Real-world study of second-line almonertinib for the treatment of advanced non-small cell lung cancer with epidermal growth factor receptor mutations
Objective To investigate the real-world prognosis,efficacy,and independent prognostic factors that influence the survival outcomes of patients with epidermal growth factor receptor(EGFR)-mutated advanced non-small cell lung cancer(NSCLC)who received second-line treatment with almonertinib.Methods We retrospectively analyzed the clinical data of 99 patients with NSCLC,who underwent almonertinib sequential therapy after the progression of first-line EGFR-tyrosine kinase inhibitors(EGFR-TKIs)in the Harbin Medical University Cancer Hospital from March 1,2020 to July 31,2023.The primary objective was to evaluate the overall survival(OS),progression-free survival(PFS),disease con-trol rate(DCR),and intracranial disease control rate(IC-DCR)of the patients.Additionally,univariate and multifactorial Cox regression analysis was carried out to identify the independent prognostic factors affecting survival.Results Among the 99 patients,52.53%(52/99)were diagnosed with brain metastasis,and 53.54%(53/99)were diagnosed with T790M+.The median PFS was 12.6 months(95%CI:10.7-17.4),and the median OS was 32.3 months(95%CI:23.8-NA).The DCR and IC-DCR were 93.94%(93/99)and 92.31%(48/52),respectively.In univariate and multivariate Cox re-gression analysis,performance status(PS)score≥ 2(HR=2.181,P=0.007),osimertinib first-line therapy(HR=10.033,P=0.041),T790M mutation unknown(HR=3.086,P=0.004)and brain metastasis(HR=1.910,P=0.040)were the in-dependent risk factors for PFS,while the T790M+(HR=0.393,P=0.034)and the continuation of almonertinib after progres-sion(HR=0.106,P<0.001)were protective factors affecting PFS.On the other hand,male patients(HR=2.550,P=0.010),PS ≥2(HR=2.888,P=0.011),21 861Q/18 G719X mutation(HR=12.623,P=0.004),osimertinib first-line therapy(HR=70.605,P=0.001),first-line therapy with afatinib(HR=56.203,P=0.001)and presence of brain metastasis(HR=4.585,P=0.001)were the independent risk factors for OS,while infection with corona virus disease 2019(HR=0.125,P=0.001)was a protective factor affecting OS.Within the brain metastasis subgroup,baseline brain metastasis(HR=0.364,P=0.005)and the number of brain metastatic lesions≥3(HR=2.570,P=0.005)were independent prognostic factors for PFS,and the number of brain metastatic lesions ≥3(HR=2.560,P=0.029)was an independent prognostic factor for OS.Conclusion The use of almonertinib as second-line therapy for advanced NSCLC patients with EGFR-mutation has shown prom-ising efficacy in real-world settings,particularly in those with brain metastasis.