Objective: To explore the efficacy and safety of real-world eribulin in the treatment of metastatic breast cancer. Methods: From December 2019 to December 2020, patients with advanced breast cancer were selected from Beijing Chaoyang District Sanhuan Cancer Hospital, Shandong Cancer Hospital, Peking University Cancer Hospital, Baotou Cancer Hospital, Shengjing Hospital Affiliated to China Medical University, and Cancer Hospital of Chinese Academy of Medical Sciences. Kaplan-Meier method and Log rank test were used for survival analysis, and Cox regression model was used for multivariate analysis. Results: The median progression-free survival (PFS) of 77 patients was 5 months, the objective response rate (ORR) was 33.8%, and the disease control rate (DCR) was 71.4%. The ORR of patients with triple-negative breast cancer was 23.1%, and the DCR was 57.7%; the ORR of patients with Luminal breast cancer was 40.0%, and the DCR was 77.8%; the ORR of patients with HER-2 overexpression breast cancer was 33.3%, and the DCR was 83.3%. ORR of 50.0% and DCR of 66.7% for patients treated with eribulin as first to second line treatment, ORR of 29.4% and DCR of 76.5% for patients treated with third to fourth line and ORR of 28.6% and DCR of 71.4% for patients treated with five to eleven line. The ORR of patients in the eribulin monotherapy group was 40.0% and the DCR was 66.0%; the ORR of patients in the combination chemotherapy or targeted therapy group was 22.2% and the DCR was 81.5%. Patients with a history of treatment with paclitaxel, docetaxel, or albumin paclitaxel during the adjuvant phase or after recurrent metastasis had an ORR of 32.9% and a DCR of 69.9% when treated with eribulin. The treatment efficacy is an independent prognostic factor affecting patient survival (P<0.001). The main adverse reactions in the whole group of patients were Grade Ⅲ-Ⅳ neutrophil decline [29.9% (23/77)], and other adverse reactions were Grade Ⅲ-Ⅳ fatigue [5.2% (4/77)], Grade Ⅲ-Ⅳ peripheral nerve abnormality [2.6% (2/77)] and Grade Ⅲ-Ⅳ alopecia [2.6% (2/77)]. Conclusions: Eribulin still has good antitumor activity against various molecular subtypes of breast cancer and advanced breast cancer that has failed multiple lines of chemotherapy, and the adverse effects can be controlled, so it has a good clinical application value.
目的： 探讨真实世界艾立布林治疗晚期乳腺癌的疗效及安全性。 方法： 选取2019年12月至2020年12月就诊于北京市朝阳区三环肿瘤医院、山东省肿瘤医院、北京大学肿瘤医院、包头市肿瘤医院、中国医科大学附属盛京医院及中国医学科学院肿瘤医院的晚期乳腺癌患者。生存分析采用Kaplan-Meier法和Log rank检验，多因素分析采用Cox回归模型。 结果： 77例患者中位无进展生存时间为5个月，客观缓解率(ORR)为33.8%，疾病控制率(DCR)为71.4%。三阴性乳腺癌患者ORR为23.1%，DCR为57.7%；Luminal型乳腺癌患者ORR为40.0%，DCR为77.8%；人表皮生长因子受体2过表达型乳腺癌患者ORR为33.3%，DCR为83.3%。艾立布林为一线至二线治疗患者的ORR为50.0%，DCR为66.7%；三线至四线治疗患者的ORR为29.4%，DCR为76.5%；五线至十一线治疗患者的ORR为28.6%，DCR为71.4%。艾立布林单药治疗组患者的ORR为40.0%，DCR为66.0%；联合化疗或靶向治疗组患者的ORR为22.2%，DCR为81.5%。在辅助治疗阶段或复发转移后有紫杉醇、多西他赛或白蛋白紫杉醇治疗史的患者接受艾立布林治疗，其ORR为32.9%，DCR为69.9%。疗效评价是患者预后的独立影响因素(P<0.001)。全组患者的主要不良反应为Ⅲ~Ⅳ度中性粒细胞下降[29.9%(23/77)]，其他不良反应分别为Ⅲ~Ⅳ度疲乏[5.2%(4/77)]、Ⅲ~Ⅳ度周围神经异常[2.6%(2/77)]和Ⅲ~Ⅳ度脱发[2.6%(2/77)]。 结论： 艾立布林对各种分子亚型乳腺癌、多线化疗失败的晚期乳腺癌仍有效，且不良反应可控，具有较好的临床应用价值。.
Keywords: Adverse reactions; Breast neoplasms; Efficacy; Eribulin.