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• W2282034756 abstract "15010 Background: At present, there are limited data available for the use of cetuximab in combination with Oxaliplatin and Capecitabine, in the first line treatment of metastatic colorectal cancer. This study aimed to determine the efficacy and safety of the combination Xelox and Cetuximab in this setting. Methods: Patients received intravenous Oxaliplatin 130mg/m2 (3h-day 1) plus oral Capecitabine 1,000mg/m2 twice daily (days 1–14) every 3 weeks (Xelox) and intravenous Cetuximab 400mg/m2 in week 1 followed by weekly doses of 250mg/m2. Treatment was continued until disease progression, intolerable toxicities or 8 cycles were reached. This study aimed to include 45 patients to obtain a 95%CI for the overall response rate (ORR-primary endpoint) with a maximum width of 15% assuming an ORR of 50–80%. Patients will be followed until death. Results: The ITT population of 49 patients was enrolled between September 2005 and January 2007. Mean age was 60 years (range:44–75 years) and 66% of patients were male. The ECOG performance status was zero in 56.2% of the patients and 72.9% of the patients had distant metastasis. 31 patients were evaluable for response in cycle 5. One patient (3.2%) achieved a CR, 17 (54.8%) had PR, 9 (29.0%) had SD, 2 (6.5%) had PD and 2 (6.5%) were non- evaluable. The ORR was 58% (95%CI:40.6%-75.4%) and the TTP was 12 months (95%CI:9.2–14.8 months). Survival and quality of life data will be available soon. 48 patients were evaluable for toxicity. 11.5% of the adverse events (AEs) were grade 3/4. 77.1% of the patients had skin rash but only 8.3% had grade 3/4. Other grade 3/4 toxicities included diarrhea (n=7;14.6%), changes in potassium (n=6;12.5%), fatigue (n=2;4.2%) and thrombosis (n=1;2.1%). 2.7% of the AEs led to dose reduction, 7.3% to dose delay and 0.3% to infusion rate reduction. 25 (52.1%) patients were discontinued: 8 (16.7%) due to AEs, 7 (14.6%) due to PD and 10 (20.8%) due to other reasons. Conclusions: Preliminary results show that an overall response was achieved in nearly 60% of the patients treated with the combination of Xelox and Cetuximab.In addition, this combination appears to be a well tolerated regimen. No significant financial relationships to disclose." @default.
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• W2282034756 date "2008-05-20" @default.
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• W2282034756 title "Preliminary results of an open label, uncontrolled, multicenter, phase II study evaluating the efficacy and safety of xelox plus cetuximab as first-line therapy in patients with metastatic colorectal cancer" @default.
• W2282034756 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.15010" @default.
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