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Bendamustine as part of conditioning of autologous stem cell transplantation in patients with aggressive lymphoma: a phase 2 study from the GELTAMO group
Author(s) -
Redondo Alba M.,
Valcárcel David,
GonzálezRodríguez Ana P.,
SuárezLledó María,
Bello José L.,
Canales Miguel,
Gayoso Jorge,
Colorado Mercedes,
Jarque Isidro,
Campo Raquel,
Arranz Reyes,
Terol María J.,
Rifón José J.,
Rodríguez María J.,
Ramírez María J,
Castro Nerea,
Sánchez Andrés,
LópezJiménez Javier,
MontesMoreno Santiago,
Briones Javier,
López Aurelio,
Palomera Luis,
LópezGuillermo Armando,
Caballero Dolores,
Martín Alejandro
Publication year - 2019
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.15713
Subject(s) - medicine , carmustine , melphalan , bendamustine , regimen , etoposide , autologous stem cell transplantation , surgery , transplantation , cytarabine , progression free survival , gastroenterology , oncology , lymphoma , chemotherapy , rituximab
Summary 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.