Ⅰ~ⅢA期非小细胞肺癌淋巴结清扫范围的前瞻性研究
Extent of lymphadenectomy in stage Ⅰ~ⅢA non-small cell lung cancer: a randomized clinical trial
摘要目的探讨非小细胞肺癌(NSCLC)外科治疗中系统性淋巴结清扫的作用。方法对可手术的504例Ⅰ~ⅢA期病例随机分成研究组和对照组。研究组在肺切除同时行系统纵隔淋巴结清扫术;对照组则在肺切除同时仅行肺门淋巴结清扫术;纵隔淋巴结肉眼怀疑转移者则行该淋巴结摘除术。凡符合入选标准病例均对术式、病理类型、病理分级、肿瘤体积、淋巴结切除总数目、淋巴结转移数目、淋巴结转移比(淋巴结转移数量/淋巴结切除总数量)、PTNM分期、辅助治疗、随访期间内的复发转移、手术并发症、生存时间、生存质量等13项指标进行观察和评价。生存分析用Kaplan-Meier法,预后分析用Cox成比例危险率模型。结果 504例中,符合研究标准的病例共320例,研究组160例,平均每例切除淋巴结9.49个;对照组160例,平均每例切除淋巴结3.63个。Ⅰ期肺癌研究组的1,3,5,9年生存率分别为91.8%、86.9%、81.4%和74.2%,对照组为88.7%、72.5%、58.5%和52.1%,差异有显著性。Ⅱ、ⅢA期两组间的生存曲线差异无显著性。影响长期生存率的因素有术后分期、淋巴结转移比和淋巴结清扫范围3个因素。结论肺叶(全肺)切除加上系统性的胸内淋巴结清扫,能减少肺癌术后局部复发率和远处转移率,提高长期生存率,可列为非小细胞肺癌的规范性术式。
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abstractsObjective To study the role of radical systematic mediastinal lymphadenectomy for non-small cell lung cancer(NSCLC). Methods All 504 operable eligible cases with NSCLC were randomly divided to a radical lymphadenectomy (RL) group and a conventional lymph node dissection group (control) treated between Aug. 1989 and Dec. 1995. For patients postoperatively eligible, thirteen parameters (operation type, pathological type and grade, tumor size,total number of dissected lymph nodes,number of metastatic lymph nodes, metastasis ratio of lymph nodes, postoperative TNM staging, adjuvant therapy, recurrence or metastasis, morbidity, survival and life quality) were evaluated. The end point of follow-up was Dec. 31,1998.Lost follow-up rate was 1.9%. The results were analyzed with soft ware SPSS7.5. The cumulative survival was calculated by the Kaplan-Meier method and compared by the log rank test. The prognostic factors were analyzed by the Cox model. Results There were 320 cases, 160 cases in each group, who entered the study. The mean numbers of dissected lymph nodes was 9.49 in the RL group and 3.63 in the control group. For stage I NSCLC patients, the 1,3,5,9-year survival rate was 91.8%, 86.9%, 81.4%,74.2% respectively in the RL group and 88.7%, 72.5%, 58.5%, 52.1% respectively in the control group (P<0.014). However, no statistically significant difference in survival rates between RL and control groups of patients with stage II and IIIA NSCLC. The postoprative TNM staging, metastasis ratio of lymph nodes, extent of lymphadenectomy were the factors influencing long term survival upon multivariable analysis. Conclusion Classical lobectomy or pneumonectomy with radical systematic mediastinal lymphadenectomy is the surgical treatment of choice for NSCLC.
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