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.
Author(s): Vose JM(1), Carter S, Burns LJ, Ayala E, Press OW, Moskowitz CH, Stadtmauer EA,
Mineshi S, Ambinder R, Fenske T, Horowitz M, Fisher R, Tomblyn M.
Affiliation(s): Author information:
(1)Section of Hematology/Oncology, University of Nebraska Medical Center, Omaha, NE
68198-7680, USA. jmvose@unmc.edu
Publication date & source: 2013, J Clin Oncol. , 31(13):1662-8
PURPOSE: This 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 METHODS: Patients 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/m(2) (day -6), etoposide 100 mg/m(2) twice daily (days -5 to -2), cytarabine
100 mg/m(2) twice daily (days -5 to -2), and melphalan 140 mg/m(2) (day -1;
B-BEAM) or rituximab 375 mg/m(2) on days -19 and -12 and the same chemotherapy
regimen (R-BEAM).
RESULTS: Two 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).
CONCLUSION: The 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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