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1. ADAMTS13 recovery in acute thrombotic thrombocytopenic purpura after caplacizumab therapy

Author

Abio Calvete, Mariola, Albert, Albert, Alberto López García, Alberto, Alegre, Adrian, Alkorta Eizagirre, Aitziber, Alonso Escobar, María Nieves, Alonso Madrigal, Cristina, Amunarriz, Cristina, Antelo Caamaño, María Luisa, Arbona Castaño, Cristina, Ballester Ruiz, Maria Carmen, Ballina Martín, Belén, Berberana Fernández de Murias, Margarita, Berrueco Moreno, Ruben, Bueno, Jose Luis, Calderón López, María Teresa, Chica Gullón, Esther, Cid Vidal, Joan, Contreras Barbeta, Enric, Cuéllar Pérez-Ávila, Clara, de la Rubia Comos, Javier, Del Orbe Barreto, Rafael Andres, Del Río Garma, Julio, Díaz Valdés, José R., Diaz-Ricart, Maribel, Diez Gallarreta, Zuriñe, Dueñas Hernando, Virginia, Eguia, Blanca, Escoda, Lourdes, Fernández Docampo, Marta, Fernandez Fuertes, Fernando, Fernández Muñoz, Hermogenes, Fernández Sánchez de Mora, Maria Carmen, Fernandez Zarzoso, Miguel, Fidalgo, Teresa, Flores Ballester, Elena, Fonte Feal, Cristina, Galvez, Francisco Javier, Garcia Arroba Peinado, Jose, García Candel, Faustino, Garcia Erce, Jose Antonio, García Gala, José María, Gimeno, JJ, Gómez, Delia, Gómez Seguí, Inés, Gomez Vazquez, Maria Jesus, Gonzalez, Carlos, González Fernández, Fernando Ataulfo, Gonzalez Porras, Jose Ramon, Gonzalez Rodriguez, Victoria Paz, Goterris Viciedo, Rosa, Guerra Domínguez, Luisa, Guillén García, Helga, Hernandez, Adoracion, Hernández Castellet, José Carlos, Hernandez Mohedo, Francisca, Hernandez Vazquez, Laura, Hidalgo Soto, Marta, Hong Tam, Azueg Hang, Kerguelen Fuentes, Ana Lilia, Leal Bento, Marta, Lopes, Raquel, López, Olga, López Chuliá, Francisca, Maria Jose Busto, Maria Jose, Martín Hernández, María Paz, Martinez Estefano, Elvira, Martinez Nieto, Jorge, Martinez Redondo, Consuelo, Martinez Revuelta, Eva, Medina Marrero, Laura, Mingot Castellano, María Eva, Morales Sanz, María Dolores, Moreno, Gemma, Moreno Beltrán, Mª Esperanza, Moreno Chulilla, Jose Antonio, Nistal Gil, Sara, Oliva Hernandez, Ana Yurena, Pascual, Teresa, Pascual Izquierdo, Crisina, Paumard Rodríguez, Elena, Pecos, Patricia, Peña Marcos, Francisco, Pereira Coelho, Daniela Sofia, Pérez Segura, Gloria Maria, Perez-Lopez, Olga, Prieto Pareja, Elena, Ramiro, Laia, Richart López, Luis Alberto, Rodriguez Dominguez, Maria Jesus, Rodriguez Nuñez, Antonio, Ruiz Sainz, María Elena, Saez Serrano, Isabel, Salinas Argente, Ramón, Sanchez, Maria Elena, Sanchez Anton, Piva, Sánchez Fernández, Mª Soledad, Sebastian, Elena, Simona, Gabriela, Solanich Moreno, Xabier, Soledad Casado, Soledad, Tallón, Jose David, Turcu, Violeta, Valledor Méndez, Manuel, Vidan Y Estevez, Julia, Viejo Llorente, Aurora, Bienert, Álvaro, Serrano, Alfons, Llorente, Laura, Campuzano, Verónica, Tallón, Inmaculada, Pons, Verónica, Linares, Mónica, Valles, Ana, Martínez Francés, Antonio, Freiria, Carmen, González Arias, Elena, Araujo, Enmanuel, Marco de Lucas, Fernando, López, Juan Antonio, Uribe Barrientos, Marisol, Calviño, Michael, Gómez Calafat, Montse, Marco Vera, Pascual, Fariña, Sabela, Zalba, Saioa, Monsalvo, Silvia, Escamilla, Virginia, Mingot-Castellano, María-Eva, García-Candel, Faustino, Martínez-Nieto, Jorge, García-Arroba, José, de la Rubia-Comos, Javier, Gómez-Seguí, Inés, Paciello-Coronel, María-Liz, Valcárcel-Ferreiras, David, Jiménez, Moraima, Cid, Joan, Lozano, Miquel, García-Gala, José-María, Angós-Vazquez, Sonia, Vara-Pampliega, Miriam, Guerra-Domínguez, Luisa, Ávila-Idrobo, Laura-Francisca, Oliva-Hernandez, Ana, Zalba-Marcos, Saioa, Tallón-Ruiz, Inmaculada, Ortega-Sánchez, Sandra, Goterris-Viciedo, Rosa, Moreno-Jiménez, Gemma, Domínguez-Acosta, Lourdes, Araiz-Ramírez, María, Hernández-Mateos, Luis, Flores-Ballesteros, Elena, del Río-Garma, Julio, and Pascual-Izquierdo, Cristina

