کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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3995439 | 1258940 | 2010 | 7 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study](/preview/png/3995439.png)
SummaryBackgroundPatients 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.MethodsFrom 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/m2 cetuximab on day 1, 1000 mg/m2 gemcitabine on day 1, and 100 mg/m2 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.Findings30 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.InterpretationCetuximab 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.FundingAssociation of Research on the Biology of Liver Tumors, Vienna, Austria.
Journal: - Volume 11, Issue 12, December 2010, Pages 1142–1148