目的 探索ⅠB期肺腺癌患者的辅助治疗方案.方法 收集2013年1月～2021年12月在我院行手术治疗的IB期肺腺癌患者,根据术后不同辅助治疗模式分为辅助靶向治疗组(EGFR-TKIs)、辅助化疗组(CT)和临床观察组(CO).对比3组患者的临床资料和随访结果,无疾病生存期、总生存的分析采用Kaplan-Meier法并行log-rank检验,COX回归分析患者无疾病生存期(DFS)的预测因素.主要研究终点是5年DFS率,次要研究终点为DFS、3年总生存期(OS)以及辅助治疗的安全性.结果 共纳入653例术后诊断为IB期肺腺癌患者,其中EGFR-TKIs组111例,CT组108例,CO组434例.中位随访时间43个月,TKIs组、CT组和CO组的5年DFS率分别为92.8%、80.7%及81.7%,TKIs组的5年DFS率显著高于CO组(P<0.01).TKIs组、CT组和CO组的3年OS均无统计学差异.亚组分析显示,T3～4 cmN0M0中TKIs组、CT组和CO组的5年DFS率分别为92.6%、84.0%及81.4%,TKIs组的5年DFS率显著高于CO组(P<0.05),3组间的3年OS无统计学差异.而T2ViscPlN0M0中TKIs组、CT组和CO组的5年DFS率分别为95.1%、71.4%及83.5%,组间差异并无统计学意义,3组间的3年OS亦无统计学差异.多因素COX回归分析结果显示,年龄(P<0.05;HR 0.631,95%CI 0.401-0.993)、实性结节(P<0.01;HR 7.620,95%CI 3.037-19.121)、微乳头/实性成分(P<0.05;HR 1.776,95%CI 1.010-3.122)、脉管癌栓(P<0.05;HR 2.981,95%CI 1.198-7.419)及辅助治疗(P<0.01)是DFS的独立预测因素.安全性方面,皮疹、甲沟炎及腹泻仍然是靶向药物最常见的不良反应.化疗组不良反应主要为血液系统的抑制和胃肠道反应,3级以上不良反应率高于TKIs组(44.4%vs 9.0%).结论 辅助靶向治疗有助于提高T3～4 cmN0M0的IB期肺腺癌患者的DFS,但T2ViscPlN0M0患者并不能从靶向治疗中获益.辅助化疗并不能改善IB期肺腺癌患者的DFS和OS.
Objective To explore the optimal postoperative adjuvant regimens for patients with stage IB lung adenocarcinoma.Methods We respectively analyzed the data of 653 patients undergoing surgery for stage IB lung adenocarcinoma in our hospital from January,2013 to December,2021.The 5-year disease-free survival(DFS)and overall survival(OS)rates were compared among the patients receiving postoperative adjuvant therapy with epidermal growth factor-tyrosine kinase inhibitors(EGFR-TKIs group,n=111),chemotherapy(CT group,n=108)and clinical observation(CO group,n=434).Results In TKIs,CT,and CO groups,the 5-year DFS rates were 92.8%,80.7%,and 81.7%,respectively,significantly higher in TKIs group than in CO group(P<0.01).The 3-year OS rates of the 3 groups were 96.8%,97.1%,and 91.7%,respectively.Subgroup analysis showed that in TKIs,CT,and CO groups,the 5-year DFS rates of patients with with T3-4 cmN0M0 were 92.6%,84.0%,and 81.4%,respectively,significantly higher in TKIs group than in CO group(P<0.05);the 5-year DFS rates of T2ViscPlN0M0 patients were 95.1%,71.4%,and 83.5%,respectively.Multivariate COX regression analysis showed that age(P<0.05;HR=0.631,95%CI:0.401-0.993),solid nodules(P<0.01;HR=7.620,95%CI:3.037-19.121),micropapillary or solid component(P<0.05;HR=1.776,95%CI:1.010-3.122),lymphovascular invasion(P<0.05;HR=2.981,95%CI:1.198-7.419),and adjuvant therapy(P<0.01)were independent predictors of DFS.The most common adverse effects included rashes,paronychia,and diarrhea for TKIs and hematological suppression and gastrointestinal reactions for chemotherapy,and TKIs were associated with a higher incidence of grade 3 or above adverse effects(44.4%vs 9.0%).Conclusion Adjuvant therapy with TKIs helps improve DFS in patients with stage IB(T3-4cmN0M0)lung adenocarcinoma but not in patients with T2ViscPlN0M0.Adjuvant chemotherapy does not improve DFS or OS in patients with stage IB lung adenocarcinoma.
申磊磊;陈莹;云天洋;郭俊唐;柳曦;张涛;梁朝阳;刘阳
中国人民解放军总医院海南医院胸外科,海南 三亚 572000中国人民解放军总医院第一医学中心胸外科,北京 100853
IB期;肺腺癌;辅助化疗;EGFR突变;靶向治疗;无疾病生存期
stage IB;lung adenocarcinoma;adjuvant chemotherapy;epidermal growth factor receptor mutation;targeted therapy;disease-free survival
《南方医科大学学报》 2024 (005)
989-997 / 9
10.12122/j.issn.1673-4254.2024.05.22
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