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Post-transplantation cyclophosphamide is associated with increased bacterial infections

Bone Marrow Transplantation volume 59, pages 76–84 (2024)Cite this article

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Abstract

Post-transplant cyclophosphamide (PTCy) is increasingly used to reduce graft-versus-host disease after hematopoietic cell transplantation (HCT); however, it might be associated with more infections. All patients who were ≥2 years old, receiving haploidentical or matched sibling donor (Sib) HCT for acute leukemias or myelodysplastic syndrome, and either calcineurin inhibitor (CNI)- or PTCy-based GVHD prophylaxis [Haploidentical HCT with PTCy (HaploCy), 757; Sibling with PTCy (SibCy), 403; Sibling with CNI-based (SibCNI), 1605] were included. Most bacterial infections occurred within the first 100 days; 953 patients (34.5%) had at least 1 infection and 352 patients (13%) had ≥2 infections. Patients receiving PTCy had a greater incidence of bacterial infections by day 180 [HaploCy 46%; SibCy 48%; SibCNI 35%; p < 0.001]. Compared with the SibCNI without infection cohort, 1.99-fold, 3.33-fold, 2.78-fold, and 2.53-fold increased TRM was seen for the HaploCy cohort without infection and HaploCy, SibCy, and SibCNI cohorts with infection, respectively. Bacterial infections increased mortality [HaploCy (HR1.84, 99% CI: 1.45–2.33, p < 0.0001), SibCy cohort (HR,1.68, 99% CI: 1.30–2.19, p < 0.0001), and SibCNI cohort (HR,1.76, 99% CI: 1.43–2.16, p < 0.0001). PTCy was associated with increased bacterial infections regardless of donor, and bacterial infections were associated with increased mortality irrespective of GVHD prophylaxis. Patients receiving PTCy should be monitored carefully for bacterial infections following PTCy.

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Fig. 1: Bacterial Infections by Donor Type/GVHD Prophylaxis in Day 180.
Fig. 2: Bacterial Infections by Donor Type/GVHD Prophylaxis in Day 180.
Fig. 3

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Materials described in the manuscript, including all relevant raw data, belongs to CIBMTR and will be freely available to any researcher wishing to use them for non-commercial purposes, without breaching participant confidentiality per discussion with CIBMTR.

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Acknowledgements

Data Use Statement: CIBMTR supports accessibility of research in accord with the National Institutes of Health (NIH) Data Sharing Policy and the National Cancer Institute (NCI) Cancer Moonshot Public Access and Data Sharing Policy. The CIBMTR only releases de-identified datasets that comply with all relevant global regulations regarding privacy and confidentiality.

Funding

Funding

The CIBMTR is supported primarily by Public Health Service U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); 75R60222C00011 from the Health Resources and Services Administration (HRSA); N00014–21–1–2954 and N00014-23-1-2057 from the Office of Naval Research; Support is also provided by Be the Match Foundation, the Medical College of Wisconsin, the National Marrow Donor Program, Gateway for Cancer Research, Pediatric Transplantation and Cellular Therapy Consortium and from the following commercial entities: AbbVie; Actinium Pharmaceuticals, Inc.; Adaptimmune; Adaptive Biotechnologies Corporation; ADC Therapeutics; Adienne SA; Allogene; Allovir, Inc.; Amgen, Inc.; Angiocrine; Anthem; Astellas Pharma US; Atara Biotherapeutics; BeiGene; bluebird bio, inc.; Bristol Myers Squibb Co.; CareDx Inc.; CRISPR; CSL Behring; CytoSen Therapeutics, Inc.; Elevance Health; Eurofins Viracor, DBA Eurofins Transplant Diagnostics; Gamida-Cell, Ltd.; GlaxoSmithKline; HistoGenetics; Incyte Corporation; Janssen Research & Development, LLC; Janssen/Johnson & Johnson; Jasper Therapeutics; Jazz Pharmaceuticals, Inc.; Karius; Kiadis Pharma; Kite, a Gilead Company; Kyowa Kirin; Legend Biotech; Magenta Therapeutics; Mallinckrodt Pharmaceuticals; Medexus Pharma; Merck & Co.; Mesoblast; Millennium, the Takeda Oncology Co.; Miltenyi Biotec, Inc.; MorphoSys; Novartis Pharmaceuticals Corporation; Omeros Corporation; Orca Biosystems, Inc.; Ossium Health, Inc.; Pfizer, Inc.; Pharmacyclics, LLC, An AbbVie Company; Pluristem; PPD Development, LP; Regimmune; Sanofi; Sanofi-Aventis U.S. Inc.; Sobi, Inc.; Stemcyte; Takeda Pharmaceuticals; Talaris Therapeutics; Vertex Pharmaceuticals; Vor Biopharma Inc.; Xenikos BV.

