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

Overview

Journal Invest New Drugs

Publisher Springer

Specialty Oncology

Date 2013 May 17

PMID 23677653

Citations 11

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

Affiliations

Soon will be listed here.

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.

Citing Articles

Assessing the Optimal Regimen: A Systematic Review and Network Meta-Analysis of the Efficacy and Safety of Long-Acting Granulocyte Colony-Stimulating Factors in Patients with Breast Cancer.

You Z, Zhang H, Huang Y, Zhao L, Tu H, Zhang Y Cancers (Basel). 2023; 15(14).

PMID: 37509336 PMC: 10378237. DOI: 10.3390/cancers15143675.

Effects of Prophylactic Administration of Granulocyte Colony-Stimulating Factor on Peripheral Leukocyte and Neutrophil Counts Levels After Chemotherapy in Patients With Early-Stage Breast Cancer: A Retrospective Cohort Study.

Tian W, Wang Y, Zhou Y, Yao Y, Deng Y Front Oncol. 2022; 12:777602.

PMID: 35547875 PMC: 9084938. DOI: 10.3389/fonc.2022.777602.

Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis.

Rastogi S, Kalaiselvan V, Ali S, Ahmad A, Guru S, Sarwat M Biology (Basel). 2021; 10(10).

PMID: 34681169 PMC: 8533340. DOI: 10.3390/biology10101069.

Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis.

Wang Y, Chen L, Liu F, Zhao N, Xu L, Fu B Sci Rep. 2019; 9(1):15374.

PMID: 31653961 PMC: 6814815. DOI: 10.1038/s41598-019-51982-4.

Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia.

Cornes P, Gascon P, Chan S, Hameed K, Mitchell C, Field P Adv Ther. 2018; 35(11):1816-1829.

PMID: 30298233 PMC: 6223993. DOI: 10.1007/s12325-018-0798-6.

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