

Other version: http://annonc.oxfordjournals.org/cgi/content/full/19/7/1288
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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 |
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Published in | Annals of Oncology. 2008, vol. 19, no. 7, p. 1288-92 | |
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. | |
Keywords | Aged — Aged, 80 and over — Antibodies, Monoclonal/administration & dosage/adverse effects — Antineoplastic Agents/administration & dosage/adverse effects — Antineoplastic Combined Chemotherapy Protocols/therapeutic use — Colorectal Neoplasms/drug therapy/pathology/radiography — Drug Administration Schedule — Exanthema/chemically induced — Female — Follow-Up Studies — Humans — Male — Middle Aged — Neoplasm Metastasis/drug therapy/pathology/radiography — Organoplatinum Compounds/administration & dosage/adverse effects — Switzerland — Time Factors — Treatment Outcome | |
Identifiers | PMID: 18349029 | |
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![]() ![]() Other version: http://annonc.oxfordjournals.org/cgi/content/full/19/7/1288 |
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Research groups | Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland Groupe Roth Arnaud (oncologie) (285) | |
Citation (ISO format) | BORNER, M. et al. 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. In: Annals of Oncology, 2008, vol. 19, n° 7, p. 1288-92. doi: 10.1093/annonc/mdn058 https://archive-ouverte.unige.ch/unige:3410 |