{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T12:35:49Z","timestamp":1780922149769,"version":"3.54.1"},"reference-count":32,"publisher":"Wiley","issue":"13","license":[{"start":{"date-parts":[[2023,5,15]],"date-time":"2023-05-15T00:00:00Z","timestamp":1684108800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Pegylated recombinant human granulocyte colony\u2010stimulating factor (PEG\u2010rhG\u2010CSF) can be used in pediatric patients. This study assessed the safety and efficacy of PEG\u2010rhG\u2010CSF as a primary prophylactic drug against neutropenia after chemotherapy in pediatric patients with solid tumors or non\u2010Hodgkin lymphoma (NHL).<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p>This phase II study (between October 2020 and March 2022) enrolled pediatric patients with solid tumors or NHL treated with high\u2010intensity chemotherapy and with grade\u2009\u22653 myelosuppression for at least 14\u2009days during chemotherapy. Prophylactic PEG\u2010rhG\u2010CSF was given at 100\u2009\u03bcg\/kg body weight (maximum total dosage of 6\u2009mg) once 24\u201348\u2009h following chemotherapy for two cycles. The primary endpoint was the incidence of PEG\u2010rhG\u2010CSF\u2010related adverse events (AEs). The key secondary endpoints were the rates of grade 3\/4 neutropenia and febrile neutropenia (FN).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This study included 160 pediatric patients with a median age of 6.22 (0.29, 18.00) years. Fifty\u2010eight patients (36.25%) were diagnosed with sarcoma. AEs potentially related to PEG\u2010rhG\u2010CSF included bone pain (<jats:italic>n<\/jats:italic>\u2009=\u200932), fatigue (<jats:italic>n<\/jats:italic>\u2009=\u200921), pain at the injection site (<jats:italic>n<\/jats:italic>\u2009=\u200921), and myalgia (<jats:italic>n<\/jats:italic>\u2009=\u200920). The rates of grade 3\/4 neutropenia and FN during treatment were 57.28% and 29.45%, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>PEG\u2010rhG\u2010CSF is well tolerated and effective in pediatric patients with solid tumors or NHL. These findings should be substantiated with further trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov identifier: NCT04547829.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.6079","type":"journal-article","created":{"date-parts":[[2023,5,15]],"date-time":"2023-05-15T10:05:46Z","timestamp":1684145146000},"page":"14130-14137","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A multicenter phase <scp>II<\/scp> trial of primary prophylactic <scp>PEG\u2010rhG\u2010CSF<\/scp> in pediatric patients with solid tumors and <scp>non\u2010Hodgkin<\/scp> lymphoma after chemotherapy: An interim analysis"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2448-5837","authenticated-orcid":false,"given":"Junting","family":"Huang","sequence":"first","affiliation":[{"name":"Department of Pediatric Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center  Guangzhou P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suying","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Pediatric Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center  Guangzhou P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pediatric Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center  Guangzhou P. R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lian","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Hebei Tumor Hospital, Pediatric  Shijiazhuang P. R. 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