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1. 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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2. 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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3. 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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4. 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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5. 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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6. 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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7. 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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8. 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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10. 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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11. 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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13. 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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15. 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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16. 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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18. 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

19. 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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20. 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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21. 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

22. 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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23. 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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24. 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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25. 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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27. 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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29. Oral anticoagulation to prevent thrombosis recurrence in polycythemia vera and essential thrombocythemia

Author

Hernández-Boluda, Juan-Carlos, Arellano-Rodrigo, Eduardo, Cervantes, Francisco, Alvarez-Larrán, Alberto, Gómez, Montse, Barba, Pere, Mata, María-Isabel, González-Porras, José-Ramón, Ferrer-Marín, Francisca, García-Gutiérrez, Valentín, Magro, Elena, Moreno, Melania, Kerguelen, Ana, Pérez-Encinas, Manuel, Estrada, Natàlia, Ayala, Rosa, Besses, Carles, Pereira, Arturo, and on behalf of the Grupo Español de Enfermedades Mieloproliferativas Filadelfia Negativas (GEMFIN)

Published
2015
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30. A polymorphism in the XPD gene predisposes to leukemic transformation and new nonmyeloid malignancies in essential thrombocythemia and polycythemia vera

Author

Hernández-Boluda, Juan-Carlos, Pereira, Arturo, Cervantes, Francisco, Alvarez-Larrán, Alberto, Collado, María, Such, Esperanza, Arilla, M. Jesús, Boqué, Concepción, Xicoy, Blanca, Maffioli, Margherita, Bellosillo, Beatriz, Marugán, Isabel, Amat, Paula, Besses, Carles, and Guillem, Vicent

Published
2012
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31. 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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32. Assessment and prognostic value of the European LeukemiaNet criteria for clinicohematologic response, resistance, and intolerance to hydroxyurea in polycythemia vera

Author

Alvarez-Larrán, Alberto, Pereira, Arturo, Cervantes, Francisco, Arellano-Rodrigo, Eduardo, Hernández-Boluda, Juan-Carlos, Ferrer-Marín, Francisca, Angona, Anna, Gómez, Montse, Muiña, Begoña, Guillén, Helga, Teruel, Anabel, Bellosillo, Beatriz, Burgaleta, Carmen, Vicente, Vicente, and Besses, Carles

Published
2012
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33. High mortality rate in COVID-19 patients with myeloproliferative neoplasms after abrupt withdrawal of ruxolitinib

Author

Rosa Daffini, Gonzalo Carreño-Tarragona, Paola Guglielmelli, Arianna Masciulli, Maria Laura Fox, Claire N. Harrison, Daniele Cattaneo, Beatriz Bellosillo, Petros Papadopoulos, Beatriz Cuevas, Maria Angeles Foncillas, Anna Angona, Alberto Ferrari, Valentín García-Gutiérrez, Arianna Ghirardi, Andrea Patriarca, Elena Maria Elli, Juan Carlos Hernández-Boluda, Tiziano Barbui, Silvia Betti, Valerio De Stefano, Giuseppe Rossi, Marta Bellini, Carmen Montoya Morcillo, Marta Sobas, Miguel Sagues Serrano, Fabrizio Cavalca, Lina Benajiba, Francesca Palandri, Emma Lopez Abadia, Marta Garrote, Alberto Alvarez-Larrán, Natalia Curto-Garcia, Mercedes Gasior Kabat, Alessandra Carobbio, Marcio Andrade-Campos, Francesca Lunghi, Marco Ruggeri, Jean-Jaques Kiladjian, Begona Navas Elorza, Elena Magro Mazo, Elisa Rumi, Giulia Benevolo, Alessandro Rambaldi, Alessandra Iurlo, Blanca Xicoy Cirici, Alessandro M. Vannucchi, Keina Susana Quiroz Cervantes, Massimiliano Bonifacio, Steffen Koschmieder, and Santiago Osorio

Subjects
0301 basic medicine, Cancer Research, medicine.medical_specialty, Ruxolitinib, Population, Article, Myeloproliferative disease, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Risk of mortality, Medicine, education, Myelofibrosis, Survival rate, education.field_of_study, Univariate analysis, business.industry, Essential thrombocythemia, Mortality rate, Hematology, medicine.disease, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Infectious diseases, business, medicine.drug
Abstract

