Zhao Yannan, Xie Ning, Li Wei, Chen Wenyan, Lv Zheng, Zheng Yabing, Sun Tao, Liu Jieqiong, Zhang Jian, Hu Shihui, Wang Yajun, Gong Chengcheng, Li Yi, Xie Yizhao, Ge Rui, Xu Fei, Wang Biyun
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R. China.
Department of Breast Cancer Medical Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya Medical School, Central South University, Changsha, Hunan, P.R. China.
Ther Adv Med Oncol. 2021 Jul 9;13:17588359211030210. doi: 10.1177/17588359211030210. eCollection 2021.
Eribulin is a nontaxane microtubule inhibitor approved in China for patients with advanced breast cancer who show progression after ⩾2 lines of chemotherapy. The aim of this study was to determine the efficacy and safety profile of eribulin and explore potential predictive factors for the efficacy of eribulin among Chinese women with metastatic breast cancer (MBC) in real-world practice.
A total of 272 consecutive MBC patients who were treated with eribulin between November 2019 and October 2020 in 9 institutions nationwide were included in this study. Eribulin was administered intravenously at a dose of 1.4 mg/m on days 1 and 8 of a 21-day cycle. Efficacy outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Adverse events (AEs) were graded according to The National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.0.
Eribulin showed a median PFS of 4.1 months (95% confidence interval [CI] 3.6-4.6); however, the OS data were immature. The ORR was 17.6% and the CBR was 24.6%. A total of 51.8% of patients received eribulin monotherapy, while 48.2% of patients were treated with eribulin plus targeted therapy or other chemotherapy. The number of metastatic sites, duration of previous taxane treatment for MBC, and combination with bevacizumab were significant in Cox multivariate analysis ( = 0.023, = 0.048, and = 0.046, respectively) and were significantly associated with PFS of eribulin. The most common AEs with eribulin treatment were hematological toxicities, including neutropenia, leukopenia, and anemia.
Eribulin was effective with a manageable toxicity profile in clinical practice. Furthermore, when prescribed in combination with other agents, eribulin did not increase the toxic effects of each agent. Eribulin monotherapy or plus other agents is an alternative for the heavily pretreated patients with MBC.
艾瑞布林是一种非紫杉烷类微管抑制剂，在中国已被批准用于接受过至少2线化疗后出现疾病进展的晚期乳腺癌患者。本研究的目的是确定艾瑞布林的疗效和安全性，并在真实世界实践中探索中国转移性乳腺癌（MBC）女性患者中艾瑞布林疗效的潜在预测因素。
本研究纳入了2019年11月至2020年10月期间在全国9家机构接受艾瑞布林治疗的272例连续MBC患者。在21天周期的第1天和第8天，静脉注射艾瑞布林，剂量为1.4mg/m²。疗效指标包括无进展生存期（PFS）、总生存期（OS）、客观缓解率（ORR）和临床获益率（CBR）。不良事件（AE）根据美国国立癌症研究所通用毒性标准（NCI-CTC）第5.0版进行分级。
艾瑞布林的中位PFS为4.1个月（95%置信区间[CI]3.6 - 4.6）；然而，OS数据尚不成熟。ORR为17.6%，CBR为24.6%。共有51.8%的患者接受艾瑞布林单药治疗，而48.2%的患者接受艾瑞布林联合靶向治疗或其他化疗。转移部位数量、MBC既往紫杉烷治疗时长以及与贝伐单抗联合使用在Cox多因素分析中具有显著性（分别为P = 0.023、P = 0.048和P = 0.046），且与艾瑞布林的PFS显著相关。艾瑞布林治疗最常见的AE是血液学毒性，包括中性粒细胞减少、白细胞减少和贫血。
在临床实践中，艾瑞布林有效且毒性可控。此外，与其他药物联合使用时，艾瑞布林不会增加各药物的毒性作用。艾瑞布林单药治疗或联合其他药物是经过大量预处理的MBC患者的一种选择。
