PHASE-II TRIAL OF DOCETAXEL IN PATIENTS WITH ADVANCED CUTANEOUS MALIGNANT-MELANOMA PREVIOUSLY UNTREATED WITH CHEMOTHERAPY

Purpose: A phase II study was undertaken to determine the efficacy of docetaxel in patients with metastatic malignant melanoma. Patients and Methods: Between June 1992 and March 1994, 40 patients with metastati c malignant melanoma and no prior chemotherapy were treated with docet axel 100 mg/m(2) administered intravenously over 1 hour every 21 days, None of the patients had brain metastasis. Toxicity and follow-up dat a are provided. Results: One patient had a histologically confirmed co mplete response that lasted for 14+ months. Four patients held partial responses, bringing the overall response rate to 12.5% (95% confidenc e interval [CI], 6% to 30%). A patient with a partial response had a s ingle chest-wall metastasis and was rendered free of disease surgicall y after a maximal response to docetaxel and remained free of tumor rec urrence after 18+ months. Tumor was stabilized in 22 patients. The ove rall median survival time was 13 months, The main hematologic toxicity was neutropenia, which was severe but transient. Peripheral neuropath y was the limiting nonhematologic toxicity in three patients. Other im portant toxicities included cutaneous toxicity, fluid retention, oral mucositis, and hypersensitivity reactions, Preadministration of dexame thasone and diphenhydramine reduced the incidence of hypersensitivity reactions, cutaneous toxicities, and fluid retention. Conclusion: Doce taxel has definite but low-level activity against malignant melanoma. Further investigation of this drug should be conducted in multidrug co mbination programs. (C) 1995 by American Society of Clinical Oncology.