The trial was originally designed to test the treatment effect on all randomised patients but was amended to compare PFS and OS according K-RAS status before any efficacy analyses. 656 patients (60%) had wild type K-RAS in this trial.
In the wild type K-RAS population, after a median follow up of 13.2 months, the median PFS was 9.6 months in the panitumumab+FOLFOX4 group vs 8.0 months in the FOLFOX4 group (HR=0.80; CI 95% 0.66 to 0.97 ; p=0.02).r
In an updated analysis, panitumumab+FOLFOX4, compared with FOLFOX4 alone, was associated with a 4.4-month improvement in overall survival (23.8 months vs. 19.4 months; p=0.03).r
Among patients without RAS mutations, the overall survival was 26.0 months in the panitumumab-FOLFOX group vs 20.2 months in the FOLFOX4 alone group (HR=0.78; 95% CI, 0.62 to 0.99; p=0.04). Patients with non-mutated KRAS exon 2 who had other RAS mutations were associated with inferior progression-free survival and overall survival with panitumumab-FOLFOX treatment.r
(A) Kaplan-Meier Estimates of Progression-free Survival and (B) Overall Survival in the Primary Analysis Populationr
© New England Journal of Medicine 2013