Published
2024
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2. A phase I trial of selinexor plus FLAG-Ida for the treatment of refractory/relapsed adult acute myeloid leukemia patients

Author

Martínez Sánchez, María P., Megías-Vericat, Juan Eduardo, Rodríguez-Veiga, Rebeca, Vives, Susana, Bergua, Juan Miguel, Torrent, Anna, Suárez-Varela, Sara, Boluda, Blanca, Martínez-López, Joaquín, Cano-Ferri, Isabel, Acuña-Cruz, Evelyn, Torres-Miñana, Laura, Martín-Herreros, Beatriz, Serrano, Alfons, Sempere, Amparo, Barragán, Eva, Sargas, Claudia, Sanz, Miguel, Martínez-Cuadrón, David, and Montesinos, Pau

Published
2021
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3. Feasibility and results of subtype-oriented protocols in older adults and fit elderly patients with acute lymphoblastic leukemia: Results of three prospective parallel trials from the PETHEMA group

Author

Ribera, Josep-Maria, García, Olga, Oriol, Albert, Gil, Cristina, Montesinos, Pau, Bernal, Teresa, González-Campos, José, Lavilla, Esperanza, Ribera, Jordi, Brunet, Salut, Martínez, María-Pilar, Tormo, Mar, Genescà, Eulàlia, Barba, Pere, Sarrà, Josep, Monteserín, María-Carmen, Soria, Beatriz, Colorado, Mercedes, Cladera, Antònia, García-Guiñón, Antoni, Calbacho, María, Serrano, Alfons, Ortín, Xavier, Pedreño, María, Amigo, Maria-Luz, Escoda, Lourdes, and Feliu, Evarist

Published
2016
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4. Genomic Data Improves Prognostic Stratification in Adult T-Cell Acute Lymphoblastic Leukemia Patients Enrolled in Measurable Residual Disease-Oriented Trials

Author

González-Gil, Celia, primary, Morgades, Mireia, additional, Fuster-Tormo, Francisco, additional, García-Chica, Jesus, additional, Montesinos, Pau, additional, Torrent, Anna, additional, Diaz-Beyá, Marina, additional, Coll, Rosa, additional, Ribera, Jordi, additional, Zhao, Ran, additional, Hermosin, Maria Lourdes, additional, Mercadal, Santiago, additional, González-Campos, José, additional, Artola, M Teresa, additional, Vall-Llovera, Ferran, additional, Tormo, Mar, additional, Gil, Cristina, additional, Barba, Pere, additional, Novo, Andrés, additional, Bernal del Castillo, Teresa, additional, Queipo De Llano, Maria, additional, Martínez, Pilar, additional, González, Teresa, additional, Cladera, Antonia, additional, Serrano, Alfons, additional, Fernández-Martín, Rosa, additional, Ardaiz, Maria C., additional, Vidal, Maria Jesus, additional, Baena, Ángela, additional, Lopez-Bigas, Nuria, additional, Bigas, Anna, additional, Maciejewski, Jaroslaw P., additional, Orfao, Alberto, additional, Ribera, Josep-Maria, additional, and Genescà, Eulàlia, additional

