Harder J, Riecken B, Kummer O, Lohrmann C, Otto F, Usadel H, Geissler M, Opitz O, Henss H
Department of Gastroenterology and Hepatology, Freiburg University Hospital, Hugstetterstr. 55, Freiburg D-79106, Germany.
Br J Cancer. 2006 Oct 9;95(7):848-52. doi: 10.1038/sj.bjc.6603334. Epub 2006 Sep 12.
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 (alpha=0.05; beta=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.
本II期研究旨在确定吉西他滨（GEM）联合奥沙利铂（OX）化疗方案治疗不可切除胆管癌（BTC）患者的疗效和毒性。患者在第1、8、15天接受GEM 1000 mg/m²（输注30分钟），并在第1天和第15天接受OX 100 mg/m²（输注2小时）（吉西他滨联合奥沙利铂（GEMOX-3方案），每28天重复一次。数据根据单中心II期研究的Simon两阶段设计收集（α=0.05；β=0.2）。主要终点为缓解率；次要终点为疾病进展时间（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例患者部分缓解（26%，95%置信区间（CI）14-44），14例患者疾病稳定（45%，95%CI 29-62），疾病控制率为71%。9例患者（29%，95%CI 16-47）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级毒性为短暂性血小板减少（23%）、周围感觉神经病变（19%）、白细胞减少（16%）和贫血（10%）。总之，GEMOX-3方案对晚期BTC患者有效且耐受性良好。它每月只需三次门诊就诊即可在门诊环境中应用。
