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A randomized, multi-center, open-label, phase II study of once-per-cycle DA-3031, a biosimilar pegylated G-CSF, compared with daily filgrastim in patients receiving TAC chemotherapy for early-stage breast cancer

 K. H. Park  ;  J. H. Sohn  ;  S. Lee  ;  J. H. Park  ;  S. Y. Kang  ;  H. Y. Kim  ;  I. H. Park  ;  Y. H. Park  ;  Y. H. Im  ;  H. J. Lee  ;  D. S. Hong  ;  S. Park  ;  S. H. Shin  ;  H. C. Kwon  ;  J. H. Seo 
 INVESTIGATIONAL NEW DRUGS, Vol.31(5) : 1300-1306, 2013 
Journal Title
Issue Date
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Biosimilar Pharmaceuticals/administration & dosage* ; Biosimilar Pharmaceuticals/adverse effects ; Breast Neoplasms/blood ; Breast Neoplasms/drug therapy* ; Cyclophosphamide/administration & dosage ; Doxorubicin/administration & dosage ; Female ; Filgrastim ; Granulocyte Colony-Stimulating Factor/administration & dosage* ; Granulocyte Colony-Stimulating Factor/adverse effects ; Humans ; Leukocyte Count ; Middle Aged ; Neutropenia/blood ; Neutropenia/chemically induced ; Neutropenia/drug therapy* ; Polyethylene Glycols/administration & dosage* ; Polyethylene Glycols/adverse effects ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/adverse effects ; Taxoids/administration & dosage ; Treatment Outcome
Breast cancer ; Neutropenia ; Pegylated G-CSF ; TAC chemotherapy
BACKGROUNDS: A pegylated form of recombinant granulocyte-colony stimulating factor (G-CSF) was developed for prophylactic use in breast cancer. The aim of this study was to evaluate the efficacy and safety of once-per-cycle DA-3031 in patients receiving chemotherapy for breast cancer. METHODS: A total of 61 patients receiving docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy were randomized in cycle 1 to receive daily injections of filgrastim (100 μg/m(2)) or a single subcutaneous injection of pegylated filgrastim DA-3031 at a dose of either 3.6 mg or 6 mg. RESULTS: The mean duration of grade 4 neutropenia in cycle 1 was comparable among the treatment groups (2.48, 2.20, and 2.05 days for filgrastim, DA-3031 3.6 mg and 6 mg, respectively; P=0.275). No statistically significant differences were observed in the incidence of febrile neutropenia between the treatment groups (9.5 %, 15.0 %, and 5.0 % for filgrastim, DA-3031 3.6 mg and 6 mg, respectively; P=0.681) in cycle 1. The incidences of adverse events attributable to G-CSF were similar among the treatment groups. CONCLUSIONS: Fixed doses of 3.6 mg or 6 mg DA-3031 have an efficacy comparable to that of daily injections of filgrastim in ameliorating grade 4 neutropenia in patients receiving TAC chemotherapy.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
Lee, Soo Hyeon(이수현)
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