Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial
Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial
复制标题
DOI：
10.1016/s0140-6736(11)61873-4
复制
发表时间：
2012-01-28
期刊：
影响因子：
168.9
通讯作者：
Noh, Sung Hoon
中科院分区：
文献类型：
--
作者：
Bang, Yung-Jue;Kim, Young-Woo;Noh, Sung Hoon
背景D2胃切除术在美国和欧洲指南中被推荐，在东亚是可切除胃癌患者的首选。辅助化疗可改善患者术后预后，但D2切除术后的获益尚未在大规模试验中进行广泛研究。我们调查了无病生存的辅助化疗与卡培他滨加奥沙利铂D2胃切除术后的效果相比，D2胃切除术仅在患者中与II-IIIB期gastric cancer.Methods卡培他滨和奥沙利铂辅助研究胃癌（CLASSIC）研究是一项开放标签，平行组，3期，随机对照试验，在37个中心在韩国，中国和台湾。已行根治性D2胃切除术的II-IIIB期胃癌患者被随机分配接受8个3周周期的辅助化疗，即口服卡培他滨（1000 mg/m2，每日2次，每个周期的第1 - 14天）+静脉注射奥沙利铂（130 mg/m2，每个周期的第1天），持续6个月，或仅接受手术。通过中央交互式计算机系统进行区组随机化，按国家和疾病分期分层。患者和给予干预、评估结局和分析数据的研究者不设盲。主要终点是3年无病生存率，分析意向treat. This研究报告一个预先指定的中期疗效分析，之后，该试验停止后，由数据监测委员会的建议。该试验注册于ClinicalTrials.gov（NCT 00411229）。结果1035例患者随机分组（520例接受化疗和手术，515例仅接受手术）。化疗和手术组的中位随访时间为34.2个月（25.4-41.7），单纯手术组为34.3个月（25.6-41.9）。化疗和手术组的3年无病生存率为74%（95%CI 69-79），单纯手术组为59%（53-64）（风险比0.56，95%CI 0.44-0.72; p
Background D2 gastrectomy is recommended in US and European guidelines, and is preferred in east Asia, for patients with resectable gastric cancer. Adjuvant chemo therapy improves patient outcomes after surgery, but the benefits after a D2 resection have not been extensively investigated in large-scale trials. We investigated the effect on disease-free survival of adjuvant chemotherapy with capecitabine plus oxaliplatin after D2 gastrectomy compared with D2 gastrectomy only in patients with stage II-IIIB gastric cancer.Methods The capecitabine and oxaliplatin adjuvant study in stomach cancer (CLASSIC) study was an open-label, parallel-group, phase 3, randomised controlled trial undertaken in 37 centres in South Korea, China, and Taiwan. Patients with stage II-IIIB gastric cancer who had had curative D2 gastrectomy were randomly assigned to receive adjuvant chemotherapy of eight 3-week cycles of oral capecitabine (1000 mg/m(2) twice daily on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m(2) on day 1 of each cycle) for 6 months or surgery only. Block randomisation was done by a central interactive computerised system, stratified by country and disease stage. Patients, and investigators giving interventions, assessing outcomes, and analysing data were not masked. The primary endpoint was 3 year disease-free survival, analysed by intention to treat. This study reports a prespecified interim efficacy analysis, after which the trial was stopped after a recommendation by the data monitoring committee. The trial is registered at ClinicalTrials.gov (NCT00411229).Findings 1035 patients were randomised (520 to receive chemotherapy and surgery, 515 surgery only). Median follow-up was 34.2 months (25.4-41.7) in the chemotherapy and surgery group and 34.3 months (25.6-41.9) in the surgery only group. 3 year disease-free survival was 74% (95% CI 69-79) in the chemotherapy and surgery group and 59% (53-64) in the surgery only group (hazard ratio 0.56, 95% CI 0.44-0.72; p