André Nicolas, Kababri Maria El, Bertrand Pourroy, Rome Angelique, Coze Carole, Gentet Jean Claude, Bernard Jean Louis
Department of Pediatric Oncology, Children Hospital of La Timone, Marseille, France.
Anticancer Drugs. 2007 Mar;18(3):277-81. doi: 10.1097/CAD.0b013e328011a532.
The myelotoxicity of most chemotherapeutic regimens used to treat children and adolescents with cancer require the use of daily subcutaneous administration of hematological growth factors (mainly granulocyte colony-stimulating factor). Recently, pegfilgrastim (Neulasta), a product with a long half-life, resulting in once-per-cycle dosage, was introduced to prevent neutropenia in adults, and provided safety and efficacy similar to that provided by daily injection of filgrastim. To evaluate retrospectively the use of pegfilgrastim in children with cancer, we conducted a single-center retrospective study evaluating the use of pegfilgrastim in patients over 40 kg, who received chemotherapy for cancer from September 2003 to December 2005. A single subcutaneous injection of pegfilgrastim 100 microg/kg (maximum dose 6 mg) per chemotherapy cycle in children receiving myelosuppressive chemotherapy was given. One hundred and twenty-six administrations of pegfilgrastim were analyzed in 28 pediatric patients treated for cancer (11 girls, 17 boys) with a median age of 14.5 years (range 12-18 years) and median weight of 50.5 kg (range 40-82 kg). Patients received a median dose of pegfilgrastim of 100 microg/kg (range 73-117). The median total number of injections per patient was 4 (range 1-14). The incidence of grade 4 neutropenia by cycle was 48%, the mean duration of neutropenia was 3 days (range 1-13 days). The median values of absolute neutrophil count nadir was 0.425 x 10(9)/l (range 0-9.9 x 10(9)). Febrile neutropenia occurred in 18 of the 126 patients on pegfilgrastim use (14%) with full recovery in all patients. The median total duration of intravenous antibiotic therapy was 5 days (range 2-14 days). Bone pain (four) and headaches (two) were the most frequent adverse events reported. No correlation was found between the administered dose of Neulasta and hematological data. In conclusion, the use of pegfilgrastim was safe and well tolerated in children with cancer treated with myelosuppressive chemotherapy. Safety and efficacy of pegfilgrastim must be compared with filgrastim and evaluated in younger children with lower body weight.
用于治疗儿童和青少年癌症的大多数化疗方案具有骨髓毒性，这就需要每日皮下注射血液学生长因子（主要是粒细胞集落刺激因子）。最近，培非格司亭（Neulasta）这一具有长半衰期、可实现每周期一次给药的产品被引入用于预防成人中性粒细胞减少症，其安全性和有效性与每日注射非格司亭相似。为了回顾性评估培非格司亭在儿童癌症患者中的应用，我们进行了一项单中心回顾性研究，评估2003年9月至2005年12月期间体重超过40kg、接受癌症化疗的患者使用培非格司亭的情况。对接受骨髓抑制性化疗的儿童，每化疗周期皮下注射一次培非格司亭，剂量为100μg/kg（最大剂量6mg）。分析了28例接受癌症治疗的儿科患者（11名女孩，17名男孩）的126次培非格司亭给药情况，这些患者的中位年龄为14.5岁（范围12 - 18岁），中位体重为50.5kg（范围40 - 82kg）。患者接受的培非格司亭中位剂量为100μg/kg（范围73 - 117）。每位患者的注射总次数中位值为4次（范围1 - 14次）。每个周期4级中性粒细胞减少症的发生率为48%，中性粒细胞减少的平均持续时间为3天（范围1 - 13天）。中性粒细胞绝对计数最低点的中位值为0.425×10⁹/L（范围0 - 9.9×10⁹）。126例使用培非格司亭的患者中有18例发生发热性中性粒细胞减少症（14%），所有患者均完全康复。静脉抗生素治疗的总中位持续时间为5天（范围2 - 14天）。报告最多的不良事件是骨痛（4例）和头痛（2例）。未发现Neulasta的给药剂量与血液学数据之间存在相关性。总之，在接受骨髓抑制性化疗的儿童癌症患者中，培非格司亭的使用是安全的且耐受性良好。培非格司亭的安全性和有效性必须与非格司亭进行比较，并在体重更低的年幼儿童中进行评估。
