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中华乳腺病杂志(电子版) ›› 2026, Vol. 20 ›› Issue (04) : 213 -218. doi: 10.3877/cma.j.issn.1674-0807.2026.04.003

论著

艾立布林在不同分子分型晚期乳腺癌中的疗效分析:多中心回顾性研究
黎立喜1, 桑蝶2, 段博识3, 李巧佴1, 郑晓娟1, 彭雪楠1, 曾成1, 祁亚龙1, 张晓童1, 岳静1, 兰波1, 王佳玉1, 李俏1, 马飞1,()   
  1. 1 100021 北京,国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院肿瘤内科
    2 100021 北京,北京朝阳区三环肿瘤医院肿瘤内科
    3 518172 深圳,中国医学科学院肿瘤医院深圳医院肿瘤内科
  • 收稿日期:2026-01-27 出版日期:2026-08-01
  • 通信作者: 马飞
  • 基金资助:
    国家自然科学基金重点项目(82230058); 国家自然科学基金重大研究计划(92459304)

Efficacy analysis of eribulin in advanced breast cancer with different molecular subtypes: a multicenter retrospective study

Lixi Li1, Die Sang2, Boshi Duan3, Qiao'er Li1, Xiaojuan Zheng1, Xue'nan Peng1, Cheng Zeng1, Yalong Qi1, Xiaotong Zhang1, Jing Yue1, Bo Lan1, Jiayu Wang1, Qiao Li1, Fei Ma1,()   

  1. 1 Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
    2 Department of Oncology, Beijing Chaoyang Sanhuan District Cancer Hospital, Beijing 100021, China
    3 Department of Oncology, Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen 518172, China
  • Received:2026-01-27 Published:2026-08-01
  • Corresponding author: Fei Ma
  • About author:

    Li Lixi, Sang Die and Duan Boshi contributed equally to the article

引用本文:

黎立喜, 桑蝶, 段博识, 李巧佴, 郑晓娟, 彭雪楠, 曾成, 祁亚龙, 张晓童, 岳静, 兰波, 王佳玉, 李俏, 马飞. 艾立布林在不同分子分型晚期乳腺癌中的疗效分析:多中心回顾性研究[J/OL]. 中华乳腺病杂志(电子版), 2026, 20(04): 213-218.

Lixi Li, Die Sang, Boshi Duan, Qiao'er Li, Xiaojuan Zheng, Xue'nan Peng, Cheng Zeng, Yalong Qi, Xiaotong Zhang, Jing Yue, Bo Lan, Jiayu Wang, Qiao Li, Fei Ma. Efficacy analysis of eribulin in advanced breast cancer with different molecular subtypes: a multicenter retrospective study[J/OL]. Chinese Journal of Breast Disease(Electronic Edition), 2026, 20(04): 213-218.

目的

基于多中心数据,分析艾立布林单药或联合方案在不同分子分型晚期乳腺癌中的疗效。

方法

回顾性收集2021年1月至2024年12月在中国医学科学院北京协和医学院肿瘤医院(n=121)、北京朝阳区三环肿瘤医院(n=40)、中国医学科学院肿瘤医院深圳医院(n=23)接受含艾立布林治疗方案的184例晚期乳腺癌患者的临床资料。根据乳腺癌分子分型分为激素受体(HR)阳性(+)/HER-2阴性(-)(n=88)、HR+/HER-2+(n=9)、HR-/HER-2+(n=11)及三阴性乳腺癌(TNBC,n=76)4组。患者用药方案包括艾立布林单药治疗、联合抗血管治疗及联合其他化疗3种。主要研究终点为无进展生存期(PFS),次要终点包括客观缓解率(ORR)和临床获益率(CBR)。采用Kaplan-Meier法绘制生存曲线,Log-rank检验进行生存分析。

