Final overall survival (OS) analysis of first-line (1L) FOLFOX-4 ± cetuximab (cet) in patients (pts) with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in the phase 3 TAILOR trial.

作者：Shukui Qin, Weijian Guo, Jianming Xu, Qi Li, Ying Cheng, Tian Shu Liu, Jiongjie Chen, Wenfeng Chen, Jin Li · 发表于：Journal of Clinical Oncology · 年份：2018 · DOI：10.1200/jco.2018.36.15_suppl.3521 · 被引用次数：4 · 研究领域：Colorectal Cancer Treatments and Studies、Cancer Treatment and Pharmacology、Lung Cancer Treatments and Mutations

3521 Background: The survival advantage conferred by the addition of cet to FOLFOX chemotherapy was verified in TAILOR, the first prospective, randomized, phase 3 study of the addition of cet to 1L FOLFOX in pts with RAS wt mCRC. We previously presented the primary analysis of the TAILOR trial, with fewer OS events. Here, we provide the final OS results for this trial. Methods: TAILOR was an open-label, randomized, multicenter, phase 3 trial with a modified intention-to-treat (mITT) population of 393 pts from China that evaluated FOLFOX-4 ± cet in RAS wt mCRC. The primary endpoint was progression-free survival (PFS) time; secondary endpoints include OS time, overall response rate (ORR), and safety/tolerability. Results: An updated analysis (performed after 84% of events occurred) verified the survival advantage of the addition of cet to FOLFOX-4 (Table). Additionally, > 77% of pts in the cet + FOLFOX-4 arm reached ≥ 80% dose intensity of cet, confirming that cet + FOLFOX-4 has high compliance. There were no new or unexpected safety findings. Finally, 59.6% and 56.0% of pts in the cet + FOLFOX-4 and FOLFOX-4 arms, respectively, received subsequent anticancer therapy after treatment discontinuation (54.4% and 49.5% received any chemotherapy, and 17.6% and 27.0% received any targeted therapy). Clinical trial information: NCT01228734. Conclusions: The TAILOR study met all its endpoints, confirming cet in combination with FOLFOX-4 as an effective standard-of-care 1L treatment regi...