Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine
Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine
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DOI：
10.1056/nejmoa072252
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发表时间：
2007-11-01
影响因子：
158.5
通讯作者：
Arai, Kuniyoshi
中科院分区：
文献类型：
--
作者：
Sakuramoto, Shinichi;Sasako, Mitsuru;Arai, Kuniyoshi
背景：晚期胃癌对口服氟嘧啶S-1有应答。我们测试了S-1作为胃癌切除术患者的辅助化疗。方法：日本II期或III期胃癌患者行胃切除术并扩大（D2）淋巴结清扫术，随机分为手术加S-1辅助治疗和单纯手术两组。S-1组术后6周内给予S-1，持续1年。治疗方案为6周周期，原则上每天口服S-1每平方米体表面积80 mg，连续4周，随后2周不化疗。主要终点为总生存期。结果：2001年10月至2004年12月，我们随机将529例患者分配到S-1组，530例患者分配到单纯手术组。该试验在独立数据和安全监测委员会的建议下停止，因为在入组完成1年后进行的第一次中期分析显示，S-1组的总生存率高于单纯手术组（P=0.002）。随访资料分析显示，S-1组3年总生存率为80.1%，单纯手术组为70.1%。与单纯手术组相比，S-1组的死亡风险比为0.68（95%可信区间，0.52 ~ 0.87；P=0.003）。S-1组中相对常见的3级或4级不良事件（根据美国国家癌症研究所的共同毒性标准定义）为厌食症（6.0%）、恶心（3.7%）和腹泻（3.1%）。结论：S-1对于东亚地区局部进展期胃癌行D2夹层的患者是一种有效的辅助治疗。（ClinicalTrials.gov编号：NCT00152217）。
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.).