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789 results on '"Alvarez-Larrán, A."'

1. Prognostic value of response to first-line hydroxyurea according to IPSET stratification in essential thrombocythemia

Author

Santaliestra, Marta, Garrote, Marta, Noya, María Soledad, Pérez-Encinas, Manuel, Senín, Alicia, Pérez-López, Raúl, Ferrer-Marín, Francisca, Carreño-Tarragona, Gonzalo, Caballero, Gonzalo, Magro, Elena, Vélez, Patricia, Cortés Vázquez, Miguel Ángel, Moretó, Ana, Angona, Anna, Pastor-Galán, Irene, Guerra, José María, García Hernández, Carmen, Mata, María Isabel, Stuckey, Ruth, Gómez-Casares, María Teresa, Fox, Laura, Cuevas, Beatriz, García-Gutiérrez, Valentín, Triguero, Ana, Arellano-Rodrigo, Eduardo, Hernández-Boluda, Juan Carlos, and Alvarez-Larrán, Alberto

Published
2024
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2. ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options

Author

Kiladjian, Jean-Jacques, Marin, Francisca Ferrer, Al-Ali, Haifa Kathrin, Alvarez-Larrán, Alberto, Beggiato, Eloise, Bieniaszewska, Maria, Breccia, Massimo, Buxhofer-Ausch, Veronika, Cerna, Olga, Crisan, Ana-Manuela, Danaila, Catalin Doru, De Stefano, Valerio, Döhner, Konstanze, Empson, Victoria, Gora-Tybor, Joanna, Griesshammer, Martin, Grosicki, Sebastian, Guglielmelli, Paola, García-Gutierrez, Valentin, Heidel, Florian H., Illés, Arpád, Tomuleasa, Ciprian, James, Chloe, Koschmieder, Steffen, Krauth, Maria-Theresa, Krejcy, Kurt, Lazaroiu, Mihaela-Cornelia, Mayer, Jiri, Nagy, Zsolt György, Nicolini, Franck-Emmanuel, Palandri, Francesca, Pappa, Vassiliki, Reiter, Andreas Johannes, Sacha, Tomasz, Schlager, Stefanie, Schmidt, Stefan, Terpos, Evangelos, Unger, Martin, Wölfler, Albert, Cirici, Blanca Xicoy, and Klade, Christoph

Published
2024
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3. Genomic classification and outcomes of young patients with polycythemia vera and essential thrombocythemia according to the presence of splanchnic vein thrombosis and its chronology

Author

Garrote, Marta, López-Guerra, Mónica, García-Pagán, Juan Carlos, Arellano-Rodrigo, Eduardo, Ferrer-Marín, Francisca, Hernández-Boluda, Juan Carlos, Bellosillo, Beatriz, Nomdedeu, Meritxell, Hernández-Gea, Virginia, Triguero, Ana, Guijarro, Francesca, Álamo, José, Baiges, Anna, Turon, Fanny, Colomer, Dolors, Cervantes, Francisco, and Alvarez-Larrán, Alberto

Published
2024
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4. Janus kinase inhibitor ruxolitinib in combination with nilotinib and prednisone in patients with myelofibrosis (RuNiC study): A phase Ib, multicenter study

Author

Rosa Ayala, Rafael Alonso Fernández, Valentín García‐Gutiérrez, Alberto Alvarez‐Larrán, Santiago Osorio, Jose M. Sánchez‐Pina, Gonzalo Carreño‐Tarragona, Noemi Álvarez, María Teresa Gómez‐Casares, Antonia Duran, Julian Gorrochategi, Juan Carlos Hernández‐Boluda, and Joaquín Martínez‐López

Subjects
combination therapy, myelofibrosis, nilotinib, prednisone, ruxolitinib, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Abstract This phase Ib, non‐randomized, open‐label study evaluates the safety and tolerability of ruxolitinib in combination with nilotinib and prednisone in patients with naïve or ruxolitinib‐resistant myelofibrosis (MF). A total of 15 patients with primary or secondary MF received the study treatment; 13 patients had received prior ruxolitinib treatment (86.7%). Eight patients completed seven cycles (53.3%) and six patients completed twelve cycles of treatment (40%). All the patients experienced at least one adverse event (AE) during the study (the most common AEs were hyperglycemia, asthenia, and thrombocytopenia), and 14 patients registered at least one treatment‐related AE (the most common treatment‐related AEs were hyperglycemia (22.2%; three grade 3 cases). Five treatment‐related serious AEs (SAEs) were reported in two patients (13.3%). No deaths were registered throughout the study. No dose‐limiting toxicity was observed. Four out of fifteen (27%) patients experienced a 100% spleen size reduction at Cycle 7, and two additional patients achieved a >50% spleen size reduction, representing an overall response rate of 40% at Cycle 7. In conclusion, the tolerability of this combination was acceptable, and hyperglycemia was the most frequent treatment‐related AE. Ruxolitinib in combination with nilotinib and prednisone showed relevant clinical activity in patients with MF. This trial was registered with EudraCT Number 2016‐005214‐21.

Published
2023
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5. CNL and aCML should be considered as a single entity based on molecular profiles and outcomes

Author

Carreño-Tarragona, Gonzalo, Álvarez-Larrán, Alberto, Harrison, Claire, Martínez-Ávila, José Carlos, Hernández-Boluda, Juan Carlos, Ferrer-Marín, Francisca, Radia, Deepti H., Mora, Elvira, Francis, Sebastian, González-Martínez, Teresa, Goddard, Kathryn, Pérez-Encinas, Manuel, Narayanan, Srinivasan, Raya, José María, Singh, Vikram, Gutiérrez, Xabier, Toth, Peter, Amat-Martínez, Paula, Mcilwaine, Louisa, Alobaidi, Magda, Mayani, Karan, McGregor, Andrew, Stuckey, Ruth, Psaila, Bethan, Segura, Adrián, Alvares, Caroline, Davidson, Kerri, Osorio, Santiago, Cutting, Robert, Sweeney, Caroline P., Rufián, Laura, Moreno, Laura, Cuenca, Isabel, Smith, Jeffery, Morales, María Luz, Gil-Manso, Rodrigo, Koutsavlis, Ioannis, Wang, Lihui, Mead, Adam J., Rozman, María, Martínez-López, Joaquín, Ayala, Rosa, and Cross, Nicholas C. P.

