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

Kyong Hwa 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, Jae Hong Seo

Research output: Contribution to journalArticle

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Abstract

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
Volume31
Issue number5
DOIs
Publication statusPublished - 2013 Oct 1

Fingerprint

Biosimilar Pharmaceuticals
Breast Neoplasms
Drug Therapy
docetaxel
Granulocyte Colony-Stimulating Factor
Neutropenia
Febrile Neutropenia
Injections
Incidence
Subcutaneous Injections
Doxorubicin
Cyclophosphamide
Therapeutics
human pegylated granulocyte colony-stimulating factor
Filgrastim
pegylated granulocyte colony-stimulating factor
Safety

Keywords

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

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Oncology

Cite this

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. / Park, Kyong Hwa; Sohn, J. H.; Lee, S.; Park, J. H.; Kang, S. Y.; Kim, H. Y.; Park, I. H.; Park, Y. H.; Im, Y. H.; Lee, H. J.; Hong, D. S.; Park, S.; Shin, S. H.; Kwon, H. C.; Seo, Jae Hong.

In: Investigational New Drugs, Vol. 31, No. 5, 01.10.2013, p. 1300-1306.

Research output: Contribution to journalArticle

Park, Kyong Hwa ; Sohn, J. H. ; Lee, S. ; Park, J. H. ; Kang, S. Y. ; Kim, H. Y. ; Park, I. H. ; Park, Y. H. ; Im, Y. H. ; Lee, H. J. ; Hong, D. S. ; Park, S. ; Shin, S. H. ; Kwon, H. C. ; Seo, Jae Hong. / 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. In: Investigational New Drugs. 2013 ; Vol. 31, No. 5. pp. 1300-1306.
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abstract = "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.",
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AU - Sohn, J. H.

AU - Lee, S.

AU - Park, J. H.

AU - Kang, S. Y.

AU - Kim, H. Y.

AU - Park, I. H.

AU - Park, Y. H.

AU - Im, Y. H.

AU - Lee, H. J.

AU - Hong, D. S.

AU - Park, S.

AU - Shin, S. H.

AU - Kwon, H. C.

AU - Seo, Jae Hong

PY - 2013/10/1

Y1 - 2013/10/1

N2 - 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.

AB - 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.

KW - Breast cancer

KW - Neutropenia

KW - Pegylated G-CSF

KW - TAC chemotherapy

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