化疗联合伊尼妥单抗和吡咯替尼对比卡培他滨联合吡咯替尼在HER2阳性转移性乳腺癌二线治疗的疗效及安全性分析  

Efficacy and safety analysis of chemotherapy combined with inetetamab and pyrotinib versus capecitabine combined with pyrotinib in second-line treatment for HER2 positive metastatic breast cancer

作　　者：游敏晶 刘健[1] 陈木兰[1] 李娜妮[1] 吴凡[1] You Minjing;Liu Jian;Chen Mulan;Li Nani;Wu Fan(Clinical Oncology School of Fujian Medical University,Fujian Cancer Hospital,Fuzhou 350014,China)

机构地区：[1]福建医科大学肿瘤临床医学院、福建省肿瘤医院肿瘤内科,福州350014

出　　处：《中华内分泌外科杂志（中英文）》2024年第6期846-852,共7页Chinese Journal of Endocrine Surgery

基　　金：福建省自然科学基金(2022J01428)。

摘　　要：目的探索HER2阳性转移性乳腺癌曲妥珠单抗治疗失败的二线治疗患者中,比较化疗联合伊尼妥单抗和吡咯替尼(三药组),卡培他滨联合吡咯替尼(两药组)的疗效及安全性。方法回顾性分析2020年1月1日至2023年12月31日于福建省肿瘤医院以化疗+伊尼妥单抗+吡咯替尼方案治疗的人表皮生长因子受体2(HER2)阳性转移性乳腺癌二线治疗患者30例(简称"三药组"),并分析同期在医院接受卡培他滨+吡咯替尼治疗的HER2阳性转移性乳腺癌二线治疗患者28例(简称"两药组")。分析两组客观缓解率(ORR)、临床获益率(CBR)、无进展生存期(PFS)、总生存期(OS)差异,并记录治疗期间的不良反应。结果三药组ORR率高于两药组(60.0%比39.2%,P>0.05),三药组CBR率高于两药组(83.3%比57.1%,P<0.05)。单因素分析及多因素Logistic回归分析显示,组别(三药组比两药组)是唯一影响患者中位PFS的独立预后因素(P<0.05)。三药组中位PFS高于两药组(19个月比11个月,P<0.05),但至随访结束,两组均未达到中位OS(P>0.05)。三药组及两药组1年OS率分别为85%、85%,2年OS率分别为74%、63%,3年OS率分别为56%、52%。三药组最常见的血液学毒性是白细胞减少、中性粒细胞减少及贫血,最常见的非血液毒性是腹泻。在不良反应方面,两组差异无统计学意义(P>0.05)。结论化疗+伊尼妥单抗+吡咯替尼在HER2阳性转移性乳腺癌二线治疗中,相较于目前国内标准的卡培他滨+吡咯替尼方案,能显著延长中位PFS,并提高CBR,且未增加不良反应的发生率,具有较高的有效性及安全性。ObjectiveTo investigate the efficacy and safety of chemotherapy combined with inetetamab and pyrotinib(triplet therapy group),and capecitabine combined with pyrotinib(doublet therapy group)in second-line treatment for HER2-positive metastatic breast cancer patients who have failed on trastuzumab.MethodsA retrospective analysis was conducted on 30 HER2-positive metastatic breast cancer patients who underwent second-line treatment with a regimen of chemotherapy plus inetetamab and pyrotinib at Fujian Provincial Tumor Hospital between Jan.1,2020 and Dec.31,2023,and on 28 HER2-positive metastatic breast cancer patients treated with capecitabine plus pyrotinib during the same period.The study analyzed the differences in ORR(objective response rate),CBR(clinical benefit rate),PFS(progression free survival),and OS(overall survival)between the two groups and documented any adverse reactions observed during treatment.ResultsThe three-drug group exhibited a higher ORR rate than the two-drug group(60.0%vs.39.2%,P>0.05),and a higher CBR rate(83.3%vs.57.1%,P<0.05).Univariate analysis and multivariate Logistic regression analysis showed that group(three drug group compared to two drug group)was the only independent prognostic factor affecting median PFS in patients(P<0.05).The median PFS of the three drug group was higher than that of the two drug group(19 months vs.11 months,P<0.05),but by the end of follow-up,neither group had reached the median OS(P>0.05).The three-drug group and the two-drug group demonstrated 1-year OS rates of 85%and 85%,2-year OS rates of 74%and 63%,and 3-year OS rates of 56%and 52%,respectively.The most frequent hematological toxicities in the three-drug group were leukopenia,neutropenia,and anemia,with diarrhea being the most common non-hematological toxicity.No significant differences were observed in adverse reaction profiles between the two groups(P>0.05).ConclusionIn the second-line treatment of HER2 positive metastatic breast cancer,chemotherapy+inetetamab+pyrotinib significantly prolonged the me

关 键 词：人表皮生长因子受体2 阳性转移性乳腺癌 二线治疗 伊尼妥单抗 吡咯替尼 卡培他滨 

分 类 号：R737.9[医药卫生—肿瘤]