Budesonide did not improve diarrhea in ipilimumab-treated metastatic melanoma

The use of budesonide to lessen the diarrhea associated with ipilimumab was not effective, according to the findings of a multicenter, phase-2 trial.

One hundred and fifteen previously treated or treatment-naive patients with unresectable stage III or IV melanoma received ipilimumab 10 mg/kg every three weeks for four doses and were randomly assigned daily budesonide (Entocort EC, AstraZeneca), a nonabsorbed oral steroid, or placebo.

The rate of grade-2 diarrhea or higher was similar between the budesonide group (32.7%) and the placebo group (35%). Twenty-eight percent of patients in the treatment group and 32% of patients in the placebo group experienced one event of grade-2 diarrhea or higher, and adverse effects were similar between groups.

Adverse events of any grade were observed in 90% of the treatment group and 95% of the placebo group. Any grade immune-related adverse events were reported by 81% of patients in the budesonide group and by 84% of patients in the placebo group.

Clinical benefit was still observed with ipilimumab, however. The best overall response rate was 12.1% in the budesonide group and 15.8% in the placebo group, and median OS was 17.7 months in the treatment group and 19.3 months in the group assigned to placebo.

“The findings from this study do not support the routine prophylactic use of budesonide for the prevention of grade ≥2 diarrhea at the dose and schedule investigated, although it is still considered for the management of low-grade diarrhea and early colitis associated with ipilimumab,” the researchers said.

Weber J. Clin Cancer Res. 2009;doi:10.1158/1078-0432.CCR-09-1024.