Mitoxantrone, methotrexate, and 5-fluorouracil combination chemotherapy as first-line treatment in stage IV breast cancer.

Fifty patients with Stage IV breast cancer were entered into a prospective Phase II trial of combination chemotherapy that consisted of mitoxantrone (10 mg/m2), methotrexate (40 mg/m2), and 5-fluorouracil (600 mg/m2) given in a 3-weekly schedule. Objective response to treatment was seen in 18 of 48 assessable patients (38%). Responses were seen predominantly in the lung and pleura and the node and soft tissue sites of disease. The median duration of response was 7 months. Toxicity from treatment consisted predominantly of reversible leukopenia. Other toxicities such as nausea and alopecia occurred in less than one half of the patients in the study group. The combination was well-tolerated, and appears to be moderately effective.