Similar exposure and pharmacokinetics of bevacizumab in pediatric and adult cancer patients: Analysis of individual data of 152 pediatric patients.

10062 Background: Bevacizumab (BEV) is approved for various cancers. BEV pharmacokinetics (PK) is well established by a population PK (PPK) model in adults, but has not been comprehensively evaluated in children. Four pediatric studies have been conducted to assess BEV exposure (EXP) and PK in children, to explore the influence of patient variables on BEV PK and to compare BEV EXP and PK between pediatric and adult patients. Methods: BEV was administered at 5, 7.5, 10 or 15 mg/kg (Q2W or Q3W) with chemotherapy to children with primary CNS tumor (n=76), metastatic soft tissue sarcoma (n=39), osteosarcoma (n=27), or other refractory solid tumors (n=10). A nonlinear mixed effects PK model was fitted to BEV serum concentrations (Cs). Pediatric BEV EXP (trough Cs) were simulated by the pediatric PPK model under the same BSA-based or WT-based dose, and compared to adult EXP simulated by the adult PPK model. Results: Totally 1,464 BEV Cs from 152 patients between 6 months and 21 years old (median 10.8) were anal...