Severe terminal ileitis induced by single-agent nivolumab administered every four weeks

Abstract

Introduction Use of immune checkpoint inhibitors has expanded to a variety of malignancies including hepatocellular carcinoma, where nivolumab and pembrolizumab have shown durable responses in approximately a sixth of patients. Case report We report herein a patient with metastatic hepatocellular carcinoma who achieved a durable response to the second-line agent nivolumab administered intravenous 240 mg every two weeks. After 18 months of therapy, nivolumab schedule was changed to intravenous 480 mg every four weeks, per patient’s request and for convenience of administration. Four days after this change, the patient developed severe terminal ileitis. Management and outcome: This condition was managed in hospital with intravenous steroids. The patient improved clinically and was discharged on an oral steroid taper. A month later, nivolumab was reinstated at 200 mg intravenous infusions every two weeks, without any re-occurrence of terminal ileitis to date as of six months after the probable drug reaction. Discussion To our knowledge, this is the first report of terminal ileitis with nivolumab administered every four weeks. As postmarketing evaluation of nivolumab continues, similar side effects may be observed. Prompt diagnosis and steroid therapy in these cases are imperative to ensure a favorable outcome. Resuming immunotherapy once the adverse event has resolved appears to be a safe option.

Immune checkpoint inhibitor-induced myocarditis and myositis in liver cancer patients: A case report and literature review

“…Constantin et al. reported a case of Immune terminal ileitis due to an increasing dose of Nivolumab in a 58-year-old HCC man ( 33 ). Many patients were treated with targeted agents during immunotherapy ( Table 1 ).…”

Differential to Terminal Ileitis: Terminal Ileum Neuroendocrine Tumor Identified on Screening Colonoscopy

“…Immune checkpoint inhibitors have been found to cause terminal ileitis. 16 The withdrawal of the offending drugs results in resolution of the findings. In some cases, treatment with systemic steroids may be required.…”