Suspected Immune-Related Adverse Event
New symptoms in patient on ICI therapy
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Hematology & OncologyManagement
Immune Checkpoint Inhibitor Toxicity (irAE) Management
Immune Checkpoint Inhibitor Toxicity (irAE) Management: Suspected Immune-Related Adverse Event → Recognize Common irAEs → Grade Toxicity (CTCAE v5.0) → ...
Pathway Overview
14 steps
Algorithm Steps
14 total
01Start 02Action Recognize Common irAEs
Timing varies by organ system
- COMMON irAEs by organ:
- • Skin: Rash, pruritus (most common, early)
- • GI: Diarrhea, colitis (esp. anti-CTLA-4)
- • Hepatic: Elevated transaminases
- • Pulmonary: Pneumonitis, cough, dyspnea
- • Endocrine: Thyroid dysfunction, hypophysitis
- • Renal: Nephritis
- • Neurologic: Neuropathy, encephalitis, myasthenia
- • Cardiac: Myocarditis (rare but serious)
03Decision Grade Toxicity (CTCAE v5.0)
Severity guides management
- Grade 1: Mild, asymptomatic or mild symptoms
- Grade 2: Moderate, limiting ADLs
- Grade 3: Severe, limiting self-care ADLs
- Grade 4: Life-threatening
- Grade 5: Death
04Action Grade 1 Management
Continue ICI with monitoring
- Most Grade 1: Continue ICI therapy
- Close monitoring
- Symptomatic management
- EXCEPTIONS - Hold ICI even Grade 1:
- • Cardiac (myocarditis)
- • Neurologic (certain)
- • Hematologic
05Action Organ-Specific Considerations
Key differences by system
- MYOCARDITIS: Troponin, ECG, echo - cardiology stat
- PNEUMONITIS: CT chest, bronchoscopy if uncertain
- COLITIS: Colonoscopy if severe/refractory
- HEPATITIS: Rule out viral hepatitis
- HYPOPHYSITIS: AM cortisol, pituitary MRI
- THYROID: TSH, free T4 - may need replacement
- ADRENAL: Morning cortisol, stress dose steroids
06Decision Rechallenge Decision
Consider resuming ICI?
- GENERALLY SAFE TO RECHALLENGE:
- • Grade 1-2 that resolved with steroids
- • Endocrinopathies (on replacement)
- • Dermatologic (most)
- GENERALLY AVOID RECHALLENGE:
- • Grade 4 toxicity (except endocrine)
- • Myocarditis (any grade)
- • Severe pneumonitis
- • Neurologic: Guillain-Barré, myasthenia
- CAUTION: Anti-CTLA-4 has higher irAE recurrence
07Action Resume ICI Therapy
With close monitoring
- Resume when toxicity ≤Grade 1
- Steroids tapered to ≤10mg prednisone
- Close monitoring for recurrence
- Consider single-agent anti-PD-1 if combo caused toxicity
- ~50% may experience recurrence of same irAE
08Outcome irAE Managed
Continue appropriate cancer care
09Action Permanently Discontinue ICI
Alternative cancer therapy
- Consider alternative cancer treatments
- Long-term monitoring for chronic irAEs
- Hormone replacement if endocrinopathy
- Multidisciplinary follow-up
- Path rejoins step 08Shared downstream outcome
10Action Grade 2 Management
Hold ICI, consider steroids
- HOLD ICI therapy
- May initiate corticosteroids:
- • Prednisone 0.5-1 mg/kg/day
- • Or equivalent methylprednisolone
- Subspecialty consultation as needed
- Resume ICI when ≤Grade 1 AND steroid ≤10mg/day
- If no improvement in 2-3 days: escalate to Grade 3 treatment
11Decision Steroid-Refractory?
No improvement after 48-72h of high-dose steroids
12Action Additional Immunosuppression
Based on organ system
- COLITIS:
- • Infliximab 5 mg/kg (if no perforation)
- • Vedolizumab alternative
- HEPATITIS:
- • Mycophenolate mofetil
- • Avoid infliximab (hepatotoxic)
- PNEUMONITIS:
- • Infliximab or mycophenolate
- MYOCARDITIS:
- • Add infliximab, IVIG, or plasmapheresis
- • Cardiology involvement critical
13Action Steroid Taper
Once improved to Grade ≤1
- Taper over at least 4-6 weeks
- Faster tapers associated with flares
- Monitor for recurrence during taper
- Some organs need longer taper (pneumonitis, hepatitis)
- PPI and PCP prophylaxis during high-dose steroids
- Path rejoins step 05Shared downstream outcome
- Path rejoins step 13Shared downstream outcome
14Action Grade 3-4 Management
Hold ICI, high-dose steroids
- HOLD ICI therapy (may be permanent)
- HIGH-DOSE STEROIDS:
- • Prednisone 1-2 mg/kg/day OR
- • Methylprednisolone 1-2 mg/kg/day IV
- Hospitalization often required for Grade 3-4
- Subspecialty consultation mandatory
- Consider anti-CTLA-4 discontinuation after severe irAE
- Path rejoins step 11Shared downstream outcome
Guideline Source
ASCO Guideline: Management of Immune-Related Adverse Events
Clinical Safety Information
Clinical Decision Support — Not a Substitute for Clinical Judgment
Individual patient factors may require deviation from these recommendations.
Known Limitations
- Organ-specific management varies - consult subspecialty
- Some rare irAEs not covered in detail
- Steroid dosing may vary by severity and organ
- Rechallenge decisions are complex and individualized
Applicable Regions
USEU
Version 1Next review: 2027-01-11
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Frequently Asked Questions
What is the Immune Checkpoint Inhibitor Toxicity (irAE) Management?
The Immune Checkpoint Inhibitor Toxicity (irAE) Management is a management clinical algorithm for Hematology & Oncology. It provides a structured decision tree to guide clinical decision-making, based on ASCO Guideline: Management of Immune-Related Adverse Events.
What guideline is the Immune Checkpoint Inhibitor Toxicity (irAE) Management based on?
This algorithm is based on ASCO Guideline: Management of Immune-Related Adverse Events (DOI: 10.1200/JCO.21.01440).
What are the limitations of the Immune Checkpoint Inhibitor Toxicity (irAE) Management?
Known limitations include: Organ-specific management varies - consult subspecialty; Some rare irAEs not covered in detail; Steroid dosing may vary by severity and organ; Rechallenge decisions are complex and individualized. Individual patient factors may require deviation from these recommendations.
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