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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

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Summary

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/m2) 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.

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Acknowledgments

This study was funded by Dong-A Pharm. Co., LTD.

Conflicts of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Division of Oncology/Hematology, Department of Internal medicine, Korea University College of Medicine, 97 Guro-dong Gil, Guro-gu, Seoul, Korea

    K. H. Park & J. H. Seo

  2. Division of Oncology, Department of Internal medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

    J. H. Sohn & S. Lee

  3. Division of Oncology/Hematology, Department of Internal medicine, Ulsan University College of Medicine, Ulsan, Korea

    J. H. Park

  4. Division of Oncology/Hematology, Department of Internal medicine, Ajou University School of Medicine, Suwon, Korea

    S. Y. Kang

  5. Division of Oncology/Hematology, Department of Internal medicine, Hallym University Sacred Heart Hospital, Pyeongchon, Korea

    H. Y. Kim

  6. Center for Breast Cancer and Center for Clinical Trials, National Cancer Center, Goyang-si, Korea

    I. H. Park

  7. Division of Hematology/Oncology, Department of Internal medicine, Samsung Medical center, Seoul, Korea

    Y. H. Park & Y. H. Im

  8. Division of Biostatistics, Clinical Development Team, Dong-A Pharm. Co., LTD., Seoul, Korea

    H. J. Lee

  9. Division of Oncology/Hematology, Department of Internal medicine, Soonchunhyang University Hospital, Bucheon, Korea

    D. S. Hong

  10. Division of Oncology, Department of Internal medicine, Seoul St. Mary’s Hospital, Catholic University College of Medicine, Seoul, Korea

    S. Park

  11. Division of Oncology/Hematology, Department of Internal medicine, Kosin Univiersity Gospel Hospital, Busan, Korea

    S. H. Shin

  12. Division of Oncology/Hematology, Department of Internal medicine, Dong-A University College of Medicine, Busan, Korea

    H. C. Kwon

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  1. K. H. Park
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  12. S. Park
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  15. J. H. Seo
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Correspondence to J. H. Seo.

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Park, K.H., Sohn, J.H., Lee, S. et al. 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. Invest New Drugs 31, 1300–1306 (2013). https://doi.org/10.1007/s10637-013-9973-4

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  • DOI: https://doi.org/10.1007/s10637-013-9973-4

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