Wu Yi long, Huang Zhi-fan, Wang Si-yu, Yang Xue-ning, Ou Wei
Lung Cancer Research Center, 3rd University Hospital, Sun Yat-sen University of Medical Sciences, Guangzhou 510630, PR China.
Lung Cancer. 2002 Apr;36(1):1-6. doi: 10.1016/s0169-5002(01)00445-7.
We conducted a randomized trial to investigate whether systematic nodal dissection (SND) is superior to mediastinal lymph nodal sampling (MLS) in surgical treatment of non-small cell lung cancer (NSCLC).
The patients resectable clinical Stage I-IIIA NSCLC were randomly assigned to lung resection combined with SND or lung resection combined with MLS. After postoperative pathological re-staging, eligible cases were followed up until 30 November 2000. The Kaplan-Meier method was used for survival analysis. COX proportional hazards model was used for prognostic analysis.
Of the 532 patients who were enrolled in the study, 268 patients were assigned to lung resection combined with SND and 264 were assigned to lung resection combined with MLS. After surgical restaging only 471 cases were eligible for follow-up. The median survival was 59 months in the group given SND and 34 months in the group given MLS (P=0.0000 by the log rank test). There was significant difference in survival in Stage I (5-year survival 82.16 vs. 57.49%) and Stage IIIA (26.98 vs. 6.18%) by the log rank test and Breslow test. There was no significant yet marginal difference in survival by log rank test (10-year survival 32.04 vs. 26.92%, P=0.0523) but significant difference in survival by Breslow test (5-year survival 50.42 vs. 34.05%, P=0.0284) in Stage II. Types of mediastinal lymph node dissection, pTNM stage, tumor size and number of lymph node metastasis were four factors that influenced long-term survival rate by multivariate analysis.
As compared with MLS, lobectomy (pneumonectomy) combined with SND can improve survival in resectable NSCLC.
我们开展了一项随机试验,以研究在非小细胞肺癌(NSCLC)的外科治疗中,系统性淋巴结清扫术(SND)是否优于纵隔淋巴结采样术(MLS)。
将可切除的临床I-IIIA期NSCLC患者随机分为肺切除术联合SND组或肺切除术联合MLS组。术后病理重新分期后,符合条件的病例随访至2000年11月30日。采用Kaplan-Meier法进行生存分析,COX比例风险模型进行预后分析。
在纳入研究的532例患者中,268例患者被分配至肺切除术联合SND组,264例患者被分配至肺切除术联合MLS组。手术重新分期后,仅471例病例符合随访条件。接受SND组的中位生存期为59个月,接受MLS组为34个月(对数秩检验P=0.0000)。对数秩检验和Breslow检验显示,I期(5年生存率82.16%对57.49%)和IIIA期(26.98%对6.18%)的生存率存在显著差异。II期患者对数秩检验的生存率无显著但接近显著差异(10年生存率32.04%对26.92%,P=0.0523),但Breslow检验的生存率有显著差异(5年生存率50.42%对34.05%,P=0.0284)。多因素分析显示,纵隔淋巴结清扫类型、pTNM分期、肿瘤大小和淋巴结转移数量是影响长期生存率的四个因素。
与MLS相比,肺叶切除术(全肺切除术)联合SND可提高可切除NSCLC患者的生存率。