A Pilot Study of Single Pegfilgrastim Compared with Intermittent Every Other Days of 5 Shot-filgrastim in Breast Cancer Patients Receiving Adjuvant...

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Supportive Measures
Breast Cancer
Presenter Jaeho Jeong
Citation Annals of Oncology (2018) 29 (suppl_9): ix1-ix7. 10.1093/annonc/mdy426
Authors 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
  • 1Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 05505 - Seoul/KR
  • 2Department Of Internal Medicine, Inje University Sanggye Paik Hospital, 01757 - Seoul/KR
  • 3Department Of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, 03722 - Seoul/KR
  • 4Division Of Hematology And Oncology, Department Of Internal Medicine, Ulsan University Hospital, Ulsan University College of Medicine, 44033 - Ulsan/KR
  • 5Division Of Medical Oncology, Department Of Internal Medicine, Korea University Guro Hospital, 08308 - Seoul/KR
  • 6Center For Breast Cancer, National Cancer Center, 10408 - Goyang-si/KR

Abstract

Background

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.

Methods

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.

Results

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)
PegfilgrastimFilgrastim
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

Conclusions

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

NCT02685111.

Legal entity responsible for the study

Sung-Bae Kim.

Funding

Kyowa Kirin Inc.

Disclosure

All authors have declared no conflicts of interest.