SALVAGE CHEMOTHERAPY IN METASTATIC BREAST-CANCER - AN EXPERIENCE WITHTHE COMBINATION OF MITOXANTRONE, 5-FLUOROURACIL, AND L-LEUCOVORIN

From January 1992 to July 1993, 28 patients with metastatic breast can cer were entered in a phase II trial to assess the activity and toxici ty of the combination of mitoxantrone, 5-fluoruracil, and leucovorin. Patients were eligible if they had progressive disease after either ad juvant (2 patients) or previous chemotherapy for metastatic disease (2 6 patients). Twenty-five patients (89.2%) had received previous anthra cycline-based therapy. Predominant site of metastatic disease was visc eral in 22 patients, bone in 2 patients, soft tissue in 4 patients, an d the majority of patients (89.2%) had two or more sites of disease. T he regimen was administered according to the following schedule: Mitox antrone 9-12 mg/m(2) i.v. on day 1; L-Leucovorin 150 mg i.v. over 1 ho ur before 5-Fluorouracil 350 mg/m(2) i.v. push days, 1, 2 and 3. Cours es were repeated every 21 days. Twenty-six patients were evaluable for response. We observed 2 complete responses, 5 partial responses with a median duration of 38 weeks (range 23-68). The objective response ra te was:27% (95% C.I., 10% to 44%). Myelosuppression was the most frequ ent toxicity, but it was mild in the majority of patients. Nine episod es of fever and neutropenia occurred in six patients but none of these episodes was fatal. No clinical evidence of cardiotoxicity was observ ed. At a median follow-up of 78 weeks, the median time to progression was 20.5 weeks and the median overall survival was 48 weeks. We conclu de that this regimen is well tolerated and in our experience the objec tive response rate is similar to other salvage chemotherapy regimens.