Lancet. 1998 Jul 25;352(9124):257-63.
The role of postoperative radiotherapy in treatment of patients with completely resected non-small-cell lung cancer (NSCLC) remains unclear. We undertook a systematic review and meta-analysis of the available evidence from randomised trials.
Updated data were obtained on individual patients from all available randomised trials of postoperative radiotherapy versus surgery alone. Data on 2128 patients from nine randomised trials (published and unpublished) were analysed by intention to treat. There were 707 deaths among 1056 patients assigned postoperative radiotherapy and 661 among 1072 assigned surgery alone. Median follow-up was 3.9 years (2.3-9.8 for individual trials) for surviving patients.
The results show a significant adverse effect of postoperative radiotherapy on survival (hazard ratio 1.21 [95% CI 1.08-1.34]). This 21% relative increase in the risk of death is equivalent to an absolute detriment of 7% (3-11) at 2 years, reducing overall survival from 55% to 48%. Subgroup analyses suggest that this adverse effect was greatest for patients with stage I/II, N0-N1 disease, whereas for those with stage III, N2 disease there was no clear evidence of an adverse effect.
Postoperative radiotherapy is detrimental to patients with early-stage completely resected NSCLC and should not be used routinely for such patients. The role of postoperative radiotherapy in the treatment of N2 tumours is not clear and may warrant further research.
术后放疗在完全切除的非小细胞肺癌(NSCLC)患者治疗中的作用仍不明确。我们对随机试验的现有证据进行了系统评价和荟萃分析。
从所有可用的术后放疗与单纯手术的随机试验中获取个体患者的更新数据。对来自9项随机试验(已发表和未发表)的2128例患者的数据进行意向性分析。接受术后放疗的1056例患者中有707例死亡,单纯接受手术的1072例患者中有661例死亡。存活患者的中位随访时间为3.9年(各试验为2.3 - 9.8年)。
结果显示术后放疗对生存有显著不良影响(风险比1.21 [95%可信区间1.08 - 1.34])。死亡风险相对增加21%相当于2年时绝对损害7%(3% - 11%),使总生存率从55%降至48%。亚组分析表明,这种不良影响在Ⅰ/Ⅱ期、N0 - N1疾病的患者中最大,而对于Ⅲ期、N2疾病的患者,没有明确的不良影响证据。
术后放疗对早期完全切除的NSCLC患者有害,不应常规用于此类患者。术后放疗在N2肿瘤治疗中的作用尚不清楚,可能需要进一步研究。