DOI: 10.25934/pr00009480
title: Longitudinal peripheral blood markers and patient reported outcomes(PROs) as dynamic predictors to identify efficacy and safety of non–small-cell lung cancer (NSCLC) patients treated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)

description:   In the United States, lung cancer causes more deaths per year (125,070 estimated for 2024) than does any other type, and 84% of lung cancer deaths are caused by non-small cell lung cancer (NSCLC). NSCLC grows slowly compared to small cell lung cancer — but it often spreads to other parts of your body by the time it’s diagnosed. So, early detection and treatment are essential. Treatment options for NSCLC has expanded greatly in the last century. Early in the 20th century, the primary mode of treatment for NSCLC was surgery. Today, we not only have chemotherapy drugs (chemical agents with broad specificity), but also targeted therapy (uses drugs designed to "target" cancer cells without affecting normal cells). For instance, epidermal growth factor receptor (EGFR) is a type of protein found in NSCLC cells which often gets mutated and leads to tumor growth. Tyrosine kinase inhibitors (TKIs) is a type of target therapy developed to specifically prevent the activation of this EGFR protein. Hence, EGFR-TKIs had shown efficacy in patients with EGFR-variant NSCLC. To date, three generations of TKIs have been approved for the treatment of EGFR-mutant NSCLC. However, patients treated with EGFR-TKIs are likely to acquire resistance and recurrence occurs within 1 year of treatment initiation. Several recent clinical studies indicated that the blood cell counts and patient reported outcomes (PROs) were significantly related to survival outcomes in EGFR-mutant NSCLC patients. Our published research demonstrates that blood biomarkers can serve as predictive factors. Similarly, PROs encompass a wide range of physical, psychological, and social functioning aspects, including both positive and negative factors, and have been shown to predict patient treatment response and prognosis. Among these, health-related quality of life (HRQOL) represents one type of PROs.Numerous studies have shown that individual patient level of HRQOL is closely associated with the outcomes of cancer therapy . Patients with higher HRQOL score often exhibit better treatment tolerance and longer survival times. Therefore, similar to blood biomarkers, we can consider HRQOL as a dynamic indicator for monitoring treatment response. Consequently, identifying biomarkers from blood and HRQOL based on patients' subjective experiences will enable real-time disease monitoring to facilitate evaluation of EGFR-TKIs therapeutic efficacy. Hence, this study aims to use blood biomarkers and HRQOL as dynamic predictors to monitor treatment outcomes and decide treatment termination. Thus, we use shared clinical datasets from Vivli to monitor the correlation between blood biomarkers, HRQOL and treatment outcomes in NSCLC patients treated with EGFR-TKIs. By exploring the relationship between HRQOL, blood biomarkers, and treatment outcomes, we aimed to determine whether blood biomarkers and HRQOL as predictors have prognostic and predictive roles in NSCLC.