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37 results on '"Deben, G."'

1. Data-driven flow cytometry classification of blast differentiation in older patients with acute myeloid leukemia

Author

Rojas, F., Longoni, H., Milone, G., Fernández, I., Conciencia, Clínica, Ramirez, R., Canepa, C., Saba, S., Balladares, G., Ventiurini, C., Mariano, R., Negri, P., Prates, M.V., Milone, J., Fazio, P., Gelemur, M., Ciarlo, S., Bezares, F., López, L., García, J. J, Giunta, M., Kruss, M., Lafalse, D., Marquesoni, E., Casale, M.F., Gimenez, A., Brulc, E.B., Perusini, M.A., Palmer, L., Correa, M.E., Jaramillo, F.J., Rosales, J., Sossa, C., Herrera, J.C., Arango, M., Holojda, J., Golos, A., Ejduk, A., Ochrem, B., Małgorzata, G., Waszczuk-Gajda, A., Drozd-Sokolowska, J., Czemerska, M., Paluszewska, M., Zarzycka, E., Masternak, A., Hawrylecka, Dr., Podhoreka, M., Giannopoulos, K., Gromek, T., Oleksiuk, J., Armatys, bA., Helbig, G., Sobas, M., Szczepaniak, A., Rzenno, E., Rodzaj, M., Piatkowska-Jakubas, B., Skret, A., Pluta, A., Barańska, E., Vasconcelos, G., Brioso, J., Nunes, A., Bogalho, I., Espadana, A., Coucelo, M., Marini, S., Azevedo, J., Crisostomo, A.I., Ribeiro, L., Pereira, V., Botelho, A., Mariz, J.M., Guimaraes, J.E., Aguiar, E., Coutinho, J., Noriega, V., García, L., Varela, C., Debén, G., González, M.R., Encinas, M., Bendaña, A., González, S., Bello, J.L., Albors, M., Algarra, L., Romero, J.R., Bermon, J.S., Varo, M.J., López, V., López, E., Mora, C., Amorós, C., Romero, A., Jaramillo, A., Valdez, N., Molina, I., Fernández, A., Sánchez, B., García, A., Castaño, V., López, T., Bernabeu, J., Sánchez, M.J., Fernández, C., Gil, C., Botella, C., Fernández, P., Pacheco, M., Tarín, F., Verdú, J.J., García, M.J., Mellado, A., García, M.C., González, J., Castillo, T., Colado, E., Alonso, S., Recio, I., Cabezudo, M., Davila, J., Rodríguez, M.J., Barez, A., Díaz, B., Prieto, J., Arnan, M., Marín, C., Mansilla, M., Balaberdi, A., Amutio, M.E., del Orbe, R.A., Ancin, I., Ruíz, J.C., Olivalres, M., Gómez, C., gonzález, I., Celis, M., Atutxa, K., Carrascosa, T., Artola, T., Lizuain, M., Rodriguez, J .I., Arce, O., Márquez, J.A., Atuch, J., Marco de Lucas, F., Díez, Z., Dávila, B., Cantalejo, R., Díaz, M., Labrador, J., Serra, F., Hermida, G., Díaz, F.J., de Vicente, P., Álvarez, R., Alonso, C., Bergua, J.M., Ugalde, N., Pardal, E., Saldaña, R., Rodríguez, F., Martín, E., Hermosín, L., Garrastazul, M.P., Marchante, I., Raposo, J.A., Capote, F.J., Colorado, M., Batlle, A., Yañez, L., García, S., González, P., Ocio, E.M., Briz, M., Bermúdez, A., Jiménez, C., Beltrán, S., Montagud, M., Castillo, I., García, R., Gascón, A., Clavel, J., Lancharro, A., Lnares, L., Herráez, M.M., Milena, A., Romero, M.J., Hernández, B., Calle, C., Benegas, R., Bolívar, Dr., Serrano, J., Dorado, F.J., Sánchez, J., Martínez, M.C., Cerveró, C.J., Busto, M.J., Bernal, M., Moratalla, L., Mesa, Z., Jurado, M., De Miguel, D., Santos, A.B., Arbeteta, J., Pérez, E., Caminos, N., Uresandi, N., Argoitiaituart, N., Swen, J., Uranga, A., Olazaba, I., Gainza, E., Romero, P., Gil, E., Palma, A.J., Gómez, K.G., Solé, M., Rodríguez, J.N., Murillo, I.M., Marco, J., Serena, J., Marco, V., Perella, M., Costilla, L., López, J.A., Baena, A., Almagro, P., Hermosilla, M., Esteban, A., Campeny, B.A., Nájera, M.J., Herrra, P., Fernández, R., González, J.D., Torres, L., Jiménez, S., Gómez, M.T., Bilbao, C., Rodríguez, C., Hong, A., Ramos de Laón, Y., Afonso, V., Ramos, F., Fuertes, M., de Cabo, E., Aguilera, C., Megido, M., García, T., Lavilla, E., Varela, M., Ferrero, S., Arias, J., Vizcaya, L., Roldán, A., Vilches, A., Penalva, M.J., Vázquez, J., Calderón, M.T., Matilla, A., Serí, C., Otero, M.J., García, N., Sandoval, E., Franco, C., Flores, R., Bravo, P., López, A., López, J.L., Blas, C., Díez, A., Alonso, J.M., Soto, C., Arenas, A., García, J., Martín, Y., Villafuerte, P.S., Magro, E., Bautista, G., De Laiglesia, A., Rodríguez, G., Solán, L., Chicano, M., Balsalobre, P., Monsalvo, S., Font, P., Carbonell, D., Martínez, C., Humala, K., Kerguelen, A.E., Hernández, D., Gasior, M., Gómez, P., Sánchez, I., Redondo, S., Llorente, L., Bengochea, M., Pérez, J., Sebrango, A., M. santero, Morales, A., Figuera, A., Villafuerte, P., Alegre, A., Fernández, E., Alonso, A., Martínez, M.P., Martínez, J., Cedena, M.T., Moreno, L., De la Fuente, A., García, D., Chamorro, C., Pradillo, V., Martí, E., Sánchez, J.M., Delgado, I., Rosado, B., Velasco, A., Miranda, C., Salvatierra, G., Foncillas, M., Hernández, J.A., Escolano, C., Benabente, C., Martínez, R., Polo, M., Anguita, E., Riaza, R., Amores, G., Requena, M.J., Javier, F., Villaloón, L., Aláez, C., Nistal, S., Navas, B., Andreu, M.A., Herrera, P., López, J., García, M., Moreno, M.J., Queipo, M.P., Hernández, A., Barrios, M., Heiniger, A., Jiménez, A., Contento, A., López, F., Alcalá, M., Lorente, S., González, M., Morales, E.M., Gutierrez, J., Serna, M.J., Beltrán, V., Romera, M., Berenguer, M., MArtínez, A., Tejedor, A., Amigo, M.L., Ortuño, F., Jerez, A., López, O., Moraleda, J.M., Rosique, P., Gómez, J., Garay, M.C., Cerezuela, P., MArtínez, A.B., González, A., Ibáñez, J., Alfaro, M.J., Mateos, M., Goñi, M.A., Araiz, M.A., Gorosquieta, A., Zudaire, M., Viguria, M., Zabala, A., Alvarellos, M., Quispe, I., Sánchez, M.P., Hurtado, G., Pérez, M., Burguete, Y., Areizaga, N., Galicia, T., Rifón, J., Alfonso, A., Prósper, F., Marcos, M., Tamariz, L.E., Riego, V., Manubens, A., Larrayoz, M.J., Calasanz, M.J., Mañú, A., Paiva, B., Vázquez, I., Burgos, L., Pereiro, M., Rodríguez, M., Pastoriza, M.C., Mendez, J.A., Sastre, J.L., Iglesias, M., Ulibarrena, C., Campoy, F., Jaimes, D., Albarrán, B., Solano, J., Silvestre, A., Albo, C., Suarez, S., Loureiro, C., Figueroa, I., Fernández, M.A., Martínez, A., Poderós, C., Vazquez, J., Iglesias, L., Nieto, A., Torrado, T., Martínez, A.M., Amador, M.L., Oubiña, P., Feijó, E., Dios, A., Loyola, I., Roreno, R., Simiele, A., Álvarez, L., Turcu, V., Vidriales, B., Avendaño, A., Chillón, C., González, V., Govantes, J.V., Rubio, S., Tapia, M., Olivier, C., Queizán, J.A., Pérez, O., Vera, J.A., Muñoz, C., rodriguez, A., González, N., Pérez, J.A., Soria, E., I.Espigado, Falantes, J., Montero, I., García, P., Rodríguez, E., Carrillo, E., Caballero, T., García, C., Couto, C., Simón, I., Gómez, M., Aguilar, C., González, B.J., Lakhwani, S., Bienert, A., González, B., Cabello, A., Oliva, A.Y., González, H., Sancho, L., Paricio, M., Perdiguer, L., Solano, F., Lerma, A., Martínez, M.D., Gómez, M.I., Yeguas, A., Montesinos, P., Barragán, E., Sargas, C., Amigo, R., Martinez, D., Boluda, B., Rodríguez, R., Acuña, E., Cano, I., Escrivá, A., Pedreño, M., Navalón, A., Orts, M., Sayas, M.J., Fernández, M.J., Juan, M.L., Gómez, E., Gimeno, M., Donato, E., Cejalvo, M., Tormo, M., Calabuig, M., Navarro, B., Martin, I., Villamont, E., Miralles, A., Lluch, R., Moragues, M., Ruiz, M.A., Benet, C., Valero, M., Linares, M., Collado, R., Orero, M., Ibañez, P., Lis, M.J., Pérez, P.L., Roig, M., López, M., Mena, A.V., Picón, I., Cánovas, V., Palacios, A., Cuello, R., Borrego, J., burgois, M., Cantalapiedra, A., Norberto, O., Angomas, E., Cidoncha, B., Cuevas, L., Robles, D., Mendiazabal, A., Oiartzabal, I., Guinea de Castro, J.M., Montes, C., Carrasco, V., Pérez, A., Moneva, J.J., Olave, M., Bonafonte, E., Mayor, L., Azaceta, G., Palomera, L., Malo, M., Escobar, M.J., Grasa, J.M., De Rueda, B., Aulés, A., Salvador, C., Ansó, V., Iborra, A., Delagado, P., Rubio, A., Stevenazzi, M., Alpire, I., Irigoin, V., Díaz, L., Guillermo, C., Guadagna, R., Grille, S., Oliver, C., Boada, M., Vales, V., Prado, A.I., De los Santos, A.P., Simoes, Catia, Gonzalez, Carmen, Vergez, François, Sarry, Audrey, Bertoli, Sarah, Ariceta, Beñat, Martínez-Cuadrón, David, Bergua, Juan-Miguel, Vives, Susana, Algarra, Lorenzo, Tormo, Mar, Martinez, Pilar, Serrano, Josefina, Herrera, Pilar, Ramos, Fernando, Salamero, Olga, Lavilla, Esperanza, Gil, Cristina, Lopez-Lorenzo, Jose-Luis, Vidriales, Maria-Belen, Chillon, Carmen, Labrador, Jorge, Falantes, Jose-Francisco, Sayas, María-José, Ayala, Rosa, Martinez-Lopez, Joaquin, Villar, Sara, Calasanz, Maria-Jose, Prosper, Felipe, San-Miguel, Jesús F., Sanz, Miguel Á., Récher, Christian, Paiva, Bruno, and Montesinos, Pau

