[A multicenter, randomized, controlled, phase â
£ clinical study of PEG-rhG-CSF for preventing chemotherapy induced neutropenia in patients with breast cancer].
Zhonghua Yi Xue Za Zhi
; 98(16): 1231-1235, 2018 Apr 24.
Article
em Zh
| MEDLINE
| ID: mdl-29747310
ABSTRACT
Objective:
To explore the efficacy and safety of polyethylene glycal recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patiens with breast cancer.Methods:
There were two parts in the present phase â £ clinical study. One was a randomized, controlled clinical study. Patients in this study received PEG-rhG-CSF or rhG-CSF in the first cycle and followed with both PEG-rhG-CSF in the rest of 3 cycles. The other one was a single arm study. Patients who developed â ¢/â £ grade neutropenia in the screening cycle received PEG-rhG-CSF in the rest of 3 cycles chemotherapy.Results:
In the first cycle of randomized, controlled study, the incidence of â £ grade neutropenia are 31.48% and 35.58% respectively in PEG-rhG-CSF and rhG-CSF group, with no statistically significant differences (P=0.527 6). The duration of â £ grade neutropenia respectively are 2.22±1.58 and 3.00±1.59 days, with a statistically significant difference (P=0.016 6). In the single arm study, the incidence of â £ grade neutropenia was 57.76% in screening cycle. And the incidence decreased to 16.35%, 10%, and 8.57% in the followed 3 cycle after the use of PEG-rhG-CSF. The incidence of adverse effects was 5.06%, and the major adverse effect was bone pain which with an incidence of 2.8%.Conclusion:
The fixed 6mg dose of PEG-rhG-CSF can effectively prevent neutropenia in patients with breast cancer in multicycle chemotherapy and it has a low incidence of adverse events and mild adverse reaction.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Neutropenia
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
Zh
Revista:
Zhonghua Yi Xue Za Zhi
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
China