胃癌辅助化疗临床试验解读课件.ppt
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- 胃癌 辅助 化疗 临床试验 解读 课件
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1、Adjuvant Chemotherapy for Gastric Cancer with S-1,an Oral Fluoropyrimidine -ACTS-GC第1页,共35页。IntroductionMeta-analyses have shown that adjuvant chemotherapy is effective in treating gastric cancer.However,the effectiveness of specific regimens has not been verified in large clinical trials.第2页,共35页。B
2、ackgroundAdvanced gastric cancer can respond to S-1,an oral fluoropyrimidine.We tested S-1 as adjuvant chemotherapy in patients with curatively resected gastric cancer.第3页,共35页。METHODS Patients in Japan with stage II or III gastric cancer who underwent gastrectomy with extended(D2)lymph-node dissect
3、ion were randomly assigned to undergo surgery followed by adjuvant therapy with S-1 or to undergo surgery only.第4页,共35页。METHODS 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 princi
4、ple,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.第5页,共35页。Eligibility CriteriaThe criteria for eligibility were histologically proven gastric cancer of stage II
5、,IIIA,or IIIB;D2 or more extensive lymph-node dissection with R0 surgery;no hepatic,peritoneal,or distant metastasis;no tumor cells in peritoneal fluid on cytologic analysis;an age of 20 to 80 years;no previous treatment for cancer except for the initial gastric resection for the primary lesion;and
6、adequate organ function.第6页,共35页。Study Design and Treatment The primary end point was overall survival;secondary end points were relapse-free survival and the degree of safety of S-1.Patients were enrolled,within 6 weeks after surgery and randomly assigned to either the S-1 group or the surgery-only
7、 group.第7页,共35页。Study Design and Treatment Patients assigned to the S-1 group received two oral doses of 40 mg of S-1 per square meter of body-surface area per day,for 4 weeks,followed by 2 weeks of no chemotherapy.This 6-week cycle was repeated during the first year after surgery.The surgery-only g
8、roup received no anticancer treatment after surgery,unless there was a confirmed relapse.Patients in both groups were to be followed up for 5 years postoperatively.第8页,共35页。RESULTSWe randomly assigned 529 patients to the S-1 group and 530 patients to the surgeryonly group between October 2001 and De
9、cember 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).第9页,
10、共35页。RESULTSAnalysis 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).第10页,共35页。RESULTS
11、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%).第11页,共35页。Overall Survival and Relapse-Free SurvivalThe hazard ratio for death in t
12、he S-1 group,as compared with the surgery-only group,was 0.68.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 relapse in the S-1 group,as compared with the surgery-only group,was 0.62.第12页,共35页。Overall Survival and Relapse-Free Survi
13、val第13页,共35页。Overall Survival and Relapse-Free SurvivalThe rate of relapse-free survival at 3 years was 72.2%in the S-1 group and 59.6%in the surgery-only group.Among eligible patients,the hazard ratio for death in the S-1 group,as compared with the surgery-only group,was 0.66.第14页,共35页。Overall Surv
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