Clinical Study On The Efficacy And Prognostic Relevance Of PD-1 ICIs In The Treatment Of Patients With Advanced Unresectable NSCLC

Objective:In this study,we collected clinicopathological characteristics,hematological examinations,and Imaging data of patients with advanced(stage IIIb-IV)unresectable non-small cell lung cancer treated with PD-1 immune checkpoint inhibitors(ICIs)and analyzed the correlation between clinicopathological characteristics,routine blood parameters,and biochemical coagulation parameters on the clinical efficacy and long-term survival prognosis of immunotherapy patients and the occurrence of adverse events to provide a reference for predicting the clinical efficacy and long-term survival prognosis of patients treated with PD-1 ICIs.Methods:Data on patients with advanced(stage IIIb-IV)unresectable non-small cell lung cancer who attended the Gansu Provincial People’s Hospital for treatment with PD-1ICIs from January 2020 to December 2022 were collected and processed for retrospective analysis.Patients’ clinicopathological characteristics were collected: age,gender,height,weight,smoking history,pathological staging,TNM stage,drug use,driver gene expression,the occurrence of ir AEs,the occurrence of pleural effusion,the occurrence of bone metastases;routine blood indicators: absolute neutrophil count(ANC),absolute lymphocyte count(ALC),absolute monocyte count(AMC),platelets((PLT),hemoglobin(HB);biochemical coagulation indexes: alkaline phosphatase(ALP),albumin(ALB),fibrinogen(FIB),lactate dehydrogenase(LDH);and calculation of body mass index(BMI),neutrophil-to-lymphocyte ratio(NLR),lymphocyte-to-monocyte ratio(LMR),platelet-to-lymphocyte ratio(PLR).Patients have evaluated according to RECIST 1.1 criteria for evaluating the efficacy of solid tumors,and patients were followed up regularly to determine the time to disease progression.The subject operating characteristic curve(ROC curve)was used to determine the optimal cut-off values of the patients’ hematological indices.The indices were divided into above-cut-off and below-cut-off groups according to the optimal cut-off values.All data were statistically analyzed using SPSS 26.0 statistical software.One-way analysis by chi-square test and multifactor analysis by logistic regression analysis were used for efficacy assessment.The Kaplan-Meier method for univariate analysis and the Cox proportional risk regression model for multifactor analysis were used for survival assessment.P < 0.05 was considered statistically significant.Results:1.For objective remission rate(ORR),univariate analysis showed that HB was correlated with ORR(P < 0.05),while gender,age,BMI,smoking history,pathological staging,TNM stage,medication use,driver gene expression,pleural effusion,bone metastasis,ir AEs,ALC,ANC,AMC,PLT,ALP,ALB,FIB,LDH,NLR,LMR and PLR did not correlate with ORR(P > 0.05).2.In terms of disease control rate(DCR): univariate analysis showed that TNM stage,pleural effusion,ALC,ANC,AMC,PLT,HB,ALP,ALB,FIB,NLR,LMR and PLR were correlated with DCR(P < 0.05),while gender,age,BMI,smoking history,pathological typing,medication use,driver gene expression,bone metastases,ir AEs,and LDH were not correlated with DCR(P > 0.05);Multifactorial analysis showed that ANC and HB were correlated with DCR(P < 0.05)3.In terms of prognosis,univariate analysis showed that TNM stage,ir AEs,bone metastases,ALC,AMC,PLT,HB and ALP were correlated with PFS(P < 0.05),and age,sex,height,BMI,pathological typing,medication use,driver gene expression,pleural effusion,ANC,ALB,FIB,LDH,NLR,LMR,and PLR did not correlate with PFS(P > 0.05);Multifactorial analysis showed that TNM stage,the occurrence of ir AEs,and PLT were correlated with PFS(P < 0.05).4.Regarding the occurrence of ir AEs: in all 110 patients,ir AEs of all grades occurred 39 times with an incidence of 35.5%,namely diarrhea(10.0%,11/110),pruritus rash(7.3%,8/110),hypothyroidism(5.5%,6/110),hepatic impairment(4.5%,5/110),capillary hyperplasia(2.7%,3/110),hyperthyroidism(2.7%,3/110),pneumonia(0.9%,1/110),myocarditis(0.9%,1/110),and colitis(0.9%,1/110),of which grade 3 and above ir AEs occurred six times,with an incidence of 5.5%,respectively,2 cases of rash,1 case of hypothyroidism,1 case of liver injury 1 case,pneumonia 1 case,and myocarditis 1 case.Conclusion:1.In terms of efficacy assessment,hemoglobin correlates with ORR and may be a relevant indicator for predicting ORR;TNM stage,pleural effusion,ANC,ALC,AMC,PLT,NLR,LMR,PLR,HB,ALP,ALB and FIB were correlated with DCR and may be relevant predictors of DCR.2.ALC and HB can be independent risk factors to predict efficacy.3.In terms of prognostic assessment,TNM stage,bone metastases,ir AEs,ANC,AMC,PLT,HB and ALP were correlated with PFS and may be relevant predictors of PFS.4.TNM staging,ir AEs and PLT can be used as independent risk factors to predict prognosis.5.Regarding adverse reactions,ir AEs were mainly diarrhea,pruritic rash,and hypothyroidism.