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Budesonide Fails as Diarrhoea Prophylactic in Melanoma Patients Receiving Ipilimumab

PHILADELPHIA -- August 11, 2009 -- Treatment with the budesonide in patients with stage III or IV melanoma taking ipilimumab did not reduce rates of diarrhoea, a known side effect of ipilimumab, according to results of a phase 2 trial published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

These findings would "discourage the prophylactic use of budesonide to reduce the gastrointestinal side effects of ipilimumab," said researcher Jeffrey Weber, MD, PhD, a senior member at the Moffitt Cancer Center, Tampa, Florida, and Director, Donald A. Adam Comprehensive Melanoma Research Center, Tampa, Florida.

Weber and colleagues gave 10 mg/kg of ipilimumab to 115 patients every 3 weeks, for 4 doses. This was combined with daily budesonide for 1 group and placebo control for another.

After 4 months of treatment, they found that budesonide did not affect the rate of grade >=2 diarrhoea, which occurred in 32.7% of patients treated with the budesonide compared with 35% of those who received placebo, according to the study. Median overall survival was 17.7 months among those in the ipilimumab/budesonide group and 19.3 months among those in the ipilimumab/placebo group.

Additionally, the researchers saw anti-tumour 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," said Jennifer Grandis, MD, Professor of Otolaryngology and Pharmacology, University of Pittsburgh School of Medicine, and co-leader, Head and Neck Cancer Program, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania. Dr. Grandis is also an editorial board member for Clinical Cancer Research.

"The conclusion that the therapy is active in melanoma is justified, but not particularly novel. The study supports the contention that ipilimumab has use as a treatment in this disease, but more research is needed to elaborate on these findings and unveil ways to manage and potentially reduce side effects associated with this drug's use," she said.

Weber said he was not surprised by the favourable clinical results of this study and agreed that ipilimumab should be pursued in further clinical trials.

"Ipilimumab appears to result in prolonged median and overall survivals in patients with stage IV melanoma," he said. "A significant proportion of patients receiving ipilimumab may have long-term survival."

SOURCE: American Association for Cancer Research

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