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Phase 2 study of PS-341 (bortezomib) in the treatment of metastatic malignant melanoma (MMM).

7526 Background: PS-341 is an agent that appeared to have anti-melanoma properties in pre-clinical studies both in vitro and in vivo, providing a rationale for studying this agent in MMM.


METHODS
Eligible patients (pts) had measurable disease, adequate hematologic, renal, and hepatic function, and were chemonaive. PS-341 was administered at 1.5 mg/m2 IV bolus twice weekly for 2 weeks q 3 weeks.


RESULTS
27 pts were accrued, with a median age of 56 years (range: 32-77). 33% were female, 70% had an ECOG PS of 0, 30% had a PS of 1. Two pts had no prior treatment, 64% had prior surgery, and 56% had prior immunotherapy. 26 pts were evaluable for toxicity, of which 10 pts (42%) had grade 3 toxicities (at least possibly related to treatment), including: sensory neuropathy (3), thrombocytopenia (3), constipation (2), fatigue (1), ileus (1), abdominal pain (1), infection w/o neutropenia (1), and platelet transfusion (1). No grade 5 events were reported. No pts are currently receiving treatment. 74% of pts discontinued treatment due to disease progression, 15% due to adverse reactions, and 11% for refusal or other reasons. The median duration of treatment was 1.5 months. The study initially required a maximum of 45 pts, but the study was closed after the interim analysis showed insufficient activity. There were no CRs or PRs, and only 6 pts (22%) achieved stable disease for at least one cycle. Four pts were stable for 4 cycles of treatment, and all 4 of these pts went off study due to adverse reactions. To date, 56% of pts are alive, 96% have progressed, and the median time to progression was 1.5 months.


CONCLUSION
PS-341 is ineffective and toxic in metastatic melanoma pts at the dose and schedule used in this trial. Supported by N01-CM-17104. No significant financial relationships to disclose.