难治型晚期乳腺癌艾立布林真实疗效

　　艾立布林是一种非紫杉类微管抑制剂化疗药，根据随机对照研究结果，2019年被中国内陆批准用于治疗晚期乳腺癌至少二线化疗失败患者。不过，艾立布林治疗中国晚期乳腺癌女性的真实世界研究较少。

　　2021年7月9日，英国《肿瘤内科治疗进展》在线发表复旦大学附属肿瘤医院赵燕南、张剑、龚成成、李懿、王碧芸、湖南省肿瘤医院（中南大学湘雅医学院附属肿瘤医院）谢宁、江苏省人民医院（南京医科大学第一附属医院）李薇、南昌大学第一附属医院陈文艳、吉林大学白求恩第一医院吕铮、浙江省肿瘤医院（中国科学院大学附属肿瘤医院）郑亚兵、辽宁省肿瘤医院（中国医科大学肿瘤医院）孙涛、中山大学孙逸仙纪念医院刘洁琼、复旦大学附属华东医院葛睿、中山大学肿瘤防治中心徐菲等学者的YOUNGBC-12研究报告，在真实世界临床实践中，确定了艾立布林对中国晚期乳腺癌多线化疗失败女性的有效性和安全性，并探索了其疗效的可能影响因素。

YOUNGBC-12 (NCT04541420): An Observational, Retrospective Study of Eribulin in Advanced Breast Cancer

　　该多中心回顾研究对2019年11月至2020年10月全国9家医院连续272例接受艾立布林治疗的中国晚期乳腺癌患者进行回顾分析。每21天的第1天和第8天静脉注射艾立布林1.4mg/m²。疗效结局包括无进展生存、总生存、客观缓解率、临床获益率。根据美国国家癌症研究所常见毒性标准（NCI-CTC）5.0版对不良事件进行分级。

　　结果，这些患者既往中位四线化疗失败，经过中位随访7.7个月，中位无进展生存4.1个月（95%置信区间：3.6～4.6），总生存尚未达到中位。客观缓解率为17.6%，临床获益率为24.6%。

　　艾立布林单药治疗患者占51.8%，艾立布林联合靶向治疗或其他化疗患者占48.2%。

　　根据多因素比例风险回归模型分析，艾立布林无进展生存显著影响因素包括：

• 转移部位数量（P=0.023）

• 既往紫杉类治疗晚期乳腺癌持续时间（P=0.048）

• 联合贝伐珠单抗（P=0.046）

　　艾立布林发生率最高的不良事件为血液学毒性，包括中性粒细胞减少、白细胞减少、贫血。

　　因此，该多中心小样本短期随访研究结果表明，艾立布林对于真实世界临床实践有效、毒性可控。此外，当联合其他药物时，艾立布林并未增加各个药物的毒性反应。艾立布林单药或联合其他药物可以作为中国晚期乳腺癌多线治疗失败患者的替代方案。

相关链接

• 奥拉帕利＋艾日布林→三阴乳腺癌

• 艾日布林用于至少接受过一次化疗转移性乳腺癌患者的汇总分析

• 三阴性乳腺癌术前艾立布林化疗效果

• 晚期乳腺癌艾立布林＋帕妥珠＋曲妥珠

• 艾立布林单药治疗乳腺癌肝肺转移结局

• 艾立布林对晚期乳腺癌的实际效果

• 欧洲癌症杂志发表中国乳腺癌研究：E7389-C086-304

• YOUNGBC-1：转移性乳腺癌氟维司群治疗失败后

• YOUNGBC-2：氟维司群与依西美坦的多中心比较

• YOUNGBC-3：氟维司群单药对比依维莫司＋依西美坦

• YOUNGBC-5：中国晚期乳腺癌患者依维莫司相关肺炎

• YOUNGBC-9：哌柏西利失败后晚期乳腺癌治疗选择

• YOUNGBC-10：吡咯替尼＋长春瑞滨治疗晚期乳腺癌

Ther Adv Med Oncol. 2021 Jul 9;13:17588359211030210.

Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: a multicenter retrospective study.

Zhao Y, Xie N, Li W, Chen W, Lv Z, Zheng Y, Sun T, Liu J, Zhang J, Hu S, Wang Y, Gong C, Li Y, Xie Y, Ge R, Xu F, Wang B.

Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai, China; Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya Medical School, Central South University, Changsha, Hunan, China; Jiangsu Province Hospital, Nanjing, Jiangsu, China; The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China; The First Affiliated Hospital of Jilin University, Changchun, Jilin, China; Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China; Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, Liaoning, China; Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China; Huadong Hospital Affiliated to Fudan University, Shanghai, China; Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China.

BACKGROUND: 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.

PATIENTS AND METHODS: 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/m2 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.

RESULTS: 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 (p = 0.023, p = 0.048, and p = 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.

CONCLUSION: 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.

KEYWORDS: Chinese women; eribulin; metastatic breast cancer; predictive factors; real-world effectiveness

PMID: 34290830

PMCID: PMC8274129

DOI: 10.1177/17588359211030210