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
Investigational new drugs
2013Oct ; 31 ( 5 ) :1300-6.
PMID : 23677653
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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 -
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.
Breast cancer; Neutropenia; Pegylated G-CSF; TAC chemotherapy
MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Biosimilar Pharmaceuticals/*administration & dosage/adverse effects, Breast Neoplasms/blood/*drug therapy, Cyclophosphamide/administration & dosage, Doxorubicin/administration & dosage, Female, Filgrastim, Granulocyte Colony-Stimulating Factor/*administration & dosage/adverse effects, Humans, Leukocyte Count, Middle Aged, Neutropenia/blood/chemically induced/*drug therapy, Polyethylene Glycols/*administration & dosage/adverse effects, Recombinant Proteins/administration & dosage/adverse effects, Taxoids/administration & dosage, Treatment Outcome
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