Among patients with metastatic melanoma, treatment with sargramostim plus ipilimumab, compared with ipilimumab alone, resulted in longer overall survival and lower toxicity, although there was no difference in progression-free survival (PFS), according to a study published in the November 5 issue of JAMA.
F. Stephen Hodi, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, and colleagues conducted a phase 2 clinical trial in which 245 patients with unresectable stage Ill or IV melanoma were randomised to receive ipilimumab on day 1 plus sargramostim on days 1 to 14 of a 21-day cycle (n = 123) or ipilimumab alone (n = 122).
The researchers compared the effect of these treatments on length of overall survival, PFS, response rate, safety, and tolerability. Median follow-up was 13.3 months.
The overall survival was significantly improved with the addition of sargramostim to ipilimumab. The median overall survival was 17.5 months for the ipilimumab plus sargramostim group and 12.7 months for the ipilimumab-only group. The 1-year overall survival was 68.9% for the combination treatment group and 52.9% for the ipilimumab-only group. There was no difference in progression-free survival.
Adverse events were more common in the ipilimumab-only group. Toxicity was significantly lower in the ipilimumab plus sargramostim group than in the ipilimumabonly group.
"This randomised phase 2 study supports the evidence that the addition of sargramostim to ipilimumab therapy improved overall survival in patients with metastatic melanoma," the authors wrote. "These findings require confirmation in larger sample sizes and with longer follow-up."
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