Published
2024
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3. A randomized phase II study comparing consolidation with a single dose of Y-90 ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results

Author

Lopez-Guillermo A, Canales M, Dlouhy I, Mercadal S, Briones J, Garcia-Sancho A, Sancho J, Moraleda J, Terol M, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, Lopez A, Panizo C, Muntanola A, Montalban C, Conde E, Hernandez M, Soler A, Marco J, Deben G, Marin J, Tomas J, and PETHEMA GELTAMO GELCAB Spanish Int

Subjects
90Y ibritumomab tiuxetan, Follicular lymphoma, maintenance
Abstract

This is a randomized phase-2 trial aimed to compare consolidation vs. maintenance in untreated patients with follicular lymphoma (FL) responding to induction. 146 patients were enrolled from 25 Spanish institutions (ZAR2007; ClinicalTrials.gov #NCT00662948). Patients in PR or CR/CR[u] after R-CHOP were randomized 1:1 to Y-90-ibritumomab-tiuxetan 0.4 mCi/kg (arm A) vs. rituximab 375 mg/m(2) every 8 weeks for 2 years (arm B). After a median follow-up of 10.55 years, 53 patients eventually progressed with a 10-year PFS of 50% vs. 56% for patients in arm A and B, respectively (HR = 1.42; p > 0.1). No significant differences were seen in OS (10-year OS 78% vs. 84.5%; HR = 1.39, p > .1). Patients receiving Y-90-ibritumomab-tiuxetan showed higher incidence of second neoplasms than those in arm B (10-year cumulative incidence 18.5 vs. 2%, respectively; p = .038). In conclusion, in FL patients responding to R-CHOP, no significant differences were found between consolidation and maintenance, although with higher late toxicity for consolidation.

Published
2022

5. The poor prognosis of low hypodiploidy in adults with B-cell precursor acute lymphoblastic leukaemia is restricted to older adults and elderly patients

Author

Ribera J, Granada I, Morgades M, Vives S, Genesca E, Gonzalez C, Nomdedeu J, Escoda L, Montesinos P, Mercadal S, Coll R, Gonzalez-Campos J, Abella E, Barba P, Bermudez A, Gil C, Tormo M, Pedreno M, Martinez-Carballeira D, Hernandez-Rivas J, Orfao A, Martinez-Lopez J, Esteve J, Bravo P, Garcia-Guinon A, Deben G, Moraleda J, Queizan J, Ortin X, Moreno M, Feliu E, Sole F, PETHEMA Grp, and Spanish Soc Haematology

Published
2019

6. An analysis of the impact of CD56 expression in de novo acute promyelocytic leukemia patients treated with upfront all-trans retinoic acid and anthracycline-based regimens