Published
2021
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5. 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

6. 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

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

Author

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

Published
2021
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8. 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

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

Author

Ribera, Josep-Maria, primary, García, Olga, additional, Chapchap, Eduardo Cerello, additional, Gil, Cristina, additional, González-Campos, José, additional, Barba, Pere, additional, Amigo, María-Luz, additional, Moreno, María-José, additional, Lavilla, Esperanza, additional, Alonso, Natalia, additional, Bergua, Juan-Miguel, additional, Tormo, Mar, additional, Ribera, Jordi, additional, Sierra, Magdalena, additional, Martínez-Carballeira, Daniel, additional, Mercadal, Santiago, additional, Hernández-Rivas, Jesús-María, additional, Vall-llovera, Ferran, additional, Genescà, Eulàlia, additional, Cladera, Antònia, additional, Novo, Andrés, additional, Abella, Eugènia, additional, García-Cadenas, Irene, additional, Monteserín, Carmen, additional, Bermúdez, Arancha, additional, Piernas, Sonia, additional, Montesinos, Pau, additional, López, Jose-Luis, additional, García-Guiñón, Antoni, additional, Serrano, Alfons, additional, Martínez, María-Pilar, additional, Olivares, Matxalen, additional, López, Aurelio, additional, and Serrano, Josefina, additional

Published
2020
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10. A phase 3 trial of azacitidine versus a semi‐intensive fludarabine and cytarabine schedule in older patients with untreated acute myeloid leukemia.

Author

Vives, Susana, Martínez‐Cuadrón, David, Bergua Burgues, Juan, Algarra, Lorenzo, Tormo, Mar, Martínez‐Sánchez, María Pilar, Serrano, Josefina, Herrera, Pilar, Ramos, Fernando, Salamero, Olga, Lavilla, Esperanza, López‐Lorenzo, José L., Gil, Cristina, Vidriales, Belén, Falantes, Jose F., Serrano, Alfons, Labrador, Jorge, Sayas, María J., Foncillas, María Á., and Amador Barciela, María L.

Subjects
ACUTE myeloid leukemia, OLDER patients, AZACITIDINE, CYTARABINE, FLUDARABINE
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. Azacitidine improves 1‐year overall survival in comparison with a semi‐intensive chemotherapy schedule (FLUGA). The complete remission/complete remission with incomplete blood count recovery rate after 3 cycles is lower in an azacitidine arm than a FLUGA arm, but the best response achieved is similar for the 2 groups. [ABSTRACT FROM AUTHOR]

Published
2021
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11. Increased Expression Of PD-1 Checkpoint Molecule on Bone Marrow T-Cells from Patients With Multiple Myeloma: Potential Impact on Clinical Outcome?

Author

Perez-Montero, Pablo, primary, Paniagua, Angel, additional, Prieto, Mario, additional, Llorente, Laura, additional, Serrano, Alfons, additional, Mari, Pilar, additional, Rodrigo, Esther, additional, Varea, Sara, additional, Ríos, Fernando López, additional, and Perez de Oteyza, Jaime, additional

Published
2019
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12. 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

13. Frequency and Prognostic Significance of the Presence of Additional Cytogenetic Abnormalitions (ACA) to the Philadelphia (Ph) Chromosome in Young Adults with ACUTE Lymphoblastic Leukemia (ALL) Treated with the ALL Ph08 Trial from the Pethema Group

Author

Motlló, Cristina, primary, Ribera, Josep-Maria, additional, Morgades, Mireia, additional, Granada, Isabel, additional, Montesinos, Pau, additional, Mercadal, Santiago, additional, González-Campos, José, additional, Moreno, Maria-José, additional, Barba, Pere, additional, Cervera, Marta, additional, Barrios, Manuel, additional, Novo, Andrés, additional, Bernal, Teresa, additional, Hernandez-Rivas, Jesus María, additional, Abella, Eugenia, additional, Amigo, Maria Luz, additional, Tormo, Mar, additional, Martino, Rodrigo, additional, Lavilla, Esperanza, additional, Bergua, Juan, additional, Serrano, Alfons, additional, García-Belmonte, Daniel, additional, Guàrdia, Ramon, additional, Grau, Javier, additional, and Feliu, Evarist, additional

