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.

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.

• Authors: K H Park, J H Sohn, S Lee, J H Park, S Y Kang, H Y Kim, I H Park, Y H Park, Y H Im, H J Lee, D S Hong, S Park, S H Shin, H C Kwon, J H Seo
• Journal: Investigational new drugs (Invest New Drugs) Vol. 31 Issue 5 Pg. 1300-6 (Oct 2013) ISSN: 1573-0646 [Electronic] United States
• PMID: 23677653 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Biosimilar Pharmaceuticals
• Recombinant Proteins
• Taxoids
• Granulocyte Colony-Stimulating Factor
• Docetaxel
• Polyethylene Glycols
• Doxorubicin
• Cyclophosphamide
• pegylated granulocyte colony-stimulating factor
• Filgrastim

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Biosimilar Pharmaceuticals (administration & dosage, adverse effects)
• Breast Neoplasms (blood, drug therapy)
• Cyclophosphamide (administration & dosage)
• Docetaxel
• 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