Table 2 IrEC management and outcomes
Patient | ICI type/dose | Initial management | Number of steroid tapering attempts | Infliximab Dose-frequency | Doses of infliximab to clinical remission | Doses of ICI concurrently administered with infliximab | Follow up endoscopy on concurrent treatment (months) | Recurrence | # of months of follow-up on ICI/on concurrent therapy | Disease progression/Follow up |
|---|---|---|---|---|---|---|---|---|---|---|
1 | Pembrolizumb Dose: 3 mg/kg Frequency: every 3 weeks | Prednisone 40 mg > 60 mg PO daily> taper failure +azithromycin + metronidazole | 2 | 5 mg/kg - every 2 weeks for first 2 doses then every 6 weeks | 1 | 12 | Flexible Sigmoidoscopy (4 months): Endoscopic: erythematous mucosa in sigmoid, normal colon for 40 cm Histologic: Mild active chronic colitis | Patient 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 discontinued | 14.5/10.5 | - Staging scans after concurrent therapy (12 doses) showed stable disease - Developed retroperitoneal bleed and was transitioned to hospice care |
2 | Ipilimumab/Nivolumab Dose: Ipilimumab-1 mg/kg, Nivolumab- 240 mg (3 mg/kg) Frequency: combined every 6 weeks (4 doses total) followed by nivolumab alone every 2 weeks | Prednisone 60 mg PO daily>taper | 1 | 5 mg/kg - every 2 weeks for first 2 doses then every 4 weeks | 1 | 3 doses of (ipilimuab+Nivolumab) and 12 doses of nivolumab alone | Upper 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 erosion Histologic: - Gastric body: lymphocytic involvement of gastric pits - Duodenum: no diagnostic abnormality - Duodenal stricture: ulceration and expansion of lamina propria by mononuclear cells | No | 12/7.5 | - Staging scans after concurrent therapy (15 doses) showed stable disease and patient continues concurrent therapy - Developed mucositis/stomatitis that is being managed conservatively |
3 | Ipilimumab Dose: 3 mg/kg Frequency: every 3 weeks | Methylprednisolone 1 mg/kg IV twice daily >taper failure | 1 | 5 mg/kg - every 4 weeks | 1 | 2 | Not done | No | 6.5/3.5 | - 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 |
4 | Ipilimumab/Nivolumab Dose: Ipilimumab-3 mg/kg, Nivolumab-1 mg/kg Frequency: combined every 3 weeks | Prednisone 60 mg daily>taper failure | 1 | 5 mg/kg - every 4 weeks | 1 | 3 | Upper endoscopy (1 month): Endoscopic/histologic - Stomach: normal/chronic inactive gastritis - Duodenum Normal/normal Colonoscopy (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 distortion | No | 5/3 | - Staging scans showed interval progression of his disease in the chest, abdomen and pelvis. |
5 | Cemiplimab Dose: 350 mg Frequency: every 3 weeks | Prednisone 60 mg daily>taper failure | 1 | 5 mg/kg - once | 1 | 2 | Not done | No | 4/2.5 | - 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 |