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Adjuvant chemotherapy with oxaliplatin/5-fluorouracil/leucovorin (FOLFOX) versus 5-fluorouracil/leucovorin (FL) for rectal cancer patients whose postoperative yp stage 2 or 3 after preoperative chemoradiotherapy: Updated results of 3-year disease-free survival from a randomized phase II study (The ADORE).
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Background: To report the updated results of 5-fluorouracil (5-FU)/leucovorin (LV) (FL) with or without oxaliplatin (FOLFOX) in patients with curatively resected rectal cancer whose pathologic stages of ypII/III after preoperative chemoradiotherapy (CRT). Methods: This is a randomised phase II study accrued patients with curatively resected rectal cancer patients whose postoperative stage ypII (ypT3-4/ypN0) or III (any ypT/ypN1-2) after preoperative CRT with fluoropyrimidines alone. Patients were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL (5-FU 380 mg/m2, LV 20 mg/m2 on days 1-5, every 4 weeks, 4 cycles) or FOLFOX (oxaliplatin 85 mg/m2, LV 200 mg/m2, 5-FU bolus 400 mg/m2 on day 1, 5-FU infusion 2400 mg/m2 for 46 hours, every 2 weeks, 8 cycles). Randomisation was centrally coordinated and stratified by the ypStage and participating sites. The primary endpoint was 3-year disease-free survival (DFS). Results: A total of 321 patients were randomly assigned between November 2008 and June 2012; 161 patients to FL and 160 to FOLFOX. The arms were balanced. At a median follow-up of 38.2 months (IQR, 26.4 – 50.6), 3-year DFS rate was 71.6% (95% CI, 64.6 – 78.6) in the FOLFOX arm and 62.9% (95% CI, 55.4 – 70.4) in the FL arm with a hazard ratio (HR) of 0.657 (95% CI, 0.434 – 0.994, p=0.047) by intention-to-treat analysis. After adjusting for stratification and prognostic variables, HR remained unchanged favoring FOLFOX (0.560; 95% CI 0.366 – 0.856; p=0.007) in terms of 3-year DFS. In the subgroup analysis, patients with ypStage III (HR 0.602 [0.371 – 0.977], p=0.040), ypN1b (HR 0.356 [0.132 – 0.960], p=0.041), ypN2 (HR 0.414 [0.181 – 0.946], p=0.037), and minimally regressed tumors (HR 0.395 [0.188 – 0.831, p=0.014] benefited more from FOLFOX than FL. Grade-3 or -4 adverse events were not statistically different between arms. Conclusions: Adjuvant FOLFOX demonstrated improved 3-year DFS in curatively resected rectal cancer patients whose postoperative stage of ypII/III after preoperative CRT. Clinical trial information: NCT00807911.
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