| Objective:Lung cancer is the cancer with the highest incidence and death rate in China for many years.Epidermal growth factor receptor(EGFR)can blind to epidermal growth factor.Ten,they can initiate the related genes in the nucleus,promote cell division and proliferation.Which plays an important role in the occurrence and development of tumors.EGFR-TKIs can competitively inhibit the binding of EGFR and ATP.Osimertinib is a strong and irreversible third-generation EGFR-TKI that selectively inhibits EGFR sensitive mutations and T790 M mutation-positive drug-resistant mutations.However,there are fewer Chinese patients in previous clinical studies on Osimertinib.In addition,Osimertinib was listed late in China.At present,the number of pepole using of Osimertinib for longer than one year is small.The efficacy and side effects of long-term treatment are not yet accurate.The genetic mutation states of patients taking Osimertinib in the real world are not the same.This article aims to evaluate the efficacy of Osimertinib in the treatment of advanced non-small cell lung cancer in the real world by collecting data on patients who have taken Osimertinib orally in our hospital.Methods:We collected 41 patients with oral lung cancer from April 2017 to October 2018 at the Fourth Hospital of Hebei Medical University.All patients admitted to the group were confirmed by Histopathology or cytology as non-small cell lung cancer,and get Osimertinib treatment in first or second and above line.We used imaging data a month before the treatment as a baseline,the medication was examined once every 2 months,and the condition was assessed using the RECIST 1.1 solid tumor evaluation standard,while recording the adverse reactions during the pre-medication period of the patient.Until the disease progresses or an intolerable adverse reaction occurs.Results:The ORR and DCR in this study were 53.7 %,95.1%,and mPFS was 12 months.The ORR,DCR of male patients was 61.1%,94.4%,the mPFs was 10 months,and the ORR,DCR of female patients was 47.8% and 95.7%,and the mPFS was not reached.There was significant difference in mPFS.The median PFS of T790 M patients with positive,negative,and unknown mutations was 15 months,5 months,and not reached.The difference is statistically significant,P = 0.020.Through comparisons there was a statistical difference in the median PFS of positive and negative T790 M mutations,P = 0.005.In patients with T790 M mutation positive,the ORR was 56.3 % and the DCR was 96.9 %.Patients with negative T790 M mutations ORR was 33.3 % and DCR was 100 %.In patients with unknown T790 M mutations,the ORR was 50.0 % and the DCR was 83.3 %.There is no significant statistical difference between ORR and DCR of the three.According to the analysis of 37 patients who were treated with Osimertinib in the second line and above,the previous application of EGFR-TKIs had nothing to do with the T790 M mutation state after the development of the disease.In the two groups of patients with initial EGFR19 mutation and initial EGFR21 mutation,there was no statistical difference in the probability of T790 M mutation after disease progression,P = 0.194.In this study,the main adverse reactions of patients with oral Osimertinib were rash,diarrhea,skin itching,parietal sulfitis,oral ulcer and constipation.Both adverse reactions are level 1-2 and no adverse reaction events of level 3 and above occurred.In this study,11 patients had baseline brain metastasis,accounting for 26.8 %;Baseline meningeal metastasis was observed in 4 patients,accounting for 9.8 per cent.One case of new cerebral metastasis and one case of new meningeal metastasis occurred in patients with disease progression during Osimertinib treatment.Most patients with brain metastasis or meningeal metastasis opt for oral administration of Osimertinib with local radiotherapy or scabbard methotrexate,and new brain metastasis that occurs during oral Osimertinib treatment adopts increased Osimertinib dose combined with local radiotherapy.Conclusions:1.Real-world studies showed that the DCR,ORR and mPFS of patients with advanced NSCLC were 95.1%,53.7% and 12 months,respectively.2.The efficacy of Osimertinib in patients with advanced NSCLC is related to sex.The mPFS in female patients is longer than that in male patients.3.The efficacy of Osimertinib in patients with advanced NSCLC is related to T790 M status.In the real world,Osimertinib can also delay the disease progress of T790 M positive patients.4.Real-world studies have shown that Osimertinib is safe and has mild adverse reactions.The main adverse reactions are rash,diarrhea,skin pruritus,nail groove inflammation,oral ulcer,constipation.No unexpected adverse reactions were found. |