Author

Sobas M, Montesinos P, Boluda B, Bernal T, Vellenga E, Nomdedeu J, Gonzalez-Campos J, Chillon M, Holowiecka A, Esteve J, Bergua J, Gonzalez-Sanmiguel J, Gil-Cortes C, Tormo M, Salamero O, Manso F, Fernandez I, de la Serna J, Moreno M, Perez-Encinas M, Krsnik I, Ribera J, Escoda L, Lowenberg B, Sanz M, de Heredia J, Hernandez J, Arias J, Ramos F, Roman A, Negri S, Rayon C, Fernandez-Calvo F, Diaz-Mediavilla J, Gil C, Olave M, Amutio E, Pedro C, Gorosquieta A, Viguria M, Zudaire M, Molero T, Sayas M, Guardia R, Esquembre C, Garcia R, Alcala A, Lopez J, Rubio V, Amigo M, Linares M, San Miguel J, Coruna A, Deben G, de la Camara R, Molines A, Loureiro C, Allegue M, Amador L, Marti J, Madero L, Lassaletta A, Cabezudo M, Garcia-Larana J, Rojas R, Ortega F, Penarrubia M, Puente F, Lopez-Ibor B, Brunet S, Ibanez J, Sanchez P, Novo A, Guinea J, Montero A, Gonzalez M, Martin G, Martinez J, Verdeguer A, Garcia P, Conde E, Garcia J, Capote F, Bueno J, Bastida P, Rubio A, Fuster J, Gonzalez J, Perez I, Molina J, Mateos M, Ardaiz M, Rodriguez-calvillo M, Poderos C, Arnan M, Duarte R, Diaz-Morfa M, Martin-Chacon E, Calvo-Villas J, Garcia-Belmonte D, Hernandez-Maraver D, Ossenkoppele G, van der Lelie J, Sonneveld P, Zijlmans M, Maertens J, de Valk B, Wijermans P, de Groot M, Schouten H, Biesma D, van Marwijk M, de Lisa E, Golos A, Ejduk A, Armatys A, Zarzycka E, Knopinska W, Miskiewicz W, Jastrzab B, Pluta A, Paluszewska M, Podhorecka M, Gromek T, Jakubas B, Majcherek M, Skret A, Watek M, Charlinski G, Calbecka M, Becht R, Gadomska A, Rzenno E, Piszcz J, Grosicki S, Palmer L, Ciarlo S, Bezares F, Rojas F, Longoni H, Gelemur M, Fazio P, Canepa C, Saba S, Balladares G, Negri P, Giunta M, Milone J, Lafalse D, Sossa C, Jaramillo F, Mayer J, Protivankova M, Scwarz J, PETHEMA Cooperative Grp, HOVON Cooperative Grp, PALG Cooperative Grp, and GATLA Cooperative Grp

Subjects
relapse, Acute promyelocytic leukemia, CD56, ATRA, chemotherapy, prognostic
Abstract

Out of 956, there were 95 (10%) CD56+ APL patients treated with PETHEMA ATRA and chemotherapy. CD56+ expression was associated with high WBC, BCR3 isoform, and co-expression of CD2, CD34, CD7, HLA-DR, CD15, and CD117 antigens. CD56+ vs CD56- APL presented higher induction death rate (16% vs 8%, p = .02) and 5-years cumulative incidence of relapse (33% versus 10%, p = .006), irrespectively of the Sanz score (low-risk 47% versus 5%, p < .001; intermediate 23% versus 7%, p < .001; and high-risk 42% versus 21%, p = .007). In the multivariate analysis, CD56 + (p < .0001), higher relapse-risk score (p = .001), and male gender (p = .05) retained the independent predictive value. CD56+ APL also showed a greater risk of CNS relapse (6% versus 1%, p < .001) and lower 5-year OS (75% versus 83%, p = .003). The AIDA-based LPA2012 trial, with an intensified consolidation schedule for CD56+ APL, will elucidate whether an intensified consolidation schedule could mitigate the relapse rate in this setting.

Published
2019

7. Real life outcomes of patients aged >= 75 years old with acute promyelocytic leukemia: experience of the PETHEMA registry

Author

Salamero, O, Martinez-Cuadron, D, Sobas, M, Benavente, C, Vives, S, De la Serna, J, Perez-Encinas, M, Escoda, L, Gil, C, Brunet, S, Ramos, F, Esteve, J, Amigo, M, Krsnik, I, Manso, F, Arias, J, Gonzalez-Campos, J, Serrano, J, Oleksiuk, J, Barrios, M, Garcia-Boyero, R, Novo, A, Sanz, MA, Montesinos, P, Helbig, G, Holowiecka, A, Armatys, A, Hawrylecka, D, Golos, A, Ejduk, A, Majcherek, M, Skret, A, Czyzewska, J, Grosicki, S, Zarzycka, E, Watek, M, Piatkowska-Jakubas, B, Holojda, J, Pluta, A, Podhorecka, M, Gromek, T, Guzicka, E, Charlinski, G, Paluszewska, M, de Heredia, JMB, Hernandez, JM, Roman, A, Negri, S, Rayon, C, Fernandez-Calvo, FJ, Diaz-Mediavilla, J, Tormo, M, Olave, M, Amutio, E, Pedro, C, Gorosquieta, A, Viguria, M, Zudaire, M, Molero, T, Sayas, MJ, Guardia, R, Rivas, C, Esquembre, C, Garcia, R, Alcala, A, Lopez, JA, Rubio, V, Linares, M, Ribera, JM, San Miguel, JDG, Deben, G, de la C?mara, R, Molines, A, Loureiro, C, Allegue, MJ, Amador, L, Marti, JM, Madero, L, Lassaletta, A, Cabezudo, M, Garcia-Larana, J, Rojas, R, Ortega, F, Penarrubia, MJ, Puente, F, Lopez-Ibor, B, Bergua, JM, Ibanez, J, Sanchez, P, Font, LL, Guinea, JM, Montero, A, Gonzalez, M, Martin, G, Martinez, J, Verdeguer, A, Garcia, P, Conde, E, Garcia, J, Capote, FJ, Bueno, J, Bastida, P, Rubio, A, Fuster, JL, Perez, I, Molina, J, Mateos, MC, Ardaiz, MA, Rodriguez-calvillo, M, Poderos, C, Arnan, M, Duarte, R, Hernandez, JA, Diaz-Morfa, M, Martin-Chacon, E, Calvo-Villas, JM, Garcia-Belmonte, D, Hernandez-Maraver, D, and Miskiewicz, W

Subjects
induction mortality in APL, APL real life outcomes, Elderly APL, APL prognostic factors, neoplasms
Abstract

Acute promyelocytic leukemia is infrequent among patients aged >= 75 years old, a population that is rarely eligible for clinical protocols. This study aims to analyze the treatment strategies and clinical outcomes of very old APL patients reported to the international PETHEMA registry. Between 1997 and 2017, among 2501 APL cases registered 120 were >= 75 years old. Treatment approaches were: AIDA regimen, 79 patients; ATRA alone, 23; 16, supportive care (SC) and 2, other strategies. Patients treated with AIDA were younger, had better ECOG and lower leukocytes. Complete remission (CR) was achieved in 65% of AIDA-group vs. 45% in the ATRA-group, being infections followed by bleeding the most frequent causes of induction death. Patients in CR after AIDA showed 3-year DFS of 73%. Our real-life series of very old APL patients provides a reference basis for future treatment strategies aiming to improve clinical outcomes in this challenging population.

