术后辅助化疗对I期非小细胞肺癌无瘤生存时间的影响

Effect of Adjuvant Chemotherapy on DFS for Patients with Stage Ⅰ NSCLC

背景与目的手术是早期肺癌的首选治疗方法,但早期肺癌术后的预后仍有很大差异,术后是否应用辅助化疗也有争议。本研究探讨术后辅助化疗在Ⅰ期非小细胞肺癌患者中的作用,尤其是在高危人群中的作用。方法选择北京大学人民医院2009年1月-2013年6月接受手术的Ⅰa期、Ⅰb期肺癌患者,分别以是否行术后化疗分为两组,用Kaplan-Meier法进行生存分析,比较两组术后无瘤生存时间(disease-free survival,DFS)的差异;并按危险因素个数进行评分,分为0分、1分、≥2分三组,比较三组术后DFS的差异;单独比较术后化疗对≥2分的高危组患者的作用。结果经过筛选后共有465例患者纳入研究,Ⅰa期284例,Ⅰb期181例。Ⅰa期化疗组和对照组术后DFS并无明显差异(P=0.171),但化疗组生存曲线位于对照组下方,Ⅰb期两组术后DFS也无明显差异(P=0.630)。危险因素评分后的三组患者DFS有明显差异(P<0.001),危险因素越多,术后DFS越差,可看作是高危患者。但单独分析显示,术后化疗与否对这部分高危患者的DFS并无显著影响(P=0.763)。结论术后化疗对早期非小细胞肺癌的DFS并无积极作用,即使是对于具有多个高危因素的Ⅰ期非小细胞肺癌患者,术后化疗也许也不适用。

Background and objective Surgical resection is the best choice for early lung cancer, but the prognosis of early postoperative lung cancer is still very different, whether or not to apply adjuvant chemotherapy is controversial. This study examines the role of postoperative adjuvant chemotherapy in patients with stage Ⅰ non-small cell lung cancer （NSCLC）,particularly in high-risk groups. Methods Patients with pathologic stage Ⅰa and stage Ⅰb NSCLC who underwent complete （R0） resection between January 2009 and June 2013 were identified from Peking University People＆#39;s Hospital and classified into two groups based on postoperative chemotherapy or not. Kaplan-Meier and Log-rank tests were used to compare disease free survival （DFS）. Scored according to the number of risk factors, all patients were divided into three groups. Kaplan-Meier and Log-rank tests were used to compare DFS between them. The effect of postoperative chemotherapy on high-risk group was observed individually. Results A total of 465 patients including 284 cases of stage Ⅰa and 181 cases of stage Ⅰb were enrolled in this study.For stage Ⅰa there was no significant difference between the chemotherapy group and the control group in DFS （P=0.171）,but the survival curve of the chemotherapy group was located below the control group. For stage Ⅰb there was no significant difference between the two groups either （P=0.630）. But there were significant differences on DFS between the three groups according to the number of risk factors （P〈0.001）. The more risk factors mean the worse DFS. However, independent analyses showed no significant effect of postoperative chemotherapy on DFS in the high-risk group patients （P=0.763）. Conclusion Postoperative chemotherapy does not have a positive effect on DFS in early stage non-small cell lung cancer, and chemotherapy may not be appropriate even for patients with multiple risk factors.