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Updated: Sep 9, 2025

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Adrenal Insufficiency During Treatment With Immune-Checkpoint Inhibitors: How to Simplify the Diagnostic Pathway?

Alice Nervo1, Giovanni Gruosso1, Marta Marino2

  • 1Oncological Endocrinology Unit, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.

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|August 28, 2025
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Summary

Early identification of adrenal insufficiency (AI) in patients on immune-checkpoint inhibitors (ICIs) is vital. This study suggests refining morning serum cortisol cut-offs can reduce the need for further testing, improving AI diagnosis.

Keywords:
hypothalamic–pituitary–adrenal axisimmunotherapyisolated ACTH deficiencysalivary cortisolsalivary cortisoneserum cortisol

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Area of Science:

  • Endocrinology
  • Oncology
  • Clinical Diagnostics

Background:

  • Adrenal insufficiency (AI) is a critical concern in patients receiving immune-checkpoint inhibitors (ICIs).
  • Diagnosing AI during ICI therapy presents significant challenges.
  • Early detection is crucial to prevent severe health complications.

Purpose of the Study:

  • To refine diagnostic criteria for AI in ICI-treated patients.
  • To reduce the need for dynamic testing by optimizing morning serum cortisol (SC) cut-offs.
  • To explore the utility of salivary cortisol and cortisone as alternative biomarkers.

Main Methods:

  • Prospective observational study of ICI-treated cancer patients.
  • Analysis of morning SC, peak SC after low-dose ACTH stimulation test, and salivary cortisol/cortisone.
  • Evaluation of different SC thresholds (Endocrine Society guidelines and assay-specific cut-offs) for AI diagnosis.

Main Results:

  • A strong positive correlation was found between morning and peak stimulated SC (r=0.72).
  • Receiver operating characteristic (ROC) curve analysis defined optimal morning SC thresholds for AI prediction and exclusion.
  • Salivary cortisol and cortisone upon awakening showed positive correlations with peak stimulated SC (r=0.49 and r=0.56, respectively).

Conclusions:

  • Morning serum cortisol is a reliable screening tool for ICI-related AI.
  • Implementing assay-specific cut-offs can decrease the necessity for dynamic stimulation tests.
  • Salivary hormone analysis may serve as a practical alternative in specific clinical scenarios.