Disitamab vedotin plus programmed death-1 inhibitor for pre-treated HER2 overexpressed advanced gastric cancer: a multicentre retrospective real-world study

作者：Yan Xiao, Zhong Xie, Kaobin Ouyang, Ming-Yu Lai, Li Yang, Tianying Huang, Fengping Li, Huayuan Liang, Kaihua Huang, Zhiwei Li, Qing Xie, Rou Zhong, Huimin Zhang, Min Lai, Miao‐Zhen Qiu, Liying Zhao · 发表于：Annals of Medicine · 年份：2025 · DOI：10.1080/07853890.2025.2569994 · 被引用次数：2 · 研究领域：HER2/EGFR in Cancer Research、Gastric Cancer Management and Outcomes、Cancer Cells and Metastasis

Background The efficacy of pre-treated advanced gastric or gastroesophageal junction cancer (G/GEJC) with HER2 overexpressed (IHC 2+/3+) remains unsatisfactory. This retrospective real-world study aimed to analyse the safety and efficacy of disitamab vedotin (RC48) plus programmed death-1 (PD-1) inhibitor in pre-treated patients with advanced G/GEJC.Patients and methods We retrospectively reviewed consecutive patients with HER2 2+/3+ advanced G/GEJC who received RC48 plus PD-1 inhibitor or RC48 monotherapy from four Chinese hospitals (July 2021 to September 2023). ORR and DCR were estimated by logistic regression. Survival was analysed via Kaplan-Meier method and log-rank tests. Subgroup and post hoc power analyses were performed.Results Fifty-seven patients were enrolled: 36 received RC48 plus PD-1 inhibitor (combination group) and 21 received RC48 alone (monotherapy group). The combination group demonstrated a significantly higher ORR than the monotherapy group (41.7% vs. 9.5%, p = 0.011). Although the DCR was not significantly different (75.0% vs. 57.1%, p = 0.162), the combination group showed a significantly prolonged mOS (13.2 months vs. 7.1 months, p = 0.040) and a trend towards longer mPFS (5.8 months vs. 2.9 months, p = 0.142). In the combination group, patients with initial HER2 3+, second-line treatment, or liver metastasis had more favourable outcomes. The incidence of grade 3–4 TrAEs was comparable between the two groups (41.7% vs. 38.1%).Conclusions RC48 plus PD...