Tuesday, March 27, 2012 (Last Updated: 03/28/2012)TUESDAY, March 27 (HealthDay News) -- For some patients with advanced melanoma and brain metastases, ipilimumab is active, according to the results of a phase 2 study published online March 27 in The Lancet Oncology.
Kim Margolin, M.D., from the University of Washington in Seattle, and colleagues enrolled 72 patients with melanoma and brain metastases into two parallel cohorts to investigate the safety and activity of ipilimumab. Cohort A included 51 patients who were neurologically asymptomatic and were not receiving corticosteroid treatment at the time of study entry, and cohort B included 21 symptomatic patients treated with a stable dose of corticosteroids. Patients received four doses of ipilimumab, one dose every three weeks.
After 12 weeks, the researchers found that nine patients in cohort A and one in cohort B exhibited disease control (18 versus 5 percent). When the brain alone was assessed, disease control was achieved by 12 patients in cohort A and two in cohort B (24 versus 10 percent). Disease control was seen outside the brain in 14 patients in cohort A and one in cohort B (27 versus 5 percent). In cohort A, the most common grade 3 adverse events included diarrhea and fatigue, while in cohort B, they included dehydration, hyperglycemia, and increased serum concentrations of aspartate aminotransferase. Grade 4 confusion was seen in one patient in each cohort.
"Ipilimumab has activity in some patients with advanced melanoma and brain metastases, particularly when metastases are small and asymptomatic. The drug has no unexpected toxic effects in this population," the authors write.
Several authors disclosed financial ties to Bristol-Myers Squibb, which funded the trial and manufactures ipilimumab.
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