结果

184例晚期乳腺癌患者的中位PFS为4.6(95% CI:3.9~5.3)个月,ORR为33.1%(61/184),CBR为82.6%(152/184)。HR+/HER-2-、HR+/HER-2+、HR-/HER-2+及TNBC组患者的中位PFS分别为5.0(95%CI:4.1~5.9)、4.1(95%CI:2.7~5.5)、3.5(95%CI:2.2~4.8)、4.4(95%CI:3.6~5.3)个月,4组比较差异无统计学意义(χ2=2.654,P>0.05);ORR分别为39.8%(35/88)、22.2%(2/9)、36.4%(4/11)和26.3%(20/76);CBR分别为83.0%(73/88)、77.8%(7/9)、72.7%(8/11)和84.2%(64/76)。在HR+/HER-2-组中,71例既往接受过细胞周期蛋白依赖性激酶 4/6 抑制剂(CDK4/6i)治疗的患者中位PFS为5.3(95%CI:4.4~6.3)个月,ORR为39.4%(28/71)。艾立布林联合抗血管治疗(n=121)与不含抗血管治疗(n=63)患者的中位PFS分别为4.5(95%CI:3.8~5.2)、4.9(95%CI:3.4~6.5)个月,两者比较差异无统计学意义(χ2=1.693,P>0.05);联合用药方案中,艾立布林联合贝伐珠单抗、安罗替尼、阿帕替尼患者的中位PFS分别为4.4(95%CI:3.4~5.4)、4.5(95%CI:3.6~5.4)、2.9个月,三者比较差异无统计学意义(χ2=0.855,P>0.05)。

结论

艾立布林单药或联合方案对不同分子分型(包括CDK4/6i耐药HR+/HER-2-型)晚期乳腺癌患者均有一定的抗肿瘤活性。

Objective

To analyze the efficacy of eribulin alone or combination therapy in different molecular subtypes of advanced breast cancer based on multicenter data.

Methods

This retrospective study collected clinical data of 184 patients with advanced breast cancer who received eribulin treatment between January 2021 and December 2024 at the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (n=121), Beijing Chaoyang District Sanhuan Cancer Hospital (n=40), and Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences (n=23). According to molecular subtypes of breast cancer, it was classified into 4 groups: hormone receptor-positive (HR+) /HER-2- (n=88), HR+/HER-2+ (n=9), HR-/HER-2+ (n=11), and triple negative breast cancer (TNBC) (n=76). Based on treatments, patients were categorized into 3 groups: eribulin alone, combination with antiangiogenic agents, or combination with other chemotherapeutic agents. The primary endpoint was progression-free survival (PFS); secondary endpoint included objective response rate (ORR) and clinical benefit rate (CBR). The survival curve was plotted using the Kaplan-Meier method, and Log-rank method was used for survival analysis.

Results

The median PFS of all 184 patients was 4.6 months (95%CI: 3.9–5.3), the ORR was 33.1% (61/184), and CBR was 82.6% (152/184). The median PFS of HR+/HER-2-, HR+/HER-2+, HR-/HER-2+, and TNBC were 5.0 (95%CI: 4.1-5.9), 4.1 (95%CI: 2.7-5.5), 3.5 (95%CI: 2.2-4.8), and 4.4 (95%CI: 3.6-5.3) months, respectively, with no statistically significant difference between the 4 groups (χ2=2.654, P>0.05); The ORRs were 39.8% (35/88), 22.2% (2/9), 36.4% (4/11), and 26.3% (20/76), respectively; The CBRs were 83.0% (73/88), 77.8% (7/9), 72.7% (8/11), and 84.2% (64/76), respectively. In the HR+/HER-2- group, the median PFS of 71 patients who had previously received cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) treatment was 5.3 months (95% CI: 4.4-6.3), with an ORR of 39.4% (28/71). The median PFS of patients receiving combination therapy with elibulin (n=121) and without antivascular therapy (n=63) were 4.5 months (95%CI: 3.8–5.2) and 4.9 months (95%CI: 3.4–6.5) respectively, with no statistically significant difference (χ2=1.693, P>0.05) . Among combination treatments, the median PFS of eribulin combined with bevacizumab, anlotinib, and apatinib were 4.4 (95%CI: 3.4–5.4) , 4.5 (95%CI: 3.6-5.4) , and 2.9 months, respectively, with no statistically significant difference (χ2=0.855, P>0.05) .

Conclusion

Eribulin alone or in combination therapy all have a certain anti-tumor activity in patients with advanced breast cancer of different molecular types (including CDK4/6i drug resistant HR+/HER-2- subtype) .

表1 184例不同分子分型乳腺癌患者的基线临床特征(例)
图1 艾立布林治疗晚期乳腺癌患者的无进展生存曲线分析 A图为184例晚期乳腺癌患者总体无进展生存情况;B 图为不同分子分型乳腺癌患者无进展生存情况;C图为接受艾立布林不同治疗方案乳腺癌患者的无进展生存情况;D 图为接受艾立布林联合不同抗血管药物治疗乳腺癌患者的无进展生存情况 注:B图,χ2=2.654,P>0.05;C图,χ2=1.693,P>0.05;D图,χ2=0.855,P>0.05;HR为激素受体;HER为人表皮生长因子受体;TNBC为三阴性乳腺癌
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