First-line treatment of metastatic breast cancer with mitoxantrone, vinorelbine, and carboplatin.

A phase II trial was conducted with mitoxantrone (12 mg/m2, day 1), vinorelbine (30 mg/m2, day 1), and carboplatin (250 mg/m2, day 2) every 21 days. Fifty eligible women who had not received prior chemotherapy for metastatic breast cancer (MBC) entered the study. Objective responses were observed in 28 patients (56%; 95% confidence interval: 42.4-69.74%), with 4 complete (8%) and 24 partial responses (48%). Stable disease was observed in 12 patients (24%) and disease progression in 10 (20%). Responses were documented in all involved sites. The median duration of response was 6 months and the median time to tumor progression 8 months. The median survival was 26 months and the estimated 2-year survival was 52%. Grade 3/4 neutropenia was observed in 29 patients (58%) with four neutropenic episodes. Grade 3/4 anemia and thrombocytopenia was observed in 7 (14%) and 11 (22%) patients, respectively. Other toxicities included grade 2/3 nausea and vomiting in 26 patients (52%) and grade 1/2 alopecia in 38 (76%). Grade 1/2 neurosensory toxicity occurred in four patients (8%). In conclusion, this three-drug regimen is effective and well tolerated for the treatment of MBC.