A Retrospective Study Of Traditional Chinese Medicine Combined With PD-1/PD-L1 Inhibitors In The Treatment Of Patients With Metastatic Solid Malignancie

Objective:Retrospective analysis of the correlation between the efficacy,adverse effects and survival prognosis of herbal medicine and anti-tumor therapy with PD-1/PD-L1 inhibitors in patients with metastatic solid malignancies.Methods:Data were collected from 88 patients with metastatic solid malignancies who received initial anti-tumor treatment with PD-1/PD-L1 inhibitors at the Department of Oncology of the Affiliated Hospital of Liaoning University of Chinese Medicine between January 2021 and January 2023 and were screened by nadir criteria,and correlations of efficacy,survival,and irAEs were analyzed using SPSS25.0 software.For efficacy and irAEs,the cardinality test was used for univariate analysis,logistic for multivariate analysis,and ROC curve was used to calculate the area under the curve of relevant indexes to test the predictive value of meaningful variables on efficacy and irAEs;for irAEs,Pearson in-depth analysis was applied to analyze the correlation between the duration of Chinese medicine use and the type of occurrence of irAEs,the level of occurrence and the correlation of their TCM evidence score.For survival analysis,Kaplan-Meier survival curves were used for univariate analysis,and survival curves for each study variable and PFS were plotted,and Log-rank test was used to compare the differences in survival data between two groups;Cox regression analysis was used for multifactorial analysis to assess independent influences on prognosis.p<0.05 was considered statistically significant.Results:1.Univariate analysis of efficacy showed that PS score,treatment regimen,number of treatment lines and duration of herbal medicine use were correlated with immunotherapy efficacy;multivariate analysis showed that patients with PS score of 0,first-line use of immunotherapy and longer duration of herbal medicine use were statistically significant with efficacy(P<0.05);meanwhile,PS score and number of treatment lines had predictive value for efficacy.(P<0.05).2.The single factor of irAEs showed that:treatment regimen,duration of herbal medicine use and irAEs were correlated,and further analysis concluded that the duration of herbal medicine use was correlated with the level of occurrence of irAEs;multi-factor analysis of irAEs showed that:immune monotherapy and longer duration of herbal medicine were statistically significant(P<0.05)with the safety of immunotherapy,that is,for patients who received immune monotherapy and herbal medicine treatment for Patients with longer duration of treatment were less likely to develop irAEs;and treatment regimen had predictive value for irAEs(P<0.05).3.The results of univariate survival analysis were:PS score,treatment regimen,and duration of herbal medicine use were statistically significant(P<0.05);Cox’s multi-factor analysis showed that patients with PS≥3 was an independent risk factor for immunotherapy,and duration of herbal medicine use was an independent protective factor for immunotherapy.Conclusion:1.Patients with low PS score,first-line use of immunotherapy and longer duration of herbal medicine had better outcomes,and PS score and number of treatment lines predicted the efficacy of immunotherapy.2.The safety of longer duration of herbal medicine and immunotherapy monotherapy was better,and the treatment regimen could predict the occurrence of irAEs.3.Patients with longer duration of herbal medicine use had longer survival and better prognosis;patients with high PS score had shorter survival and worse prognosis.