Published
2023
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6. Real-life analysis on safety and efficacy of asciminib for ponatinib pretreated patients with chronic myeloid leukemia

Author

Luna, A., Pérez-Lamas, L., Boque, C., Giraldo, P., Xicoy, B., Ruiz Nuño, C., Vega, M. Moreno, Alvarez-Larrán, A., Salamanca, A., García-Noblejas, A., Vall-Llovera, F., Villalon, L., De las Heras, N., Ramila, E., Pérez-Encinas, M., Cuevas, B., Perez-Lopez, R., Sanchez-Guijo, F., Jiménez-Velasco, A., Lakhwani, S., Casado, L. Felipe, Rosell, A., Escola, A., Fernández, M. J., Garcia-Hernandez, C., Cervero, C., Mora, E., Sagüés, M., Suarez-Varela, S., Vélez, P., Carrascosa Mastell, P., Bitaube, R. F., Serrano, L., Cortes, M., Vera Goñi, J.A, Steegmann, J. L., de Soria, V. Gomez Garcia, Alonso-Dominguez, J. M., Araujo, M. Colorado, Coll, A. Paz, Hernandez-Boluda, J.C, and García-Gutiérrez, V.

Published
2022
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7. Application of IPSET-thrombosis in 1366 Patients Prospectively Followed From the Spanish Registry of Essential Thrombocythemia

Author

Alberto Alvarez-Larrán, Beatriz Cuevas, Patricia Velez, Soledad Noya, Gonzalo Caballero-Navarro, Francisca Ferrer-Marín, Sara Carbonell, Manuel Pérez-Encinas, María Teresa Gómez-Casares, Raúl Pérez-López, Elena Magro, Ana Moretó, Irene Pastor-Galán, Anna Angona, María Isabel Mata-Vázquez, Lucía Guerrero-Fernández, José María Guerra, Gonzalo Carreño-Tarragona, Laura Fox, Ilda Murillo, Valentín García-Gutiérrez, Elvira Mora, Ruth Stuckey, Eduardo Arellano-Rodrigo, Juan Carlos Hernández-Boluda, Arturo Pereira, and On behalf of the MPN Spanish Group (GEMFIN)

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

The International Prognostic Score of thrombosis in Essential Thrombocythemia (IPSET-thrombosis) and its revised version have been proposed to guide thrombosis prevention strategies. We evaluated both classifications to prognosticate thrombosis in 1366 contemporary essential thrombocythemia (ET) patients prospectively followed from the Spanish Registry of ET. The cumulative incidence of thrombosis at 10 years, taking death as a competing risk, was 11.4%. The risk of thrombosis was significantly higher in the high-risk IPSET-thrombosis and high-risk revised IPSET-thrombosis, but no differences were observed among the lower risk categories. Patients allocated in high-risk IPSET-thrombosis (subdistribution hazard ratios [SHR], 3.7 [95% confidence interval, CI, 1.6-8.7]) and high-risk revised IPSET-thrombosis (SHR, 3.2 [95% CI, 1.4-7.45]) showed an increased risk of arterial thrombosis, whereas both scoring systems failed to predict venous thrombosis. The incidence rate of thrombosis in intermediate risk revised IPSET-thrombosis (aged >60 years, JAK2-negative, and no history of thrombosis) was very low regardless of the treatment administered (0.9% and 0% per year with and without cytoreduction, respectively). Dynamic application of the revised IPSET-thrombosis showed a low rate of thrombosis when patients without history of prior thrombosis switched to a higher risk category after reaching 60 years of age. In conclusion, IPSET-thrombosis scores are useful for identifying patients at high risk of arterial thrombosis, whereas they fail to predict venous thrombosis. Controlled studies are needed to determine the appropriate treatment of ET patients assigned to the non-high-risk categories.

Published
2023
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8. Appropriate management of polycythaemia vera with cytoreductive drug therapy: European LeukemiaNet 2021 recommendations

Author

Marchetti, Monia, Vannucchi, Alessandro Maria, Griesshammer, Martin, Harrison, Claire, Koschmieder, Steffen, Gisslinger, Heinz, Álvarez-Larrán, Alberto, De Stefano, Valerio, Guglielmelli, Paola, Palandri, Francesca, Passamonti, Francesco, Barosi, Giovanni, Silver, Richard T, Hehlmann, Rüdiger, Kiladjian, Jean-Jacques, and Barbui, Tiziano

Published
2022
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9. Managing hematological cancer patients during the COVID-19 pandemic: an ESMO-EHA Interdisciplinary Expert Consensus

Author

Buske, C., Dreyling, M., Alvarez-Larrán, A., Apperley, J., Arcaini, L., Besson, C., Bullinger, L., Corradini, P., Giovanni Della Porta, M., Dimopoulos, M., D’Sa, S., Eich, H.T., Foà, R., Ghia, P., da Silva, M.G., Gribben, J., Hajek, R., Harrison, C., Heuser, M., Kiesewetter, B., Kiladjian, J.J., Kröger, N., Moreau, P., Passweg, J.R., Peyvandi, F., Rea, D., Ribera, J.-M., Robak, T., San-Miguel, J.F., Santini, V., Sanz, G., Sonneveld, P., von Lilienfeld-Toal, M., Wendtner, C., Pentheroudakis, G., and Passamonti, F.

