Zhu Peng-Fei, Yang Liu, Chen Zhe-Ling
Cancer Center, Department of Medical Oncology, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.
Front Oncol. 2025 Jun 6;15:1578011. doi: 10.3389/fonc.2025.1578011. eCollection 2025.
Apatinib and immune checkpoint inhibitors (ICIs) have shown promise as third-line treatments for advanced gastric cancer (AGC). This study compared the efficacy and safety of apatinib combined with ICIs versus apatinib monotherapy in AGC patients after second-line treatment failure.
We conducted a retrospective analysis of 48 AGC patients with postoperative recurrence/metastasis treated at Zhejiang Provincial People's Hospital between January 2018 and September 2022. Patients received either apatinib plus ICIs (n=23) or apatinib alone (n=25). Primary endpoints were overall survival (OS) and progression-free survival (PFS); Secondary endpoints included safety and subgroup analyses.
With median follow-up of 4.25 months, the combination group showed significantly longer median OS (6.0 vs 3.0 months, HR=0.44, 95%CI 0.24-0.82, =0.009) and PFS (3.0 vs 2.0 months, =0.155). Subgroup analysis revealed patients with liver metastasis receiving combination therapy had superior OS (7.5 vs 4.0 months, =0.036). The objective response rate was higher with combination therapy (4.3% vs 0%), though not statistically significant (=0.292). Safety profiles were comparable between groups, with no significant increase in severe adverse events with combination therapy.
Apatinib combined with ICIs demonstrated improved survival outcomes compared to apatinib monotherapy in AGC, particularly for patients with liver metastasis, without increasing severe toxicity.
阿帕替尼和免疫检查点抑制剂（ICIs）已显示出作为晚期胃癌（AGC）三线治疗的潜力。本研究比较了阿帕替尼联合ICIs与阿帕替尼单药治疗在二线治疗失败的AGC患者中的疗效和安全性。
我们对2018年1月至2022年9月在浙江省人民医院接受治疗的48例术后复发/转移的AGC患者进行了回顾性分析。患者接受阿帕替尼加ICIs（n = 23）或单独使用阿帕替尼（n = 25）。主要终点为总生存期（OS）和无进展生存期（PFS）；次要终点包括安全性和亚组分析。
中位随访4.25个月，联合治疗组的中位OS（6.0 vs 3.0个月，HR = 0.44，95%CI 0.24 - 0.82，P = 0.009）和PFS（3.0 vs 2.0个月，P = 0.155）显著更长。亚组分析显示，接受联合治疗的肝转移患者的OS更佳（7.5 vs 4.0个月，P = 0.036）。联合治疗的客观缓解率更高（4.3% vs 0%），但差异无统计学意义（P = 0.292）。两组的安全性相当，联合治疗未显著增加严重不良事件。
与阿帕替尼单药治疗相比，阿帕替尼联合ICIs在AGC中显示出更好的生存结果，特别是对于肝转移患者，且未增加严重毒性。