Author information

Authors and Affiliations

  1. Division of Hematology/Oncology/Cell Therapy, Rush University, Chicago, IL, USA

    Celalettin Ustun & Sunita Nathan

  2. CIBMTR® (Center for International Blood and Marrow Transplant Research), Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA

    Min Chen, Soyoung Kim & Marcie Riches

  3. Division of Biostatistics, Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA

    Soyoung Kim

  4. CIBMTR® (Center for International Blood and Marrow Transplant Research), National Marrow Donor Program/Be The Match, Minneapolis, MN, USA

    Jeffery J. Auletta

  5. Hematology/Oncology/BMT and Infectious Diseases, Nationwide Children’s Hospital, Columbus, OH, USA

    Jeffery J. Auletta

  6. A.C. Camargo Cancer Center, Sao Paulo, Brazil

    Marjorie V. Batista

  7. Sarah Cannon Transplant and Cell Therapy Network, Nashville, TN, USA

    Minoo Battiwalla

  8. Division of Hematology/Oncology, Department of Medicine, University of Massachusetts Chan Medical School and Medical Center, Worcester, MA, USA

    Jan Cerny

  9. Yale Cancer Center and Yale School of Medicine, New Haven, CT, USA

    Lohith Gowda

  10. Fred Hutchinson Cancer Center, Seattle, WA, USA

    Joshua A. Hill

  11. University of Washington School of Medicine, Seattle, WA, USA

    Joshua A. Hill

  12. Section of Hematology/Oncology, University of Chicago Medicine, Chicago, IL, USA

    Hongtao Liu

  13. Stem Cell Transplant and Cellular Immunotherapy Program, MedStar Georgetown University Hospital, Washington, DC, USA

    Pashna N. Munshi

  14. Department of Medicine, University of British Columbia, Vancouver, Canada

    Matthew D. Seftel

  15. Division of Hematology & Oncology, Department of Medicine, University of Florida, Gainesville, FL, USA

    John R. Wingard

  16. The University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA

    Roy F. Chemaly

  17. Cincinnati Children’s Hospital Medical Center, University of Cincinnati School of Medicine, Cincinnati, OH, USA

    Christopher E. Dandoy

  18. Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Miguel-Angel Perales

  19. Department of Medicine, Weill Cornell Medical College, New York, NY, USA

    Miguel-Angel Perales & Genovefa A. Papanicolaou

  20. Infectious Diseases Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Genovefa A. Papanicolaou

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  1. Celalettin Ustun
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Contributions

CU and GAP conceived the concept, analyzed data, searched literature, wrote and edited the article; MR, MC and SK created and analyzed data, did statistical analyses, wrote and edited the article; JJA, MVB, MB, JC, LG, JAH, HL, PNM, SN, MDS, JRW, RFC, CED, MAP analyzed data, searched literature, wrote and edited the article.

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Correspondence to Celalettin Ustun.

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MVB reports compensation (honoraria) from from United Medical, Astra Zeneca, and Merck Sharp Dohme; and research support from National Health Institute- National Cancer Institute (NIH-NCI), National Council for Scientific and Technological Development (CNPq) and FAPESP - Fundação de Amparo à Pesquisa do Estado de São Paulo. MB reports research support (institution) from Novartis. JC reports consulting fees (Advisory Board Membership) for Jazz Pharmaceuticals, Pfizer, and Amgen; Data Safety Monitoring Board member for Allovir Inc.; and stocks with Actinium Pharmaceuticals, Bluebird Bio/2Seventy, Dynavax Technologies, aTyr Pharma, Gamida Cell, Miragen Therapeutics, Mustang Bio, Novavax, Ovid Therapeutics, Sorrento Therapeutics, TG Therapeutics, Vaxart, and Veru. JAH reports compensation (consulting) for Karius; research support from Karius; and significant payments (Scientific Advisory Board) for Karius (limit $10,000). HL reports compensation (advisor/consultant/speaker) for Agios, Pfizer, CTI Biopharm, Nkarta, Servier; research support (funding paid to my institution) for clinical trials from Miltenyi Biotec, Alexion, Astellas, Nkarta, ImmuOnco, Cellularity and Marker. PNM reports Speaker’s Bureau participation for Incyte and Kite; and consultancy for Incyte. JRW reports compensation (consultant) for Cidara, Celgene, Merck, Shire, Orca and Ansun. RFC reports compensation (advisor/consultant/speaker) for Merck, Takeda, Karius, Therapeutics Partners, Ansun, Eurofins-Viracor, Genentech, Qiagen, Oxford Immunotec, Astellas, Roche, Aseptico, AiCuris, and Shinogi; and significant payments (grants and funding paid to my institution for research) from Merck, Ansun, AiCuris, Eurofins-Viracor, Karius, Genentech, Freestyle, and Takeda. MAP reports compensation (honoraria) from Adicet, Allovir, Caribou Biosciences, Celgene, Bristol-Myers Squibb, Equilium, Exevir, Incyte, Karyopharm, Kite/Gilead, Merck, Miltenyi Biotec, MorphoSys, Nektar Therapeutics, Novartis, Omeros, OrcaBio, Syncopation, VectivBio AG, and Vor Biopharma; Data Safety Monitoring Board participation for Cidara Therapeutics, Medigene, and Sellas Life Sciences; scientific advisory board participation for NexImmune; ownership interests in NexImmune and Omeros; significant payments (honoraria in excess of $5000) from Bristol-Myers Squibb, Incyte, Kite/Gilead, Merck, Nektar Therapeutics, Novartis, Omeros, Cidara Therapeutics (DSMB) and research support (institutional in excess of $5000) for clinical trials from Incyte, Kite/Gilead, Miltenyi Biotec, Nektar Therapeutics, and Novartis; and equity interest in Omeros. MR is an employee of IQVIA Biotech, a clinical research organization. GAP reports compensation (consultant/other) for Allovir, Astellas, Cidara, Merck, Takeda, Therapeutics Partners and Octapharma; and research funding (paid to my institution) from Merck and Takeda.

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Ustun, C., Chen, M., Kim, S. et al. Post-transplantation cyclophosphamide is associated with increased bacterial infections. Bone Marrow Transplant 59, 76–84 (2024). https://doi.org/10.1038/s41409-023-02131-z

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