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Table 1 Clinical studies evaluating adjuvant GM-CSF in patients with surgically resected melanoma

From: Current status of granulocyte–macrophage colony-stimulating factor in the immunotherapy of melanoma

Citation Evaluable patients GM-CSF dose schedule Control Clinical response
Spitler et al. [37] 48 125 μg/m2 for 14 d, 28-d cycles, for 1 y Historical OS: 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 y Observation OS: 6.6 y (GM-CSF) vs 6.8 y (control) OS: 8.6 (GM-CSF) vs 5.2 y (control)
Isla et al. [42] 24 150 mg/d for 2 y None DFS at 1 y: 88.8%
Elias et al. [43] 45 125 μg/m2 for 14 d, then IL-2 9 × 106 IU/m2 for 4 d,/28-d cycle, ± autologous vaccine None DFS at 15.9 mo: 60% OS at 21 mo: 64% (21 mo follow-up)
Spitler et al. [38] 98 125 μg/m2 for 14 d, 28-d cycles, for 3 y None DFS: 1.4 y 5-y survival: 60%
Lawson et al. [40] 743 250 μg/m2 for 14 d, 28-d cycles, for 1 y Placebo OS: 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)
  1. DFS = disease-free survival; GM-CSF = granulocyte-macrophage colony-stimulating factor; HR = hazard ratio; IL-2 = interleukin-2; OS = overall survival.