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.
abstract: OBJECTIVE
  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).
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Section of Hematology/Oncology, University of Nebraska Medical Center, Omaha, NE 68198-7680, USA. jmvose@unmc.edu
authors.forename: Julie M
authors.initials: JM
authors.lastname: Vose
authors.forename: Shelly
authors.initials: S
authors.lastname: Carter
authors.forename: Linda J
authors.initials: LJ
authors.lastname: Burns
authors.forename: Ernesto
authors.initials: E
authors.lastname: Ayala
authors.forename: Oliver W
authors.initials: OW
authors.lastname: Press
authors.forename: Craig H
authors.initials: CH
authors.lastname: Moskowitz
authors.forename: Edward A
authors.initials: EA
authors.lastname: Stadtmauer
authors.forename: Shin
authors.initials: S
authors.lastname: Mineshi
authors.forename: Richard
authors.initials: R
authors.lastname: Ambinder
authors.forename: Timothy
authors.initials: T
authors.lastname: Fenske
authors.forename: Mary
authors.initials: M
authors.lastname: Horowitz
authors.forename: Richard
authors.initials: R
authors.lastname: Fisher
authors.forename: Marcie
authors.initials: M
authors.lastname: Tomblyn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003561:Cytarabine / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000628:therapy*; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D011446:Prospective Studies; D016499:Radioimmunotherapy; D012008:Recurrence; D000069283:Rituximab; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D003561:Cytarabine; D000069283:Rituximab; D005047:Etoposide; C119496:tositumomab I-131; D008558:Melphalan; D002330:Carmustine