Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2026
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.
Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundPatients 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.
methodsThis 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).
resultsThirty 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.
conclusionsPerioperative 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.
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