Results from a phase II study published in the Journal of the American Medical Association, revealed that life expectancy of patients with advanced melanoma might be increased if these are treated with a combination of ipilimumab (Yervoy) and sargramostim, compared to ipilimumab alone.
Skin cancer is by far the most common of all cancers, and although Melanoma accounts for less than 2% of cases, it is responsible for the majority of skin cancer deaths. The American Cancer Society’s estimations for melanoma in the United States in 2014 are of 76,100 new cases and of 9,710 deaths, with a rising trend. Since it is a treatable condition early detection of melanoma is fundamental for a good outcome.
In a non-blinded randomised controlled trial, F. Stephen Hodi, M.D., an assistant professor of medicine at the Dana-Farber Cancer Institute in Boston, and colleagues, allocated 245 patients with metastatic melanoma (stage III or IV) to treatment with intravenous ipilimumab alone (anti-CLTA-4 antibody) or ipilimumab plus injections of sargramostim (a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator). The patients were followed for a median of 13.3 months.
Results revealed that the patients who were given the treatment combination had a median survival of 17.5 months, compared to 12.7 months for those patients on ipilimumab alone. At follow-up, overall survival was nearly of 69% for those on the combination therapy, and of 53% for those on ipilimumab alone. However, although the group under combo therapy tended to live longer, both groups had an identical progression-free-survival of 3.1 months.
Conclusions for this study reflect that among patients with unresectable stage III or stage IV melanoma, treatment with a combination of sargramostim plus ipilimumab, compared with ipilimumab alone, resulted in longer overall survival and lower toxicity, but no difference in progression-free survival. However, “patients did live longer, as well as having less serious side effects, when given the combination,” Dr. Hodi said in an WebMD news release.
Larger clinical trials with longer follow-up are required to corroborate these findings, but as Dr. Hodi stated “this opens the possibility of improving clinical outcomes and decreasing serious side effects in treating advanced melanoma with ipilimumab.”.
Moreover, “the future is really with combination therapies, how we combine targeted therapies, and the results of this trial suggest that the combination of sargramostim and ipilimumab should be part of that mix,” Dr. Hodi concluded.
Research advances such as the ones reported in this study, if replicated, could alter the poor outcome for patients with advanced melanoma.