Published
2016
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14. Comparison of Efficacy and Safety of Two Types of E.coli Asparaginase (Native or Pegylated) for Treatment of Adult Patients with High-Risk (HR), Philadelphia (Ph) Chromosome-Negative ALL Included in the Prospective MRD-Oriented Protocol ALL-HR-11 from the Spanish Pethema Group

Author

Ribera, Josep-Maria, primary, Morgades, Mireia, additional, Montesinos, Pau, additional, García-Cadenas, Irene, additional, Barba, Pere, additional, Soria, Beatriz, additional, Bermúdez, Arancha, additional, Moreno, MªJosé, additional, González-Campos, José, additional, Vives, Susana, additional, Gil, Cristina, additional, Abella, Eugenia, additional, Guàrdia, Ramon, additional, Bernal, Teresa, additional, Martínez-Sánchez, Pilar, additional, Amigo, MªLuz, additional, Mercadal, Santiago, additional, Serrano, Alfons, additional, López-Martínez, Aurelio, additional, Vall-llovera, Ferran, additional, Sánchez-Sánchez, MªJosé, additional, Peñarrubia, MªJesús, additional, Calbacho, María, additional, Méndez, Jose-Angel, additional, Bergua, Juan, additional, Cladera, Antònia, additional, Tormo, Mar, additional, García-Belmonte, Daniel, additional, Ciudad, Juana, additional, Feliu, Evarist, additional, and Orfao, Alberto, additional

Published
2016
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15. Post-Remission Treatment with Chemotherapy or Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) of High-Risk (HR) Philadelphia Chromosome-Negative (Ph-neg) Adult Acute Lymphoblastic Leukemia (ALL) According to Minimal Residual Disease (MRD). Preliminary Results of the Pethema ALL-HR-11 Trial

Author

Ribera, Josep-Maria, primary, Morgades, Mireia, additional, Ciudad, Juana, additional, Barba, Pere, additional, Martino, Rodrigo, additional, Montesinos, Pau, additional, Vives, Susana, additional, Moreno, MªJosé, additional, Soria, Beatriz, additional, Gil, Cristina, additional, González-Campos, José, additional, Amigo, MªLuz, additional, Novo, Andrés, additional, Tormo, Mar, additional, Bermúdez, Arancha, additional, Serrano, Alfons, additional, Bernal, Teresa, additional, López, Aurelio, additional, Bergua, Juan, additional, Escoda, Lourdes, additional, Martínez, Pilar, additional, Alonso, Natalia, additional, Mercadal, Santiago, additional, Abella, Eugenia, additional, Guàrdia, Ramon, additional, Vall-llovera, Ferran, additional, Cladera, Antònia, additional, Esteve, Jordi, additional, García-Boyero, Raimundo, additional, Feliu, Evarist, additional, and Orfao, Alberto, additional

Published
2015
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16. Incidence, Treatment and Prognosis of Patients with Relapsed Burkitt Lymphoma/Leukemia Treated with Specific Chemotherapy or Immunochemotherapy in Spain

Author

Pineda, Alberto, primary, Sancho, Juan-Manuel, additional, Garcia, Olga, additional, Esteve, Jordi, additional, Tormo, Mar, additional, Martinez, Pilar, additional, Vall-llovera, Ferran, additional, Martino, Rodrigo, additional, Montesinos, Pau, additional, Gonzalez-Campos, Jose, additional, Bergua, Juan, additional, Calbacho, María, additional, Gil, Cristina, additional, Vicent, Ana, additional, Cladera, Antònia, additional, Hernandez, Jesus, additional, Moreno, Maria-José, additional, Serrano, Alfons, additional, Alonso, Natalia, additional, García, Raimundo, additional, Barba, Pere, additional, Fernandez, Angeles, additional, Miralles, Pilar, additional, Novo, Andrés, additional, Moraleda, Jose Maria, additional, Hernández, José Ángel, additional, Abella, Eugenia, additional, Sanchez, Magdalena, additional, Lopez, Maria-Elsa, additional, Bernal, Teresa, additional, Mateos, Mª Carmen, additional, Lavilla, Esperanza, additional, and Ribera, Josep-Maria, additional

Published
2015
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17. Efficacy and safety of native versus pegylated Escherichia coli asparaginase for treatment of adults with high-risk, Philadelphia chromosome-negative acute lymphoblastic leukemia.

