PMID- 37802015
OWN - NLM
STAT- MEDLINE
DCOM- 20231205
LR  - 20231217
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Print)
IS  - 0960-9776 (Linking)
VI  - 72
DP  - 2023 Dec
TI  - An observational, prospective, open label, multicenter study to evaluate the 
      safety and effectiveness of pegfilgrastim as secondary prophylaxis to decrease 
      the incidence of febrile neutropenia in Korean female patients with breast 
      cancer.
PG  - 103585
LID - S0960-9776(23)00561-1 [pii]
LID - 10.1016/j.breast.2023.103585 [doi]
LID - 103585
AB  - PURPOSE: Pegfilgrastim is a widely used long-acting granulocyte 
      colony-stimulating factor (G-CSF) that prevents febrile neutropenia (FN) in 
      patients with breast cancer receiving chemotherapy. This study aimed to evaluate 
      the incidence of chemotherapy-related FN events and other adverse events (AEs) 
      during chemotherapy in Korean patients with breast cancer treated with 
      pegfilgrastim as secondary prophylactic support. MATERIALS AND METHODS: This was 
      a multicenter, open-label, prospective, observational study. A total of 1255 
      patients were enrolled from 43 institutions. The incidence of FN was evaluated as 
      the primary endpoint. The secondary endpoints included (1) incidence of bone 
      pain, (2) proportion of patients with a relative dose intensity (RDI) of >/=85%, 
      and (3) proportion of patients with AE. RESULTS: Pegfilgrastim administration 
      reduced FN by 11.8-1.6%. The highest incidence of bone pain was observed at the 
      time point of the 1st day after the administration and mild bone pain was the 
      most common of all bone pain severity. The mean RDI was 98.5 +/- 7.3%, and the 
      proportion of the patients with and RDI>/=85% was 96.9% (1169/1233). AEs were 
      reported in 52.6% of the patients, and serious drug reactions occurred in only 
      0.7%. CONCLUSION: The use of pegfilgrastim as secondary prophylaxis was effective 
      and safe for preventing FN in patients with breast cancer who were treated with 
      chemotherapy.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Lee, Anbok
AU  - Lee A
AD  - Department of Surgery, Chung-Ang University Gwangmyeong Hospital, Chung-Ang 
      University College of Medicine, Gyeonggi-do, Republic of Korea.
FAU - Kang, Taewoo
AU  - Kang T
AD  - Busan Cancer Center and Biomedical Research Institute, Pusan National University 
      Hospital, and Department of Surgery, Pusan National University, School of 
      Medicine, Busan, Republic of Korea.
FAU - Kang, Su Hwan
AU  - Kang SH
AD  - Department of Surgery, Yeungnam University Hospital, Daegu, Republic of Korea.
FAU - Park, Woo-Chan
AU  - Park WC
AD  - Department of Surgery, College of Medicine, The Catholic University of Korea, 
      Seoul, Republic of Korea.
FAU - Lim, Woosung
AU  - Lim W
AD  - Department of Surgery, Ewha Womans University School of Medicine, Seoul, Republic 
      of Korea.
FAU - Chang, Myung-Chul
AU  - Chang MC
AD  - Department of Surgery, Dankook University College of Medicine, Cheonan, Republic 
      of Korea.
FAU - Kim, Hyun Yul
AU  - Kim HY
AD  - Department of Surgery, Pusan National University Yangsan Hospital, Pusan National 
      University School of Medicine, Yangsan, Republic of Korea.
FAU - Song, Jeong-Yoon
AU  - Song JY
AD  - Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee 
      University College of Medicine, Seoul, Republic of Korea.
FAU - Lee, Jihyoun
AU  - Lee J
AD  - Department of Surgery, Soonchunhyang University Hospital, Seoul, Republic of 
      Korea.
FAU - Byun, Kyung Do
AU  - Byun KD
AD  - Department of Surgery, Busan Paik Hospital, Inje University College of Medicine, 
      Busan, Republic of Korea.
FAU - Kim, Hyun-Ah
AU  - Kim HA
AD  - Department of Surgery, Korea Cancer Center Hospital, Korea Institute of 
      Radiological & Medical Sciences, Seoul, Republic of Korea.
FAU - Son, Gil Soo
AU  - Son GS
AD  - Department of Surgery, Korea University College of Medicine, Seoul, Republic of 
      Korea.
