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AML-184: Administration of Cyclophosphamide for GVHD Prophylaxis After Stem Cell Transplantation From Unrelated Donors And Infections: A Multi-Center Experience

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      Context:

      There is still no clear information about the incidence and consequences of infections with cyclophosphamide (PTCy) administration as prophylaxis against graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

      Objectives:

      Revealing the incidence of pre-vaccination bacterial and viral infections (cytomegalovirus [CMV], herpes virus, and BK-polyomavirus hemorrhagic-cystitis), infection-related mortality, and predictive factors associated with PTCy application after allo-HSCT was the study aim.

      Design:

      Patients who underwent allo-HSCT from 9/10–10/10 HLA tissue-matched, unrelated donors and received cyclophosphamide for post-transplant GVHD prophylaxis from 3 centers between 2015 and 2020 were retrospectively reviewed. Infections that developed in the first 100 days after transplantation were recorded.

      Patients:

      Forty-one patients, M/F: 25/16, were included in the study. The mean age was 40.8 years (21–67), with 23 AML, 11 ALL, 3 NHL, 2 MDS, one biphenotypic leukemia, and 1 HL diagnosis. HLA tissue compatibility was 9/10 in 32 patients and 10/10 in 9 patients. All patients received one myeloablative priming regimen [TBI (800–1200 cGy)+Flu (30 mg/m2×5), Cy (60 mg/kg×2) + TBI (1200 cGy), treosulfan (10 g/m2×3) + Flu (40 mg/m2×4)]. In GVHD prophylaxis, PTCy was administered 72 and 96 hours following transplantation in combination with calcineurin inhibitors ± methotrexate ± mycophenolate mofetil. Levofloxacin, valacyclovir, fluconazole, and trimethoprim-sulfamethoxazole were empirically given to all patients along with the transplant preparation regimen.

      Results:

      At least one episode of febrile neutropenia (FEN) developed in all patients during the transplantation process. More than one episode of FEN developed in 22% of the patients. One patient died due to septic shock on post-transplant day 9. The incidence of CMV infection requiring treatment was 36.6% in the first 100 days and 41.5% at 1 year. All patients except 1 were CMV IgG-positive before transplantation. CMV reactivation was observed in 50% (15/15) of donor/patient CMV IgG (+/+). CMV reactivation was found in 30% (3/7) of the donor/patient CMVIgG (–/+) patients. Only one of these patients received antiviral therapy due to multiple reactivations. In 4 patients, CMV pneumonia developed, and 3 of them died. The rate of polyomavirus-associated cystitis was 7.3% (3/41). In the first year after transplantation, invasive fungal infection occurred in only 4 patients (9.8%), herpes virus infection occurred in 1 patient. Three patients received tenofovir–entecavir treatment because of anti-HBcIg positivity, and HBV reactivation was not detected in any of the patients.

      Conclusion:

      GVHD prophylaxis containing PTCy after allo-HSCT from an unrelated donor does not have an increased risk in terms of bacterial, viral, or fungal infections and can be used safely.

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