New exploration of pembrolizumab treatment for ALK-mutated advanced non-small cell lung cancer after resistance to targeted therapy
Objective To explore the efficacy of pembrolizumab treatment after resistance to targeted therapy in patients with advanced non-small cell lung cancer(NSCLC)with anaplastic lymphoma kinase(ALK)mutation.Methods It was a prospective,controlled,single-center,randomized,single-blind clinical study.Ninety-five patients with advanced NSCLC with ALK mutation who were resistant to targeted therapy were selected from Xi'an Gaoxin Hospital from March 2020 to July 2022,and were divided into a control group and an experimental group by the random number table method.In the control group,47 cases were enrolled,2 cases were shed,and 45 cases were finally included in the analysis.In the experimental group,48 cases were enrolled,2 cases were shed,and 46 cases were finally included in the analysis.The control group included 29 males and 16 females,aged(56.85±8.67)years;there were 12 cases of stage Ⅲ B and 33 cases of stage Ⅳ;there were 12 cases of squamous cell carcinoma and 33 cases of adenocarcinoma.The experimental group included 26 males and 20 females,aged(55.02±8.23)years;there were 15 cases of stage Ⅲ B and 31 cases of stage Ⅳ;there were 10 cases of squamous cell carcinoma and 36 cases of adenocarcinoma.The control group received alectinib treatment,and the experimental group received pembrolizumab treatment on the basis of the control group.With 21 days as a treatment cycle,both groups were treated for 3 cycles.The levels of matrix metalloproteinase-9(MMP-9),serum cytokeratin 19 fragment antigen 21-1(CYFRA21-1),neuron-specific enolase(NSE),carbohydrate antigen 9(CA9),endostatin(ES),vascular endothelial growth factor(VEGF),natural killer(NK)cells,CD8+,and CD4+before and after treatment,clinical efficacy,and adverse drug reactions were compared between the two groups;the survival conditions of the two groups were recorded.Independent sample t test,paired t test,and x2 test were used.Results After treatment,the levels of CYFRA21-1,NSE,CA9,MMP-9,VEGF,and CD8+in both groups were lower than those before treatment(all P＜0.05),and those in the experimental group were lower than those in the control group(all P＜0.05);the levels of ES,CD4+,and NK cells in both groups were higher than those before treatment(all P＜0.05),and those in the experimental group were higher than those in the control group(all P＜0.05).The total effective rate of the experimental group was higher than that of the control group[78.26％(36/46)vs.57.78％(26/45)](x2=4.396,P=0.036).There was no statistically significant difference in the total incidence of adverse drug reactions between the two groups(x2=0.385,P=0.535).After 1 year of follow-up,1 case was lost in the experimental group and 2 cases in the control group,with a follow-up rate of 97.70％.The 1-year overall survival rate of the experimental group was 55.56％(25/45),and that of the control group was 34.88％(15/43).There was a statistically significant difference in the overall survival(OS)curve between the two groups(Log-rank x2=7.805,P=0.005).Conclusion Pembrolizumab treatment for ALK-mutated advanced NSCLC after resistance to targeted therapy shows significant efficacy,which can improve the immune function,reduce the tumor marker levels,increases the survival rate,and improve the angiogenesis regulatory factors,without significantly increasing the incidence of adverse drug reactions.
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