A longitudinal assessment of treatment experience, symptoms and potential associations with biomarkers in cancer patients undergoing immune checkpoint inhibitor therapy

Obiettivo

Immuno-oncology (IO) and specifically immune checkpoint inhibitors (ICIs) have recently shown significant clinical benefit in a growing number of different tumor types. However 60-90% of the patients experience immune-related adverse events (irAEs) associated with inflammatory or autoimmune responses that can affect any organ and system. Early recognition and treatment of these irAEs is crucial to reduce morbidity, organ complications and ultimately, mortality. Patient reported outcomes (PROs) result in earlier detection of symptom occurrence and severity compared to clinician reports, which tend to understate these experiences, and can serve as a reliable complementary indicator for AEs before their clinical manifestation. Although the use of PROs is highly recommended to be included as an endpoint in clinical trials, no IO-specific-PRO tool has been developed to date and the use of general cancer-specific instruments does not address the needs, concerns and specific symptoms experienced by patients undergoing ICI therapy. The overall objective of this project is therefore to gain a comprehensive understanding of patients’ experience over the immunotherapeutic treatment course based on qualitative interviews with patients, their caregivers and healthcare professionals. This will enable evaluating the need for adaptation or development of new IO-PRO measures. Furthermore, variations in immune-related biomarkers might predict the appearance and severity of symptoms and serve as surrogates for high-grade AEs risk stratification. Hence, this project will additionally investigate potential associations between symptoms and biomarkers over the treatment course in order to elucidate existing correlations. Results derived from this study will facilitate the development of more efficient and targeted care interventions based on the characteristics of the individual in the future, together advancing a patient-centered model of care in IO.