Published
2019

8. Clinical significance of complex karyotype at diagnosis in pediatric and adult patients with de novo acute promyelocytic leukemia treated with ATRA and chemotherapy

Author

Labrador J, Luno E, Vellenga E, Brunet S, Gonzalez-Campose J, Chillon M, Holowiecka A, Esteve J, Bergua J, Gonzalez-Sanmiguel J, Gil C, Tormo M, Salamero O, Manso F, Fernandez I, de laSerna J, Moreno M, Perez-Encinas M, Krsnik I, Ribera J, Cervera J, Calasanz M, Boluda B, Sobas M, Lowenberg B, Sanz M, Montesinos P, Palmer L, Ciarlo S, Bezares F, Rojas F, Longoni H, Gelemur M, Fazio P, Canepa C, Saba S, Balladares G, Negri P, Giunta M, Milone J, Prates M, Lafalse D, Sossa C, Jaramillo F, Mayer J, Protivankova M, Scwarz J, Holowiecka-Goral A, Jakubas B, Skret-Norwicz A, Bizgalska-Skrzypek P, Pluta A, Becht R, Kielbinski M, Watek M, Paluszewska M, Gadomska A, Rzenno E, Piszcz J, Ejduk A, Dobrzanska J, Calbecka M, Kostyra A, Malek M, Grosicki S, Knopinska W, Beltran de Heredia J, Hernandez J, Arias J, Ramos F, Roman A, de la Serna J, Negri S, Rayon C, Fernandez-Calvo F, Diaz-Mediavilla J, Olave M, Amutio E, Pedro C, Gorosquieta A, Viguria M, Zudaire M, Molero T, Sayas M, Guardia R, Rivas C, Esquembre C, Garcia R, Alcala A, Lopez J, Rubio V, Amigo M, Linares M, Gonzalez San Miguel J, Deben G, Escoda L, de la Camara R, Molines A, Loureiro C, Allegue M, Amador L, Marti J, Madero L, Lassaletta A, Cabezudo M, Garcia-Larana J, Rojas R, Ortega F, Penarrubia M, Puente F, Lopez-Ibor B, Ibanez J, Sanchez P, Novo A, Font L, Guinea J, Montero A, Gonzalez M, Martin G, Martinez J, Verdeguer A, Garcia P, Conde E, Garcia J, Capote F, Bueno J, Bastida P, Rubio A, Fuster J, Gonzalez J, Perez I, Molina J, Mateos M, Ardaiz M, Rodriguez-calvillo M, Poderos C, Arnan M, Duarte R, Diaz-Morfa M, Martin-Chacon E, Calvo-Villas J, Garcia-Belmonte D, Hernandez-Maraver D, Ossenkoppele G, van der Lelie J, Sonneveld P, Zijlmans M, Maertens J, de Valk B, Wijermans P, de Groot M, Schouten H, Biesma D, Kooy M, de Lisa E, PETHEMA Grp, HOVON Grp, PALG Grp, and GATLA Grp

Subjects
relapse, complex karyotype, Acute promyelocytic leukemia, ATRA, chemotherapy, prognostic
Abstract

Although additional cytogenetic abnormalities (ACA) do not affect the prognosis of patients with t(15;17) acute promyelocytic leukemia (APL), the role of a complex karyotype (CK) is yet to be clarified. We aimed to investigate the relationship of CK with relapse incidence in 1559 consecutive APL patients enrolled in three consecutive trials. Treatment consisted of AIDA induction followed by risk-adapted consolidation. A CK (CK) was defined as the presence of >= 2 ACA, and a very CK (CK+) as >= 3 ACA. Eighty-nine patients (8%) had a CK, of whom 41 (4%) had CK+. The 5-year cumulative incidence of relapse (CIR) in patients with CK was 18%, and 12% in those with

Published
2019

9. Incidence, risk factors, and outcome of bacteremia following autologous hematopoietic stem cell transplantation in 720 adult patients

Author

Pinana JL, Montesinos P, Martino R, Vazquez L, Rovira M, Lopez J, Batlle M, Figuera A, Barba P, Lahuerta JJ, Deben G, Perez-Lopez C, Garcia R, Rosique P, Lavilla E, Gascon A, Martinez-Cuadron D, and Sanz MA

Subjects
Infectious related mortality, Neutropenic fever, Total parenteral nutrition, Fluoroquinolone prophylaxis, Bacteremia, Autologous stem cell transplantation
Abstract

Bacteremia is the most frequent infectious complication during neutropenia in patients receiving autologous hematopoietic stem cell transplantation (ASCT). The objective of this study was to analyze the incidence, characteristics, risk factors, and outcome of bacteremia during the early period after ASCT. A total of 720 patients undergoing ASCT in two observational prospective consecutive multicenter studies of the Programa Espaol para el Tratamiento de las Hemopatias group were analyzed. Bacteremia occurred in 20 % of patients. Coagulase-negative Staphylococcus was the most frequent (66 %) among the gram-positive agents and Escherichia coli (49 %) among the gram-negative agents. Multivariate analysis showed that the length of neutropenia < 1 Au 10(9)/L (more than 9 days) [relative risk (RR) of 2.6, p < 0.001] was the sole risk factor for overall bacteremia. We identified the length of neutropenia < 1 Au 10(9)/L (more than 9 days) (RR 4.98, p < 0.001) and the use of prophylactic fluoroquinolones (RR 0.46, p < 0.01) as specific risk factors for gram-negative bacteremia. Risk factors for gram-positive bacteremia were the use of total parenteral nutrition (RR 1.92, p < 0.01) and deep neutropenia (< 0.1 Au 10(9)/L), with duration over 5 days (RR 1.67, p < 0.027). Bacteremia showed an increased morbidity with no impact on neither overall nor infectious related mortality. The identification of such risk factors may be helpful to implement prophylactic and therapeutic risk-adapted strategies to reduce the incidence of bacteremia in ASCT.

Published
2014

10. R-ESHAP as salvage therapy for patients with relapsed or refractory diffuse large B-cell lymphoma: the influence of prior exposure to rituximab on outcome. A GEL/TAMO study

Author

Martin A, Conde E, Arnan M, Canales M, Deben G, Sancho J, Andreu R, Salar A, Garcia-Sanchez P, Vazquez L, Nistal S, Requena M, Donato E, Gonzalez J, Leon A, Ruiz C, Grande C, Gonzalez-Barca E, Caballero M, and GEL TAMO Cooperative Grp

Subjects
rituximab, diffuse large B-cell lymphoma, R-ESHAP, salvage therapy
Abstract

Background The role of re-treatment with rituximab in aggressive B-cell lymphomas still needs to be defined. This study evaluated the influence of prior exposure to rituximab on response rates and survival in patients. with diffuse large B-cell lymphoma treated with rituximab plus etoposide, cytarabine, cisplatinum and methylprednisolone (R-ESHAP). Design and Methods We retrospectively analyzed 163 patients with relapsed or refractory diffuse large B-cell lymphoma who received R-ESHAP as salvage therapy with a curative purpose. Patients were divided into two groups according to whether rituximab had been administered(n=94, "R+" group) or not (n=69, "R-" group) prior to R-ESHAP Results Response rates were significantly higher in the R- group in the univariate but not in the multivariate analysis. In the analysis restricted to the R+ group, we observed very low complete remission and overall response rates in patients with primary refractory disease (8% and 33%, respectively), as compared to those in patients who were in first partial remission (41% and 86%) or who had relapsed disease (50% and 75%) (p

