A randomized study comparing yttrium-90 ibritumomab tiuxetan (Zevalin) and high-dose BEAM chemotherapy versus BEAM alone as the conditioning regimen before autologous stem cell transplantation in patients with aggressive lymphoma

Avichai Shimoni, Irit Avivi, Jacob M. Rowe, Moshe Yeshurun, Itai Levi, Reuven Or, Paulina Patachenko, Abraham Avigdor, Tzila Zwas, Arnon Nagler

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: High-dose chemotherapy combined with autologous stem-cell transplantation (ASCT) is the standard therapy for refractory/relapsed aggressive lymphoma. In the era of rituximab-containing frontline regimens, it is becoming more challenging to salvage patients in this setting, and novel approaches are required. This is a randomized study evaluating the safety and efficacy of standard-dose ibritumomab tiuxetan (Zevalin) combined with high-dose BEAM chemotherapy (Z-BEAM) and ASCT in refractory/relapsed aggressive lymphoma. METHODS: Forty-Three patients with CD20+-aggressive lymphoma were randomized to a treatment arm (Z-BEAM, n = 22) or control arm (BEAM alone, n = 21). Ibritumomab tiuxetan was given at 0.4 mCi/kg on day -14 before ASCT. RESULTS: Patient characteristics, engraftment kinetics, and toxicity profile were similar between the 2 groups. Two-year progression-free survival (PFS) for all patients was 48% (95% confidence interval, 32%-64%): 59% and 37% after Z-BEAM and BEAM alone, respectively (P =.2). Multivariate analysis identified advanced age (hazard ratio [HR], 8.3; P =.001), high-risk disease (relapse within 12 months of diagnosis and/or secondary International Prognostic Index >2; HR, 2.8; P =.04), positive positron emission tomography-computed tomography pretransplant (HR, 2.4; P =.07), and BEAM alone (HR, 2.8; P =.03) as poor prognostic factors. Intermediate-risk patients with 1 or 2 risk factors had better PFS with Z-BEAM compared with BEAM: 69% and 29%, respectively (P =.07). Two-year overall survival was 91% and 62% after Z-BEAM and BEAM, respectively (P =.05). Similar prognostic factors determined survival. The HR for BEAM alone in the multivariate analysis was 8.1 (P =.01). CONCLUSIONS: Standard-dose ibritumomab tiuxetan combined with BEAM high-dose chemotherapy is safe and possibly more effective than BEAM alone as a conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.

Original languageEnglish
Pages (from-to)4706-4714
Number of pages9
JournalCancer
Volume118
Issue number19
DOIs
StatePublished - 1 Oct 2012
Externally publishedYes

Keywords

  • BEAM
  • ibritumomab tiuxetan
  • non-Hodgkin lymphoma
  • stem cell transplantation

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