MITOMYCIN-C AND MITOXANTRONE IN ANTHRACYCLINE-PRETREATED ADVANCED BREAST-CANCER PATIENTS - A PHASE-II STUDY

Twenty-one patients with anthracycline-pretreated advanced breast canc er were treated with mitomycin C plus mitoxantrone (MM), 10 Mg/m2, on day 1 of a 28-day cycle. All patients were evaluated for toxicity and response. Overall, 83 cycles were administered, with a median number o f 4 cycles per patient. Hematologic toxicity, not requiring hospitaliz ation, was the major side effect. Vomiting occurred in 19.2% of cycles . Objective response rate was 33.3% (95% confidence interval: 12.2-53. 1%); best responses were 1 complete and 6 partial; also 7 stable and 7 progressive disease were recorded. The best responding site was the v iscera, the worst was bone. Responses were seen preferentially in seco nd- rather than in third-line therapy and in patients who had responde d to previous chemotherapy, although differences were not statisticall y significant. Kaplan-Meier estimated median time to progression and o verall survival were 26 weeks (range: 2-67 weeks) and 35 weeks (range: 6-79 weeks), respectively. In conclusion the MM regimen showed accept able toxicity and appreciable activity in anthracycline-pretreated adv anced breast cancer.