Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer.
Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer.
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DOI：
10.1038/sj.bjc.6603334
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发表时间：
2006-10-09
影响因子：
8.8
通讯作者：
Henss, H.
中科院分区：
文献类型：
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作者：
Harder, J.;Riecken, B.;Kummer, O.;Lohrmann, C.;Otto, F.;Usadel, H.;Geissler, M.;Opitz, O.;Henss, H.
本II期研究旨在确定吉西他滨（GEM）和奥沙利铂（OX）化疗方案在不可切除的胆道癌（BTC）患者中的疗效和毒性。患者在第1、8、15天接受GEM 1000 mg m−2（30分钟输注）治疗，在第1和15天接受OX 100 mg m−2（2小时输注）治疗（吉西他滨和奥沙利铂（GEMOX-3方案），每28天重复一次。根据单中心II期研究的Simon 2阶段设计收集数据（α=0.05; β=0.2）。主要终点为缓解率;次要终点为至疾病进展时间（TTP）、中位生存期和安全性。2002年7月至2005年4月期间，31例患者入组本研究。治疗反应如下：8例患者部分反应（26%，95%CI 14-44），14例患者病情稳定（45%，95%CI 29-62），导致疾病控制率为71%。9例患者（29%，95%CI 16-47）出现疾病进展。中位TTP为6.5个月。中位总生存期为11个月。常见毒性标准（CTC）3-4级毒性为一过性血小板减少症（23%）、外周感觉神经病变（19%）、白细胞减少症（16%）和贫血（10%）。总之，GEMOX-3方案在晚期BTC患者中有效且耐受性良好。它可以应用于门诊设置，每月只有三次访问。
This phase II study was conducted to determine the efficacy and toxicity of a gemcitabine (GEM) and oxaliplatin (OX) chemotherapy protocol in patients with unresectable biliary tract cancer (BTC). Patients were treated with GEM 1000 mg m−2 (30 min infusion) on days 1, 8, 15, and OX 100 mg m−2 (2 h infusion) on days 1 and 15 (gemcitabine and oxaliplatin (GEMOX-3 protocol), repeated every 28 days. The data were collected according to the Simon 2-stage design for a single centre phase II study (α=0.05; β=0.2). Primary end point was response rate; secondary end points were time-to-progression (TTP), median survival, and safety profile. Thirty-one patients were enrolled in the study between July 2002 and April 2005. Therapeutic responses were as follows: partial response in eight patients (26%, 95% confidence interval (CI) 14–44), stable disease in 14 patients (45%, 95%CI 29–62), resulting in a disease control rate of 71%. Nine patients (29%, 95%CI 16–47) had progressive disease. Median TTP was 6.5 months. Median overall survival was 11 months. Common Toxicity Criteria (CTC) Grade 3–4 toxicities were transient thrombocytopenia (23%), peripheral sensory neuropathy (19%), leucopenia (16%), and anaemia (10%). In conclusion the GEMOX-3 protocol is active and well tolerated in patients with advanced BTC. It can be applied in an outpatient setting with three visits per month only.
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