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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

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Abstract

Purpose

To explore the efficacy and safety of daily administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF), and a single subcutaneous injection of polyethylene glycol recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, a sustained-duration rhG-CSF) in neutropenia induced after chemotherapy.

Methods

Each patient received two cycles of chemotherapy. In the trial cycle, the patients received a single subcutaneous injection of PEG-rhG-CSF 100 µg/kg 72 h after completion of chemotherapy; and in the control cycle, rhG-CSF 5 µg/kg/day was subcutaneous injected once a day which began 72 h after completion of chemotherapy for continued 14 days or until the absolute neutrophil count (ANC) was ≥ 10.0 × 109/l twice. Therapeutic effect on primary endpoint was the incidence and duration of grade IV ANC neutropenia: comparing the incidence and the mean time of duration of PEG-rhG-CSF with those of rhG-CSF under the circumstance of ANC < 0.5 × 109/l. The immune populations evaluated included, CD3+ T cells, CD4+ T cells, CD8+ T cells, and NK cells.

Results

After chemotherapy, comparing to PEG-rhG-CSF, the CD4/CD8 ratio (0.84 ± 0.19 vs.1.06 ± 0.25) and the number of NK cells of rhG-CSF group (12.18 ± 2.13 vs. 15.78 ± 2.57) decreased significantly. The number of NK cells (12.18 ± 2.13 vs. 13.78 ± 2.57) of rhG-CSF group after chemotherapy is significantly less than that before chemotherapy, and the number of CD3+ (54.31 ± 7.51 vs. 57.96 ± 5.55), CD4+ (26.28 ± 6.25 vs. 29.48 ± 6.44), CD8+ (29.97 ± 6.47 vs. 31.68 ± 5.96) is lower than that before chemotherapy in rhG-CSF group, but the difference is not significant.

Conclusion

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.

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Acknowledgements

The authors would like to thank doctors, nurses, patients and their family members for their kindness to support our study.

Funding

This study was funded by the National Clinical Key Specialty Construction Program, Fujian Natural Science Foundation (2015J01381), and the Training Project of Young Talents in Fujian Health System (2015-ZQN-JC-6).

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Authors and Affiliations

  1. Department of Medical Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, The Teaching Hospital, Fujian University of Traditional Chinese Medicine, Fuzhou, 350014, Fujian, China

    Weiwei Huang, Jian Liu, Fan Wu, Nani Li, Kan Chen, Yi Hong, LiLi Wang, Hongyu Zhen & Lin Lin

  2. Department of Surgical Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, The Teaching Hospital, Fujian University of Traditional Chinese Medicine, Fuzhou, 350014, Fujian, China

    Yi Zeng

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  1. Weiwei Huang
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Correspondence to Yi Zeng.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Huang, W., Liu, J., Zeng, Y. et al. Randomized controlled clinical trial of polyethylene glycol recombinant human granulocyte colony-stimulating factor in the treatment of neutropenia after chemotherapy for breast cancer. Cancer Chemother Pharmacol 82, 607–613 (2018). https://doi.org/10.1007/s00280-018-3639-z

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