We retrospectively compared clinical outcomes in 1593 T-replete unrelated donor (URD) marrow transplant recipients with AML, MDS and CML who received myeloablative conditioning regimens of either BU and CY (BuCy), standard-dose Cy/TBI (1000-1260 cGy) or high-dose Cy/TBI (1320-1500 cGy). Subjects were drawn from patients transplanted between 1991 and 1999 facilitated by the National Marrow Donor Program. Patients who received high-dose Cy/TBI regimens were slightly younger, more likely to receive a mismatched transplant and to have intermediate or advanced disease compared with patients in the BuCy or standard-dose TBI group. Neutrophil recovery was significantly higher in the standard-dose CY/TBI group compared with the high-dose Cy/TBI or BuCy group. Patients who received the high-dose Cy/TBI regimen had an increased risk of developing grades III-IV aGVHD when compared with the control group who received BuCy (P=0.011). OS, disease-free survival (DFS), TRM and relapse were not significantly different between any of the regimens. We conclude that BuCy, standard-dose and high-dose Cy/TBI regimens have equivalent efficacy profiles for OS, DFS, TRM and relapse risk in patients undergoing T-replete URD marrow transplantation for AML, CML and MDS.
Bibliographical noteFunding Information:
We acknowledge Esteban M Abella, MD, Asad Bashey, MD, PhD, Scott I Bearman, MD, Arkadiusz Dudek, MD, PhD, FACP, Stephanie Elkins, MD, Nancy A. Kernan, MD and James Wade, MD for their contributions to this manuscript. The CIBMTR is supported by Public Health Service Grant/Cooperative Agreement U24-CA76518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 5U01HL069294 from NHLBI and NCI; a contract HHSH234200637015C with Health Resources and Services Administration (HRSA/DHHS); two Grants N00014-06-1-0704 and N00014-08-1-0058 from the Office of Naval Research; and grants from AABB; Aetna; American Society for Blood and Marrow Transplantation; Amgen Inc.; anonymous donation to the Medical College of Wisconsin; Association of Medical Microbiology and Infectious Disease Canada; Astellas Pharma US Inc.; Baxter International Inc.; Bayer HealthCare Pharmaceuticals; BloodCenter of Wisconsin; Blue Cross and Blue Shield Association; Bone Marrow Foundation; Canadian Blood and Marrow Transplant Group; Celgene Corporation; CellGenix GmbH; Centers for Disease Control and Prevention; ClinIm-mune Labs; CTI Clinical Trial and Consulting Services; Cubist Pharmaceuticals; Cylex Inc.; CytoTherm; DOR BioPharma Inc.; Dynal Biotech, an Invitrogen Company; Enzon Pharmaceuticals Inc.; European Group for Blood and Marrow Transplantation; Gambro BCT Inc.; Gamida Cell Ltd; Genzyme Corporation; Histogenetics Inc.; HKS Medical Information Systems; Hospira Inc.; Infectious Diseases Society of America; Kiadis Pharma; Kirin Brewery Co., Ltd; Merck & Company; The Medical College of Wisconsin; MGI Pharma Inc.; Michigan Community Blood Centers; Millennium Pharmaceuticals Inc.; Miller Pharmacal Group; Milliman USA Inc.; Miltenyi Biotec Inc.; National Marrow Donor Program; Nature Publishing Group; New York Blood Center; Novartis Oncology; Oncology Nursing Society; Osiris Therapeutics Inc.; Otsuka Pharmaceutical Development & Commercialization Inc.; Pall Life Sciences; PDL BioPharma Inc.; Pfizer Inc.; Pharmion Corporation; Saladax Biomedical Inc.; Schering Plough Corporation; Society for Healthcare Epidemiology of America; StemCyte Inc.; StemSoft Software Inc.; Sysmex; Teva Pharmaceutical Industries; The Marrow Foundation; THERAKOS Inc.; Vidacare Corporation; Vion Pharmaceuticals Inc.; ViraCor Laboratories; ViroPharma Inc.; and Wellpoint Inc. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense or any other agency of the US Government.
- TBI conditioning regimens
- unrelated donor transplantation