Weycker Derek, Li Xiaoyan, Figueredo Jacqueline, Barron Rich, Tzivelekis Spiros, Hagiwara May
Policy Analysis Inc. (PAI), Four Davis Court, Brookline, MA, 02445, USA.
Amgen Inc, Thousand Oaks, CA, USA.
Support Care Cancer. 2016 May;24(5):2309-2316. doi: 10.1007/s00520-015-3036-7. Epub 2015 Nov 25.
Contrary to the approved indication for pegfilgrastim prophylaxis, some patients receive it on the same day as the last administration of chemotherapy in clinical practice, which could adversely impact risk of febrile neutropenia (FN). An evaluation of the timing of pegfilgrastim prophylaxis and FN risk was undertaken.
A retrospective cohort design and data from two US private health care claims repositories were employed. Study population comprised adults who received intermediate/high-risk chemotherapy regimens for solid tumors or non-Hodgkin's lymphoma (NHL) and received pegfilgrastim prophylaxis in ≥1 cycle; all cycles with pegfilgrastim were pooled for analyses. Odds ratios (OR) for FN during the cycle were estimated for patients who received pegfilgrastim on the same day (day 1) as the last administration of chemotherapy versus days 2-4 from chemotherapy completion.
The study population included 45,592 patients who received pegfilgrastim in 179,152 cycles (n = 37,095 in cycle 1); in 12 % of cycles, patients received pegfilgrastim on the same day as chemotherapy. Odds of FN were higher for patients receiving pegfilgrastim prophylaxis on the same day as chemotherapy versus days 2-4 from chemotherapy in cycle 1 (OR = 1.6, 95 % CI = 1.3-1.9, p < 0.001) and all cycles (OR = 1.5, 95 % CI = 1.3-1.6, p < 0.001).
In this large-scale evaluation of adults who received intermediate/high-risk regimens for solid tumors or NHL in US clinical practice, FN incidence was found to be significantly higher among those who received pegfilgrastim prophylaxis on the same day as chemotherapy completion versus days 2-4 from chemotherapy completion, underscoring the importance of adhering to the indicated administration schedule.
与聚乙二醇化重组人粒细胞刺激因子预防的批准适应证相反,在临床实践中,一些患者在化疗最后一次给药的同一天接受该药,这可能会对发热性中性粒细胞减少症(FN)的风险产生不利影响。因此对聚乙二醇化重组人粒细胞刺激因子预防的给药时间与FN风险进行了评估。
采用回顾性队列设计,并利用来自两个美国私人医疗保健理赔数据库的数据。研究人群包括接受实体瘤或非霍奇金淋巴瘤(NHL)中/高风险化疗方案且在≥1个周期中接受聚乙二醇化重组人粒细胞刺激因子预防的成年人;将所有接受聚乙二醇化重组人粒细胞刺激因子的周期汇总进行分析。估计在周期内接受聚乙二醇化重组人粒细胞刺激因子的时间为化疗最后一次给药当天(第1天)的患者与化疗结束后第2 - 4天的患者发生FN的比值比(OR)。
研究人群包括45,592例在179,152个周期中接受聚乙二醇化重组人粒细胞刺激因子的患者(第1周期中有37,095例);在12%的周期中,患者在化疗当天接受聚乙二醇化重组人粒细胞刺激因子。在第1周期(OR = 1.6,95%置信区间 = 1.3 - 1.9,p < 0.001)和所有周期(OR = 1.5,95%置信区间 = 1.3 - 1.6,p < 0.001)中,化疗当天接受聚乙二醇化重组人粒细胞刺激因子预防的患者发生FN的几率高于化疗结束后第2 - 4天。
在美国临床实践中对接受实体瘤或NHL中/高风险方案的成年人进行的这项大规模评估中,发现化疗结束当天接受聚乙二醇化重组人粒细胞刺激因子预防的患者与化疗结束后第2 - 4天接受预防的患者相比,FN发生率显著更高,这突出了遵循指定给药方案的重要性。