Taxol in malignant melanoma.

Taxol is a major new antitumor agent with significant activity against a number of human cancers. Preclinical investigation demonstrated significant activity against B16 melanoma and against cells derived from melanoma in a human stem cell assay. To determine whether there are sufficient clinical phase II data for Taxol activity against melanoma to warrant phase III clinical trials, data from the three published trials of Taxol in patients with metastatic malignant melanoma plus data from an ongoing Albert Einstein Cancer Center study of Taxol plus granulocyte-colony stimulating factor were analyzed for response rate and quality. Of 73 evaluable patients, complete plus partial responses occurred in 12 (16.4%). An additional nine patients had objective responses not qualifying for partial response, and 10 others had stabilization of previously progressive disease. Two complete responders remain disease free at 33+ and 46+ months. Patients with stable disease, minimal response, or partial response had a median duration of response of approximately 5 months (range 1-17 months). Responses occurred in liver, lung, skin, and other tissues. Taxol as a single agent has activity comparable with that of dacarbazine, cisplatin, or interleukin-2 in metastatic malignant melanoma. Pilot studies of Taxol combinations are warranted.