Meeting
2014 ASCO Annual Meeting
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).
Authors
Yong Sang Hong
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
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
Organizations
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
Research Funding
Other
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.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Details
Session Type
Oral Abstract Session
Session Title
Gastrointestinal (Colorectal) Cancer
Track
Gastrointestinal Cancer—Colorectal and Anal
Sub Track
Colorectal Cancer
Clinical Trial Registration Number
NCT00807911
Citation
J Clin Oncol 32:5s, 2014 (suppl; abstr 3502)
DOI
10.1200/jco.2014.32.15_suppl.3502
Abstract #
3502
Abstract Disclosures
Similar Abstracts
Abstract
2013 ASCO Annual Meeting
Adjuvant chemotherapy with oxaliplatin/5-fluorouracil/leucovorin (FOLFOX) versus 5-fluorouracil/leucovorin (FL) in patients with locally advanced rectal cancer after preoperative chemoradiotherapy followed by surgery: A randomized phase II study (The ADORE).
First Author: Yong Sang Hong
Abstract
2018 ASCO Annual Meeting
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.
First Author: Yong Sang Hong
Abstract
2024 ASCO Gastrointestinal Cancers Symposium
Total neoadjuvant therapy (TnT) with FOLFOX followed by short course radiation in locally advanced rectal cancer: A phase II study.
First Author: Janice Zhao
Abstract
2023 ASCO Annual Meeting
Adjuvant chemotherapy in ypStage III locally advanced rectal cancer after neoadjuvant treatment with an oxaliplatin-based regimen.
First Author: Runkai Cai