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
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)...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-12-01
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| Series: | Breast |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0960977623005611 |
| _version_ | 1797430067295420416 |
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| author | Anbok Lee Taewoo Kang Su Hwan Kang Woo-Chan Park Woosung Lim Myung-Chul Chang Hyun Yul Kim Jeong-yoon Song Jihyoun Lee Kyung Do Byun Hyun-Ah Kim Gil Soo Son Ju-Yeon Kim Se Jeong Oh Min Sung Chung Young Jin Choi Hyuk-Jai Shin Jong Min Baek Youngbum Yoo Eunhae Um Jin Hyuk Choi Beom Seok Kwak Min Ho Park Suok Hyun Lee Cheol Seung Kim Ilkyun Lee Je-Ryong Kim Han Shin Lee Cheol Wan Lim |
| author_facet | Anbok Lee Taewoo Kang Su Hwan Kang Woo-Chan Park Woosung Lim Myung-Chul Chang Hyun Yul Kim Jeong-yoon Song Jihyoun Lee Kyung Do Byun Hyun-Ah Kim Gil Soo Son Ju-Yeon Kim Se Jeong Oh Min Sung Chung Young Jin Choi Hyuk-Jai Shin Jong Min Baek Youngbum Yoo Eunhae Um Jin Hyuk Choi Beom Seok Kwak Min Ho Park Suok Hyun Lee Cheol Seung Kim Ilkyun Lee Je-Ryong Kim Han Shin Lee Cheol Wan Lim |
| author_sort | Anbok Lee |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T09:22:16Z |
| format | Article |
| id | doaj.art-942da54f68354348ae05f72091777fc1 |
| institution | Directory Open Access Journal |
| issn | 1532-3080 |
| language | English |
| last_indexed | 2024-03-09T09:22:16Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Breast |
| spelling | doaj.art-942da54f68354348ae05f72091777fc12023-12-02T06:58:48ZengElsevierBreast1532-30802023-12-0172103585An 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 cancerAnbok Lee0Taewoo Kang1Su Hwan Kang2Woo-Chan Park3Woosung Lim4Myung-Chul Chang5Hyun Yul Kim6Jeong-yoon Song7Jihyoun Lee8Kyung Do Byun9Hyun-Ah Kim10Gil Soo Son11Ju-Yeon Kim12Se Jeong Oh13Min Sung Chung14Young Jin Choi15Hyuk-Jai Shin16Jong Min Baek17Youngbum Yoo18Eunhae Um19Jin Hyuk Choi20Beom Seok Kwak21Min Ho Park22Suok Hyun Lee23Cheol Seung Kim24Ilkyun Lee25Je-Ryong Kim26Han Shin Lee27Cheol Wan Lim28Department of Surgery, Chung-Ang University Gwangmyeong Hospital, Chung-Ang University College of Medicine, Gyeonggi-do, Republic of KoreaBusan Cancer Center and Biomedical Research Institute, Pusan National University Hospital, and Department of Surgery, Pusan National University, School of Medicine, Busan, Republic of KoreaDepartment of Surgery, Yeungnam University Hospital, Daegu, Republic of KoreaDepartment of Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Surgery, Ewha Womans University School of Medicine, Seoul, Republic of KoreaDepartment of Surgery, Dankook University College of Medicine, Cheonan, Republic of KoreaDepartment of Surgery, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Republic of KoreaDepartment of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, Republic of KoreaDepartment of Surgery, Soonchunhyang University Hospital, Seoul, Republic of KoreaDepartment of Surgery, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of KoreaDepartment of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences, Seoul, Republic of KoreaDepartment of Surgery, Korea University College of Medicine, Seoul, Republic of KoreaDepartment of Surgery, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of KoreaDepartment of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Surgery, College of Medicine, Hanyang University, Seoul, Republic of KoreaDepartment of Surgery, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of KoreaDepartment of Surgery, Myongji Hospital, Hanyang University, Goyang, Republic of KoreaDepartment of Surgery, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Surgery, Konkuk University Medical Center, Seoul, Republic of KoreaDepartment of Surgery, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of KoreaDepartment of Breast Surgery, Kosin University Gospel Hospital, Busan, Republic of KoreaDepartment of Surgery, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Republic of KoreaDepartment of Surgery, Chonnam National University Medical School and Chonnam National University Hwasun Hospital, Hwasun 58128, Republic of KoreaDepartment of Surgery, Cheil Hospital, Seoul, Republic of KoreaDepartment of Surgery, Presbyterian Medical Center, Jeonju, Republic of KoreaDepartment of Surgery, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of KoreaDepartment of Surgery, Chungnam National University College of Medicine, Daejeon, Republic of KoreaDepartment of Surgery, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of KoreaDepartment of Surgery, Soonchunhyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon, 14584, Republic of Korea; Corresponding author.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.http://www.sciencedirect.com/science/article/pii/S0960977623005611 |
| spellingShingle | Anbok Lee Taewoo Kang Su Hwan Kang Woo-Chan Park Woosung Lim Myung-Chul Chang Hyun Yul Kim Jeong-yoon Song Jihyoun Lee Kyung Do Byun Hyun-Ah Kim Gil Soo Son Ju-Yeon Kim Se Jeong Oh Min Sung Chung Young Jin Choi Hyuk-Jai Shin Jong Min Baek Youngbum Yoo Eunhae Um Jin Hyuk Choi Beom Seok Kwak Min Ho Park Suok Hyun Lee Cheol Seung Kim Ilkyun Lee Je-Ryong Kim Han Shin Lee Cheol Wan Lim 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 Breast |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://www.sciencedirect.com/science/article/pii/S0960977623005611 |
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