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Background: The efficacy of docetaxel and carboplatin with oral estramustine was evaluated in patients with castration-resistant prostate cancer. Patients and Methods: Patients were treated with intravenous docetaxel at 30 mg/m2 on days 1, 8, 15, and 22 of a 28-day cycle. Intravenous carboplatin (area under the curve, 6 mg/ml/min) was administered on day 1. Patients received oral estramustine at 626.8 mg/day throughout the treatment protocol. Patients were evaluated for response, with treatment continued until cancer progression or onset of severe adverse events. Results: Twenty patients with castration-resistant prostate cancer were treated for a median of 3.5 cycles. Prostate-specific antigen decreased by more than 30% in 18 patients, including 14 patients with a decrease of more than 50%. Median overall survival was 11 months, prostate-specific antigen progression-free survival was 6.5 months, and radiographic progression-free survival was 7 months. Conclusion: Docetaxel and carboplatin with oral estramustine shows efficacy against castration-resistant prostate cancer.

We evaluated the efficacy and toxicity of intermittent docetaxel (DCT) with estramustine (EM) for hormone-refractory prostate cancer (HRPC).Fifteen patients were enrolled. They received injected DCT (70 mg/m2 body surface) on day 1 in association with oral EM 560 mg/day (days 1-5). Treatments were repeated every 3 weeks. Serum prostate-specific antigen (PSA) levels were categorized based on the first three courses. Patients exhibiting either a response or stable disease (SD) could have a holiday from treatment (intermittent schedule). The holiday continued until elevation of the PSA level from the nadir baseline level occurred three times. All patients were evaluated for toxicity and quality of life (QOL). Survival curves were established using Kaplan-Meier graphs.The median number of courses of DCT/EM therapy was five (range, 3-12 courses). The response rate of the first cycle was 53%: 3 patients with complete response (CR), 5 patients with partial response (PR), 4 patients with SD, and 3 patients with disease progression. Eight patients were able to begin the second re-entry cycle. No patients showed a CR, 2 patients exhibited PR, 4 patients had SD, and the overall response rate was 25%. The survival rates were 93% at 1 year, and 26.1% at 2 years Grade 3-4 anemia was observed in 2 patients (13.3%), neutropenia in 11 (73.3%), and thrombocytopenia in 2 (13.3%). The QOL scale showed good QOL after 6 months, with improvement in the score for nausea and vomiting.Intermittent DCT/EM therapy was well tolerated, and has the potential to prolong survival, with a high QOL, in patients with HRPC.

5005 Background: Docetaxel-estramustine improves survival in patients (pts) with castrate-resistant prostate cancer (CaP). This phase III trial assessed docetaxel-estramustine in pts with high-risk...

4513 Background: Docetaxel improves survival in patients (pts) with castrate-resistant prostate cancer (CaP). This phase III trial assessed docetaxel-based chemotherapy in pts with high-risk locali...

15609 Background: The TET regimen was developed to test the potential synergy and tolerability of low dose, metronomic chemotherapy plus an anti-angiogenesis agent in the treatment of AIPC in elderly men. Preliminary results were presented in 2004 (ASCO Proceedings #4681); we now present the final results 5 years from protocol initiation. Methods: Eligible patients had progressive AIPC, an adequate PS (0–2) and were chemotherapy naïve. All patients received the TET regimen: Docetaxel (Taxotere [T]) 25 mg/m2 weekly for three weeks per month, Estramustine 140 mg po tid x 3 days per week (with T) and Thalidomide (Thal) 100–200 mg as tolerated. After six monthly cycles of TET, patients with responding or stable disease received maintenance Thal until progression. Coumadin 2 mg daily was given for thromboprophylaxis. A total of 19 patients out of an intended 25 were accrued from 6/01 to 9/05. Results: The median age was 79 (59–86); 70% of patients were ≥ 75 years of age. The median PSA was 83 (20–2266), median Gleason score 7, bone metastases were present in 14/19 patients and measurable disease in 12/19 patients. 17 patients completed at least one cycle of TET and were eligible for analysis. The PSA declined >50% in 10/17 (59%); there was 1 PR and 7 SD by RECIST criteria. Of six patients that received maintenance Thal, only one had PSA stabilization for more than three months. The median survival was 17 months. The major grade ¾ toxicities included non-life threatening DVT (3 patients), asthenia (6 patients), edema and dyspnea (one patient each). Thal 200 mg was especially poorly tolerated, requiring dose reductions in over half of the patients. Conclusions: In this trial of elderly men with AIPC, low-dose TET did not seem to improve upon the results previously reported for docetaxel or docetaxel/estramustine. The observed toxicities make it doubtful that a higher dose TET regimen could be tolerated by this population. Thalidomide maintenance was ineffective in maintaining responses. No significant financial relationships to disclose.

4789 Background: Recently, docetaxel have shown promising clinical results in patients with hormone-refractory prostate cancer (HRPC). However, their optimal treatment schedule has not been establi...