食管癌同步放化疗奈达铂加氟脲苷方案剂量递增试验  

Dose escalation of nedaplatin combined with floxuridine in concurrent chemoradiotherapy for esophageal carcinoma

作　　者：洪金省[1] 张纬建[1] 柯春林[1] 蔡传书[1] 何清[1] 董锋[1] 

机构地区：[1]福建医科大学附属第一医院放疗科,福州350005

出　　处：《中国新药杂志》2008年第24期2137-2140,共4页Chinese Journal of New Drugs

基　　金：福建省自然科学基金资助项目(X0750028);福建省卫生厅青年基金资助项目(2006-1-9)

摘　　要：目的:探讨奈达铂(NDP)加氟脲苷(FUDR)方案应用于食管癌同步放化疗时的最大耐受剂量(MTD)并观察其毒副反应。方法:共入选13例初治食管鳞癌患者。放射治疗采用常规分割方法,照射剂量为60Gy/30次,6周。同步化疗采用剂量递增方法,起始剂量为NDP 20 mg.m-2,FUDR 300 mg.m-2,d 1用药,以后每周用药1次,共6次。递增剂量为NDP 5 mg.m-2,FUDR 50 mg.m-2。DLT定义为3级或3级以上毒性反应。每剂量组至少5例,如无剂量限制毒性(DLT)出现则进入下一剂量组,直到出现DLT。出现DLT的前一剂量即为MTD。结果:DLT为3级放射性食管炎,发生于NDP 30 mg.m-2,FUDR 400 mg.m-2剂量水平,共有2例患者发生;其前一剂量水平NDP 25 mg.m-2,FUDR 350 mg.m-2即为MTD。主要毒性反应为放射性食管炎、放射性肺炎、厌食、呕吐、白细胞减少、血小板下降和肝功能损害。结论:食管癌同步放化疗奈达铂加氟脲苷每周方案的最大耐受量为NDP 25 mg.m-2,FUDR 350 mg.m-2。Objective：To explore the maximum-tolerated dose （MTD）, and to observe the side effects of escalating nedaplatin combined with floxuridine in concurrent chemoradiotherapy for esophageal squamous cell carcinoma. Methods：Thirteen untreated patients with esophageal carcinoma received conventional fractionation radiotherapy were enrolled in this study. The total radiation dose was 60Gy/30 fractionations for six weeks. Concurrent ehemotherapy was implemented by dose-esealating. The starting dose was nedaplatin 20 mg· m^-2 and floxuridine 300 mg· m^-2 on day 1. This regimen was repeated every week with the escalating doses of nedaplatin 5 mg· m^-2 and floxuridine 50 mg· m^-2 Each group contained at least 5 patients. Dose-limiting toxicity （DLT） was defined as grade 3 or greater side effects. If no DLT was observed, the next dose level was administered; these courses were repeated until DLT appeared. MTD was defined as one dose level below that induced DLT. Results：The radiationinduced esophagitis with DLT defined as grade 3 was found in 2 patients at the level of nedaplatin 30 mg· m^-2 and floxuridine 400 mg· m^-2 MTD of nedaplatin was 25 mg· m^-2 and that of floxuridine was 350 mg· m^-2. The major side effects were radiation-induced esophagitis, radiation-induced pneumonitis, anorexia, vomiting, leucopenia, thrombopenia and liver function impairment. Conclusion： Maximum tolerated dose of weekly nedaplatin combined with floxuridine are nedaplatin 25 mg· m^-2 and floxuridine 350 mg· m^-2 in concurrent chemoradiotherapy in the patients with esophageal carcinoma.

关 键 词：食管肿瘤/放射疗法 食管肿瘤/化学疗法 同步放化疗 剂量递增 

分 类 号：R735.1[医药卫生—肿瘤]