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

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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/m2) 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.

Original languageEnglish
Pages (from-to)1300-1306
Number of pages7
JournalInvestigational New Drugs
Issue number5
Publication statusPublished - 2013 Oct 1



  • Breast cancer
  • Neutropenia
  • Pegylated G-CSF
  • TAC chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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