PMID- 33683460 OWN - NLM STAT- MEDLINE DCOM- 20211008 LR - 20211008 IS - 1433-7339 (Electronic) IS - 0941-4355 (Linking) VI - 29 IP - 9 DP - 2021 Sep TI - Pegteograstim prophylaxis for chemotherapy-induced neutropenia and febrile neutropenia: a prospective, observational, postmarketing surveillance study in Korea. PG - 5383-5390 LID - 10.1007/s00520-021-06127-7 [doi] AB - PURPOSE: This observational study aimed to evaluate the safety and efficacy of pegteograstim prophylaxis in patients with lymphoma and solid malignancies. METHODS: This study was conducted at 18 sites in Korea between November 2015 and August 2018. RESULTS: In total, 611 patients (female, 61.2%) with a median age of 58 (range, 18-88) years were included. Most patients had lymphomas (n = 371, 60.7%) and breast cancer (n = 230, 37.6%) and were administered R-CHOP21 (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone per 21 days) (n = 284, 46.5%) and AC (doxorubicin and cyclophosphamide) (n = 177, 29.0%). The total pegteograstim dose in the 611 patients was 14,970 mg (2495 doses), with each patient receiving an average daily dose of 6.0 mg. Neutropenia grade 4 occurred in 97 patients (15.9%), and febrile neutropenia (FN) occurred in 31 patients (5.1%). Among the 611 patients, 267 patients (43.7%) developed 882 adverse events (AEs), and 11 patients (1.8%) experienced 18 adverse drug reactions (ADRs). There were 62 patients (10.2%) who experienced 81 cases of serious adverse events (SAEs), with FN and pneumonia being the most frequent at 14 and 13 episodes, respectively, in 13 patients (2.1%). Meanwhile, 1 patient (0.2%) developed 2 episodes of serious ADRs (grade 1 and grade 2 hypotension). No safety concerns in the elderly and patients with liver and/or renal disease were identified. CONCLUSION: The prophylactic use of pegteograstim might have good overall safety and efficacy in patients with lymphomas and solid malignancies in routine clinical practice, even in those who are elderly and have liver and renal diseases. CI - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Cheon, Jaekyung AU - Cheon J AD - Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunwhandoro, Dong-gu, Ulsan, 44033, Republic of Korea. FAU - Im, Hyeon-Su AU - Im HS AD - Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunwhandoro, Dong-gu, Ulsan, 44033, Republic of Korea. FAU - Shin, Ho-Jin AU - Shin HJ AD - Division of Hematology-Oncology, Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Republic of Korea. FAU - Kim, Inho AU - Kim I AD - Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. FAU - Lee, Won Sik AU - Lee WS AD - Department of Hematology and Oncology, Inje University Busan Paik Hospital, Busan, Republic of Korea. FAU - Lee, Kyung-Hun AU - Lee KH AD - Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. FAU - Park, Seong Kyu AU - Park SK AD - Department of Hematology and Oncology, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea. FAU - Kim, Min Kyoung AU - Kim MK AD - Department of Hematology and Oncology, Yeungnam University College of Medicine, Deagu, Republic of Korea. FAU - Choi, Un Jong AU - Choi UJ AD - Department of Hematology and Oncology, Wonkwang University Hospital, Iksan, Republic of Korea. FAU - Kim, Jung Han AU - Kim JH AD - Department of Hematology and Oncology, Kangnam Sacred-Heart Hospital, Seoul, Republic of Korea. FAU - Lee, IlKyun AU - Lee I AD - Department of Hematology and Oncology, Catholic Kwandong University International ST. Mary's Hospital, Gangneung, Republic of Korea. FAU - Jo, Jae-Cheol AU - Jo JC AUID- ORCID: 0000-0001-6014-7977 AD - Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunwhandoro, Dong-gu, Ulsan, 44033, Republic of Korea. jcjo@uuh.ulsan.kr. LA - eng PT - Journal Article PT - Observational Study DEP - 20210308 PL - Germany TA - Support Care Cancer JT - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JID - 9302957 RN - 0 (Antineoplastic Agents) RN - 143011-72-7 (Granulocyte Colony-Stimulating Factor) RN - 80168379AG (Doxorubicin) RN - 8N3DW7272P (Cyclophosphamide) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - *Breast Neoplasms/drug therapy MH - *Chemotherapy-Induced Febrile Neutropenia/epidemiology/prevention & control MH - Cyclophosphamide/adverse effects MH - Doxorubicin/therapeutic use MH - Female MH - Granulocyte Colony-Stimulating Factor/therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Republic of Korea MH - Young Adult OTO - NOTNLM OT - Breast cancer OT - Lymphoma OT - Pegteograstim OT - Prophylaxis EDAT- 2021/03/09 06:00 MHDA- 2021/10/09 06:00 CRDT- 2021/03/08 12:14 PHST- 2020/06/09 00:00 [received] PHST- 2021/03/03 00:00 [accepted] PHST- 2021/03/09 06:00 [pubmed] PHST- 2021/10/09 06:00 [medline] PHST- 2021/03/08 12:14 [entrez] AID - 10.1007/s00520-021-06127-7 [pii] AID - 10.1007/s00520-021-06127-7 [doi] PST - ppublish SO - Support Care Cancer. 2021 Sep;29(9):5383-5390. doi: 10.1007/s00520-021-06127-7. Epub 2021 Mar 8.