Abstract:

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.

Key words: EGFR mutation, NSCLC, EGFR TKI monotherapy, Combination therapy