Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer
Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer
复制标题
DOI：
10.1056/nejmoa1414325
复制
发表时间：
2015-05-14
影响因子：
158.5
通讯作者：
Ohtsu, Atsushi
中科院分区：
文献类型：
--
作者：
Mayer, Robert J.;Van Cutsem, Eric;Ohtsu, Atsushi
首先在日本进行的早期临床试验表明，TAS-102（一种联合曲氟尿苷和盐酸替吡嘧啶的口服药物）可有效治疗难治性结直肠癌。我们进行了一项3期临床试验，以进一步评估TAS-102在全球此类患者人群中的疗效和安全性。METHODS在这项双盲研究中，我们将800例患者以2：1的比例随机分配至接受TAS-102或安慰剂组。主要终点为总生存期，TAS-102组中位总生存期从安慰剂组的5.3个月提高到7.1个月，TAS-102组与安慰剂组相比死亡的风险比为0.68（95%置信区间[CI]，0.58 - 0.81; P
BACKGROUNDEarly clinical trials conducted primarily in Japan have shown that TAS-102, an oral agent that combines trifluridine and tipiracil hydrochloride, was effective in the treatment of refractory colorectal cancer. We conducted a phase 3 trial to further assess the efficacy and safety of TAS-102 in a global population of such patients.METHODSIn this double-blind study, we randomly assigned 800 patients, in a 2: 1 ratio, to receive TAS-102 or placebo. The primary end point was overall survival.RESULTSThe median overall survival improved from 5.3 months with placebo to 7.1 months with TAS-102, and the hazard ratio for death in the TAS-102 group versus the placebo group was 0.68 (95% confidence interval [CI], 0.58 to 0.81; P