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Investigational New Drugs

, Volume 31, Issue 5, pp 1300–1306 | Cite as

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

  • 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. SeoEmail author
PHASE II STUDIES

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.

Keywords

Breast cancer Neutropenia Pegylated G-CSF TAC chemotherapy 

Notes

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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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • K. H. Park
    • 1
  • J. H. Sohn
    • 2
  • S. Lee
    • 2
  • J. H. Park
    • 3
  • S. Y. Kang
    • 4
  • H. Y. Kim
    • 5
  • I. H. Park
    • 6
  • Y. H. Park
    • 7
  • Y. H. Im
    • 7
  • H. J. Lee
    • 8
  • D. S. Hong
    • 9
  • S. Park
    • 10
  • S. H. Shin
    • 11
  • H. C. Kwon
    • 12
  • J. H. Seo
    • 1
    Email author
  1. 1.Division of Oncology/Hematology, Department of Internal medicineKorea University College of MedicineSeoulKorea
  2. 2.Division of Oncology, Department of Internal medicine, Severance HospitalYonsei University College of MedicineSeoulKorea
  3. 3.Division of Oncology/Hematology, Department of Internal medicineUlsan University College of MedicineUlsanKorea
  4. 4.Division of Oncology/Hematology, Department of Internal medicineAjou University School of MedicineSuwonKorea
  5. 5.Division of Oncology/Hematology, Department of Internal medicineHallym University Sacred Heart HospitalPyeongchonKorea
  6. 6.Center for Breast Cancer and Center for Clinical TrialsNational Cancer CenterGoyang-siKorea
  7. 7.Division of Hematology/Oncology, Department of Internal medicineSamsung Medical centerSeoulKorea
  8. 8.Division of Biostatistics, Clinical Development TeamDong-A Pharm. Co., LTD.SeoulKorea
  9. 9.Division of Oncology/Hematology, Department of Internal medicineSoonchunhyang University HospitalBucheonKorea
  10. 10.Division of Oncology, Department of Internal medicine, Seoul St. Mary’s HospitalCatholic University College of MedicineSeoulKorea
  11. 11.Division of Oncology/Hematology, Department of Internal medicineKosin Univiersity Gospel HospitalBusanKorea
  12. 12.Division of Oncology/Hematology, Department of Internal medicineDong-A University College of MedicineBusanKorea

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