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Oxaliplatin-Based Adjuvant Chemotherapy for Rectal Cancer After Preoperative Chemoradiotherapy (ADORE): Long-Term Results of a Randomized Controlled Trial.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2019 Nov 20; Vol. 37 (33), pp. 3111-3123. Date of Electronic Publication: 2019 Oct 08. - Publication Year :
- 2019
-
Abstract
- Purpose: We evaluated the role of oxaliplatin as adjuvant chemotherapy in patients with rectal cancer who received preoperative chemoradiotherapy (CRT) with fluoropyrimidine monotherapy and total mesorectal excision (TME).<br />Methods: The ADORE trial (adjuvant oxaliplatin in rectal cancer) is a multicenter, randomized trial in patients with postoperative ypStage II (ypT3-4N0) or III (ypT <subscript>any</subscript> N1-2) rectal cancer after fluoropyrimidine-based preoperative CRT and TME. Patients were randomly assigned (1:1) to receive adjuvant chemotherapy either with FL (fluorouracil 380 mg/m <superscript>2</superscript> and leucovorin 20 mg/m <superscript>2</superscript> ) or FOLFOX (oxaliplatin 85 mg/m <superscript>2</superscript> , leucovorin 200 mg/m <superscript>2</superscript> , and fluorouracil bolus 400 mg/m <superscript>2</superscript> on day 1, fluorouracil infusion 2,400 mg/m <superscript>2</superscript> for 46 hours). Stratification factors included ypStage and participating center. Primary end point was disease-free survival (DFS).<br />Results: A total of 321 patients were enrolled between November 19, 2008, and June 12, 2012. Six-year DFS rates were 68.2% in the FOLFOX arm versus 56.8% in the FL arm, with a stratified hazard ratio of 0.63 (95% CI, 0.43 to 0.93; P = .018) by intention-to-treat analysis. In the subgroup analysis for DFS, FOLFOX was favorable versus FL in patients with ypStage III, ypN1b, ypN2, high-grade histology, minimally regressed tumor, and an absence of lymphovascular or perineural invasion. Six-year overall survival rate was 78.1% in the FOLFOX arm versus76.4% in the FL arm (hazard ratio, 0.73; 95% CI, 0.45 to 1.19; P = .21). In the subgroup analysis for OS, FOLFOX was favorable versus FL in patients with ypN2 and minimally regressed tumor.<br />Conclusion: Adjuvant FOLFOX improved DFS in patients with rectal cancer with ypStage II and III disease after preoperative CRT. Adjuvant FOLFOX may be considered on the basis of the postoperative pathologic stage in those who received preoperative CRT and TME.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Chemoradiotherapy
Chemotherapy, Adjuvant
Disease-Free Survival
Female
Fluorouracil administration & dosage
Humans
Leucovorin administration & dosage
Male
Middle Aged
Neoplasm Recurrence, Local pathology
Organoplatinum Compounds administration & dosage
Oxaliplatin administration & dosage
Oxaliplatin adverse effects
Preoperative Care methods
Quality of Life
Rectal Neoplasms pathology
Rectal Neoplasms radiotherapy
Rectal Neoplasms surgery
Survival Rate
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Rectal Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 37
- Issue :
- 33
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 31593484
- Full Text :
- https://doi.org/10.1200/JCO.19.00016