Randomized controlled trial of adjuvant uracil–tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer

Abstract

Background: This prospective randomized study compared the survival of patients with tumour node metastasis (TNM) stage T2 N1–2 gastric cancer treated by gastrectomy alone or gastrectomy followed by uracil–tegafur. Methods: Patients were randomly assigned to surgery alone or to surgery and postoperative uracil–tegafur 360 mg per m2 per day orally for 16 months. The primary endpoint was overall survival. Relapse-free survival and site of recurrence were secondary endpoints. Results: Of 190 registered patients, 95 were randomized to each group; two patients with early cancer were subsequently excluded from the chemotherapy group. The trial was terminated before the target number of patients was reached because accrual was slower than expected. Drug-related adverse effects were mild, with no treatment-related deaths. At a median follow-up of 6·2 years, overall and relapse-free survival rates were significantly higher in the chemotherapy group (hazard ratio for overall survival 0·48, P = 0·017; hazard ratio for relapse-free survival 0·44, P = 0·005), confirming the survival benefit shown in an interim analysis performed 2 years earlier. Conclusion: Interim and final analyses revealed a significant survival benefit for postoperative adjuvant chemotherapy with uracil–tegafur in patients with serosa-negative, node-positive gastric cancer. Registration number: NCT00152243 (http://www.clinicaltrials.gov).