We report the clinical presentation and risk factors for survival in 175 patients with myeloproliferative neoplasms (MPN) and COVID-19, diagnosed between February and June 2020. After a median follow-up of 50 days, mortality was higher than in the general population and reached 48% in myelofibrosis (MF). Univariate analysis, showed a significant relationship between death and age, male gender, decreased lymphocyte counts, need for respiratory support, comorbidities and diagnosis of MF, while no association with essential thrombocythemia (ET), polycythemia vera (PV), and prefibrotic-PMF (pre-PMF) was found. Regarding MPN-directed therapy ongoing at the time of COVID-19 diagnosis, Ruxolitinib (Ruxo) was significantly more frequent in patients who died in comparison with survivors (p=0.006). Conversely, multivariable analysis found no effect of Ruxo alone on mortality, but highlighted an increased risk of death in the 11 out of 45 patients who discontinued treatment. These findings were also confirmed in a propensity score matching analysis. In conclusion, we found a high risk of mortality during COVID-19 infection among MPN patients, especially in MF patients and/or discontinuing Ruxo at COVID-19 diagnosis. These findings call for deeper investigation on the role of Ruxo treatment and its interruption, in affecting mortality in MPN patients with COVID-19.

Published
2021
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34. 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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35. Antiplatelet therapy versus observation in low-risk essential thrombocythemia with a CALR mutation

Author

Alberto Alvarez-Larrán, Arturo Pereira, Paola Guglielmelli, Juan Carlos Hernández-Boluda, Eduardo Arellano-Rodrigo, Francisca Ferrer-Marín, Alimam Samah, Martin Griesshammer, Ana Kerguelen, Bjorn Andreasson, Carmen Burgaleta, Jiri Schwarz, Valentín García-Gutiérrez, Rosa Ayala, Pere Barba, María Teresa Gómez-Casares, Chiara Paoli, Beatrice Drexler, Sonja Zweegman, Mary F. McMullin, Jan Samuelsson, Claire Harrison, Francisco Cervantes, Alessandro M. Vannucchi, and Carlos Besses

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

The role of antiplatelet therapy as primary prophylaxis of thrombosis in low-risk essential thrombocythemia has not been studied in randomized clinical trials. We assessed the benefit/risk of low-dose aspirin in 433 patients with low-risk essential thrombocythemia (271 with a CALR mutation, 162 with a JAK2V617F mutation) who were on antiplatelet therapy or observation only. After a follow up of 2215 person-years free from cytoreduction, 25 thrombotic and 17 bleeding episodes were recorded. In CALR-mutated patients, antiplatelet therapy did not affect the risk of thrombosis but was associated with a higher incidence of bleeding (12.9 versus 1.8 episodes per 1000 patient-years, P=0.03). In JAK2V617F-mutated patients, low-dose aspirin was associated with a reduced incidence of venous thrombosis with no effect on the risk of bleeding. Coexistence of JAK2V617F-mutation and cardiovascular risk factors increased the risk of thrombosis, even after adjusting for treatment with low-dose aspirin (incidence rate ratio: 9.8; 95% confidence interval: 2.3–42.3; P=0.02). Time free from cytoreduction was significantly shorter in CALR-mutated patients with essential thrombocythemia than in JAK2V617F-mutated ones (median time 5 years and 9.8 years, respectively; P=0.0002) and cytoreduction was usually necessary to control extreme thrombocytosis. In conclusion, in patients with low-risk, CALR-mutated essential thrombocythemia, low-dose aspirin does not reduce the risk of thrombosis and may increase the risk of bleeding.

