Efficacy
At a median follow-up of 57.0 months, the difference in the proportion of patients that had died (20.9% in the XELOX group vs 23.9% in the 5FU/FA group) was not statistically significant (HR, 0.87; 95% CI, 0.72 to 1.05; P = 0.1486). XELOX was superior to bolus FU/FA in terms of disease-free survival (DFS) (HR 0.80; 95% CI, 0.69 to 0.93; P = 0.0045) with 3 year DFS rates of 70.9% and 66.5% respectively. The 5-year overall survival (OS) for XELOX and FU/FA were 77.6% and 74.2% respectively.r
In the IDEA analysis, patients received adjuvant chemotherapy (ACT) 39.5% received CAPOX and the remainder received FOLFOX. In the overall population, the 5-year OS was 82.4% with 3 months of therapy and 82.8% with 6 months of therapy, with an estimated OS HR of 1.02 (95% CI 0.95 to 1.11). The absolute difference in 5-year OS rate was -0.4% (95% CI -2.1–1.3%). Five-year OS rate in 3 compared to 6 months treatment in CAPOX was 82·1% versus 81·2% with an estimated HR of 0·96 (95% CI, 0·85-1·08; NI FDRadj p, 0·033), and FOLFOX was 82·6% and 83·8%, estimated HR of 1·07 (95% CI, 0·97-1·18; NI FDRadj p, 0·34). CAPOX had considerably less toxicity, especially neuro toxicity.r
Kaplan-Meier curves IDEA Collaboration - 5 year DFS, 3 months versus 6 months ACT r
© Lancet Oncol 2020
Kaplan-Meier curves IDEA Collaboration - combined 5 year OS for 3 months versus 6 months ACT r
© Lancet Oncol 2020
Kaplan-Meier curves IDEA Collaboration - 5 year OS 3 months versus 6 months by type of ACT r
© Lancet Oncol 2020
Disease-free survival, intent-to-treat populationr
© J Clin Oncol 2011
Overall survival, intent-to-treat populationr
© J Clin Oncol 2011