WEEKLY DOCETAXEL IN HORMONE REFRACTORY PROSTATE CARCINOMA: RESULTS OF A STUDY OF FASE II

Background: Docetaxel has demonstred beneficial activity in hormone-refractory prostate cancer as a single agent and in combination regimens. Traditionally, the recommended administration schedule of docetaxel has been once every 3 weeks. Data on the weekly administration schedule of docetaxel, compared with the every-3-week schedule, suggest it to be equally efficacious with potential fewer toxicities. We assessed the efficacy and safety of the weekly administration of docetaxel in this patients setting. Patients and methods: Twenty four patients were treated with dexamethasone 8 mg i.v. followed by docetaxel 30 mg/mq i.v. weekly for a cycle of three consecutive weeks every month. Elegibility criteria were: histo-citologically proven metastatic prostate cancer, progressive disease after previous hormonal treatment, measurable or evaluable disease (as evidenced by a PSA level > 20 ng/ml), ECOG PS-1,age < 75 years, adequate haematological, cardiac amd renal function, and informed written consent. WHO criteria were utilized for response assessment in measurable lesions, PSA response was defined as a reduction from baseline of at least 50% on two consecutive measurement at 3 week interval. Results: All patients are evaluable for efficacy and toxicity. Median age 67 (range 46-75); ECOG PS 0/1= 11/13; 10 soft tissue metastatic measurable and evaluable patients, 14 only evaluable patients. Patients received a median of 4 cycles (range 2- 8); a total of 111 chemotherapy cycles was administered. PSA response was detected in 56% of patients and 30% of patients had reduction of pain. Toxycities: grade 3-4 neutropenia was detected in 6 patients (25%), anemia grade 3 in two; alopecia in six patients and neil change in 4 patients. Conclusion: Weekly docetaxel is a well tolerated regimen with a significant activity in the treatment of hormone refractory advanced prostate cancer patients.