Hua Yunqi, Gao Yuqian, Luo Shuang, Song Ge, Tian Xiaoling, Wang Chenlin, Lv Shuang, Zhang Xinyi, Shao Guo
Department of Oncology, Baotou Cancer Hospital, Baotou, Inner Mongolia 014040, China.
Department of Graduate School, Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou 014030, China.
Int Immunopharmacol. 2025 May 8;154:114487. doi: 10.1016/j.intimp.2025.114487. Epub 2025 Apr 2.
Previous trials have revealed better treatment efficacy of programmed cell death 1 (PD-1) inhibitors combined with chemotherapy as first-line treatments than chemotherapy alone in advanced gastric cancer (GC) patients, but real-world evidence is still lacking. Hence, this real-world study aimed to investigate the efficacy and safety of PD-1 inhibitors plus chemotherapy as first-line treatments compared with chemotherapy alone in advanced GC patients.
In total, 102 advanced GC patients were allocated into a combination group (receiving chemotherapy combined with a PD-1 inhibitor as a first-line treatment) (n = 48) or a chemotherapy group (receiving chemotherapy only as a first-line treatment) (n = 54) according to their actual treatment regimens.
The objective response rate (ORR) was greater in the combination group than in the chemotherapy group (25.0 % versus 9.3 %, P = 0.033), whereas the disease control rate (DCR) was not different between the groups (83.3 % versus 66.7 %, P = 0.054). Progression-free survival (PFS) was prolonged in the combination group than in the chemotherapy group (P = 0.018). The median (95 % confidence interval) PFS was 19.7 (12.2-27.2) months in the combination group and 16.5 (7.3-25.7) months in the chemotherapy group. Multivariate logistic regression analyses revealed that PD-1 inhibitors combined with chemotherapy were independently associated with an increased ORR (odds ratio: 4.180, P = 0.024), increased DCR (odds ratio: 2.928, P = 0.049), and prolonged PFS (hazard ratio: 0.388, P = 0.030). No difference was found in total or each specific grade III-IV adverse reaction between the groups (all P > 0.05).
Treatment with a PD-1 inhibitor plus chemotherapy as a first-line treatment shows better treatment efficacy with similar safety to that of chemotherapy alone in advanced GC patients.
既往试验显示，程序性细胞死亡蛋白1（PD-1）抑制剂联合化疗作为一线治疗方案，在晚期胃癌（GC）患者中的治疗效果优于单纯化疗，但仍缺乏真实世界证据。因此，本项真实世界研究旨在探讨PD-1抑制剂联合化疗作为一线治疗方案与单纯化疗相比，在晚期GC患者中的疗效和安全性。
根据实际治疗方案，将102例晚期GC患者分为联合治疗组（接受化疗联合PD-1抑制剂作为一线治疗）（n = 48）和化疗组（仅接受化疗作为一线治疗）（n = 54）。
联合治疗组的客观缓解率（ORR）高于化疗组（25.0%对9.3%，P = 0.033），而两组的疾病控制率（DCR）无差异（83.3%对66.7%，P = 0.054）。联合治疗组的无进展生存期（PFS）较化疗组长（P = 0.018）。联合治疗组的中位（95%置信区间）PFS为19.7（12.2 - 27.2）个月，化疗组为16.5（7.3 - 25.7）个月。多因素逻辑回归分析显示，PD-1抑制剂联合化疗与ORR增加（优势比：4.180，P = 0.024）、DCR增加（优势比：2.928，P = 0.049）和PFS延长（风险比：0.388，P = 0.030）独立相关。两组之间的总或各特定III - IV级不良反应均无差异（所有P > 0.05）。
在晚期GC患者中，PD-1抑制剂联合化疗作为一线治疗方案显示出更好的治疗效果，且安全性与单纯化疗相似。
