Weycker Derek, Bensink Mark, Lonshteyn Alexander, Doroff Robin, Chandler David
a Policy Analysis Inc. (PAI) , Brookline , MA , USA.
b Amgen Inc. , Thousand Oaks , CA , USA.
Curr Med Res Opin. 2017 Dec;33(12):2107-2113. doi: 10.1080/03007995.2017.1386858. Epub 2017 Oct 16.
Pegfilgrastim prophylaxis (PP) is recommended 1-3 days following administration of chemotherapy during the cycle. Some patients, however, receive PP before or after the recommended timing. While evidence suggests that risk of febrile neutropenia (FN) may be lower when PP is administered per recommendation, such evidence is based on older data. We undertook a new study to compare FN risk between patients who received PP on the last day of chemotherapy ("day 0") or 4-5 days following chemotherapy ("days 4-5"), versus 1-3 days following chemotherapy ("days 1-3"), using recent data from US clinical practice.
A retrospective cohort design and data from two US private healthcare claims repositories (2010-2016) were employed. Patients received intermediate/high-risk chemotherapy regimens for solid tumors or non-Hodgkin's lymphoma, and PP in ≥1 cycle; all cycles with PP were pooled for analyses. Adjusted odds ratios (OR) for FN during the cycle were estimated for patients who received PP on day 0 or days 4-5, vs. days 1-3, using generalized estimating equations.
The study population included 53,814 patients who received PP in 217,273 cycles; in 9% of cycles, patients received PP on day 0 (8%) or days 4-5 (<1%). Odds of FN in cycle 1 were significantly higher among patients receiving PP on day 0 (OR: 1.4 [95% CI: 1.2-1.7]) or days 4-5 (1.9 [1.2-3.0]), vs. days 1-3, in that cycle. Results for subsequent cycles of chemotherapy were comparable to those for the first cycle.
In this large-scale retrospective evaluation of cancer chemotherapy patients receiving PP in recent US clinical practice, PP was administered before or after the recommended timing in 9% of cycles. FN incidence was significantly higher in these cycles providing additional real-world evidence that PP should be administered the day after chemotherapy in alignment with recently updated US practice guidelines.
培非格司亭预防用药(PP)建议在化疗周期给药后的1 - 3天进行。然而,一些患者在推荐时间之前或之后接受PP。虽然有证据表明按推荐时间给予PP时发热性中性粒细胞减少症(FN)的风险可能较低,但此类证据基于较旧的数据。我们开展了一项新研究,利用美国临床实践的最新数据,比较在化疗最后一天(“第0天”)或化疗后4 - 5天(“第4 - 5天”)接受PP的患者与化疗后1 - 3天(“第1 - 3天”)接受PP的患者之间的FN风险。
采用回顾性队列设计,并使用来自两个美国私人医疗保健理赔数据库(2010 - 2016年)的数据。患者接受实体瘤或非霍奇金淋巴瘤的中/高风险化疗方案,并在≥1个周期中接受PP;所有接受PP的周期合并进行分析。使用广义估计方程,估计在第0天或第4 - 5天接受PP的患者与第1 - 3天接受PP的患者在该周期内发生FN的调整比值比(OR)。
研究人群包括53,814例在217,273个周期中接受PP的患者;在9%的周期中,患者在第0天(8%)或第4 - 5天(<1%)接受PP。在第1周期中,与在第1 - 3天接受PP的患者相比,在第0天(OR:1.4 [95% CI:1.2 - 1.7])或第4 - 5天(1.9 [1.2 - 3.0])接受PP的患者发生FN的几率显著更高。后续化疗周期的结果与第一个周期相当。
在这项对近期美国临床实践中接受PP的癌症化疗患者的大规模回顾性评估中,9%的周期中PP在推荐时间之前或之后给药。这些周期中FN发生率显著更高,提供了更多现实世界的证据,表明应按照美国最近更新的实践指南在化疗后一天给予PP。