A phase II study of biweekly docetaxel and vinorelbine for hormone-refractory prostate cancer (HRPC)

Abstract

14529 Background: Docetaxel is active in HRPC alone, with prednisone, and with estramustine. We evaluated the efficacy and toxicity of its combination with vinorelbine, another active drug in HPRC. Methods: Patients with metastatic HRPC, no praevious chemotherapy, ECOG PS=0–2 and adequate organ function were included. Docetaxel was administered at 40 mg/m2 and vinorelbine at 20 mg/m2 days 1 and 14. Cycles were repeated every 28 days until disease progression, occurrence of unacceptable toxicity or voluntary withdrawal. A maximum of 6 cycles was allowed. Results: A total of 25 patients were included, with median age73 years (61–81) and ECOG PS 0–1 in 96% of patients. Median number of metastatic lesion was 1 (84% of patients), located in bone (96%), lymph nodes (12%), pleural effusion (4%) and liver (4%). A total of 128 cycles (median 5, range 2–9) and 243 infusions (median 10, range 4–17) were administered. Median relative dose intensity for both drugs was 91.68%. Toxicity: Grade III/IV hematologic toxicity per patient was neutropenia (48%) and anemia (4%). Febrile neutropenia was observed in 2 patients. Grade III/IV non-hematologic toxicity per patient was asthenia (8%), diarrhea (4%) and constipation (4%). There were no toxic deaths. Efficacy: Of 22 evaluable patients (3 have just begun chemotherapy), 1 achieved CR, 12 PR, 5 SD and 4 progressed (PSA response), resulting in an ORR of 59% (95% CI: 38.5–79.6%). Median TTP were 340 days (95% CI: 274.47–405.53). Median OS has not been achieved. Mean OS was 765.8 days (95% CI: 590.84–940.76). Conclusions: Biweekly docetaxel and vinorelbine is an active and feasible regimen in HRPC. No significant financial relationships to disclose.