Inetetamab combined with sirolimus and chemotherapy for the treatment of HER2‐positive metastatic breast cancer patients with abnormal activation of the PI3K/Akt/mTOR pathway after trastuzumab treatment

作     者：Qiao Li Dan Lv Xiaoying Sun Mengyuan Wang Li Cai Feng Liu Chenghui Li Jiuda Zhao Jing Sun Yehui Shi Fei Ma 

作者机构：Department of Medical OncologyNational Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina Department of Medical OncologyCancer Hospital of Huanxing Chaoyang DistrictBeijingChina Department of Breast SurgeryChongqing University Three Gorges HospitalChongqing UniversityWanzhouChina Department of Medical OncologyThe Affiliated Tumour Hospital of Harbin Medical UniversityHarbinChina Department of Breast SurgeryFuyang Cancer HospitalFuyangChina Department of Medical OncologyAnqing Hospital Affiliated to Medical University of AnhuiAnqingChina Affiliated Hospital of Qinghai UniversityAffiliated Cancer Hospital of Qinghai UniversityXiningChina Department of Medical OncologyAnyang Cancer HospitalAnyangChina Tianjin Medical University Cancer Institute and HospitalNational Clinical Research Center for CancerTianjinChina 

出 版 物：《Cancer Innovation》 (肿瘤学创新（英文）)

年 卷 期：2024年第3卷第5期

页      面：102-111页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：CAMS Innovation Fund for Medical Sciences Grant/Award Numbers:2021‐I2M‐1‐014 2022‐I2M‐2‐002 

主　　题：chemotherapy inetetamab metastatic HER2‐positive breast cancer PAM pathway pyrotinib sirolimus 

摘      要：Background:We explored the efficacy and safety of inetetamab combined with sirolimus and chemotherapy for the treatment of human epidermal factor receptor 2(HER2)‐positive metastatic breast cancer patients with abnormal activation of the PI3K/Akt/mTOR(PAM)pathway after trastuzumab ***:For this prospective multicenter clinical study,HER2‐positive metastatic breast cancer patients with PAM pathway mutations confirmed by histology or peripheral blood genetic testing were enrolled from July 2021 to September *** were randomly assigned to a trial or control *** patients in the trial group received inetetamab combined with sirolimus and chemotherapy,while the control group patients received pyrotinib and *** RECIST v1.1 standard was used to evaluate *** statistics were used to summarize the clinicopathological features,and the Kaplan–Meier method was used to generate survival *** log‐rank test was used to compare progression‐free survival(PFS)between the two ***:A total of 59 HER2‐positive metastatic breast cancer patients with abnormal activation of the PAM pathway were included,of which 37 received inetetamab combined with sirolimus and chemotherapy treatment and 22 received pyrotinib and chemotherapy *** median PFS was 4.64 months in the inetetamab group and 5.69 months in the pyrotinib group,with no statistically significant difference(p=0.507).The objective response rates were 27.3%for the inetetamab group and 29.4%for the pyrotinib *** safety assessment indicated that the adverse event(AE)incidences were 86.1%(31/36)in the inetetamab group and 78.9(15/19)in the pyrotinib group,with 9(25%)and four(21.1%)Grade 3/4 AEs in the inetetamab and pyrotinib groups,***:For metastatic HER2‐positive breast cancer patients with abnormal PAM pathway activation and previous trastuzumab treatment,the combination of inetetamab with sirolimus and chemotherapy is equivalen