GM-CSF plus antigenic peptide vaccination in locally advanced melanoma patients

Twenty-four (24) pretreated patients with relapsed high-risk resected The American Joint Committee on Cancer(AJCC) stage IIA-IVmelanoma received adjuvant peptide vaccinations derived from the melanosomal antigens MelanA/MART1, MAGE-1, gp100, and tyrosinase, according to patient tumor-associated human leukocyte antigen (HLA) restricted antigen expression, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Pretreatment was comprised of surgery (n = 23 primary tumor; n = 23 metastases), local radiotherapy (n = 2), immunotherapy (n = 23), chemotherapy (n = 10), and chemoimmmunotherapy (n = 1), respectively. All patients received peptide vaccines in an adjuvant setting. Seven (7) patients were relapse free for 3 + up to 25 + months. Of the patients exhibiting progressive disease (n = 17), 13 patients developed metastases during vaccination (9 local, 4 distant), and 4 patients developed metastases (2 local, 2 distant) after finishing vaccine therapy. Two (2)-year local and distant metastases-free survival, 2-year distant metastases-free survival, and 2-year overall survival were calculated as 8.6%, 68%, and 85%, respectively. Vaccine treatment was well tolerated, with no severe side-effects. Twenty (20) of 24 patients developed local delayed-type hypersensitivity (DTH) reactions to synthetic peptide vaccination. Transient fever (n = 2) and pain in muscle/bone (n = 2) occurred rarely. In conclusion, antigenic peptide vaccination, combined with GM-CSF, is safe and may yield clinical benefits in relapsed high-risk resected melanoma patients.