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比较非格司亭和聚乙二醇化非格司亭预防乳腺癌患者中性粒细胞减少并维持辅助化疗剂量强度的效果。

Comparison of filgrastim and pegfilgrastim to prevent neutropenia and maintain dose intensity of adjuvant chemotherapy in patients with breast cancer.

作者信息

Kourlaba Georgia, Dimopoulos Meletios A, Pectasides Dimitrios, Skarlos Dimosthenis V, Gogas Helen, Pentheroudakis George, Koutras Angelos, Fountzilas George, Maniadakis Nikos

机构信息

The Stavros Niarchos Foundation-Collaborative Center for Clinical Epidemiology and Outcomes Research (CLEO), National and Kapodistrian University of Athens School of Medicine, Athens, Greece,

出版信息

Support Care Cancer. 2015 Jul;23(7):2045-51. doi: 10.1007/s00520-014-2555-y. Epub 2014 Dec 19.

Abstract

PURPOSE

The aim of this study was to compare the effectiveness of prophylactic single fixed dose of pegfilgrastim and daily administration of filgrastim on febrile neutropenia (FN), severe neutropenia, treatment delay, and dose reduction in patients with breast cancer receiving dose-dense adjuvant chemotherapy.

METHODS

A retrospective cohort study with 1058 breast cancer patients matched by age and chemotherapy was conducted. The primary endpoints were FN, severe (grade 3, 4) neutropenia, dose reduction (>10 % reduction of the dose planned), and treatment delay (dose given more than 2 days later).

RESULTS

Eighteen episodes of FN (3.4%) in the filgrastim group and 23 (4.3%) in the pegfilgrastim group (p = 0.500) were recorded. More than half of the total episodes (27/41) occurred during the first 4 cycles of treatment. Patients who received filgrastim were almost three times more likely to experience a severe neutropenia episode and were significantly more likely to experience a dose reduction (18.5%) compared to those who received pegfilgrastim (10.8%) (p < 0.001). The percentage of patients, who received their planned dose on time, was significantly lower in patients receiving filgrastim (58%) compared to those receiving pegfilgrastim (72.4%, p < 0.001).

CONCLUSIONS

No significant difference was detected on FN rate between daily administration of filgrastim and single administration of pegfilgrastim. However, patients receiving pegfilgrastim had a significantly lower rate of severe neutropenia, as well as dose reduction and treatment delay, thus, achieving a higher dose density.

摘要

目的

本研究旨在比较预防性单次固定剂量聚乙二醇化重组人粒细胞刺激因子与每日注射重组人粒细胞刺激因子对接受剂量密集辅助化疗的乳腺癌患者发热性中性粒细胞减少症(FN)、严重中性粒细胞减少症、治疗延迟及剂量降低的有效性。

方法

开展一项回顾性队列研究,纳入1058例按年龄和化疗方案匹配的乳腺癌患者。主要终点为FN、严重(3级、4级)中性粒细胞减少症、剂量降低(计划剂量降低超过10%)及治疗延迟(给药时间推迟超过2天)。

结果

记录到重组人粒细胞刺激因子组出现18例FN(3.4%),聚乙二醇化重组人粒细胞刺激因子组出现23例(4.3%)(p = 0.500)。超过半数的病例(27/41)发生在治疗的前4个周期。接受重组人粒细胞刺激因子治疗的患者发生严重中性粒细胞减少症的可能性几乎是接受聚乙二醇化重组人粒细胞刺激因子治疗患者的3倍,且出现剂量降低(18.5%)的可能性显著高于后者(10.8%)(p < 0.001)。与接受聚乙二醇化重组人粒细胞刺激因子治疗的患者(72.4%)相比,接受重组人粒细胞刺激因子治疗的患者按时接受计划剂量的比例显著更低(58%)(p < 0.001)。

结论

每日注射重组人粒细胞刺激因子与单次注射聚乙二醇化重组人粒细胞刺激因子的FN发生率无显著差异。然而,接受聚乙二醇化重组人粒细胞刺激因子治疗的患者严重中性粒细胞减少症、剂量降低及治疗延迟的发生率显著更低,从而实现了更高的剂量强度。

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