Annals of medicine · 2025
Disitamab vedotin plus programmed death-1 inhibitor for pre-treated HER2 overexpressed advanced gastric cancer: a multicentre retrospective real-world study.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Yan Xiao, Xie Zhong, Ouyang Kaobin, Lai Mingyu, Yang Li, Huang Tianying, Li Fengping, Liang Huayuan, Huang Kaihua, Li Zhiwei, Xie Qing, Zhong Rou, Zhang Huimin, Lai Min, Qiu Miaozhen, Zhao Liying
Аннотация
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-1 inhibitor for pre-treated advanced G/GEJC patients with HER2 2+/3+ demonstrated superior efficacy than RC48 monotherapy and favourable safety. This combination represents a potential therapeutic strategy, but further large-scale prospective studies are still needed.
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-1 inhibitor for pre-treated advanced G/GEJC patients with HER2 2+/3+ demonstrated superior efficacy than RC48 monotherapy and favourable safety. This combination represents a potential therapeutic strategy, but further large-scale prospective studies are still needed.