SO-19 Biomarker analysis using plasma angiogenesis factors in the TRUSTY study: A randomized phase 2/3 study of trifluridine/tipiracil plus bevacizumab as second-line treatment for metastatic colorectal cancer

In primary analysis from the TRUSTY study, trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) failed to show non-inferiority in terms of overall survival (OS) irinotecan and fluoropyrimidine BEV as second-line treatment patients (pts) with metastatic colorectal cancer (mCRC) who first-line chemotherapy oxaliplatin either or an anti-EGFR antibody (median OS: 14.8 vs. 18.1 months; hazard ratio [HR]: 1.38; 95% CI: 0.99–1.93; p = 0.59 for non-inferiority; Kuboki Y et al., ASCO 2021). Here we report relationship between plasma levels angiogenesis-related factors efficacy FTD/TPI mCRC. Pts provided informed consent biomarker research were included this analysis. Plasma samples collected prior start study treatment. Comprehensive measurements 17 (Angiopoietin-2, HGF, IFN-γ, IL-6, IL-8, PlGF, VEGF-A, VEGF-D, OPN, sNeuropilin-1, sVEGFR1, sVEGFR2, sVEGFR3, TSP-2, sICAM-1, sVCAM-1, TIMP-1) performed using a multiplex assay Luminex® technology. The cut-off value was defined median each factor. Disease control rate (DCR) progression-free (PFS) measures compared 2 groups high low marker. arm, available 65 intention-to-treat population (N=197). Baseline characteristics male/female: 35/30, age: 64.0 (range: 25–84), RAS status wild-type/mutant: 29/36, antibody/bevacizumab treatment: 17/48. DCR 55.4% PFS 3.9 months A higher observed pts lower HGF (72.0 39.4%, risk ratio: 1.83; 1.12–2.98) IL-8 (67.9 40.0%, 1.70; 1.02–2.82). significantly longer (5.5 3.3 months, HR: 0.33; 0.14–0.79) 0.31; 0.14–0.70). addition, IL-6 (6.0 3.5 0.19; 0.07–0.50), OPN 0.39; 0.17–0.88), TSP-2 (4.9 3.6 0.42; 0.18–0.98), TIMP-1 (7.4 0.26; 0.10–0.67) had PFS. at baseline may serve predictor better mCRC, although further studies are warranted.