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

A phase II trial was conducted with mitoxantrone (12 mg/m(2), day 1), vinor elbine (30 mg/m(2), day 1), and carboplatin (250 mg/m2, day 2) every 21 day s. Fifty eligible women who had not received prior chemotherapy for metasta tic boast cancer (MBC) entered the study. Objective responses were observed in 28 patients (56%; 95% confidence interval: 42.4-69.74%), with 4 complet e (8%) and 24 partial responses (48%). Stable disease was observed in 12 pa tients (24%) and disease progression in 10 (20%). Responses were documented in all involved sites. The median duration of response was 6 months and th e median time to tumor progression 8 months. The median survival was 26 mon ths and the estimated 2-year survival was 52%. Grade 3/4 neutropenia was ob served in 29 patients (58%) with four neutropenic episodes. Grade 3/4 anemi a and thrombacytopenia was observed in 7 (14%) and 11 (22%) patients, respe ctively. Other toxicities included grade 2/3 nausea and vomiting in 26 pati ents (52%) and grade 1/2 alopecia in 38 (76%). Grade 1/2 neurosensory toxic ity occurred in four patients (8%). In conclusion, this three-drug regimen is effective and well tolerated for the treatment of MBC.