PMID- 37183837
OWN - NLM
STAT- MEDLINE
DCOM- 20230721
LR  - 20230723
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 12
IP  - 13
DP  - 2023 Jul
TI  - A multicenter phase II trial of primary prophylactic PEG-rhG-CSF in pediatric 
      patients with solid tumors and non-Hodgkin lymphoma after chemotherapy: An 
      interim analysis.
PG  - 14130-14137
LID - 10.1002/cam4.6079 [doi]
AB  - BACKGROUND: Pegylated recombinant human granulocyte colony-stimulating factor 
      (PEG-rhG-CSF) can be used in pediatric patients. This study assessed the safety 
      and efficacy of PEG-rhG-CSF as a primary prophylactic drug against neutropenia 
      after chemotherapy in pediatric patients with solid tumors or non-Hodgkin 
      lymphoma (NHL). PATIENTS AND METHODS: This phase II study (between October 2020 
      and March 2022) enrolled pediatric patients with solid tumors or NHL treated with 
      high-intensity chemotherapy and with grade >/=3 myelosuppression for at least 
      14 days during chemotherapy. Prophylactic PEG-rhG-CSF was given at 100 mug/kg body 
      weight (maximum total dosage of 6 mg) once 24-48 h following chemotherapy for two 
      cycles. The primary endpoint was the incidence of PEG-rhG-CSF-related adverse 
      events (AEs). The key secondary endpoints were the rates of grade 3/4 neutropenia 
      and febrile neutropenia (FN). RESULTS: This study included 160 pediatric patients 
      with a median age of 6.22 (0.29, 18.00) years. Fifty-eight patients (36.25%) were 
      diagnosed with sarcoma. AEs potentially related to PEG-rhG-CSF included bone pain 
      (n = 32), fatigue (n = 21), pain at the injection site (n = 21), and myalgia 
      (n = 20). The rates of grade 3/4 neutropenia and FN during treatment were 57.28% 
      and 29.45%, respectively. CONCLUSION: PEG-rhG-CSF is well tolerated and effective 
      in pediatric patients with solid tumors or NHL. These findings should be 
      substantiated with further trials. CLINICAL TRIAL REGISTRATION: 
      ClinicalTrials.gov identifier: NCT04547829.
CI  - (c) 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
FAU - Huang, Junting
AU  - Huang J
AUID- ORCID: 0000-0002-2448-5837
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
FAU - Lu, Suying
AU  - Lu S
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
FAU - Wang, Juan
AU  - Wang J
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
FAU - Jiang, Lian
AU  - Jiang L
AD  - Department of Pediatrics, Hebei Tumor Hospital, Pediatric, Shijiazhuang, P. R. 
      China.
FAU - Luo, Xuequn
AU  - Luo X
AD  - Department of Pediatrics, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, P. R. China.
FAU - He, Xiangling
AU  - He X
AD  - Department of Pediatric Hematology and Oncology, Hunan Provincial People's 
      Hospital, Changsha, P. R. China.
FAU - Wu, Yanpeng
AU  - Wu Y
AD  - Department of Pediatrics, The Fifth Affiliated Hospital, Guangzhou Medical 
      University, Guangzhou, P. R. China.
FAU - Wang, Yi
AU  - Wang Y
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
FAU - Zhu, Xiuli
AU  - Zhu X
AD  - Department of Pediatrics, Hebei Tumor Hospital, Pediatric, Shijiazhuang, P. R. 
      China.
FAU - Chen, Jian
AU  - Chen J
AD  - Department of Pediatrics, Hebei Tumor Hospital, Pediatric, Shijiazhuang, P. R. 
      China.
FAU - Tang, Yanlai
AU  - Tang Y
AD  - Department of Pediatrics, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, P. R. China.
FAU - Chen, Keke
AU  - Chen K
AD  - Department of Pediatric Hematology and Oncology, Hunan Provincial People's 
      Hospital, Changsha, P. R. China.
FAU - Tian, Xin
AU  - Tian X
AD  - Department of Pediatric Hematology and Oncology, Hunan Provincial People's 
      Hospital, Changsha, P. R. China.
FAU - Shi, Boyun
AU  - Shi B
AD  - Department of Pediatrics, The Fifth Affiliated Hospital, Guangzhou Medical 
      University, Guangzhou, P. R. China.
FAU - Guo, Lanying
AU  - Guo L
AD  - Department of Pediatrics, The Fifth Affiliated Hospital, Guangzhou Medical 
      University, Guangzhou, P. R. China.
FAU - Zhu, Jia
AU  - Zhu J
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
FAU - Sun, Feifei
AU  - Sun F
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
FAU - Zhen, Zijun
AU  - Zhen Z
AUID- ORCID: 0000-0002-4442-0897
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
FAU - Zhang, Yizhuo
AU  - Zhang Y
AUID- ORCID: 0000-0002-6128-3476
AD  - Department of Pediatric Oncology, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen 
      University Cancer Center, Guangzhou, P. R. China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04547829
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230515
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - I4QL0KKG3K (pegylated granulocyte colony-stimulating factor)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Humans
MH  - Child
MH  - *Lung Neoplasms/drug therapy
MH  - *Lymphoma, Non-Hodgkin/drug therapy/etiology
MH  - Granulocyte Colony-Stimulating Factor/adverse effects
MH  - Polyethylene Glycols/adverse effects
MH  - Recombinant Proteins/adverse effects
MH  - *Neutropenia/chemically induced/prevention & control/drug therapy
MH  - Pain/chemically induced
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
PMC - PMC10358250
OTO - NOTNLM
OT  - chemotherapy
OT  - febrile neutropenia
OT  - lymphoma
OT  - pediatric cancer
OT  - pegylated granulocyte colony-stimulating factor
COIS- The authors declare no conflict of interest.
EDAT- 2023/05/15 13:06
MHDA- 2023/07/21 06:43
PMCR- 2023/05/15
CRDT- 2023/05/15 06:13
PHST- 2023/03/24 00:00 [revised]
PHST- 2022/11/16 00:00 [received]
PHST- 2023/05/04 00:00 [accepted]
PHST- 2023/07/21 06:43 [medline]
PHST- 2023/05/15 13:06 [pubmed]
PHST- 2023/05/15 06:13 [entrez]
PHST- 2023/05/15 00:00 [pmc-release]
AID - CAM46079 [pii]
AID - 10.1002/cam4.6079 [doi]
PST - ppublish
SO  - Cancer Med. 2023 Jul;12(13):14130-14137. doi: 10.1002/cam4.6079. Epub 2023 May 
      15.