Clinical study of Furmonertinib combined with Toripalimab in the treatment of advanced non-small cell lung cancer with EGFR gene mutation positivity
Objective To explore the efficacy and safety of Furmonertinib combined with Toripalimab in the treatment of advanced non-small cell lung cancer(NSCLC)with epidermal growth factor receptor(EGFR)gene mutation positivity.Methods This study was a randomized controlled trial.A total of 164 patients with EGFR gene mutation-positive advanced NSCLC admitted to Ankang Central Hospital from February 2019 to February 2021 were selected as the study objects.They were divided into an experimental group and a control group by the random number table method,with 82 cases in each group.There were 45 males and 37 females in the experimental group,aged(63.28±6.75)years.There were 45 males and 37 females in the control group,aged(65.02±7.19)years.The basic treatment included intravenous infusion of pemetrexed at a dose of 500 mg·m-2,once every 21 days,with 21 days as a treatment cycle.The control group received oral administration of 40 mg of Furmonertinib mesylate tablets,twice a day.On the basis of the control group,the experimental group received intravenous infusion of Toripalimab injection at a dose of 3 mg·kg1 every 21 days,with 21 days as a treatment cycle.After 3 cycles of treatment,the efficacy,adverse reactions,and levels of cytokeratin19 fragment antigen 21-1(CYFRA21-1),carbohydrate antigen-199(CA-199),CD4+,and CD4+/CD8+were compared between the two groups.The survival prognosis of the two groups was compared after 2 years of follow-up.x2 test and t test were used.Results During the treatment period,5 cases were lost to follow-up in the experimental group,resulting in data collection from 77 cases;in the control group,8 cases were lost to follow-up,resulting in data collection from 74 cases.After 3 cycles of treatment,the levels of CYFRA21-1 in the experimental group and the control group were(5.18±1.62)μg·L1 and(7.03±1.89)μg·L1,the levels of CA-199 were(36.71±6.93)U·ml1 and(49.46±8.02)U·ml1,the levels of CD4+were(39.06±5.32)％and(31.92±4.15)％,and the levels of CD4+/CD8+were(1.48±0.53)and(1.05±0.48),with statistically significant differences between the two groups(t=6.467,10.465,9.171,and 5.219,all P＜0.05).The disease control rates of the experimental group and the control group were 88.31％(68/77)and 75.68％(56/74),respectively,with a statistically significant difference between the two groups(x2=4.103,P=0.043).By the end of follow-up,30 patients in the experimental group died,and the median progression-free survival(PFS)was 19 months,which did not reach the median overall survival(OS).In the control group,35 patients died,and the median PFS was 15 months,which did not reach the median OS.There was a statistically significant difference in the PFS between the two groups(Log-rank x2=2.608,P=0.031).Conclusion In the treatment of EGFR gene mutation-positive advanced NSCLC,Furmonertinib combined with Toripalimab can improve the disease control rate,reduce the levels of tumor markers(CYFRA21-1 and CA-199),and prolong the PFS,which does not increase the incidence of adverse drug reactions,with good safety.
Non small cell lung cancerAdvanced stageEpidermal growth factor receptor-tyrosine kinase inhibitorFurmonertinibToripalimab
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维普
