表柔比星—顺铂—雷替曲塞联合化疗在晚期食管癌和胃癌患者中的II期研究.doc

A phase II study of epirubicin, cisplatin and raltitrexed combination chemotherapy (ECT) in patients with advanced oesophageal and gastric adenocarcinoma 表柔比星—顺铂—雷替曲塞联合化疗方案在晚期食管癌和胃癌患者中的II期研究 H. J. Mackay,1 A. Mclnnes,1 J. Paul,1 N. Raby,2 F. J. Lofts,3 A. C. McDonald,1 M. Soukop,4 G. M. Fullarton,5 A. L. Harris,6 J. Garcia-Vargas7 T. R. J. Evans1 Summary 摘要： Background: The aim of this study was to evaluate the efficacy of the combination of epirubicin, cisplatin and ralitrexed (Tomudex), ECT, in patients with advanced oesophageal or gastric adenocarcinoma. Efficacy was assessed primarily as response rate and secondarily in terms of toxicity, time to progression and survival. 背景：本项研究的目的在于评估表柔比星、顺铂、雷替曲塞联合化疗方案(ECT)在晚期食管癌和胃癌治疗中的疗效。疗效的评估主要基于反应率、继发毒性、疾病进展和生存时间的检测。 Patients and methods. Twenty-one patients with histologically and/or cytologically proven unresectable (7) or metastatic (14) gastro-oesophageal adenocarcinoma, who had bi-dimensionally measurable disease, with ECOG performance status s￡ 2, with adequate haematological, hepatic and renal function received first-line chemotherapy with epirubicin (50 mg/m), cisplatin (60 mg/m2) and Tomudex (2.5 mg/m2), ECT, at three-weekly intervals. Treatment consisted of three cycles of chemotherapy, with a further three cycles if there was disease response or stabilisation. 患者与方法：试验所涉及的21例患者都有病理学和/或细胞学证实的晚期（7例）或转移性（14例）胃食管腺癌，他们都有二维可测量的病变，ECOG评分≦2，并且都有充足的血液、肝、和肾功能以接受表柔比星（50mg/m2）、顺铂（60mg/m2）和雷替曲塞（2.5mg/m2）（ECT方案）一线化疗，治疗的时间间隔为3周。治疗过程包括3个周期的化疗，如果出现疾病应答或病情稳定，则再进行3个周期的治疗。 Results: ECT is an active regimen in the treatment of advanced gastro-oesophageal adenocarcinoma with an overall intention-to-treat response rate of 29% (95% confidence intervals (CI): ll%-52%). In addition, 4 (19%) patients had stable disease. Median time to progression was 19 weeks (95% CI: 7-31 weeks). Median overall survival was 18 weeks (95% CI: 11-24 weeks). Seventeen patients failed to complete the six cycles of treatment due to disease progression (5), t