Published
2022
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13. Safety and efficacy of asciminib treatment in chronic myeloid leukemia patients in real-life clinical practice

Author

Valentín Garcia-Gutiérrez, Alejandro Luna, Juan M. Alonso-Dominguez, Natalia Estrada, Concepcion Boque, Blanca Xicoy, Pilar Giraldo, Anna Angona, Alberto Alvarez-Larrán, Fermin Sanchez-Guijo, María José Ramírez, Elvira Mora, Patricia Vélez, Ana Rosell, Mercedes Colorado Araujo, Beatriz Cuevas, Miguel Sagüés, Montserrat Cortes, Manuel Perez Encinas, Luis Felipe Casado Montero, Melania Moreno Vega, Luis Serrano, Valle Gomez, Carmen Garcia-Hernandez, Sunil Lakhwani, Antonio Paz Coll, Raquel de Paz, Sara Suarez-Varela, Andrés Fernandez-Ruiz, Raul Perez Lopez, Almudena Ortiz-Fernández, Antonio Jiménez-Velasco, Juan Luis Steegmann-Olmedillas, and Juan Carlos Hernández-Boluda

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Published
2021
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14. Predicting Survival after Allogeneic Hematopoietic Cell Transplantation in Myelofibrosis: Performance of the Myelofibrosis Transplant Scoring System (MTSS) and Development of a New Prognostic Model

Author

Hernández-Boluda, Juan-Carlos, Pereira, Arturo, Alvarez-Larran, Alberto, Martín, Ana-Africa, Benzaquen, Ana, Aguirre, Lourdes, Mora, Elvira, González, Pedro, Mora, Jorge, Dorado, Nieves, Sampol, Antonia, García-Gutiérrez, Valentín, López-Godino, Oriana, Fox, María-Laura, Reguera, Juan Luis, Pérez-Encinas, Manuel, Pascual, María-Jesús, Xicoy, Blanca, Parody, Rocío, González-Pinedo, Leslie, Español, Ignacio, Avendaño, Alejandro, Correa, Juan-Gonzalo, Vallejo, Carlos, Jurado, Manuel, García-Cadenas, Irene, Osorio, Santiago, Durán, María-Antonia, Sánchez-Guijo, Fermín, Cervantes, Francisco, and Piñana, José-Luis

Published
2020
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15. Clinico-biological characteristics of patients with myelofibrosis: an analysis of 1,000 cases from the Spanish Registry of Myelofibrosis

Author

Pastor-Galán, Irene, Hernández-Boluda, Juan Carlos, Correa, Juan-Gonzalo, Alvarez-Larrán, Alberto, Ferrer-Marín, Francisca, Raya, José María, Ayala, Rosa, Velez, Patricia, Pérez-Encinas, Manuel, Estrada, Natalia, García-Gutiérrez, Valentín, Fox, María Laura, Payer, Angel, Kerguelen, Ana, Cuevas, Beatriz, Durán, María Antonia, Ramírez, María José, Gómez-Casares, María Teresa, Mata-Vázquez, María Isabel, Mora, Elvira, Martínez-Valverde, Clara, Arbelo, Elisa, Angona, Anna, Magro, Elena, Antelo, María Luisa, Somolinos, Nieves, and Cervantes, Francisco

Published
2020
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16. Características clínico-biológicas de los pacientes con mielofibrosis: un análisis de 1.000 casos del Registro Español de Mielofibrosis

Author

Pastor-Galán, Irene, Hernández-Boluda, Juan Carlos, Correa, Juan-Gonzalo, Alvarez-Larrán, Alberto, Ferrer-Marín, Francisca, Raya, José María, Ayala, Rosa, Velez, Patricia, Pérez-Encinas, Manuel, Estrada, Natalia, García-Gutiérrez, Valentín, Fox, María Laura, Payer, Angel, Kerguelen, Ana, Cuevas, Beatriz, Durán, María Antonia, Ramírez, María José, Gómez-Casares, María Teresa, Mata-Vázquez, María Isabel, Mora, Elvira, Martínez-Valverde, Clara, Arbelo, Elisa, Angona, Anna, Magro, Elena, Antelo, María Luisa, Somolinos, Nieves, and Cervantes, Francisco

Published
2020
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17. miR-146a rs2431697 identifies myeloproliferative neoplasm patients with higher secondary myelofibrosis progression risk

Author

Ferrer-Marín, F., Arroyo, A. B., Bellosillo, B., Cuenca, E. J., Zamora, L., Hernández-Rivas, J. M., Hernández-Boluda, J. C., Fernandez-Rodriguez, C., Luño, E., García Hernandez, C., Kerguelen, A., Fiallo-Suárez, D. V., Gómez-Casares, M. T., Ayala, R., Vélez, P., Boqué, C., García-Gutierrez, V., Arrizabalaga, B., Estrada, N., Cifuentes, R., Arcas, I., de los Reyes-García, A. M., Besses, C., Vicente, V., Alvarez-Larrán, A., Teruel-Montoya, R., González-Conejero, R., and Martínez, C.

Published
2020
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18. P997: PROTEOMIC ANALYSIS ON PLATELETS OF ESSENTIAL THROMBOCYTHEMIA PATIENTS UNDERSCORES THE ROLE OF MITOCHONDRIA IN JAK2 V617F PLATELET REACTIVITY AND FUNCTION

Author

X. Guerrero-Carreño, S. Smits, A. Esteban Lasso, J. A. Escudero García, M. Samiotaki, A. Alvarez-Larrán, A. Angona, A. J. Sáen Marín, V. García Gutiérrez, D. Dekkers, J. Demmers, C. M. Benavente Cuesta, F. Ferrer-Marín, J. C. Hernández-Boluda, F. J. Iborra, I. M. De Cuyper, P. Vandenberghe, and P. Papadopoulos

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2022
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20. P1030: MANIFEST-2, A GLOBAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL STUDY OF PELABRESIB (CPI-0610) AND RUXOLITINIB VS PLACEBO AND RUXOLITINIB IN JAK INHIBITOR-NAÏVE MYELOFIBROSIS PATIENTS

Author

C. Harrison, R. K. Rampal, V. Gupta, S. Verstovsek, M. Talpaz, J.-J. Kiladjian, R. Mesa, A. Kuykendall, A. Vannucchi, F. Palandri, S. Grosicki, T. Devos, E. Jourdan, M. J. Wondergem, H. K. Al-Ali, V. Buxhofer-Ausch, A. Alvarez-Larrán, S. Akhani, R. Muñoz-Carerras, Y. Sheykin, G. Colak, M. Harris, and J. Mascarenhas

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2022
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21. Essential thrombocythaemia: A contemporary approach with new drugs on the horizon.

