title: 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.
abstract: BACKGROUND
  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.
authors.affiliation: Division of Oncology/Hematology, Department of Internal medicine, Korea University College of Medicine, 97 Guro-dong Gil, Guro-gu, Seoul, Korea.
authors.forename: K H
authors.initials: KH
authors.lastname: Park
authors.forename: J H
authors.initials: JH
authors.lastname: Sohn
authors.forename: S
authors.initials: S
authors.lastname: Lee
authors.forename: J H
authors.initials: JH
authors.lastname: Park
authors.forename: S Y
authors.initials: SY
authors.lastname: Kang
authors.forename: H Y
authors.initials: HY
authors.lastname: Kim
authors.forename: I H
authors.initials: IH
authors.lastname: Park
authors.forename: Y H
authors.initials: YH
authors.lastname: Park
authors.forename: Y H
authors.initials: YH
authors.lastname: Im
authors.forename: H J
authors.initials: HJ
authors.lastname: Lee
authors.forename: D S
authors.initials: DS
authors.lastname: Hong
authors.forename: S
authors.initials: S
authors.lastname: Park
authors.forename: S H
authors.initials: SH
authors.lastname: Shin
authors.forename: H C
authors.initials: HC
authors.lastname: Kwon
authors.forename: J H
authors.initials: JH
authors.lastname: Seo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007958:Leukocyte Count; D008875:Middle Aged; D009503:Neutropenia / Q000097:blood / Q000139:chemically induced / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D011092:Polyethylene Glycols; D004317:Doxorubicin; D003520:Cyclophosphamide; C423652:pegylated granulocyte colony-stimulating factor; D000069585:Filgrastim