Published
2016
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36. Clinico-biological characteristics of patients with myelofibrosis: an analysis of 1,000 cases from the Spanish Registry of Myelofibrosis

Author

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

Subjects
Moderate to severe, Pediatrics, medicine.medical_specialty, Constitutional symptoms, business.industry, medicine.disease, Transplantation, 03 medical and health sciences, 0302 clinical medicine, Chronic Myeloproliferative Neoplasm, Clinical heterogeneity, medicine, Elderly people, 030212 general & internal medicine, Myelofibrosis, business, Prognostic models
Abstract

BACKGROUND AND OBJECTIVE MYELOFIBROSIS: is an infrequent chronic myeloproliferative neoplasm. We aimed to describe the clinico-biological characteristics, treatment, and evolutive course of myelofibrosis patients in Spain.; MATERIAL AND METHODS: A total of 1,000 patients from the Spanish Registry of Myelofibrosis diagnosed with primary (n=641) or secondary (n=359) myelofibrosis were analysed.; RESULTS: Median age was 68 years. The frequency of constitutional symptoms, moderate to severe anaemia (Hb

Published
2020
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37. Genomic characterization of patients with polycythemia vera developing resistance to hydroxyurea

Author

Alvarez-Larrán, Alberto, Díaz-González, Alvaro, Such, Esperanza, Mora, Elvira, Andrade-Campos, Marcio, García-Hernández, Carmen, Gómez-Casares, Maria-Teresa, García-Gutiérrez, Valentín, Carreño-Tarragona, Gonzalo, Garrote, Marta, Fernández-Ibarrondo, Lierni, Cervera, José, Bellosillo Paricio, Beatriz, Cervantes, Francisco, Hernández-Boluda, Juan Carlos, and MPN Spanish Group (GEMFIN)

Subjects
Cancer Research, Letter, Trastorns mieloproliferatius, business.industry, Policitèmia, Antineoplastic Agents, Genomics, Hematology, Prognosis, medicine.disease, Bioinformatics, Gene Expression Regulation, Neoplastic, Survival Rate, Myeloproliferative disease, Polycythemia vera, Oncology, Drug Resistance, Neoplasm, Biomarkers, Tumor, medicine, Humans, Hydroxyurea, business, Polycythemia Vera, Cancer genetics, Genètica
Abstract

Data de publicació electrónica: 05-05-2020

Published
2020
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38. 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. Passamonti, F. and 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. Passamonti, F.

Abstract

Background: The COVID-19 pandemic has created enormous challenges for the clinical management of patients with hematological malignancies (HMs), raising questions about the optimal care of this patient group. Methods: This consensus manuscript aims at discussing clinical evidence and providing expert advice on statements related to the management of HMs in the COVID-19 pandemic. For this purpose, an international consortium was established including a steering committee, which prepared six working packages addressing significant clinical questions from the COVID-19 diagnosis, treatment, and mitigation strategies to specific HMs management in the pandemic. During a virtual consensus meeting, including global experts and lead by the European Society for Medical Oncology and the European Hematology Association, statements were discussed and voted upon. When a consensus could not be reached, the panel revised statements to develop consensual clinical guidance. Results and conclusion: The expert panel agreed on 33 statements, reflecting a consensus, which will guide clinical decision making for patients with hematological neoplasms during the COVID-19 pandemic. © 2022 The Authors

Published
2022

39. 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., Passamonti, F., 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.

Abstract

Background: The COVID-19 pandemic has created enormous challenges for the clinical management of patients with hematological malignancies (HMs), raising questions about the optimal care of this patient group. Methods: This consensus manuscript aims at discussing clinical evidence and providing expert advice on statements related to the management of HMs in the COVID-19 pandemic. For this purpose, an international consortium was established including a steering committee, which prepared six working packages addressing significant clinical questions from the COVID-19 diagnosis, treatment, and mitigation strategies to specific HMs management in the pandemic. During a virtual consensus meeting, including global experts and lead by the European Society for Medical Oncology and the European Hematology Association, statements were discussed and voted upon. When a consensus could not be reached, the panel revised statements to develop consensual clinical guidance. Results and conclusion: The expert panel agreed on 33 statements, reflecting a consensus, which will guide clinical decision making for patients with hematological neoplasms during the COVID-19 pandemic.

