Overall survival (OS) is improved for patients with advanced melanoma who develop moderate colitis after ipilimumab monotherapy. However, this effect does not occur in those treated with dual therapy. These study results were published in The Oncologist.
Ipilimumab monotherapy or ipilimumab/nivolumab dual therapy are FDA-approved treatments for advanced melanoma, but they often cause immune-related adverse events (irAEs). A team of researchers sought to build on a small body of research that suggests that the patients who develop colitis may have improved survival.
The researchers analyzed data from patients with stage IV melanoma who had been treated with anti-CTLA4 therapy between 2008 and 2019. The study included 171 patients who received ipilimumab monotherapy and 91 who received combination therapy with ipilimumab and nivolumab.
Overall, 25 (14.6%) patients in the monotherapy arm developed immune checkpoint inhibitor (ICI)-associated colitis within 90 days of any infusion. Approximately half of the cases were moderate and half were severe. Fourteen (56%) patients received oral glucocorticoid treatment for moderate colitis. Eleven (44%) patients received intravenous glucocorticoids or infliximab for severe colitis.
The researchers found that moderate colitis, which necessitated treatment with oral glucocorticoids, seemed to be associated with an improved overall survival; however, patients receiving dual therapy did not have the same experience.
The results also can inform the ongoing discussion about whether ICIs should be resumed after a discontinuation. These study findings noted high rates of recurrent colitis observed after patients restarted ipilimumab: 60% in the monotherapy group and 80% in the dual therapy group.
“Therefore, this study suggests that in those developing moderate colitis after ICI, there is a high risk of recurrent colitis if restarting anti-CTLA4 and no observed benefit in resumption of ICI on survival,” they stated in their report, adding that this information can guide informed decision making.
The study was limited by its nonrandomized retrospective design at 1 institution, which means the results may not be generalizable.
Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Anstadt EJ, Chu B, Yegya-Raman N, et al. Moderate colitis not requiring intravenous steroids is associated with improved survival in stage IV melanoma after anti-CTLA4 monotherapy, but not combination therapy. Oncologist. 2022;(27)9:799-808. doi:10.1093/oncolo/oyac108