Maeda Shigeto, Saimura Michiyo, Minami Shigeki, Kurashita Kaname, Nishimura Reiki, Kai Yuichiro, Yano Hiroshi, Mashino Kohjiro, Mitsuyama Shoshu, Shimokawa Mototsugu, Tamura Kazuo
Department of Surgery, National Hospital Organization Nagasaki Medical Center, Omura, Nagasaki, Japan.
Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan.
Breast. 2017 Apr;32:66-72. doi: 10.1016/j.breast.2016.12.017. Epub 2017 Jan 3.
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.
In this phase II, 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.
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.
Eribulin exhibited efficacy and manageable tolerability in Japanese women with pretreated MBC in first- to third-line use. (ID: UMIN000007121).
尽管艾日布林对接受过蒽环类药物和紫杉烷类药物预处理的晚期/转移性乳腺癌（MBC）患者具有生存获益且耐受性可接受，但早期使用艾日布林的临床获益证据有限。我们研究了MBC患者一线至三线使用艾日布林的疗效和安全性。
在日本九州14个地点进行的这项II期开放标签单臂研究中，2011年12月1日至2013年11月30日纳入了组织学确诊的人表皮生长因子受体2阴性MBC女性患者（数据截止日期：2014年11月30日）。评估了客观缓解率（ORR；主要终点）、疾病控制率（DCR）、无进展生存期（PFS）、缓解持续时间（DOR）、总生存期（OS）和安全性。
在招募的53例患者中，47例入组。ORR为17.0%（95%置信区间，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 - 不可评估）。常见的3/4级不良事件为中性粒细胞减少（25例患者；53.2%）、白细胞减少（16例患者；42.1%）和发热性中性粒细胞减少（4例患者；
