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Introduction <p>This study aimed to assess real-world treatment patterns, human epidermal growth factor receptor 2 (HER2) testing, and clinical outcomes in patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer (GC/GEJC) in China.</p> Methods <p>A multicenter retrospective study (REHEARSAL Study; NCT06585501) was conducted across nine hospitals in China. Patients with HER2-positive, locally advanced unresectable or metastatic GC/GEJC who initiated first-line therapy were included. Treatment patterns in the first, second, and third lines, HER2 testing practice, and real-world clinical outcomes were assessed.</p> Results <p>In total, 805 patients were included (median age of 62.00&#xa0;years; 77.14% male and 22.86% female). From 2018 to 2023, the first-line treatment pattern showed an increase in the use of anti-HER2 therapies—from 60.83 to 90.19%. There was a notable increased application of HER2 monoclonal antibody (mAb) with immunotherapy (from 0.83 to 60.78%) in the first line. In the second line, 12.28% of patients were administered vascular endothelial growth factor receptor inhibitor in 2023. HER2-antibody–drug conjugate monotherapy and combination therapy had become the predominant third-line treatment (50.00%) in 2023. Tissue biopsy was the primary sample type for HER2 testing (99.25%). Re-biopsy was performed in 6.96% of cases. Anti-HER2 therapies exhibited benefits with a median real-world progression-free survival of 8.94, 5.52, and 4.96&#xa0;months in the first-, second-, and third-line settings, respectively.</p> Conclusion <p>In China, HER2 mAb with or without immunotherapy remained the main first-line option for HER2-positive locally advanced unresectable or metastatic GC/GEJC, with a rising trend toward combination with immunotherapy. The second-line outcomes highlight the urgent need for effective treatment options, underscoring the importance of further real-world studies to better define their role.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT06585501.</p>

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Real-World Treatment Patterns, HER2 Testing Practices, and Clinical Outcomes in HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

  • 期刊论文

  • 发表日期：

    2026年5月30日

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  • Yakun Wang,
  • Bo Liu,
  • Jingdong Zhang,
  • Yanqiao Zhang,
  • Xianglin Yuan,
  • Kai Chen,
  • Xianhe Xie,
  • Xiujuan Qu,
  • Liu Yang,
  • Li Zhang,
  • Xiaotian Zhang

摘要

Introduction

This study aimed to assess real-world treatment patterns, human epidermal growth factor receptor 2 (HER2) testing, and clinical outcomes in patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer (GC/GEJC) in China.

Methods

A multicenter retrospective study (REHEARSAL Study; NCT06585501) was conducted across nine hospitals in China. Patients with HER2-positive, locally advanced unresectable or metastatic GC/GEJC who initiated first-line therapy were included. Treatment patterns in the first, second, and third lines, HER2 testing practice, and real-world clinical outcomes were assessed.

Results

In total, 805 patients were included (median age of 62.00 years; 77.14% male and 22.86% female). From 2018 to 2023, the first-line treatment pattern showed an increase in the use of anti-HER2 therapies—from 60.83 to 90.19%. There was a notable increased application of HER2 monoclonal antibody (mAb) with immunotherapy (from 0.83 to 60.78%) in the first line. In the second line, 12.28% of patients were administered vascular endothelial growth factor receptor inhibitor in 2023. HER2-antibody–drug conjugate monotherapy and combination therapy had become the predominant third-line treatment (50.00%) in 2023. Tissue biopsy was the primary sample type for HER2 testing (99.25%). Re-biopsy was performed in 6.96% of cases. Anti-HER2 therapies exhibited benefits with a median real-world progression-free survival of 8.94, 5.52, and 4.96 months in the first-, second-, and third-line settings, respectively.

Conclusion

In China, HER2 mAb with or without immunotherapy remained the main first-line option for HER2-positive locally advanced unresectable or metastatic GC/GEJC, with a rising trend toward combination with immunotherapy. The second-line outcomes highlight the urgent need for effective treatment options, underscoring the importance of further real-world studies to better define their role.

Trial Registration

ClinicalTrials.gov identifier, NCT06585501.