奈达铂同步放化疗治疗老年食管癌的疗效观察

摘要

目的 探讨奈达铂同步放化疗治疗老年食管癌的疗效.方法 以年龄65岁以上的食管癌患者为研究对象.第一阶段临床试验(12例)为剂量递增试验,奈达铂剂量20、25、30 mg/m2逐渐递增(每个剂量至少4例/量),30 mg/m2后不再增加剂量.依据第一阶段临床试验所得出的最大耐受剂量(30 mg/m2)进行第二阶段临床试验(31例).入组的62例患者按随机数字表法分为放化组和单放组,各31例.食管局部放疗采用6MVX线三维适形放疗,肿瘤吸收剂量(DT) 60 ～ 64 Gy.观察其近期疗效、不良反应及远期疗效.结果 第一阶段临床试验剂量递增至奈达铂30 mg/m2未出现限制性不良反应.第二阶段临床试验中22例患者完成6周期化疗,26例完成5周期化疗,29例完成4周期化疗,31例完成3周期化疗.患者均完成了DT 60～ 64 Gy放疗.放化组与单放组完全缓解率分别为64.5％ (20/31)、38.7％(12/31),差异有统计学意义(P＜0.05).放化组与单放组的1、2、3年生存率分别为74.0％ (23/31)、62.4％(19/31)、38.2％(12/31)和64.5％ (20/31)、34.5％(11/31) 、18.6％ (6/31),总生存率Log-rank检查差异有统计学意义(x2=4.675,P =0.031).结论 应用单药奈达铂同步放疗治疗老年食管癌,大多数患者能耐受30 mg/m2的同期化疗剂量,对体弱耐受性差的患者可适当减量,放疗同期使用奈达铂有放疗增敏作用.%Objective To discuss the effect of weekly nedaplatin in aged patients with esophageal cancer.Methods Esophageal cancer patients older than 65 were eligible for the study.Phase Ⅰ study was dose-escalation trial with 12 patients.All patients received radiotherapy with three dimentional conformal radiotherapy technique.Concurrent nedaplatin started from the dose of 20 mg/m2 to 25 mg/m2,30 mg/m2 for the weekly schedule (≥4 patients per dose group),and the doses were steadily escalated to 30 mg/m2.According to the appropriate dose from phase Ⅰ study,we conduced phase Ⅱ clinical trial with 31 patients.Results In phase Ⅰ study,nedaplatin dose was escalated to 30 mg/m2 and DLT had not been reached.In phase Ⅱ study,22 patients completed 6 cycles of chemotherapy,26 patients completed 5 cycles and 29 patients completed 4 cycles.All patients completed radiotherapy.Complete remission rate in chemotherapy and radiotherapy group and simply radiotherapy group was 64.5％ (20/31) and 38.7％ (12/31) (P ＜0.05).1,2,3 year survival rates in chemotherapy,radiotherapy group and simply radiotherapy group were 74.0％ (23/31),62.4％ (19/31),38.2％ (12/31) and 64.5％ (20/31),34.5％(11/31),18.6％ (6/31),overall survival rate of Log-rank was statistically significant (x2 =4.675,P =0.031).Conclusions Weekly 30 mg/m2 nedaplatin concurrent with radiotherapy is well tolerated when given to aged patients with esophageal cancer.For patients with poor performance status,the nedaplatin dose needs to be reduced.