Author

Ribera, Josep-Maria, Morgades, Mireia, Montesinos, Pau, Martino, Rodrigo, Barba, Pere, Soria, Beatriz, Bermúdez, Arancha, Moreno, María-José, González-Campos, José, Vives, Susana, Gil, Cristina, Abella, Eugenia, Guàrdia, Ramon, Martínez-Carballeira, Daniel, Martínez-Sánchez, Pilar, Amigo, María-Luz, Mercadal, Santiago, Serrano, Alfons, López-Martínez, Aurelio, and Vall-Llovera, Ferran

Subjects
ASPARAGINASE, LYMPHOBLASTIC leukemia treatment, ESCHERICHIA coli, TREATMENT effectiveness, ADULTS, ERWINIA chrysanthemi, DRUG toxicity, DISEASE remission, MEDICAL care, THERAPEUTICS
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. [ABSTRACT FROM AUTHOR]

Published
2018
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19. Bendamustine In Combination With Rituximab As First-Line Treatment For Indolent Non-Hodgkin Lymphoma: Retrospective Analysis Of An Spanish Registry

Author

Solorzano, Silvia, primary, Martinez-Chamorro, Carmen, additional, Panizo, Carlos, additional, Quero, Cristina, additional, Deben, Guillermo, additional, Paz, Jose, additional, Batlle, Ana, additional, Serrano, Alfons, additional, Muentes, Zayda, additional, Gutierrez, Antonio, additional, and Tomas, Jose Francisco, additional

Published
2013
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20. Different Prognosis According to Subtype-Oriented Protocols in Elderly Patients with Acute Lymphoblastic Leukemia (ALL). Comparison of Three Prospective Parallel Trials from the Pethema Group

Author

Ribera, Josep-Maria, primary, Garcia, Olga, additional, Fernandez, Pascual, additional, Montesinos, Pau, additional, Brunet, Salut, additional, Martinez, Maria del Pilar, additional, Lavilla, Esperanza, additional, Bernal, Teresa, additional, González, Jose, additional, Tormo, Mar, additional, Barba, Pere, additional, Monteserín, Carmen, additional, Sarrá, Josep, additional, Fernandez, Marta, additional, Colorado, Mercedes, additional, Novo, Andrés, additional, Garcia, Antonio, additional, Calbacho, Maria, additional, Abella, Eugenia, additional, Moreno, Maria-Jose, additional, Hernández-Rivas, Jesús-Maria, additional, Lopez, Maria-Elsa, additional, Alonso, Natalia, additional, Serrano, Alfons, additional, and Feliu, Evarist, additional

Published
2013
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21. Intensive (2+5) Or Semi-Intensive (FLUGA) Chemotherapy For Patients With Acute Myeloid Leukemia Who Are 70 Years Of Age Or Older

Author

Montesinos, Pau, primary, Martínez-Cuadrón, David, additional, Lavilla, Esperanza, additional, Díaz-Mediavilla, Joaquín, additional, Herrera, Pilar, additional, Raimundo, García, additional, Bergua, Juan, additional, Fernandez, Pascual, additional, Pedreño, Maria, additional, Serrano, Alfons, additional, Algarra, Lorenzo, additional, Martí, Edelmira, additional, Rayón, Chelo, additional, Jaramillo, Francisco, additional, Perez-Encinas, Manuel, additional, Galego, Andrea, additional, Riaza, Rosalía, additional, Martínez Sánchez, Mª Pilar, additional, Simiele, Adriana, additional, Sossa, Claudia, additional, Rodríguez-Veiga, Rebeca, additional, Piñana, José Luís, additional, and Sanz, Miguel, additional

Published
2013
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22. Methylen Blue Photoinactivated Plasma vs Fresh Frozen Plasma in Thrombotic Thrombocytopenic Purpura Treatment: A Multicentric Prospective Cohort Study.

