Pérez-Encinas, M.M. (Manuel M.)

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    Characteristics and outcomes of adult patients in the PETHEMA registry with relapsed or refractory FLT3-ITD mutation-positive acute myeloid leukemia
    (2022) Espadana, A. (Ana); García-Boyero, R. (Raimundo); Serrano, J. (Josefina); Martínez-López, J. (Joaquín); Amigo, M.L. (Mari Luz); Montesinos, P. (Pau); Martínez-Sánchez, P. (Pilar); Pérez-Encinas, M.M. (Manuel M.); Rodríguez-Gutiérrez, J.I. (Juan I.); López, A. (Andrés); López, J.A. (Juan A.); Vasconcelos, G. (Graça); Rodríguez-Veiga, R. (Rebeca); Vidriales, M.B. (María Belén); Rodríguez-Arbolí, E. (Eduardo); Bergua, J. (Juan); Mariz, J. (José); Bernal, T. (Teresa); Rodríguez-Medina, C. (Carlos); Tormo, M. (Mar); Labrador, J. (Jorge); Vives, S. (Susana); Martínez-Chamorro, C. (Carmen); Sanz, M.A. (Miguel A.); Algarra, L. (Lorenzo); Polo, M. (Marta); García-Fortes, M. (María); Barragán, E. (Eva); Noriega, V. (Víctor); Boluda, B. (Blanca); Chillón, M.C. (María del Carmen); Calasanz-Abinzano, M.J. (Maria Jose); Martínez-Cuadron, D. (David); Aguiar, E. (Eliana); Alonso-Domínguez, J.M. (Juan M.); Herrera, P. (Pilar); Gil, C. (Cristina); Sayas, M.J. (María J.)
    Simple Summary Most adult patients with acute myeloid leukemia (AML) relapse after achieving complete remission with chemotherapy; however, there is no standard second-line (salvage) treatment. We retrospectively investigated 404 patients aged >= 18 years with relapsed/refractory (R/R) AML with an FMS-like tyrosine kinase 3 (FLT3) mutation, treated at a PETHEMA (NCT02607059) site between 1998 and 2018. Patients received salvage treatment with intensive therapy (n = 261), non-intensive therapy (n = 63) or supportive care (n = 80). Complete remission was achieved by 48% of patients who received intensive therapy vs. 19% with non-intensive therapy. Intensive/non-intensive therapy prolonged overall survival significantly compared with supportive therapy. Of evaluable patients, 22% received an allogeneic stem-cell transplant after complete remission. The majority of patients with FLT3-mutated R/R AML received intensive salvage therapy, with the best outcomes being obtained when intensive salvage treatment was combined with stem-cell transplant. This retrospective study investigated outcomes of 404 patients with relapsed/refractory (R/R) FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) acute myeloid leukemia (AML) enrolled in the PETHEMA registry, pre-approval of tyrosine kinase inhibitors. Most patients (63%) had received first-line intensive therapy with 3 + 7. Subsequently, patients received salvage with intensive therapy (n = 261), non-intensive therapy (n = 63) or supportive care only (n = 80). Active salvage therapy (i.e., intensive or non-intensive therapy) resulted in a complete remission (CR) or CR without hematological recovery (CRi) rate of 42%. More patients achieved a CR/CRi with intensive (48%) compared with non-intensive (19%) salvage therapy (p < 0.001). In the overall population, median overall survival (OS) was 5.5 months; 1- and 5-year OS rates were 25% and 7%. OS was significantly (p < 0.001) prolonged with intensive or non-intensive salvage therapy compared with supportive therapy, and in those achieving CR/CRi versus no responders. Of 280 evaluable patients, 61 (22%) had an allogeneic stem-cell transplant after they had achieved CR/CRi. In conclusion, in this large cohort study, salvage treatment approaches for patients with FLT3-ITD mutated R/R AML were heterogeneous. Median OS was poor with both non-intensive and intensive salvage therapy, with best long-term outcomes obtained in patients who achieved CR/CRi and subsequently underwent allogeneic stem-cell transplant.