Liu Xiaoyu, Zhang Peng, Li Chao, Song Xiang, Liu Zhaoyun, Shao Wenna, Li Sumei, Wang Xinzhao, Yu Zhiyong
First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, China.
Department of General Surgery, Zouping People's Hospital, Binzhou, China.
Front Oncol. 2023 Jun 19;13:1136380. doi: 10.3389/fonc.2023.1136380. eCollection 2023.
Inetetamab (cipterbin) is an innovative anti-HER2 humanized monoclonal antibody. The efficacy and safety of a combination of inetetamab and vinorelbine in the first-line treatment of human epidermal receptor positive (HER2+) metastatic breast cancer (MBC) have been confirmed. We aimed to investigate real-world data of inetetamab in complex clinical practice.
We retrospectively reviewed the medical records of patients who received inetetamab as a salvage treatment at any line setting from July 2020 to June 2022. The main endpoint was progression-free survival (PFS).
A total of 64 patients were included in this analysis. The median progression-free survival (mPFS) was 5.6 (4.6-6.6) months. Of the patients, 62.5% received two or more lines of therapy before treatment with inetetamab. The most common chemotherapy and anti-HER2 regimens combined with inetetamab were vinorelbine (60.9%) and pyrotinib (62.5%), respectively. Patients treated with inetetamab plus pyrotinib plus vinorelbine benefited the most (p=0.048), with the mPFS of 9.3 (3.1-15.5) months and an objective response rate of 35.5%. For patients with pyrotinib pretreatment, inetetamab plus vinorelbine plus pyrotinib agents resulted in mPFS of 10.3 (5.2-15.4) months. Regimens (inetetamab plus vinorelbine plus pyrotinib vs. other therapeutic agents) and visceral metastases (yes vs. no) were independent predictors of PFS. Patients with visceral metastases treated with inetetamab plus vinorelbine plus pyrotinib had a mPFS of 6.1(5.1-7.1) months. The toxicity of inetetamab was tolerable, with the most common grade 3/4 adverse event being leukopenia (4.7%).
HER2+ MBC patients pretreated with multiple-line therapies still respond to inetetamab-based treatment. Inetetamab combined with vinorelbine and pyrotinib may be the most effective treatment regimen, with a controllable and tolerable safety profile.
伊尼妥单抗（赛普汀）是一种创新的抗HER2人源化单克隆抗体。伊尼妥单抗与长春瑞滨联合用于一线治疗人表皮生长因子受体2阳性（HER2+）转移性乳腺癌（MBC）的疗效和安全性已得到证实。我们旨在研究伊尼妥单抗在复杂临床实践中的真实世界数据。
我们回顾性分析了2020年7月至2022年6月期间在任何线次接受伊尼妥单抗挽救治疗的患者的病历。主要终点为无进展生存期（PFS）。
本分析共纳入64例患者。中位无进展生存期（mPFS）为5.6（4.6 - 6.6）个月。其中，62.5%的患者在接受伊尼妥单抗治疗前接受过两线或更多线的治疗。与伊尼妥单抗联合使用的最常见化疗方案和抗HER2方案分别为长春瑞滨（60.9%）和吡咯替尼（62.5%）。接受伊尼妥单抗联合吡咯替尼和长春瑞滨治疗的患者获益最大（p = 0.048），mPFS为9.3（3.1 - 15.5）个月，客观缓解率为35.5%。对于接受过吡咯替尼预处理的患者，伊尼妥单抗联合长春瑞滨加吡咯替尼药物导致mPFS为10.3（5.2 - 15.4）个月。治疗方案（伊尼妥单抗联合长春瑞滨加吡咯替尼与其他治疗药物）和内脏转移（有与无）是PFS的独立预测因素。接受伊尼妥单抗联合长春瑞滨加吡咯替尼治疗的内脏转移患者的mPFS为6.1（5.1 - 7.1）个月。伊尼妥单抗的毒性是可耐受的，最常见的3/4级不良事件是白细胞减少（4.7%）。
接受多线治疗预处理的HER2+MBC患者对基于伊尼妥单抗的治疗仍有反应。伊尼妥单抗联合长春瑞滨和吡咯替尼可能是最有效的治疗方案，安全性可控且可耐受。
