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Your search keyword '"Serrano, Alfons"' showing total 4 results
Start Over Author "Serrano, Alfons" Publication Type Electronic Resources
4 results on '"Serrano, Alfons"'

1. A phase 3 trial of azacitidine versus a semi-intensive fludarabine and cytarabine schedule in older patients with untreated acute myeloid leukemia

Author

Instituto de Salud Carlos III, Celgene, Vives, Susana, Martínez-Cuadrón, David, Bergua, Juan, Algarra, Lorenzo, Tormo, Mar, Martínez-Sánchez, María Pilar, Serrano-López, Josefina, Herrera, Pilar, Ramos, Fernando, Salamero, Olga, Lavilla, Esperanza, López-Lorenzo, José L., Gil, Cristina, Vidriales, Maria Belén, Falantes-González, José Francisco, Serrano, Alfons, Labrador, Jorge, Sayas, María-José, Foncillas, María-Ángeles, Amador Barciela, María L., Olave, María-Teresa, Colorado, Mercedes, Gascón, Adriana, Fernández, María Á., Simiele, Adriana, Pérez-Encinas, Manuel, Rodríguez-Veiga, Rebeca, García, Olga, Martínez-López, Joaquín, Barragán, Eva, Paiva, Bruno, Sanz, Miguel Ángel, Montesinos, Pau, Instituto de Salud Carlos III, Celgene, Vives, Susana, Martínez-Cuadrón, David, Bergua, Juan, Algarra, Lorenzo, Tormo, Mar, Martínez-Sánchez, María Pilar, Serrano-López, Josefina, Herrera, Pilar, Ramos, Fernando, Salamero, Olga, Lavilla, Esperanza, López-Lorenzo, José L., Gil, Cristina, Vidriales, Maria Belén, Falantes-González, José Francisco, Serrano, Alfons, Labrador, Jorge, Sayas, María-José, Foncillas, María-Ángeles, Amador Barciela, María L., Olave, María-Teresa, Colorado, Mercedes, Gascón, Adriana, Fernández, María Á., Simiele, Adriana, Pérez-Encinas, Manuel, Rodríguez-Veiga, Rebeca, García, Olga, Martínez-López, Joaquín, Barragán, Eva, Paiva, Bruno, Sanz, Miguel Ángel, and Montesinos, Pau

Abstract

[Background] Options to treat elderly patients (≥65 years old) newly diagnosed with acute myeloid leukemia (AML) include intensive and attenuated chemotherapy, hypomethylating agents with or without venetoclax, and supportive care. This multicenter, randomized, open-label, phase 3 trial was designed to assess the efficacy and safety of a fludarabine, cytarabine, and filgrastim (FLUGA) regimen in comparison with azacitidine (AZA)., [Methods] Patients (n = 283) were randomized 1:1 to FLUGA (n = 141) or AZA (n = 142). Response was evaluated after cycles 1, 3, 6, and 9. Measurable residual disease (MRD) was assessed after cycle 9. When MRD was ≥0.01%, patients continued with the treatment until relapse or progressive disease. Patients with MRD < 0.01% suspended treatment to enter the follow-up phase. [Results] The complete remission (CR) rate after 3 cycles was significantly better in the FLUGA arm (18% vs 9%; P = .04), but the CR/CR with incomplete recovery rate at 9 months was similar (33% vs 29%; P = .41). There were no significant differences between arms in early mortality at 30 or 60 days. Hematologic toxicities were more frequent with FLUGA, especially during induction. The 1-year overall survival (OS) rate and the median OS were superior with AZA versus FLUGA: 47% versus 27% and 9.8 months (95% confidence interval [CI], 5.6-14 months) versus 4.1 months (95% CI, 2.7-5.5 months; P = .005), respectively. The median event-free survival was 4.9 months (95% CI, 2.8-7 months) with AZA and 3 months (95% CI, 2.5-3.5 months) with FLUGA (P = .001). [Conclusions] FLUGA achieved more remissions after 3 cycles, but the 1-year OS rate was superior with AZA. However, long-term outcomes were disappointing in both arms (3-year OS rate, 10% vs 5%). This study supports the use of an AZA backbone for future combinations in elderly patients with AML.

