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A pilot study on intermittent every other days of 5-dose Filgrastim compared with single Pegfilgrastim in breast Cancer patients receiving adjuvant Docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy

  • Byeong Seok Sohn
  • Jae Ho Jeong
  • Jin-Hee Ahn
  • Kyung Hae Jung
  • Jeong Eun Kim
  • Joo Hyuk Sohn
  • Su-Jin Koh
  • Jae Hong Seo
  • Keun Seok Lee
  • Sung-Bae KimEmail author
PHASE II STUDIES
  • 47 Downloads

Summary

Aim To compare the efficacy and safety of intermittent every other days 5-dose filgrastim with single pegfilgrastim in patients with breast cancer receiving adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. Methods In this pilot study, Korean patients who had undergone complete resection for breast cancer and scheduled for adjuvant TAC chemotherapy were enrolled. Patients were randomized to receive either intermittent 5 doses of filgrastim (5 mcg/kg/day) or once-a-cycle pegfilgrastim (6 mg) as primary prophylaxis during the first three cycles of the TAC chemotherapy. Absolute neutrophil count (ANC) was analyzed as well. Results A total of 22 patients were randomly and equally divided into filgrastim or pegfilgrastim arms. Febrile neutropenia (FN) occurred in 1 patient in the pegfilgrastim arm (1 of 33 cycles) and none in the filgrastim arm. G3 neutropenia occurred in 1 patient (1 of 33 cycles) in the filgrastim arm and 2 patients (4 of 33 cycles) in the pegfilgrastim arm (P = 0.476). G4 neutropenia occurred in 11 patients (28 of 33 cycles) in the filgrastim arm and 9 patients (18 of 33 cycles) in the pegfilgrastim arm (P = 0.476). Except for on day 9 in cycle 3, there was no significant difference between the two groups in terms of ANC. Conclusion We observed no significant differences between the two methods of prophylaxis in terms of FN and G3/4 neutropenia incidence in patients receiving adjuvant TAC chemotherapy. Intermittent every other days 5-dose filgrastim may be available alternative to pegfilgrastim.

Keywords

Breast cancer Docetaxel Doxorubicin Cyclophosphamide Filgrastim Pegfilgrastim 

Notes

Funding

Funding for this study came from Kyowa Hakko Kirin, Ltd.

Compliance with ethical standards

Conflict of interest

All authors declare that there exist no conflicts of interest in this study.

Ethical approval

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Oncology, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulSouth Korea
  2. 2.Department of Internal MedicineInje University Sanggye Paik HospitalSeoulSouth Korea
  3. 3.Department of Medical Oncology, Yonsei Cancer CenterYonsei University College of MedicineSeoulSouth Korea
  4. 4.Department of Hematology and OncologyUlsan University Hospital, University of Ulsan College of MedicineUlsanSouth Korea
  5. 5.Division of Medical Oncology, Department of Internal MedicineKorea University Guro Hospital, Korea University School of MedicineSeoulSouth Korea
  6. 6.Center for Breast Cancer, Research Institute and HospitalNational Cancer CenterGoyangSouth Korea

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