真实世界艾立布林治疗HER2阴性转移性乳腺癌的疗效及安全性分析

Efficiency and safety of Eribulin in patients with HER2 negative metastatic breast cancer:a real world study

目的:探讨以艾立布林为基础的治疗方案在真实世界治疗HER2阴性转移性乳腺癌的临床疗效及安全性。方法:本研究回顾性分析2020年1月—2021年11月南京医科大学附属医院肿瘤内科收治的接受艾立布林单药或联合方案治疗的60例HER2阴性转移性乳腺癌患者的临床资料。结果:本研究纳入的人群中,18例(30.00%)患者接受艾立布林单药治疗,42例(70.00%)患者接受艾立布林联合方案治疗。中位随访5个月时,中位无进展生存期(progression-free survival,PFS)为4.30个月(95%CI:3.86~5.69个月),中位总生存期尚未成熟,客观缓解率为25.00%,疾病控制率为76.67%。Log-rank单因素分析显示艾立布林单药对比联合方案的疗效有显著差异(中位PFS 2.93个月vs.4.70个月,P=0.042)。COX多因素分析提示年龄和化疗线数是艾立布林治疗HER2阴性转移性乳腺癌患者PFS的独立危险因素(P=0.022,0.048)。艾立布林治疗相关的Ⅲ~Ⅳ级不良事件主要为血液学毒性,包括中性粒细胞减少、白细胞减少、贫血以及淋巴细胞减少,未出现治疗相关性严重不良事件及死亡。结论:以艾立布林为基础的方案能有效治疗HER2阴性转移性乳腺癌,安全性良好。

Objective:To observe the efficacy and safety of Eribulin-based regimen in patients with HER2 negative metastatic breast cancer in the real world.Methods:We retrospectively analyzed clinical data of 60 patients with HER2-negative metastatic breast cancer who received Eribulin-based therapy in Jiangsu Province Hospital between January 2020 and November 2021.Results:30%of patients received Eribulin monotherapy while 70%of patients received Eribulin-based combination therapy.After a median follow-up of 5 months,the median progression-free survival(PFS)was 4.30 months(95%CI:3.86-5.69 months),Median overall survival(OS)was not reached.The overall response rate(ORR)was 25.00%,and disease control rate(DCR)was 76.67%.Log-rank univariate analysis showed that there was a statistically significant difference between Eribulin monotherapy versus Eribulin-based combination regimen(2.93 months vs.4.7 months,P=0.042).Multivariate analysis indicated that age and chemotherapy lines were independent risk factors for PFS in patients with HER2-negative metastatic breast cancer treated with Eribulin(P=0.022,0.048).The most common gradeⅢ-Ⅳadverse events(AE)associated with Eribulin include neutropenia,leukopenia,anemia,and lymphopenia,and no treatmentrelated severe adverse event(SAE)or deaths were observed.Conclusion:Our research indicated that Eribulin-based regimen can effectively treat HER2-negative metastatic breast cancer with controllable side effects.