RT Journal Article T1 Bendamustine as part of conditioning of autologous stem cell transplantation in patients with aggressive lymphoma: a phase 2 study from the GELTAMO group. A1 Redondo, Alba M A1 Valcárcel, David A1 González-Rodríguez, Ana P A1 Suárez-Lledó, María A1 Bello, José L A1 Canales, Miguel A1 Gayoso, Jorge A1 Colorado, Mercedes A1 Jarque, Isidro A1 Del Campo, Raquel A1 Arranz, Reyes A1 Terol, María J A1 Rifón, José J A1 Rodríguez, María J A1 Ramírez, María J A1 Castro, Nerea A1 Sánchez, Andrés A1 López-Jiménez, Javier A1 Montes-Moreno, Santiago A1 Briones, Javier A1 López, Aurelio A1 Palomera, Luis A1 López-Guillermo, Armando A1 Caballero, Dolores A1 Martín, Alejandro A1 Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO), K1 BEAM K1 aggressive lymphomas K1 autologous stem-cell transplantation K1 bendamustine K1 clinical trial AB We conducted a phase 2 trial to evaluate the safety and efficacy of bendamustine instead of BCNU (carmustine) in the BEAM (BCNU, etoposide, cytarabine and melphalan) regimen (BendaEAM) as conditioning for autologous stem-cell transplantation (ASCT) in patients with aggressive lymphomas. The primary endpoint was 3-year progression-free survival (PFS). Sixty patients (median age 55 [28-71] years) were included. All patients (except one who died early) engrafted after a median of 11 (9-72) and 14 (4-53) days to achieve neutrophil and platelet counts of >0.5 × 109 /l and >20 × 109 /l, respectively. Non-relapse mortality at 100 days and 1 year were 3.3% and 6.7%, respectively. With a median follow-up of 67 (40-77) months, the estimated 3-year PFS and overall survival (OS) were 58% and 75%, respectively. Patients in partial response at study entry had significantly worse PFS and OS than patients who underwent ASCT in complete metabolic remission, and this was the only prognostic factor associated with both PFS (Relative risk [RR], 0.27 [95% confidence interval {CI} [0.12-0.56]) and OS (RR, 0.40 [95% CI 0.17-0.97]) in the multivariate analysis. BendaEAM conditioning is therefore a feasible and effective regimen in patients with aggressive lymphomas. However, patients not in complete metabolic remission at the time of transplant had poorer survival and so should be considered for alternative treatment strategies. YR 2018 FD 2018-12-12 LK https://hdl.handle.net/10668/25042 UL https://hdl.handle.net/10668/25042 LA en DS RISalud RD Apr 7, 2025