Characterizing Thyroid Hormone Replacement, Baseline Thyrotropin, and Survival in Immune Checkpoint Inhibitor–Associated Thyroid Dysfunction
Authors' conclusion
The levothyroxine dose needed for overt hypothyroidism from ICI-TD is similar to athyreotic hypothyroidism. While baseline TSH in the upper normal range is associated with an increased risk of ICI-TD, there is no absolute baseline TSH value that accurately predicts ICI-TD in the clinical setting.
Study context
- Population
- Adults with cancer who received immune checkpoint inhibitors (ICIs), December 1, 2012 to December 31, 2019; 28 with preexisting primary hypothyroidism excluded; median age 64.8 years, 42.8% womenmedian follow-up 19.2 months
- Participants
- 811 adults
- Exposure
- Patients with ICI-TD vs without
- ICI-TDn = 122
- Outcome
- Incidence of new-onset ICI-TD
- Follow-up
- Median 19.2 months
Methodological detailsKaplan-Meier and log-rank tests, Cox regression addressing immortal time bias
- Kaplan-Meier and log-rank tests
- Cox regression addressing immortal time bias
Main finding
As reported in the abstract
Developed ICI-TD
122
15.0%
Observational data: associations, not effects.
Further findings
| Outcome | ICI-TD | No ICI-TD | P value |
|---|---|---|---|
| Pre-treatment log2(TSH) · median pre-treatmentHigher with ICI-TD | 1.2 | 0.79 | P = 0.008 |
| Corresponding TSH | 2.3 mIU/L | 1.7 mIU/L |
ICI-TD by ICI regimen
- ICI-TD most frequent after combination ICI therapy vs CTLA-4 and PD-1/PD-L1 monotherapy (p = 0.002)
- 32%
Patient characteristics by ICI-TD status
- No significant differences in age, sex, race, malignancy type or personal history of autoimmunity
Levothyroxine dose in overt hypothyroidism
- Median levothyroxine dose, highest in overt hypothyroidism
- 1.41 mcg/kg/day
Pre-treatment log2(TSH) · median pre-treatment
- AUC <0.6, lacking predictive ability
Overall survival (OS)
- Survival benefit of ICI-TD not apparent after addressing immortal time bias and adjusting for other variables
Original publication
Characterizing Thyroid Hormone Replacement, Baseline Thyrotropin, and Survival in Immune Checkpoint Inhibitor–Associated Thyroid Dysfunction. Thyroid. Published 18 June 2025. doi:10.
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