目的:本研究旨在显示pegfilrastim从3.6mg改为1.8mg后,中性粒细胞计数和发热性中性粒细胞减少症频率的趋势。
方法:本病例系列研究于2016年4月至2021年12月在兵库县Amagasaki综合医疗中心进行。所有由于不良事件或中性粒细胞计数显著升高而将其正常剂量3.6mg的pegfilgrastim降低至1.8mg的患者均包括在内。任何类型的化疗都是可以接受的。在接受1.8mgpegfilgrastim后1个月内退出的患者被排除在外。主要结果是接受1.8mgpegfilgrastim后的中性粒细胞计数。次要结果是发热性中性粒细胞减少症,通过5.0版不良事件通用术语标准进行评估。
结果:该研究包括7名患者,他们使用了剂量密集的表柔比星和环磷酰胺,曲妥珠单抗,帕妥珠单抗,和多西他赛,多西他赛,或者多西他赛和环磷酰胺。使用1.8mgpegfilgrastim后,中性粒细胞计数从平均值18,944[标准偏差(SD)=-7,768]变为仅4,447(SD=1,224)。患者在使用1.8mg和3.6mgpegfilgrastim剂量期间出现1至3级不良事件,包括发热性中性粒细胞减少症,和痛苦。四名患者(57%)抱怨1级或2级疲劳和厌食症。从3.6mgpegfilgrastim切换到1.8mg后,3例患者(42%)出现不良事件.
结论:在因中性粒细胞计数显著升高而出现不良事件的患者中,将pegfilgrastim的剂量减少一半可能会减少不良事件.
OBJECTIVE: This study aimed to show the trend of neutrophil counts and frequency of febrile neutropenia after changing pegfilgrastim from 3.6 mg to 1.8 mg.
METHODS: This
case-series study was performed between April 2016 and December 2021 at Hyogo Prefectural Amagasaki General Medical Center. All patients who reduced their normal dose of 3.6 mg
pegfilgrastim to 1.8 mg due to adverse events or markedly elevated neutrophil counts were included. Any type of chemotherapy was acceptable. Patients who dropped out within 1 month of receiving 1.8 mg
pegfilgrastim were excluded. The primary outcome was the neutrophil counts after receiving 1.8 mg
pegfilgrastim. The secondary outcome was febrile neutropenia, which was evaluated by the Common Terminology Criteria for Adverse Events v5.0.
RESULTS: The study included seven patients who used a regimen of dose-dense epirubicin and cyclophosphamide, trastuzumab, pertuzumab, and docetaxel, docetaxel, or docetaxel and cyclophosphamide. After using 1.8 mg pegfilgrastim, neutrophil counts changed from a mean of 18,944 [standard deviation (SD)=-7,768] to only 4,447 (SD=1,224). The patients experienced grades 1 to 3 adverse events during the use of 1.8 mg and 3.6 mg pegfilgrastim doses, including febrile neutropenia, and pain. Four patients (57%) complained of grade 1 or 2 fatigue and anorexia. After switching from 3.6 mg pegfilgrastim to 1.8 mg, three patients (42%) experienced adverse events.
CONCLUSIONS: In patients who experienced adverse events due to markedly elevated neutrophil counts with pegfilgrastim, reducing the dose of
pegfilgrastim by half may reduce adverse events.