Berghmans T, Paesmans M, Meert A P, Mascaux C, Lothaire P, Lafitte J J, Sculier J P
Department of Intensive Care and Thoracic Oncology, Institut Jules Bordet, Rue Héger-Bordet, 1 - 1000 Bruxelles, Belgium.
Lung Cancer. 2005 Jul;49(1):13-23. doi: 10.1016/j.lungcan.2005.01.002.
The recent publication of many randomised trials about (neo)adjuvant chemotherapy in resectable non-small cell lung cancer (NSCLC) has prompted our group to update a prior meta-analysis of the literature. Randomised studies published in French and English between 1965 and June 2004 were included in this analysis. A qualitative assessment of each trial was first performed using the European lung cancer working party (ELCWP) and the Chalmers' scales. In absence of statistically significant quality difference between positive and negative trials, a quantitative aggregation (meta-analysis) of the individual results was performed. Two trials for which data were available on ASCO virtual meeting website were also included in the meta-analysis. Twenty-five studies eligible for this analysis assessed chemotherapy as induction (n = 6) or adjuvant to surgery (n = 19). No quality difference was detected between positive and negative trials according to the two scores, whatever all trials were combined or only adjuvant chemotherapy studies were considered. The overall meta-analysis showed that the hazard ratio (HR) of the combined results was 0.66 (95% CI 0.48-0.93) in favour of the addition of induction chemotherapy to a standard surgical procedure and 0.84 (95% CI 0.78-0.89) in favour of adjuvant chemotherapy. The effect was significant for adjuvant chemotherapy in stages I and II with a HR of 0.88 (95% CI 0.83-0.94). It was not statistically significant in stage III although the trend was in favour of chemotherapy whatever adjuvant (HR = 0.85; 95% CI 0.69-1.04) or (neo)adjuvant (HR = 0.65; 95% CI 0.41-1.04) chemotherapy was tested. In conclusion, our meta-analysis shows the efficacy of adjuvant chemotherapy in stages I and II resected NSCLC. More data are needed to confirm such a role for induction chemotherapy. Further trials should separate stage III disease from earlier stages.
近期发表了许多关于可切除非小细胞肺癌(NSCLC)新辅助化疗的随机试验,促使我们团队更新之前对相关文献的荟萃分析。本分析纳入了1965年至2004年6月间以法语和英语发表的随机研究。首先使用欧洲肺癌工作组(ELCWP)和查尔默斯量表对每个试验进行定性评估。由于阳性和阴性试验之间在统计学上无显著质量差异,因此对个体结果进行了定量汇总(荟萃分析)。荟萃分析还纳入了两项可在ASCO虚拟会议网站上获取数据的试验。25项符合本分析条件的研究评估了化疗作为诱导治疗(n = 6)或手术辅助治疗(n = 19)的情况。根据这两个评分,无论所有试验合并分析还是仅考虑辅助化疗研究,阳性和阴性试验之间均未检测到质量差异。总体荟萃分析显示,综合结果的风险比(HR)为0.66(95%可信区间0.48 - 0.93),支持在标准手术程序中加用诱导化疗;HR为0.84(95%可信区间0.78 - 0.89),支持辅助化疗。辅助化疗在Ⅰ期和Ⅱ期的效果显著,HR为0.88(95%可信区间0.83 - 0.94)。Ⅲ期虽无统计学意义,但无论检测辅助化疗(HR = 0.85;95%可信区间0.69 - 1.04)还是新辅助化疗(HR = 0.65;95%可信区间0.41 - 1.04),趋势均支持化疗。总之,我们的荟萃分析显示辅助化疗对Ⅰ期和Ⅱ期切除的NSCLC有效。需要更多数据来证实诱导化疗的这种作用。进一步的试验应将Ⅲ期疾病与早期疾病区分开来。