Author

Ferrer‐Marín, Francisca, Hernández‐Boluda, Juan Carlos, and Alvarez‐Larrán, Alberto

Subjects
MYELOFIBROSIS, MYELOPROLIFERATIVE neoplasms, ACUTE leukemia, DRUGS, EVIDENCE-based management, PROGNOSIS
Abstract

Summary: Essential thrombocythaemia (ET) is a myeloproliferative neoplasm characterized by an increased risk of vascular complications and a tendency to progress to myelofibrosis and acute leukaemia. ET patients have traditionally been stratified into two thrombosis risk categories based on age older than 60 years and a history of thrombosis. More recently, the revised IPSET‐thrombosis scoring system, which accounts for the increased risk linked to the JAK2 mutation, has been incorporated into most expert recommendations. However, there is increasing evidence that the term ET encompasses different genomic entities, each with a distinct clinical course and prognosis. Moreover, the effectiveness and toxicity of cytoreductive and anti‐platelet treatments differ depending on the molecular genotype. While anti‐platelets and conventional cytoreductive agents, mainly hydroxycarbamide (hydroxyurea), anagrelide and pegylated interferon, remain the cornerstone of treatment, recent research has shed light on the effectiveness of novel therapies that may help improve outcomes. This comprehensive review focuses on the evolving landscape of treatment strategies in ET, with an emphasis on the role of molecular profiling in guiding therapeutic decisions. Besides evidence‐based management according to revised IPSET‐thrombosis stratification, we also provide specific observations for those patients with CALR‐, MPL‐mutated and triple‐negative ET, as well as cases with high‐risk mutations. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Safety and efficacy of asciminib treatment in chronic myeloid leukemia patients in real-life clinical practice

Author

Garcia-Gutiérrez, Valentín, Luna, Alejandro, Alonso-Dominguez, Juan M., Estrada, Natalia, Boque, Concepcion, Xicoy, Blanca, Giraldo, Pilar, Angona, Anna, Alvarez-Larrán, Alberto, Sanchez-Guijo, Fermin, Ramírez, María José, Mora, Elvira, Vélez, Patricia, Rosell, Ana, Colorado Araujo, Mercedes, Cuevas, Beatriz, Sagüés, Miguel, Cortes, Montserrat, Encinas, Manuel Perez, Casado Montero, Luis Felipe, Moreno Vega, Melania, Serrano, Luis, Gomez, Valle, Garcia-Hernandez, Carmen, Lakhwani, Sunil, Paz Coll, Antonio, de Paz, Raquel, Suarez-Varela, Sara, Fernandez-Ruiz, Andrés, Perez Lopez, Raul, Ortiz-Fernández, Almudena, Jiménez-Velasco, Antonio, Steegmann-Olmedillas, Juan Luis, and Hernández-Boluda, Juan Carlos

Published
2021
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26. Prognostic risk models for transplant decision-making in myelofibrosis

Author

Hernández-Boluda, Juan-Carlos, Pereira, Arturo, Correa, Juan-Gonzalo, Alvarez-Larrán, Alberto, Ferrer-Marín, Francisca, Raya, José-María, Martínez-López, Joaquín, Velez, Patricia, Pérez-Encinas, Manuel, Estrada, Natalia, García-Gutiérrez, Valentín, Fox, María-Laura, Payer, Angel, Kerguelen, Ana, Cuevas, Beatriz, Durán, María-Antonia, Ramírez, María-José, Gómez-Casares, María-Teresa, Mata-Vázquez, María-Isabel, Mora, Elvira, Gómez, Montse, and Cervantes, Francisco

Published
2018
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27. Janus kinase inhibitor ruxolitinib in combination with nilotinib and prednisone in patients with myelofibrosis (RuNiC study): A phase Ib, multicenter study

Author

Ayala, Rosa, primary, Fernández, Rafael Alonso, additional, García‐Gutiérrez, Valentín, additional, Alvarez‐Larrán, Alberto, additional, Osorio, Santiago, additional, Sánchez‐Pina, Jose M., additional, Carreño‐Tarragona, Gonzalo, additional, Álvarez, Noemi, additional, Gómez‐Casares, María Teresa, additional, Duran, Antonia, additional, Gorrochategi, Julian, additional, Hernández‐Boluda, Juan Carlos, additional, and Martínez‐López, Joaquín, additional

Published
2023
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30. Toxicity of Asciminib in Real Clinical Practice: Analysis of Side Effects and Cross-Toxicity with Tyrosine Kinase Inhibitors

