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 

机构地区：[1]Department of Oncology,The First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210029,China [2]Department of Pathology,The First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210029,China [3]Radiology Department,The First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210029,China [4]Department of Oncology,Affiliated Jinling Hospital,Medical School of Nanjing University,Nanjing,Jiangsu 210000,China

出　　处：《Cancer Pathogenesis and Therapy》2024年第1期31-37,共7页癌症发生与治疗（英文）

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

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 trastuzumab.In 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 treatment.Methods In this prospective,single-arm,phase 2 trial,patients with HER2-positive advanced breast cancer with disease progression after trastuzumab were recruited.Patients 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 toxicity.The primary endpoint was progression-free survival(PFS).The secondary endpoints included objective response rate(ORR),overall survival(OS),disease control rate(DCR),and safety.Results Between February 13,2022 and December 25,2022,30 patients were screened and enrolled in this study.The 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 metastasis.The median PFS was 8.63 months(95%confidence interval[CI]4.15-13.12 months).The median OS was not reached.The 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 occurred.Conclusions 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.

关 键 词：Human epidermal growth factor receptor 2 Breast cancer Inetetamab Pyrotinib VINORELBINE 

分 类 号：R73[医药卫生—肿瘤]