Table 1.
Selected grade 3/4 adverse events, % | Dinutuximab beta STI | Dinutuximab beta LTI | ||
---|---|---|---|---|
Alone (n = 186a) | + IL-2 (n = 192a) | Alone (n = 171a) | + 50% IL-2b (n = 150a) | |
Immunotherapy-related pain | 16 | 26 | 7 | 18 |
Fever | 14 | 40 | 13 | 29 |
Hypersensitivity reaction | 10 | 20 | 3 | 3 |
Capillary leak syndrome | 4 | 15 | 4 | 8 |
Diarrhoea | 7 | 21 | 11 | 12 |
Neurotoxicity | ||||
Central | 2 | 6 | 1 | 1 |
Peripheral | 1 | 2 | 1 | 1 |
AST/ALT | 17 | 23 | 21 | 26 |
Haematological toxicities | ||||
Haemoglobin | 42 | 66 | 53 | 66 |
White blood cells | 26 | 36 | 32 | 33 |
Granulocytes | 33 | 58 | 43 | 67 |
Platelets | 34 | 61 | 33 | 51 |
Hypotension | 7 | 17 | 2 | 3 |
Infection | 26 | 34 | 32 | 33 |
General condition | 16 | 41 | 16 | 21 |
ALT alanine aminotransferase, AST aspartate aminotransferase, IL-2 interleukin 2, LTI long-term infusion, SIOPEN International Society of Paediatric Oncology European Neuroblastoma, STI short-term infusion
aNot all patients were evaluable for each adverse event
bHalf the dose administered in the STI study (3 × 106 IU/m2/day rather than 6 × 106 IU/m2/day)