Published
2008

11. Differentiation syndrome in patients with acute promyelocytic leukemia treated with all-trans retinoic acid and anthracycline chemotherapy: characteristics, outcome, and prognostic factors

Author

Montesinos, P, Bergua, JM, Vellenga, E, Rayon, C, Parody, R, de la Serna, J, Leon, A, Esteve, J, Milone, G, Deben, G, Rivas, C, Gonzalez, M, Tormo, M, Diaz-Mediavilla, J, Gonzalez, JD, Negri, S, Amutio, E, Brunet, S, Löwenberg, Bob, Sanz, MA, Montesinos, P, Bergua, JM, Vellenga, E, Rayon, C, Parody, R, de la Serna, J, Leon, A, Esteve, J, Milone, G, Deben, G, Rivas, C, Gonzalez, M, Tormo, M, Diaz-Mediavilla, J, Gonzalez, JD, Negri, S, Amutio, E, Brunet, S, Löwenberg, Bob, and Sanz, MA

Abstract

Differentiation syndrome (DS) can be a life-threatening complication in patients with acute promyelocytic leukemia (APL) undergoing induction therapy with all-trans retinoic acid ( ATRA). Detailed knowledge about DS has remained limited. We present an analysis of the incidence, characteristics, prognostic factors, and outcome of 739 APL patients treated with ATRA plus idarubicin in 2 consecutive trials (Programa Espanol de Tratamientos en Hematologa [PETHEMA] LPA96 and LPA99). Overall, 183 patients (24.8%) experienced DS, 93 with a severe form (12.6%) and 90 with a moderate form (12.2%). Severe but not moderate DS was associated with an increase in mortality. A bimodal incidence of DS was observed, with peaks occurring in the first and third weeks after the start of ATRA therapy. A multivariate analysis indicated that a WBC count greater than 5 x 10(9)/L and an abnormal serum creatinine level correlated with an increased risk of developing severe DS. Patients receiving systematic prednisone prophylaxis (LPA99 trial) in contrast to those receiving selective prophylaxis with dexamethasone (LPA96 trial) had a lower incidence of severe DS. Patients developing severe DS showed a reduced 7-year relapse-free survival in the LPA96 trial (60% vs 85%, P = .003), but this difference was not apparent in the LPA99 trial (86% vs 88%). (Blood. 2009; 113: 775-783)

Published
2009

12. Central nervous system involvement at first relapse in patients with acute promyelocytic leukemia treated with all-trans retinoic acid and anthracycline monochemotherapy without intrathecal prophylaxis

Author

Montesinos, P, Diaz-Mediavilla, J, Deben, G, Prates, V, Tormo, M, Rubio, V, Perez, I, Fernandez, I, Viguria, M, Rayon, C, Gonzalez, J, de la Serna, J, Esteve, J, Bergua, JM, Rivas, C, Gonzalez, M, Gonzalez, JD, Negri, S, Brunet, S, Löwenberg, Bob, Sanz, MA, Montesinos, P, Diaz-Mediavilla, J, Deben, G, Prates, V, Tormo, M, Rubio, V, Perez, I, Fernandez, I, Viguria, M, Rayon, C, Gonzalez, J, de la Serna, J, Esteve, J, Bergua, JM, Rivas, C, Gonzalez, M, Gonzalez, JD, Negri, S, Brunet, S, Löwenberg, Bob, and Sanz, MA

Abstract

Background The prevalence of and risk factors for central nervous system recurrence in patients with acute promyelocytic leukemia are not well established and remain a controversial matter. Design and Methods Between 1996 and 2005, 739 patients with newly diagnosed acute promyelocytic leukemia enrolled in two consecutive trials (PETHEMA LPA96 and LPA99) received induction therapy-with all-trans retinoic acid and idarubicin. Consolidation therapy comprised three courses of anthracycline monochemotherapy (LPA96), with all-trans retinoic acid and reinforced doses of idarubicin in patients with an intermediate or high risk of relapse (LPA99). Central nervous system prophylaxis was not given. Results Central nervous system relapse was documented in 11 patients. The 5-year cumulative incidence of central nervous system relapse was 1.7% (LPA96 3.2% and LPA99 1.2%; p=0.09). The cumulative incidence was 0%, 0.8%, and 5.5% in low-, intermediate-, and high-risk patients, respectively. Relapse risk score (p=0.0001) and the occurrence of central nervous system hemorrhage during induction (5-year cumulative incidence 18.7%, p=0.006) were independent risk factors for central nervous system relapse. Conclusions This study shows a low incidence of central nervous system relapse in patients with acute promyelocytic leukemia following therapy with all-trans retinoic acid and anthracycline without specific central nervous system prophylaxis. Central nervous system relapse was significantly associated with high white blood cell counts and prior central nervous system hemorrhage, which emerged as independent prognostic factors.

Published
2009

13. Central nervous system involvement at first relapse in patients with acute promyelocytic leukemia treated with all-trans retinoic acid and anthracycline monochemotherapy without intrathecal prophylaxis

Author

Montesinos, P., primary, Diaz-Mediavilla, J., additional, Deben, G., additional, Prates, V., additional, Tormo, M., additional, Rubio, V., additional, Perez, I., additional, Fernandez, I., additional, Viguria, M., additional, Rayon, C., additional, Gonzalez, J., additional, de la Serna, J., additional, Esteve, J., additional, Bergua, J. M., additional, Rivas, C., additional, Gonzalez, M., additional, Gonzalez, J. D., additional, Negri, S., additional, Brunet, S., additional, Lowenberg, B., additional, and Sanz, M. A., additional

Published
2009
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14. Identification of Neoplastic Infiltration of the Cerebrospinal Fluid (CSF) in Patients with Aggressive B-Cell Non-Hodgkin’s Lymphoma (B-NHL) without Clinical Evidence of Leptomeningeal Disease: A Comparative Analysis of the Utility of Flow Cytometry (FCM) Versus Conventional Cytology (CC).

