Journal
LANCET ONCOLOGY
Volume 11, Issue 12, Pages 1142-1148Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/S1470-2045(10)70247-3
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Funding
- Roche
- Bayer
- Sandoz
- Sanofi Aventis
- Amgen
- Merck Serono
- Astra Zeneca
- Pfizer
- Association of Research on the Biology of Liver Tumors Vienna Austria
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Background Patients with biliary tract cancer have a poor prognosis and until recently no standard palliative chemotherapy has been defined We aimed to investigate the efficacy and safety of cetuximab in combination with gemcitabine and oxaliplatin (GEMOX) for first line treatment of biliary tract cancer Methods From Oct 1, 2006 to July 26 2008 patients with unresectable locally advanced or metastatic biliary tract cancer were sequentially enrolled and treated at one centre in Austria All patients received intravenous infusions of 500 mg/m(2) cetuximab on day 1 1000 mg/m(2) gemcitabine on day 1 and 100 mg/m(2) oxaliplatin on day 2 every 2 weeks for 12 cycles The primary outcome was overall response rate Analysis was by intention to treat Adverse reactions were assessed according to National Cancer Institute Common Toxicity Criteria The study is completed and registered with ClinicalTrials gov number NCT01216345 Findings 30 patients with median age of 68 years (IQR 62-73) were enrolled and included in the analysis Objective response occurred in 19 patients (63%, 95% CI 56 2-69 8) of whom three (10%, 3 2-16 8) achieved complete response and 16 (53% 46 2-59 8) achieved partial response Nine patients underwent potentially curative secondary resection after major response to therapy Grade 3 adverse events were recorded in 13 patients skin rash (n=4), peripheral neuropathy (n=4), thrombocytopenia (n=3), nausea (n=1) diarrhoea (n=1) and neutropenia (n=1) no grade 4 adverse events were recorded Interpretation Cetuximab plus GEMOX was well tolerated and had encouraging antitumour activity leading to secondary resection in a third of patients These findings warrant further study of cetuximab plus GEMOX in a large randomised trial
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