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A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer

Authors
Park, K. H.Lee, S.Park, J. H.Kang, S. Y.Kim, H. Y.Park, I. H.Park, Y. H.Im, Y. H.Lee, H. J.Park, S.Lee, S. I.Jung, K. H.Kim, Y. S.Seo, Jae Hong
Issue Date
Feb-2017
Publisher
SPRINGER
Keywords
Breast cancer; Pegylated G-CSF; TAC chemotherapy; Neutropenia
Citation
SUPPORTIVE CARE IN CANCER, v.25, no.2, pp 505 - 511
Pages
7
Indexed
SCI
SCIE
SCOPUS
Journal Title
SUPPORTIVE CARE IN CANCER
Volume
25
Number
2
Start Page
505
End Page
511
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/5278
DOI
10.1007/s00520-016-3429-2
ISSN
0941-4355
1433-7339
Abstract
This multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN). Seventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 mu g/m(2)/day for up to 10 days or a single subcutaneous injection of DA-3031 at fixed doses of 6 mg on day 2 of each chemotherapy cycle. The mean duration of grade 4 (G4) neutropenia in cycle 1 was 2.08 +/- 0.85 days for the filgrastim group and 2.28 +/- 1.14 days for the DA-3031 group. The difference between groups was 0.2 +/- 1.10 days (95 % confidence interval (CI) = -0.26, 0.66), which supported non-inferiority. No statistically significant differences were observed in nadir absolute neutrophil count (ANC) (154.34/mm(3) and 161.75/mm(3) for the filgrastim and DA-3031 groups, respectively; P = 0.8414) or in time to ANC recovery (10.03 +/- 0.75 and 9.83 +/- 1.56 days in the filgrastim and DA-3031 groups, respectively; P = 0.0611) during cycle 1. Serious AEs occurred in six (15.8 %) patients receiving filgrastim and in ten (27.8 %) patients receiving DA-3031; however, none was determined to be related to the study drug. DA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy.
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Park, Kyong Hwa
Anam Hospital (Department of Medical Oncology and Hematology, Anam Hospital)
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