Prednimustine in combination with methotrexate and 5-FU (PMF): a pilot study.

A group of 47 patients with advanced breast cancer were treated with a combination of prednimustine, methotrexate, 5-FU, and tamoxifen. In this combination, with methotrexate and 5-FU administered at standard doses, hematologic toxicity of prednimustine at a dose of 100 mg/m2 orally on Days 1-5 repeated every 4 weeks was acceptable. Nausea and vomiting occurred in 40 of the 47 patients but was only grade 1-2 in 35 of these patients. Only one patient had alopecia to the extent of requiring a wig. Response to treatment could be evaluated in 28 patients; 21 achieved a response (complete or partial lasting a median of 13 months.