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Matched Pair Comparison of Busulfan/Cyclophosphamide/Etoposide (BuCyE) to Carmustine/Etoposide/Cytarabine/Melphalan (BEAM) Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation (autoHCT) for Lymphoma

Track: Poster Abstracts
Wednesday, February 26, 2014, 6:45 PM-7:45 PM
Longhorn Hall E (Exhibit Level 1) (Gaylord Texan)
Marcelo C. Pasquini, MD, MS , CIBMTR, CIBMTR/Medical College of Wisconsin, Milwaukee, WI
Jennifer Le Rademacher, PhD , Biostatistics, Medical College of Wisconsin, Milwaukee, WI
Christopher Flowers, MD , Department of Hematology and Medical Oncology, Winship Cancer Institute, Division of BMT,, Emory University, Atlanta, GA
Michael Lill, MD , Cedars Sinai Medical Center, Los Angeles, CA
Luciano J. Costa, MD, PhD , Medical University of South Carolina, Charleston, SC
Tsiporah B. Shore, MD, FRCPC, FACP , Cornell Medical Center Hematology/Oncology, The New York Hospital, New York, NY
William Vaughan, MD , Bone Marrow Transplantation and Cell Therapy Program, University of Alabama in Birmingham, Birmingham, AL
Michael Craig, MD , West Virginia University - Health Science Center, Morgantown, WV
Cesar O. Freytes, MD , South Texas Veterans Health Care System and University of Texas Health Science Center San Antonio, San Antonio, TX
Thomas C. Shea, MD , Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC
Mitchell E. Horwitz, MD , Adult Stem Cell Transplant Program, Division of Cellular Therapy, Department of Medicine, Duke University Medical Center, Durham, NC
Joseph W. Fay, MD, FACP , Baylor University Medical Center, Dallas, TX
Shin Mineishi, MD , Bone Marrow Transplantation Program, University of Alabama at Birmingham, Birmingham, AL
Damiano Rondelli, MD , Department of Medicine, Section of Hematology-Oncology, University of Illinois Hospital & Health Sciences System, Chicago, IL
James Mason, MD , Scripps Clinic, La Jolla, CA
Vijay Reddy, MD, PhD , University of Florida, Gainesville, FL
Ira Braunschweig, MD , Oncology, Montefiore Medical Center, Bronx, NY
Weiyun Ai, MD, PhD , University of California San Francisco, San Francisco, CA
Elizabeth Armstrong, MS , Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
Angela Smith, MS, PA , Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
Cathy Zhao, PhD , Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
Agnes Elekes, MD , Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
Jeanette Carreras, MPH , CIBMTR, Medical College of Wisconsin, Milwaukee, WI
Kazunobu Kato, MD, PhD , Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
Edmund K. Waller, MD, PhD , Department of Hematology and Medical Oncology, Winship Cancer Institute, Division of BMT, Emory University, Atlanta, GA

AutoHCT is the standard therapy for patients with lymphoma who relapse after initial therapy because it improves progression free (PFS) and overall survival (OS). BEAM is the most frequently utilized regimen but other regimens such as those incorporating intravenous Bu are now being investigated. This study compares outcomes from BuCyE in patients enrolled in a phase II multicenter clinical trial from 2010 to 2012, to recipients of BEAM registered with the Center for International Blood and Transplant Center (CIBMTR) from 2008 to 2011. After an interim analysis the clinical trial protocol was amended to enroll patients 65 y and younger due to excess transplant related mortality (TRM) with BuCyE in older patients. 184 recipients of BuCyE with lymphoma in complete or partial response (PR) were matched to a maximum of 4:1 with 729 controls based on age, performance status, disease status prior to transplant and lymphoma histology. 177 cases had 4 matched controls and 97% of controls had an age difference from controls of 5 years or less. Median age is 50 years, 76% with performance status greater than 90%, 35% with Hodgkin lymphoma (HL), 34% diffuse large B-cell lymphoma (DLBCL), 16% mantle cell, 12% follicular and 3% other Non-Hodgkin Lymphoma (NHL) histologies; 43% were in PR and median follow up was 22 months in both cohorts. Two-year cumulative incidences of TRM were 3.3% (95% Confidence Interval [CI] 1.4-6.6%) and 3.9% (95% CI, 2.4-5.7%), for BuCyE and BEAM, respectively. Corresponding two-year probabilities of OS were 76% (95% CI, 68-82%) and 78% (95% CI, 74-82%). Multivariate analysis demonstrated a significant interaction between disease and conditioning regimen in evaluation of disease progression (PRG) and treatment failure (1-PFS) outcomes (Table). Analyses by histology demonstrated that among patients with DLBCL and other NHL histologies, there were no differences in outcomes between conditioning groups. Among patients with HL, the two-year cumulative incidence of PRG  were 66% (95% CI, 53-77%) and 38% (95% CI, 31-45%) and two-year PFS were 33% (95% CI, 21-46%) and 59% (95% CI, 52-66%) for BuCyE and BEAM, respectively with no difference in TRM or OS. BuCyE were associated with comparable outcomes after an autoHCT with BEAM conditioning among patients younger than 65 years with NHL. In a subset of patients with HL, BuCyE was associated with higher PRG and shorter PFS compared to BEAM conditioning.

 

Outcome

Disease

N

(BuCyE/BEAM)

BuCyE vs. BEAMa HR (95% CI)

p-value

Treatment failure b, c

DLBCL

62/ 244

0.94 (0.57 – 1.57)

0.82

 

Other NHL

57/222

1.00 (0.62 – 1.63)

0.99

 

HL

64/253

2.08 (1.44 – 3.02)

<.001

PRG b

DLBCL

62/244

0.95 (0.55 – 1.63)

0.85

 

Other NHL

 57/222

0.95 (0.59 – 1.54)

0.84

 

HL

64/253

2.19 (1.50 – 3.20)

<.001

a  BEAM is the reference   b Adjusted for disease status at transplant c Inverse of progression free survival.

Disclosures:
M. C. Pasquini, Otsuka, Independent Contractor: Research Funding

J. Le Rademacher, Otsuka, Independent Contractor: Research Funding

L. J. Costa, Otsuka, Independent Contractor: Research Funding

C. O. Freytes, Otsuka, Merck, Grant/research support: Advisory Board, Consultancy and Otsuka Travel Grant

E. Armstrong, Otsuka, Employee: Salary

A. Smith, Otsuka, Employee: Salary

C. Zhao, Otsuka, Employee: Salary

A. Elekes, Otsuka, Employee: Salary

J. Carreras, Otsuka, Independent Contractor: Research Funding

K. Kato, Otsuka, Employee: Salary

E. K. Waller, Otsuka, Consultant: Consultancy
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