Safety of bevacizumab in patients younger than 4 years of age.

Abstract

Limited data exist regarding the safety and efficacy of bevacizumab in pediatric patients under the age of 4 years. Here, we report a large cohort of pediatric patients under 4 years of age treated with bevacizumab. The primary objective was to document adverse events with a possible relationship to bevacizumab. Patients (n = 16) were identified through retrospective chart review and harbored a variety of conditions (44% central nervous system (CNS) tumors, 31% vascular anomalies, 13% neuroblastoma, 12% other). The median age was 34.3 months (range 4.9-47.3), including five patients <2 years of age. Patients received bevacizumab for a median duration of 6.2 months, alone or with chemotherapy, and a median dose of 9.25 mg/kg (range 7.0-11.8). Partial responses were seen in 19% of patients, and clinical improvements were seen in 69%. Adverse events known to be associated with bevacizumab occurred in 37%. Outcomes observed in this population resemble those reported for bevacizumab in older pediatric patients. The overall pattern and frequency of adverse events observed was similar to those seen in reports of older pediatric patients with a variety of conditions. The highest level of efficacy observed was seen among patients with vascular malformations or with low-grade CNS tumors. Our results suggest that the use of bevacizumab is safe for the youngest children.