- 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.
- 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.
- 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
- Limited sample size.