Autoimmune Endocrine Disease Related Antibodies Before the Start of Immune Checkpoint Inhibitor Therapy

Immune checkpoint inhibitor therapy (ICI) is the current standard of care for many malignancies, due to its unique mechanism of action. These therapies release the brakes of the immune system by targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4, e.g., ipilimumab, tremelimumab), programmed cell death-1 (PD-1, e.g., cemiplimab, dostarlimab, pembrolizumab, nivolumab) or its ligand (PD-L1, e.g., atezolizumab, avelumab, durvalumab). The flip side of the coin are immune-related adverse events (IrAE), including skin, intestinal and endocrinological toxicity, although any organ system can potentially be affected. The prospective follow-up of the endocrine autoantibodies is an area of interest as the presence of thyroid autoantibodies is associated with the occurrence of thyroiditis with immunotherapy. In turn, the occurrence of thyroiditis with immunotherapy is related to improved oncologic prognosis. Therefore, it would be of value to analyze whether the presence of thyroid autoimmunity (with positive thyroperoxidase and/or thyroglobulin autoantibodies) before the start of immunotherapy could be a marker of improved oncologic prognosis and outcome. Furthermore, there is a gap in our knowledge of the impact of autoantibodies against less common endocrinopathies, such as hypophysitis (inflammation of the pituitary gland), adrenalitis (inflammation of the adrenal glands) or pancreas (type-1 like diabetes mellitus). Finding a prognostic factor for these types of endocrinopathy is equally important, as these patients may present with life-threatening endocrinopathy (adrenal crisis, diabetic ketoacidosis) and should be recognized and treated in a timely manner. The main purpose of the current study is to evaluate the association between the autoimmune endocrine disease-related antibodies, the development of endocrine irAE and the impact on the tumor response including progression-free survival and overall survival. For this study, the investigators aim to perform a blood sample before and during the immunotherapy, for the analysis of the autoimmune endocrine disease related antibodies (Ab): anti-thyroglobulin Ab (aTg), anti-thyroperoxidase Ab (aTPO), anti-TSH-receptor Ab (TSI), pituitary Ab, adrenal Ab, and anti-GAD. The included patients will be prospectively followed up.