Phase III Randomized Study of Rituximab/Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) Compared With Iodine-131 Tositumomab/BEAM With Autologous Hematopoietic Cell Transplantation for Relapsed Diffuse Large B-Cell Lymphoma: Results From the BMT CTN 0401 Trial

Julie M Vose; Shelly Carter; Linda J Burns; Ernesto Ayala; Oliver W Press; Craig H Moskowitz; Edward A Stadtmauer; Shin Mineshi; Richard Ambinder; Timothy Fenske; Mary Horowitz; Richard Fisher; Marcie Tomblyn

doi:10.1200/JCO.2012.45.9453

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Phase III Randomized Study of Rituximab/Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) Compared With Iodine-131 Tositumomab/BEAM With Autologous Hematopoietic Cell Transplantation for Relapsed Diffuse Large B-Cell Lymphoma: Results From the BMT CTN 0401 Trial

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Phase III Randomized Study of Rituximab/Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) Compared With Iodine-131 Tositumomab/BEAM With Autologous Hematopoietic Cell Transplantation for Relapsed Diffuse Large B-Cell Lymphoma: Results From the BMT CTN 0401 Trial

Julie M Vose, Shelly Carter, Linda J Burns, Ernesto Ayala, Oliver W Press, Craig H Moskowitz, Edward A Stadtmauer, Shin Mineshi, Richard Ambinder, Timothy Fenske, …

Journal of clinical oncology, Vol.31(13), pp.1662-1668

2013-05-01

DOI: https://doi.org/10.1200/JCO.2012.45.9453

PMCID: PMC3635682

PMID: 23478060

Abstract

PurposeThis clinical trial evaluated standard-dose radioimmunotherapy with a chemotherapy-based transplantation regimen followed by autologous hematopoietic cell transplantation versus rituximab with the same regimen in patients with relapsed diffuse large B-cell lymphoma (DLBCL).Patients and MethodsPatients with chemotherapy-sensitive persistent or relapsed DLBCL were randomly assigned to receive iodine-131 tositumomab (dosimetric dose of 5 mCi on day −19 and therapeutic dose of 0.75 Gy on day −12), carmustine 300 mg/m2(day −6), etoposide 100 mg/m2twice daily (days −5 to −2), cytarabine 100 mg/m2twice daily (days −5 to −2), and melphalan 140 mg/m2(day −1; B-BEAM) or rituximab 375 mg/m2on days −19 and −12 and the same chemotherapy regimen (R-BEAM).ResultsTwo hundred twenty-four patients were enrolled, with 113 patients randomly assigned to R-BEAM and 111 patients assigned to B-BEAM. Two-year progression-free survival (PFS) rates, the primary end point, were 48.6% (95% CI, 38.6% to 57.8%) for R-BEAM and 47.9% (95% CI, 38.2% to 57%; P = .94) for B-BEAM, and the 2-year overall survival (OS) rates were 65.6% (95% CI, 55.3% to 74.1%) for R-BEAM and 61% (95% CI, 50.9% to 69.9%; P = .38) for B-BEAM. The 100-day treatment-related mortality rates were 4.1% (95% CI, 0.2% to 8.0%) for R-BEAM and 4.9% (95% CI, 0.8% to 9.0%; P = .97) for B-BEAM. The maximum mucositis score was higher in the B-BEAM arm (0.72) compared with the R-BEAM arm (0.31; P < .001).ConclusionThe B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS rates for patients with chemotherapy-sensitive relapsed DLBCL. No differences in toxicities other than mucositis were noted.

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Collaboration types: Domestic collaboration
Citation topics: 1 Clinical & Life Sciences; 1.130 Lymphomas; 1.130.132 Lymphoma
Web Of Science research areas: Oncology
ESI research areas: Clinical Medicine

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Title: Phase III Randomized Study of Rituximab/Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) Compared With Iodine-131 Tositumomab/BEAM With Autologous Hematopoietic Cell Transplantation for Relapsed Diffuse Large B-Cell Lymphoma: Results From the BMT CTN 0401 Trial
Creators: Julie M Vose - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Shelly Carter - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Linda J Burns - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Ernesto Ayala - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Oliver W Press - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Craig H Moskowitz - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Edward A Stadtmauer - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Shin Mineshi - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Richard Ambinder - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Timothy Fenske - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Mary Horowitz - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Richard Fisher - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Marcie Tomblyn - Julie M. Vose, University of Nebraska Medical Center, Omaha, NE; Shelly Carter, EMMES, Rockville; Richard Ambinder, Johns Hopkins Medical Center, Baltimore, MD; Linda J. Burns, University of Minnesota, Minneapolis, MN; Ernesto Ayala and Marcie Tomblyn, H. Lee Moffitt Cancer Center, Tampa, FL; Oliver W. Press, Fred Hutchinson Cancer Center, Seattle, WA; Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York; Richard Fisher, University of Rochester, Rochester, NY; Edward A. Stadtmauer
Publication Details: Journal of clinical oncology, Vol.31(13), pp.1662-1668
Academic Unit: Miller School of Medicine; UMMG Department of Medicine
Language: English
Resource Type: Journal article
PMID: 23478060
PMCID: PMC3635682
Record Identifier: 991031614199402976