Efficacy analysis of pegylated filgrastim as prophylaxis for chemo-therapy-induced neutropenia
10.3969/j.issn.1000-8179.20150577
- VernacularTitle:聚乙二醇化重组人粒细胞集落刺激因子预防化疗后中性粒细胞减少的有效性分析
- Author:
Sheng YANG
;
Xiaohui HE
;
Peng LIU
;
Shengyu ZHOU
;
Mei DONG
;
Yan QIN
;
Jianliang YANG
;
Changgong ZHANG
;
Xiaohong HAN
;
Yuankai SHI
- Publication Type:Journal Article
- Keywords:
pegylated filgrastim;
chemotherapy;
neutropenia;
filgrastim;
adverse effect
- From:
Chinese Journal of Clinical Oncology
2015;(12):626-631
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy of a single injection of pegylated filgrastim with daily doses of filgrastim as pro-phylaxis for chemotherapy-induced neutropenia in Chinese cancer patients. Methods:Single-institution data from a phase 2 study and a phase 3 trial on pegylated filgrastim were combined to analyze the efficacy and safety parameters. In the two randomized crossover tri-als, patients with previously untreated cancers received two cycles of chemotherapy with identical regimen. In the study cycle, the pa-tients received a single subcutaneous injection of pegylated filgrastim (100 μg/kg), whereas those in the control cycle received daily subcutaneous injections of filgrastim (5μg/kg). Results:Among the 56 patients enrolled, 53 were evaluable for efficacy. These patients received one cycle with pegylated filgrastim prophylaxis and one cycle with filgrastim support each. Results indicated that 94.3%(50/53) of the cycles with pegylated filgrastim or filgrastim support did not develop grade 4 neutropenia. Moreover, febrile neutropenia did not occur in the cycles. The incidence rates of antibiotic administration were 7.5%(4/53) and 3.8%(2/53) in the pegylated filgrastim and filgrastim cycles, respectively (P=0.678). The median duration of filgrastim administration was 10 days (3-14 days). Generally, the safety profile of pegylated filgrastim is similar to that of filgrastim, including skeletal pain, pain at the injection site, palpitation, fever, and fatigue. Conclusion:A single dose of pegylated filgrastim demonstrated comparable efficacy with 10 consecutive doses of filgras-tim as prophylaxis for chemotherapy-induced neutropenia.
