Bendamustine as part of conditioning of autologous stem cell transplantation in patients with aggressive lymphoma: a phase 2 study from the GELTAMO group
Por:
Redondo, AM, Valcarce, D, Gonzalez-Rodriguez, AP, Suarez-Lledo, M, Bello, JL, Canales, M, Gayoso, J, Colorado, M, Jarque, I, del Campo, R, Arranz, R, Terol, MJ, Rifon, JJ, Rodriguez, MJ, Ramirez, MJ, Castro, N, Sanchez, A, Lopez-Jimenez, J, Montes-Moreno, S, Briones, J, Lopez, A, Palomera, L, Lopez-Guillermo, A, Caballero, D, Martin, A
Publicada:
1 mar 2019
Resumen:
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 x 10(9)/l and >20 x 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.
Filiaciones:
Redondo, AM:
Hosp Univ Salamanca, Dept Haematol, IBSAL, CIBERONC, Paseo San Vicente 58-182, Salamanca 37007, Spain
Valcarce, D:
Univ Autonoma Barcelona, Hosp Vall dHebron, Dept Haematol, Barcelona, Spain
VHIO, Expt Haematol Unit, Barcelona, Spain
Gonzalez-Rodriguez, AP:
Hosp Cent Asturias, Dept Haematol, Oviedo, Spain
Suarez-Lledo, M:
Hosp Clin Barcelona, Dept Haematol, Barcelona, Spain
Bello, JL:
CHUS, Dept Haematol, Santiago De Compostela, Spain
Canales, M:
Hosp La Paz, Dept Haematol, Madrid, Spain
Gayoso, J:
Hosp Gregorio Maranon, Dept Haematol, Madrid, Spain
Colorado, M:
Hosp Marques Valdecilla, Dept Haematol, Santander, Spain
Jarque, I:
Hosp Univ La Fe, Dept Haematol, CIBERONC, Valencia, Spain
del Campo, R:
Hosp Son Llitzer, Dept Haematol, Palma De Mallorca, Spain
Arranz, R:
Hosp La Princesa, Dept Haematol, Madrid, Spain
Terol, MJ:
Hosp Clin Valencia, Dept Haematol, Valencia, Spain
Rifon, JJ:
Clin Univ Navarra, Dept Haematol, Pamplona, Spain
Rodriguez, MJ:
Hosp Univ Canarias, Dept Haematol, Las Palmas Gran Canaria, Spain
Ramirez, MJ:
Hosp Jerez, Dept Haematol, Jerez de la Frontera, Spain
Castro, N:
Hosp 12 Octubre, Dept Haematol, Madrid, Spain
Sanchez, A:
Hosp Virgen Arrixaca, Dept Haematol, Murcia, Spain
Lopez-Jimenez, J:
Hosp Univ Ramon & Cajal, Dept Haematol, Madrid, Spain
Montes-Moreno, S:
Hosp Univ Marques Valdecilla, IFIMAV, Dept Pathol, Santander, Spain
Briones, J:
Hosp Santa Creu & Sant Pau, Dept Haematol, Barcelona, Spain
Lopez, A:
Hosp Arnau de Villanova, Dept Haematol, Valencia, Spain
Palomera, L:
Hosp Clin Zaragoza, Dept Haematol, Zaragoza, Spain
Lopez-Guillermo, A:
Hosp Clin Barcelona, Dept Haematol, Barcelona, Spain
Caballero, D:
Hosp Univ Salamanca, Dept Haematol, IBSAL, CIBERONC, Paseo San Vicente 58-182, Salamanca 37007, Spain
Martin, A:
Hosp Univ Salamanca, Dept Haematol, IBSAL, CIBERONC, Paseo San Vicente 58-182, Salamanca 37007, Spain
Bronze
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