Aggressive lymphoma: switching BEAM's carmustine for bendamustine

  • Redondo AM & al.
  • Br J Haematol
  • 12 dic. 2018

  • de David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In patients with aggressive lymphomas, replacing the carmustine component of the BEAM (carmustine, etoposide, cytarabine, and melphalan) conditioning regimen with bendamustine (Benda-EAM) is feasible and efficacious.
  • Inferior survival was reported in patients not in complete remission (CR) at time of transplant.

Why this matters

  • Carmustine is a common component of conditioning regimens in this setting, but currently has limited availability in some countries.

Study design

  • Phase 2 study to investigate the safety and efficacy of Benda-EAM in 60 patients with aggressive lymphomas planned for autologous stem cell transplantation (auto-SCT).
  • Median patient age, 55 (range, 28-70) years.
  • 62% were in metabolic CR at study entry.
  • Funding: Mundipharma.

Key results

  • 75% of patients achieved CR with Benda-EAM; 10% achieved partial response.
  • Estimated 3-year survival outcomes:
    • PFS: 58%.
    • OS: 75%.
  • In univariate analysis, CR status during auto-SCT was the only prognostic factor for:
    • PFS: HR, 0.29; 95% CI, 0.14-0.60; P=.001.
    • OS: HR, 0.40; 95% CI, 0.17-0.97; P=.043.
  • 3.3% 100-day nonrelapse mortality (NRM); 6.7% 1-year NRM.
  • 6.7% developed acute renal failure.
  • Infections were the most common toxicity.
  • No cases of grade III-IV cardiac/hepatic toxicity

Limitations

  • Limited sample size.