Clinical studies evaluating adjuvant GM-CSF in patients with surgically resected melanoma

CitationEvaluable patientsGM-CSF dose scheduleControlClinical response
Spitler et al. [37]48125 μg/m2 for 14 d, 28-d cycles, for 1 yHistoricalOS: 37.5 mo
Markovic et al. [41]70 (Stage IV) 149 (Stage III)125 μg/m2 for 14 d, 28-d cycles, for 1 y 125 μg/m2 for 14 d, 28-d cycles, for 1 yObservationOS: 6.6 y (GM-CSF) vs 6.8 y (control) OS: 8.6 (GM-CSF) vs 5.2 y (control)
Isla et al. [42]24150 mg/d for 2 yNoneDFS at 1 y: 88.8%
Elias et al. [43]45125 μg/m2 for 14 d, then IL-2 9 × 106 IU/m2 for 4 d,/28-d cycle, ± autologous vaccineNoneDFS at 15.9 mo: 60% OS at 21 mo: 64% (21 mo follow-up)
Spitler et al. [38]98125 μg/m2 for 14 d, 28-d cycles, for 3 yNoneDFS: 1.4 y 5-y survival: 60%
Lawson et al. [40]743250 μg/m2 for 14 d, 28-d cycles, for 1 yPlaceboOS: 62.4 mo for placebo vs. 69.6 mo for GM-CSF (HR, 0.96) DFS: 9.2 mo for placebo vs. 11.5 mo for GM-CSF (HR, 0.88)

DFS = disease-free survival; GM-CSF = granulocyte-macrophage colony-stimulating factor; HR = hazard ratio; IL-2 = interleukin-2; OS = overall survival.