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Aims <p>To assess the risk of new-onset type 1 diabetes mellitus (T1DM) and diabetic ketoacidosis (DKA) in metastatic cancer patients treated with immune checkpoint inhibitors (ICIs) compared to those receiving non-ICI therapies.</p> Method <p>A retrospective cohort study using TriNetX global electronic health records (2014–2025) from multiple healthcare systems. Adult metastatic cancer patients initiating ICI or non-ICI therapy were included. Patients with preexisting diabetes within 6 months were excluded. After 1:1 propensity score matching, 25,463 patients remained in each group. Outcomes were identified by ICD-10 codes.</p> Results <p>Median follow-up was 764 days (ICI) vs. 692 days (non-ICI). ICI use was associated with a higher risk of T1DM (HR, 2.35; 95% CI, 1.81–3.04) and DKA (HR, 10.58; 95% CI, 4.21–26.59). Cumulative incidence analyses supported these findings, with ICIs showing higher risks of T1DM (0.75% vs. 0.32%; RR, 2.32 [95% CI, 1.79-3.00]) and DKA (0.20% vs. 0.04%; RR, 5.00 [95% CI, 2.54–9.86]). Subgroup analyses identified elevated baseline HbA1c (&gt; 6.0%), male sex, white race, and dual checkpoint blockade as high-risk factors.</p> Conclusion <p>ICIs significantly increase the risk of T1DM and DKA. These findings highlight the need for vigilant glycemic monitoring in cancer patients treated with ICIs, especially within identified high-risk subgroups.</p>

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Immune checkpoint inhibitor therapy and risk of type 1 diabetes mellitus in metastatic cancer patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月3日

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  • Ming-Hsun Lin,
  • Ren-Hua Ye,
  • Hong-Jie Jhou,
  • Hsin-Yu Chen,
  • Li-Ting Kao,
  • Tina Yi-Jin Hsieh,
  • Yu-Han Chen,
  • Andrea Yue-En Sun,
  • Xiaoyi Zhang,
  • Ming-Shen Dai,
  • Ching-Liang Ho,
  • Po-Huang Chen,
  • Cho-Hao Lee

摘要

Aims

To assess the risk of new-onset type 1 diabetes mellitus (T1DM) and diabetic ketoacidosis (DKA) in metastatic cancer patients treated with immune checkpoint inhibitors (ICIs) compared to those receiving non-ICI therapies.

Method

A retrospective cohort study using TriNetX global electronic health records (2014–2025) from multiple healthcare systems. Adult metastatic cancer patients initiating ICI or non-ICI therapy were included. Patients with preexisting diabetes within 6 months were excluded. After 1:1 propensity score matching, 25,463 patients remained in each group. Outcomes were identified by ICD-10 codes.

Results

Median follow-up was 764 days (ICI) vs. 692 days (non-ICI). ICI use was associated with a higher risk of T1DM (HR, 2.35; 95% CI, 1.81–3.04) and DKA (HR, 10.58; 95% CI, 4.21–26.59). Cumulative incidence analyses supported these findings, with ICIs showing higher risks of T1DM (0.75% vs. 0.32%; RR, 2.32 [95% CI, 1.79-3.00]) and DKA (0.20% vs. 0.04%; RR, 5.00 [95% CI, 2.54–9.86]). Subgroup analyses identified elevated baseline HbA1c (> 6.0%), male sex, white race, and dual checkpoint blockade as high-risk factors.

Conclusion

ICIs significantly increase the risk of T1DM and DKA. These findings highlight the need for vigilant glycemic monitoring in cancer patients treated with ICIs, especially within identified high-risk subgroups.