1366 COOMBES ET AL Table 4.Three-and 5-Yeo og With%Confid 5-year 95%C0 3%C国 %C 30.251 m56 4 60059.2 32.5.528 142328 one)and ischemic heart disea (one).Reason He were not given for the remaining 10 patients. The death have bee clude the far as orouracil were 64(48%) Three ients ha Th during treatm ent with FAM four completed during the trial. had wBC lue 5 of less than2×10 and si 10L.That this was not ne arily drug-related in all pa alopecia.seen in and 0 globin ofes than and ora DISCUSSION did not lead. indicate that this regimen confers no significan 100 00 A 8 80 980- 60 560 40 401 Log037-105 Logrank test .4.14 df.1 p.0.04 ears ce ran satio 35 Fig 3.Overall survival in gastric cancer by T stage:(A)T,-T.(B)T-T 第40 hemaononee8w88ga02mg8e8Xa2a2g,20g7gm12s231aa4 第36页
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FAM vNO TREATMENT IN GASTRIC CANCER 1367 al During 61496 al recurre obin (g/dL ×10 为 99 24 le 10/ 4 carcino omas may b cfitfrom& As P p wher carried out to determine whether thisisa real randiomization,andnofolow-upwasreceivedfor for the failure of FAM to su din stinal Tum (met med,nt oy by the bu Yamamura et al have ted a neficial effe as luded from the cer.lnadiion.aCeD nan study has eeandT Hattori have failed rat apan).ftuoro racil,andm cin inar zed agentswouldrestinsenihc the irenbun 2420 but the ropean Orga Cancer is currently in progress,but no results 第37页
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1368 COOMBES ET AL ing prospectively the FAM regimen for TT therapy. ACKNOWLEDGMENT fom FAM.and (3)of ewan compu some benefit conducting this tria APPENDIX A.R Hos 12d is:Ro nd:C.M M D.C Bo itute,At tas H De iti c J.Wiig C G P RO tnel United AZ e The b REFERENCES 0.Bulpitt CJ:Su nalysis.Lancet 2-31-34.1988 12.H DA.n urg 139:19 PV.ct al 3.Blake JRS y.Clir 5-21.1981 d 5-f Ga stinal Tum Study G 161219 Miller AR H o) 198 n0 Methyi-C omycin 0K- 第38页
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FAM NO TREATMENT IN GASTRIC CANCER 1369 J5rg16175-180.198 20.HattoriT.InokuchiK.Taguchi T.eta Postoperative mmor密g8g2gm氨eRz名ra2a1sa4 第39页
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The NEW ENGLAND JOURNAL f MEDICINE ORIGINAL ARTICLE Adjuvant Chemotherapy for Gastric Cancer with S-1,an Oral Fluoropyrimidine Shinichi Sakuramoto,M.D.Mitsuru Sasako,M.D.,Toshiharu Yamaguchi,M.D. Akira Kurita,M.D.,and Kuniyoshi Arai,M.D.,for the ACTS-GC Group* ABSTRACT 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. ME METHODS Patients in Japan with stage IIl gastric cancer who underwent gastrectomy with ministration of S-1 was started within6weeks after su Hos yand Center motherapy was given for the following2 weeks.The primary end point was overall at the survival. RESULTS 530 patients to the surgery 。ted in the ment was completed,showe up data showed that the Med72025781020 80.1%in the S-1 group and 70. interval,0.52=0003).Adverse events of grade3or grade(defined accord omon in the srou were anorexi)nu ad diarhea treamerpatients who have undergone rforcallcdcan(mm 1810 N ENGLEG NOVEMER1.2007 Downloaded from ww nejm.orgon February2010.Copyright2007 Massachusetts Medical Society.All rights reserved. 第40页
original article The new england journal o f medicine 1810 n engl j med 357;18 www.nejm.org november 1, 2007 Adjuvant Chemotherapy for Gastric Cancer with S-1, an Oral Fluoropyrimidine Shinichi Sakuramoto, M.D., Mitsuru Sasako, M.D., Toshiharu Yamaguchi, M.D., Taira Kinoshita, M.D., Masashi Fujii, M.D., Atsushi Nashimoto, M.D., Hiroshi Furukawa, M.D., Toshifusa Nakajima, M.D., Yasuo Ohashi, Ph.D., Hiroshi Imamura, M.D., Masayuki Higashino, M.D., Yoshitaka Yamamura, M.D., Akira Kurita, M.D., and Kuniyoshi Arai, M.D., for the ACTS-GC Group* 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@med.kitasato-u.ac.jp. *The investigators in the Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC) group are listed in the Appendix. N Engl J Med 2007;357:1810-20. Copyright © 2007 Massachusetts Medical Society. ABSTRACT 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 surgeryonly 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.) Downloaded from www.nejm.org on February 9, 2010 . Copyright © 2007 Massachusetts Medical Society. All rights reserved. 义 第 40 页