吉西他滨、顺铂双路径用药联合125Ⅰ粒子植入治疗Ⅲ期非小细胞肺癌的临床对照研究

目的 探讨吉西他滨、顺铂双路径用药联合125I粒子植入治疗Ⅲ期非小细胞肺癌的价值.方法 60例Ⅲ期非小细胞肺癌患者应用随机数字表法随机分为两组.A组(血管介入组)30例,第1天采用Seldinger法插管进行支气管动脉化疗灌注.用药剂量:吉西他滨1000 mg/m2;顺铂100 mg/m2,第1天灌注时取总量的1/3.余量顺铂于第2天和第3大静脉滴注.第8天吉西他滨1000 mg/m2静脉滴注,21 d为1个疗程.B组(血管介入+125I粒子植入组)30例,双路径用药同A组,于动脉灌注后第10天行局麻下125I粒子植入术,21 d为1个疗程.两组均至少完成2个疗程评价.患者治疗后的影像评价标准为完全缓解(CR)、部分缓解(PR)、稳定(SD)、进展(PD).有效率为(CR+PR)/30,临床获益率为(CR+PR+SD)/30.采用非参数秩和检验比较A、B组的近期疗效(治疗2个疗程),x2检验比较年生存率,Kaplan-Meier法计算中位生存期、log-rank法检验组间中位生存期差异.结果 近期疗效.A组:PR 17例,SD稳定9例,PD 4例,有效率为56.7%(17/30),临床获益率为86.7%(26/30);B组:CR 2例,PR 21例,SD 7例,有效率为76.7%(23/30),临床获益率为100%(30/30).B组效果优于A组,差异有统计学意义(P=0.036).1年生存率B组(76.7%,23/30)高于A组(46.7%,14/30),差异有统计学意义(P=0.017).2年生存率B组(63.3%,19/30)高于A组(36.7%,11/30),差开有统计学意义(P=0.039).B组中位生存期(27个月)高于A组(10个月),组间差异有统计学意义(P=0.006).结论 吉西他滨、顺铂双路径用药联合125I粒子植入治疗Ⅲ期非小细胞肺癌的疗效明显优于单纯同方案双路径用药的疗效.

Abstract：

Objective To assess the therapeutic effect of combination chemotherapy of gemcitabine and cisplatin by double way plus implantation of radioactive seed 125I implantation in treating stage Ⅲ non-small cell lung cancer. Methods Sixty cases with stage Ⅲ non-small cell lung cancer were randomly divided into two groups with random number table. In group A (in interventional treatment group, n = 30),the gemcitabine 1000 mg/m2 and one third of the cisplatin 100 mg/m2 was given using seldinger technique for transcatheter bronchial arterial infusion chemotherapy on day 1. Two-thirds of the cisplatin 100 mg/m2 was infused in veins on day 2 and 3. The gemcitabine 1000 mg/m2 was infused in veins on day 8, 21 days for a period. In group B (interventional - 125I groups), the method of combination chemotherapy of gemcitabine and cisplatin was the same as in Group A. After ten days of arterial perfusion, 125I seeds were implantated, 21 days for a period. All patients received at least 2 cycles. The imaging evaluation of patients after treatment standards included complete remission (CR), partial remission (PR), stable (SD),progressive disease (PD), effective rate (CR + PR)/30 and clinical benefit rate (CR + PR + SD)/30.Non-parametric rank sum test was used to compare short-term effect of the two groups treatment of two cycles.x2 test was used to compare year survival, Kaplan-Meier method was used to calculate median survival,log-rank test method was used to difference between the groups. Results In group A, there were 17 PR,9SD and 4 PD. The overall response rate was 56. 7% (17/30) and clinical beneficial rate was 86. 7% (26/30). In Group B, there were 2 CR, 21 PR, 7 SD. The overall response rate was 76.7% (23/30) and clinical beneficial rate was 100% (30/30). There was significant difference between the two groups (P =0. 036). In group A, the 1 year survival rate was 46. 7% (14/30) and the 2 year survival rate was 36. 7%(11/30), median survival time (MST) was 10 months . In group B, the 1 year survival rate was 76. 7%(23/30) and the 2 year survival rate was 63. 3% (19/30) , median survival time (MST) was 27 months.There was a significant difference between two group in 1 year survival rate (P = 0. 017), 2 year survival rate (P = 0. 039) and median survival time (P = 0. 006). Conclusion The treatment effects of Ⅲ stage non-small cell lung cancer by gemcitabine and cisplatin combination chemotherapy with double way plus radioactive seed 125I implantation was better than gemcitabine and cisplatin combination chemotherapy with double way.