非小细胞肺癌放化综合治疗的前瞻性随机研究

A randomized prospective study on combined chemoradiotherapy for non-small cell lung cancer

目的 对比观察非小细胞肺癌单纯放疗和放化综合治疗的疗效。方法 从 1995年 1月到 1997年 12月 ,将符合入组条件的 82例非小细胞肺癌患者随机分为放疗组和化放疗综合治疗组。其中完成治疗计划的有 74例 ,35例属单纯放疗组 ,39例属化放疗综合治疗组。综合治疗组中 2 1例为增敏化疗 (氟脲嘧啶、顺铂 ) ,在放疗的第 1、4周给药 ;18例为联合方案化疗 ,在放疗前、中、后进行 ,最少两周期 ,药物为卡铂、顺铂、足叶乙甙、异环磷酰胺、环磷酰胺等。结果 近期完全缓解率在单放组为 2 3 % (8/35 ) ,放化组为 41% (16 /39)。单放组与综合治疗组的 1、2、3年生存率分别为 48%、2 7%、18%与 6 5 %、39%、19% ,中位生存期分别为 11个月和 18.9个月 ,各组差异均无显著性 (P >0 .0 5 )。单纯组与综合治疗组Ⅲ期病例的 1、2、3年生存率分别为42 %、2 5 %、13 %与 6 7%、38%、2 1% ,各组间比较差异均有显著性 (P <0 .0 5 )。增敏组与联合化疗方案组的 1、2、3年生存率分别为 5 8%、38%、2 6 %和 72 %、36 %、12 % ,各组间比较均无显著性差异 (P >0 .0 5 )。结论 放化综合治疗可以显著提高Ⅲ期非小细胞肺癌的 1、2、3年生存率 。

Objective To observe and compare the effect of radiation alone and combined chemoradiation for nonsmall cell lung cancer. Methods From January, 1995 to December, 1997, 82 eligible patients with nonsmall cell lung cancer were randomized into two groups and 74 of them could be evaluated: radiation group (35 cases) and combined group (39 cases). In the combined group, 21 cases received sensibilization chemotherapy (fluoracil and cisplatin were administered in the first and fourth week of radiation) and 18 cases received combined chemotherapy regimen (carboplatin and cisplatin, etoposide, ifosphamide, cyclophosphamide and so on, were administered before, during or after radiation for at least two courses). Results The complete response was 23% (8/35) in the radiation group and 41% (16/39) in the combined group. The 1 , 2 and 3 year survival rates in the radiation group and combined group were 48% and 65%, 27% and 38%, 18% and 19% respectively (P>0.05); the median survival time was 11 months and 18.9 months respectively. For stage Ⅲ patients, the 1 , 2 and 3 year survival rates were 42% and 67%, 25% and 38%, 13% and 21% respectively in the radiation group and combined group (P<0.05), and 58% and 72%, 38% and 36%, 26% and 12% respectively in the sensibilization chemotherapy group and combined chemotherapy regimen group (P>0.05). Conclusion Combined chemoradiation therapy can strikingly increase the 1, 2 and 3year survival rate for stage Ⅲ patients with nonsmall cell lung cancer, and the survival rate for sensibilization chemotherapy and combined chmotherapy regimen needs more observation on enough cases.