Send to

Choose Destination
J Clin Oncol. 2018 Oct 20;36(30):3031-3039. doi: 10.1200/JCO.2018.78.3183. Epub 2018 Sep 10.

Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial.

Author information

Shukui Qin, Bayi Hospital, Nanjing University of Chinese Medicine, Nanjing; Jin Li, Fudan University Cancer Hospital and Tongji University East Hospital; Liwei Wang, Shanghai First People's Hospital; Jun Zhang, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Tianshu Liu, Affiliated Zhongshan Hospital of Fudan University, Shanghai; Jianming Xu, 307 Hospital of the Chinese People's Liberation Army; Guanghai Dai, Chinese People's Liberation Army General Hospital; Junyuan Wang and Jiongjie Chen, Merck Serono, Beijing; Ying Cheng, Jilin Cancer Hospital; Wei Li, First Affiliated Hospital of Jilin University, Jilin; Yuxian Bai, Affiliated Hospital of Harbin Medical University, Harbin; Nong Xu, First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou; Li-zhu Lin, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou; Qiong Wu, First Affiliated Hospital of Bengbu Medical College, Bengbu; Yunfeng Li, Yunnan Province Cancer Hospital, Kunming; Jianwei Yang, Fujian Province Cancer Hospital; Xuenong Ouyang, Fuzhou General Hospital, Fuzhou; Hongming Pan, Sir Run Run Shaw Hospital Affiliated With School of Medicine, Zhejiang University, Zhejiang; Wensheng Qiu, Affiliated Hospital of Qingdao University, Qingdao; Kaichun Wu, Xijing Hospital, Fourth Military Medical University, Shaanxi; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Houjie Liang, Southwest Cancer Center, Southwest Hospital, Third Military Medical University, Chongqing; Chunhong Hu, Second Xiangya Hospital of Central South University, Changsha; Min Tao, First Affiliated Hospital of Suzhou University, Suzhou; Qiang Yao, Tianjin People's Hospital, Tianjin, People's Republic of China; and S. Peter Eggleton, Merck KGaA, Darmstadt, Germany.



Cetuximab in combination with chemotherapy is a standard-of-care first-line treatment regimen for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC); however, the efficacy of cetuximab plus leucovorin, fluorouracil, and oxaliplatin (FOLFOX) has never before been proven in a controlled and randomized phase III trial. To our knowledge, the TAILOR trial ( identifier: NCT01228734) is the first randomized, multicenter, phase III study of the addition of cetuximab to first-line FOLFOX prospectively choosing a RAS wt population and thus providing confirmative data for the efficacy and safety of cetuximab plus FOLFOX versus FOLFOX alone.


TAILOR is an open-label, randomized (1:1), multicenter, phase III trial in patients from China comparing FOLFOX-4 with or without cetuximab in RAS wt (KRAS/NRAS, exons 2 to 4) mCRC. The primary end point of TAILOR was progression-free survival time; secondary end points included overall survival time, overall response rate, and safety and tolerability.


In the modified intent-to-treat population of 393 patients with RAS wt mCRC, adding cetuximab to FOLFOX-4 significantly improved the primary end point of progression-free survival time compared with FOLFOX-4 alone (hazard ratio, 0.69; 95% CI, 0.54 to 0.89; P = .004; median, 9.2 v 7.4 months, respectively), as well as the secondary end points of overall survival time (current assessment after 300 events: hazard ratio, 0.76; 95% CI, 0.61 to 0.96; P = .02; median, 20.7 v 17.8 months, respectively) and overall response rate (odds ratio, 2.41; 95% CI, 1.61 to 3.61; P < .001; 61.1% v 39.5%, respectively). Treatment was well tolerated, and there were no new or unexpected safety findings.


The TAILOR study met all of its objectives and relevant clinical end points, confirming cetuximab in combination with FOLFOX as an effective standard-of-care first-line treatment regimen for patients with RAS wt mCRC.

[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center