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.

Abstract

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 μg/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.

• Authors: Junting Huang, Suying Lu, Juan Wang, Lian Jiang, Xuequn Luo, Xiangling He, Yanpeng Wu, Yi Wang, Xiuli Zhu, Jian Chen, Yanlai Tang, Keke Chen, Xin Tian, Boyun Shi, Lanying Guo, Jia Zhu, Feifei Sun, Zijun Zhen, Yizhuo Zhang
• Journal: Cancer medicine (Cancer Med) Vol. 12 Issue 13 Pg. 14130-14137 (07 2023) ISSN: 2045-7634 [Electronic] United States
• PMID: 37183837 (Publication Type: Clinical Trial, Phase II, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Chemical References

• pegylated granulocyte colony-stimulating factor
• Granulocyte Colony-Stimulating Factor
• Polyethylene Glycols
• Recombinant Proteins

Topics

• Humans
• Child
• Lung Neoplasms (drug therapy)
• Lymphoma, Non-Hodgkin (drug therapy, etiology)
• Granulocyte Colony-Stimulating Factor (adverse effects)
• Polyethylene Glycols (adverse effects)
• Recombinant Proteins (adverse effects)
• Neutropenia (chemically induced, prevention & control, drug therapy)
• Pain (chemically induced)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)