Efficacy
In the MOISAIC trial published 2009, disease free survival (DFS) at 5 years was significantly increased in the intention to treat (ITT) population (HR 0.80, 95% CI 0.68 to 0.93, p=0.003) and in the sub-group of patients with Stage III disease (0.78, 95% CI 0.65 to 0.93, p = 0.005) in the oxaliplatin-containing arm. The overall survival (OS) at 6 years was 78.5% in the oxaliplatin containing arm and 76% in the infusional 5FU/LV alone arm (HR 0.84, 95% CI 0.71 to 1.0, p = 0.46). There was no evidence of a benefit of this regimen in the subgroup of patients with Stage II disease.r
In the IDEA analysis, patients received adjuvant chemotherapy (ACT), 39% 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 in 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 ACTr
© Lancet Oncol 2020
Kaplan-Meier curves IDEA Collaboration - combined 5 year OS for 3 versus 6 months ACTr
© Lancet Oncol 2020
Kaplan-Meier curves IDEA Collaboration - 5 year OS 3 months versus 6 months by type of ACT r
© Lancet Oncol 2020
Overall survivalr
© J Clin Oncol 2009