Evidence map›Paper›PMID 37183837›Full record

Trial reportCancer medicine2023

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.

Junting Huang, Suying Lu, Juan Wang, Lian Jiang, Xuequn Luo, Xiangling He, Yanpeng Wu, Yi Wang, Xiuli Zhu, Jian Chen and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04547829 (Safety and Efficacy of Pegylated Recombinant Human Granulocyte-colony Stimulating Factor), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04547829 phase2unknown statusnot on this map

Safety and Efficacy of Pegylated Recombinant Human Granulocyte-colony Stimulating Factor(PEG-rhG-CSF) in Preventing Neutropenia in Children With Tumor After Chemotherapy:A Multi-center, Single Arm Trial.

TypeinterventionalSponsorSun Yat-sen UniversityRan2020 to 2023Enrolled108ConditionsPediatric CancerArmspegylated recombinant human granulocyte-colony stimulating factor
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 4 institutions in 1 country.

Junting HuangDepartment 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.ORCID 0000-0002-2448-5837
Suying LuDepartment 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.
Juan WangDepartment 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.
Lian JiangDepartment of Pediatrics, Hebei Tumor Hospital, Pediatric, Shijiazhuang, P. R. China.
Xuequn LuoDepartment of Pediatrics, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, P. R. China.
Xiangling HeDepartment of Pediatric Hematology and Oncology, Hunan Provincial People's Hospital, Changsha, P. R. China.
Yanpeng WuDepartment of Pediatrics, The Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, P. R. China.
Yi WangDepartment 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.
Xiuli ZhuDepartment of Pediatrics, Hebei Tumor Hospital, Pediatric, Shijiazhuang, P. R. China.
Jian ChenDepartment of Pediatrics, Hebei Tumor Hospital, Pediatric, Shijiazhuang, P. R. China.
Yanlai TangDepartment of Pediatrics, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, P. R. China.
Keke ChenDepartment of Pediatric Hematology and Oncology, Hunan Provincial People's Hospital, Changsha, P. R. China.
Xin TianDepartment of Pediatric Hematology and Oncology, Hunan Provincial People's Hospital, Changsha, P. R. China.
Boyun ShiDepartment of Pediatrics, The Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, P. R. China.
Lanying GuoDepartment of Pediatrics, The Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, P. R. China.
Jia ZhuDepartment 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.
Feifei SunDepartment 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.
Zijun ZhenDepartment 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.ORCID 0000-0002-4442-0897
Yizhuo ZhangDepartment 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.ORCID 0000-0002-6128-3476
Sun Yat-sen University · CNHebei Medical University · CNHunan Provincial People's Hospital · CNSecond Affiliated Hospital of Guangzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPegylated 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

methodsThis 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).

resultsThis 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.

conclusionPEG-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 registrationClinicalTrials.gov identifier: NCT04547829.

Indexed as

Lung NeoplasmsLymphoma, Non-HodgkinNeutropeniaAntineoplastic Combined Chemotherapy ProtocolsChildGranulocyte Colony-Stimulating FactorHumansPainPolyethylene GlycolsRecombinant ProteinsGranulocyte Colony-Stimulating Factorpegylated granulocyte colony-stimulating factorPolyethylene GlycolsRecombinant Proteinschemotherapyfebrile neutropenialymphomapediatric cancerpegylated granulocyte colony-stimulating factor

Identifiers

PMID37183837
PMCPMC10358250
OpenAlexW4376614030

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.