Improvements in clinical benefit with vinorelbine in the treatment of hormone-refractory prostate cancer: A phase II trial

Background: Clinical activity is difficult to assess by traditional respons e endpoints in patients with advanced prostate cancer. We used clinical ben efit response to assess the activity of vinorelbine (Navelbine(R)) in patie nts with hormone-refractory prostate cancer. Patients and methods: Forty-nine men with hormone-refractory prostate cance r received vinorelbine weekly for eight weeks followed by every-other-week dosing. Clinical benefit response was defined by improvement in 1 of the fo llowing categories for at least 12 weeks and stable response or better in t he other 2: pain index (analgesic consumption and pain intensity), Karnofsk y performance status, and tumor status. Results: Of 37 evaluable patients, 14 (39%) achieved clinical benefit for a median duration of 6 months (range 3-24 months). Toxicities consisted prim arily of brief neutropenia and mild nausea. Conclusion: These findings indicate that vinorelbine is well tolerated in m en with hormone-refractory prostate cancer and produces durable clinical be nefit as defined by improvement in pain index and performance status.