Published
2021

2. Chemotherapy or allogeneic transplantation in high-risk Philadelphia chromosome–negative adult lymphoblastic leukemia

Author

Ribera, Josep-Maria, Morgades, Mireia, Ciudad, Juana, Montesinos, Pau, Esteve, Jordi, Genescà, Eulàlia, Barba, Pere, Ribera, Jordi, García-Cadenas, Irene, Moreno, María José, Martínez-Carballeira, Daniel, Torrent, Anna, Martínez-Sánchez, Pilar, Monsalvo, Silvia, Gil, Cristina, Tormo, Mar, Artola, María Teresa, Cervera, Marta, González-Campos, José A., Rodríguez, Carlos, Bermudez, A., Novo, Andrés, Soria, Beatriz, Coll, Rosa, Amigo, María Luz, López-Martínez, Aurelio, Fernández, Rosa, Serrano, Josefina, Mercadal, Santiago, Cladera, Antonia, Giménez-Conca, Alberto, Peñarrubia, María J., Abella, Eugènia, Vall‐Llovera, Ferran, Hernández, Jesús M., Garcia-Guiñon, Antonio, Bergua, Juan, Rueda, Beatriz de, Sánchez-Sánchez, María-José, Serrano, Alfons, Calbacho, M., Alonso, Natalia, Méndez, Jose-Angel, García-Boyero, Raimundo, Olivares, Matxalen, Barrena, Susana, Zamora, Lurdes, Granada, Isabel, Lhermitte, Ludovic, Feliu, Evarist, Orfao, Alberto, Ribera, Josep-Maria, Morgades, Mireia, Ciudad, Juana, Montesinos, Pau, Esteve, Jordi, Genescà, Eulàlia, Barba, Pere, Ribera, Jordi, García-Cadenas, Irene, Moreno, María José, Martínez-Carballeira, Daniel, Torrent, Anna, Martínez-Sánchez, Pilar, Monsalvo, Silvia, Gil, Cristina, Tormo, Mar, Artola, María Teresa, Cervera, Marta, González-Campos, José A., Rodríguez, Carlos, Bermudez, A., Novo, Andrés, Soria, Beatriz, Coll, Rosa, Amigo, María Luz, López-Martínez, Aurelio, Fernández, Rosa, Serrano, Josefina, Mercadal, Santiago, Cladera, Antonia, Giménez-Conca, Alberto, Peñarrubia, María J., Abella, Eugènia, Vall‐Llovera, Ferran, Hernández, Jesús M., Garcia-Guiñon, Antonio, Bergua, Juan, Rueda, Beatriz de, Sánchez-Sánchez, María-José, Serrano, Alfons, Calbacho, M., Alonso, Natalia, Méndez, Jose-Angel, García-Boyero, Raimundo, Olivares, Matxalen, Barrena, Susana, Zamora, Lurdes, Granada, Isabel, Lhermitte, Ludovic, Feliu, Evarist, and Orfao, Alberto

Abstract

The need for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with Philadelphia chromosome–negative (Ph−) acute lymphoblastic leukemia (ALL) with high-risk (HR) features and adequate measurable residual disease (MRD) clearance remains unclear. The aim of the ALL-HR-11 trial was to evaluate the outcomes of HR Ph− adult ALL patients following chemotherapy or allo-HSCT administered based on end-induction and consolidation MRD levels. Patients aged 15 to 60 years with HR-ALL in complete response (CR) and MRD levels (centrally assessed by 8-color flow cytometry) <0.1% after induction and <0.01% after early consolidation were assigned to receive delayed consolidation and maintenance therapy up to 2 years in CR. The remaining patients were allocated to allo-HSCT. CR was attained in 315/348 patients (91%), with MRD <0.1% after induction in 220/289 patients (76%). By intention-to-treat, 218 patients were assigned to chemotherapy and 106 to allo-HSCT. The 5-year (±95% confidence interval) cumulative incidence of relapse (CIR), overall survival (OS), and event-free survival probabilities for the whole series were 43% ± 7%, 49% ± 7%, and 40% ± 6%, respectively, with CIR and OS rates of 45% ± 8% and 59% ± 9% for patients assigned to chemotherapy and of 40% ± 12% and 38% ± 11% for those assigned to allo-HSCT, respectively. Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph− adult ALL patients up to 60 years with adequate MRD response after induction and consolidation. Better postremission alternative therapies are especially needed for patients with poor MRD clearance.

Published
2021

3. Treatment of Frail Older Adults and Elderly Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia: Results of a Prospective Trial With Minimal Chemotherapy

Author

Generalitat de Catalunya, Ribera, Josep-Maria, García, Olga, Cerello Chapchap, Eduardo, Gil, Cristina, González-Campos, José A., Barba, Pere, Amigo, María Luz, Moreno, María José, Lavilla, Esperanza, Alonso, Natalia, Bergua, Juan, Tormo, Mar, Ribera, Jordi, Sierra, Magdalena, Martínez-Carballeira, Daniel, Mercadal, Santiago, Hernandez-Sánchez, Jesus M., Vall‐Llovera, Ferran, Genescà, Eulàlia, Cladera, Antonia, Novo, Andrés, Abella, Eugènia, Monteserín, Carmen, García-Cadenas, Irene, Bermúdez, A., Piernas, Sonia, Montesinos, Pau, López, Jose-Luis, Garcia-Guiñon, Antonio, Serrano, Alfons, Martínez, Pilar, Olivares, Matxalen, López, Aurelio, Serrano, Josefina, Generalitat de Catalunya, Ribera, Josep-Maria, García, Olga, Cerello Chapchap, Eduardo, Gil, Cristina, González-Campos, José A., Barba, Pere, Amigo, María Luz, Moreno, María José, Lavilla, Esperanza, Alonso, Natalia, Bergua, Juan, Tormo, Mar, Ribera, Jordi, Sierra, Magdalena, Martínez-Carballeira, Daniel, Mercadal, Santiago, Hernandez-Sánchez, Jesus M., Vall‐Llovera, Ferran, Genescà, Eulàlia, Cladera, Antonia, Novo, Andrés, Abella, Eugènia, Monteserín, Carmen, García-Cadenas, Irene, Bermúdez, A., Piernas, Sonia, Montesinos, Pau, López, Jose-Luis, Garcia-Guiñon, Antonio, Serrano, Alfons, Martínez, Pilar, Olivares, Matxalen, López, Aurelio, and Serrano, Josefina

