Fernandes Ricardo, Mazzarello Sasha, Stober Carol, Vandermeer Lisa, Dudani Shaan, Ibrahim Mohamed F K, Majeed Habeeb, Perdrizet Kirstin, Shorr Risa, Hutton Brian, Fergusson Dean, Clemons Mark
Department of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre and University of Ottawa, 501 Smyth Road, Box 912, Ottawa, ON, K1H 8L6, Canada.
Ottawa Hospital Research Institute, Ottawa, Canada.
Breast Cancer Res Treat. 2017 Jan;161(1):1-10. doi: 10.1007/s10549-016-4028-0. Epub 2016 Oct 25.
Due to the high rate of febrile neutropenia (FN) with docetaxel-cyclophosphamide (DC) chemotherapy, primary FN prophylaxis is recommended. However, the optimal choice of prophylaxis [i.e., granulocyte-colony stimulating factors (G-CSF) or antibiotics] is unknown. A systematic review was performed to address this knowledge gap.
Embase, Ovid Medline, Pubmed, the Cochrane database of systematic reviews, and Cochrane register of controlled trials were searched from 1946 to April 2016 for studies evaluating primary prophylactic FN treatments in breast cancer patients receiving DC chemotherapy. Outcome measures evaluated included: incidence of FN and treatment-related hospitalizations, chemotherapy dose reduction/delays/discontinuations, and adverse events. Screening and data collection were performed by two independent reviewers.
Of 2105 identified records, 7 studies (n = 2535) met the pre-specified eligibility criteria. Seven additional studies (n = 621) were identified from prior systematic reviews. There were 3 randomized controlled trials (RCTs) (n = 2256) and 11 retrospective studies (n = 900). Study sample sizes ranged from 30 to 982 patients (median 99.5), evaluating pegfilgrastim (n = 1274), filgrastim (n = 1758), and oral ciprofloxacin (n = 108). Given the heterogeneity of patients and study design, a narrative synthesis of results was performed. Median FN rates with and without primary prophylaxis were 6.6 % (IQR 3.9-10.6 %) and 31.3 % (IQR 25-33 %), respectively. No FN-related deaths were reported. No RCT directly compared G-CSF with antibiotic interventions.
Primary FN prophylaxis reduces the incidence of FN. Despite considerable cost and toxicity differences between G-CSF and antibiotics, there is insufficient data to make a recommendation of one strategy over another.
由于多西他赛-环磷酰胺(DC)化疗导致发热性中性粒细胞减少(FN)的发生率较高,因此推荐进行原发性FN预防。然而,预防的最佳选择[即粒细胞集落刺激因子(G-CSF)或抗生素]尚不清楚。进行了一项系统评价以填补这一知识空白。
检索1946年至2016年4月期间的Embase、Ovid Medline、Pubmed、Cochrane系统评价数据库和Cochrane对照试验注册库,以查找评估接受DC化疗的乳腺癌患者原发性预防性FN治疗的研究。评估的结局指标包括:FN的发生率和与治疗相关的住院、化疗剂量减少/延迟/停药以及不良事件。由两名独立的审阅者进行筛选和数据收集。
在2105条识别记录中,7项研究(n = 2535)符合预先设定的纳入标准。从先前的系统评价中又识别出7项研究(n = 621)。有3项随机对照试验(RCT)(n = 2256)和11项回顾性研究(n = 900)。研究样本量从30至982例患者不等(中位数99.5),评估了培非格司亭(n = 1274)、非格司亭(n = 1758)和口服环丙沙星(n = 108)。鉴于患者和研究设计的异质性,对结果进行了叙述性综合分析。有和没有原发性预防的FN发生率中位数分别为6.6%(四分位间距3.9 - 10.6%)和31.3%(四分位间距25 - 33%)。未报告与FN相关的死亡。没有RCT直接比较G-CSF与抗生素干预措施。
原发性FN预防可降低FN的发生率。尽管G-CSF和抗生素在成本和毒性方面存在相当大的差异,但尚无足够数据推荐一种策略优于另一种策略。