肿瘤药学2025，Vol.15Issue(4)：433-443,11.DOI:10.3969/j.issn.2095-1264.2025.04.01
德曲妥珠单抗在HER2阳性及HER2低表达晚期乳腺癌中的疗效与安全性:一项单中心真实世界研究
Efficacy and safety of trastuzumab deruxtecan in HER2-positive and HER2-low metastatic breast cancer:a single-center real-world study
摘要
Abstract
Objective To evaluate the real-world efficacy and safety of trastuzumab deruxtecan(T-DXd)in patients with human epidermal growth factor receptor 2(HER2)-positive and HER2-low expression advanced breast cancer,and to explore prognostic factors.Methods A total of 144 patients with advanced breast cancer who received T-DXd treatment at the Department of Medical Oncology,Hunan Cancer Hospital,from April 2022 to August 2024 were included.Among them,86 patients(59.7%)had HER2-positive disease and 58(40.3%)had HER2-low expression.Treatment response was assessed every two cycles according to RECIST v1.1.Median progression-free survival(PFS)was estimated using the Ka-plan-Meier method,and prognostic factors were analyzed using the Cox proportional hazards model.Results The median age of all enrolled patients was 53.0 years,and 87.5%had visceral metastases.The median number of prior lines of therapy was three.The objective response rate(ORR)was 38.2%,and the disease control rate(DCR)was 89.6%.The median PFS was 8.93 months(95%CI:7.70-13.20).Compared with the HER2-low group,the HER2-positive group demonstrated supe-rior ORR(44.2%vs.29.3%)and median PFS(13.20 months vs.6.70 months)(P<0.001).Multivariate analysis revealed that among HER2-positive patients,ECOG performance status≥1(HR=3.109,P=0.004)and prior anti-HER2 therapy(HR=4.934,P=0.002)were independent risk factors for shorter PFS.Among HER2-low patients,a history of taxane chemo-therapy(HR=5.133,P=0.017)and HER2 heterogeneity(HR=2.363,P=0.022)were associated with poor prognosis,while re-ceiving more than three lines of chemotherapy was associated with longer PFS(HR=0.333,P=0.045).Regarding safety,The most common adverse events were elevated aspartate aminotransferase(AST)(63.9%),neutropenia(58.3%),and leukopenia(57.6%).The incidence of grade≥3 adverse events was relatively low(neutropenia 7.0%,thrombocytopenia 2.3%).The inci-dence of interstitial lung disease(ILD)was 3.5%,including two grade 3 events(1.4%).Conclusion T-DXd demonstrated substantial real-world efficacy in both HER2-positive and HER2-low advanced breast cancer,with greater benefit ob-served in HER2-positive patients.ECOG performance status,treatment history,and HER2 expression level were key prog-nostic factors.In clinical practice,individualized treatment strategies should be developed based on molecular characteris-tics and prior therapy,with close monitoring for hematologic toxicities and ILD.关键词
乳腺肿瘤/人表皮生长因子受体2/德曲妥珠单抗/疗效/安全性Key words
Breast neoplasms/Human epidermal growth factor receptor 2/Trastuzumab deruxtecan/Efficacy/Safety分类
医药卫生引用本文复制引用
刘斌亮,曹敏,水峥嵘,吴晖,高建湘,胡旭明,欧阳取长,胡哲煜,谢宁,刘莉萍,李晶,肖华伍,杨小红,田璨,鲁军..德曲妥珠单抗在HER2阳性及HER2低表达晚期乳腺癌中的疗效与安全性:一项单中心真实世界研究[J].肿瘤药学,2025,15(4):433-443,11.基金项目
湖南省自然科学基金资助项目(2023JJ60464) （2023JJ60464）
湖南省自然科学基金青年基金资助项目(2024JJ6289) （2024JJ6289）
长沙市自然科学基金资助项目(kq2403120) （kq2403120）
湖南省肿瘤医院攀登计划资助项目(ZX2021005) （ZX2021005）
湖南省肿瘤医院攀登计划启航基金资助项目(QH2023006) （QH2023006）
湖南省肿瘤医院高层次人才五年行动计划支持(20250731-1050). （20250731-1050）
