原发 pegfilgrastim 预防对新辅助/辅助 FEC-100 化疗相对剂量强度的影响。

Impact of Primary Pegfilgrastim Prophylaxis on Relative Dose Intensity in Neoadjuvant/Adjuvant FEC-100 Chemotherapy.

机构信息

Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan

Division of Applied Pharmaceutical Education and Research Hoshi University, Tokyo, Japan.

出版信息

Anticancer Res. 2020 Feb;40(2):915-921. doi: 10.21873/anticanres.14024.

DOI:10.21873/anticanres.14024

PMID:32014935

Abstract

BACKGROUND/AIM: This study aimed was to clarify the impact of pegfilgrastim (PEG) 3.6 mg primary prophylaxis of febrile neutropenia (FN) on the average relative dose intensity (ARDI) of neoadjuvant/adjuvant FEC-100 for breast cancer.

MATERIALS AND METHODS

This retrospective, single-centre cohort study including 296 patients who received FEC-100 compared PEG and non-PEG groups. The PEG group received PEG 3.6 mg as a single subcutaneous injection in each study cycle. The primary endpoint was the ARDI of FEC-100. The secondary endpoints were patient percentage of ARDI≥85%, factors associated with ARDI≥85%, and reasons for reduced ARDI.

RESULTS

The PEG group showed significantly higher mean ARDI (95.6% versus 90.7%, p<0.001) and patient percentage of ARDI≥85% (93.0% versus 79.9%, p=0.001). PEG was significantly associated with ARDI≥85% (p=0.009). Neutropenia and FN, the main reasons for reduced ARDI, were significantly lower in the PEG group (p<0.05).

CONCLUSION

Primary PEG 3.6 mg prophylaxis increased the ARDI of FEC-100.

摘要

背景/目的：本研究旨在阐明培格非格司亭（PEG）3.6mg 作为发热性中性粒细胞减少症（FN）一级预防对乳腺癌新辅助/辅助 FEC-100 方案平均相对剂量强度（ARDI）的影响。

材料和方法

这是一项回顾性、单中心队列研究，共纳入 296 例接受 FEC-100 方案治疗的患者，分为 PEG 组和非 PEG 组。PEG 组在每个研究周期接受 PEG 3.6mg 单次皮下注射。主要终点是 FEC-100 的 ARDI。次要终点是 ARDI≥85%的患者比例、与 ARDI≥85%相关的因素以及 ARDI 降低的原因。

结果

PEG 组的平均 ARDI（95.6%比 90.7%，p<0.001）和 ARDI≥85%的患者比例（93.0%比 79.9%，p=0.001）均显著更高。PEG 与 ARDI≥85%显著相关（p=0.009）。中性粒细胞减少症和 FN 是导致 ARDI 降低的主要原因，在 PEG 组中显著较低（p<0.05）。