Published
2022

40. Impact of ruxolitinib on survival of patients with myelofibrosis in the real world: update of the ERNEST Study

Author

Guglielmelli, Paola, Ghirardi, Arianna, Carobbio, Alessandra, Masciulli, Arianna, Maccari, Chiara, Mora, Barbara, Rumi, Elisa, Triguero, Ana, Finazzi, Maria Chiara, Pettersson, Helna, Paoli, Chiara, Mannelli, Francesco, Vanni, Daniele, Rambaldi, Alessandro, Passamonti, Francesco, Alvarez-Larràn, Alberto, Andreasson, Bjorn, Vannucchi, Alessandro M., and Barbui, Tiziano

Published
2022
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41. 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

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

Published
2022
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42. P997: PROTEOMIC ANALYSIS ON PLATELETS OF ESSENTIAL THROMBOCYTHEMIA PATIENTS UNDERSCORES THE ROLE OF MITOCHONDRIA IN JAK2 V617F PLATELET REACTIVITY AND FUNCTION

Author

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

Published
2022
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43. P1026: COMPARATIVE GENOMIC PROFILING OF MYELOPROLIFERATIVE NEOPLASMS PRESENTING WITH AND WITHOUT SPLANCHNIC VEIN THROMBOSIS

Author

Garrote, M., primary, López-Guerra, M., additional, Arellano-Rodrigo, E., additional, Magaz, M., additional, Triguero, A., additional, Carbonell, S., additional, Alamo, J. R., additional, Turon, F., additional, Hernandez-Gea, V., additional, Baiges, A., additional, Colomer, D., additional, García-Pagán, J. C., additional, Cervantes, F., additional, and Alvarez-Larrán, A., additional

Published
2022
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44. Busulfan in patients with polycythemia vera or essential thrombocythemia refractory or intolerant to hydroxyurea

Author

Alvarez-Larrán, Alberto, Martínez-Avilés, Luz, Hernández-Boluda, Juan Carlos, Ferrer-Marín, Francisca, Antelo, María Luisa, Burgaleta, Carmen, Mata, M. Isabel, Xicoy, Blanca, Martínez-Trillos, Alejandra, Gómez-Casares, M. Teresa, Durán, M. Antonia, Marcote, Bárbara, Ancochea, Agueda, Senín, Alicia, Angona, Anna, Gómez, Montse, Vicente, Vicente, Cervantes, Francisco, Bellosillo, Beatriz, and Besses, Carles

Published
2014
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48. Natural killer cell receptors and ligand variants modulate response to tyrosine kinase inhibitors in patients with chronic myeloid leukemia

Author

Laia Closa, Blanca Xicoy, Lurdes Zamora, Natalia Estrada, Dolors Colomer, Maria J. Herrero, Francisco Vidal, Alberto Alvarez‐Larrán, and Jose L. Caro

Subjects
natural killer cells, Immunology, Ligands, NKG2D, HLA, chronic myeloid leukemia, NK Cell Lectin-Like Receptor Subfamily K, MICA, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, killer cell immunoglobulin receptors, Genetics, Immunology and Allergy, Humans, Receptors, Natural Killer Cell, Protein Kinase Inhibitors, Alleles, Retrospective Studies
Abstract

Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm treated with tyrosine kinase inhibitors (TKIs). Although survival rates have improved, response to these treatments is highly heterogeneous. Variations in response rates may be due to different causes such as, treatment adherence, mutations in the BCR-ABL1 gene, clonal evolution and amplification of the BCR-ABL1 gene, but innate immune response is also considered to play a very important role and, specifically, NK cell activity through their receptors and ligands, could be determinant. The aim of this retrospective study was to explore the role of different activating and inhibiting KIR genes as well as the activating NKG2D receptor, present in NK cells, and also their respective ligands, HLA-A, -B, -C, -G, -F, MICA and MICB, in the progression of 190 patients with CML and treated at two hospitals from Barcelona between 2000 and 2019. Early molecular response (EMR), major molecular response (MMR) or MR3.0 and deep molecular response (DMR) or MR4.0 were correlated. As control samples, healthy donors from the Barcelona Blood Bank were analyzed. The presence of KIR2DL2/KIR2DS2 was associated with the achievement of EMR, MR3.0, and MR4.0. Carriers of the higher expression NKG2D variant and MICA*009:01 were also likely to achieve molecular response (MR). The most remarkable difference between CML patients and controls was a higher frequency of the lower expression NKG2D variant in CML patients. In summary, our results showed that activating NK receptor phenotypes might help to achieve MR and DMR in CML patients treated with TKIs although confirmatory studies are necessary.