Author

Alvarez-Larrán, Alberto, primary, Del Río-Garma, Julio, additional, de la Rubia, Javier, additional, Zamora, Concepción, additional, Galmés, Antonio, additional, Ramírez, Consuelo, additional, Rodríguez-Vicente, Pilar, additional, Martínez, Clara, additional, Alegre, Adrian, additional, Viejo, Aurora, additional, Arbona, Cristina, additional, Serrano, Alfons, additional, Castellá, María Dolors, additional, Corral, Mercedes, additional, Peña, Francisco, additional, and Pereira, Arturo, additional

Published
2007
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26. Comparison of Efficacy and Safety of Two Types of E.coliAsparaginase (Native or Pegylated) for Treatment of Adult Patients with High-Risk (HR), Philadelphia (Ph) Chromosome-Negative ALL Included in the Prospective MRD-Oriented Protocol ALL-HR-11 from the Spanish Pethema Group

Author

Ribera, Josep-Maria, Morgades, Mireia, Montesinos, Pau, García-Cadenas, Irene, Barba, Pere, Soria, Beatriz, Bermúdez, Arancha, Moreno, MªJosé, González-Campos, José, Vives, Susana, Gil, Cristina, Abella, Eugenia, Guàrdia, Ramon, Bernal, Teresa, Martínez-Sánchez, Pilar, Amigo, MªLuz, Mercadal, Santiago, Serrano, Alfons, López-Martínez, Aurelio, Vall-llovera, Ferran, Sánchez-Sánchez, MªJosé, Peñarrubia, MªJesús, Calbacho, María, Méndez, Jose-Angel, Bergua, Juan, Cladera, Antònia, Tormo, Mar, García-Belmonte, Daniel, Ciudad, Juana, Feliu, Evarist, and Orfao, Alberto

Abstract

Background and objective. Asparaginase (ASP) is an essential drug for ALL treatment. Two types of E.coliASP (native and pegylated) are used in clinical trials for treatment of children and adults with ALL, but to our knowledge direct comparison between these two types of ASP in the same protocol has not been performed. This study aimed to compare the efficacy and safety of native vs. PEG-ASP in adult patients with HR, Ph-negative ALL.

Published
2016
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27. Methylen Blue Photoinactivated Plasma vsFresh Frozen Plasma in Thrombotic Thrombocytopenic Purpura Treatment: A Multicentric Prospective Cohort Study.

Author

Alvarez-Larrán, Alberto, Del Río-Garma, Julio, de la Rubia, Javier, Zamora, Concepción, Galmés, Antonio, Ramírez, Consuelo, Rodríguez-Vicente, Pilar, Martínez, Clara, Alegre, Adrian, Viejo, Aurora, Arbona, Cristina, Serrano, Alfons, Castellá, María Dolors, Corral, Mercedes, Peña, Francisco, and Pereira, Arturo

Abstract

Plasma exchange (PE) with plasma infusion is the treatment of choice for Thrombotic Thrombocytopenic Purpura (TTP) but doubts remain as to whether all kinds of plasma are equally effective. Since October 2004, a multicentric prospective cohort study is being conducted in Spain to compare Methylene Blue Photoinactivated Plasma (MBPIP) with Fresh Frozen Plasma (FFP) in the treatment of TTP. Sixty-three first episodes of idiopathic TTP were included. MBPIP was used in 38 and FFP in 25. The treatment schedule consisted of daily PE (> 40 mL/kg of body weight) and costicosteroids (1.5 mg/kg/d). Response was defined as the achievement of a platelet count >= 150 x 109/L for at least three consecutive days, normal LDH level and absence of TTP-related symptoms and signs. Recurrence was defined as a fall in platelet count below 50 x 109/L or below 50% of the highest count achieved after response. Response lasting for more than 15 days was considered as remission. The prognostic significance of the kind of plasma used was investigated by logistic regression analysis after adjustment for other variables that had previously been found to influence on response to PE (gender; the Rock score; days from first medical attendance to PE; volume of plasma infused in the first 7 days of treatment). Both groups were comparable with regard to clinical and biological parameters at diagnosis. A severe deficit in ADAMTS13 activity was found in 9 out 12 (75%) patients treated with MBPIP and in 12 out of 16 (75%) patients treated with FFP. When compared to FFP, patients treated with MBPIP required a higher number of PEs (16±13 vs9±7, p=0.004) and a larger volume of plasma (763±678 ml/kg vs413±326 ml/kg, p=0.02) to achieve a remission and presented more recurrences while on PE treatment (21 out of 38 vs6 out of 25, p=0.02). Splenectomy or rituximab was required in eight patients (21%) treated with MBPIP to achieve a remission vs in none out of the 25 patients treated with FFP (p= 0.02). After adjustment for other prognostic variables, patients in the MBPIP group had a lower likelihood of remission by the 8th treatment day (OR: 5.1; 95% CI: 1.6 – 15.9) and a higher risk of recurrence while on PE treatment (OR: 4.2; 95% CI: 1.3 – 13.5). In conclusion, MBPIP is less effective than FFP in the treatment of TTP.

