PURPOSE: We conducted a phase III randomized clinical trial to compare two myeloablative conditioning regimens for allogeneic hematopoietic cell transplantation (HCT) in patients with leukemia and myelodysplastic syndrome. PATIENTS AND METHODS: After randomization, 64 patients received busulfan (3.2 mg/kg per day × 4 days) plus cyclophosphamide (60 mg/kg per day × 2 days; BuCy), and 62 patients received busulfan (same dose and schedule) plus fludarabine (30 mg/m(2) per day × 5 days; BuFlu). RESULTS:The median age was 41 years (range, 17 to 59 years). Five patients in the BuFlu arm experienced graft failure (primary, n = 1; secondary, n = 4). At 4 weeks after HCT, the median percentage of recipient hematopoietic chimerism was significantly greater in the BuFlu arm (0% v 5.5%; P < .001), and complete donor chimerism was greater in the BuCy arm (97.2% v 44.4%; P < .001). Severe (grade 3 or higher) infection and gastrointestinal adverse events were significantly more common in the BuCy arm, but the frequencies of hepatic adverse events were similar in the two arms. Nonrelapse mortality was similar in the two arms, but the BuCy arm had better overall survival (OS), relapse-free survival (RFS), and event-free survival (EFS; OS at 2 years, 67.4% v 41.4%, P = .014; RFS, 74.7% v 54.9%, P = .027; EFS, 60.7% v 36.0%, P = .014). CONCLUSION: Our results indicate that the BuFlu regimen is not a suitable replacement for the BuCy regimen in young adults who are eligible for myeloablative conditioning therapy for allogeneic HCT.
RCT Entities:
PURPOSE: We conducted a phase III randomized clinical trial to compare two myeloablative conditioning regimens for allogeneic hematopoietic cell transplantation (HCT) in patients with leukemia and myelodysplastic syndrome. PATIENTS AND METHODS: After randomization, 64 patients received busulfan (3.2 mg/kg per day × 4 days) plus cyclophosphamide (60 mg/kg per day × 2 days; BuCy), and 62 patients received busulfan (same dose and schedule) plus fludarabine (30 mg/m(2) per day × 5 days; BuFlu). RESULTS: The median age was 41 years (range, 17 to 59 years). Five patients in the BuFlu arm experienced graft failure (primary, n = 1; secondary, n = 4). At 4 weeks after HCT, the median percentage of recipient hematopoietic chimerism was significantly greater in the BuFlu arm (0% v 5.5%; P < .001), and complete donor chimerism was greater in the BuCy arm (97.2% v 44.4%; P < .001). Severe (grade 3 or higher) infection and gastrointestinal adverse events were significantly more common in the BuCy arm, but the frequencies of hepatic adverse events were similar in the two arms. Nonrelapse mortality was similar in the two arms, but the BuCy arm had better overall survival (OS), relapse-free survival (RFS), and event-free survival (EFS; OS at 2 years, 67.4% v 41.4%, P = .014; RFS, 74.7% v 54.9%, P = .027; EFS, 60.7% v 36.0%, P = .014). CONCLUSION: Our results indicate that the BuFlu regimen is not a suitable replacement for the BuCy regimen in young adults who are eligible for myeloablative conditioning therapy for allogeneic HCT.
Authors: Christopher Bredeson; Jennifer LeRademacher; Kazunobu Kato; John F Dipersio; Edward Agura; Steven M Devine; Frederick R Appelbaum; Marcie R Tomblyn; Ginna G Laport; Xiaochun Zhu; Philip L McCarthy; Vincent T Ho; Kenneth R Cooke; Elizabeth Armstrong; Angela Smith; J Douglas Rizzo; Jeanne M Burkart; Marcelo C Pasquini Journal: Blood Date: 2013-09-30 Impact factor: 22.113
Authors: Gheath Alatrash; Kelly M Kidwell; Peter F Thall; Antonio Di Stasi; Julianne Chen; Madhushree Zope; Alyssa K Crain; Richard E Champlin; Uday Popat; Elizabeth J Shpall; Roy B Jones; Borje S Andersson Journal: Bone Marrow Transplant Date: 2018-12-10 Impact factor: 5.483
Authors: Christopher G Kanakry; Paul V O'Donnell; Terry Furlong; Marcos J de Lima; Wei Wei; Marta Medeot; Marco Mielcarek; Richard E Champlin; Richard J Jones; Peter F Thall; Borje S Andersson; Leo Luznik Journal: J Clin Oncol Date: 2014-09-29 Impact factor: 44.544
Authors: J R Passweg; M Labopin; J Cornelissen; L Volin; G Socié; A Huynh; R Tabrizi; D Wu; C Craddock; N Schaap; J Kuball; P Chevallier; J Y Cahn; D Blaise; A Ghavamzadeh; K Bilger; F Ciceri; C Schmid; S Giebel; A Nagler; M Mohty Journal: Bone Marrow Transplant Date: 2015-06-01 Impact factor: 5.483
Authors: Hans C Lee; Rima M Saliba; Gabriela Rondon; Julianne Chen; Yasmeen Charafeddine; L Jeffrey Medeiros; Gheath Alatrash; Borje S Andersson; Uday Popat; Partow Kebriaei; Stefan Ciurea; Betul Oran; Elizabeth Shpall; Richard Champlin Journal: Biol Blood Marrow Transplant Date: 2015-07-14 Impact factor: 5.742
Authors: Y S Jethava; S Sica; B Savani; F Socola; M Jagasia; M Mohty; A Nagler; A Bacigalupo Journal: Bone Marrow Transplant Date: 2017-05-15 Impact factor: 5.483
Authors: Lindsey R Lombardi; Christopher G Kanakry; Marianna Zahurak; Nadira Durakovic; Javier Bolaños-Meade; Yvette L Kasamon; Douglas E Gladstone; William Matsui; Ivan Borrello; Carol Ann Huff; Lode J Swinnen; Robert A Brodsky; Richard F Ambinder; Ephraim J Fuchs; Gary L Rosner; Richard J Jones; Leo Luznik Journal: Leuk Lymphoma Date: 2015-10-12
Authors: J De La Serna; J Sanz; A Bermúdez; M Cabrero; D Serrano; C Vallejo; V Gómez; J M Moraleda; S G Perez; M D Caballero; E Conde; J J Lahuerta; G Sanz Journal: Bone Marrow Transplant Date: 2016-03-07 Impact factor: 5.483