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Efficacy of Pharmacokinetics-Directed Busulfan, Cyclophosphamide, and Etoposide Conditioning and Autologous Stem Cell Transplantation for Lymphoma: Comparison of a Multicenter Phase II Study and CIBMTR Outcomes. Biol Blood Marrow Transplant 2016 07;22(7):1197-1205

Date

04/05/2016

Pubmed ID

27040394

Pubmed Central ID

PMC4914052

DOI

10.1016/j.bbmt.2016.03.018

Scopus ID

2-s2.0-84975229745   9 Citations

Abstract

Busulfan, cyclophosphamide, and etoposide (BuCyE) is a commonly used conditioning regimen for autologous stem cell transplantation (ASCT). This multicenter, phase II study examined the safety and efficacy of BuCyE with individually adjusted busulfan based on preconditioning pharmacokinetics. The study initially enrolled Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) patients ages 18 to 80 years but was amended due to high early treatment-related mortality (TRM) in patients > 65 years. BuCyE outcomes were compared with contemporaneous recipients of carmustine, etoposide, cytarabine, and melphalan (BEAM) from the Center for International Blood and Marrow Transplant Research. Two hundred seven subjects with HL (n = 66) or NHL (n = 141) were enrolled from 32 centers in North America, and 203 underwent ASCT. Day 100 TRM for all subjects (n = 203), patients > 65 years (n = 17), and patients ≤ 65 years (n = 186) were 4.5%, 23.5%, and 2.7%, respectively. The estimated rates of 2-year progression-free survival (PFS) were 33% for HL and 58%, 77%, and 43% for diffuse large B cell lymphoma (DLBCL; n = 63), mantle cell lymphoma (MCL; n = 29), and follicular lymphoma (FL; n = 23), respectively. The estimated rates of 2-year overall survival (OS) were 76% for HL and 65%, 89%, and 89% for DLBCL, MCL, and FL, respectively. In the matched analysis rates of 2-year TRM were 3.3% for BuCyE and 3.9% for BEAM, and there were no differences in outcomes for NHL. Patients with HL had lower rates of 2-year PFS with BuCyE, 33% (95% CI, 21% to 46%), than with BEAM, 59% (95% CI, 52% to 66%), with no differences in TRM or OS. BuCyE provided adequate disease control and safety in B cell NHL patients ≤ 65 years but produced worse PFS in HL patients when compared with BEAM.

Author List

Flowers CR, Costa LJ, Pasquini MC, Le-Rademacher J, Lill M, Shore TB, Vaughan W, Craig M, Freytes CO, Shea TC, Horwitz ME, Fay JW, Mineishi S, Rondelli D, Mason J, Braunschweig I, Ai W, Yeh RF, Rodriguez TE, Flinn I, Comeau T, Yeager AM, Pulsipher MA, Bence-Bruckler I, Laneuville P, Bierman P, Chen AI, Kato K, Wang Y, Xu C, Smith AJ, Waller EK

Author

Marcelo C. Pasquini MD, MS Professor in the Medicine department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Aged
Busulfan
Carmustine
Cyclophosphamide
Cytarabine
Drug Combinations
Etoposide
Hematopoietic Stem Cell Transplantation
Hodgkin Disease
Humans
Lymphoma
Lymphoma, Non-Hodgkin
Melphalan
Middle Aged
North America
Survival Analysis
Transplantation Conditioning
Transplantation, Autologous
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a