Published
2007
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28. Frequency and prognostic significance of additional cytogenetic abnormalities to the Philadelphia chromosome in young and older adults with acute lymphoblastic leukemia.

Author

Motlló C, Ribera JM, Morgades M, Granada I, Montesinos P, Mercadal S, González-Campos J, Moreno MJ, Barba P, Cervera M, Barrios M, Novo A, Bernal T, Hernández-Rivas JM, Abella E, Amigo ML, Tormo M, Martino R, Lavilla E, Bergua J, Serrano A, García-Belmonte D, Guàrdia R, Grau J, and Feliu E

Subjects
Adolescent, Adult, Age Factors, Female, Humans, Karyotype, Male, Middle Aged, Monosomy, Precursor Cell Lymphoblastic Leukemia-Lymphoma pathology, Precursor Cell Lymphoblastic Leukemia-Lymphoma therapy, Prognosis, Treatment Outcome, Young Adult, Chromosome Aberrations, Philadelphia Chromosome, Precursor Cell Lymphoblastic Leukemia-Lymphoma genetics, Precursor Cell Lymphoblastic Leukemia-Lymphoma mortality
Abstract

About 25-35% of adult patients with acute lymphoblastic leukemia show the Philadelphia (Ph) chromosome. Few series have evaluated the prognosis of additional cytogenetic alterations (ACA) to the Ph chromosome. We analyzed the frequency, type and prognostic significance ofACA in adults (18-60 years) treated in the ALL-Ph-08 trial. Fifty-two out of 74 patients (70%) showed ACA and 19 (26%) presented monosomies associated with t(9;22) (monosomal karyotype, MK). Similar complete response (CR) rate, CR duration, overall survival and event-free survival (EFS) were observed in patients with or without ACA, but patients with MK showed shorter CR duration and EFS than the remaining. On multivariate analysis, the only variable with prognostic impact for CR duration and EFS was the presence of MK (p = .003 and p = .036, respectively). Although ACA associated with the Ph chromosome are frequent, only monosomies were associated with poor prognosis in this group of patients.

Published
2018
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30. [Thrombotic thrombocytopenic purpura during treatment with interpheron].

Author

Serrano A, Xicoy B, Grifols JR, and Ribera JM

Subjects
Adult, Antiviral Agents administration & dosage, Hepatitis C diagnosis, Hepatitis C drug therapy, Humans, Interferon-alpha administration & dosage, Interferon-alpha adverse effects, Interferon-beta administration & dosage, Male, Middle Aged, Multiple Sclerosis diagnosis, Multiple Sclerosis drug therapy, Purpura, Thrombotic Thrombocytopenic diagnosis, Ribavirin administration & dosage, Ribavirin therapeutic use, Time Factors, Antiviral Agents adverse effects, Interferon-beta adverse effects, Purpura, Thrombotic Thrombocytopenic chemically induced
Published
2007
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31. [Bone marrow aplasia as an onset form of multisystemic sarcoidosis].

Author

Serrano A, Xicoy B, Fité E, and Ribera JM

Subjects
Anemia, Aplastic drug therapy, Anemia, Aplastic pathology, Biopsy, Needle, Bone Marrow pathology, Humans, Immunosuppressive Agents therapeutic use, Male, Middle Aged, Sarcoidosis drug therapy, Sarcoidosis pathology, Treatment Outcome, Anemia, Aplastic etiology, Sarcoidosis complications
Published
2006
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