Multi-Institutional Study of Post-Transplantation Cyclophosphamide As Single-Agent Graft-Versus-Host Disease Prophylaxis After Allogeneic Bone Marrow Transplantation Using Myeloablative Busulfan and Fludarabine Conditioning
| العنوان: | Multi-Institutional Study of Post-Transplantation Cyclophosphamide As Single-Agent Graft-Versus-Host Disease Prophylaxis After Allogeneic Bone Marrow Transplantation Using Myeloablative Busulfan and Fludarabine Conditioning |
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| المؤلفون: | Peter F. Thall, Wei Wei, Richard J. Jones, Richard E. Champlin, Marcos de Lima, Leo Luznik, Christopher G. Kanakry, Marco Mielcarek, Paul O'Donnell, Terry Furlong, Marta Medeot, Borje S. Andersson |
| المصدر: | Journal of Clinical Oncology. 32:3497-3505 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2014. |
| سنة النشر: | 2014 |
| مصطلحات موضوعية: | Adult, Male, Oncology, Cancer Research, medicine.medical_specialty, Transplantation Conditioning, Cyclophosphamide, Graft vs Host Disease, Disease, Human leukocyte antigen, Internal medicine, Humans, Medicine, Autogenous bone, Busulfan, Aged, business.industry, Marrow transplantation, Incidence, Hematopoietic Stem Cell Transplantation, Bayes Theorem, ORIGINAL REPORTS, Middle Aged, Myeloablative Agonists, medicine.disease, Fludarabine, Treatment Outcome, Graft-versus-host disease, Immunology, Female, business, Immunosuppressive Agents, Vidarabine, medicine.drug |
| الوصف: | Purpose The clinical safety and efficacy of intravenous busulfan and fludarabine (IV Bu/Flu) myeloablative conditioning as well as graft-versus-host disease (GVHD) prophylaxis with high-dose, post-transplantation cyclophosphamide (PTCy) have been demonstrated independently in several single-institutional studies. We hypothesized that combining these two promising approaches in a multi-institutional study of human leukocyte antigen (HLA) -matched bone marrow transplantation would provide low rates of severe acute and chronic GVHD, low toxicity, and effective disease control. Patients and Methods Ninety-two adult patients (median age, 49 years; range, 21 to 65 years) with high-risk hematologic malignancies were enrolled at three centers (clinical trial No. NCT00809276). Forty-five patients received related allografts, and 47 received unrelated allografts. GVHD prophylaxis was solely with PTCy at 50 mg/kg/day on post-transplantation days +3 and +4. Results The cumulative incidences of grades 2 to 4 acute, grades 3 to 4 acute, and chronic GVHD were 51%, 15%, and 14%, respectively. Nonrelapse mortality (NRM) at 100 days and 1 year were 9% and 16%, respectively. With a median follow-up period of 2.2 years, the 2-year disease-free survival (DFS) and overall survival (OS) rates were 62% and 67%, respectively. Donor relatedness did not affect NRM, DFS, or OS. Patients in complete remission (CR) without evidence of minimal residual disease (MRD) had markedly better DFS (80%) and OS (80%) than patients in CR with MRD or with active disease at the time of transplantation (DFS, P = .0005; OS, P = .019). Conclusion This multi-institutional study demonstrates that PTCy can be safely and effectively combined with IV Bu/Flu myeloablative conditioning and confirms PTCy's efficacy as single-agent, short-course GVHD prophylaxis for both acute and chronic GVHD after bone marrow transplantation from HLA-matched donors. |
| تدمد: | 1527-7755 0732-183X 0080-9276 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::32d8226652c90ef82f312298022513bc https://doi.org/10.1200/jco.2013.54.0625 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....32d8226652c90ef82f312298022513bc |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X 00809276 |
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