Phase II Study of Carboplatin, Vinorelbine and Capecitabine in Patients with Metastatic Breast Cancer

M. Rabinowitz, A. Mangalik, F. Lee, C. Jennings, A. Parsons, C. Verschraegen, M. Royce, I. Rabinowitz
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Abstract

Most patients with breast cancer receive anthracyclines and taxanes in either the adjuvant or metastatic setting. Carboplatin, vinorelbine and capecitabine each has single agent activity in breast cancer. In addition they are non-cross resistant and generally have non-overlapping toxicities. The purpose of this study is to assess the response rate of this triplet combination in women with metastatic breast cancer previously treated with anthracycline and taxane based chemotherapy. The dosing schedule was carboplatin 300mg/m2 day 1, vinorelbine 25mg/m2 day 1 & 8 and capecitabine 1500mg/m2/day on days 1-14 every 21 days. Twenty three patients were evaluable for both efficacy and toxicities. Seventy eight percent of patients had refractory disease. The overall response rate was 65%. Complete responses were observed in 13%, and partial responses in 52%. The median progression free survival was 5.5 months. The Kaplan-Meier estimated median survival was 17.5 months. Two patients (8%) progressed on chemotherapy and 43% of patients received additional systemic therapy following participation in this study. Grade 3-4 neutropenia, anemia, and thrombocytopenia occurred in 30%, 7% and 5% of 128 cycles, respectively. Thirty seven percent of cycles required G-CSF support. One patient died of respiratory failure, possibly related to treatment. The regimen of carboplatin, vinorelbine and capecitabine has significant activity in this refractory heavily pretreated population, making it a promising therapeutic option in women with metastatic breast cancer.
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卡铂、长春瑞滨和卡培他滨治疗转移性乳腺癌的II期研究
大多数乳腺癌患者接受蒽环类药物和紫杉烷类药物辅助治疗或转移治疗。卡铂,长春瑞滨和卡培他滨在乳腺癌中都有单药活性。此外,它们不具有交叉抗性,通常具有不重叠的毒性。本研究的目的是评估这种三联疗法在既往接受过蒽环类和紫杉烷类化疗的转移性乳腺癌患者中的反应率。给药方案为卡铂300mg/m2第1天,长春瑞滨25mg/m2第1天和第8天,卡培他滨1500mg/m2/天,第1-14天每21天。23例患者的疗效和毒性均可评估。78%的患者患有难治性疾病。总体应答率为65%。13%的患者完全缓解,52%的患者部分缓解。中位无进展生存期为5.5个月。Kaplan-Meier估计中位生存期为17.5个月。2例患者(8%)化疗进展,43%的患者在参与本研究后接受了额外的全身治疗。在128个周期中,3-4级中性粒细胞减少、贫血和血小板减少的发生率分别为30%、7%和5%。37%的周期需要G-CSF支持。一名患者死于呼吸衰竭,可能与治疗有关。卡铂、长春瑞滨和卡培他滨的方案在这种难治的重度预处理人群中具有显著的活性,使其成为转移性乳腺癌妇女的一种有希望的治疗选择。
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