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Outcomes of allogeneic hematopoietic cell transplantation under letermovir prophylaxis for cytomegalovirus infection

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Abstract

Cytomegalovirus (CMV) infection is a major infectious complication following allogeneic hematopoietic cell transplantation (allo-HCT). Although letermovir (LMV) prophylaxis dramatically reduces the incidence of early clinically significant CMV (csCMV) infection, it remains unclear whether it has a beneficial effect on nonrelapse mortality (NRM) and overall survival (OS). Herein, we evaluated the impact of LMV prophylaxis on posttransplant outcomes using the registry database of the Japanese Society for Transplantation and Cellular Therapy. Adult patients who underwent allo-HCT between 2017 and 2019 were analyzed (n = 6004). LMV prophylaxis was administered to 1640 patients (LMV group) and it significantly reduced the incidence of csCMV infection compared with those not administered LMV prophylaxis (15.4% vs 54.1%; p < 0.01). However, it did not improve the 1-year NRM (hazard ratio [HR], 0.93; p = 0.40) and OS (HR, 0.96; p = 0.49). In the LMV group, 74 patients had breakthrough csCMV infection and showed inferior NRM (HR, 3.44; p < 0.01) and OS (HR, 1.93; p = 0.02) compared with those without infection. After completing LMV prophylaxis, 252 patients had late csCMV infection and showed inferior NRM (HR, 1.83; p < 0.01) and OS (HR, 1.58; p < 0.01). Our findings suggest that managing breakthrough and late csCMV infections is important for improving long-term outcomes.

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Data availability

The data of this study is not publicly available due to ethical restrictions that it exceeds the scope of the recipient/donor’s consent for research use in the registry.

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Acknowledgements

The authors are grateful for the work of all the physicians and data managers at the centers that contributed valuable data on transplantation to the Japanese Society for Transplantation and Cellular Therapy (JSTCT). They also thank all the members of the Transplant Registry Unified Management committees at JSTCT for their dedicated data management.

Funding

This work was partially supported by JSPS KAKENHI Grant Number 18H02840.

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Authors and Affiliations

  1. Department of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, 791-0295, Japan

    Katsuto Takenaka

  2. Department of Hematology, Osaka International Cancer Institute, Osaka, Japan

    Shigeo Fuji

  3. Department of Hematology, Hokkaido University Faculty of Medicine, Graduate School of Medicine, Sapporo, Japan

    Toshihiro Matsukawa & Takahide Ara

  4. Department of Hematology, Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital, Tokyo, Japan

    Naoyuki Uchida

  5. Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan

    Takeshi Kobayashi

  6. Department of Hematology, Kanagawa Cancer Center, Yokohama, Japan

    Masatsugu Tanaka

  7. Department of Hematology, Hyogo Medical University Hospital, Nishinomiya, Japan

    Kazuhiro Ikegame

  8. Department of Hematology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya, Japan

    Yukiyasu Ozawa

  9. Division of Hematology, Jichi Medical University Saitama Medical Center, Saitama, Japan

    Yoshinobu Kanda & Hideki Nakasone

  10. Department of Hematology and Oncology, Anjo Kosei Hospital, Anjo, Japan

    Masashi Sawa

  11. Department of Hematology, University of Tsukuba Hospital, Tsukuba, Japan

    Yumiko Maruyama

  12. Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan

    Takahiro Fukuda

  13. Department of Hematology, Osaka Metropolitan University Hospital, Osaka, Japan

    Hirohisa Nakamae

  14. Preparation Department, Japanese Red Cross Kinki Block Blood Center, Osaka, Japan

    Takafumi Kimura

  15. Department of Hematology, Oita University Hospital, Oita, Japan

    Masao Ogata

  16. Department of Hematology and Oncology, Dokkyo Medical University, Tochigi, Japan

    Sachiko Seo

  17. Japanese Data Center for Hematopoietic Cell Transplantation, Nagakute, Japan

    Yoshiko Atsuta

  18. Department of Registry Science for Transplant and Cellular Therapy, Aichi Medical University, School of Medicine, Nagakute, Japan

    Yoshiko Atsuta

  19. Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya, Japan

    Keitaro Matsuo

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  1. Katsuto Takenaka
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Contributions

KT, SF, TM, MO, SS, KM, and HN designed the study. KT performed the statistical analyses and wrote the manuscript. NO, TK, MT, TA, KI, YO, YK, MS, YM, TF, and HN provided patient data. TK and YA collected patient data. All authors interpreted the data and reviewed and approved the final manuscript.

Corresponding author

Correspondence to Katsuto Takenaka.

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Ethical approval

This study was approved by the data management committee of the JSTCT and by the ethics committee of the Ehime University School of Medicine. All procedures performed in studies 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.

Informed consent

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

Conflict of interest

K.T. has received a speaker honoraria from MSD, outside the submitted work. Other authors declare no competing financial interests regarding this paper.

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Takenaka, K., Fuji, S., Matsukawa, T. et al. Outcomes of allogeneic hematopoietic cell transplantation under letermovir prophylaxis for cytomegalovirus infection. Ann Hematol 103, 285–296 (2024). https://doi.org/10.1007/s00277-023-05474-1

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