TAXOL IN ADVANCED, HORMONE-REFRACTORY CARCINOMA OF THE PROSTATE - A PHASE-II TRIAL OF THE EASTERN-COOPERATIVE-ONCOLOGY-GROUP

Background. Recent clinical trials have documented activity for combin ations of chemotherapeutic agents that target the microtubular apparat us in patients with hormone-refractory prostate cancer. Taxol has a no vel antimicrotubular mechanism, acting by stabilizing polymerized tubu lin. Methods. Twenty-three patients with hormone-refractory prostate c ancer and bidimensionally measurable disease were treated with Taxol b y 24-hour continuous infusion at 135-170 mg/M2 every 21 days for a max imum of 6 cycles. Results. Eighty-five courses of Taxol were administe red to 23 patients. One patient (4.3%) experienced a partial response lasting 9 months, and four other patients with radiographically stable disease had minor reductions in the serum prostate-specific antigen ( PSA) of 16-24%. Eleven patients (47.8%) had stable disease, and progre ssive disease developed in 9 patients (39.1%) during therapy. Median s urvival was 9 months. Leukopenia was the dose-limiting toxicity with 1 3% of patients having Grade 3 and 61% having Grade 4 toxicity, and gra nulocytopenic fever developed in 26%. Three patients experienced sudde n cardiovascular events while participating in the study, including on e patient with a nonfatal, non-Q-wave myocardial infarction that occur red during a taxol infusion, and two patients who had sudden deaths 9 days and 30 days after receiving their last taxol dose, respectively. Conclusions. In the subset of patients with hormone-refractory prostat e cancer and bidimensionally measurable disease, Taxol at this dosage has only minor activity.