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 language | English |
|---|---|
| Pages (from-to) | 1300-1306 |
| Number of pages | 7 |
| Journal | Investigational New Drugs |
| Volume | 31 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2013 Oct 1 |
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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 journal › Article
}
TY - JOUR
T1 - 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
AU - Park, Kyong Hwa
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
UR - http://www.scopus.com/inward/record.url?scp=84884813602&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84884813602&partnerID=8YFLogxK
U2 - 10.1007/s10637-013-9973-4
DO - 10.1007/s10637-013-9973-4
M3 - Article
VL - 31
SP - 1300
EP - 1306
JO - Investigational New Drugs
JF - Investigational New Drugs
SN - 0167-6997
IS - 5
ER -