Impact of primary tumor location (TL) on outcomes of first-line (1L) FOLFOX-4 (F) ± cetuximab (cet) in patients (pts) with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in the phase 3 TAILOR trial.
683 Background: In the RAS wt population of TAILOR, adding cet to 1L F significantly improved progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). In this subgroup analysis, we evaluate the impact of TL. Methods: TAILOR is a randomized phase 3 trial that includes a modified intention-to-treat (mITT) population of 393 pts from China with RASwt mCRC treated with F ± cet. The primary endpoint of TAILOR is PFS; key secondary endpoints include OS and ORR. TL was categorized in evaluable pts in the mITT population (left-sided = splenic flexure, descending colon, sigmoid colon, and rectum; right-sided = appendix, cecum, ascending colon, hepatic flexure, ± transverse colon). Results: Efficacy data for the TL subgroups are summarized in the table. Additionally, the prognostic effect of TL (left- vs right-sided) within the treatment arms could be shown for PFS (HR = 1.72; p = .007), OS (HR = 1.84; p = .002), and ORR (OR = 0.40; p = .014) in the cet + F arm and PFS (HR = 1.97; p = .002), OS (HR = 1.43; p = .073), and ORR (OR = 0.41; p = .028) in the F arm. Regarding the potential predictive value of TL, the p values for the interaction between TL and treatment are: PFS (.676), OS (.339), and ORR (.986). Conclusions: In TAILOR, adding cet to 1L F clearly benefitted RAS wt pts with left-sided tumors in terms of PFS, OS, and ORR; for pts with right-sided tumors, the HRs for PFS and the ORs for ORR also consistently suggested a benefit showing a trend in favor of cet. Clinical trial information: NCT01228734. [Table: see text]