E. George Elias, MD, PhD, FACS

Cytokines have been used in the treatment of patients with cutaneousmelanoma. Granulocyte-macrophage colony-stimulating factor(GM-CSF, sargramostim [Leukine]) leads to dendritic cell/macrophagepriming and activation, and also increases interleukin-2 (IL-2)receptor expression on T lymphocytes. IL-2 creates lymphokineactivatedkiller cells and tumor-infiltrating lymphocyte cells. In thisopen-label, single-arm study of 16 high-risk patients, we combined thesetwo agents to take advantage of their different but complementary functions.All patients underwent potentially curative surgery. Postoperatively,each patient received GM-CSF at 125 μg/m2/d subcutaneously(SC) for 14 days; this was followed by IL-2 at 9 million IU/m2/d SC for4 days, and then 10 to 12 days of no treatment. In addition, patientswho had large tumors that could yield over 100 million live tumor cellsreceived autologous melanoma vaccines. The duration of follow-upranged from 21 to 42 months (median: 27 months). During follow-up,five patients developed metastases. This program was carried out on anoutpatient basis, and no hospitalization was required. It was well toleratedwith minimal side effects. The combination treatment regimen ofGM-CSF and IL-2 with or without autologous vaccine used adjuvantlyappears to benefit high-risk melanoma patients; further clinical testingof this regimen is warranted.