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The safety and efficacy of hematopoietic stem cell mobilization using biosimilar filgrastim in related donors

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Abstract

In April 2014, the Japan Society for Hematopoietic Cell Transplantation started a prospective observational study entitled “A short-term follow-up investigation of related hematopoietic stem cell donors receiving biosimilar G-CSF to mobilize peripheral blood stem cells.” A total of 106 donors were registered from 25 transplant facilities through the end of March 2017. The study cohort consisted of 47 men and 58 women, and their median age was 38.5 years (range 15–65 years). The mean total count of collected CD34-positive cells/recipient body weight for all 106 donors was 4.40 ± 2.38 × 10 6/kg. The yield of CD34-positive cells was weakly correlated with donor age was observed. However, gender, WBC count on day 4, G-CSF dose reduction, type of apheresis device, collection speed, and treated blood volume had no significant impact on the collection efficacy of CD34-positive cells. The safety profile of biosimilar G-CSF was also acceptable: 126 adverse events in 73 donors were reported, but none was serious. The most common adverse events were low back pain, headache, and bone pain. This prospective study confirmed that biosimilar G-CSF had comparable efficacy and safety to reference G-CSF for CD34-positive cell mobilization in healthy related donors.

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Acknowledgements

We thank all the participating centers and collaborators of transplant facilities; Department of Hematology, Steel Memorial Muroran Hospital; Department of Hematology, Niigata City General Hospital; Department of Hematology, Hitachi General Hospital; Department of Hematology, Japanese Red Cross Narita Hospital, Department of Hematology, Kanagawa Cancer Center; Department of Pediatrics, Seirei Hamamatsu General Hospital; Department of Hematology, Ishikawa Prefectural Central Hospital; Department of Hematology, Komaki City Hospital; Department of Hematology, Kyoto City Hospital; Department of Hematology/Oncology, Kansai Medical University Hospital; Department of Hematology, Shinko Hospital; Department of Hematology and Oncology, Children's Cancer Center, Kobe Children's Hospital, Department of Hematology, Hyogo Cancer Center; Department of Hematology, Tottori Prefectural Central Hospital; Department of Hematology, Kochi Medical School Hospital; Department of Hematology, National Hospital Organization Kumamoto Medical Center

Funding

This study is funded by Chugai Pharmaceutical, Kyowa Hakko Kirin, Mochida Pharmaceutical Company and Sanofi.

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Authors and Affiliations

  1. Department of Hematology, Yamagata Prefectural Central Hospital, 1800 Aoyagi, Yamagata-City, Yamagata, 990-2292, Japan

    Riko Tsumanuma, Eijiro Omoto & Hiroaki Kumagai

  2. Department of Hematology, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Japan

    Yuta Katayama & Koji Iwato

  3. Department of Hematology, Kanazawa University Hospital, Kanazawa, Japan

    Go Aoki

  4. Department of Hematology, Tsukuba Memorial Hospital, Tsukuba, Japan

    Yuji Sato

  5. Department of Hematology, Hakodate City Hospital, Hakodate, Japan

    Yutaka Tsutsumi

  6. Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan

    Nobuhiro Tsukada

  7. Department of Hematology and Chemotherapy, Yamanashi Prefectural Central Hospital, Kofu, Japan

    Masaki Iino

  8. Japanese Data Center for Hematopoietic Cell Transplantation, Nagoya, Japan

    Yoshiko Atsuta

  9. Department of Promotion for Blood and Marrow Transplantation, Aichi Medical University School of Medicine, Nagakute, Japan

    Yoshihisa Kodera

  10. Division of Hematology, Department of Medicine, Keio University School of Medicine, Minato, Japan

    Shinichiro Okamoto

  11. Department of Innovative Medical Science, Tokai University School of Medicine, Isehara, Japan

    Hiromasa Yabe

Authors
  1. Riko Tsumanuma
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  2. Eijiro Omoto
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  3. Hiroaki Kumagai
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  4. Yuta Katayama
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  5. Koji Iwato
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  6. Go Aoki
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  7. Yuji Sato
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  8. Yutaka Tsutsumi
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  9. Nobuhiro Tsukada
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  10. Masaki Iino
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  11. Yoshiko Atsuta
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  12. Yoshihisa Kodera
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  13. Shinichiro Okamoto
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  14. Hiromasa Yabe
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Contributions

Administrative support, conception, and design: YA, YK, SO, HY. Provision of study data: all authors. Collection and assembly of data: JSCT secretariat. Data analysis and interpretation: RH, EO. Manuscript writing: RH, EO, SO, HY. Final approval of manuscript: all authors.

Corresponding author

Correspondence to Riko Tsumanuma.

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Conflict of interest

S Okamoto: Honoraria from Chugai, Mochida, Kyowa Kirin, Sanofi and Grant support from Chugai, Kyowa Kirin, Mochida, Sanofi. Other authors state that they have no relationship to disclose.

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Tsumanuma, R., Omoto, E., Kumagai, H. et al. The safety and efficacy of hematopoietic stem cell mobilization using biosimilar filgrastim in related donors. Int J Hematol 115, 882–889 (2022). https://doi.org/10.1007/s12185-022-03318-8

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  • DOI: https://doi.org/10.1007/s12185-022-03318-8

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