Inetetamab combined with pyrotinib and oral vinorelbine for patients with human epidermal growth factor receptor 2 positive advanced breast cancer:A single-arm phase 2 clinical trial

作     者：Nan Jin Yi Xu Siqi Wang Chunxiao Sun Xueqi Yan Fan Yang Yan Liang Weiwei Chen Xiang Huang Nan Jin;Yi Xu;Siqi Wang;Chunxiao Sun;Xueqi Yan;Fan Yang;Yan Liang;Weiwei Chen;Xiang Huang

作者机构：Department of OncologyThe First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsu 210029China Department of PathologyThe First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsu 210029China Radiology DepartmentThe First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsu 210029China Department of OncologyAffiliated Jinling HospitalMedical School of Nanjing UniversityNanjingJiangsu 210000China 

出 版 物：《Cancer Pathogenesis and Therapy》 (癌症发生与治疗（英文）)

年 卷 期：2024年第2卷第1期

页      面：31-37页

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

基　　金：This study was supported by the Chinese Society of Clinical Oncology(CSCO)Research Foundation of Beijing(No.Y-pierrefabre202101-0109) 

主　　题：Human epidermal growth factor receptor 2 Breast cancer Inetetamab Pyrotinib Vinorelbine 

摘      要：Background Human epidermal growth factor receptor 2(HER2)-targeted agents have significantly improved the outcomes of patients with HER2-positive breast cancer;however,a large proportion of patients still develop resistance to *** this study,we investigated the efficacy and safety of inetetamab,another anti-HER2 antibody,combined with pyrotinib and oral vinorelbine in patients with HER2-positive advanced breast cancer so as to provide new ideas for the *** In this prospective,single-arm,phase 2 trial,patients with HER2-positive advanced breast cancer with disease progression after trastuzumab were *** received a combination of inetetamab(loading dose of 8 mg/kg and subsequent doses of 6 mg/kg intravenously once every 3 weeks),pyrotinib(400 mg orally once daily),and vinorelbine(60 mg/m^(2)orally once weekly)until disease progression or intolerable *** primary endpoint was progression-free survival(PFS).The secondary endpoints included objective response rate(ORR),overall survival(OS),disease control rate(DCR),and *** Between February 13,2022 and December 25,2022,30 patients were screened and enrolled in this *** median age of the patients at enrollment was 54 years,12 patients(40.0%)had hormone-receptor-positive disease and 23 patients(76.7%)had visceral *** median PFS was 8.63 months(95%confidence interval[CI]4.15-13.12 months).The median OS was not *** ORR was 53.3%(16/30)and the DCR was 96.7%(29/30).The most common Grade III/IV adverse events were leukopenia(n=5,16.7%),neutropenia(n=4,13.3%),and diarrhea(n=3,10%).No treatment-related serious adverse events or deaths *** The combination regimen of inetetamab,pyrotinib,and oral vinorelbine showed encouraging efficacy and favorable safety in patients with HER2-positive advanced breast cancer and could be considered as an alternative treatment option for the patients.