Analysis of the predictive effect of serum TMB level detection on immunotherapy for malignant tumors
Objective By detecting the level of tumor mutation load(TMB)in the serum of patients with malignant tumors,and analyzing the relationship between the level of TMB and the efficacy of immunotherapy in patients with malignant tumors,so as to provide a theoretical basis for the evaluation of the efficacy of immunotherapy in tumor patients.Methods 46 patients with malignant tumors clearly diagnosed by cytopathology(pleural effusion,abdominal effusion,etc.)or histopathology(endoscopic biopsy,percutaneous puncture biopsy,metastatic lesion puncture biopsy,etc.)were tested by next-generation sequencing(NGS)and received either immunotherapy alone or immunotherapy combined with chemotherapy.The clinical characteristics of the patients were analyzed to compare the efficacy of patients with different genders,TNM stages,lymph node metastases,drug use,treatment modalities,and TMB levels,and ordered Logistic regression model was used to analyze the influence of each variable on the efficacy and the influence of TMB level on efficacy in patients of different ages.Results There was no significant difference in the therapeutic effect of patients with different gender,lymph node metastasis and treatment modalities(P>0.05).There were 16 patients with TNM stage Ⅲ,including 1 patient(6.3%)with progressive disease(PD),2 patients(12.5%)with stable disease(SD),13 patients(81.3%)with partial remission(PR);there were 30 cases in stage Ⅳ,including 6 cases(20.0%)of PD,18 cases(60.0%)of SD,and 6 cases(20.0%)of PR.In first-line drug treatment,there were 1 case(4.2%)of PD,6 cases(25.0%)of SD,17 cases(70.8%)of PR,and in second-and third-line drug treatment,there were 6 cases of PD(27.3%),14 cases of SD(63.6%),and 2 cases of PR(9.1%).The TMB level was(2.48±3.32)mut/Mb in PD patients,(3.23±2.96)mut/Mb in SD patients,and(11.95±6.69)mut/Mb in PR patients.The treatment effect of patients with different TNM stage,medications and TMB level were compared,and the difference was statistically significant(P<0.05).The ordered Logistic regression model was used,and the efficacy was taken as the dependent variable.The results of the specific ordered Logistic regression model showed that there was a significant positive predictive effect of TMB level on efficacy(B=0.339,P<0.05),indicating that the higher the TMB level,the more the efficacy was promoted.There was a significant positive predictive effect of TNM staging on efficacy(B=2.660,P<0.05),and the efficacy of staging Ⅲ was significantly higher than that of staging Ⅳ.There was a significant positive predictive effect of first-line medication on efficacy(B=3.622,P<0.05);lymph node metastasis was not a significant predictor of efficacy(B=-0.859,P>0.05);immunotherapy alone or immunotherapy combined with chemotherapy did not have significant predictive effect on the efficacy(B=-0.731,-2.299;P>0.05),indicating that the treatment modality did not significantly improve the efficacy.Logistic regression analysis showed that TMB level was a protective factor for efficacy in patients aged≥60 years(P<0.05).Conclusion The expression level of TMB in patients with malignant tumors has a significant positive predictive effect on the efficacy of immunotherapy,and age is also found to be one of the factors affecting the efficacy.
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