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目的:探讨NSCLC(非小细胞肺癌)新辅助化疗及辅助化疗高级别循证医学证据的应用对相关NSCLC临床治疗效果的总体影响,验证其临床应用价值。方法:2004年1月～2009年8月北京肿瘤医院胸外二科接受手术+新辅助化疗或辅助化疗的NSCLC病例191例,均采用含铂双药联合化疗方案。分析依据循证医学证据选择进行新辅助化疗及辅助化疗的病例在患者群体中的分布特点,观察化疗T评效、RO手术切除率,并以SPSS16.0软件统计总生存率(overall survival,OS)、中位生存期(median survivaltime,MST)、无病生存率(disease free survival,DFS),与既往高级别循证医学证据的数据比对,评估循证医学证据的应用价值及合理应用选择。结果:全部病例中19.37%选择新辅助化疗+手术治疗,共37例,其中ⅢB期占24_3%,ⅢA期54.1%;80.63%选择手术+辅助化疗,共154例。新辅助化疗+手术组:有效(RR=CR+PR)率70.3%,病理完全缓解(pCR)5.4%;中位生存时间MST 14.6(6.18～23.01)个月;总生存率,1年86.0%,3年53.9%;无病生存率,1年62.1%,3年23.4%。手术+辅助化疗组:中位生存时间MST25.9(19.03～32.77)个月;总生存率,1年93.3%,3年73.8%;无病生存率,1年71.0%,3年34.0%。结论:高级别循证医学证据对临床NSCLC新辅助及辅助化疗的应用具有重要且显著的影响,具备充分循证医学证据的辅助化疗成为主要的治疗选择,而新辅助化疗的应用相对较少;对于应用新辅助化疗或辅助化疗的选择,病例相对集中于循证医学研究证据支持的主要受益人群:Ⅱ～ⅢA期及有切除可能的部分ⅢB期病例,且新辅助化疗应用以提高切除率为主。
Objective: To investigate the overall impact of NSCLC (non-small cell lung cancer) neoadjuvant chemotherapy and adjuvant chemotherapy with high-level evidence-based medical evidence on the clinical efficacy of NSCLC and to verify its clinical value. Methods: From January 2004 to August 2009, 191 cases of NSCLC underwent surgery + neoadjuvant chemotherapy or adjuvant chemotherapy in Beijing Thoracic Hospital. All patients were treated with platinum-based combination chemotherapy. To analyze the distribution characteristics of neoadjuvant chemotherapy and adjuvant chemotherapy in patients based on the evidence of evidence-based medicine and to observe the effect of chemotherapy T and resection rate of RO, and the overall survival (OS) was calculated by SPSS16.0 software Median survival time (MST), and disease free survival (DFS) were compared with those of previous high-level evidence-based medical evidence to evaluate the value of evidence-based medical application and the rational application of options . Results: 19.37% of the patients selected neoadjuvant chemotherapy plus surgery for operation, of which 37 cases were ⅢB (24.3%), ⅢA (54.1%) and 80.63% (54%) were selected operation and adjuvant chemotherapy. Neoadjuvant chemotherapy + surgery group: effective rate (RR = CR + PR) 70.3%, pathologic complete response (pCR) 5.4%; median survival time MST 14.6 (6.18 ~ 23.01) months; overall survival rate, 1 year 86.0% , 53.9% in 3 years; disease-free survival rate, 62.1% in one year and 23.4% in three years. Surgical + adjuvant chemotherapy group: median survival time MST25.9 (19.03 ~ 32.77) months; overall survival rate of 93.3% for 1 year, 73.8% for 3 years; disease-free survival rate of 71.0% for 1 year and 34.0% for 3 years. CONCLUSION: High-level evidence-based medical evidence has important and significant impact on the application of neoadjuvant and adjuvant chemotherapy in clinical NSCLC. Adjuvant chemotherapy with evidence-based medical evidence is the main treatment option, while neoadjuvant chemotherapy is relatively less used. For the application of neoadjuvant chemotherapy or adjuvant chemotherapy, the cases are relatively concentrated in the main beneficiaries supported by the evidence-based medical research: stage Ⅱ ~ ⅢA and partial resectable stage ⅢB, and neoadjuvant chemotherapy to improve the resection rate was the Lord.