CAO/ARO/AIO-94试验（资讯详情：预测直肠癌长期预后的工具：肿瘤消退分级量表）确定了术前化放疗（CRT），全直肠系膜切除术（TME）手术，和5-FU辅助化疗作为局部晚期直肠癌标准治疗。

该项CAO/ARO/AIO-04试验的目标是整合更有效的系统性治疗。早期次要终点的初步结果已经在2012年《Lancet Oncology》上发表。在本次会议上，呈现的是该试验的主要终点：3年的无疾病生存期（DFS）。

研究方法

cT3/4或者cN+直肠癌患者随机分配为两组：（1）术前50.4Gy+静脉滴注5-FU 1g/m2（第1～5天和第29～33天），序贯TME-手术和4个周期的口服5-FU 500 mg/m²，维持5天；（2）术前50.4Gy+静脉滴注5-FU （250mg/m²，第1～14天和第22～35天），奥沙利铂（50mg/m²，第1，8，22和29天），序贯TME和8个周期的辅助奥沙利铂（100mg/m²第1天），亚叶酸钙（400mg/m²第1天）+静脉滴注5-FU（2400mg/m²，第1～2天）。将随机分配到不完全手术切除，局部或者转移性复发或者死亡的时间间隔，无论哪一种情况先发生，定义为主要终点，主要终点是3年的DFS。

研究结果

一共有637例患者随机分配到组1，628例患者分配到组2。经过50个月的中位随访时间，组1中有198例患者出现DFS-相关事件，与组2中的159例患者进行比较（HR 0.79，95%置信区间0.64～0.98，利用混合效应Cox模型得出P=0.03）。三年时的DFS比例在组1是71.2%（95%置信区间，67.6～74.9%），而组2这一值为75.9%（95%置信区间，72.4%～79.5%），使用具体分层log-rank检验P值为0.03。在组1和组2中3～4级晚期整体治疗相关毒性发生率分别为23%和26%（P=0.14）。在治疗过程中，含奥沙利铂治疗组的3～4级感觉神经病变发生率为7%，随访1年后降低为3%。

结论

对于局部晚期直肠癌患者来说，将奥沙利铂添加到以5-FU为基础的新辅助术前化放疗和辅助化疗中，可以明显提高患者的无疾病生存期。

医脉通整理报道，转载请注明出处。

会议专题》》》2014年ASCO年会专题报道

阅读摘要原文

Preoperativechemoradiotherapy and postoperative chemotherapy with 5-fluorouracil and oxaliplatinversus 5-fluorouracil alone in locally advanced rectal cancer: Results of the GermanCAO/ARO/AIO-04 randomized phase III trial.（Abstract 3500）

Background: The CAO/ARO/AIO-94 trial established preoperative chemoradiotherapy (CRT)，total mesorectal excision (TME) surgery，and adjuvant chemotherapy with 5-FU asstandard treatment for locally advanced rectal cancer.The goal of the CAO/ARO/AIO-04 trial was the integrating of more effective systemic treatment.First results of early secondary endpoints have been published (Rödel et al.，Lancet Oncol 2012). Here we present the primary endpoint，disease-free survival(DFS) at 3 years. 

Patients and Methods: Patients with cT3/4 or cN+ rectalcancer were randomised into two arms:1) preoperative 50.4 Gy plus infusional 5-FU 1g/m² days 1-5 and 29-33，followed by TME-surgery and 4 cycles of bolus 5-FU 500mg/m² for 5 days)，and 2) preoperative 50.4 Gy plus infusional 5-FU(250mg/m² days 1-14 and 22-35)，oxaliplatin (50mg/m² days 1，8，22，and 29)，followed by TME and 8 cycles of adjuvant oxaliplatin (100mg/m² day 1)，leucovorin (400mg/m² day 1) and infusional 5-FU (2400 mg/m² day 1-2).The primary endpoint was DFS at 3 years defined as the interval from randomization to incomplete surgical resection，locoregional or metastatic recurrence ordeath，whichever occurred first. 

Results: A total of 637 patients were randomlyassigned to arm 1 and 628 to arm 2. After a median follow-up time of 50 months，198 patients in arm 1 had had a DFS-related event，as compared with 159 patients in arm 2 (HR 0.79，95% confidence interval 0.64 to 0.98，P=0.03 by themixed effects Cox model).The rate of DFS at three years was 71.2% (95% confidence interval，67.6% to 74.9%) in arm 1 and 75.9% (95% confidence interval，72.4% to 79.5%) in arm 2 (P=0.03 by the exact stratified log-ranktest).Grade 3-4 late overall treatment-related toxicity occurred in 23% in arm 1 and 26% in arm 2 (P=0.14).The incidence of grade 3-4 sensory neuropathy in the oxaliplatin containing arm was 7% during treatment，decreasing to 3% at one year of follow-up. 

Conclusions: Adding oxaliplatin to 5-FU-based neoadjuvant CRT and adjuvant chemotherapy in locally advanced rectal cancer significantly improved DFS.

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