Millan N C, Poveda M J, Cruz O, Mora J
Department of Pediatric Hematology and Oncology, Hospital Sant Joan de Déu de Barcelona, Passeig de Sant Joan de Déu num 2, Esplugues del Llobregat, 08950, Barcelona, Spain.
Clin Transl Oncol. 2016 May;18(5):464-8. doi: 10.1007/s12094-015-1389-5. Epub 2015 Aug 29.
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.
关于贝伐单抗在4岁以下儿科患者中的安全性和有效性的数据有限。在此，我们报告一大群4岁以下接受贝伐单抗治疗的儿科患者。
主要目的是记录与贝伐单抗可能相关的不良事件。通过回顾性病历审查确定了16例患者，他们患有多种疾病（44%为中枢神经系统（CNS）肿瘤，31%为血管异常，13%为神经母细胞瘤，12%为其他）。
中位年龄为34.3个月（范围4.9 - 47.3个月），包括5例年龄小于2岁的患者。患者接受贝伐单抗治疗的中位持续时间为6.2个月，单独使用或与化疗联合使用，中位剂量为9.25 mg/kg（范围7.0 - 11.8）。19%的患者出现部分缓解，69%的患者有临床改善。已知与贝伐单抗相关的不良事件发生在37%的患者中。该人群中观察到的结果与 older pediatric patients 中报道的贝伐单抗的结果相似。观察到的不良事件的总体模式和频率与患有各种疾病的 older pediatric patients 的报告中所见相似。在血管畸形或低级别CNS肿瘤患者中观察到的疗效水平最高。
我们的结果表明，贝伐单抗对最小的儿童使用是安全的。
