Zhang Yu-Fei, Zhang Rou-Mei, Gu Wen-Xin, Jin Yi-Ting, Ma Chun-Lai
Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai, PR China.
Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, PR China.
Curr Med Res Opin. 2024 Dec;40(12):2147-2154. doi: 10.1080/03007995.2024.2423736. Epub 2024 Nov 6.
Polyethylene glycol recombinant human granulocyte colony-stimulating factors (PEG-rhG-CSFs) are used to prevent or treat chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). This study aimed to compare the efficacy and safety of same-day versus next-day PEG-rhG-CSF administration following chemotherapy and the effects of 3 mg versus 6 mg dosages.
We retrospectively analyzed cohort data of patients with breast cancer who underwent chemotherapy and received PEG-rhG-CSF either within 24 h (same-day group) or 24 h (next-day group) after chemotherapy. The incidences of CIN and FN were assessed in each chemotherapy cycle between the two groups. The primary endpoint was the incidence of FN in the first cycle and throughout all cycles. The secondary endpoints included the incidences of various grades of CIN (CIN1-CIN4), antibiotic use, chemotherapy regimen modifications, and overall safety.
Among the 2385 chemotherapy cycles with prophylactic PEG-rhG-CSF in 620 patients, 798 and 1587 cycleswere in the same-day and next-day group, respectively. No statistically significant differences were observed in the incidence of FN in the first cycle or across all cycles, CIN1-4, or adverse reactions between the two groups. However, the same-day group exhibited significantly higher rates of antibiotic use (2.88% vs. 0.42%, = .03) and chemotherapy regimen modification (4.68% vs. 1.45%, < .001). Subgroup analysis indicated no differences in outcomes for the 6 mg dosage, but a significantly lower incidence of CIN was observed in the same-day group receiving 3 mg ( = .025).
These findings suggest that same-day administration of PEG-rhG-CSF is as effective and safe as next-day administration in preventing FN and CIN during chemotherapy.
聚乙二醇重组人粒细胞集落刺激因子(PEG-rhG-CSFs)用于预防或治疗化疗引起的中性粒细胞减少症(CIN)和发热性中性粒细胞减少症(FN)。本研究旨在比较化疗后当日与次日给予PEG-rhG-CSF的疗效和安全性,以及3mg与6mg剂量的效果。
我们回顾性分析了接受化疗并在化疗后24小时内(当日组)或24小时后(次日组)接受PEG-rhG-CSF的乳腺癌患者的队列数据。评估两组在每个化疗周期中CIN和FN的发生率。主要终点是第一个周期和所有周期中FN的发生率。次要终点包括各级CIN(CIN1-CIN4)的发生率、抗生素使用情况、化疗方案调整以及总体安全性。
在620例接受预防性PEG-rhG-CSF的2385个化疗周期中,当日组和次日组分别有798个和1587个周期。两组在第一个周期或所有周期中FN的发生率、CIN1-4或不良反应方面未观察到统计学上的显著差异。然而,当日组的抗生素使用率(2.88%对0.42%,P = 0.03)和化疗方案调整率(4.68%对1.45%,P < 0.001)显著更高。亚组分析表明,6mg剂量组的结果无差异,但接受3mg的当日组CIN发生率显著更低(P = 0.025)。
这些发现表明,在化疗期间预防FN和CIN方面,当日给予PEG-rhG-CSF与次日给予一样有效和安全。