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Phase III Trial of Capecitabine Plus Oxaliplatin As Adjuvant Therapy for Stage III Colon Cancer: A Planned Safety Analysis in 1,864 Patients

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

From the Martin Luther University, Halle, Germany; US Oncology, Ocala, FL; University of Pennsylvania, Philadelphia, PA; Vall d'Hebron University Hospital; Institut Català d'Oncologia, Barcelona, Spain; Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Ottawa Regional Cancer Center, Ottawa, Canada; The Queen Elizabeth Hospital, Adelaide; Box Hill Hospital, Box Hill, Australia; National University Hospital, Singapore; University Hospital Gasthuisberg, Leuven, Belgium; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; St Lukes' Cancer Centre, Royal Surrey County Hospital, Guildford, Surrey; Kent Oncology Centre, Maidstone, United Kingdom; Istituto Europeo di Oncologia, Milan, Italy; and F. Hoffmann-La Roche AG, Basel, Switzerland

Address reprint requests to Hans-Joachim Schmoll, MD, PhD, Martin Luther University, Ernst-Grube-Strasse 40, 06120 Halle, Germany; e-mail: hans-joachim.schmoll{at}medizin.uni-halle.de

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.

Supported by F. Hoffmann-La Roche Ltd.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005; the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006; and the World Congress of Gastrointestinal Cancer, Barcelona, Spain, June 28-July 1, 2006.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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