Metastatic melanoma patients treated with sargramostim and ipilimumab experienced longer overall survival and less toxicity than patients treated with ipilimumab alone.
Metastatic melanoma patients treated with sargramostim and ipilimumab experienced longer overall survival and less toxicity than patients treated with ipilimumab alone. However, the combination therapy did not increase progression-free survival, according to a study published November 5, 2014 in the Journal of the American Medical Association (JAMA).
Researchers at the Dana-Farber Cancer Institute, Boston, studied 245 patients with unresectable stage III or stage IV melanoma. Subjects were randomly assigned to receive intravenous ipilimumab on day one, along with sargramostim, injected into the skin on days one to 14, on a 21-day cycles, or ipilimumab only.
When they compared the two treatments, researchers found median overall survival was 17.5 months in combination therapy group versus 12.7 months among ipilimumab-only patients. One-year overall survival was 68.9 percent in the ipilimumab plus sargramostim group and 52.9 percent with ipilimumab only.
Patients in the ipilimumab-only group suffered more adverse events and higher toxicity than those in the combination therapy group.
“Although the overall adverse effect profile was consistent with that reported previously for ipilimumab, there were significantly fewer high-grade treatment-related events, including deaths that occurred in patients receiving sargramostim. Most notably the combination showed a difference in serious gastrointestinal toxicities, particularly colonic perforation,” the authors write.
While the findings of this phase 2 trial need confirmation in larger studies, with longer followup, the authors write their research findings support evidence that sargramostim added to ipilimumab improves metastatic melanoma overall survival.
Source: Hodi SF, Lee S, McDermott DF, Rao UN, Butterfield LH, Tarhini AA, Leming P, Puzanov I, Shin D, Kirkwood JM. Ipilimumab Plus Sargramostim vs Ipilimumab Alone for Treatment of Metastatic Melanoma: A Randomized Clinical Trial. JAMA. 2014;312(17):1744-1753.