Immune Checkpoint Inhibitors Linked with Enterocolitis Flare in 25% Patients with Pre-Existing Colitis

Just over a quarter of patients with pre-existing colitis who received immune checkpoint inhibitors for cancer treatment experienced an enterocolitis flare and discontinued the treatment, according to a study published online in JCO Oncology Practice.

“Enterocolitis is among the leading adverse events associated with immune checkpoint inhibitors. There are limited retrospective data regarding the safety of immune checkpoint inhibitors in patients with inflammatory bowel disease because they have been generally excluded from clinical trials testing immune checkpoint inhibitors,” researchers wrote. “Furthermore, there are no outcome data available in patients with microscopic colitis, a leading cause of chronic diarrhea.”

Researchers from Dana-Farber Cancer Institute and Brigham and Women’s Hospital reviewed the records of 548 patients with cancer treated with at least one dose of either a programmed cell death-1 (PD-1)/PD-1 ligand inhibitor, cytotoxic T-lymphocyte-associated antigen 4 inhibitor, or both between 2011 and 2018. Among them, 25 had pre-existing colitis: 21 with inflammatory bowel disease and four with microscopic colitis.
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Seven patients with pre-existing colitis, or 28%, experienced an enterocolitis flare with immune checkpoint inhibitor treatment, according to the study. Enterocolitis flares occurred in three of the four patients with microscopic colitis and in four of the 21 patients with inflammatory bowel disease. All subsequently stopped immune checkpoint inhibitor therapy.

While all seven patients were treated with systemic corticosteroids, two required an anti–tumor necrosis factor agent, and one required an anti-integrin agent and colectomy for refractory colitis, researchers reported.

“In our cohort, exacerbation of enterocolitis occurred in a notable percentage of patients with inflammatory bowel disease and a majority of patients with microscopic colitis, leading to discontinuation of immune checkpoint inhibitors,” they wrote. “Although these data suggest that patients with cancer with pre-existing inflammatory bowel disease/microscopic colitis may be treated with immune checkpoint inhibitors, additional studies are needed to validate our results.”

—Jolynn Tumolo

Reference

Grover S, Ruan AB, Srivoleti P, et al. Safety of immune checkpoint inhibitors in patients with pre-existing inflammatory bowel disease and microscopic colitis [published online ahead of print May 13, 2020]. JCO Oncol Pract. doi:10.1200/JOP.19.00672