Author

Orfao, A., primary, Quijano, S., primary, Lopez, A., primary, Deben, G., primary, Salar, A., primary, Poderos, C., primary, Sancho, J.M., primary, Vallejo, C., primary, Arias, J., primary, Garcia, J.A., primary, Capote, F., primary, Morado, M., primary, Nicolas, C., primary, Briones, J., primary, Fernandez, S., primary, Carmona, A., primary, Vazquez, L., primary, and Miguel, J.F. San, primary

Published
2006
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20. CLINICAL SIGNIFICANCE OF THE PRESENCE OF OCCULT CNS INVOLVEMENT ASSESSED BY FLOW CYTOMETRY IN PATIENTS WITH NON HODGKIN'S LYMPHOMA AT HIGH RISK OF CNS RELAPSE

Author

Sancho, J. M., Orfao, A., Quijano, S., Garcia, O., Panizo, C., Perez-Ceballos, E., Deben, G., Salar, A., Gonzalez-Barca, E., Alonso, N., Garcia-Vela, J. A., Capote, J., Penalver, F. J., Provencio, M., Arias, J., Plaza, J., Caballero, D., Morado, M., Cruz, M., Palacios, A., Carmona, A., Conde, E., Molero, T., Romero, E., Mateos, M. C., Penarrubia, M. J., and Jose-Maria Ribera

22. Comparison of intensive chemotherapy, allogeneic or autologous stem cell transplantation as post-remission treatment for adult patients with high-risk acute lymphoblastic leukemia. Results of the PETHEMA ALL-93 trial

Author

Jose-Maria Ribera, Oriol, Albert, Bethencourt, Concepcion, Parody, Ricardo, Hernandez-Rivas, Jesus-Maria, Moreno, Maria-Jose, Del Potro, Eloy, Tormo, Mar, Rivas, Concepcion, Besalduch, Joan, Sanz, Miguel-Angel, Ortega, Juan-Jose, Feliu, E., Queipo Llano, M. J., Fernandez-Abellan, P., Terol, M. J., Besalduch, J., Novo, A., Moscardo, F., Arias, J., Moraleda, J. M., Heras, I., Bueno, J., Fernandez-Calvo, J., Borrego, D., Martin-Reina, V., Deben, G., Carbonell, F., Orts, M., Vivancos, P., Grande, C., Bello, Jl, Queizan, J. A., Guinea, J., Brunet, S., Bergua, J. L., Rodriguez-Villa, A., Atutxa, K., Diaz-Morfa, G., Hernandez-Nieto, L., Gamez, F., Llorente, A., Ortega-Rivas, F., Penarrubia, M. D., Poderos, C., Marti, J. M., and Gardella, S.

25. R-ESHAP as salvage therapy for patients with relapsed or refractory diffuse large B-cell lymphoma: the influence of prior exposure to rituximab on outcome. A GEL/TAMO study

Author

Angel Leon, Concepción Ruiz, Eva González-Barca, Juan M. Sancho, Alejandro Martín, Eulogio Conde, Antonio Salar, Guillermo Deben, María-José Requena, Miguel Canales, M. D. Caballero, Lourdes Vázquez, Sara Nistal, Jose J. Gonzalez, Montserrat Arnan, Pedro Garcia-Sanchez, Eva M. Donato, Carlos Grande, Rafael Andreu, Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea (GEL/TAMO cooperative group), [Martín,A] Complejo Hospitalario de Zamora. [Conde,E] Hospital Marqués de Valdecilla, Santander. [Arnan,M, González-Barca,E] Hospital Duran i Reynals, L’Hospitalet de Llobregat. [Canales,MA] Hospital La Paz, Madrid, [Deben,G] Hospital Juan Canalejo, La Coruña. [Sancho,JM] Hospital Germans Trias i Pujol, Badalona. [Andreu,R] Hospital Dr. Peset, Valencia. [Salar,A] Hospital del Mar, Barcelona. [García-Sanchez,P] Hospital Clínico de Madrid. [Vázquez,L, and Caballero,MD] Hospital Universitario de Salamanca. [Nistal,S] Hospital Universitario de Getafe. [Requena,MJ] Hospital Severo Ochoa, Leganés. [Donato,EM] Hospital General de Castellón. [González, JA] Hospital Virgen del Puerto, Plasencia. [León,A] Hospital General de Jerez, Jerez de la Frontera. [Ruiz,C] Hospital Carlos Haya, Málaga. [Grande,C] Hospital Doce de Octubre, Madrid, Spain.

Subjects
Linfoma de células B grandes difuso, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Combined Modality Therapy::Salvage Therapy [Medical Subject Headings], medicine.medical_specialty, Named Groups::Persons::Age Groups::Adult::Young Adult [Medical Subject Headings], Chemicals and Drugs::Inorganic Chemicals::Chlorine Compounds::Cisplatin [Medical Subject Headings], Salvage therapy, Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidine Nucleosides::Cytidine::Cytarabine [Medical Subject Headings], Named Groups::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings], Diseases::Immune System Diseases::Immunoproliferative Disorders::Lymphoproliferative Disorders::Lymphoma::Lymphoma, Non-Hodgkin::Lymphoma, B-Cell::Lymphoma, Large B-Cell, Diffuse [Medical Subject Headings], Gastroenterology, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Retrospective Studies [Medical Subject Headings], hemic and lymphatic diseases, Internal medicine, medicine, Named Groups::Persons::Age Groups::Adult [Medical Subject Headings], Refractory Diffuse Large B-Cell Lymphoma, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal [Medical Subject Headings], Named Groups::Persons::Age Groups::Adult::Aged [Medical Subject Headings], Etoposide, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical Protocols::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings], business.industry, Diffuse large B-Cell lymphoma, Hematology, R-ESHAP, medicine.disease, Surgery, Lymphoma, Tratamiento de última línea, Chemicals and Drugs::Polycyclic Compounds::Steroids::Steroids, Fluorinated::Dexamethasone [Medical Subject Headings], Protocolos de quimioterapia antineoplásica combinada, Named Groups::Persons::Age Groups::Adolescent [Medical Subject Headings], Cytarabine, Rituximab, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Murine-Derived [Medical Subject Headings], Chemicals and Drugs::Carbohydrates::Glycosides::Glucosides::Etoposide [Medical Subject Headings], business, ESHAP, Diffuse large B-cell lymphoma, medicine.drug
Abstract

Journal Article; Multicenter Study; "Comment in Salvage therapy for relapsed or refractory diffuse large B-cell lymphoma: impact of prior rituximab. [Haematologica. 2008]" (Nota tomada de PubMed) BACKGROUND The role of re-treatment with rituximab in aggressive B-cell lymphomas still needs to be defined. This study evaluated the influence of prior exposure to rituximab on response rates and survival in patients with diffuse large B-cell lymphoma treated with rituximab plus etoposide, cytarabine, cisplatinum and methylprednisolone (R-ESHAP). DESIGN AND METHODS We retrospectively analyzed 163 patients with relapsed or refractory diffuse large B-cell lymphoma who received R-ESHAP as salvage therapy with a curative purpose. Patients were divided into two groups according to whether rituximab had been administered (n=94, "R+" group) or not (n=69, "R-" group) prior to R-ESHAP. RESULTS Response rates were significantly higher in the R- group in the univariate but not in the multivariate analysis. In the analysis restricted to the R+ group, we observed very low complete remission and overall response rates in patients with primary refractory disease (8% and 33%, respectively), as compared to those in patients who were in first partial remission (41% and 86%) or who had relapsed disease (50% and 75%) (p

Published
2008

26. A randomized phase II study comparing consolidation with a single dose of 90 Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results.

