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Purpose <p>This retrospective cohort study aimed to evaluate sex-specific differences in the onset, progression, and outcomes of immune checkpoint inhibitor (ICI)-induced overt thyroid dysfunction in a real-world oncology population.</p> Methods <p>We retrospectively screened electronic medical records of 410 patients with cancer, treated with ICIs who developed to thyroid dysfunction (2018–2024). A total of 118 patients with new-onset overt thyroid dysfunction were included. Thyroid dysfunction was classified as thyrotoxicosis and hypothyroidism and analyzed separately. Kaplan–Meier analysis estimated the time to onset, progression from thyrotoxicosis to hypothyroidism, and subsequent recovery or improvement. Group differences were assessed by log-rank tests. Multivariable Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs).</p> Results <p>Among the 118 patients, 53 (44.92%) developed overt thyrotoxicosis and 65 (55.08%), overt hypothyroidism. Median time to onset was 10.00 weeks (interquartile range [IQR]: 6.00–16.75). Thyrotoxicosis onset occurred earlier than hypothyroidism (median: 7.00 weeks; IQR: 5.00–9.00 vs. 14.00 weeks; IQR: 10.00–19.00; <i>P</i> &lt; 0.001). Females experienced earlier thyrotoxicosis onset than males (median: 6.50 vs. 8.00 weeks; adjusted HR: 5.35; 95% CI: 1.10–26.10; <i>P</i> = 0.038). Among patients with overt thyrotoxicosis, 83.02% progressed to hypothyroidism within 7.00 weeks (IQR: 4.75–9.00) with no sex difference. The median recovery time from thyrotoxicosis was 123.50 weeks (IQR: 98.50–145.50), with males showing longer recovery (median 128.00 vs. 105.00 weeks; HR: 0.53; 95% CI: 0.25–1.10; <i>P</i> = 0.042), but it was not significant after adjustment. Among patients with overt hypothyroidism, 88.33% showed improvements within 8.00 weeks (IQR: 5.00–11.00), without a significant sex difference.</p> Conclusions <p>Female patients experience earlier onset of ICI-induced overt thyrotoxicosis and faster recovery from hypothyroidism than males. These sex-specific temporal patterns indicate the need for intensified thyroid monitoring every 2–3 weeks during the first 2 months of ICI therapy in female patients.</p>

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Sex differences in the onset and outcomes of immune checkpoint inhibitor-induced overt thyroid dysfunction: a retrospective study

  • 期刊论文

  • 发表日期：

    2025年10月11日

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  • Yu Bai,
  • Yue Yin,
  • Yuanyuan Jiao,
  • Yanhua Zhang,
  • Hong Liu

摘要

Purpose

This retrospective cohort study aimed to evaluate sex-specific differences in the onset, progression, and outcomes of immune checkpoint inhibitor (ICI)-induced overt thyroid dysfunction in a real-world oncology population.

Methods

We retrospectively screened electronic medical records of 410 patients with cancer, treated with ICIs who developed to thyroid dysfunction (2018–2024). A total of 118 patients with new-onset overt thyroid dysfunction were included. Thyroid dysfunction was classified as thyrotoxicosis and hypothyroidism and analyzed separately. Kaplan–Meier analysis estimated the time to onset, progression from thyrotoxicosis to hypothyroidism, and subsequent recovery or improvement. Group differences were assessed by log-rank tests. Multivariable Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs).

Results

Among the 118 patients, 53 (44.92%) developed overt thyrotoxicosis and 65 (55.08%), overt hypothyroidism. Median time to onset was 10.00 weeks (interquartile range [IQR]: 6.00–16.75). Thyrotoxicosis onset occurred earlier than hypothyroidism (median: 7.00 weeks; IQR: 5.00–9.00 vs. 14.00 weeks; IQR: 10.00–19.00; P < 0.001). Females experienced earlier thyrotoxicosis onset than males (median: 6.50 vs. 8.00 weeks; adjusted HR: 5.35; 95% CI: 1.10–26.10; P = 0.038). Among patients with overt thyrotoxicosis, 83.02% progressed to hypothyroidism within 7.00 weeks (IQR: 4.75–9.00) with no sex difference. The median recovery time from thyrotoxicosis was 123.50 weeks (IQR: 98.50–145.50), with males showing longer recovery (median 128.00 vs. 105.00 weeks; HR: 0.53; 95% CI: 0.25–1.10; P = 0.042), but it was not significant after adjustment. Among patients with overt hypothyroidism, 88.33% showed improvements within 8.00 weeks (IQR: 5.00–11.00), without a significant sex difference.

Conclusions

Female patients experience earlier onset of ICI-induced overt thyrotoxicosis and faster recovery from hypothyroidism than males. These sex-specific temporal patterns indicate the need for intensified thyroid monitoring every 2–3 weeks during the first 2 months of ICI therapy in female patients.