IrEC management and outcomes

PatientICI type/doseInitial managementNumber of steroid tapering attemptsInfliximabDose-frequencyDoses of infliximab to clinical remissionDoses of ICI concurrently administered with infliximabFollow up endoscopy on concurrent treatment (months)Recurrence# of months of follow-up on ICI/on concurrent therapyDisease progression/Follow up
1PembrolizumbDose: 3 mg/kgFrequency: every 3 weeksPrednisone 40 mg > 60 mg PO daily> taper failure+azithromycin + metronidazole25 mg/kg- every 2 weeks for first 2 doses then every 6 weeks112Flexible Sigmoidoscopy (4 months):Endoscopic: erythematous mucosa in sigmoid, normal colon for 40 cmHistologic: Mild active chronic colitisPatient developed Clostridium difficile colitis then flare of irEC.Treatment:- Infliximab 10 mg/kg- Methylprednisolone 1 mg/kg BID then prednisone 75 mg PO BID followed by a taper- PO vancomycin- Immunotherapy was discontinued14.5/10.5- Staging scans after concurrent therapy (12 doses) showed stable disease- Developed retroperitoneal bleed and was transitioned to hospice care
2Ipilimumab/NivolumabDose:Ipilimumab-1 mg/kg, Nivolumab- 240 mg (3 mg/kg)Frequency: combined every 6 weeks (4 doses total) followed by nivolumab alone every 2 weeksPrednisone 60 mg PO daily>taper15 mg/kg- every 2 weeks for first 2 doses then every 4 weeks13 doses of (ipilimuab+Nivolumab) and 12 doses of nivolumab aloneUpper endoscopy (3 months):Endoscopic:- Gastric body: localized mild inflammation characterized by erythema and friability- Duodenum: an acquired benign-appearing, intrinsic moderate stenosis was found in the second portion of the duodenum associated with a small erosionHistologic:- Gastric body: lymphocytic involvement of gastric pits- Duodenum: no diagnostic abnormality- Duodenal stricture: ulceration and expansion of lamina propria by mononuclear cellsNo12/7.5- Staging scans after concurrent therapy (15 doses) showed stable disease and patient continues concurrent therapy- Developed mucositis/stomatitis that is being managed conservatively
3IpilimumabDose: 3 mg/kgFrequency: every 3 weeksMethylprednisolone 1 mg/kg IV twice daily >taper failure15 mg/kg- every 4 weeks12Not doneNo6.5/3.5- Staging scans showed stable bulk of disease after concurrent therapy (2 doses) with ongoing slight progression in one metastatic lesion in the lung- Developed skin rash (ipilimumab cutaneous toxicity) that was managed successfully with topical steroids
4Ipilimumab/NivolumabDose:Ipilimumab-3 mg/kg, Nivolumab-1 mg/kgFrequency: combined every 3 weeksPrednisone 60 mg daily>taper failure15 mg/kg- every 4 weeks13Upper endoscopy (1 month):Endoscopic/histologic- Stomach: normal/chronic inactive gastritis- Duodenum Normal/normalColonoscopy (1 month):- Sigmoid/transverse colon ulcers: fragments of colonic mucosa with crypt architectural disarray and mildly increased cellularity of the lamina propria.Colonoscopy(3 months)- Colonic mucosa with scattered crypt epithelial apoptosis and minimal crypt architectural distortionNo5/3- Staging scans showed interval progression of his disease in the chest, abdomen and pelvis.
5CemiplimabDose: 350 mgFrequency: every 3 weeksPrednisone 60 mg daily>taper failure15 mg/kg- once12Not doneNo4/2.5- Staging scans demonstrated interval decrease in the disease burden in the chest and lymph nodes- Patient developed radiation/checkpoint pneumonitis and was treated with high dose oral steroids