Author

López-Guillermo A, Canales MÁ, Dlouhy I, Mercadal S, Briones J, Martín García-Sancho A, Sancho JM, Moraleda JM, Terol MJ, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, López A, Panizo C, Muntañola A, Montalbán C, Conde E, Hernández MT, Soler A, García Marco JA, Deben G, Marín J, and Tomás JF

Subjects
Antibodies, Monoclonal, Antibodies, Monoclonal, Murine-Derived therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Disease-Free Survival, Follow-Up Studies, Humans, Radioimmunotherapy methods, Rituximab adverse effects, Treatment Outcome, Yttrium Radioisotopes therapeutic use, Lymphoma, Follicular diagnosis, Lymphoma, Follicular drug therapy, Lymphoma, Follicular etiology
Abstract

This is a randomized phase-2 trial aimed to compare consolidation vs. maintenance in untreated patients with follicular lymphoma (FL) responding to induction. 146 patients were enrolled from 25 Spanish institutions (ZAR2007; ClinicalTrials.gov #NCT00662948). Patients in PR or CR/CR[u] after R-CHOP were randomized 1:1 to 90 Y-ibritumomab-tiuxetan 0.4 mCi/kg (arm A) vs. rituximab 375 mg/m 2 every 8 weeks for 2 years (arm B). After a median follow-up of 10.55 years, 53 patients eventually progressed with a 10-year PFS of 50% vs. 56% for patients in arm A and B, respectively (HR = 1.42; p  > 0.1). No significant differences were seen in OS (10-year OS 78% vs. 84.5%; HR = 1.39, p  > .1). Patients receiving 90 Y-ibritumomab-tiuxetan showed higher incidence of second neoplasms than those in arm B (10-year cumulative incidence 18.5 vs. 2%, respectively; p  = .038). In conclusion, in FL patients responding to R-CHOP, no significant differences were found between consolidation and maintenance, although with higher late toxicity for consolidation.

Published
2022
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27. Genomic mutation profile in progressive chronic lymphocytic leukemia patients prior to first-line chemoimmunotherapy with FCR and rituximab maintenance (REM).

Author

González-Rincón J, Garcia-Vela JA, Gómez S, Fernández-Cuevas B, Nova-Gurumeta S, Pérez-Sanz N, Alcoceba M, González M, Anguita E, López-Jiménez J, González-Barca E, Yáñez L, Pérez-Persona E, de la Serna J, Fernández-Zarzoso M, Deben G, Peñalver FJ, Fernández MC, de Oteyza JP, Andreu MÁ, Ruíz-Guinaldo MÁ, Paz-Arias R, García-Malo MD, Recasens V, Collado R, Córdoba R, Navarro-Matilla B, Sánchez-Beato M, and García-Marco JA

Subjects
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Combined Modality Therapy, DNA Mutational Analysis, Female, Genomics, Humans, Male, Middle Aged, RNA Splicing, Vidarabine administration & dosage, Cyclophosphamide administration & dosage, Gene Expression Regulation, Leukemic, Immunotherapy methods, Leukemia, Lymphocytic, Chronic, B-Cell genetics, Leukemia, Lymphocytic, Chronic, B-Cell therapy, Mutation, Rituximab administration & dosage, Vidarabine analogs & derivatives
Abstract

Chronic Lymphocytic Leukemia (CLL) is the most prevalent leukemia in Western countries and is notable for its variable clinical course. This variability is partly reflected by the mutational status of IGHV genes. Many CLL samples have been studied in recent years by next-generation sequencing. These studies have identified recurrent somatic mutations in NOTCH1, SF3B1, ATM, TP53, BIRC3 and others genes that play roles in cell cycle, DNA repair, RNA metabolism and splicing. In this study, we have taken a deep-targeted massive sequencing approach to analyze the impact of mutations in the most frequently mutated genes in patients with CLL enrolled in the REM (rituximab en mantenimiento) clinical trial. The mutational status of our patients with CLL, except for the TP53 gene, does not seem to affect the good results obtained with maintenance therapy with rituximab after front-line FCR treatment., Competing Interests: J.A. Garcia-Marco has received honoraria for advisory board and speaker’s bureau from Mundipharma, Glaxo, AbbVie, Roche, Gilead, and Janssen, and research support from Hoffman-La Roche and Janssen. Jaime Pérez de Oteyza declares a consulting and advisory role for Hoffman-La Roche. The other authors have no conflicts of interest to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Published
2021
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28. Clinical Outcomes of 217 Patients with Acute Erythroleukemia According to Treatment Type and Line: A Retrospective Multinational Study.

Author

Almeida AM, Prebet T, Itzykson R, Ramos F, Al-Ali H, Shammo J, Pinto R, Maurillo L, Wetzel J, Musto P, Van De Loosdrecht AA, Costa MJ, Esteves S, Burgstaller S, Stauder R, Autzinger EM, Lang A, Krippl P, Geissler D, Falantes JF, Pedro C, Bargay J, Deben G, Garrido A, Bonanad S, Diez-Campelo M, Thepot S, Ades L, Sperr WR, Valent P, Fenaux P, Sekeres MA, Greil R, and Pleyer L

Subjects
Adult, Aged, Aged, 80 and over, Azacitidine administration & dosage, Azacitidine analogs & derivatives, Biomarkers, Bone Marrow pathology, Cytogenetic Analysis, Decitabine, Female, Humans, Leukemia, Erythroblastic, Acute diagnosis, Male, Middle Aged, Proportional Hazards Models, Retrospective Studies, Survival Analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Leukemia, Erythroblastic, Acute drug therapy, Leukemia, Erythroblastic, Acute mortality
Abstract

Acute erythroleukemia (AEL) is a rare disease typically associated with a poor prognosis. The median survival ranges between 3-9 months from initial diagnosis. Hypomethylating agents (HMAs) have been shown to prolong survival in patients with myelodysplastic syndromes (MDS) and AML, but there is limited data of their efficacy in AEL. We collected data from 210 AEL patients treated at 28 international sites. Overall survival (OS) and PFS were estimated using the Kaplan-Meier method and the log-rank test was used for subgroup comparisons. Survival between treatment groups was compared using the Cox proportional hazards regression model. Eighty-eight patients were treated with HMAs, 44 front line, and 122 with intensive chemotherapy (ICT). ICT led to a higher overall response rate (complete or partial) compared to first-line HMA (72% vs. 46.2%, respectively; p ≤ 0.001), but similar progression-free survival (8.0 vs. 9.4 months; p = 0.342). Overall survival was similar for ICT vs. HMAs (10.5 vs. 13.7 months; p = 0.564), but patients with high-risk cytogenetics treated with HMA first-line lived longer (7.5 for ICT vs. 13.3 months; p = 0.039). Our results support the therapeutic value of HMA in AEL.

Published
2017
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29. Bosutinib shows low cross intolerance, in chronic myeloid leukemia patients treated in fourth line. Results of the Spanish compassionate use program.

