奈达铂同步放化疗治疗老年食管癌的疗效观察  

Observation of concurrent nedaplatin chemotherapy in aged patients with esophageal cancer

作　　者：朱琪伟[1] 黄灿红[1] 万志龙[1] 蔡晶[1] 

机构地区：[1]江苏省南通市肿瘤医院放疗科,226361

出　　处：《中国医药》2013年第5期643-645,共3页China Medicine

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、30mg／m2逐渐递增（每个剂量至少4例／量），30mg/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（30mg/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）60～64Gy。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30mg/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DT60—64Gy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30mg/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 pa- tients 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 cycies of chemo- therapy, 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 pa- tients with esophageal cancer. For patients with poor performance status, the nedaplatin dose needs to be reduced.

关 键 词：食管癌 奈达铂 同步放化疗 老年患者 

分 类 号：R735.1[医药卫生—肿瘤]