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• W2891756618 abstract "3591 Background: FIRE-3 compared 1st-line therapy with FOLFIRI plus either cetuximab or bevacizumab in 592 KRAS exon 2 wt mCRC patients (pts). Methods: Tumor DNA was profiled by next-generation sequencing to explore molecular markers of prognosis. The biomarker evaluable subpopulation (n = 373) was representative of the ITT population. Treatment efficacy was determined in the quadruple wild-type (wt) population (RAS, BRAF, AKT, PI3K = “MAPK/mTOR wt”). Kaplan-Meier estimation and log-rank tests were employed for overall survival (OS). Hazard ratios (HR) were estimated using the Cox proportional hazard method. P-values were not adjusted for multiple testing Results: Overall frequencies were (%,n): MSI-h 2.7% (10); BRAFmut 12.1% (45); RASmut 32.7% (122); quadruple wt: 47.7% (178); TMB > 8: 15% (56). RAS, BRAF, MSI-h and quadruple-wt status were prognostic. Pts with low-frequent RAS mutations (RASmut < 5%) had a significantly longer OS when compared to pts with higher RAS mutational frequency. Conclusions: NGS analysis revealed distinct subgroups of mCRCs with different prognosis. MSI status had prognostic impact, but TMB could not be validated as a prognostic or predictive marker. Overall survival. N Events N (% ) Median [ 95%CI ] N Events N (%) Median [ 95%CI ] HR [ 95%CI ], p-value MSI MSI-H 10 10 ( 100) 18.8 [ 2.5, 24.5 ] MSS 343 298 ( 87) 25.4 [ 23.1, 27.6 ] 1.92 [ 1.02, 3.62 ], 0.0432 TMB status 1 high 10 9 ( 90) 19.8 [ 2.5, 25.2 ] intermediate 114 100 ( 88) 25.7 [ 21.5, 29.1 ] 1.28 [ 0.65, 2.54 ], 0.4725 high 10 9 ( 90) 19.8 [ 2.5, 25.2 ] low 236 206 ( 87) 23.8 [ 21.4, 26.7 ] 1.16 [ 0.60, 2.27 ], 0.6568 intermediate 114 100 ( 88) 25.7 [ 21.5, 29.1 ] low 236 206 ( 87) 23.8 [ 21.4, 26.7 ] 0.91 [ 0.71, 1.15 ], 0.4186 TMB status 2 < = 8 304 268 ( 88) 23.8 [ 21.8, 26.1 ] > 8 56 47 ( 84) 27.5 [ 18.7, 31.1 ] 1.23 [ 0.90, 1.68 ], 0.1924 BRAF wt 328 289 ( 88) 26.4 [ 23.9, 28.8 ] Mut 45 39 ( 87) 15.9 [ 10.9, 19.1 ] 0.57 [ 0.41, 0.80 ], 0.0012 RAS wt 251 212 ( 85) 27.9 [ 24.7, 31.9 ] Mut 122 116 ( 95) 20.6 [ 17.4, 23.6 ] 0.62 [ 0.49, 0.78 ], 0.0000 MAPK wt 178 151 ( 85) 30.8 [ 26.4, 35.2 ] mut 195 177 ( 91) 20.8 [ 18.5 , 23.7 ] 0.64 [ 0.51, 0.79 ], 0.0001" @default.
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• W2891756618 date "2018-05-20" @default.
• W2891756618 modified "2023-09-25" @default.
• W2891756618 title "Somatic DNA mutations, tumor mutational burden (TMB), and MSI Status: Association with efficacy in patients (pts) with metastatic colorectal cancer (mCRC) of FIRE-3 (AIO KRK-0306)." @default.
• W2891756618 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.3591" @default.
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