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Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial

Scheithauer, W. ; McKendrick, J. ; Begbie, S. ; Borner, M. ; Burns, W. I. ; Burris, H. A. ; Cassidy, J. ; Jodrell, D. ; Koralewski, P. ; Levine, E. L. ; Marschner, N. ; Maroun, J. ; Garcia-Alfonso, P. ; Tujakowski, J. ; Van Hazel, G. ; Wong, A. ; Zaluski, J. ; Twelves, C.

In: Annals of Oncology, 2003, vol. 14, no. 12, p. 1735-1743

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    Titre
    • Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial
    Auteur
    • Scheithauer, W.. Vienna University Medical School, Vienna, Austria
    • McKendrick, J.. Box Hill Hospital, Melbourne
    • Begbie, S.. Port Macquarie Hospital, Port Macquarie, Australia
    • Borner, M.. Institute of Medical Oncology, Berne, Switzerland
    • Burns, W. I.. St Vincent's Hospital, Melbourne, Australia
    • Burris, H. A.. Sarah Cannon Cancer Center, Nashville, TN, USA
    • Cassidy, J.. University of Aberdeen, Aberdeen
    • Jodrell, D.. University of Edinburgh, Western General Hospital, Edinburgh, UK
    • Koralewski, P.. Rydygier Memorial Hospital, Krakow, Poland
    • Levine, E. L.. The Christie Hospital and Holt Radium Institute, Manchester, UK
    • Marschner, N.. Outpatient Cancer Centre, Freiburg, Germany
    • Maroun, J.. Ottawa Regional Cancer Centre, Ottawa, Canada
    • Garcia-Alfonso, P.. Hospital Gregorio Marañón, Madrid, Spain
    • Tujakowski, J.. Regional Center of Oncology, Bydgoszcz, Poland
    • Van Hazel, G.. The Mount Hospital, Perth, and Sir Charles Gairdner Hospital, Nedlands, Australia
    • Wong, A.. Tom Baker Cancer Centre, Calgary, Canada
    • Zaluski, J.. Great Poland Cancer Center, Poznan, Poland
    • Twelves, C.. Beatson Oncology Centre, Glasgow
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Annals of Oncology, 2003, vol. 14, no. 12, p. 1735-1743. Oxford University Press
    Autre version électronique
    Classification
    • Santé
    Identifiant OAI-PMH
    • oai:doc.rero.ch:290271
    Summary
    Background: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil-leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes' C colon cancer. Patients and methods: Patients aged 18-75 years with resected Dukes' C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m2 twice daily, days 1-14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m2 with i.v. leucovorin 20 mg/m2 on days 1-5, repeated every 28 days (n = 974). Results: Patients receiving capecitabine experienced significantly (P <0.001) less diarrhea, stomatitis, nausea/vomiting, alopecia and neutropenia, but more hand-foot syndrome than those receiving 5-FU/LV. Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia, febrile neutropenia/sepsis and stomatitis (P <0.001), although more experienced grade 3 hand-foot syndrome than those treated with 5-FU/LV (P <0.001). Capecitabine demonstrates a similar, favorable safety profile in patients aged <65 years or ≥65 years old. Conclusions: Based on its improved safety profile, capecitabine has the potential to replace 5-FU/LV as standard adjuvant treatment for patients with colon cancer. Efficacy results are expected to be available in 2004. Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal cancer