 10 months for those with measurable disease. Conclusion: This therapy is efficacious and moderately well tolerated in HR PC and should be compared in a phase III trial with mitoxantrone and predni sone. J Clin Oncol 19:2509-2576. (C) 2001 by American Society of Clinical O ncology.