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Background <p>Immunotherapy has brought clinical benefits for patients with advanced or late-stage gastric cancer. This real-world study aimed to evaluate the efficacy and safety of neoadjuvant immunochemotherapy in patients with locally advanced gastric cancer (LAGC).</p> Methods <p>Patients with LAGC (cT2-4bN1-3M0) were enrolled in this retrospective study. Patients received either neoadjuvant immunochemotherapy or chemotherapy alone before surgery. The primary endpoint was the pathological complete response (pCR) rate.</p> Results <p>A total of 111 patients were included in this study, with 49 received neoadjuvant PD-1 inhibitors combined with chemotherapy (Group A) and 62 received chemotherapy alone (Group B). pCR rate of Group A was significantly higher than that of Group B (22.4% vs. 4.8%, <i>P</i> = 0.011). Compared with the clinical TNM stage before neoadjuvant therapy, 32 (65.3%) patients in Group A had T downstaging, 27 (55.1%) had N downstaging, and 42 (85.7%) had overall TNM downstaging. There was no significant difference in 1-year OS rate (100% vs. 93.5%; <i>P</i> = 0.195) and 1-year DFS rate (81.6% vs. 75.8%; <i>P</i> = 0.144) between the two groups. 11.7% patients in Group A and 9.8% patients in Group B experienced grade ≥ 3 adverse TRAEs, myelosuppression, elevated ALT/AST, nausea, and decreased appetite. However, there was no significant difference between the two groups (<i>P</i> = 0.240).</p> Conclusions <p>Here, neoadjuvant immunochemotherapy suggested a potential clinical benefit of the pCR rate, T downstaging, and a favorable safety profile for LAGC. However, further multicenter, large-scale randomized clinical trials are urgently needed to confirm the long-term survival benefit.</p>

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The efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy for locally advanced gastric cancer: a single-center, real-world clinical study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月18日

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  • Xuan Pan,
  • Huayun Zhu,
  • Xingwang Li,
  • Siwen Liu,
  • Shuchen Dong,
  • Chao Yue,
  • Pingping Wu,
  • Yan Sun

摘要

Background

Immunotherapy has brought clinical benefits for patients with advanced or late-stage gastric cancer. This real-world study aimed to evaluate the efficacy and safety of neoadjuvant immunochemotherapy in patients with locally advanced gastric cancer (LAGC).

Methods

Patients with LAGC (cT2-4bN1-3M0) were enrolled in this retrospective study. Patients received either neoadjuvant immunochemotherapy or chemotherapy alone before surgery. The primary endpoint was the pathological complete response (pCR) rate.

Results

A total of 111 patients were included in this study, with 49 received neoadjuvant PD-1 inhibitors combined with chemotherapy (Group A) and 62 received chemotherapy alone (Group B). pCR rate of Group A was significantly higher than that of Group B (22.4% vs. 4.8%, P = 0.011). Compared with the clinical TNM stage before neoadjuvant therapy, 32 (65.3%) patients in Group A had T downstaging, 27 (55.1%) had N downstaging, and 42 (85.7%) had overall TNM downstaging. There was no significant difference in 1-year OS rate (100% vs. 93.5%; P = 0.195) and 1-year DFS rate (81.6% vs. 75.8%; P = 0.144) between the two groups. 11.7% patients in Group A and 9.8% patients in Group B experienced grade ≥ 3 adverse TRAEs, myelosuppression, elevated ALT/AST, nausea, and decreased appetite. However, there was no significant difference between the two groups (P = 0.240).

Conclusions

Here, neoadjuvant immunochemotherapy suggested a potential clinical benefit of the pCR rate, T downstaging, and a favorable safety profile for LAGC. However, further multicenter, large-scale randomized clinical trials are urgently needed to confirm the long-term survival benefit.