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838 - A Pilot Study of Single Pegfilgrastim Compared with Intermittent Every Other Days of 5 Shot-filgrastim in Breast Cancer Patients Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) Chemotherapy (G-CSF 105 trial: NCT02685111)


24 Nov 2018


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Supportive Care and Symptom Management

Tumour Site

Breast Cancer


Jaeho Jeong


Annals of Oncology (2018) 29 (suppl_9): ix1-ix7. 10.1093/annonc/mdy426


J. Jeong1, B.S. Sohn2, J. Ahn1, K.H. Jung1, J.E. Kim1, J. Oh1, H. Lee1, J.H. Sohn3, S. Koh4, J.H. Seo5, K.S. Lee6, S. Kim1

Author affiliations

  • 1 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 2 Department Of Internal Medicine, Inje University Sanggye Paik Hospital, 01757 - Seoul/KR
  • 3 Department Of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, 03722 - Seoul/KR
  • 4 Division Of Hematology And Oncology, Department Of Internal Medicine, Ulsan University Hospital, Ulsan University College of Medicine, 44033 - Ulsan/KR
  • 5 Division Of Medical Oncology, Department Of Internal Medicine, Korea University Guro Hospital, 08308 - Seoul/KR
  • 6 Center For Breast Cancer, National Cancer Center, 10408 - Goyang-si/KR


Abstract 838


The aim of this study is to compare the efficacy and safety of primary prophylaxis with once-per-cycle pegfilgrastim and intermittent every other day filgrastim in Korean patients with breast cancer treated with adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy.


As a pilot study, patients who had undergone complete resection for breast cancer and scheduled to receive adjuvant TAC chemotherapy were enrolled in this study. Patients were randomized to receive a single injection of pegfilgrastim 6mg at Day 2 (D2) or intermittent 5 shots of filgrastim 5 mg/kg/day at D3, D5, D7, D9, and D11 as primary prophylaxis. Both prophylactic regimens were compared during the first 3 cycles of adjuvant chemotherapy. During the study period of adjuvant TAC chemotherapy, complete blood counts were collected on D1, D7, D9, and D14 of each cycle and routine physical examination was performed.


Twenty-two patients were randomized. Eleven of 22 patients received pegfilgrastim, and the other 11 patients received intermittent filgrastim. Grade 4 neutropenia occurred in 11 of 11 patients (28 of 33 cycles) on intermittent filgrastim and 9 of 11 patients (18 of 33 cycles) on pegfilgrastim. Only one episode of febrile neutropenia was observed in 1 patient of pegfilfgrastim group.Table: 15P

Mean ANC during study period

Mean ANC (SD)
Cycle 1Day 13456 (428)3625 (314)
Day 7271 (92)2143 (916)
Day 91249 (316)1307 (451)
Day 144747 (442)5555 (1023)
Cycle 2Day 16178 (1024)6880 (1243)
Day 71495 (415)1590 (833)
Day 91634 (368)1464 (845)
Day 145785 (365)5876 (962)
Cycle 3Day 16650 (767)6272 (1056)
Day 71598 (1003)2036 (731)
Day 9*2694 (646)892 (411)
Day 145773 (575)7343 (1371)

Abbreviations: ANC, absolute neutrophil count; SD, standard deviation *P = 0.030


In this pilot study, there was no significant difference between two regimens of primary prophylaxis for febrile neutropenia in patients treated with adjuvant TAC chemotherapy. In case that the use of pegfilgrastim is limited, intermittent every other day 5-shots of filgrastim might be an alternative primary prophylaxis.

Editorial acknowledgement

Clinical trial identification


Legal entity responsible for the study

Sung-Bae Kim.


Kyowa Kirin Inc.


All authors have declared no conflicts of interest.

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