PURPOSE This study aimed to evaluate the efficacy and safety of neoadjuvant programmed cell death-1 (PD-1) inhibitors plus apatinib and chemotherapy (PAC) in patients with locally advanced gastric cancer (LAGC). MATERIALS AND METHODS Seventy-three patients with resectable LAGC were enrolled and named the PAC group (n=39) or apatinib plus chemotherapy (AC) group (n=34) based on the treatment they chose. Neoadjuvant therapy was administered in a 21-day cycle for 3 consecutive cycles, after which surgery was performed. RESULTS The PAC group exhibited a higher objective response rate than the AC group (74.4% vs. 58.8%, P=0.159). Moreover, the PAC group showed a numerically better response profile than the AC group (P=0.081). Strikingly, progression-free survival (PFS) (P=0.019) and overall survival (OS) (P=0.049) were prolonged, whereas disease-free survival (DFS) tended to be longer in the PAC group than in the AC group (P=0.056). Briefly, the 3-year PFS, DFS, and OS rates were 76.1%, 76.1%, and 86.7% in the PAC group and 46.9%, 49.9%, and 70.3% in the AC group, respectively. Furthermore, PAC (vs. AC) treatment (hazard ratio=0.286, P=0.034) was independently associated with prolonged PFS in multivariate Cox regression analyses. The incidence of adverse events did not differ between the two groups (all P>0.05), where leukopenia, anemia, hypertension, and other adverse events were commonly observed in the PAC group. CONCLUSIONS Neoadjuvant PAC therapy may achieve a preferable pathological response, delayed progression, and prolonged survival compared to AC therapy with a similar safety profile in patients with LAGC; however, further validation is warranted.

中文翻译：

---

新辅助 PD-1 抑制剂加阿帕替尼和化疗对比阿帕替尼加化疗治疗局部晚期胃癌患者：一项前瞻性队列研究。

目的 本研究旨在评估新辅助程序性细胞死亡 1 (PD-1) 抑制剂加阿帕替尼和化疗 (PAC) 治疗局部晚期胃癌 (LAGC) 的疗效和安全性。材料和方法 73 名可切除的 LAGC 患者被纳入，并根据他们选择的治疗方法命名为 PAC 组 (n=39) 或阿帕替尼联合化疗 (AC) 组 (n=34)。新辅助治疗以 21 天为一个周期，连续进行 3 个周期，之后进行手术。结果 PAC组的客观缓解率高于AC组（74.4% vs. 58.8%，P=0.159）。此外，PAC 组在数值上比 AC 组表现出更好的反应曲线 (P=0.081)。引人注目的是，无进展生存期 (PFS) (P=0.019) 和总生存期 (OS) (P=0.049) 得到延长，而 PAC 组的无病生存期 (DFS) 往往比 AC 组更长 (P=0.056)。简而言之，PAC 组的 3 年 PFS、DFS 和 OS 率分别为 76.1%、76.1% 和 86.7%，AC 组分别为 46.9%、49.9% 和 70.3%。此外，在多变量 Cox 回归分析中，PAC（与 AC）治疗（风险比 = 0.286，P = 0.034）与延长的 PFS 独立相关。两组不良事件发生率无差异（均P>0.05），PAC组常见白细胞减少、贫血、高血压等不良事件。结论 与 AC 治疗相比，新辅助 PAC 治疗可能在 LAGC 患者中实现更好的病理反应、延迟进展和延长生存期，且安全性相似；但是，需要进一步验证。