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Immune-related Adverse Events from Immune Checkpoint Inhibitor Therapy

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23 Table 2. Gastrointestinal (GI) Toxicities G1: Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline. • Continue ICPi. Alternatively, ICPi may be held temporarily and resumed if toxicity does not exceed Grade 1 or resolves. • May also include supportive care with medications such as loperamide if infection has been ruled out in patients with diarrhea only and not colitis-related symptoms as a temporary measure. • Monitor for dehydration and recommend dietary changes. • Patient should be closely monitored by phone or electronic medical system for symptoms changes by clinical providers every 3 days or more frequently if needed until stabilized. • May obtain gastroenterolog y consult for prolonged G1 cases and consider endoscopy with biopsies. G2: Increase of 4–6 stools per day over baseline; moderate increase in ostomy output compared to baseline. • Hold ICPi at least until recovery to G1 — see last bullets. • May also include supportive care with medications such as loperamide if infection has been ruled out in patients with diarrhea only and not colitis-related symptoms as a temporary measure. • Consider consult with gastroenterology for ≥G2. • Administer corticosteroids, unless diarrhea is transient, starting with initial dose of 1 mg/kg/day prednisone or equivalent until symptoms improve to G1, and then start taper over 4–6 weeks. • Consider adding narrower-spectrum/more potent agents, including anti-tumor necrosis factor (infliximab) or anti- integrin (vedolizumab) antibody to patients whose colitis is corticosteroid-refractory (i.e., no decrease by one grade in 72 hours) or dependent or with high-risk endoscopic features * on initial endoscopy exam. • When symptoms improve to ≤G1, taper corticosteroids over 4–6 weeks; may consider shorter tapers in patients also treated with biologics. • Endoscopic evaluation with esophagogastroduodenoscopy/colonoscopy is highly recommended for cases Grade ≥2 to stratify patients for early treatment of biologics based on the endoscopic findings. • Resuming ICPi after symptoms improve to

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