Minimum 7-Year Follow-Up of a Prospective Phase II Trial of Preoperative S-1 Plus Oxaliplatin Chemotherapy for Clinical Stage III Gastric Cancer.

Authors

Sayuri Konishi, Dai Manaka, Yuji Yoshida, Shu Yamamoto, Kota Yamashita, Ryo Kudo, Michina Morioka, Ryo Takahashi, Daisuke Yamaguchi, Shigehiko Fujii

Published in

Asia-Pacific journal of clinical oncology. Oct 18, 2026. Epub Oct 18, 2026.

Abstract

We report long-term outcomes from a prospective Phase II trial of two cycles of preoperative S-1 plus oxaliplatin (SOX) chemotherapy in patients with clinical Stage III gastric cancer (GC), with at least 7 years of follow-up for all surviving patients.
Patients received two cycles of preoperative SOX followed by laparoscopic D2 gastrectomy and postoperative adjuvant therapy. Overall survival (OS), relapse-free survival (RFS), treatment compliance, and clinically documented late adverse events were evaluated. Associations between clinicopathological factors and survival were explored using Kaplan-Meier analysis and the log-rank test.
Thirty-four patients were analyzed. Preoperative SOX completion was 100%, with clinical and pathological response rates of 73.5% and 58.8%, respectively. R0 resection was achieved in 97.1%, and adjuvant therapy was initiated in 94.1% and completed in 61.8%. At analysis, 18 patients had died and 16 remained alive; all survivors had at least 7 years of follow-up and none were lost to follow-up. Five-year OS and RFS were 61.8% and 58.8%, respectively. In exploratory analyses, ypN0-1 status and a preoperative neutrophil-to-lymphocyte ratio < 4.3 were associated with better OS and RFS. No severe treatment-related late adverse events were documented during routine follow-up, although late toxicities were not systematically assessed.
Two-cycle preoperative SOX was highly feasible, with high treatment compliance and favorable long-term outcomes in this prospective single-arm cohort. Associations of ypN status and preoperative neutrophil-to-lymphocyte ratio with long-term outcomes were exploratory and require validation in larger comparative studies.
UMIN000036139.

PMID:
42894432
Bibliographic data and abstract were imported from PubMed on 19 Oct 2026.

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