非小细胞肺癌根治术后放射治疗价值的前瞻性研究

A randomized clinical trial of postoperative radiotherapy of the patients with non-small cell lung cancer after radical surgery

目的 评价术后放疗对根治术后N1与N2 非小细胞肺癌的作用。方法 1982年 2月至 1995年12月收治的 36 6例小于 6 5岁的N1与N2 非小细胞肺癌病例 ,随机分为术后放疗组 (n =184)和单纯手术组 (n= 182 )。结果 术后放疗组和单纯手术组 5年生存率分别为 43 .4%± 5 .1%和 40 .5 %± 4.6 % (P =0 .5 6 ) ,5年无瘤生存率分别为 42 .9%± 5 .2 %和 38.3 %± 4.5 % (P =0 .2 8)。T3 4 N1M0 患者在术后放疗组的 5年生存率和5年无瘤生存率分别为 5 8.1%± 15 .5 %和 6 5 %± 12 % ,单纯手术组则分别为 39.9%± 10 .2 % (P =0 .0 92 )和40 %± 10 % (P =0 .0 5 7)。术后放疗可明显减少胸内复发 (P <0 .0 1)。结论 术后放疗可减少局部复发 ,对总的生存改善不明显 ,但对T3 4

Objective To study the value of postoperative radiotherapy of nonsmall cell lung cancer (NSCLC) with lymph node metastasis (N1 to N2) after radical surgery. Methods From February,1982 to December, 1995, three hundred and sixtysix patients with NSCLC with N1 or N2 disease were randomized into postoperative radiation group (S+R) and surgery alone group (S alone). Radiation fields covered the ipsilateral hilum and most part of mediastinum. The midplane dose was 60?Gy/30?fx for 6 weeks. One hundred and thirtyfour patients in S+R and 162 patients in S alone were available for analysis. Clinical data of the two groups were comparable in both arms, except for the numbers of patient with N2 disease. Results The overall 5year survival rates of S+R group and S alone group were 43.4%±5.1% and 40.5%± 4.6% (P= 0.56 ) respectively. The 5year diseasefree survival rates were 42.9%±5.2% in S+R and 38.3%±4.5% in S alone (P= 0.28 ) respectively. The overall 5year survival rate and 5year diseasefree survival rate of patients with T 34 N1M0 disease were 58.1%±15.5% and 65%±12% in S+R group, and 39.9%±10.2%(P=0.092) and 40%±10%(P= 0.057 ) in S alone. There was less locoregional recurrence in S+R than in S alone (P<0.01). Distant metastasis was similar in the two groups. Conclusion Postoperative radiation has a significant impact in decreasing local relapse, but not in overall survival. However, it may be benefit to those patients with advanced local diseases (T 34 ) and early N disease (N1).