Patients with unresectable stage III or IV melanoma taking ipilimumab and the oral steroid budesonide(Drug information on budesonide) to reduce side effects did not have less diarrhea, according to results of a phase II trial.
These findings would "discourage the prophylactic use of budesonide to reduce the gastrointestinal side effects of ipilimumab," said lead researcher Jeffrey Weber, MD, PhD, director of the Donald A. Adam Comprehensive Melanoma Research Center in Tampa, Fla.
Dr. Weber and colleagues gave 10 mg/kg of ipilimumab to 115 patients every three weeks for four doses. This was combined with daily budesonide for one group and placebo control for another.
After four months of treatment, they found that budesonide did not affect the rate of diarrhea—it occurred in 32.7% of patients treated with the drug and 35% of those who received placebo. Median overall survival was 17.7 months among those treated with budesonide compared with 19.3 months among those who received placebo (Clin Cancer Res online, August 11, 2009).
Additionally, the researchers saw antitumor responses in 10% to 15% of patients without an apparent difference between patients treated with budesonide and those who received placebo.
"This study attempted to decrease the side effects of ipilimumab by using a preventative enteric steroid regimen. This approach failed to accomplish that goal," commented Jennifer Grandis, MD, an editorial board member for Clinical Cancer Research.