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) |