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https://hdl.handle.net/2440/44021
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Type: | Journal article |
Title: | Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: A planned safety analysis in 1 864 patients |
Author: | Schmoll, H. Cartwright, T. Tabernero, J. Nowacki, M. Figer, A. Maroun, J. Price, T. Lim, R. Van Custem, E. Park, Y. McKendrick, J. Topham, C. Soler-Gonzalez, G. de Braud, F. Hill, M. Sirzen, F. Haller, D. |
Citation: | Journal of Clinical Oncology, 2007; 25(1):102-109 |
Publisher: | Amer Soc Clinical Oncology |
Issue Date: | 2007 |
ISSN: | 0732-183X 1527-7755 |
Statement of Responsibility: | Hans-Joachim Schmoll, Thomas Cartwright, Josep Tabernero, Marek P. Nowacki, Arie Figer, Jean Maroun, Timothy Price, Robert Lim, Eric Van Cutsem, Young-Suk Park, Joseph McKendrick, Claire Topham, Gemma Soler-Gonzalez, Filipo de Braud, Mark Hill, Florin Sirzén, Daniel G. Haller |
Abstract: | Purpose: To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer. Patients and Methods: Patients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned. Results: The safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6% in the XELOX group and 0.6% in the FU/LV group. Conclusion: XELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months |
Keywords: | Humans Colonic Neoplasms Organoplatinum Compounds Fluorouracil Leucovorin Deoxycytidine Antineoplastic Combined Chemotherapy Protocols Disease-Free Survival Treatment Outcome Chemotherapy, Adjuvant Safety Research Design Adult Aged Aged, 80 and over Middle Aged Capecitabine Oxaliplatin |
Rights: | © 2007 American Society of Clinical Oncology. |
DOI: | 10.1200/JCO.2006.08.1075 |
Published version: | http://dx.doi.org/10.1200/jco.2006.08.1075 |
Appears in Collections: | Aurora harvest 6 Medicine publications |
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