Abstract

[Background]: The treatment of acute lymphoblastic leukemia (ALL) in older adults and elderly patients is a challenge, and modern protocols include targeted therapy and immunotherapy in combination with attenuated or minimal chemotherapy. However, frail patients are excluded from these trials, and reports on the outcome of this subgroup of patients are scarce. Our objective was to analyze the outcome of unfit older adults and elderly patients with Philadelphia chromosome-negative ALL included in a prospective trial (ALL-07FRAIL)., [Patients and Methods]: Older adults and elderly patients with Charlson Comorbidity Index (CCI) ≥ 4 were included. Induction therapy consisted of vincristine and dexamethasone, and maintenance therapy with mercaptopurine and methotrexate for 2 years., [Results]: Seventy-two patients with a median age of 67 years (range, 57-89 years) and a median CCI of 5 (range, 4-12) were included. The rates of early withdrawal, early death, resistance, and complete response (CR) were 5%, 10%, 31%, and 54%, respectively. Six patients with CR abandoned the study, 5 died in CR, and 23 relapsed (cumulative relapse incidence 75%). The medians of disease-free and overall survival (OS) were 6.9 months (95% confidence interval [CI], 0.3-13.5 months) and 7.6 months (95% CI, 6.3-8.9 months), respectively. The most frequent toxic events were hematologic (neutropenia 77% and thrombocytopenia 54%, of grade III-IV in all cases). Eastern Cooperative Oncology Group score but not the CCI had significant impact on OS., [Conclusion]: Complete remission with very attenuated chemotherapy can be attained in one-half of older or elderly infirm patients with ALL. These results suggest that some of these patients could benefit from the concomitant or subsequent use of immunotherapy and/or targeted therapy.

Published
2020

4. Efficacy and safety of native versus pegylated Escherichia coli asparaginase for treatment of adults with high-risk, Philadelphia chromosome-negative acute lymphoblastic leukemia

Author

Instituto de Salud Carlos III, Generalitat de Catalunya, Fundación la Caixa, Ribera, Josep-Maria, Morgades, Mireia, Montesinos, Pau, Martino, Rodrigo, Barba, Pere, Soria, Beatriz, Bermúdez, A., Moreno, María José, González-Campos, José A., Vives, Susana, Gil, Cristina, Abella, Eugènia, Guàrdia, Ramón, Martínez-Carballeira, Daniel, Martínez-Sánchez, Pilar, Amigo, María Luz, Mercadal, Santiago, Serrano, Alfons, López-Martínez, Aurelio, Vall‐Llovera, Ferran, Sánchez-Sánchez, María-José, Peñarrubia, María J., Calbacho, M., Méndez, Jose-Angel, Bergua, Juan, Cladera, Antonia, Tormo, Mar, García-Belmonte, Daniel, Feliu, Evarist, Ciudad, Juana, Orfao, Alberto, Instituto de Salud Carlos III, Generalitat de Catalunya, Fundación la Caixa, Ribera, Josep-Maria, Morgades, Mireia, Montesinos, Pau, Martino, Rodrigo, Barba, Pere, Soria, Beatriz, Bermúdez, A., Moreno, María José, González-Campos, José A., Vives, Susana, Gil, Cristina, Abella, Eugènia, Guàrdia, Ramón, Martínez-Carballeira, Daniel, Martínez-Sánchez, Pilar, Amigo, María Luz, Mercadal, Santiago, Serrano, Alfons, López-Martínez, Aurelio, Vall‐Llovera, Ferran, Sánchez-Sánchez, María-José, Peñarrubia, María J., Calbacho, M., Méndez, Jose-Angel, Bergua, Juan, Cladera, Antonia, Tormo, Mar, García-Belmonte, Daniel, Feliu, Evarist, Ciudad, Juana, and Orfao, Alberto

Abstract

Native or pegylated (PEG) asparaginase (ASP) are commonly used in treatment of acute lymphoblastic leukemia (ALL), but have been scarcely compared in the same trial in adult patients. Native vs. PEG-ASP administered according to availability in each center were prospectively evaluated in adults with high-risk ALL. Ninety-one patients received native ASP and 35 PEG-ASP in induction. No significant differences were observed in complete remission, minimal residual disease levels after induction and after consolidation, disease-free survival, and overall survival. No significant differences in grades 3–4 toxicity were observed in the induction period, although a trend for higher hepatic toxicity was observed in patients receiving PEG-ASP. In this trial the type of ASP did not influence patient response and outcome.

Published
2018

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