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
- Authors
- Park, KH[Park, K. H.]; Sohn, JH[Sohn, J. H.]; Lee, S[Lee, S.]; Park, JH[Park, J. H.]; Kang, SY[Kang, S. Y.]; Kim, HY[Kim, H. Y.]; Park, IH[Park, I. H.]; Park, YH[Park, Y. H.]; Im, YH[Im, Y. H.]; Lee, HJ[Lee, H. J.]; Hong, DS[Hong, D. S.]; Park, S[Park, S.]; Shin, SH[Shin, S. H.]; Kwon, HC[Kwon, H. C.]; Seo, JH[Seo, J. H.]
- Issue Date
- Oct-2013
- Publisher
- SPRINGER
- Citation
- INVESTIGATIONAL NEW DRUGS, v.31, no.5, pp.1300 - 1306
- Indexed
- SCIE
SCOPUS
- Journal Title
- INVESTIGATIONAL NEW DRUGS
- Volume
- 31
- Number
- 5
- Start Page
- 1300
- End Page
- 1306
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/59143
- DOI
- 10.1007/s10637-013-9973-4
- ISSN
- 0167-6997
- 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 mu g/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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Collections - Medicine > Department of Medicine > 1. Journal Articles
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