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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

1
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.

Abstract

PURPOSE:

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 ( ClinicalTrials.gov 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.

PATIENTS AND METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

PMID:
30199311
PMCID:
PMC6324088
DOI:
10.1200/JCO.2018.78.3183
[Indexed for MEDLINE]
Free PMC Article

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