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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

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Abstract

Purpose

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).

Methods

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 μg/m2/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.

Results

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/mm3 and 161.75/mm3 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.

Conclusions

DA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy.

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Author information

Authors and Affiliations

  1. Division of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, 73 Inchonro, Sungbuk-Gu, Seoul, 02481, South Korea

    K. H. Park & Jae Hong Seo

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

    S. Lee

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

    J. H. Park

  4. Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea

    S. Y. Kang

  5. Division of Oncology/Hematology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Pyeongchon, Anyang-si, Gyeonggi-do, South Korea

    H. Y. Kim

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

    I. H. Park

  7. Division of Hematology/Oncology, Department of Internal Medicine, Samsung Medical Center, Seoul, South Korea

    Y. H. Park & Y. H. Im

  8. Product Development HQ, Dong-A ST, Seoul, South Korea

    H. J. Lee

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

    S. Park

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

    S.I. Lee

  11. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

    K.H. Jung

  12. Division of Oncology/Hematology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, South Korea

    Y.S. Kim

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  1. K. H. Park
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  9. H. J. Lee
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  14. Jae Hong Seo
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Corresponding author

Correspondence to Jae Hong Seo.

Ethics declarations

The study protocol was approved by the institutional review board of each participating center and the Ministry of Food and Drug Safety. All patients gave written informed consent before any study-related procedure was performed.

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Park, K.H., Lee, S., Park, J.H. et al. 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. Support Care Cancer 25, 505–511 (2017). https://doi.org/10.1007/s00520-016-3429-2

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  • DOI: https://doi.org/10.1007/s00520-016-3429-2

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