对于潜在可切除的Ⅲ期至Ⅳ期HER2阳性胃癌患者，在术前化疗或化疗免疫治疗中添加曲妥珠单抗。
Additions of trastuzumab to preoperative chemotherapy or chemoimmunotherapy for patients with potentially resectable stage III to IV HER2-positive gastric cancer.
作者信息
Zhang Xuchen, Tian Yulong, Wang Huiyun, Song Shanai, Chen Yunqing, Liu Ning, Zhang Chuantao, Huang Xiao, Jiang Haitao, Hou Helei
机构信息
Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.
Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China.
出版信息
Front Immunol. 2025 Jul 18;16:1624943. doi: 10.3389/fimmu.2025.1624943. eCollection 2025.
BACKGROUND
Whether the addition of trastuzumab to chemo(immuno)therapy for the preoperative treatment of patients with potentially resectable HER2-positive gastric cancer has clinical benefits remains to be explored. This real-world observational study was designed to evaluate the efficacy and safety of trastuzumab plus chemo(immuno)therapy for neoadjuvant or conversion therapy in patients with potentially resectable HER2-positive gastric cancer.
METHODS
We retrospectively collected the clinical data of treatment-naïve patients with potentially resectable stage III to IV HER2-positive gastric cancer who received preoperative therapy prior to D2 gastrectomy. The main outcomes of interest included tumour regression grade (TRG), treatment-related adverse events (TRAEs), and event-free survival (EFS).
RESULTS
A total of 40 patients were included in the analysis, specifically, 27 patients (67.5%, 95% CI 0.520-0.799) received preoperative trastuzumab plus chemo(immuno)therapy, and 13 patients (32.5%, 95% CI 0.201-0.480) received chemo(immuno)therapy. All these patients subsequently underwent D2 gastrectomy. Regarding surgical outcomes, TRG0/1 rates were 33.3% (95% CI 0.186-0.522) in the trastuzumab-containing treatment group and 15.4% (95% CI 0.043-0.422) in the chemotherapy/chemoimmunotherapy group. Regarding safety, 66.7% (95% CI 0.478-0.814) of patients in the trastuzumab-containing treatment group and 61.5% (95% CI 0.355-0.823) of patients in the chemotherapy/chemoimmunotherapy group experienced preoperative TRAEs. The probabilities of EFS were not statistically significant between the two groups by the last follow-up.
CONCLUSION
Additions of trastuzumab to preoperative chemotherapy or chemoimmunotherapy resulted in a TRG0/1 rate of 33.3% among patients with potentially resectable HER2-positive gastric cancer, and the combined regimen exhibited a favourable safety profile.
背景
对于可切除的HER2阳性胃癌患者，术前化疗（免疫治疗）联合曲妥珠单抗是否具有临床益处仍有待探索。本真实世界观察性研究旨在评估曲妥珠单抗联合化疗（免疫治疗）用于可切除的HER2阳性胃癌患者新辅助或转化治疗的疗效和安全性。
方法
我们回顾性收集了未经治疗的可切除的III至IV期HER2阳性胃癌患者的临床数据，这些患者在D2胃切除术前行术前治疗。主要观察指标包括肿瘤退缩分级（TRG）、治疗相关不良事件（TRAEs）和无事件生存期（EFS）。
结果
共有40例患者纳入分析，具体而言，27例患者（67.5%，95%CI 0.520 - 0.799）接受术前曲妥珠单抗联合化疗（免疫治疗），13例患者（32.5%，95%CI 0.201 - 0.480）接受化疗（免疫治疗）。所有这些患者随后均接受了D2胃切除术。关于手术结果，含曲妥珠单抗治疗组的TRG0/1率为33.3%（95%CI 0.186 - 0.522），化疗/化疗免疫治疗组为15.4%（95%CI 0.043 - 0.422）。关于安全性，含曲妥珠单抗治疗组66.7%（95%CI 0.478 - 0.814）的患者和化疗/化疗免疫治疗组61.5%（95%CI 0.355 - 0.823）的患者经历了术前TRAEs。末次随访时，两组间EFS概率无统计学差异。
结论
对于可切除的HER2阳性胃癌患者，术前化疗或化疗免疫治疗联合曲妥珠单抗使TRG0/1率达到33.3%，联合方案显示出良好的安全性。
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