Colorado, M. (Mercedes)

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2018 - 20192

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    A precision medicine test predicts clinical response after idarubicin and cytarabine induction therapy in AML patients
    (Elsevier BV, 2019) García-Boyero, R. (Raimundo); Serrano, J. (Josefina); Ballesteros, J. (Joan); Martínez-López, J. (Joaquín); Perez-Simon, J.A. (José Antonio); Pérez-Oteyza, J. (Jaime); Rodríguez-Macías, G. (Gabriela); Montesinos, P. (Pau); Jiménez-Bravo, S. (Santiago); López, J.A. (Juan A.); Vidriales, M.B. (María Belén); Bergua, J. (Juan); Troconiz, I.F. (Iñaki F.); Rojas, J.L. (José Luis); Hernández-Campo, P. (Pilar); Lavilla, E. (Esperanza); Tormo, M. (Mar); Colorado, M. (Mercedes); Moscardó, F. (Federico); Vives, S. (Susana); Primo, D. (Daniel); Gorrochategui, J. (Julián); Villoria, J. (Jesús); Sanz, M. (Miguel); Martínez-Cuadron, D. (David); Spanish PETHEMA group; Linares-Gómez, M. (María); Herrera, P. (Pilar); Gil, C. (Cristina)
    Complete remission (CR) after induction therapy is the first treatment goal in acute myeloid leukemia (AML) patients and has prognostic impact. Our purpose is to determine the correlation between the observed CR/CRi rate after idarubicin (IDA) and cytarabine (CYT) 3 + 7 induction and the leukemic chemosensitivity measured by an ex vivo test of drug activity. Bone marrow samples from adult patients with newly diagnosed AML were included in this study. Whole bone marrow samples were incubated for 48 h in well plates containing IDA, CYT, or their combination. Pharmacological response parameters were estimated using population pharmacodynamic models. Patients attaining a CR/CRi with up to two induction cycles of 3 + 7 were classified as responders and the remaining as resistant. A total of 123 patients fulfilled the inclusion criteria and were evaluable for correlation analyses. The strongest clinical predictors were the area under the curve of the concentration response curves of CYT and IDA. The overall accuracy achieved using MaxSpSe criteria to define positivity was 81%, predicting better responder (93%) than non-responder patients (60%). The ex vivo test provides better yet similar information than cytogenetics, but can be provided before treatment representing a valuable in-time addition. After validation in an external cohort, this novel ex vivo test could be useful to select AML patients for 3 + 7 regimen vs. alternative schedules.
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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
    (2018) Gayoso, J. (Jorge); López-Guillermo, A. (Armando); Castro, N. (Nerea); Suárez-Lledó, M. (María); Briones, J. (Javier); Bello, J. I. (José I.); Rodríguez, M.J. (María José); López, A. (Andrés); Ramirez, M.J. (María Javier); Rifon, J. J. (Jose J.); Montes-Moreno, S. (Santiago); López-Jiménez, J. (Javier); Martin, A. (Alejandro); Caballero, D. (Dolores); Colorado, M. (Mercedes); Valcarcel, D. (David); Palomera, L. (Luis); Terol, M.J. (María José); Canales-Albendea, M. A. (Miguel Ángel); Sanchez, A. (Andrés); del Campo, R. (Raquel); Redondo, A. M. (Alba M.); Jarque, I. (Isidro); Arranz, R. (Reyes); González-Rodriguez, A.P. (Ana Pilar)
    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.