Long-term results of the ADORE trial: Adjuvant oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) versus 5-fluorouracil and leucovorin (FL) after preoperative chemoradiotherapy and surgery for locally advanced rectal cancer.

3501Background: To report the long-term survival outcomes of the ADORE, a randomized controlled trial, compared adjuvant FOLFOX vs FL in patients with resected rectal cancer whose pathologic stages of ypII/III after preoperative chemoradiotherapy (CRT). Methods: This is a randomized phase II study accrued patients with curatively resected rectal cancer patients whose postoperative ypStage II/III after preoperative CRT with fluoropyrimidines alone. Patients were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL or FOLFOX for 4 months. Randomization was centrally coordinated and stratified by the ypStage and participating sites. The primary endpoint was disease-free survival (DFS). Results: A total of 321 patients were randomly assigned between Nov 2008 and Jun 2012; 161 patients to FL and 160 to FOLFOX. At a median follow-up of 74.1 months (IQR, 56.2 – 88.0), 6-year DFS rate was 68.2% in the FOLFOX arm vs 56.8% in the FL arm with an adjusted hazard ratio (HR) of 0.63 (95% CI, 0.43–0.9...