LBA11INDEPENDENT RADIOLOGICAL EVALUATION OF OBJECTIVE RESPONSE, EARLY TUMOR SHRINKAGE, AND DEPTH OF RESPONSE IN FIRE-3 (AIO KRK-0306) IN THE FINAL RAS EVALUABLE POPULATION

2014 
0.92* PFS (months) (95% CI) 10.3 (9.5 - 11.8) 10.2 (9.3 - 11.7) 0.77 0.97 OS (months) (95% CI) 33.1 (24.5 - 39.4) 25.0 (23.0 - 28.1) 0.0059 0.697 p = log-rank test; * = one-sided Fisher’s exact test; HR = Hazard ratio 459 patients (77.5%) were evaluable according to RECIST. ORR significantly favored the FOLFIRI plus cetuximab arm (71.4% vs. 56.4%; two sided Fisher’s exact test p = 0.015). The proportion of patients reaching ETS was significantly greater in the FOLFIRI plus cetuximab treated population (67.5% vs. 47.9% p = 0.0013), and was significantly associated with PFS in the cetuximab arm (logrank test p = 0.023) and OS (logrank test p = 0.0005 and p = 0.0043) in the respective treatment arms. Depth of response was significantly greater in FOLFIRI plus cetuximab treated patients (48.2% vs. 33.0%,
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