日本临床肿瘤研究组肺癌外科系列研究之回顾与解读

JCOG lung cancer surgery trial series: review and interpretation

手术切除是目前治疗早期非小细胞肺癌(NSCLC)最有效的方式。20世纪90年代以来,由于越来越多的磨玻璃结节(GGO)被检出,早期肺癌的病理学类型逐渐发生转变。术前薄层CT可以较好地预测GGO的恶性程度与淋巴结转移,对影像学预测的低度恶性结节可以进行安全的局限性切除,这使得肺叶切除术的地位受到了质疑。JCOG0201研究确定了肺腺癌的放射学非侵袭性标准以后,日本临床肿瘤研究组(JCOG)及西日本肿瘤研究组(WJOG)陆续开展了一系列前瞻性的影像学指导研究,以探讨早期肺癌的最佳手术方式。JCOG0804是一项单臂、非随机、验证性试验,评估亚肺叶切除(楔形切除术和肺段切除术)在GGO为主型周围型肺癌中的有效性及安全性,研究的主要终点是5年无复发生存率。JCOG0802/WJOG4607L是一项多中心、开放标签、Ⅲ期、随机、对照、非劣效性研究,主要研究肺段切除术与肺叶切除术对小周围型NSCLC的非劣效性,研究的主要终点是5年总生存率。JCOG1211也是一项非随机验证性研究,验证肺段切除术在临床T1N0期GGO为主型肺癌中的有效性,研究的主要终点是5年无复发生存率。JCOG0804和JCOG0802的研究结果已经正式发表,JCOG1211的主要分析结果也已经公布,文章系统回顾并解读了JCOG肺癌外科系列研究结果。

Surgery is so far the most effective treatment for early-stage non-small cell lung cancer(NSCLC).Since the 1990s,the pathology spectrum of early-stage lung cancer has gradually changed because of the increased detection of ground-glass opacity(GGO).The findings from preoperative thin-section computed tomography are strong predictors for the invasiveness and lymph node involvement of GGO,and limited surgery is believed to be implemented safely for radiological less invasive lesions,which calls into question the dominance of lobectomy.After the JCOG0201 trial establishing the radiologic criteria of pathological noninvasiveness for lung adenocarcinoma,the Japan Clinical Oncology Group(JCOG)and the West Japan Oncology Group(WJOG)have successively carried out a series of prospective imaging-guided trials to investigate the optimal surgical procedure for early-stage lung cancer.JCOG0804,was a single-arm,non-randomized,confirmatory trial to evaluate the efficacy and safety of sublobar resection(wedge resection and segmentectomy)for GGO dominant peripheral lung cancer.The primary end point was 5-year relapse-free survival.JCOG0802/WJOG4607L,was a multicentre,open-label,phase 3,randomized,controlled,non-inferiority trial to investigate if segmentectomy was non-inferior to lobectomy in patients with small-sized peripheral NSCLC.The primary endpoint was 5-year overall survival.JCOG1211 was also a non-randomized confirmatory trial to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant GGO.The primary endpoint was 5-year relapse-free survival.The findings of JCOG0804 and JCOG0802,and the primary analysis results of JCOG1211 have been officially published.This article systematically reviewed and interpreted the results of the JCOG lung cancer surgery trial series.