ArticleTranslational cancer research2025
Polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) primary prophylaxis significantly reduces the duration of neutropenia in non-Hodgkin's lymphoma patients treated with chemotherapy: a randomised trial (NCT05834751).
Article in Translational cancer research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05834751 (Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.), which is not on this map. Not yet cited in PubMed.
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Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.
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Abstract
Background: Neutropenia is one of the most common complications of chemotherapy in lymphoma patients. To treat and prevent this condition, polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF; mecapegfilgrastim) has been developed. This study compared the efficacy of PEG-rhG-CSF with that of recombinant human granulocyte colony-stimulating factor (G-CSF) in preventing neutropenia after chemotherapy for lymphoma. Methods: A prospective randomized study of 154 patients with lymphoma admitted to The First Hospital of Jilin University from September 2020 to September 2022 was conducted. The predetermined sample size is established with a power analysis-driven approach, followed by rigorous non-inferiority testing to evaluate therapeutic equivalence. The patients were randomized at a 1:1 ratio to receive PEG-rhG-CSF or G-CSF. The duration and incidence of grade 3 or higher neutropenia (≥ G3 neutropenia), and the occurrence rates of febrile neutropenia (FN) and ≥ G3 neutropenia were compared between the two groups. A subgroup analysis was performed based on the chemotherapy regimen and tumor origin. Results: The duration of ≥ G3 neutropenia in the first cycle of chemotherapy was 1.56±2.23 days in the PEG-rhG-CSF group and 2.34±2.82 days in the G-CSF group (P=0.059). The incidence of ≥ G3 neutropenia in the first cycle of chemotherapy was 44.16% in the PEG-rhG-CSF group and 53.25% in the G-CSF group (P=0.26). The incidence of ≥ G3 neutropenia in cycles 2-4 of chemotherapy was 22.08% in the PEG-rhG-CSF group and 38.96% in the G-CSF group (P=0.02). After four cycles, the complete response rate of the PEG-rhG-CSF group was 73.58%, while that of the G-CSF group was 63.64%. Conclusions: PEG-rhG-CSF was more effective than G-CSF in preventing neutropenia induced by chemotherapy regimens with a moderate- to-high-risk of FN in patients with lymphoma and contributes to better chemotherapy efficacy. Trial Registration: ClinicalTrials.gov NCT05834751.
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