A phase II, multicenter, single-arm trial of eribulin as first- or second-line chemotherapy for HER2-negative advanced or metastatic breast cancer: evaluation of efficacy, safety, and patient-reported outcomes
A phase II, multicenter, single-arm trial of eribulin as first- or second-line chemotherapy for HER2-negative advanced or metastatic breast cancer: evaluation of efficacy, safety, and patient-reported outcomes
复制标题
DOI：
10.1007/s00280-018-3567-y
复制
发表时间：
2018-05-01
影响因子：
3
通讯作者：
Uchiyama, Kazuhisa
中科院分区：
文献类型：
--
作者：
Kimura, Kosei;Iwamoto, Mitsuhiko;Uchiyama, Kazuhisa
尽管厄立布林是转移性乳腺癌（MBC）早期治疗的合适选择，但厄立布林一线或二线用于人表皮生长因子受体2 （HER2）阴性乳腺癌的数据仍然有限。因此，我们进行了一项II期试验，以调查埃瑞布林用于her2阴性MBC一线或二线化疗的有效性和安全性。我们在日本进行了一项II期、开放标签、单臂、多中心研究。符合条件的患者是组织学证实的her2阴性MBC患者，没有化疗或只有一种化疗方案。主要终点是总缓解率（ORR），次要终点包括临床获益率（ORR + 6个月疾病稳定；CBR）、无进展生存期（PFS）、总生存期（OS）、反应持续时间（DOR）、安全性和健康相关生活质量（HRQoL）。2013年3月至2017年2月，共有35名her2阴性MBC患者入组（数据截止日期为2017年7月31日）。ORR为37.1% （95% CI 21.1-53.2%）。CBR为54.3% （95% CI 37.8-70.8%）。中位PFS为6.2个月（95% CI 2.7-9.4个月），中位OS为21.4个月（95% CI 11.5-32.9个月）。常见的3/4级不良事件为中性粒细胞减少（42.9%）和发热性中性粒细胞减少（2.9%）。虽然大多数非血液学不良事件的严重程度较轻，但有1例患者死于肺炎。在HRQoL分析中，伊瑞布林似乎维持了许多患者的HRQoL。埃立布林作为一线或二线化疗对her2阴性MBC患者有效且毒性可控。
Although eribulin is a suitable option for early-line treatment of metastatic breast cancer (MBC), data on first- or second-line use of eribulin for human epidermal growth factor receptor 2 (HER2)-negative MBC are still limited. Therefore, we conducted a phase II trial to investigate the efficacy and safety of eribulin for first- or second-line chemotherapy for HER2-negative MBC.We performed a phase II, open-label, single-arm, multicenter study in Japan. Eligible patients were women with histologically confirmed HER2-negative MBC without chemotherapy or only one chemotherapy line for MBC. The primary endpoint was the overall response rate (ORR) and the secondary endpoints included the clinical benefit rate (ORR + stable disease for 6 months; CBR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety, and health-related quality of life (HRQoL).A total of 35 patients with HER2-negative MBC were enrolled between March 2013 and February 2017 (data cut-off July 31, 2017). The ORR was 37.1% (95% CI 21.1-53.2%). The CBR was 54.3% (95% CI 37.8-70.8%). The median PFS was 6.2 months (95% CI 2.7-9.4 months) and median OS was 21.4 months (95% CI 11.5-32.9 months). Common grade 3/4 adverse events were neutropenia (42.9%) but febrile neutropenia (2.9%). Although the majority of non-hematological adverse events were mild in severity, one patient died of pneumonitis. In HRQoL analysis, eribulin appeared to maintain HRQoL of many patients.Eribulin as first- or second-line chemotherapy is effective and has manageable toxicity for patients with HER2-negative MBC.