Neither adjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF) nor peptide vaccination (PV) significantly improved relapse-free survival (RFS) or overall survival (OS) in patients with high-risk resected melanoma. This according to a placebo-controlled study of 815 patients with completely resected stage IV or high-risk stage III melanoma. Researchers found:

• There were no significant improvements in OS in the GM-CSF group vs placebo.

• Median OS times were: GM-CSF=69.6 months; placebo=59.3 months.

• 5-year OS probability rates were: GM-CSF=52.3%; placebo=49.4%.

• Median RFS times were: GM-CSF=11.4 months; placebo=8.8 months.

• 5-year RFS probability rates were: GM-CSF=31.2%; placebo=27.0%

• GM-CSF-treated patients with resected visceral metastases showed a trend toward improved OS.

• RFS and OS were not significantly different in patients who received PV.

• Treatment-related grade 3 or greater adverse events were similar between GM-CSF and placebo groups.

Citation: Lawson DH, Lee S, Zhao F, et al. Randomized, placebo-controlled, phase III trial of yeast-derived granulocyte-macrophage colony-stimulating factor (GM-CSF) versus peptide vaccination versus GM-CSF plus peptide vaccination versus placebo in patients with no evidence of disease after complete surgical resection of locally advanced and/or stage IV melanoma: A trial of the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group (E4697). [Published online ahead of print September 8, 2015]. J Clin Oncol. doi:10.1200/JCO.2015.62.0500.