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Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK

Borner, M. ; Koeberle, D. ; Von Moos, R. ; Saletti, P. ; Rauch, D. ; Hess, V. ; Trojan, A. ; Helbling, D. ; Pestalozzi, B. ; Caspar, C. ; Ruhstaller, T. ; Roth, A. ; Kappeler, A. ; Dietrich, D. ; Lanz, D. ; Mingrone, W.

In: Annals of Oncology, 2008, vol. 19, no. 7, p. 1288-1292

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    Titre
    • Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK
    Auteur
    • Borner, M.. *Correspondence to: Prof M. Borner, Institute of Medical Oncology, Inselspital, 3010 Bern, Switzerland. Tel: 0041 632 84 42; Fax: 0041 632 41 19
    • Koeberle, D.
    • Von Moos, R.
    • Saletti, P.
    • Rauch, D.
    • Hess, V.
    • Trojan, A.
    • Helbling, D.
    • Pestalozzi, B.
    • Caspar, C.
    • Ruhstaller, T.
    • Roth, A.
    • Kappeler, A.
    • Dietrich, D.
    • Lanz, D.
    • Mingrone, W.
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Annals of Oncology, 2008, vol. 19, no. 7, p. 1288-1292. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:302721
    Summary
    Background: To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC). Patients and methods: In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles. Results: Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B. Conclusion: Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials