Phase III Randomized Study of Rituximab/Carmustine, Etopo-side, 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

Research output: Contribution to journalArticle

100 Scopus citations

Abstract

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/m2 (day 6), etoposide 100 mg/m2 twice daily (days 5 to 2), cytarabine 100 mg/m2 twice daily (days 5 to 2), and melphalan 140 mg/m2 (day 1; B-BEAM) or rituximab 375 mg/m2 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.

Original languageEnglish (US)
Pages (from-to)1662-1668
Number of pages7
JournalJournal of Clinical Oncology
Volume31
Issue number13
DOIs
StatePublished - May 1 2013

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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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