1. Adding sargramostim to ipilimumab for advanced melanoma resulted in improvement in overall survival and fewer adverse events when compared to ipilimumab alone.
2. Adding sargramostim to ipilimumab for advanced melanoma demonstrated no improvement in progression free survival.
Evidence Rating Level: 2 (Good)
Study Rundown: Melanoma is a leading cause of cancer incidence and mortality in the United States. Ipilimumab, a monoclonal antibody against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), and sargramostim, a granulocyte-macrophage colony-stimulating factor (GM-CSF) have both been used to treat metastatic melanoma. This phase II randomized trial examined the effect of adding sargramostim to ipilimumab on overall and progression free survival in individuals with advanced melanoma, defined as unresectable stage III or IV disease. While the addition of sargramostim to ipilimumab resulted in an increase in overall survival and fewer adverse events, it did not improve progression free survival.
Strengths of this study include its randomized design and careful use of inclusion and exclusion criteria. However, results may have been influenced by bias due to the lack of investigator blinding and are limited by the short follow-up period. Nevertheless, this study ultimately demonstrated the potential benefits of combined ipilimumab/sargramostim therapy for the treatment of advanced melanoma and emphasizes the need for a larger randomized controlled trial to more fully understand the benefits of this treatment regimen.
Relevant Reading: Improved survival with ipilimumab in patients with metastatic melanoma.
In-Depth [randomized controlled trial]: This study randomized 425 individuals with advanced melanoma (i.e., unresectable stage III or IV disease) to receive ipilimumab and sargramostim or ipilimumab alone to determine if adding sargramostim to ipilimumab improves overall or progression free survival. The participants were predominantly male and Caucasian and the ages of participants ranged from 21-89 years. The median follow-up time was 13.3 months (range 0.03-19.9 months). The addition of sargramostim to ipilimumab resulted in an overall survival benefit (log-rank p=0.01), but not a progression free survival benefit (log-rank p=0.37). The addition of sargramostim to ipilimumab also demonstrated fewer adverse effects than ipilimumab alone, notably with regards to colonic perforation.
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