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Objective <p>The development of treatments for advanced gastric cancer (AGC) has made significant advances over the past decade. Although clinical trials for novel drugs targeting HER2-positive AGC are ongoing, current clinical management still faces challenges. Therefore, further comparison of the effectiveness of such combination therapies is needed.</p> Methods <p> comprehensive search was conducted in the PubMed, Embase, and Cochrane databases, with the search cut-off date set to May 2025. Outcomes were evaluated using indicators such as progression-free survival (PFS) and overall survival (OS).</p> Results <p>Our study included only randomized controlled trials comparing combination regimens of targeted and/or immunotherapy, involving 3,231 patients across eight different interventions.The network meta-analysis revealed that no treatment regimen demonstrated a statistically significant improvement in OS or PFS. However, a trend toward improved PFS was observed with HLX22 plus HLX02 and chemotherapy compared to trastuzumab-based chemotherapy, although the difference was not statistically significant (MD=-0.94, 95% CI: -5.26-3.37). Pembrolizumab in combination with trastuzumab and chemotherapy significantly improved the objective response rate (ORR).Cumulative ranking probabilities indicated that trastuzumab plus chemotherapy may be associated with the longest PFS, while chemotherapy alone ranked highest in OS, though all confidence intervals included the null value.</p> Conclusion <p> No first-line regimen significantly improved OS or PFS in HER2-positive advanced gastric cancer. However, HLX22-based and immune-combination strategies show potential clinical value—particularly in enhancing ORR—and merit further investigation.</p>

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Efficacy and Safety of Different Treatment Regimens for Previously Untreated Patients with HER2-positive Advanced Gastric Cancer: A Meta-Analysis of Randomized Controlled Trials

  • 期刊论文

  • 发表日期：

    2025年12月13日

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  • Yuqi He,
  • Qi Kang,
  • Shanshan Xu,
  • Zhongliang Zhang,
  • Sheng Li

摘要

Objective

The development of treatments for advanced gastric cancer (AGC) has made significant advances over the past decade. Although clinical trials for novel drugs targeting HER2-positive AGC are ongoing, current clinical management still faces challenges. Therefore, further comparison of the effectiveness of such combination therapies is needed.

Methods

comprehensive search was conducted in the PubMed, Embase, and Cochrane databases, with the search cut-off date set to May 2025. Outcomes were evaluated using indicators such as progression-free survival (PFS) and overall survival (OS).

Results

Our study included only randomized controlled trials comparing combination regimens of targeted and/or immunotherapy, involving 3,231 patients across eight different interventions.The network meta-analysis revealed that no treatment regimen demonstrated a statistically significant improvement in OS or PFS. However, a trend toward improved PFS was observed with HLX22 plus HLX02 and chemotherapy compared to trastuzumab-based chemotherapy, although the difference was not statistically significant (MD=-0.94, 95% CI: -5.26-3.37). Pembrolizumab in combination with trastuzumab and chemotherapy significantly improved the objective response rate (ORR).Cumulative ranking probabilities indicated that trastuzumab plus chemotherapy may be associated with the longest PFS, while chemotherapy alone ranked highest in OS, though all confidence intervals included the null value.

Conclusion

No first-line regimen significantly improved OS or PFS in HER2-positive advanced gastric cancer. However, HLX22-based and immune-combination strategies show potential clinical value—particularly in enhancing ORR—and merit further investigation.