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本研究中,参加试验的患者(来自北美,南美,欧洲,亚洲,非洲和澳大利亚治疗中心)年龄均在18岁以上,均为化疗难治性转移性结直肠癌,ECOG评分在2分或以下,KRAS外显子2的状态为野生型。使用计算机生成的随机序列,研究人员以1:1分配患者(按地理区域和ECOG评分进行分层)接受帕尼单抗(6 mg/kg,每2周一次)或西妥昔单抗(初始剂量为400 mg/m2,之后250 mg/m2,每周一次)治疗。研究期间(2010年2月2日至2012年7月19日),共招募了1 010例患者并对他们进行了随机分组的治疗,并对其中999例进行了治疗研究。这些患者中499例接受帕尼单抗,500例接受西妥昔单抗。总生存期初步分析显示,帕尼单抗不比西妥昔单抗差(Z分数-3.19,p=0.0007)。帕尼单抗及西妥昔单抗的中位总生存期分别为10.4个月(95%CI[9.4-11.6])和10.0
In this study, patients (all centers in North America, South America, Europe, Asia, Africa and Australia) aged 18 years and over were all refractory metastatic colorectal cancer with an ECOG score of 2 or less , KRAS exon 2 is wild type. Using computer-generated randomized sequences, the researchers assigned patients to panitumumab (6 mg / kg every 2 weeks) at 1: 1 (stratified by geographic region and ECOG score) or cetuximab Dose of 400 mg / m2, followed by 250 mg / m2, once a week) treatment. During the study period (February 2, 2010 to July 19, 2012), a total of 1,100 patients were enrolled and randomly assigned to receive treatment and 999 of them were enrolled in the study. Of these patients, 499 received panitumumab and 500 received cetuximab. Preliminary analysis of overall survival showed no difference between panitumumab and cetuximab (Z score -3.19, p = 0.0007). Median overall survival for panitumumab and cetuximab was 10.4 months (95% CI [9.4-11.6]) and 10.0