Weycker Derek, Bensink Mark, Wu Hongsheng, 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):2115-2120. doi: 10.1080/03007995.2017.1386638. Epub 2017 Oct 16.
Evidence suggests that not all cancer chemotherapy patients who receive first-cycle pegfilgrastim prophylaxis (PP) continue to receive it in later cycles, and that these patients may be subsequently at higher risk of febrile neutropenia (FN). Available evidence, however, may not be reflective of current clinical practice. We undertook an evaluation to estimate the odds of FN, beginning with second chemotherapy cycle, among patients who received PP in that cycle and all previous cycles versus those who received PP in all previous cycles only, using recent real-world data.
A matched-cohort design and data from two US healthcare claims repositories (2010-2015) were employed. The source population comprised cancer patients who received intermediate/high-risk chemotherapy and first-cycle PP. From the source population, beginning with the second cycle, all patients who received PP in all previous cycles were identified. From this subset, patients who did not receive PP in the cycle of interest ("comparison patients") were matched to those who received PP in that cycle ("PP patients"); the same process was repeated for subsequent cycles. Odds ratios (ORs) for FN (broad and narrow definitions) were estimated using generalized estimating equations.
Among 47,254 patients in the source population, 9% did not receive second-cycle PP and were matched to those who did. FN odds in cycle 2 were significantly higher among comparison patients versus PP patients (OR [broad definition]: 1.7, p < .001); OR [narrow definition]: 4.3, p < .001). Results for subsequent cycles and for the last cycle, respectively, were comparable (OR [range, broad definition]: 1.6 to 3.1, p < .001 for all; OR [range, narrow definition]: 2.7 to 11.8, p < .001 for all).
In this real-world evaluation of cancer chemotherapy patients who received first-cycle PP, FN risk was substantially higher among patients who did not receive PP in subsequent cycles versus those who continued PP.
有证据表明，并非所有接受首个周期培非格司亭预防（PP）的癌症化疗患者在后续周期中仍会继续接受该治疗，且这些患者随后发生发热性中性粒细胞减少（FN）的风险可能更高。然而，现有证据可能无法反映当前的临床实践。我们利用近期的真实世界数据进行了一项评估，以估计在第二个化疗周期开始时，在该周期及之前所有周期均接受PP的患者与仅在之前所有周期接受PP的患者相比发生FN的几率。
采用匹配队列设计和来自两个美国医疗保健索赔数据库（2010 - 2015年）的数据。源人群包括接受中/高风险化疗和首个周期PP的癌症患者。从源人群开始，从第二个周期起，识别出在之前所有周期均接受PP的所有患者。从该子集中，将在感兴趣周期未接受PP的患者（“对照患者”）与在该周期接受PP的患者（“PP患者”）进行匹配；后续周期重复相同过程。使用广义估计方程估计FN（宽泛和狭义定义）的比值比（OR）。
在源人群的47254名患者中，9%未接受第二个周期的PP，并与接受该治疗的患者进行了匹配。对照患者在第2周期发生FN的几率显著高于PP患者（OR [宽泛定义]：1.7，p <.001）；OR [狭义定义]：4.3，p <.001）。后续周期和最后一个周期的结果分别具有可比性（OR [范围，宽泛定义]：1.6至3.1，所有p <.001；OR [范围，狭义定义]：2.7至11.8，所有p <.001）。
在这项对接受首个周期PP的癌症化疗患者的真实世界评估中，后续周期未接受PP的患者发生FN的风险显著高于继续接受PP的患者。
