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Background <p>Patients with advanced gastric cancer and para-aortic and/or bulky lymph node metastases have extremely poor prognosis after surgery alone. The OGSG1701 phase II trial evaluated the efficacy and safety of perioperative administration of capecitabine and oxaliplatin (CapeOx). Short-term results showed promising response and resection rates. Herein, we report the final survival outcomes.</p> Methods <p>This multicenter, single-arm, phase II trial enrolled patients with histologically proven, HER2-negative or unknown gastric cancer with para-aortic (no.16a2/16b1) and/or bulky lymph node metastases. Patients received three cycles of preoperative CapeOx followed by gastrectomy with D2 ± para-aortic lymphadenectomy, and five cycles of postoperative CapeOx. The primary endpoint was response rate; the key secondary endpoints included overall survival (OS) and progression-free survival (PFS).</p> Results <p>Thirty patients from 14 institutions were enrolled between 2018 and 2022. At a minimum follow-up of 36&#xa0;months, the 3- and 5-years OS rates were 79.0% (95% confidence interval [CI], 59.0–90.0%) and 61.0% (95% CI 38.9–77.1%), respectively. Median OS was 64.9&#xa0;months (95% CI 41.2–not estimable). The 3&#xa0;years PFS rate was 46.7% (95% CI 28.4–63.0%), and the median PFS was 29.0&#xa0;months (95% CI 9.4–not estimable). No additional treatment-related deaths occurred during the long-term follow-up.</p> Conclusions <p>Perioperative CapeOx therapy resulted in encouraging long-term survival in patients with advanced gastric cancer and extensive nodal metastasis. These findings support its potential role as a perioperative strategy for biologically high-risk gastric cancer, with an acceptable safety profile.</p>

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Long-term survival outcomes from a phase II trial of perioperative capecitabine plus oxaliplatin for advanced gastric cancer with extensive lymph node metastases: OGSG 1701

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  • 发表日期：

    2026年3月13日

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  • Shunji Endo,
  • Yutaka Kimura,
  • Naotoshi Sugimoto,
  • Ryohei Kawabata,
  • Atsushi Takeno,
  • Shigeyuki Tamura,
  • Jin Matsuyama,
  • Masato Nakamura,
  • Hiroki Takeshita,
  • Motohiro Imano,
  • Atsushi Yasuda,
  • Hironaga Satake,
  • Shogen Boku,
  • Masahito Kotaka,
  • Tomohira Takeoka,
  • Yukinori Kurokawa,
  • Toshimasa Tsujinaka,
  • Toshio Shimokawa,
  • Taroh Satoh

摘要

Background

Patients with advanced gastric cancer and para-aortic and/or bulky lymph node metastases have extremely poor prognosis after surgery alone. The OGSG1701 phase II trial evaluated the efficacy and safety of perioperative administration of capecitabine and oxaliplatin (CapeOx). Short-term results showed promising response and resection rates. Herein, we report the final survival outcomes.

Methods

This multicenter, single-arm, phase II trial enrolled patients with histologically proven, HER2-negative or unknown gastric cancer with para-aortic (no.16a2/16b1) and/or bulky lymph node metastases. Patients received three cycles of preoperative CapeOx followed by gastrectomy with D2 ± para-aortic lymphadenectomy, and five cycles of postoperative CapeOx. The primary endpoint was response rate; the key secondary endpoints included overall survival (OS) and progression-free survival (PFS).

Results

Thirty patients from 14 institutions were enrolled between 2018 and 2022. At a minimum follow-up of 36 months, the 3- and 5-years OS rates were 79.0% (95% confidence interval [CI], 59.0–90.0%) and 61.0% (95% CI 38.9–77.1%), respectively. Median OS was 64.9 months (95% CI 41.2–not estimable). The 3 years PFS rate was 46.7% (95% CI 28.4–63.0%), and the median PFS was 29.0 months (95% CI 9.4–not estimable). No additional treatment-related deaths occurred during the long-term follow-up.

Conclusions

Perioperative CapeOx therapy resulted in encouraging long-term survival in patients with advanced gastric cancer and extensive nodal metastasis. These findings support its potential role as a perioperative strategy for biologically high-risk gastric cancer, with an acceptable safety profile.