Immune Checkpoint Inhibitors and Hypothyroidism: An Emerging Public Health Challenge Identified Through a Systematic Review of ClinicalTrials.gov
Year: 2026
Type: review
Study design: Systematic Review
Abstract: Immune checkpoint inhibitors (ICIs) have transformed cancer treatment, but their growing use has exposed a class of immune-related side effects with lasting consequences, most notably hypothyroidism. Unlike many other drug-related toxicities, ICI-associated hypothyroidism is frequently permanent, requiring lifelong thyroid hormone replacement. As the number of long-term cancer survivors continues to rise, this condition is an underrepresented public health problem. This study aimed to characterize how often hypothyroidism is reported as an adverse event (AE) across ICI clinical trials using publicly available data from ClinicalTrials.gov and to examine the public health implications of these findings. We expected hypothyroidism to be common, particularly with programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors and combination regimens, and that registry-reported frequencies would be high enough to justify wider surveillance beyond individual clinical care. Using a PRISMA 2020-aligned registry-based systematic review, we screened interventional oncology trials with posted results and extracted thyroid-related AE data for descriptive analysis. Across eligible trials, hypothyroidism was consistently reported, with trial-reported proportions ranging from low single digits to over 30%, with the highest frequencies seen in combination ICI regimens. These findings demonstrate that ICI-associated hypothyroidism is frequently reported across clinical trials and support the need for standardized thyroid monitoring, long-term endocrine follow-up, and integration of thyroid toxicity surveillance into survivorship care and health system planning.
Source: Cureus
Authors: Jeffrey Wu, Xuetao Wu, Hong Ren
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
Funder: Massachusetts General Hospital
OpenAlex ID: W7214554325
