Abstract
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.
Publication types
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Clinical Trial
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Clinical Trial, Phase II
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Alopecia / chemically induced
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Anemia / chemically induced
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents, Phytogenic / administration & dosage
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Antineoplastic Agents, Phytogenic / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Breast Neoplasms / pathology*
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Carboplatin / administration & dosage
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Carboplatin / adverse effects
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Confidence Intervals
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Disease Progression
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Female
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Follow-Up Studies
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Humans
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Lung Neoplasms / drug therapy
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Lung Neoplasms / secondary*
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Lymphatic Metastasis*
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Middle Aged
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Mitoxantrone / administration & dosage
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Mitoxantrone / adverse effects
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Neutropenia / chemically induced
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Paresthesia / chemically induced
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Remission Induction
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Soft Tissue Neoplasms / drug therapy
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Soft Tissue Neoplasms / secondary*
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Survival Rate
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Thrombocytopenia / chemically induced
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Vinblastine / administration & dosage
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Vinblastine / adverse effects
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Vinblastine / analogs & derivatives
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Vinorelbine
Substances
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Antineoplastic Agents
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Antineoplastic Agents, Phytogenic
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Vinblastine
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Carboplatin
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Mitoxantrone
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Vinorelbine