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A correction has been published: N Engl J Med 2008;358(18):1977.
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Background Advanced gastric cancer can respond to S-1, an oral fluoropyrimidine. We tested S-1 as adjuvant chemotherapy in patients with curatively resected gastric cancer.
Methods Patients in Japan with stage II or III gastric cancer who underwent gastrectomy with extended (D2) lymph-node dissection were randomly assigned to undergo surgery followed by adjuvant therapy with S-1 or to undergo surgery only. In the S-1 group, administration of S-1 was started within 6 weeks after surgery and continued for 1 year. The treatment regimen consisted of 6-week cycles in which, in principle, 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks. The primary end point was overall survival.
Results We randomly assigned 529 patients to the S-1 group and 530 patients to the surgery-only group between October 2001 and December 2004. The trial was stopped on the recommendation of the independent data and safety monitoring committee, because the first interim analysis, performed 1 year after enrollment was completed, showed that the S-1 group had a higher rate of overall survival than the surgery-only group (P=0.002). Analysis of follow-up data showed that the 3-year overall survival rate was 80.1% in the S-1 group and 70.1% in the surgery-only group. The hazard ratio for death in the S-1 group, as compared with the surgery-only group, was 0.68 (95% confidence interval, 0.52 to 0.87; P=0.003). Adverse events of grade 3 or grade 4 (defined according to the Common Toxicity Criteria of the National Cancer Institute) that were relatively common in the S-1 group were anorexia (6.0%), nausea (3.7%), and diarrhea (3.1%).
Conclusions S-1 is an effective adjuvant treatment for East Asian patients who have undergone a D2 dissection for locally advanced gastric cancer. (ClinicalTrials.gov number, NCT00152217
[ClinicalTrials.gov]
.)
Source Information
From Kitasato University School of Medicine, Sagamihara (S.S.); National Cancer Center Hospital (M.S.), the Cancer Institute Hospital (T.Y., T.N.), Nihon University School of Medicine (M.F.), University of Tokyo (Y.O.), and Tokyo Metropolitan Komagome Hospital (K.A.) — all in Tokyo; National Cancer Center Hospital East, Kashiwa (T.K.); Niigata Cancer Center Hospital, Niigata (A.N.); Sakai City Hospital, Sakai (H.F., H.I.); Osaka City General Hospital, Osaka (M.H.); Aichi Cancer Center Hospital, Nagoya (Y.Y.); and National Hospital Organization Shikoku Cancer Center, Matsuyama (A.K.) — all in Japan.
Address reprint requests to Dr. Sakuramoto at the Department of Surgery, Kitasato University School of Medicine, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan, or at sakura{at}med.kitasato-u.ac.jp.
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