In the past, it was believed that when advanced-stage prostate cancer became resistant to hormonal management, no chemotherapy should be administered, as survival was not prolonged. Mitoxanthrone and prednisone were mostly administered, while recently, other agents such as docetaxel or paclitaxel have been tested both with and without hormonal treatment. The objective of the present phase II study was to determine the survival and the response rate of patients after the chemotherapy was administered. Sixty-five patients with advanced prostate cancer were included. The inclusion criteria involved histological confirmation of adenocarcinoma and resistance to hormonal therapy. The majority of the patients had stage IVa or IVb disease and a performance status of 0-1 to 2. The treatment involved chemotherapy in combination with a luteinizing hormone-releasing hormone (LHRH) or dexamethasone or estramustine. The hormone treatment preceded the cytotoxic administration and no amelioration in the patients nor prostate serum antigen (PSA) reduction was observed. The initial cytotoxic agents administered were docetaxel 75 mg/m2 in 25 patients, mitoxanthrone 10 mg/m2 in 15 patients, epirubicin 75 mg/m2 in 15 patients and paclitaxel 175 mg/m2 in 10 patients, all repeated every 3 weeks. The response rate was documented by bone scan, CT scan of the abdomen (and occasionally of the chest) and by the PSA serum value. Clinical benefit was also estimated. Thirty-three (50.77%) patients achieved a partial response; stable disease was observed in 24 (36.92%) patients and disease progression in 8 (12.31%). Twenty-two (33.85%) experienced clinical benefit. A significant PSA reduction was seen in 35 (53.85%) patients. The median survival was 18 months and the range 3-84 months. One, 2, 3 and five-year survival was 75.38, 23.07, 12.30 and 4.66%, respectively. Toxicity was well-tolerated. Patients with hormone-resistant advanced prostate cancer do have good prospects for receiving substantial benefit with the addition of chemotherapy, as observed in the present trial.

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