Background: Bevacizumab is a monoclonal antibody directed against vascular endothelial growth factor (VEGF). The safety profile of bevacizumab was evaluated in a cohort of children with either recurrent or poor-prognosis malignancies. Patients and Methods: Bevacizumab was administered intravenously at the dosage of 5-10 mg/kg every 14-28 days alone or in combination with other agents. Toxicity was reported according to common toxicity criteria version 4. Results: Seventeen patients received a total of 156 bevacizumab doses (median 5 doses/pt) for a median treatment duration of 2 months (range 1-21). Grade II-III lymphopenia was recorded in 10 patients, while grade III proteinuria and grade I epistaxis occurred in one patient each. Grade III wound dehiscence was observed in one case and 3 severe adverse events (SAEs) were recorded: one reversible posterior leukoencephalopathy syndrome (RPLS) with grade IV seizures and grade IV hypertension, one grade IV hypertension and a post-operative grade IV enterocutaneous fistula. Conclusion: In the present cohort, the overall incidence of SAEs (17%) was higher than previously reported, thus, further studies should be justified to better characterize the safety profile of bevacizumab in the pediatric population.
De Pasquale, M. D., Castellano, A., De Sio, L., De Laurentis, C., Mastronuzzi, A., Serra, A., Cozza, R., Jenkner, A., De Ioris, M. A., Bevacizumab in pediatric patients: How safe is it?, <<ANTICANCER RESEARCH>>, 2011; 31 (11): 3953-3957 [https://hdl.handle.net/10807/329920]
Bevacizumab in pediatric patients: How safe is it?
Mastronuzzi, AngelaWriting – Original Draft Preparation
;
2011
Abstract
Background: Bevacizumab is a monoclonal antibody directed against vascular endothelial growth factor (VEGF). The safety profile of bevacizumab was evaluated in a cohort of children with either recurrent or poor-prognosis malignancies. Patients and Methods: Bevacizumab was administered intravenously at the dosage of 5-10 mg/kg every 14-28 days alone or in combination with other agents. Toxicity was reported according to common toxicity criteria version 4. Results: Seventeen patients received a total of 156 bevacizumab doses (median 5 doses/pt) for a median treatment duration of 2 months (range 1-21). Grade II-III lymphopenia was recorded in 10 patients, while grade III proteinuria and grade I epistaxis occurred in one patient each. Grade III wound dehiscence was observed in one case and 3 severe adverse events (SAEs) were recorded: one reversible posterior leukoencephalopathy syndrome (RPLS) with grade IV seizures and grade IV hypertension, one grade IV hypertension and a post-operative grade IV enterocutaneous fistula. Conclusion: In the present cohort, the overall incidence of SAEs (17%) was higher than previously reported, thus, further studies should be justified to better characterize the safety profile of bevacizumab in the pediatric population.
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