Author

Pérez-Lamas, Lucía, primary, Luna, Alejandro, additional, Boque, Concepción, additional, Xicoy, Blanca, additional, Giraldo, Pilar, additional, Pérez López, Raúl, additional, Ruiz Nuño, Concepción, additional, De las Heras, Natalia, additional, Mora Casterá, Elvira, additional, López Marín, Javier, additional, Segura Díaz, Adrián, additional, Gómez, Valle, additional, Vélez Tenza, Patricia, additional, Sierra Pacho, Magdalena, additional, Vera Goñi, Juan Antonio, additional, Moreno Vega, Melania, additional, Alvarez-Larrán, Alberto, additional, Cortés, Montse, additional, Pérez Encinas, Manuel, additional, Carrascosa Mastell, Patricia, additional, Angona, Anna, additional, Rosell, Ana, additional, Lakhwani, Sunil, additional, Colorado, Mercedes, additional, Ramila, Elena, additional, Cervero, Carlos, additional, Cuevas, Beatriz, additional, Villalón Blanco, Lucía, additional, de Paz, Raquel, additional, Paz Coll, Antonio, additional, Fernández, María José, additional, Felipe Casado, Luis, additional, Alonso-Domínguez, Juan Manuel, additional, Anguita Arance, María Magdalena, additional, Salamanca Cuenca, Araceli, additional, Jiménez-Velasco, Antonio, additional, Prendes, Santiago Osorio, additional, Santaliestra, Marta, additional, Lis Chulvi, María José, additional, Hernández-Boluda, Juan Carlos, additional, and García-Gutiérrez, Valentín, additional

Published
2023
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37. Toxicity of Asciminib in Real Clinical Practice: Analysis of Side Effects and Cross-Toxicity with Tyrosine Kinase Inhibitors

Author

Lucía Pérez-Lamas, Alejandro Luna, Concepción Boque, Blanca Xicoy, Pilar Giraldo, Raúl Pérez López, Concepción Ruiz Nuño, Natalia De las Heras, Elvira Mora Casterá, Javier López Marín, Adrián Segura Díaz, Valle Gómez, Patricia Vélez Tenza, Magdalena Sierra Pacho, Juan Antonio Vera Goñi, Melania Moreno Vega, Alberto Alvarez-Larrán, Montse Cortés, Manuel Pérez Encinas, Patricia Carrascosa Mastell, Anna Angona, Ana Rosell, Sunil Lakhwani, Mercedes Colorado, Elena Ramila, Carlos Cervero, Beatriz Cuevas, Lucía Villalón Blanco, Raquel de Paz, Antonio Paz Coll, María José Fernández, Luis Felipe Casado, Juan Manuel Alonso-Domínguez, María Magdalena Anguita Arance, Araceli Salamanca Cuenca, Antonio Jiménez-Velasco, Santiago Osorio Prendes, Marta Santaliestra, María José Lis Chulvi, Juan Carlos Hernández-Boluda, Valentín García-Gutiérrez, [Pérez-Lamas L, Luna A] Hospital Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain. [Boque C] Hospital Duran i Reynals-ICO, Barcelona, Spain. [Xicoy B] Josep Carreras Leukaemia Research Institute, ICO-Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain. [Giraldo P] Hospital Quirón Salud Zaragoza, Zaragoza, Spain. [Pérez López R] Hospital Virgen de la Arrixaca, Murcia, Spain. [Cortés M] Hospital General de Granollers, Granollers, Spain, and Hospital General de Granollers

Subjects
Cancer Research, acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas [COMPUESTOS QUÍMICOS Y DROGAS], Leucèmia mieloide, asciminib, Medicaments - Efectes secundaris, Chemically-Induced Disorders::Drug-Related Side Effects and Adverse Reactions [DISEASES], Chronic myeloid leukemia, toxicities, trastornos inducidos químicamente::efectos colaterales y reacciones adversas relacionados con medicamentos [ENFERMEDADES], Asciminib, Leucèmia mieloide crònica, Tiroxina - Inhibidors, Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors [CHEMICALS AND DRUGS], drug intolerance, Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Myeloid::Leukemia, Myelogenous, Chronic, BCR-ABL Positive [DISEASES], Drug intolerance, Myeloid leukemia, Oncology, chronic myeloid leukemia, Drug resistance, Toxicities, neoplasias::neoplasias por tipo histológico::leucemia::leucemia mieloide::leucemia mielogenosa crónica BCR-ABL positiva [ENFERMEDADES], Resistència als medicaments
Abstract

Simple Summary After the recent irruption of asciminib into the therapeutic arsenal for chronic myeloid leukemia, real-life data remain scarce to determine which patients may benefit most from this drug. Data on the efficacy of the drug in real-world setting have been reported, but a detailed analysis of the toxicity profile and the influence of prior intolerance to classical tyrosine kinase inhibitors (TKIs) has not been performed. The aim of the present analysis is to study in detail the toxicity profile of asciminib as well as to describe the risk of cross-toxicity with classical TKIs. These results may help to select the patient profile with the best chance of therapeutic success with asciminib monotherapy. (1) Background: Despite the prognostic improvements achieved with tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML), a minority of patients still fail TKIs. The recent introduction of asciminib may be a promising option in intolerant patients, as it is a first-in-class inhibitor with a more selective mechanism of action different from the ATP-competitive inhibition that occurs with TKIs. Therefore, our goal was to analyze toxicities shown with asciminib as well as to study cross-toxicity with previous TKIs. (2) Methods: An observational, multicenter, retrospective study was performed with data from 77 patients with CML with therapeutic failure to second-generation TKIs who received asciminib through a managed-access program (MAP) (3) Results: With a median follow-up of 13.7 months, 22 patients (28.5%) discontinued treatment: 32% (7/22) due to intolerance and 45% (10/22) due to resistance. Fifty-five percent of the patients reported adverse effects (AEs) with asciminib and eighteen percent grade 3-4. Most frequent AEs were: fatigue (18%), thrombocytopenia (17%), anemia (12%), and arthralgias (12%). None of the patients experienced cardiovascular events or occlusive arterial disease. Further, 26%, 25%, and 9% of patients required dose adjustment, temporary suspension, or definitive discontinuation of treatment, respectively. Toxicities under asciminib seemed lower than with prior TKIs for anemia, cardiovascular events, pleural/pericardial effusion, diarrhea, and edema. Cross-toxicity risk was statistically significant for thrombocytopenia, anemia, neutropenia, fatigue, vomiting, and pancreatitis. (4) Conclusion: Asciminib is a molecule with a good safety profile and with a low rate of AEs. However, despite its new mechanism of action, asciminib presents a risk of cross-toxicity with classical TKIs for some AEs.

