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, David Valcárcel, Ana P. González-Rodríguez, María Suárez-Lledó, José L. Bello, Miguel Canales, Jorge Gayoso, Mercedes Colorado, Isidro Jarque, Raquel del Campo, Reyes Arranz, María J. Terol, José J. Rifón, María J. Rodríguez, María J. Ramírez, Nerea Castro, Andrés Sánchez, Javier López-Jiménez, Santiago Montes-Moreno, Javier BrionesAurelio López, Luis Palomera, Armando López-Guillermo, Dolores Caballero, Alejandro Martín

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6 Citations (Scopus)

Abstract

© 2018 British Society for Haematology and John Wiley & Sons Ltd 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 × 10 9 /l and >20 × 10 9 /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.
Original languageEnglish
Pages (from-to)797-807
JournalBritish Journal of Haematology
Volume184
DOIs
Publication statusPublished - 1 Mar 2019

Keywords

  • aggressive lymphomas
  • autologous stem-cell transplantation
  • BEAM
  • bendamustine
  • clinical trial

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