131515-144

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).

Subcategory: 
Category: 
Gastrointestinal (Colorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Colorectal) Cancer
Abstract Number: 
3502
Citation: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 3502)
Author(s): 
Yong Sang Hong, Byung-Ho Nam, Kyu-Pyo Kim, Jae-Lyun Lee, Joon Oh Park, Young Suk Park, Sun Young Kim, Tae-You Kim, Jee Hyun Kim, Joong Bae Ahn, Kyung Hae Jung, Tae Won Kim; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, South Korea; Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea; Department of Internal Medicine and Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea; Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea; Department of Internal Medicine, Cancer Metastasis Research Center, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

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.