基于英菲他单抗治疗HER2阳性晚期乳腺癌患者的真实世界治疗模式：一项回顾性单中心研究。
Inetetamab-based therapy in real-world treatment patterns with HER2-positive advanced breast cancer patients: a retrospective single-center study.
作者信息
Jiang Mingxia, Liu Jiaxuan, He Maiyue, Zhang Mengqi, Zhou Shihan, Chen Shanshan, Cai Ruigang, Mo Hongnan, Lan Bo, Zhang Pin, Xu Binghe, Li Qiao
机构信息
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
出版信息
Ther Adv Med Oncol. 2024 Sep 9;16:17588359241275422. doi: 10.1177/17588359241275422. eCollection 2024.
BACKGROUND
Inetetamab is a novel antibody targeting human epidermal growth factor receptor 2 (HER2) developed in China. Due to its optimized antibody-dependent cell-mediated cytotoxicity effect compared with trastuzumab, it has shown good efficacy and safety in the treatment of HER2-positive advanced breast cancer (ABC).
OBJECTIVES
This study aimed to investigate the efficacy and safety of inetetamab combination therapy in the treatment of HER2-positive ABC in real-world clinical practice.
DESIGN
Retrospective study.
METHODS
A total of 133 patients with HER2-positive ABC who were treated with inetetamab-based regimens between March 2020 and January 2024 were retrospectively included in this study. The main endpoint was median progression-free survival (mPFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.
RESULTS
The study included 133 HER2-positive ABC patients, and the median age was 55 years. The mPFS was 8.0 (6.7-9.3) months. The ORR was 50.4%, while the DCR was 88.7%. The mPFS for patients receiving inetetamab-based therapy as first to second, third to fourth, and later lines of metastatic treatment were 14.0, 7.0, and 6.0 months, respectively. Patients treated with inetetamab plus pyrotinib plus chemotherapy, especially with capecitabine, had the best outcomes (mPFS = 14.0 months). Multivariate analysis revealed that prior HER2-TKI treatment was significantly associated with worse PFS (hazard ratios 2.829, 95% confidence interval 1.265-6.328, = 0.011). Subgroup analysis indicated that patients without visceral metastases had significantly better PFS (14.0 months vs 8.0 months, = 0.003). The overall incidence of any grade adverse events (AEs) was 100%, with most being grades 1-2. Severe complications included neutropenia (37.6%) and leukopenia (33.1%).
CONCLUSIONS
Inetetamab-based combination therapy shows promising efficacy and good safety in patients with HER2-positive ABC. It is one of the late-line treatment options for Chinese patients with HER2-positive ABC.
背景
伊尼妥单抗是我国自主研发的一种新型抗人表皮生长因子受体2（HER2）抗体。与曲妥珠单抗相比，其抗体依赖性细胞介导的细胞毒性作用得到优化，在HER2阳性晚期乳腺癌（ABC）治疗中显示出良好的疗效和安全性。
目的
本研究旨在探讨伊尼妥单抗联合治疗在真实世界临床实践中治疗HER2阳性ABC的疗效和安全性。
设计
回顾性研究。
方法
本研究回顾性纳入了2020年3月至2024年1月期间接受以伊尼妥单抗为基础方案治疗的133例HER2阳性ABC患者。主要终点为中位无进展生存期（mPFS）。次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和安全性。
结果
该研究纳入了133例HER2阳性ABC患者，中位年龄为55岁。mPFS为8.0（6.7 - 9.3）个月。ORR为50.4%，而DCR为88.7%。接受以伊尼妥单抗为基础的治疗作为一线至二线、三线至四线及后续转移性治疗线的患者的mPFS分别为14.0、7.0和6.0个月。接受伊尼妥单抗联合吡咯替尼加化疗，尤其是联合卡培他滨治疗的患者疗效最佳（mPFS = 14.0个月）。多因素分析显示既往HER2-TKI治疗与较差的PFS显著相关（风险比2.829，95%置信区间1.265 - 6.328，P = 0.011）。亚组分析表明无内脏转移的患者PFS显著更好（14.0个月对8.0个月，P = 0.003）。任何级别的不良事件（AE）总发生率为100%，大多数为1 - 2级。严重并发症包括中性粒细胞减少（37.6%）和白细胞减少（33.1%）。
结论
以伊尼妥单抗为基础的联合治疗在HER2阳性ABC患者中显示出有前景的疗效和良好的安全性。它是中国HER2阳性ABC患者的晚期治疗选择之一。
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