24
Treatment
Table 2. Gastrointestinal (GI) Toxicities
G3: Increase of ≥7
stools per day over
baseline; incontinence;
hospitalization indicated;
severe increase in ostomy
output compared to
baseline; limiting self-care
ADL.
Follow G2 recommendations as listed, with the
following additions for G3:
• Administer corticosteroids (initial dose of 1 to 2 mg/
kg/day prednisone or equivalent) until symptoms
improve to G1, and then start taper over 4–6 weeks.
Consider IV methylprednisolone, especially if concern
for concurrent upper GI inflammation.
• Consider early introduction of infliximab or
vedolizumab in addition to steroids in patients with
high-risk endoscopic features
*
on initial endoscopy
exam or inadequate response to steroids (persistent
symptoms after 3 days).
• Consider hospitalization for patients with dehydration
or electrolyte imbalance.
• Consider repeat colonoscopy in patients who are
immunosuppression-refractory.
• Should consider permanently discontinuing CTLA-4
agents.
G4: Life-threatening
consequences; urgent
intervention indicated.
Follow G2–G3 recommendations as listed, with the
following additions for G4:
• Permanently discontinue treatment.
• Should provide inpatient care.
• Administer 1 to 2 mg/kg/day methylprednisolone or
equivalent until symptoms improve to G1, and then
start taper over 4–6 weeks.
• Consider early biologics (infliximab or vedolizumab) if
inadequate response to steroids after 3 days. Consider
lower GI endoscopy if symptoms are refractory despite
treatment or there is concern of new infections.
Additional Considerations:
• May consider fecal microbiota transplant, JAK inhibitor tofacitinib or interleukin
(IL) -12 blocking antibody ustekinumab in patients who are refractory to the previous
immunosuppressants.
• Patients with both irAE-related hepatitis and irAE-related colitis are less common,
and management may include permanently discontinuing ICPi and offering other
immunosuppressant agents (e.g., prednisone, mycophenolate) that work systemically
for both conditions. Infliximab is contraindicated for hepatic irAE.
• Currently, enteritis and/or gastritis alone as the cause of gastrointestinal toxicity is
uncommon and endoscopy with biopsy is recommended as the evaluation tool. It may
be managed similarly to colitis including steroid and/or biologics etc.
*
High-risk endoscopic features include large deep ulceration, multiple ulcers, and extensive colitis
beyond le colon.
(cont'd)