Hematology/Oncology Department, Ospedale Pediatrico Bambino Gesù IRCCS, Piazza S.Onofrio 4, 00165 Roma, Italy.
Anticancer Res. 2011 Nov;31(11):3953-7.
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.
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.
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 entero-cutaneous fistula.
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.
贝伐珠单抗是一种针对血管内皮生长因子（VEGF）的单克隆抗体。贝伐珠单抗的安全性在一组患有复发性或预后不良的恶性肿瘤的儿童中进行了评估。
贝伐珠单抗以 5-10mg/kg 的剂量静脉给药，每 14-28 天一次，单独使用或与其他药物联合使用。毒性根据通用毒性标准 4.0 版报告。
17 名患者共接受了 156 次贝伐珠单抗治疗（中位剂量为 5 次/患者），中位治疗时间为 2 个月（范围为 1-21）。10 名患者出现 II-III 级淋巴细胞减少症，1 名患者出现 III 级蛋白尿和 I 级鼻出血。1 例出现 III 级伤口裂开，3 例严重不良事件（SAE）：1 例可逆性后部白质脑病综合征（RPLS）伴 IV 级癫痫发作和 IV 级高血压，1 例 IV 级高血压和术后 IV 级肠-皮肤瘘。
在本队列中，SAE 的总发生率（17%）高于先前报道，因此，应进行进一步研究以更好地描述贝伐珠单抗在儿科人群中的安全性特征。
