| Introdudion:Lung cancer is the leading cause of cancer-related death worldwide,and non-small cell lung cancer(NSCLC)is a common type of lung cancer.Targeted is one of the first-line therapies for advanced non-small cell lung cancer patients.Almonertinib,as the third-generation epidermal growth factor receptor tyrosine kinase inhibitor in China,has been proved to be effective and safe in the treatment of patients with advanced nonsmall cell lung cancer.Objective:To evaluate the efficacy and safety of Almonertinib mesylate tablets in patients with advanced lung adenocarcinoma.Methods:We retrospectively analyzed the efficacy and safety of Almonertinib treatment in patients with lung adenocarcinoma who were admitted to the Affiliated Hospital of the PLAMilitary Academy ofMedical Sciences from January 1,2020 to July 31,2022.The primary endpoints were progression free survival(PFS),disease control rate(DCR)and objective response rate(ORR);The secondary endpoints were overall survival(OS)and assessment of safety.Results:Atotal of2 2 patients with advanced lumg adenocarcinoma treated with Almonertinib were emolled in this study,including 6 patients with exon 19 deletion mutation,9 patients with exon 21 L858R mutation,5 patients withT790M mutation,1 patident with EFGR mutation negative and 1 patient without genetic testing.The ORR was 40.9%,and the DCR was 90.9%.The duration of response was more than 6 months in 10 patients,accounting for 45.5%of the total.The median PFS was 3.6 months(95%CI:0.0-7.1),the median OS was not reached,and the estimated mean survival time was 28.0 months(95%CI:24.7-313).The 1-,3-,6-,12-and 18-month PFS rates of 17 patients were 100%,68.2%,45.5%,3.6%and 4.5%respectively.Among them,the ORR ofpatients with brain metastases(n=12)was 41.7%,DCR was 91.7%,and median PFS was 1.9 months The ORR and DCR ofp atients without brain metastases(n=10)were 40%and 90%,and median PFS was 6.4 months,respectively.Patients with EGFR sensitive mutations without T790M mutarion had an ORR of 46.7%and a DCR of 100%.Patients with T790M mutation had an ORR of 20%and a DCR of 60%.the ORR,DCR,and median PFS of EGFR mutant patients without Osimertinib treatment were 41.7%,100%and 8.7 months(95$CI:0.0～17.6),respectively.The ORR,DCR and median PFS ofpatients with EGFR mutations treated with Osimertinib were 37.5%75%and 3.0 months(95%CI:1.5～4.6),respectively For the comparison ofPFS,pF=0.021(a=0.05).The PFS of 1 patient with all driver gene negative was 18.4 months.The PFS of 1 patient without gene detection was 6.1 months.Treatment-related adverse events of any grade were rash,diarrhea,fever,fatigue,elevated alanine aminotransferase and aspartate aminotransferase levels elevated lactate dehydrogenase levels,urinary tract infection,interstitial pneumonia,and pulmonary infection Grade 3 or above treatment-related adverse events were interstitial pneumonia and pulmonary infection,and the incidence of grade 3 or above adverse events was 9.1%.No patients had devated serum creatine kinase,and no treatment-related death was found.Conclusions:Almonertinib can benefit patients with lung adenocarcinoma wbo progressed after EGFRTKIs(including Osimertinib)or multiple chemotherapy,regardless of brain metastasis and T790M mutation.The magnitude of benefit was greater in patients with lung adenocarcinoma who had not previously received Osimertinib than in those who had previously received Osimertinib.The adverse events above grade 3 were interstitial pneumonia and pulmonary infection,and the safety was good... |
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