FAU - Kim, Ju-Yeon
AU  - Kim JY
AD  - Department of Surgery, Gyeongsang National University Hospital, Gyeongsang 
      National University School of Medicine, Jinju, Republic of Korea.
FAU - Oh, Se Jeong
AU  - Oh SJ
AD  - Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, Republic of Korea.
FAU - Chung, Min Sung
AU  - Chung MS
AD  - Department of Surgery, College of Medicine, Hanyang University, Seoul, Republic 
      of Korea.
FAU - Choi, Young Jin
AU  - Choi YJ
AD  - Department of Surgery, Chungbuk National University Hospital, Chungbuk National 
      University College of Medicine, Cheongju, Republic of Korea.
FAU - Shin, Hyuk-Jai
AU  - Shin HJ
AD  - Department of Surgery, Myongji Hospital, Hanyang University, Goyang, Republic of 
      Korea.
FAU - Baek, Jong Min
AU  - Baek JM
AD  - Department of Surgery, Yeouido St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, Republic of Korea.
FAU - Yoo, Youngbum
AU  - Yoo Y
AD  - Department of Surgery, Konkuk University Medical Center, Seoul, Republic of 
      Korea.
FAU - Um, Eunhae
AU  - Um E
AD  - Department of Surgery, Ilsan Paik Hospital, Inje University College of Medicine, 
      Goyang, Republic of Korea.
FAU - Choi, Jin Hyuk
AU  - Choi JH
AD  - Department of Breast Surgery, Kosin University Gospel Hospital, Busan, Republic 
      of Korea.
FAU - Kwak, Beom Seok
AU  - Kwak BS
AD  - Department of Surgery, Dongguk University Ilsan Hospital, Dongguk University 
      College of Medicine, Goyang, Republic of Korea.
FAU - Park, Min Ho
AU  - Park MH
AD  - Department of Surgery, Chonnam National University Medical School and Chonnam 
      National University Hwasun Hospital, Hwasun 58128, Republic of Korea.
FAU - Lee, Suok Hyun
AU  - Lee SH
AD  - Department of Surgery, Cheil Hospital, Seoul, Republic of Korea.
FAU - Kim, Cheol Seung
AU  - Kim CS
AD  - Department of Surgery, Presbyterian Medical Center, Jeonju, Republic of Korea.
FAU - Lee, Ilkyun
AU  - Lee I
AD  - Department of Surgery, Catholic Kwandong University International St. Mary's 
      Hospital, Incheon, Republic of Korea.
FAU - Kim, Je-Ryong
AU  - Kim JR
AD  - Department of Surgery, Chungnam National University College of Medicine, Daejeon, 
      Republic of Korea.
FAU - Lee, Han Shin
AU  - Lee HS
AD  - Department of Surgery, Gyeongsang National University Changwon Hospital, 
      Gyeongsang National University School of Medicine, Jinju, Republic of Korea.
FAU - Lim, Cheol Wan
AU  - Lim CW
AD  - Department of Surgery, Soonchunhyang University Bucheon Hospital, 170 Jomaru-ro, 
      Wonmi-gu, Bucheon, 14584, Republic of Korea. Electronic address: 
      cwlim@schmc.ac.kr.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20231002
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 3A58010674 (pegfilgrastim)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Breast Neoplasms/drug therapy
MH  - Incidence
MH  - Prospective Studies
MH  - *Febrile Neutropenia/chemically induced/epidemiology/prevention & control
MH  - Pain
MH  - Republic of Korea/epidemiology
PMC - PMC10568407
COIS- The study was sponsored by Kyowa Kirin Korea Co., Ltd. All authors received 
      research grants from Kyowa Kirin Korea Co., Ltd.
EDAT- 2023/10/07 00:41
MHDA- 2023/12/05 12:43
PMCR- 2023/10/02
CRDT- 2023/10/06 18:11
PHST- 2023/08/02 00:00 [received]
PHST- 2023/09/25 00:00 [revised]
PHST- 2023/09/25 00:00 [accepted]
PHST- 2023/12/05 12:43 [medline]
PHST- 2023/10/07 00:41 [pubmed]
PHST- 2023/10/06 18:11 [entrez]
PHST- 2023/10/02 00:00 [pmc-release]
AID - S0960-9776(23)00561-1 [pii]
AID - 103585 [pii]
AID - 10.1016/j.breast.2023.103585 [doi]
PST - ppublish
SO  - Breast. 2023 Dec;72:103585. doi: 10.1016/j.breast.2023.103585. Epub 2023 Oct 2.