食管癌同期放化疗中奈达铂剂量递增临床Ⅰ期试验  

A Phase Ⅰ Clinical Trial of Dose Escalation of Nedaplatin in Concurrent Chemoradiotherapy for Patients with Esophageal Carcinoma

作　　者：王玉斌[1] 徐莹玲[1] 陈文俊[1] 周绪堂[1] 王建化[1] 林玉成[1] 李芙瑶[1] 郑维锷[1] 张武[1] 

机构地区：[1]温州医学院附属第三医院,浙江瑞安325200

出　　处：《肿瘤学杂志》2011年第8期595-598,共4页Journal of Chinese Oncology

基　　金：温州市卫生局课题(温卫2008093)

摘　　要：[目的]探讨在食管癌同期放化疗中多西紫杉醇固定周剂量时奈达铂(NDP)的周最大耐受剂量(MTD),并观察其不良反应。[方法]共入选20例初治食管鳞癌患者,采用三维适形放疗方法,DT:60～64Gy/30～32f,42～44d,同步化疗方案固定多西紫杉醇剂量20mg/w,共6w,NDP采用周剂量递增方法,起始剂量12mg/m2,递增剂量为6 mg/m2。剂量限制性毒性(DLT)定义为≥3级不良反应,出现DLT的前一剂量即为MTD。[结果]NDP 24mg/m2剂量水平时共有2例患者发生3～4级的DLT;NDP 18mg/m2、多西紫杉醇20mg即为MTD。主要不良反应为放射性食管炎、放射性肺炎、乏力和骨髓抑制。[结论]食管癌同步放化疗中固定多西紫杉醇20mg每周剂量时奈达铂每周最大耐受剂量为 18mg/m2。[Purpose] To investigate the weekly maximum-tolerated dose（MTD） of nedaplatin when combined with weekly docetaxel fixed dose in concurrent chemoradiotherapy for esophageal carcinoma,and its toxicity.[Methods] Twenty initial treatment cases with esophageal squamous cell carcinoma were enrolled in this study.All patients received 3-dimensional conformal radiation therapy,the total radiation dose was 60～64Gy/30～32f for 42～44 days.Concurrent chemotherapy was implemented by dose-escalating.The starting dose of nedaplatin was 12mg/m2 and docetaxel was 20mg,this regimen was repeated every week with the escalating doses of nedaplatin 6mg/m2.Dose-limiting toxicity（DLT） was defined as ≥grade 3 toxicity.MTD was defined as last one dose level before induced DLT.[Results] The DLT defined as grade 3 or 4 was found in 2 patients at the level of nedaplatin 24mg/m2,MTD of nedaplatin was 18mg/m2.The main toxicity was radiation esophagitis,radiation pneumonitis,hypodynamia and myelosuppression.[Conclusion] Weekly maximum tolerated dose of nedaplatin is 18mg/m2 when combined with docetaxel fixed 20mg per week in concurrent chemoradiotherapy for patients with esophageal carcinoma.

关 键 词：食管肿瘤 放射疗法 药物疗法 奈达铂 剂量递增 

分 类 号：R735.1[医药卫生—肿瘤]