A single-center, randomized controlled trial of PEG-rhG-CSF and common rhG-CSF to promote neutrophil recovery after induction chemotherapy in newly diagnosed acute myeloid leukemia.
10.3760/cma.j.issn.0253-2727.2019.06.009
- Author:
Kai Qi LIU
1
;
Ying WANG
;
Zi ZHAO
;
Dong LIN
;
Chun Lin ZHOU
;
Bing Cheng LIU
;
Xiao Yuan GONG
;
Xing Li ZHAO
;
Shu Ning WEI
;
Guang Ji ZHANG
;
Ben Fa GONG
;
Yan LI
;
Yun Tao LIU
;
Ying Chang MI
;
Jian Xiang WANG
;
Hui WEI
Author Information
1. Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, Tianjin 300020, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Acute myeloid leukemia;
Chemotherapy, induction;
Granulocyte stimulating factor;
Neutropenia;
Pegylation
- MeSH:
Granulocyte Colony-Stimulating Factor/therapeutic use*;
Humans;
Induction Chemotherapy/adverse effects*;
Leukemia, Myeloid, Acute/drug therapy*;
Neutropenia;
Neutrophils;
Prospective Studies;
Recombinant Proteins
- From:
Chinese Journal of Hematology
2019;40(6):497-501
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To compare the time of the recovery of neutrophils or leukocytes by pegylated recombinant human granulocyte stimulating factor (PEG-rhG-CSF) or common recombinant human granulocyte stimulating factor (rhG-CSF) in the myelosuppressive phase after induction chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients. At the same time, the incidences of infection and hospitalization were compared. Methods: A prospective randomized controlled trial was conducted in patients with newly diagnosed AML who met the enrollment criteria from August 2014 to December 2017. The patients were randomly divided into two groups according to a 1:1 ratio: PEG-rhG-CSF group and rhG-CSF group. The time of neutrophil or leukocyte recovery, infection rate and hospitalization interval were compared between the two groups. Results: 60 patients with newly diagnosed AML were enrolled: 30 patients in the PEG-rhG-CSF group and 30 patients in the rhG-CSF group. There were no significant differences in age, chemotherapy regimen, pre-chemotherapy ANC, WBC, and induction efficacy between the two groups (P>0.05) . The median time (range) of ANC or WBC recovery in patients with PEG-rhG-CSF and rhG-CSF were 19 (14-35) d and 19 (15-26) d, respectively, with no statistical difference (P=0.566) . The incidences of infection in the PEG-rhG-CSF group and the rhG-CSF group were 90.0%and 93.3%, respectively, and there was no statistical difference (P=1.000) . The median days of hospitalization (range) was 20.5 (17-49) days and 21 (19-43) days, respectively, with no statistical difference (P=0.530) . Conclusions: In AML patients after induction therapy, there was no significant difference between the application of PEG-rhG-CSF and daily rhG-CSF in ANC or WBC recovery time, infection incidence and hospitalization time.
