Combination chemotherapy with epirubicin and mitomycin C as first-line treatment in advanced breast cancer.

From December 1988 to February 1991, 112 consecutive patients were submitted to epirubicin + mitomycin C chemotherapy as first-line treatment for advanced breast cancer. Epirubicin (75 mg/m2) was given every 3 weeks and mitomycin C (10 mg/m2) every 6 weeks. Only patients with visceral involvement or with a disease-free interval of less than 12 months were considered eligible. 102 patients were evaluated for response and toxicity in the present analysis. The main sites of involvement were viscera, soft tissues, bone in 71 (69.6%), 19 (18.6%) and 12 (11.8%) patients, respectively. Multiple site involvement was present in 66 (64.7%) cases. A total of 726 courses of therapy were administered (range 2-14; mean 7.2). Follow-up ranged from 96 to 210 weeks (median follow-up 138 weeks). Response rate was complete response (CR): 21.6% [95% confidence interval (CI) +/- 0.8], partial response (PR) 49.0% (95% CI +/- 0.1), stable disease (SD) 12.7% (95% CI +/- 0.1), progressive disease (PD) 16.7% (95% CI +/- 0.1), CR + PR: 70.6% (95% CI +/- 0.1). Median values of survival and time to progression were 79.4 and 42 weeks, respectively. At 2 years, 37.2 +/- 4.7% and 12.8 +/- 3.3% of the patients, respectively, were alive or without evidence of progression. Toxicity was generally mild. One hundred and four (14.3%) cycles in 53 patients were delayed due to haematological (82) or cardiac (3) toxicity, infectious disease (11) or causes not related to the treatment (8).