Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Milan.
Ann Oncol. 2010 Jul;21(7):1482-1485. doi: 10.1093/annonc/mdp576. Epub 2009 Dec 11.
American Society of Clinical Oncology guidelines recommend the use of growth factor after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support. This randomized trial aims to demonstrate the noninferiority of pegfilgrastim (PEG) compared with filgrastim (FIL) after HDC.
Eighty patients were assigned to FIL at a daily dose of 5 mug/kg or a single fixed dose of PEG (6 mg) 1 day after PBSC. The primary end point was the duration of neutropenia both in terms of absolute neutrophil count (ANC) <0.5 x 10(9)/l and of days to reach an ANC >0.5 x 10(9)/l.
The mean duration of neutropenia was 6 and 6.2 days and the mean time to reach an ANC >0.5 x 10(9)/l was 11.5 and 10.8 in the FIL and PEG group, respectively. No differences were observed in the mean time to reach an ANC >1.0 x 10(9)/l (12.2 versus 12.0 days) in the incidence of fever (62% versus 56%) and of documented infections (31% versus 25%). The mean duration of antibiotic therapy was 5.7 and 4.0 days in FIL and PEG group, respectively.
PEG is not inferior to FIL in hematological reconstitution and represents an effective alternative after HDC and PBSC.
美国临床肿瘤学会指南建议在高剂量化疗（HDC）和外周血干细胞（PBSC）支持后使用生长因子。这项随机试验旨在证明培非格司亭（PEG）在 HDC 后与非格司亭（FIL）相比不劣效。
80 名患者被分配至 FIL 组，每日剂量为 5 mcg/kg，或 PEG（6mg）组，在 PBSC 后 1 天给予单次固定剂量。主要终点是中性粒细胞减少症的持续时间，无论是以绝对中性粒细胞计数（ANC）<0.5 x 10(9)/l 还是达到 ANC>0.5 x 10(9)/l 的天数来衡量。
中性粒细胞减少症的平均持续时间分别为 6 天和 6.2 天，达到 ANC>0.5 x 10(9)/l 的平均时间分别为 11.5 天和 10.8 天，在 FIL 和 PEG 组中。在达到 ANC>1.0 x 10(9)/l 的平均时间（12.2 天对 12.0 天）、发热发生率（62%对 56%）和有记录的感染发生率（31%对 25%）方面没有差异。抗生素治疗的平均持续时间分别为 5.7 天和 4.0 天，在 FIL 和 PEG 组中。
PEG 在血液重建方面并不劣于 FIL，是 HDC 和 PBSC 后的有效替代方案。
