Policy Analysis Inc. (PAI), Four Davis Court, Brookline, MA, 02445, USA.
Amgen Inc., Thousand Oaks, CA, USA.
BMC Cancer. 2019 Aug 9;19(1):792. doi: 10.1186/s12885-019-6010-9.
BACKGROUND: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy. Clinical practice guidelines recommend routine prophylactic coverage with granulocyte colony-stimulating factor (G-CSF)-such as pegfilgrastim-for most patients receiving chemotherapy with an intermediate to high risk for FN. Patterns of pegfilgrastim prophylaxis during the chemotherapy course and associated FN risks in US clinical practice have not been well characterized. METHODS: A retrospective cohort design and data from two commercial healthcare claims repositories (01/2010-03/2016) and Medicare Claims Research Identifiable Files (01/2007-09/2015) were employed. Study population included patients who had non-metastatic breast cancer or non-Hodgkin's lymphoma and received intermediate/high-risk regimens. Pegfilgrastim prophylaxis use and FN incidence were ascertained in each chemotherapy cycle, and all cycles were pooled for analyses. Adjusted odds ratios for FN were estimated for patients who did versus did not receive pegfilgrastim prophylaxis in that cycle. RESULTS: Study population included 50,778 commercial patients who received 190,622 cycles of chemotherapy and 71,037 Medicare patients who received 271,944 cycles. In cycle 1, 33% of commercial patients and 28% of Medicare patients did not receive pegfilgrastim prophylaxis, and adjusted odds of FN were 2.6 (95% CI 2.3-2.8) and 1.6 (1.5-1.7), respectively, versus those who received pegfilgrastim prophylaxis. In cycle 2, 28% (commercial) and 26% (Medicare) did not receive pegfilgrastim prophylaxis; corresponding adjusted FN odds were comparably elevated (1.9 [1.6-2.2] and 1.6 [1.5-1.8]). Results in subsequent cycles were similar. Across all cycles, 15% of commercial patients and 23% of Medicare patients did not receive pegfilgrastim prophylaxis despite having FN in a prior cycle, and prior FN increased odds of subsequent FN by 2.1-2.4 times. CONCLUSIONS: Notwithstanding clinical practice guidelines, a large minority of patients did not receive G-CSF prophylaxis, and FN incidence was substantially higher among this subset of the population. Appropriate use of pegfilgrastim prophylaxis may reduce patient exposure to this potentially fatal but largely preventable complication of myelosuppressive chemotherapy.
背景：发热性中性粒细胞减少症（FN）是骨髓抑制性化疗的严重并发症。临床实践指南建议对接受中高危 FN 风险化疗的大多数患者常规预防性使用粒细胞集落刺激因子（G-CSF）-例如培非格司亭。在美国临床实践中，在化疗过程中培菲格司亭预防的模式和相关 FN 风险尚未得到很好的描述。
方法：采用回顾性队列设计和来自两个商业医疗保健索赔数据库（2010 年 1 月至 2016 年 3 月）和医疗保险索赔研究可识别文件（2007 年 1 月至 2015 年 9 月）的数据。研究人群包括患有非转移性乳腺癌或非霍奇金淋巴瘤且接受中/高危方案治疗的患者。在每个化疗周期中确定培菲格司亭预防的使用情况和 FN 发生率，并对所有周期进行汇总分析。在该周期中未接受培菲格司亭预防的患者与接受培菲格司亭预防的患者相比，FN 的调整优势比进行了估计。
结果：研究人群包括 50778 名接受 190622 个化疗周期的商业患者和 71037 名接受 271944 个化疗周期的医疗保险患者。在第 1 周期中，33%的商业患者和 28%的医疗保险患者未接受培菲格司亭预防，FN 的调整优势比分别为 2.6（95%CI 2.3-2.8）和 1.6（1.5-1.7），与接受培菲格司亭预防的患者相比。在第 2 周期中，28%（商业）和 26%（医疗保险）未接受培菲格司亭预防；相应的调整 FN 比值同样升高（1.9 [1.6-2.2] 和 1.6 [1.5-1.8]）。后续周期的结果相似。在所有周期中，尽管在前一个周期中发生了 FN，但仍有 15%的商业患者和 23%的医疗保险患者未接受培菲格司亭预防，并且先前的 FN 使随后 FN 的发生风险增加了 2.1-2.4 倍。
结论：尽管有临床实践指南，但仍有少数患者未接受 G-CSF 预防，而该人群中 FN 的发生率明显更高。适当使用培非格司亭预防可能会降低患者因骨髓抑制性化疗而面临这种潜在致命但在很大程度上可预防的并发症的风险。
Expert Opin Biol Ther. 2015
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