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Background <p>A multi-institutional phase II study (OGSG 1402) evaluated the efficacy and safety of neoadjuvant docetaxel, cisplatin, and S-1 (DCS) therapy for type 4 or large type 3 gastric cancers.</p> Methods <p>Patients with macroscopic type 4 or large type 3 gastric cancer received two or three cycles of neoadjuvant DCS therapy (docetaxel 40&#xa0;mg/m<sup>2</sup> and cisplatin 60&#xa0;mg/m<sup>2</sup> intravenously on day 1, and S-1 80–120&#xa0;mg/body orally for 14&#xa0;days, every 4&#xa0;weeks), followed by gastrectomy with D2 lymphadenectomy. After R0 resection, adjuvant S-1 chemotherapy was administered for 1&#xa0;year. The primary endpoint was the R0 resection rate.</p> Results <p>Between March 2015 and June 2018, 48 patients were enrolled, 47 of whom were eligible. The R0 resection rate was 68.1% (32/47, 95% confidence interval [CI] 52.9–80.9). Forty-two patients (89.4%) completed neoadjuvant chemotherapy (NAC). The most common grade 3 or 4 adverse event during NAC was neutropenia (23/47, 48.9%). Surgical morbidity of Clavien–Dindo grade IIIa or higher occurred in 8.5% (4/47) of patients. The pathological response rate, defined as grades 1b to 3, was 42.6% (20/47, 95% CI 28.3–57.8). The 5-year overall survival rate was 38.3% (95% CI 24.6–51.8) and the 5-year progression-free survival rate was 29.8% (95% CI 17.6–43.0).</p> Conclusions <p>In patients with type 4 or large type 3 gastric cancer, neoadjuvant DCS therapy did not meet the predefined threshold for the R0 resection rate. Despite its acceptable feasibility and manageable toxicity, the addition of docetaxel to the S-1 plus cisplatin regimen is unlikely to provide a survival benefit for this high-risk population.</p> Trial registration <p>The study was registered with UMIN-CTR (number UMIN 000015631).</p>

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A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 followed by gastrectomy for type 4 or large type 3 gastric cancer (OGSG 1402)

  • 期刊论文

  • 发表日期：

    2026年3月17日

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  • Ryo Tanaka,
  • Sang-Woong Lee,
  • Kazumasa Fujitani,
  • Shunji Endo,
  • Junji Kawada,
  • Toshifumi Yamaguchi,
  • Yusuke Akamaru,
  • Ko Takachi,
  • Noriko Wada,
  • Osamu Takayama,
  • Haruna Furukawa,
  • Masaaki Motoori,
  • Keijiro Sugimura,
  • Yoshio Oka,
  • Izumi Komoto,
  • Shugo Ueda,
  • Tomono Kawase,
  • Jin Matsuyama,
  • Toru Masuzawa,
  • Yukinori Kurokawa,
  • Toshimasa Tsujinaka,
  • Toshio Shimokawa,
  • Taro Satoh

摘要

Background

A multi-institutional phase II study (OGSG 1402) evaluated the efficacy and safety of neoadjuvant docetaxel, cisplatin, and S-1 (DCS) therapy for type 4 or large type 3 gastric cancers.

Methods

Patients with macroscopic type 4 or large type 3 gastric cancer received two or three cycles of neoadjuvant DCS therapy (docetaxel 40 mg/m2 and cisplatin 60 mg/m2 intravenously on day 1, and S-1 80–120 mg/body orally for 14 days, every 4 weeks), followed by gastrectomy with D2 lymphadenectomy. After R0 resection, adjuvant S-1 chemotherapy was administered for 1 year. The primary endpoint was the R0 resection rate.

Results

Between March 2015 and June 2018, 48 patients were enrolled, 47 of whom were eligible. The R0 resection rate was 68.1% (32/47, 95% confidence interval [CI] 52.9–80.9). Forty-two patients (89.4%) completed neoadjuvant chemotherapy (NAC). The most common grade 3 or 4 adverse event during NAC was neutropenia (23/47, 48.9%). Surgical morbidity of Clavien–Dindo grade IIIa or higher occurred in 8.5% (4/47) of patients. The pathological response rate, defined as grades 1b to 3, was 42.6% (20/47, 95% CI 28.3–57.8). The 5-year overall survival rate was 38.3% (95% CI 24.6–51.8) and the 5-year progression-free survival rate was 29.8% (95% CI 17.6–43.0).

Conclusions

In patients with type 4 or large type 3 gastric cancer, neoadjuvant DCS therapy did not meet the predefined threshold for the R0 resection rate. Despite its acceptable feasibility and manageable toxicity, the addition of docetaxel to the S-1 plus cisplatin regimen is unlikely to provide a survival benefit for this high-risk population.

Trial registration

The study was registered with UMIN-CTR (number UMIN 000015631).