Efficacy and safety of eribulin as first- to third-line treatment in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes
Efficacy and safety of eribulin as first- to third-line treatment in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes
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DOI：
10.1016/j.breast.2016.12.017
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发表时间：
2017-04-01
期刊：
影响因子：
3.9
通讯作者：
Tamura, Kazuo
中科院分区：
文献类型：
--
作者：
Maeda, Shigeto;Saimura, Michiyo;Tamura, Kazuo
目的：尽管埃布林对接受蒽环类药物和紫杉烷类药物预治疗的晚期/转移性乳腺癌(MBC)患者有生存益处和可接受的耐受性，但早期使用埃布林的临床益处的证据有限。材料与方法：本研究在日本九州14个地点进行H期开放式单臂研究，研究对象为2011年12月1日至2013年11月30日(截止日期：2014年11月30日)经组织学证实为人表皮生长因子受体2阴性的多核细胞白血病患者。客观评价有效率(ORR；主要终点)、疾病控制率(DCR)、无进展生存期(PFS)、应答持续时间(DOR)、总生存期(OS)和安全性。ORR为17.0%(95%可信区间，7.6~30.8)，DCR为66.0%(51.2~77.8)，中位PFS为4.9个月(3.5~7.0)，DOR为6.6个月(1.9~14.3)，中位OS为17.4个月(10.1-不可评价)。常见的3/4级不良反应为中性粒细胞减少症(25例，占53.2%)、白细胞减少症(16例，占42.1%)和发热中性粒细胞减少症(4例，占8.5%)。在长期治疗过程中，毒性没有增加。亚组分析显示，与二、三线治疗相比，一线治疗可导致更高的ORR和延长的PFS和OS，且二/三线治疗患者的不良事件发生率并不高于一线治疗患者。结论：Eribuin对使用一线至三线治疗的日本MBC患者具有疗效和可控耐受性。(ID：UMIN000007121)。(C)2016年提交人。爱思唯尔有限公司出版。
Objectives: Despite the survival benefit and acceptable tolerability of eribulin for advanced/metastatic breast cancer (MBC) patients pretreated with anthracyclines and taxanes, there is limited evidence of the clinical benefit of early eribulin use. We investigated the efficacy and safety of first- to third-line eribulin use in patients with MBC.Materials and methods: In this phase H, open-label, single-arm study conducted at 14 sites in Kyushu, Japan, women with histologically confirmed human epidermal growth factor receptor 2 negative MBC were enrolled between December 1, 2011 and November 30, 2013 (Data cut-off: November 30, 2014). Objective response rate (ORR; primary endpoint), disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety were evaluated.Results: Of 53 recruited patients, 47 were enrolled. The ORR was 17.0% (95% confidence interval, 7.6-30.8), DCR was 66.0% (51.2-77.8), median PFS was 4.9 months (3.5-7.0), DOR was 6.6 months (1.9-14.3), and median OS was 17.4 months (10.1-not evaluable). The common grade 3/4 adverse events were neutropenia (25 patients; 53.2%), leucopenia (16 patients; 42.1%) and febrile neutropenia (4 patients; 8.5%). Toxicity did not increase during the long-term treatment. Subgroup analysis indicated that first-line treatment led to higher ORR and prolonged PFS and OS than second-/third-line treatment and that incidence of adverse events in patients of second-/third-line treatment was not higher than that in patients of first-line treatment.Conclusion: Eribulin exhibited efficacy and manageable tolerability in Japanese women with pretreated MBC in first- to third-line use. (ID: UMIN000007121). (C) 2016 The Authors. Published by Elsevier Ltd.