Table 2.
Toxicity | 0.3 mg/kg (N = 1) | 1 mg/kg (N = 1) | 3 mg/kg (N = 3) | 6 mg/kg (N = 3) | 9 mg/kg (N = 3) | 12 mg/kg (N = 16) | Total (%) |
---|---|---|---|---|---|---|---|
Any event | 1 | 1 | 3 | 3 | 2 | 14 | 24 (88.9) |
DLTs | |||||||
Grade 4 neutropenia lasting ≥7 d with febrile neutropenia | 1 | 1 (3.7) | |||||
Other grade 3/4 toxicities | |||||||
Neutropenia | 1 | 1 | 2 (7.4) | ||||
Thrombocytopenia | 2 | 2 (7.4) | |||||
Tumor lysis syndrome | 1 | 1 (3.7) | |||||
Increased AST | 1 | 1 (3.7) | |||||
Grade 1/2 toxicities occurring in >1 patient | |||||||
Infusion reaction | 1 | 1 | 1 | 2 | 2 | 11 | 18 (66.7) |
Increased AST | 1 | 2 | 1 | 4 (14.8) | |||
Increased alanine aminotransferase | 2 | 1 | 2 | 5 (18.5) | |||
Neutropenia | 1 | 1 | 2 (7.4) | ||||
Thrombocytopenia | 1 | 2 | 3 (11.1) | ||||
Fever | 1 | 1 | 1 | 1 | 4 (14.8) | ||
Chills | 1 | 1 | 1 | 3 (11.1) | |||
Peripheral sensory neuropathy | 1 | 2 | 3 (11.1) | ||||
Diarrhea | 1 | 1 | 2 (7.4) | ||||
Flushing | 1 | 1 | 2 (7.4) | ||||
Hyperuricemia | 1 | 1 | 2 (7.4) | ||||
Hypocalcemia | 1 | 1 | 2 (7.4) | ||||
Increased lipase | 1 | 1 | 2 (7.4) |