Table 2.

On-study adverse events

S-IL-2* (140 cycles given)
M-IL-2 (140 cycles given)
Grade 2, n (%)Grade 3, n (%)Grade 2, n (%)Grade 3, n (%)
GM-CSF + vaccine–related
    Injection-site reaction66 (47.1)0 (0)106 (75.7)0 (0)
GM-CSF–related
    Dyspnea13 (9.3)1 (0.7)1 (0.7)0 (0)
    Arthralgias12 (8.6)0 (0)0 (0)0 (0)
IL-2–related
    Constitutional
        Fatigue31 (22.1)7 (5.0)6 (4.3)0 (0)
        Fever4 (2.9)2 (1.4)0 (0)0 (0)
        Arthralgias9 (6.4)0 (0)0 (0)0 (0)
    Metabolic
        Hyperglycemia9 (6.4)7 (5.0)8 (5.7)0 (0)
    Blood
        Lymphopenia25 (17.9)6 (4.3)28 (20.0)4 (2.9)
    Gastrointestinal
        Dehydration/anorexia3 (2.1)1 (0.7)1 (0.7)0 (0)
        Diarrhea7 (5.0)2 (1.4)4 (2.9)2 (1.4)
    Pulmonary
        Dyspnea15 (10.7)1 (0.7)1 (0.7)1 (0.7)
  • Abbreviaton: GM-CSF, granulocyte-macrophage colony-stimulating factor.

  • * Adjuvant IL-2 given at 4.0 MIU/M2 on days 8-12 of each cycle.

  • Adjuvant IL-2 given at 0.6 MIU/M2 on days 8-21 of each cycle.

  • Number of cycles with adverse events and percentage of total number of cycles given.