Scientific publications
Bendamustine as part of conditioning of autologous stem cell transplantation in patients with aggressive lymphoma: a phase 2 study from the GELTAMO group
Alba M Redondo 1 , David Valcárcel 2 3 , Ana P González-Rodríguez 4 , María Suárez-Lledó 5 , José L Bello 6 , Miguel Canales 7 , Jorge Gayoso 8 , Mercedes Colorado 9 , Isidro Jarque 10 , Raquel Del Campo 11 , Reyes Arranz 12 , María J Terol 13 , José J Rifón 14 , María J Rodríguez 15 , María J Ramírez 16 , Nerea Castro 17 , Andrés Sánchez 18 , Javier López-Jiménez 19 , Santiago Montes-Moreno 20 , Javier Briones 21 , Aurelio López 22 , Luis Palomera 23 , Armando López-Guillermo 5 , Dolores Caballero 1 , Alejandro Martín 1 , Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO)
Abstract
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.
CITATION Br J Haematol. 2019 Mar;184(5):797-807. doi: 10.1111/bjh.15713. Epub 2018 Dec 12.
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