Abstract

Abstract Disclosure: K. Kethireddi: None. S. Jhetam: None. S.B. Parthasarathy: None. Background: Nivolumab is an anti PD-1 mAB (Programmed Cell Death protein) used in the treatment of melanoma, renal, head & neck and other cancers. Use of Nivolumab either as a single therapy or in combination with other immune check point inhibitors (CPI) like Ipilimumab, Pembrolizumab often results in immune mediated endocrinopathies. Existing literature on Nivolumab indicates median time to the onset of hyperthyroidism, hypothyroidism, type 1 diabetes mellitus, and hypophysitis as 1.5 months, 2.9 months, 4.4 months and 4.9 months respectively. Our objective is to add to the existing body of knowledge, compare local data on presentation and other variables of these endocrinopathies with recommendations to improve diagnosis and access to treatment of these endocrinopathies. Design: It is a retrospective analysis of the patients who received Nivolumab (single or combination therapy) between 2019 and 2022 in our hospital. Methodology: A total of 83 patients were treated either with single therapy Nivolumab (n=44) or combination therapy (n=39) and were screened for immune endocrine toxicities. Data was collected mainly from hospital based clinical software for routine use. Data was also collected on prior endocrine tests such as Hba1c and Thyroid function, if done prior to commencement of immunotherapy. Major results: Nineteen patients (23%) developed immune related endocrinopathies which included Thyroiditis/hypothyroidism (n= 12) followed by adrenalitis (n= 6), Type 1 Diabetes (n=1) and hypophysitis (n=3). Onset of thyroid dysfunction occurred between 4 to 8 weeks, adrenalitis between 8 to 32 weeks, hypophysitis between 4 weeks to 12 weeks and 24 weeks for type 1 diabetes mellitus. All patients were appropriately counselled and were provided with Patient Information leaflet. Regular screening bloods (Hba1c, Glucose, Cortisol and Thyroid function tests) were requested in most patients. Emergency presentations of Diabetic ketoacidosis (n=1) and Adrenal insufficiency (n=2) were noted with no mortality. Conclusion: 23% of the patients on Nivolumab had immune mediated endocrinopathy with Thyroiditis/Hypothyroidism being the commonest and the earliest endocrine abnormality. A Standard Operating Procedure for acute endocrine emergencies post Immunotherapy based on Society for Endocrinology guidance, needs to be implemented with education to create greater awareness given the expected high prevalence of these endocrinopathies post Immune CPI therapies. We recommend oral steroid (prednisolone/hydrocortisone) rescue pack and patient education on SMBG (Self-monitoring of blood glucose) as a part of sick day rule management in these patients and we believe this to be lifesaving and resource saving measure given the critical nature of these endocrine emergencies post immune CPI therapies. Presentation: Saturday, June 17, 2023

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