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https://hdl.handle.net/2440/72751
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Type: | Journal article |
Title: | Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer |
Author: | Haller, D. Tabernero, J. Maroun, J. de Braud, F. Price, T. Van Cutsem, E. Hill, M. Gilberg, F. Rittweger, K. Schmoll, H. |
Citation: | Journal of Clinical Oncology, 2011; 29(11):1465-1471 |
Publisher: | Amer Soc Clinical Oncology |
Issue Date: | 2011 |
ISSN: | 0732-183X 1527-7755 |
Statement of Responsibility: | Daniel G. Haller, Josep Tabernero, Jean Maroun, Filippo de Braud, Timothy Price, Eric Van Cutsem, Mark Hill, Frank Gilberg, Karen Rittweger and Hans-Joachim Schmoll |
Abstract: | PURPOSE: This multicenter, randomized trial compared capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil (FU) and folinic acid (FA) as adjuvant therapy for patients with stage III colon cancer. PATIENTS AND METHODS: Patients who had undergone curative resection were randomly assigned to XELOX (oxaliplatin 130 mg/m2 on day 1 plus capecitabine 1,000 mg/m2 twice daily on days 1 to 14 every 3 weeks for 24 weeks) or a standard bolus FU/FA adjuvant regimen (Mayo Clinic for 24 weeks or Roswell Park for 32 weeks). The primary study end point was disease-free survival (DFS). RESULTS: The intention-to-treat population comprised 1,886 patients; 944 patients were randomly assigned to XELOX and 942 to FU/FA (Mayo Clinic, n _ 664; Roswell Park, n _ 278). After 57 months of follow-up for the primary analysis, 295 patients (31.3%) in the XELOX group had relapsed, developed a new primary colon cancer, or died compared with 353 patients (37.5%) in the FU/FA group (hazard ratio [HR] for DFS, 0.80; 95% CI, 0.69 to 0.93; P _ .0045). The 3-year DFS rate was 70.9% with XELOX and 66.5% with FU/FA. The HR for overall survival (OS) for XELOX compared to FU/FA was 0.87 (95% CI, 0.72 to 1.05; P _ .1486). The 5-year OS for XELOX and FU/FA were 77.6% and 74.2%, respectively. Follow-up is ongoing. Preplanned multivariate and subgroup analyses supported the robustness of these findings. CONCLUSION: The addition of oxaliplatin to capecitabine improves DFS in patients with stage III colon cancer. XELOX is an additional adjuvant treatment option for these patients. |
Keywords: | Humans Colonic Neoplasms Organoplatinum Compounds Fluorouracil Leucovorin Deoxycytidine Antineoplastic Combined Chemotherapy Protocols Neoplasm Staging Disease-Free Survival Chemotherapy, Adjuvant Proportional Hazards Models Adult Aged Aged, 80 and over Middle Aged Female Male Capecitabine Oxaliplatin |
Rights: | © 2011 by American Society of Clinical Oncology |
DOI: | 10.1200/JCO.2010.33.6297 |
Published version: | http://dx.doi.org/10.1200/jco.2010.33.6297 |
Appears in Collections: | Aurora harvest Medicine publications |
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