Head & neck · 2026
Calculating Glucagon-Like Pepide-1 Receptor Agonist-Associated Medullary Thyroid Cancer Risk: A Novel Integration of the Surveillance, Epidemiology and End Results Cancer Registry and the FDA Adverse Event Reporting System.
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D'Arcy Stella J, Kennedy Sophia L, Thomas Jerin A, Rahman Husneara, Sison Cristina, Kamdar Dev, Periera Lucio, Miles Brett, Frank Douglas, Seetharamu Nagashree, Taneja Charit, Mandal Rajarsi
Аннотация
BACKGROUND: GLP-1 receptor agonists carry an FDA boxed warning for medullary thyroid carcinoma (MTC) risk, though conflicting clinical evidence has generated tremendous controversy regarding this association.
METHODS: We analyzed SEER and FAERS databases to compare MTC and papillary thyroid cancer (PTC) reporting proportions (RP) between the general population and GLP-1RA users (n = 109 168), controlling for surveillance bias by comparing against other endocrine and non-endocrine drugs. Negative binomial regression was used to estimate the incidence rate ratios (IRR) in the FAERS dataset among patients with reported AEs.
RESULTS: The 10-year mean MTC RP in SEER/FAERS was 0.0002%/0.0014%, while PTC was 0.012%/0.0087%. Strikingly, GLP-1RA users showed increased RPs as compared to the total FAERS RPs: MTC 0.071% (50.7-fold increase) and PTC 0.164% (18.9-fold increase) with significantly elevated IRRs (p = 0.0001) compared to reference groups.
CONCLUSION: GLP-1RAs showed a higher RP for MTC compared to other drug classes, warranting prospective studies to investigate further.
METHODS: We analyzed SEER and FAERS databases to compare MTC and papillary thyroid cancer (PTC) reporting proportions (RP) between the general population and GLP-1RA users (n = 109 168), controlling for surveillance bias by comparing against other endocrine and non-endocrine drugs. Negative binomial regression was used to estimate the incidence rate ratios (IRR) in the FAERS dataset among patients with reported AEs.
RESULTS: The 10-year mean MTC RP in SEER/FAERS was 0.0002%/0.0014%, while PTC was 0.012%/0.0087%. Strikingly, GLP-1RA users showed increased RPs as compared to the total FAERS RPs: MTC 0.071% (50.7-fold increase) and PTC 0.164% (18.9-fold increase) with significantly elevated IRRs (p = 0.0001) compared to reference groups.
CONCLUSION: GLP-1RAs showed a higher RP for MTC compared to other drug classes, warranting prospective studies to investigate further.