Abstract 1129P
Background
The relationship between efficacy of immune check point inhibitors (ICI) and development of immune related adverse events (irAEs) was reported. The early stages of irAEs have some similarities with adjuvant-induced autoimmune/pro-inflammatory syndrome (ASIA). ASIA and irAES are preautoimmune conditions caused by hyperstimulation of the immune system - due to the checkpoint inhibition or different adjuvants respectively. For ASIA diagnosis the questionnaire based on clinical symptoms characteristic for autoimmune processes, trigger and hereditary factors was created. The aim of the study is to evaluate predictive significance of ASIA symptoms in patients taking ICI in comparison with determination of PD-L1 expression.
Methods
The study involved 49 patients (pts) with various solid tumors undergoing treatment in the city Oncological Center taking checkpoint inhibitors therapy. All patients were interviewed with ASIA questionnaire. After 3 months the Disease Control Rate (DCR) was assessed. Statistical analysis was performed in GraphPad Prism 6 (Graph Pad Software, USA) using Fisher, Mann-Whitney, ROC statistical analysis. The project is supported by grant (14. W03.31.0009).
Results
PD-L1 expression (cut-off >5%) as predictive marker in studied patients showed no statistical significance with sensitivity 80%, specificity 31%. As an additional predictive marker of therapy efficacy the index based on the ASIA symptoms developed, the presence of previous autoimmune diseases, hereditary of autoimmune diseases was proposed. Use of the index >1.5 units for prediction of DCR achievement showed sensitivity 61% and specificity 71%, p= 0.028. Index based on combination of PD-L1 determination and ASIA index for DCR assessment with reference >2.5 units showed sensitivity 100.0% and specificity 70.00%, p=0.007.
Conclusions
The new index based on ASIA criteria and PD-L1 expression showed higher predictive value in assessment of disease control rate after 3 months in comparison with determination of these parameters separately. This is a pilot study on small sample for a short period and proceeding investigation is needed to prove the practical significance of the results obtained.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Russian Government Grant (14. W03.31.0009).
Disclosure
All authors have declared no conflicts of interest.