伊尼妥单抗联合方案在HER2阳性转移性乳腺癌中的疗效与安全性  

Efficacy and safety of inetetamab⁃based therapy in HER2 positive metastatic breast cancer

作　　者：黄香[1] 金楠 吴昕煜 殷咏梅[1] HUANG XiangJIN Nan;WU Xinyu;YIN Yongmei(Department of Oncology,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China)

机构地区：[1]南京医科大学第一附属医院肿瘤科,江苏南京210029

出　　处：《南京医科大学学报（自然科学版）》2023年第12期1675-1680,共6页Journal of Nanjing Medical University(Natural Sciences)

基　　金：国家自然科学基金(82272667);希思科临床肿瘤学研究基金(Y⁃pierrefabre202101⁃0109)。

摘　　要：目的:观察真实世界中注射用重组抗人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)人源化单克隆抗体伊尼妥单抗用于HER2阳性转移性乳腺癌患者的临床疗效和安全性。方法:回顾性收集2020年7月—2022年12月期间南京医科大学第一附属医院肿瘤科收治的经含伊尼妥单抗方案治疗的HER2阳性转移性乳腺癌患者的临床资料,分析伊尼妥单抗联合方案治疗后患者的无进展生存期(progression⁃free survival,PFS)、总生存期(overall survival,OS)、客观缓解率(objective response rate,ORR)和疾病控制率(disease control rate,DCR)等疗效指标,并观察治疗期间的不良反应。结果:共纳入经伊尼妥单抗治疗的HER2阳性转移性乳腺癌患者60例,其中9例伊尼妥单抗作为一线治疗,14例作为二线治疗,13例作为三线治疗,24例作为四线及以上治疗;伊尼妥单抗联合化疗24例,联合吡咯替尼+化疗32例,联合其他用药方案4例。总体人群中的中位PFS为6.23个月,伊尼妥单抗一/二线治疗中位PFS为12.27个月,三线及以上治疗中位PFS为5.63个月,伊尼妥单抗联合化疗中位PFS为4.60个月,伊尼妥单抗联合吡咯替尼+化疗中位PFS为7.73个月。总人群中ORR为35.0%,DCR为81.7%。治疗中与伊尼妥单抗相关的主要不良反应为贫血、白细胞减少及中性粒细胞减少。结论:伊尼妥单抗对于HER2阳性转移性乳腺癌患者具有良好的疗效和安全性,尤其是联合吡咯替尼+化疗用于一/二线治疗。Objective:To evaluate the clinical efficacy and safety of inetetamab⁃based therapy in patients with human epidermal growth factor receptor 2(HER2)positive metastatic breast cancer(MBC).Methods:A retrospective analysis of the clinical data of 60 patients with HER2 positive MBC who received inetetamab⁃based therapy in Jiangsu Provin Hospital from July 2020 to December 2022 was conducted.The progression⁃free survival(PFS),overall survival(OS),objective response rate(ORR)and disease control rate(DCR)of patients treated with inetetamab therapy were analyzed.Results:A total of 60 patients with HER2 positive MBC over all lines of treatment with inetetamab were enrolled(one,n=9;two,n=14;three,n=13;four or higher,n=24),in cluding 24 cases of inetetamab combined with chemotherap 32 cases of inetetamab plus pyrotinib and chemotherapy,and 4 cases of inetetamab combined with other drug regimens.At the end of follow up,the median PFS of the 60 patients was 6.23 months.The median PFS of patients who received inetetamab⁃based therapy as a first⁃or second⁃line therapy was significantly longer than third or later line,12.27 vs.5.63 months.Compared with treatment in combination with chemotherapy,combination with pyrotinib and chemotherapy provided a better PFS(7.73 vs.4.60 months).The ORR and DCR were 35.0%and 81.7%,respectively.The most common adverse events were anemia,leucopenia and neutrocytopenia.Conclusion:Inetetamab,especially in combination with pyrotinib and chemotherapy,has a significant efficacy and good safety in patients with HER2 positive MBC.

关 键 词：人表皮生长因子受体 伊尼妥单抗 乳腺肿瘤 

分 类 号：R737.9[医药卫生—肿瘤]