Cutaneous immune-related adverse events of immunotherapy medications in the treatment of cancers and association with survival.

The project background: Immune checkpoint inhibitors (ICIs) are typical immunotherapy drugs, a type of cancer treatment that helps your immune system fight cancer. As an immune checkpoint blockade, ICIs block immune checkpoints from taking the brakes off of cancer-fighting T cells. ICIs are the most important innovations in oncology therapeutics and have improved the treatment landscape of advanced malignancies. It has been estimated that in 2019 over 200 thousand patients were eligible for treatment with ICI therapy annually in the US alone. However, despite the efficacy of ICIs, immune-related adverse events (irAEs) occur in more than a third of all treated patients and are associated with lasting morbidity, mortality, and impaired quality of life, of which cutaneous irAEs (cirAEs, irAEs relating to or affecting the skin) are the most frequently reported toxic effects, occurring in 20% to 40% of all treated patients. Actually, it has been reported that cirAEs are the most common side effect secondary to immunotherapy, presented as both local reaction in skin and/or systemic poisoning.
Necessity of the research: The indications of ICIs in cancer treatment have expanded, so a growing number of patients will be exposed to immunotherapy. In turn, an increasing number and severity of cirAEs will occur if not intervened upon. However, prior studies examining these toxicities in detail have considered only the presentation of events evaluated by dermatologists. The associations between cirAEs and survival outcomes remain underexplored across care settings.
How the research will add to medical science or patient care: Fully categorizing the spectrum of cirAEs encountered in the context of immune checkpoint blockade and understanding the association between cirAEs and overall survival will help to tailor therapy and manage these side effects most effectively.
How the research will be conducted: This research will enroll all clinical trials in Vivli database that involves ICIs therapy of cancer. The types of cirAEs and management, overall survival will be recorded and analyzed.
What design and methods you have you chosen and why: Cohort study design will be applied in this study. Cox proportional hazards model (a statistical method to analyze the effect of several risk factors on survival, or the time it takes for a specific event to happen) will be performed to determine the prognostic association of cirAEs with overall survival.