背景:Pegfilgrastim,长效粒细胞集落刺激因子(G-CSF),通常用于预防发热性中性粒细胞减少症(FN),可能危及生命的并发症,骨髓抑制化疗后。pegfilgrastim的FDA标签规定,它不应在骨髓抑制化疗给药之前14天或24小时内给药,排除在双周(Q2W)方案中使用pegfilgrastim。国家综合癌症网络和欧洲癌症研究和治疗组织指南支持在接受Q2W方案的患者中使用预防性pegfilgrastim。这项研究的目的是系统回顾来自随机临床试验(RCT)和观察性研究的证据,这些研究描述了预防性pegfilgrastim在接受Q2W方案的患者中预防FN的有效性和安全性。
方法:OvidMEDLINE,Embase,进行了Cochrane图书馆文献检索,以评估有关疗效的证据,有效性,在接受Q2W化疗方案的非骨髓性恶性肿瘤FN高(>20%)或中等(10-20%)风险的患者中,预防性pegfilgrastim与不预防性pegfilgrastim或其他G-CSF预防的安全性。针对FN绝对或相对风险的研究,1-4级中性粒细胞减少症,所有原因或任何住院治疗,剂量延迟或剂量减少,不良事件,或死亡率被包括在内。还包括比较物是Q3W化疗方案的主要预防性pegfilgrastim的研究。
结果:最初的文献检索确定了2258种出版物。13种出版物符合资格标准,包括八个回顾,一个潜在的,一项1期剂量递增研究,和三个RCT。在报告FN发生率的13项研究中有9项,在九项报告中性粒细胞减少症发生率的研究中,与接受非格司亭的患者相比,接受Q2W方案的患者预防性使用pegfilgrastim导致FN或中性粒细胞减少的发生率降低或相当,没有G-CSF,Q3W方案中的lipefilgrastim或pegfilgrastim。在九项报告安全性数据的研究中,在pegfilgrastim和比较者之间观察到较低或相当的安全性.
结论:在各种非髓系恶性肿瘤中,预防性使用pegfilgrastim可有效降低接受高危或中危Q2W方案的患者的FN风险,具有可接受的安全性。
背景:PROSPERO注册号:CRD42019155572。
BACKGROUND: Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is commonly used to prevent febrile neutropenia (FN), a potentially life-threatening complication, following myelosuppressive chemotherapy. The FDA label for
pegfilgrastim specifies that it should not be administered 14 days before or within 24 h of administration of myelosuppressive chemotherapy, precluding the use of
pegfilgrastim in biweekly (Q2W) regimens. The National Comprehensive Cancer Network and the European Organisation for Research and Treatment of Cancer guidelines support the use of prophylactic pegfilgrastim in patients receiving Q2W regimens. The objective of this study was to systematically
review evidence from randomized clinical trials (RCTs) and observational studies that describe the effectiveness and safety of prophylactic
pegfilgrastim in preventing FN among patients receiving Q2W regimens.
METHODS: An Ovid MEDLINE, Embase, and Cochrane Library literature search was conducted to evaluate the evidence regarding efficacy, effectiveness, and safety of prophylactic pegfilgrastim versus no prophylactic pegfilgrastim or prophylaxis with other G-CSF in patients who were receiving Q2W chemotherapy regimens with high (> 20%) or intermediate (10-20%) risk of FN for a non-myeloid malignancy. Studies that addressed absolute or relative risk of FN, grade 1-4 neutropenia, all-cause or any hospitalization, dose delays or dose reductions, adverse events, or mortality were included. Studies where the comparator was a Q3W chemotherapy regimen with primary prophylactic pegfilgrastim were also included.
RESULTS: The initial literature search identified 2258 publications. Thirteen publications met the eligibility criteria, including eight retrospective, one prospective, one phase 1 dose escalation study, and three RCTs. In nine of the 13 studies reporting incidence of FN, and in seven of the nine studies reporting incidence of neutropenia, administration of prophylactic pegfilgrastim in patients receiving Q2W regimens resulted in decreased or comparable rates of FN or neutropenia compared with patients receiving filgrastim, no G-CSF, lipefilgrastim or pegfilgrastim in Q3W regimens. In six of the nine studies reporting safety data, lower or comparable safety profiles were observed between pegfilgrastim and comparators.
CONCLUSIONS: In a variety of non-myeloid malignancies, administration of prophylactic pegfilgrastim was efficacious in reducing the risk of FN in patients receiving high- or intermediate-risk Q2W regimens, with an acceptable safety profile.
BACKGROUND: PROSPERO registration no: CRD42019155572 .