目的

了解EGFR TKI（EGFR TKI）单药对比EGFR TKI联合化疗或抗血管生成药治疗在真实世界晚期EGFR突变NSCLC患者中的使用情况，并进一步探索两种治疗方式的疗效差异。

方法

收集2018年1月1日至2024年3月31日就诊于北京大学首钢医院呼吸与危重症医学科诊断为EGFR突变的晚期NSCLC患者，按照一线治疗使用不同代EGFR TKI情况和是否单药治疗情况进行分组，分析其临床特征及病理特征，并对不同治疗亚组的疗效结果进行研究。

结果

66例晚期EGFR突变NSCLC患者入组单药治疗组34例（1代EGFR TKI 20例，2代EGFR TKI 3例，3代EGFR TKI 11例），联合治疗组32例（1代EGFR TKI 15例，2代EGFR TKI 4例，3代EGFR TKI 13例）。单因素分析发现吸烟史和慢性阻塞性肺疾病（COPD）是影响选择联合治疗的因素（P=0.022和P=0.044）。联合治疗组在总体及不同代EGFR TKI治疗亚组上rwORR数值和中位rwPFS数值均高于单药组，但这种差异均无统计学意义（P＞0.05）。在总体生存（OS）方面，单药组和联合治疗组在总体人群及1代EGFR TKI组和3代EGFR TKI组上的差异均无统计学意义（P＞0.05），但在样本量有限的2代EGFR TKI组观察到2组间差异有统计学意义（P＜0.05）。

结论

有吸烟史和COPD病史患者是影响选择联合治疗方案的因素；相较于单药治疗，联合治疗在rwORR和rwPFS方面有获益趋势，提示联合治疗可成为部分EGFR突变晚期NSCLC患者的一种更优的一线治疗选择。

Objective

To understand the clinical practice of epidermal growth factor receptor tyrosine kinase inhibitor （EGFR TKI） therapy alone and in combination with chemotherapy or antiangiogenic therapy in the real-world setting for patients with advanced EGFR-mutant NSCLC， and to explore the difference in efficacy between the two treatment regimens.

Methods

Between January 1， 2018 and March 31， 2024， patients with advanced EGFR-mutant NSCLC were identified at the Department of Respiratory and Critical Care Medicine of Peking University Shougang Hospital. Subgroups were analysed according to the use of different generations of EGFR TKIs for first-line treatment and whether or not using monotherapy. Clinical and pathological characteristics were analysed， and the efficacy results of the different treatment subgroups were also investigated.

Results

Sixty-six patients with advanced EGFRmutated NSCLC were enrolled， including 34 in the monotherapy group （1st generation EGFR TKIs： 20； 2nd generation EGFR TKIs：3； and 3rd generation EGFR TKIs： 11） and 32 in the combination therapy group （1st generation EGFR TKIs： 15； 2nd generation EGFR TKIs： 4； and 3rd generation EGFR TKIs： 13）. Univariate analysis demonstrated that smoking history and chronic obstructive pulmonary disease （COPD） were factors influencing the choice of combination therapy （P=0.022 and P=0.044）. The combination therapy group had higher real-world objective response rate （rwORR） and median real-world progression free survival （rwPFS）values than the monotherapy group in the overall population and subgroups using different generations of EGFR TKI subgroups， but none of these differences were statistically significant （P＞0.05）. In terms of overall survival， there was no statistically significant difference between the monotherapy and combination therapy groups in the overall population， as well as in the 1st generation and 3rd generation EGFR TKI groups （P＞0.05）. However， a statistically significant difference was observed in the 2nd generation EGFR TKI subgroup with a limited sample size （P＜0.05）.

Conclusion

History of smoking and COPD are factors influencing the choice of combination regimen. There is a trend towards benefit in rwORR and rwPFS with combination therapy compared to monotherapy， suggesting that combination therapy could be a superior firstline treatment option for some patients with advanced EGFR-mutated NSCLC.