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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; Sohn, JH; Lee, S; Park, JH; Kang, SY; Kim, HY; Park, IH; Park, YH; Im, YH; Lee, HJ; Hong, DS; Park, S; Shin, SH; Kwon, HC; Seo, JH
Citation
Investigational new drugs, 31(5):1300-1306, 2013
Journal Title
Investigational new drugs
ISSN
0167-69971573-0646
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 μg/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.
MeSH terms
AdultAgedAntineoplastic Combined Chemotherapy Protocols/adverse effectsBiosimilar Pharmaceuticals/*administration & dosage/adverse effectsBreast Neoplasms/blood/*drug therapyCyclophosphamide/administration & dosageDoxorubicin/administration & dosageFemaleGranulocyte Colony-Stimulating Factor/*administration & dosage/adverse effectsHumansLeukocyte CountMiddle AgedNeutropenia/blood/chemically induced/*drug therapyPolyethylene Glycols/*administration & dosage/adverse effectsRecombinant Proteins/administration & dosage/adverse effectsTaxoids/administration & dosageTreatment Outcome
DOI
10.1007/s10637-013-9973-4
PMID
23677653
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Hematology-Oncology
AJOU Authors
강, 석윤
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