a Policy Analysis Inc. (PAI) , Brookline , MA , USA.
b Amgen Inc. , Thousand Oaks , CA , USA.
Curr Med Res Opin. 2018 Sep;34(9):1705-1711. doi: 10.1080/03007995.2018.1495621. Epub 2018 Jul 25.
Two recent evaluations reported that risk of febrile neutropenia (FN) may be higher when pegfilgrastim prophylaxis (PP) is administered on same day as chemotherapy rather than per recommendation (1-3 days following chemotherapy). Such evidence is based largely on the experience of younger privately insured adults and may not be generalizable to older patients in US clinical practice.
A retrospective cohort design and data from Medicare Claims Research Identifiable Files (January 2008-September 2015) were employed. Patients were aged ≥65 years, had breast cancer or non-Hodgkin's lymphoma, received chemotherapy with intermediate/high risk for FN, and received PP in ≥1 cycle; cycles with PP were stratified based on administration day (same-day ["Day 0"] vs. 1-3 days following chemotherapy ["Days 1-3"]) and were pooled for analyses. Adjusted odds ratios (ORs) for FN during the cycle were estimated for patients who received PP on Day 0 versus Days 1-3.
Study population included 65,003 patients who received PP in 261,184 cycles; in 5% of cycles, patients received PP on Day 0. Incidence proportion for FN in cycle 1 was 11.4% for Day 0 versus 8.4% for Days 1-3; adjusted OR was 1.4 (p < .001). Incidence proportion for FN when considering all cycles was 7.7% for Day 0 and 6.0% for Days 1-3; adjusted OR was 1.3 (p < .001). Adjusted ORs when considering all cycles and only inpatient FN episodes (1.3, p < .001) and the narrow definition for FN (1.5, p < .001) were similar.
Among Medicare patients receiving chemotherapy and PP in US clinical practice, PP was administered before the recommended timing in 5% of cycles and FN incidence was significantly higher in these cycles. Along with prior research, study findings support recently updated US practice guidelines indicating that PP should be administered the day after chemotherapy.
最近有两项评估报告称,培非格司亭预防(PP)与化疗同日给药而非按推荐方案(化疗后 1-3 天)给药时,发热性中性粒细胞减少症(FN)的风险可能更高。这种证据主要基于年轻的私人保险成年人的经验,可能不适用于美国临床实践中的老年患者。
采用回顾性队列设计和医疗保险索赔研究可识别文件(2008 年 1 月至 2015 年 9 月)的数据。患者年龄≥65 岁,患有乳腺癌或非霍奇金淋巴瘤,接受中/高危 FN 化疗,且至少接受过一个周期的 PP;根据给药日(同日[第 0 天]与化疗后 1-3 天[第 1-3 天])对接受 PP 的周期进行分层,并对其进行汇总分析。对第 0 天与第 1-3 天接受 PP 的患者进行分析,评估该周期内 FN 的调整比值比(OR)。
研究人群包括 65003 例在 261184 个周期中接受 PP 的患者;其中 5%的周期中患者第 0 天接受 PP。第 1 周期中 FN 的发生率在第 0 天为 11.4%,第 1-3 天为 8.4%;调整 OR 为 1.4(p<0.001)。考虑所有周期时 FN 的发生率在第 0 天为 7.7%,第 1-3 天为 6.0%;调整 OR 为 1.3(p<0.001)。考虑所有周期和仅住院 FN 发作(1.3,p<0.001)以及 FN 的狭义定义(1.5,p<0.001)时,调整 OR 相似。
在美国临床实践中接受化疗和 PP 的 Medicare 患者中,5%的周期中 PP 给药时间早于推荐时间,这些周期中 FN 的发生率显著更高。与之前的研究结果一致,本研究结果支持最近更新的美国实践指南,该指南指出 PP 应在化疗后一天给药。