Vinorelbine and estramustine in androgen-independent metastatic prostate cancer - A phase II study

BACKGROUND. The aim of this study was to determine the safety and activity of vinorelbine in combination with estramustine in men with androgen-indepe ndent metastatic prostate cancer. METHODS. Twenty-five men with androgen-independent metastatic prostate canc er were treated with the combination of vinorelbine and estramustine. Vinor elbine 25 mg/m(2) was administered by intravenous bolus on Days 1 and 8. Es tramustine 140 mg was administered three times a day by mouth on Days 1 thr ough 14. Treatment was repeated every 21 days. RESULTS. A total of 132 cycles of treatment were administered. The median n umber of cycles per patient was 5 (range: 1-16). Mild Grade 1 or 2 gastroin testinal toxicity and fatigue were the most common adverse effects. Hematol ogic toxicity was minimal. Treatment resulted in a sustained > 50% decrease in serum prostate-specific antigen (PSA) in 6 of 25 patients (24% of patie nts; 95% confidence interval (CI) 9-45%). The median duration of PSA respon se was 10 weeks (range: 3-39 weeks). Of the five men with bidimensionally m easurable disease, none achieved a complete or partial response. There were no documented improvements in post-treatment bone scans. Median overall su rvival time was 14.1 months. CONCLUSIONS. The combination of vinorelbine and estramustine is a well-tole rated and modestly active regimen in men with androgen-independent metastat ic prostate cancer. Cancer 2000;89:1824-8. (C) 2000 American Cancer Society .