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Incidence, risk factors and therapy response of acute graft-versus-host disease after myeloablative hematopoietic stem cell transplantation with posttransplant cyclophosphamide

Bone Marrow Transplantation (2024)Cite this article

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Abstract

Posttransplant cyclophosphamide, sirolimus and mycophenolate mofetil (PTCy/siro/MMF) constitutes an innovative and well-tolerated acute graft-versus-host disease (aGVHD) prophylaxis after allogeneic stem cell transplantation (allo-HSCT), but risk factors for aGVHD incidence and therapy failure in this setting are scarce. This study prospectively registered all consecutive adult patients with hematologic malignancies who received a myeloablative allo-HSCT using PTCy/siro/MMF prophylaxis at our institution between 2017 and 2023. A total of 385 patients were included, of whom 44%, 34% and 22% were transplanted from matched sibiling, matched unrelated and haploidentical donors, respectively. The 180-day cumulative incidence of aGVHD was 21% (95% confidence interval [CI] 17–25%) for grade II–IV and 11% (95% CI 8–14%) grade III–IV aGVHD. The use of haploidentical donors was associated with an increased risk of severe aGVHD. Among 75 patients receiving first-line systemic corticosteroids, 49% achieved a sustained complete response, while 23% and 24% developed steroid-dependent (SD-aGVHD) and steroid-refractory aGVHD (SR-aGVHD), respectively. SR-aGVHD was associated with worse salvage treatment response and overall survival compared to SD-aGVHD. The 1-year cumulative incidence of aGVHD-related mortality was 5.4% (95% CI, 3.3–8.1). Risk factors for aGVHD-related mortality included haploidentical donors, older donors, diagnosis of myeldysplastic neoplasms, and grade IV aGVHD. This study confirms a low incidence aGVHD with PTCy/siro/MMF prophylaxis. SR-aGVHD showed poorer response to salvage therapies and worse survival, while haploidentical donors and older donor age were negative predictors for aGVHD-related deaths.

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Fig. 1: Cumulative incidence of acute graft-versus-host disease.
Fig. 2: Patient flow through the different lines of treatment.
Fig. 3: Overall survival according to acute graft-versus-host disease response to therapy.

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Data availability

Anonymized data are available for researchers upon e-mail request to the corresponding author.

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Funding

Project “CM23/00215”, funded by Instituto de Salud Carlos III (ISCIII) and co-funded by the European Union.

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Author notes

  1. These authors contributed equally: A. Balaguer, J. Sanz.

Authors and Affiliations

  1. Hematology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain

    P. Asensi Cantó, I. Gómez-Seguí, J. Montoro, M. Villalba Montaner, P. Chorão, P. Solves Alcaína, M. Santiago Balsera, P. Lloret Madrid, C. Sopeña Pell-Ilderton, D. Martínez Campuzano, P. Granados Serrano, J. Eiris del Río, A. Louro, P. Rebollar, A. Perla, J. De la Rubia Comos, M. A. Sanz, A. Balaguer & J. Sanz

  2. CIBERONC, Instituto Carlos III, Madrid, Spain

    I. Gómez-Seguí, P. Solves Alcaína & J. De la Rubia Comos

  3. School of Medicine and Dentistry, Catholic University of Valencia, Valencia, Spain

    J. Montoro & J. De la Rubia Comos

  4. Transfusion Centre, Valencia, Spain

    J. Solís Ruiz

  5. Internal Medicine Department, University of Chile, Santiago, Chile

    R. Benavente

  6. Department of Medicine, University of Valencia, Valencia, Spain

    M. A. Sanz & J. Sanz

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Contributions

PAC, IGS, MAS, AB and JS conceptualization and writing original draft. JM, MVM, PC, PSA, MSB, PLM, JSR, CSP, DMC, PGS, JEDR, AL, PR, PA, RB, and JDLR review and editing

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Correspondence to I. Gómez-Seguí.

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This project was approved by an ethical committee (Comité de Ética de la Investigación con Medicamentos – Hospital Universitario y Politécnico La Fe). Registry number: 09/2019-465. All methods were performed in accordance with the relevant guidelines and regulations. Informed consent was obtained from all participants.

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Asensi Cantó, P., Gómez-Seguí, I., Montoro, J. et al. Incidence, risk factors and therapy response of acute graft-versus-host disease after myeloablative hematopoietic stem cell transplantation with posttransplant cyclophosphamide. Bone Marrow Transplant (2024). https://doi.org/10.1038/s41409-024-02391-3

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