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Background <p>The combination chemotherapy of alpha-PD-1/PD-L1 has become the standard treatment option for some cancer patients. However, studies have shown that not all patients benefit from improved survival rates, especially the use of PD-1/PD-L1 inhibitors in combination with chemotherapy for progression-free survival (PFS) in patients with gastric or gastroesophageal cancer (GC/GEJC) remains highly controversial. To address this issue, we conducted a meta-analysis of randomized controlled trials (RCTs) aimed at comparing the efficacy of PD-1/PD-L1 inhibitors combined with chemotherapy versus chemotherapy in GC/GEJC patients.</p> Method <p>By searching relevant databases, RCTs published up to November 2024 were collected, and the hazard ratios (HR) and 95% confidence intervals (CI) of overall survival (OS) and PFS were calculated. Meanwhile, the odds ratios (OR) and 95% CI of treatment-related adverse events (TRAEs) were evaluated.</p> Result <p>A total of 6842 patients were included in seven trials. In the summary analysis of OS, compared with the chemotherapy group, the PD-1/PD-L1 inhibitor combined with the chemotherapy group showed significant improvement in OS (HR = 0.80; 95% CI = 0.76–0.85; <i>p</i> &lt; 0.0001) and PFS (HR = 0.86; 95% CI = 0.71–0.81; <i>p</i> &lt; 0.0001). Additionally, there were significant differences in the incidence of TRAEs (OR = 1.59; 95% CI = 1.21–2.02; <i>p</i> = 0.0001) and grade 3–4 TRAEs (OR = 1.43; 95% CI = 1.30–1.58; <i>p</i> &lt; 0.0001).</p> Conclusion <p>When compared to chemotherapy, the combination of PD-1/PD-L1 inhibitors with chemotherapy improves survival but with higher toxicity risks, requiring careful benefit-risk evaluation in clinical practice.&#xa0;</p>

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The efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone in advanced or metastatic gastric or gastroesophageal junction cancer: a meta-analysis of randomized controlled trials

  • 期刊论文

  • 发表日期：

    2025年6月10日

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  • Hu Piao,
  • Li Wenping,
  • Li Chengde,
  • Li Haoming,
  • Zhang Xiaohan,
  • Liu Yingdi,
  • Zhang Xuezheng,
  • Mao Shumei

摘要

Background

The combination chemotherapy of alpha-PD-1/PD-L1 has become the standard treatment option for some cancer patients. However, studies have shown that not all patients benefit from improved survival rates, especially the use of PD-1/PD-L1 inhibitors in combination with chemotherapy for progression-free survival (PFS) in patients with gastric or gastroesophageal cancer (GC/GEJC) remains highly controversial. To address this issue, we conducted a meta-analysis of randomized controlled trials (RCTs) aimed at comparing the efficacy of PD-1/PD-L1 inhibitors combined with chemotherapy versus chemotherapy in GC/GEJC patients.

Method

By searching relevant databases, RCTs published up to November 2024 were collected, and the hazard ratios (HR) and 95% confidence intervals (CI) of overall survival (OS) and PFS were calculated. Meanwhile, the odds ratios (OR) and 95% CI of treatment-related adverse events (TRAEs) were evaluated.

Result

A total of 6842 patients were included in seven trials. In the summary analysis of OS, compared with the chemotherapy group, the PD-1/PD-L1 inhibitor combined with the chemotherapy group showed significant improvement in OS (HR = 0.80; 95% CI = 0.76–0.85; p < 0.0001) and PFS (HR = 0.86; 95% CI = 0.71–0.81; p < 0.0001). Additionally, there were significant differences in the incidence of TRAEs (OR = 1.59; 95% CI = 1.21–2.02; p = 0.0001) and grade 3–4 TRAEs (OR = 1.43; 95% CI = 1.30–1.58; p < 0.0001).

Conclusion

When compared to chemotherapy, the combination of PD-1/PD-L1 inhibitors with chemotherapy improves survival but with higher toxicity risks, requiring careful benefit-risk evaluation in clinical practice.