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, K. H.; 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, J. H.
- Issue Date
- Oct-2013
- Publisher
- Kluwer Academic Publishers
- Keywords
- Breast cancer; Neutropenia; Pegylated G-CSF; TAC chemotherapy
- Citation
- Investigational New Drugs, v.31, no.5, pp 1300 - 1306
- Pages
- 7
- Journal Title
- Investigational New Drugs
- Volume
- 31
- Number
- 5
- Start Page
- 1300
- End Page
- 1306
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/13341
- DOI
- 10.1007/s10637-013-9973-4
- ISSN
- 0167-6997
1573-0646
- 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 - College of Medicine > Department of Internal Medicine > 1. Journal Articles
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