Inetetamab-based therapy in real-world treatment patterns with HER2-positive advanced breast cancer patients: a retrospective single-center study.

IF 4.3 2区医学 Q2 ONCOLOGY

Therapeutic Advances in Medical Oncology Pub Date : 2024-09-09 DOI:10.1177/17588359241275422

Mingxia Jiang,Jiaxuan Liu,Maiyue He,Mengqi Zhang,Shihan Zhou,Shanshan Chen,Ruigang Cai,Hongnan Mo,Bo Lan,Pin Zhang,Binghe Xu,Qiao Li

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Abstract

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, p = 0.011). Subgroup analysis indicated that patients without visceral metastases had significantly better PFS (14.0 months vs 8.0 months, p = 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.

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基于伊奈他单抗的 HER2 阳性晚期乳腺癌患者实际治疗模式：一项回顾性单中心研究。

背景伊替他单抗（Inetetamab）是中国开发的一种靶向人表皮生长因子受体2（HER2）的新型抗体。本研究旨在探讨伊奈他单抗联合治疗HER2阳性晚期乳腺癌（ABC）的疗效和安全性。方法回顾性纳入2020年3月至2024年1月期间接受伊美他单抗方案治疗的133例HER2阳性ABC患者。主要终点是中位无进展生存期（mPFS）。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%，DCR为88.7%。作为转移性治疗的第一线到第二线、第三线到第四线以及更高线，接受伊奈他单抗治疗的患者的mPFS分别为14.0个月、7.0个月和6.0个月。伊奈他单抗加吡罗替尼加化疗（尤其是卡培他滨）的患者疗效最好（mPFS = 14.0个月）。多变量分析显示，既往接受过HER2-TKI治疗与较差的PFS显著相关（危险比2.829，95%置信区间1.265-6.328，P = 0.011）。亚组分析表明，无内脏转移的患者的 PFS 明显更好（14.0 个月 vs 8.0 个月，p = 0.003）。任何级别的不良事件（AEs）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症（37.6%）和白细胞减少症（33.1%）。结论伊替单抗联合疗法对HER2阳性ABC患者具有良好的疗效和安全性，是中国HER2阳性ABC患者的晚期治疗方案之一。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutic Advances in Medical Oncology ONCOLOGY-

CiteScore

8.20

自引率

2.00%

发文量

160

审稿时长

15 weeks

期刊介绍： Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).