Published
2021

49. Allogeneic hematopoietic cell transplantation in older myelofibrosis patients: A study of the chronic malignancies working party of EBMT and the Spanish Myelofibrosis Registry

Author

Hans Martin, Dietrich W. Beelen, Vicenzo Pavone, Nicolaus Kröger, Patrick Hayden, Jan J. Cornelissen, Uwe Platzbecker, Alberto Alvarez-Larrán, Arturo Pereira, Ibrahim Yakoub-Agha, Nienke Zinger, J. M. Raya, Luuk Gras, Hermann Einsele, Didier Blaise, Moniek de Witte, Tomasz Czerw, Keith Wilson, Stig Lenhoff, Jürgen Finke, Donal McLornan, William Krüger, Adriano Salaroli, Valentín García-Gutiérrez, Henrik Sengeloev, Juan Carlos Hernández-Boluda, Katja Sockel, and Hematology

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Population, Medizin, Hematopoietic stem cell transplantation, Cohort Studies, Internal medicine, medicine, Humans, Transplantation, Homologous, Registries, education, Survival rate, Survival analysis, Aged, education.field_of_study, business.industry, Age Factors, Hematopoietic Stem Cell Transplantation, Hematology, Survival Analysis, Transplantation, Primary Myelofibrosis, Spain, Cohort, Female, business, Busulfan, Cohort study, medicine.drug
Abstract

Allogeneic hematopoietic cell transplantation (allo-HCT) is increasingly used in older myelofibrosis (MF) patients, but its risk/benefit ratio compared to non-transplant approaches has not been evaluated in this population. We analyzed the outcomes of allo-HCT in 556 MF patients aged > 65years from the EBMT registry, and determined the excess mortality over the matched general population of MF patients > 65years managed with allo-HCT (n=556) or conventional drug treatment (n=176). The non-transplant cohort included patients with intermediate-2 or high risk DIPSS from the Spanish Myelofibrosis Registry. After a median follow-up of 3.4years, the estimated 5-year survival rate, non-relapse mortality (NRM), and relapse incidence after transplantation was 40%, 37%, and 25%, respectively. Busulfan-based conditioning was associated with decreased mortality (HR: 0.7, 95% CI: 0.5-0.9) whereas the recipient CMV+/donor CMV- combination (HR: 1.7, 95% CI: 1.2-2.4) and the JAK2 mutated genotype (HR: 1.9, 95% CI: 1.1-3.5) predicted higher mortality. Busulfan-based conditioning correlated with improved survival due to less NRM, despite its higher relapse rate when compared with melphalan-based regimens. Excess mortality was higher in transplanted patients than in the non-HCT cohort in the first year of follow-up (ratio: 1.93, 95% CI: 1.13-2.80), whereas the opposite occurred between the 4th and 8th follow-up years (ratio: 0.31, 95% CI: 0.18-0.53). Comparing the excess mortality of the two treatments, male patients seemed to benefit more than females from allo-HCT, mainly due to their worse prognosis with non-transplant approaches. These findings could potentially enhance counseling and treatment decision-making in elderly transplant-eligible MF patients. This article is protected by copyright. All rights reserved.

Published
2021
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50. Impact of ruxolitinib on survival of patients with myelofibrosis in the real world: update of the ERNEST Study

Author

Chiara Maccari, Tiziano Barbui, Elisa Rumi, Francesco Mannelli, Ana Triguero, Daniele Vanni, Francesco Passamonti, Chiara Paoli, Maria Chiara Finazzi, Paola Guglielmelli, Barbara Mora, Arianna Masciulli, Alberto Alvarez-Larrán, Bjorn Andreasson, Alessandra Carobbio, Alessandro Rambaldi, Arianna Ghirardi, Helna Pettersson, and Alessandro M. Vannucchi

Subjects
Oncology, medicine.medical_specialty, Ruxolitinib, business.industry, Hematology, medicine.disease, Pyrimidines, Primary Myelofibrosis, Internal medicine, Nitriles, medicine, Humans, Pyrazoles, business, Myelofibrosis, medicine.drug
Published
2021

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