Journal
CANCER CHEMOTHERAPY AND PHARMACOLOGY
Volume 79, Issue 1, Pages 155-164Publisher
SPRINGER
DOI: 10.1007/s00280-016-3216-2
Keywords
Chemotherapy; Pediatric; G-CSF; Neutropenia; Phase 1; Pharmacodynamics
Categories
Funding
- Teva Branded Pharmaceutical Products RD
Ask authors/readers for more resources
Neutropenia is a common complication from chemotherapy, limiting optimal dosing and treatment. Lipegfilgrastim is a long-acting granulocyte colony-stimulating factor developed for the management of chemotherapy-induced neutropenia. The objectives of this phase 1, multinational, open-label, single-arm study were to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of a single body weight-adjusted dose of lipegfilgrastim and to evaluate the efficacy, safety, and tolerability of the drug in children with Ewing family of tumors or rhabdomyosarcoma treated with myelosuppressive chemotherapy. Enrolled patients received lipegfilgrastim (100 A mu g/kg) 24 h after the last chemotherapy treatment in week 1. Patients were stratified into three age groups: 2 to < 6, 6 to < 12, and 12 to < 18 years. Blood samples for PK analyses were obtained at baseline and at 3, 8, 24, 30, 48, 72, 96, 144, and 240 h postdose for the two oldest groups and up to 144 h in the youngest group. Twenty-one patients were enrolled and received lipegfilgrastim, seven in each age group. Lipegfilgrastim exposure levels were comparable across age groups, with concentrations maintained over a prolonged period after a single injection. Differences in PD were mainly associated with chemotherapy type. Most investigator-reported adverse events were attributed to chemotherapy and not to lipegfilgrastim. Severe adverse events were noted in 57% of patients; febrile neutropenia, leukopenia, neutropenia, and thrombocytopenia were more frequent among the oldest patients. Results support the use of a body weight-adjusted dose to achieve equivalent initial peak exposure levels of lipegfilgrastim in children of various ages.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available