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Ha Nguyen Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Komal Shah Division of Diagnostic Imaging, Department of Diagnostic Radiology, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Steven G Waguespack Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Mimi I Hu Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Mouhammed Amir Habra Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Maria E Cabanillas Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Naifa L Busaidy Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Roland Bassett Division of Science, Department of Biostatistics, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Shouhao Zhou Division of Science, Department of Biostatistics, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Priyanka C Iyer Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Garrett Simmons Division of Diagnostic Imaging, Department of Diagnostic Radiology, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Diana Kaya Division of Diagnostic Imaging, Department of Diagnostic Radiology, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Marie Pitteloud Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Sumit K Subudhi Division of Cancer Medicine, Department of Genitourinary Medical Oncology, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Adi Diab Division of Cancer Medicine, Department of Melanoma Medical Oncology, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Ramona Dadu Division of Internal Medicine, Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas Anderson Cancer Center, Houston, Texas, USA

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Data on the diagnosis, natural course and management of immune checkpoint inhibitor (ICI)-related hypophysitis (irH) are limited. We propose this study to validate the diagnostic criteria, describe characteristics and hormonal recovery and investigate factors associated with the occurrence and recovery of irH. A retrospective study including patients with suspected irH at the University of Texas MD Anderson Cancer Center from 5/2003 to 8/2017 was conducted. IrH was defined as: (1) ACTH or TSH deficiency plus MRI changes or (2) ACTH and TSH deficiencies plus headache/fatigue in the absence of MRI findings. We found that of 83 patients followed for a median of 1.75 years (range 0.6–3), the proposed criteria used at initial evaluation accurately identified 61/62 (98%) irH cases. In the irH group (n = 62), the most common presentation was headache (60%), fatigue (66%), central hypothyroidism (94%), central adrenal insufficiency (69%) and MRI changes (77%). Compared with non-ipilimumab (ipi) regimens, ipi has a stronger association with irH occurrence (P = 0.004) and a shorter time to irH development (P < 0.01). Thyroid, gonadal and adrenal axis recovery occurred in 24, 58 and 0% patients, respectively. High-dose steroids (HDS) or ICI discontinuation was not associated with hormonal recovery. In the non-irH group (n = 19), one patient had isolated central hypothyroidism and six had isolated central adrenal insufficiency. All remained on hormone therapy at the last follow-up. We propose a strict definition of irH that identifies the vast majority of patients. HDS and ICI discontinuation is not always beneficial. Long-term follow-up to assess recovery is needed.

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