Published
2023

38. Real-world analysis of main clinical outcomes in patients with polycythemia vera treated with ruxolitinib or best available therapy after developing resistance/intolerance to hydroxyurea

Author

Alvarez-Larrán, Alberto, Garrote, Marta, Ferrer-Marín, Francisca, Pérez-Encinas, Manuel, Mata-Vazquez, M Isabel, Bellosillo, Beatriz, Arellano-Rodrigo, Eduardo, Gómez, Montse, García, Regina, García-Gutiérrez, Valentín, Gasior, Mercedes, Cuevas, Beatriz, Angona, Anna, Gómez-Casares, María Teresa, Martínez, Clara M, Magro, Elena, Ayala, Rosa, Del Orbe-Barreto, Rafael, Pérez-López, Raúl, Fox, Maria Laura, Raya, José-María, Guerrero, Lucía, García-Hernández, Carmen, Caballero, Gonzalo, Murillo, Ilda, Xicoy, Blanca, Ramírez, M José, Carreño-Tarragona, Gonzalo, Hernández-Boluda, Juan Carlos, Pereira, Arturo, MPN Spanish Group (Grupo Español de Enfermedades Mieloproliferativas Filadelfia Negativas), Institut Català de la Salut, [Alvarez-Larrán A, Garrote M] Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. [Ferrer-Marín F] Hospital Morales Messeguer, Universidad Católica San Antonio de Murcia, Murcia, Centro de Investigación Biomédica en Red de Enfermedades Raras, Murcia, Spain. [Pérez-Encinas M] Hospital Clínico Universitario, Santiago de Compostela, Spain. [Mata-Vazquez MI] Hospital Costa del Sol, Marbella, Spain. [Bellosillo B] Hospital del Mar, Barcelona, Spain. [Fox ML] Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Cancer Research, Medicaments antineoplàstics - Ús terapèutic, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Myelofibrosis, Hemorrhage, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores], Myeloproliferative neoplasms, neoplasias::neoplasias por localización::neoplasias hematológicas::neoplasias de la médula ósea::policitemia vera [ENFERMEDADES], Nitriles, Other subheadings::Other subheadings::/adverse effects [Other subheadings], Humans, Hydroxyurea, Retrospective Studies, Neoplasms::Neoplasms by Site::Hematologic Neoplasms::Bone Marrow Neoplasms::Polycythemia Vera [DISEASES], acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos [COMPUESTOS QUÍMICOS Y DROGAS], diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Neoplasms, Second Primary, Thrombosis, Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Polycythemia vera, Leukemia, Myeloid, Acute, Pyrimidines, Ruxolitinib, Oncology, Policitèmia - Tractament, Primary Myelofibrosis, Avaluació de resultats (Assistència sanitària), Pyrazoles, Therapy, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents [CHEMICALS AND DRUGS]
Abstract

Altres ajuts: Novartis. Background: Ruxolitinib is approved for patients with polycythemia vera (PV) who are resistant/intolerant to hydroxyurea, but its impact on preventing thrombosis or disease-progression is unknown. Methods: A retrospective, real-world analysis was performed on the outcomes of 377 patients with resistance/intolerance to hydroxyurea from the Spanish Registry of Polycythemia Vera according to subsequent treatment with ruxolitinib (n = 105) or the best available therapy (BAT; n = 272). Survival probabilities and rates of thrombosis, hemorrhage, acute myeloid leukemia, myelofibrosis, and second primary cancers were calculated according to treatment. To minimize biases in treatment allocation, all results were adjusted by a propensity score for receiving ruxolitinib or BAT. Results: Patients receiving ruxolitinib had a significantly lower rate of arterial thrombosis than those on BAT (0.4% vs 2.3% per year; P =.03), and this persisted as a trend after adjustment for the propensity to have received the drug (incidence rate ratio, 0.18; 95% confidence interval, 0.02-1.3; P =.09). There were no significant differences in the rates of venous thrombosis (0.8% and 1.1% for ruxolitinib and BAT, respectively; P =.7) and major bleeding (0.8% and 0.9%, respectively; P =.9). Ruxolitinib exposure was not associated with a higher rate of second primary cancers, including all types of neoplasia, noncutaneous cancers, and nonmelanoma skin cancers. After a median follow-up of 3.5 years, there were no differences in survival or progression to acute leukemia or myelofibrosis between the 2 groups. Conclusions: The results suggest that ruxolitinib treatment for PV patients with resistance/intolerance to hydroxyurea may reduce the incidence of arterial thrombosis. Lay Summary: Ruxolitinib is better than other available therapies in achieving hematocrit control and symptom relief in patients with polycythemia vera who are resistant/intolerant to hydroxyurea, but we still do not know whether ruxolitinib provides an additional benefit in preventing thrombosis or disease progression. We retrospectively studied the outcomes of 377 patients with resistance/intolerance to hydroxyurea from the Spanish Registry of Polycythemia Vera according to whether they subsequently received ruxolitinib (n = 105) or the best available therapy (n = 272). Our findings suggest that ruxolitinib could reduce the incidence of arterial thrombosis, but a disease-modifying effect could not be demonstrated for ruxolitinib in this patient population.

