Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study.
Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study.
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DOI：
10.1038/sj.bjc.6604628
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发表时间：
2008-09-16
影响因子：
8.8
通讯作者：
Scheithauer, W.
中科院分区：
文献类型：
--
作者：
Andre, T.;Reyes-Vidal, J. M.;Fartoux, L.;Ross, P.;Leslie, M.;Rosmorduc, O.;Clemens, M. R.;Louvet, C.;Perez, N.;Mehmud, F.;Scheithauer, W.
晚期胆道癌（BTC）通常在晚期/转移阶段被诊断，预后不良。吉西他滨和奥沙利铂（GEMOX）的组合在这种情况下显示出有希望的活性。这项国际II期研究评估了GEMOX作为晚期BTCs患者一线治疗的疗效和安全性。符合条件的既往未经治疗的局部晚期或转移性BTC患者接受吉西他滨1000 mg m−2（第1天）和奥沙利铂100 mg m−2（第2天），每2周一次。入组了70例患者; 72.9%患有转移性疾病。67名患者接受了治疗。治疗人群中有10例确认的部分缓解（14.9%; 95%置信区间（CI），7.4-25.7%）（RECIST）。24例患者（35.8%）病情稳定。非胆囊癌患者的客观缓解率为20.5%（9/44例患者），胆囊癌患者为4.3%（1/23例患者）。意向治疗人群的中位总生存期为8.8个月（95% CI，6.9-11.1%），无进展生存期为3.4个月（95% CI，2.5-4.6%）。3/4级毒性包括血小板减少（14.9%的患者）、丙氨酸氨基转移酶升高（13.4%）、贫血（10.4%）、中性粒细胞减少（11.9%）和疼痛（11.9%）。在这项研究中，GEMOX在非胆囊癌中表现出活性，但在胆囊癌中活性较差。GEMOX在晚期BTCs中耐受性良好。
Advanced biliary tract carcinomas (BTCs) are often diagnosed at an advanced/metastatic stage and have a poor prognosis. The combination of gemcitabine and oxaliplatin (GEMOX) has shown promising activity in this setting. This international phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTC received gemcitabine 1000 mg m−2 (day 1) and oxaliplatin 100 mg m−2 (day 2), every 2 weeks. Seventy patients were enroled; 72.9% had metastatic disease. Sixty-seven patients were treated. There were 10 confirmed partial responses (14.9%; 95% confidence interval (CI), 7.4–25.7%) in the treated population (RECIST). Twenty-four patients (35.8 %) had stable disease. The objective response rate was 20.5% in patients with non-gallbladder cancers (9/44 patients) and 4.3% in patients with gallbladder cancers (1/23). Median overall survival for the intent-to-treat population was 8.8 months (95% CI, 6.9–11.1%) and progression-free survival was 3.4 months (95% CI, 2.5–4.6%). Grade 3/4 toxicities included thrombocytopenia (14.9% of patients), alanine aminotransferase elevation (13.4%), anaemia (10.4%), neutropenia (11.9%) and pain (11.9%). In this study, GEMOX demonstrated activity in non-gallbladder carcinoma, but poor activity in gallbladder carcinoma. GEMOX is well tolerated in advanced BTCs.
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