Randomized controlled clinical trial of polyethylene glycol recombinant human granulocyte colony-stimulating factor in the treatment of neutropenia after chemotherapy for breast cancer

Huang, Weiwei; Liu, Jian; Zeng, Yi; Wu, Fengjie; Li, Nani; Chen, Kan; Hong, Yi; Wang, Lili; Zhen, Hongyu; Lin, Lin

doi:10.1007/s00280-018-3639-z

Cited by 12 publications

(20 citation statements)

References 22 publications

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“…Among the 26 articles, 17 articles were excluded: 7 articles were only an abstract, 1 article was not in English, 4 articles were only related to long-acting G-CSF, 3 articles included patients with other types of cancer, and 2 articles were not RCTs. Thus, nine studies [19][20][21][22][23][24][25][26][27] were ultimately included in our present systematic review. Two of the identified papers were by the same author [19,20]; therefore, we examined the data carefully.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Zheng

Mei

et al. 2020

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Background PEGylated granulocyte colony-stimulating factor (G-CSF) is a safe alternative to G-CSF to improve chemotherapyinduced neutropenia (CIN). This superiority has resulted in its increased use by physicians; however, the superiority of PEGylated G-CSF for CIN in breast cancer has not been conclusively determined. Objectives To assess the superiority of PEGylated G-CSF for CIN in breast cancer in terms of effectiveness and safety via a systematic review and meta-analysis. Methods A literature search in PubMed, Embase, Cochrane Library, and Web of Science was performed for eligible studies published from database inception to December 2019. All studies comparing PEGylated G-CSF and G-CSF for CIN of breast cancer were reviewed. After literature selection, data extraction and quality assessment were performed by two reviewers independently. Meta-analysis was conducted using Revman, version 5.2. Results Nine randomized controlled trials were finally identified. The publication bias of these studies was acceptable. For the endpoint of effectiveness, analysis of the incidence/duration of grade ≥ 3 neutropenia, the duration of grade 4 neutropenia, the incidence of febrile neutropenia (FN), and the time to absolute neutrophil count recovery showed no advantage of PEGylated G-CSF over G-CSF for CIN of breast cancer (P > 0.05), with the premise of a sufficient dose of G-CSF according to the guidelines. No significant differences in grade 4 adverse events were observed between the groups (P = 0.29), and PEGylated G-CSF did not increase the incidence of skeletal and/or muscle pain compared with G-CSF (P = 0.32). Conclusion PEGylated G-CSF was as effective and safe as G-CSF to reduce CIN in breast cancer but did not show an obvious superiority. However, in clinical practice, PEGylated G-CSF has an obvious advantage in terms of convenience, which could improve patient's quality of life.

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Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Zheng

Mei

et al. 2020

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“…PEG‐rhG‐CSF is a long‐acting rhG‐CSF widely used to prevent leukopenia, neutropenia, and FN caused by chemotherapy in patients with cancer. In addition, it may have immune‐modulatory effects; however, the evidence is very limited . This is the first prospective study to explore the influence of PEG‐rhG‐CSF on the immune status of patients with SCLC.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, it may have immune-modulatory effects; however, the evidence is very limited. 8,10 This is the first prospective study to explore the influence of PEG-rhG-CSF on the immune status of patients with SCLC. We found that PEG-rhG-CSF has a regulatory effect on the immune system by monitoring dynamic changes in the TCR repertoire and lymphocyte subsets before and after routine chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…It is reported that PEG‐rhG‐CSF enhances the antitumor activity of monoclonal antibodies such as rituximab and trastuzumab elicited via antibody‐dependent cellular cytotoxicity or phagocytosis in preclinical models and clinical trials . The regulatory effects on immune cells seems greater for PEG‐rhG‐CSF than rhG‐CSF . Based on limited evidences, the specific effects of PEG‐rhG‐CSF on the immune cells, such as lymphocytes, remains unclear.…”

Section: Introductionmentioning

confidence: 99%

“…8,9 The regulatory effects on immune cells seems greater for PEG-rhG-CSF than rhG-CSF. 10 Based on limited evidences, the specific effects of PEG-rhG-CSF on the immune cells, such as lymphocytes, remains unclear.…”

Section: Introductionmentioning

confidence: 99%

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Pegylated recombinant human granulocyte colony‐stimulating factor regulates the immune status of patients with small cell lung cancer

et al. 2020

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Background Small cell lung cancer (SCLC) is an aggressive disease involving immunodeficiency for which chemotherapy is the standard treatment. Pegylated recombinant human granulocyte colony‐stimulating factor (PEG‐rhG‐CSF) is widely used for primary or secondary prophylaxis of febrile neutropenia (FN) in chemotherapy. However, whether PEG‐rhG‐CSF influences immune cells, such as lymphocytes, remains unclear. Methods A total of 17 treatment‐naïve SCLC patients were prospectively enrolled and divided into the PEG‐rhG‐CSF and control groups according to their FN risk. Longitudinal sampling of peripheral blood was performed before, after and 4–6 days after the first cycle of chemotherapy. Flow cytometry was used to assess lymphocyte subsets, including CD3+ T, CD4+ T, CD8+ T, NK, and B cells. The diversity and clonality of the T‐cell receptor (TCR) repertoire was analyzed by next‐generation sequencing. Results In the PEG‐rhG‐CSF group, the proportions of CD3+ T and CD4+ T cells had increased significantly (P = 0.002, P = 0.020, respectively), whereas there was no increase in CD8+ T cells. Further, TCR diversity increased (P = 0.009) and clonality decreased (P = 0.004) significantly after PEG‐rhG‐CSF treatment. However, these factors showed opposite trends before and after chemotherapy. Vβ and Jβ gene fragment types, which determine TCR diversity, were significantly amplified in the PEG‐rhG‐CSF group. The change in TCR diversity was significantly correlated with changes in the CD3+ T or CD4+ T cell proportions, but not the CD8+ T cell proportion. Conclusions PEG‐rhG‐CSF regulates the immune status of SCLC patients; CD4+ T cells may be the main effector cells involved in this process. These findings may optimize the treatment of SCLC. Key points PEG‐rhG‐CSF regulates SCLC immunity. PEG‐rhG‐CSF increased CD3+ T and CD4+T cell proportions. PEG‐rhG‐CSF increased TCR diversity and decreased clonality in peripheral blood. Change in TCR diversity were correlated with CD3+ T or CD4+ T changes.

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Nanoparticles as a Therapeutic Delivery System for Skin Cancer Prevention and Treatment

Chang¹,

Yu²,

Saltzman³

et al. 2023

JID Innovations

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Randomized controlled clinical trial of polyethylene glycol recombinant human granulocyte colony-stimulating factor in the treatment of neutropenia after chemotherapy for breast cancer

Abstract: The efficacy and side effects of a single subcutaneous injection of PEG-rhG-CSF were similar to that of rhG-CSF multiple administrations. PEG-rhG-CSF may have the effect of promoting immune function repairing.

Cited by 12 publications

References 22 publications

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis

Pegylated recombinant human granulocyte colony‐stimulating factor regulates the immune status of patients with small cell lung cancer

Nanoparticles as a Therapeutic Delivery System for Skin Cancer Prevention and Treatment

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