Published
2022

39. Autoimmune biomarkers in porto‐sinusoidal vascular disease: Potential role in its diagnosis and pathophysiology

Author

Alba Díaz, Genís Campreciós, Eira Cerda Reyes, Valeria Perez-Campuzano, Marta Magaz, Gilberto Silva-Junior, Laura Rubio, Ana Triguero, Alberto Alvarez-Larrán, Guillermo Muñoz-Sánchez, Virginia Hernández-Gea, Erica Lafoz, Manel Juan, Lara Orts, Anna Baiges, Susana Seijo, Juan Carlos García-Pagán, Europa Azucena González-Navarro, and Fanny Turon

Subjects
Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, Population, medicine.disease_cause, Gastroenterology, Autoimmunity, Internal medicine, Hypertension, Portal, medicine, Humans, Vascular Diseases, education, Autoantibodies, education.field_of_study, Hepatology, Vascular disease, business.industry, Autoantibody, medicine.disease, Pathophysiology, Splenomegaly, Portal hypertension, Liver function, business, Biomarkers
Abstract

BACKGROUND AND AIMS Porto-sinusoidal vascular disease (PSVD) is a rare disease that requires excluding cirrhosis and other causes of portal hypertension for its diagnosis because it lacks a specific diagnostical test. Although it has been occasionally associated with autoimmune diseases, the pathophysiology of PSVD remains unknown. The aim of this study was to evaluate the potential role of autoimmunity in the pathophysiology and diagnosis of PSVD. METHODS Thirty-seven consecutive patients with PSVD and 39 with cirrhosis matched by gender, signs of portal hypertension and liver function were included (training set). By using Indirect Immunofluorescence, ELISA and slot-blot methods data 22 autoantibodies were identified in patients with PSVD and cirrhosis. Presence of anti-endothelial cells antibodies (AECA) was assayed by a cell-based ELISA. Thirty-one PSVD, 40 cirrhosis patients, 15 patients with splenomegaly associated with haematological disease and 14 healthy donors were included in a validation set. FINDINGS The proportion of patients with at least one positive antibody was statistically significantly higher in patients with PSVD compared with cirrhosis (92% vs 56%; P

Published
2021
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40. Application of IPSET‐thrombosis in 1366 Patients Prospectively Followed From the Spanish Registry of Essential Thrombocythemia.

Author

Alvarez‐Larrán, Alberto, Cuevas, Beatriz, Velez, Patricia, Noya, Soledad, Caballero‐Navarro, Gonzalo, Ferrer‐Marín, Francisca, Carbonell, Sara, Pérez‐Encinas, Manuel, Gómez‐Casares, María Teresa, Pérez‐López, Raúl, Magro, Elena, Moretó, Ana, Pastor‐Galán, Irene, Angona, Anna, Mata‐Vázquez, María Isabel, Guerrero‐Fernández, Lucía, Guerra, José María, Carreño‐Tarragona, Gonzalo, Fox, Laura, and Murillo, Ilda

Published
2023
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41. Risk of thrombosis according to need of phlebotomies in patients with polycythemia vera treated with hydroxyurea

Author

Alberto Alvarez-Larrán, Manuel Pérez-Encinas, Francisca Ferrer-Marín, Juan Carlos Hernández-Boluda, María José Ramírez, Joaquín Martínez-López, Elena Magro, Yasmina Cruz, María Isabel Mata, Pilar Aragües, María Laura Fox, Beatriz Cuevas, Sara Montesdeoca, José Angel Hernández-Rivas, Valentín García-Gutiérrez, María Teresa Gómez-Casares, Juan Luis Steegmann, María Antonia Durán, Montse Gómez, Ana Kerguelen, Abelardo Bárez, Mari Carmen García, Concepción Boqué, José María Raya, Clara Martínez, Manuel Albors, Francesc García, Carmen Burgaleta, and Carlos Besses

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Hematocrit control below 45% is associated with a lower rate of thrombosis in polycythemia vera. In patients receiving hydroxyurea, this target can be achieved with hydroxyurea alone or with the combination of hydroxyurea plus phlebotomies. However, the clinical implications of phlebotomy requirement under hydroxyurea therapy are unknown. The aim of this study was to evaluate the need for additional phlebotomies during the first five years of hydroxyurea therapy in 533 patients with polycythemia vera. Patients requiring 3 or more phlebotomies per year (n=85, 16%) showed a worse hematocrit control than those requiring 2 or less phlebotomies per year (n=448, 84%). There were no significant differences between the two study groups regarding leukocyte and platelet counts. Patients requiring 3 or more phlebotomies per year received significantly higher doses of hydroxyurea than the remaining patients. A significant higher rate of thrombosis was found in patients treated with hydroxyurea plus 3 or more phlebotomies per year compared to hydroxyurea with 0–2 phlebotomies per year (20.5% vs. 5.3% at 3 years; P

Published
2017
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43. High rate of recurrent venous thromboembolism in patients with myeloproliferative neoplasms and effect of prophylaxis with vitamin K antagonists

Author

De Stefano, V, Ruggeri, M, Cervantes, F, Alvarez-Larrán, A, Iurlo, A, Randi, M L, Elli, E, Finazzi, M C, Finazzi, G, Zetterberg, E, Vianelli, N, Gaidano, G, Rossi, E, Betti, S, Nichele, I, Cattaneo, D, Palova, M, Ellis, M H, Cacciola, R, Tieghi, A, Hernandez-Boluda, J C, Pungolino, E, Specchia, G, Rapezzi, D, Forcina, A, Musolino, C, Carobbio, A, Griesshammer, M, Sant’Antonio, E, Vannucchi, A M, and Barbui, T

Published
2016
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44. Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis

Author

Harrison, Claire N, primary, Gupta, Vikas K, additional, Gerds, Aaron T, additional, Rampal, Raajit, additional, Verstovsek, Srdan, additional, Talpaz, Moshe, additional, Kiladjian, Jean-Jacques, additional, Mesa, Ruben, additional, Kuykendall, Andrew T, additional, Vannucchi, Alessandro M, additional, Palandri, Francesca, additional, Grosicki, Sebastian, additional, Devos, Timothy, additional, Jourdan, Eric, additional, Wondergem, Marielle J, additional, Al-Ali, Haifa Kathrin, additional, Buxhofer-Ausch, Veronika, additional, Alvarez-Larrán, Alberto, additional, Patriarca, Andrea, additional, Kremyanskaya, Marina, additional, Mead, Adam J, additional, Akhani, Sanjay, additional, Sheikine, Yuri, additional, Colak, Gozde, additional, and Mascarenhas, John, additional

