Cetuximab, gemcitabine and capecitabine in patients with inoperable biliary tract cancer: A phase 2 study
Cetuximab, gemcitabine and capecitabine in patients with inoperable biliary tract cancer: A phase 2 study
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DOI：
10.1016/j.ejca.2013.07.143
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发表时间：
2013-12-01
影响因子：
8.4
通讯作者：
Hitre, E.
中科院分区：
文献类型：
--
作者：
Rubovszky, G.;Lang, I.;Hitre, E.
目的：胆道癌是一种罕见的疾病，预后不佳。化疗在无法手术的疾病中有其作用，但靶向药物如西妥昔单抗的作用仍有待确定。在胆道癌表皮生长因子受体高表达的基础上，本研究旨在观察西妥昔单抗、吉西他滨和卡培他滨在探索性2期试验中的疗效。患者和方法：不能手术的胆道癌患者应用吉西他滨(1000 mg/m(2)，第1天和第8天)联合治疗，卡培他滨1300 mg/m(2)/d，第1~14天；西妥昔单抗400 mg/m(2)负荷，250 mg/m(2)维持量，21 d为一个周期。结果：34例患者(平均59.7岁)中，16例为肝内胆管细胞癌，8例为肝外胆管细胞癌，10例为胆囊癌。总有效率17.6%(2例完全缓解，4例部分缓解)，临床受益率为76.5%。中位随访15.4个月，中位无进展生存期为34.3周，中位总生存期为62.8周。表现状态和化疗疗效是独立的、显著的生存指标。在这项研究中只记录到了轻微的副作用。结论：西妥昔单抗、吉西他滨和卡培他滨联合治疗不能手术的胆道癌疗效令人鼓舞，耐受性良好。(C)2013爱思唯尔有限公司。保留所有权利。
Purpose: Biliary tract cancer is rare and has dismal prognosis. Chemotherapy has its role in inoperable disease but the role of targeted agents like cetuximab remains to be defined. On the basis of high epidermal growth factor receptor expression of biliary tract cancers this study aims to investigate the efficacy of cetuximab, gemcitabine and capecitabine in an exploratory phase 2 trial.Patients and methods: Inoperable biliary tract cancer patients were treated with the combination of gemcitabine (1000 mg/m(2) on day 1 and 8), capecitabine (1300 mg/m(2)/d on day 1-14) and weekly cetuximab (400 mg/m(2) loading and 250 mg/m(2) maintenance dose) in 21-d cycles until progression or the appearance of intolerable side-effects.Results: Out of 34 patients (mean age 59.7 years) accrued in this study 16 had intrahepatic, eight extrahepatic cholangiocarcinoma and 10 gall bladder cancer. The best overall response rate was 17.6% (two complete responses and four partial responses) and the clinical benefit rate was 76.5%. After a median of 15.4 months follow-up the median progression free survival was 34.3 weeks and the median overall survival was 62.8 weeks. The performance status and chemotherapy efficacy were independent and significant markers of survival. Only moderate side-effects were registered in this study. KRAS mutation was evaluable in 24 tumours, all of these were of wild type.Conclusion: The efficacy of cetuximab, gemcitabine and capecitabine combination is encouraging and a well tolerated treatment of inoperable biliary tract cancers. (C) 2013 Elsevier Ltd. All rights reserved.