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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
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
ID
1194670
Author(s)
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; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland
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
Journal
Annals of oncology
Volume
19
Number
7
Pages / Article-Number
1288-92
Keywords
capecitabine, cetuximab, metastatic colorectal cancer, oxaliplatin, randomized phase II
Abstract
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/m(2) on day 1 and capecitabine 1000 mg/m(2) 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.