Published
2022
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45. Protection Against Breakthrough Delta/Omicron Variants in Vaccinated Patients with Myeloproliferative Neoplasms (MPN)

Author

Barbui, Tiziano, Carobbio, Alessandra, Ghirardi, Arianna, Iurlo, Alessandra, De Stefano, Valerio, Sobas, Marta Anna, Rumi, Elisa, Elli, Elena Maria, Lunghi, Francesca, Gasior Kabat, Mercedes, Cuevas, Beatriz, Guglielmelli, Paola, Bonifacio, Massimiliano, Marchetti, Monia, Alvarez-Larran, Alberto, Fox, Laura Maria, Bellini, Marta, Daffini, Rosa, Benevolo, Giulia, Carreño, Gonzalo, Patriarca, Andrea, Al-Ali, Haifa Kathrin, Andrade, Marcio, Palandri, Francesca, Harrison, Claire, Foncillas, Maria Angeles, Osorio, Santiago, Koschmieder, Steffen, Magro, Elena, Kiladjian, Jean-Jacques, Bolaños, Estefanía, Heidel, Florian H., Quiroz, Keina, Griesshammer, Martin, García Gutiérrez, Valentín, Marin Sanchez, Alberto, Hernandez Boluda, Juan Carlos, Lopez Abadia, Emma, Carli, Giuseppe, Sagüés, Miguel, Kusec, Rajko, Xicoy, Blanca, Guenova, Margarita, Navas, Begoña, Angona, Anna, Cichocka, Edyta, Masternak, Anna, Cattaneo, Daniele, Bucelli, Cristina, Betti, Silvia, Borsani, Oscar, Cavalca, Fabrizio, Carbonell, Sara, Curto-Garcia, Natalia, Benajiba, Lina, Rambaldi, Alessandro, and Vannucchi, Alessandro M.

Published
2022
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46. Coexisting Myeloproliferative and Lymphoproliferative Neoplasms: A European Multicenter Retrospective Study

Author

Fiallo Suarez, Dolly Viviana Viviana, Stuckey, Ruth, Bilbao, Cristina, Tapia Torres, Maria, Lemes Castellano, Maria Angelina, Fernández-Fuertes, Fernando, Pérez-Ortiz, Leonor, Borsani, Oscar, Rumi, Elisa, Ianotto, Jean-Christophe, Ferrer Marin, Francisca, Gasior Kabat, Mercedes, Cuevas, Beatriz, Lewandowski, Krzysztof, Alvarez-Larran, Alberto, Sobas, Marta Anna, Santoro, Marco, Foncillas, María Ángeles, Drozd-Sokolowska, Joanna, Kandula, Zuzanna, Hernandez Boluda, Juan Carlos, Angona, Anna, Carreño, Gonzalo, Senin, María Alicia, Mata Vazquez, Maria Isabel, Fox, Maria Laura, Del Orbe, Rafael, Velez Tenza, Patricia, Vallansot, Rolando, and Gómez-Casares, María Teresa

Published
2022
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47. Toxicity of Asciminib in Real Clinical Practice; Analysis of Side Effects and Cross-Intolerance with Tyrosine Kinase Inhibitors

Author

Pérez-Lamas, Lucía, Luna, Alejandro, Boque, Concepcion, Senin, María Alicia, Xicoy, Blanca, Giraldo, Pilar, Perez Lopez, Raul, Ruiz Nuño, Concepción, De las Heras, Natalia, Mora Casterá, Elvira, Garcia-Hernandez, Carmen, Segura Diaz, Adrian, Steegmann, Juan Luis, Velez Tenza, Patricia, Sanchez-Guijo, Fermin, Garcia-Noblejas Moya, Ana Maria, Juan Vera Goñi, Juan Antonio, Moreno Vega, Melania, Alvarez-Larran, Alberto, Cortes, Montse, Perez Encinas, Manuel, Serrano, Luis, Angona, Anna, Rosell, Ana, Lakhwani, Sunil, Colorado, Mercedes, Ramila, Elena, Cervero, Carlos, Cuevas, Beatriz, Villalon Blanco, Lucia, Hernandez Boluda, Juan Carlos, Paz Coll, Antonio, Gómez García de Soria, Valle, Fernández, Maria Jose, Casado, Luis Felipe, Alonso-Dominguez, Juan Manuel, Anguita Arance, Maria Magdalena, Carrascosa Mastell, Patricia, Salamanca Cuenca, Araceli, Jiménez-Velasco, Antonio, Ramírez, María José, López Esteban, Miguel, Sierra Pacho, Magdalena, Santaliestra, Marta, Alda Alvarez, Olga, de Paz, Raquel, and García Gutiérrez, Valentín

Published
2022
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48. Risk of Progression in Chronic Phase-Chronic Myeloid Leukemia (CML) Patients Eligible for Tyrosine Kinase Inhibitor Discontinuation: The Tfr-PRO Study

Author

Zambrotta, Giovanni, Assouline, Sarit, Nicolini, Franck E., Abruzzese, Elisabetta, Miggiano, Maria Cristina, Elena, Chiara, Alvarez-Larran, Alberto, Triguero, Ana, Iurlo, Alessandra, Bucelli, Cristina, Lunghi, Francesca, Capodanno, Isabella, Maffioli, Margherita, Galimberti, Sara, Caocci, Giovanni, Stagno, Fabio, Saussele, Susanne, Fava, Carmen, le Coutre, Philipp, Bonifacio, Massimiliano, Guglielmana, Veronica, Colombo, Federica, Antolini, Laura, and Gambacorti-Passerini, Carlo

Published
2022
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