新辅助化疗及辅助化疗相关循证医学证据的应用对NSCLC治疗的影响

郑庆锋; 王宇昭; 朱赛楠; 刘毅强; 李少雷; 吴楠; 陈晋峰; 张力建; 杨跃

doi:10.3969/j.issn.1000-8179.2011.04.015

摘要: 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、 R0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 sur?vival time， 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。

Abstract: The Impact of Neoadjuvant Chemotherapy and Adjuvant Chemotherapy on NSCLCSupported by Evidence-based MedicineQingfeng ZHENG1, YuzhaoWANG1, Sainan ZHU2, Yiqiang LIU3, Shaolei LI1, NanWU1, Jinfeng CHEN1, Lijian ZHANG1, Yue YANG1Corresponding author: Yue YANG, E-mail: zlyangyue@bjmu.edu.cn1The Second Department of Thoracic Surgery, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Pe-king University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100142, China2Department of Biostatistics, Peking University First Hospital, Beijing 100034, China3Department of Pathology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking UniversitySchool of Oncology, Beijing Cancer Hospital & Institute, Beijing 100142, ChinaAbstract Objective: To investigate the effect of neoadjuvant chemotherapy and adjuvant chemotherapy on NSCLC on the basisof evidence-based medicine. Methods: From January 2004 to August 2009, there were 191 cases who had received platinum-basedtwo-drug combination chemotherapy. The group distribution characteristics of these cases were analyzed and the effect of chemothera-py was observed by T staging assessment and R0 resection ratio. Overall survival ( OS ), the median survival time ( MST ) and diseasefree survival ( DFS ) were analyzed with SPSS 16.0. These research data were compared with previous data of high-level evidence. Re-sults: Of the 191 cases, 37 ( 19.37% ) cases were treated with neoadjuvant chemotherapy ( NCT ) followed by surgery ( stage ⅢB ac-counted for 24.3%, ⅢA 74.1% ) and 154 cases accepted surgery followed by adjuvant chemotherapy ( ACT ). In the NCT plus surgerygroup, the response rate ( RR = CR + PR ) was 70.3%, pathological complete response ( pCR ) was 5.4%, the MST was 14.6 months(arranged 6.18 to 23.01), the 1-year survival was 86.0%, and the 3-year survival was 53.9%. The 1-year DFS was 62.1%, and the 3-yearDFS was 23.4%. In the surgery plus ACT group, the MST was 25.9 months ( 19.03-32.77 ), the 1-year survival was 93.3%, and the3-year survival was 73.8%. The 1-year DFS was 71.0%, and the 3-year DFS was 34.0%. Conclusion: According to high-level evi-dence, adjuvant chemotherapy can be better treatment option for the majority of NSCLC cases. Patients of stage Ⅱ-ⅢA and some re-sectable patients of stageⅢB can get most benefits from neoadjuvant chemotherapy and adjuvant chemotherapy.Keywords Non-small cell lung cancer; Neoadjuvant chemotherapy; Adjuvant chemotherapy; Overall survival;Disease free survival