Author

García-Gutiérrez V, Martinez-Trillos A, Lopez Lorenzo JL, Bautista G, Martin Mateos ML, Alvarez-Larrán A, Iglesias Pérez A, Romo Collado A, Fernandez A, Portero A, Cuevas B, Ruiz C, Romero E, Ortega F, Mata I, Tallón J, García Garay Mdel C, Ramirez Sánchez MJ, de Las Heras N, Giraldo P, Bobillo S, Guinea JM, Deben G, Valencia S, Sebrango A, Boqué C, Maestro B, and Steegmann JL

Subjects
Adult, Aged, Benzamides therapeutic use, Dasatinib, Drug Resistance, Neoplasm, Female, Humans, Imatinib Mesylate, Leukemia, Myeloid, Chronic-Phase enzymology, Leukemia, Myeloid, Chronic-Phase mortality, Leukemia, Myeloid, Chronic-Phase pathology, Male, Middle Aged, Piperazines therapeutic use, Protein-Tyrosine Kinases antagonists & inhibitors, Protein-Tyrosine Kinases metabolism, Pyrimidines therapeutic use, Retrospective Studies, Spain, Survival Analysis, Thiazoles therapeutic use, Aniline Compounds therapeutic use, Antineoplastic Agents therapeutic use, Compassionate Use Trials, Leukemia, Myeloid, Chronic-Phase drug therapy, Nitriles therapeutic use, Protein Kinase Inhibitors therapeutic use, Quinolines therapeutic use
Abstract

The role of bosutinib as rescue treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML) patients after failing three previous tyrosine kinase inhibitors (TKIs) is currently unknown. We report here the largest series (to our knowledge) of patients treated with bosutinib in fourth-line, after retrospectively reviewing 30 patients in chronic phase, and pretreated with imatinib, nilotinib, and dasatinib. With a median follow up of 11.1 months, the probability to either maintain or improve their CCyR response was 56.6% (17/30) and 11 patients (36.7%) achieved or maintained their baseline MMR. In patients not having baseline CCyR, the probabilities of obtaining CCyR, MMR, and MR4.5 were 13, 11, and 14%, respectively. The probabilities of obtaining MMR and deep molecular response MR4.5 in patients with baseline CCyR were 40.0% (6/15) and 20.0% (3/15). At 20 months, progression-free survival was 73%. Grade 3-4 hematological toxicities were more frequent in resistant than intolerant patients (45.4 vs. 0.0%). Nonhematological toxicities were also more frequent in resistant patients, being diarrhea the most conspicuous one. Bosutinib seems to be an appropriate treatment option for patients resistant or intolerant to three prior TKI's., (© 2015 Wiley Periodicals, Inc.)

Published
2015
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30. Does microgranular variant morphology of acute promyelocytic leukemia independently predict a less favorable outcome compared with classical M3 APL? A joint study of the North American Intergroup and the PETHEMA Group.

Author

Tallman MS, Kim HT, Montesinos P, Appelbaum FR, de la Serna J, Bennett JM, Deben G, Bloomfield CD, Gonzalez J, Feusner JH, Gonzalez M, Gallagher R, Miguel JD, Larson RA, Milone G, Paietta E, Rayon C, Rowe JM, Rivas C, Schiffer CA, Vellenga E, Shepherd L, Slack JL, Wiernik PH, Willman CL, and Sanz MA

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Cytarabine administration & dosage, Daunorubicin administration & dosage, Female, Follow-Up Studies, Humans, Infant, Leukemia, Promyelocytic, Acute classification, Male, Middle Aged, Remission Induction, Survival Rate, Treatment Outcome, Tretinoin administration & dosage, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Leukemia, Promyelocytic, Acute drug therapy, Leukemia, Promyelocytic, Acute pathology, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local pathology
Abstract

Few studies have examined the outcome of large numbers of patients with the microgranular variant (M3V) of acute promyelocytic leukemia (APL) in the all-trans retinoic acid era. Here, the outcome of 155 patients treated with all-trans retinoic acid-based therapy on 3 clinical trials, North American Intergroup protocol I0129 and Programa para el Estudio de la Terapéutica en Hemopatía Maligna protocols LPA96 and LPA99, are reported. The complete remission rate for all 155 patients was 82%, compared with 89% for 748 patients with classical M3 disease. The incidence of the APL differentiation syndrome was 26%, compared with 25% for classical M3 patients, and the early death rate was 13.6% compared with 8.4% for patients with classical M3 morphology. With a median follow-up time among survivors of 7.6 years (range 3.6-14.5), the 5-year overall survival, disease-free survival, and cumulative incidence of relapse for patients with M3V were 70%, 73%, and 24%, respectively. With a median follow-up time among survivors of 7.6 years (range 0.6-14.3), the 5-year overall survival, disease-free survival, and cumulative incidence of relapse among patients with classical M3 morphology were 80% (P = .006 compared with M3V), 81% (P = .07), and 15% (P = .005), respectively. When outcomes were adjusted for the white blood cell count or the relapse risk score, none of these outcomes were significantly different between patients with M3V and classical M3 APL.

Published
2010
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31. Clinical significance of occult cerebrospinal fluid involvement assessed by flow cytometry in non-Hodgkin's lymphoma patients at high risk of central nervous system disease in the rituximab era.

Author

Sancho JM, Orfao A, Quijano S, García O, Panizo C, Pérez-Ceballos E, Deben G, Salar A, González-Barca E, Alonso N, García-Vela JA, Capote J, Peñalver FJ, Provencio M, Arias J, Plaza J, Caballero D, Morado M, Feliu E, and Ribera JM

Subjects
Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Murine-Derived, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Central Nervous System Diseases cerebrospinal fluid, Central Nervous System Diseases complications, Central Nervous System Diseases diagnosis, Central Nervous System Neoplasms complications, Central Nervous System Neoplasms drug therapy, Central Nervous System Neoplasms pathology, Female, Humans, Lymphoma, Non-Hodgkin complications, Lymphoma, Non-Hodgkin drug therapy, Lymphoma, Non-Hodgkin pathology, Male, Microscopy methods, Middle Aged, Predictive Value of Tests, Recurrence, Risk Factors, Rituximab, Central Nervous System Neoplasms cerebrospinal fluid, Central Nervous System Neoplasms diagnosis, Flow Cytometry methods, Lymphoma, Non-Hodgkin cerebrospinal fluid, Lymphoma, Non-Hodgkin diagnosis
Abstract

Background and Aim: Flow cytometry (FCM) analysis of cerebrospinal fluid (CSF) is more sensitive than conventional cytology (CC) for diagnosis of lymphomatous meningeosis, but the clinical significance of occult central nervous system (CNS) disease (positive FCM with negative CC) remains unknown., Patients and Methods: CSF samples from 105 patients with newly diagnosed aggressive lymphomas at high risk of CNS involvement were prospectively studied by both CC and FCM, and results were correlated with cumulative incidence of CNS relapse and overall survival (OS). Patients were divided into three groups: 1) patients without CNS involvement (CC-/FCM-; n=83); 2) individuals with occult CNS disease (FCM+/CC-; n=15); and 3) cases with CNS disease (CC+/FCM+; n=7)., Results: Six cases showed CNS relapse or progression: two in Group 1 (2.4%), two in Group 2 (13%) and two in Group 3 (28.5%) (Group 2 vs. 1, P=0.04; Group 3 vs. 1, P<0.001). Patients from Groups 2 (P=0.05) and 3 (P<0.001) also showed a higher cumulative incidence of CNS relapse than those from Group 1. Significant differences were observed in OS between FCM-/CC- and FCM+/CC+ cases (P=0.02), while patients with occult CNS disease (FCM+/CC-) displayed intermediate OS rates, although differences did not reach statistical significance., Conclusions: The presence of occult CNS involvement at diagnosis in patients with NHL at high risk of CNS disease is associated with a higher probability of CNS relapse., (© 2010 John Wiley & Sons A/S.)

Published
2010
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32. Efficacy and safety of liposomal cytarabine in lymphoma patients with central nervous system involvement from lymphoma.

Author

Garcia-Marco JA, Panizo C, Garcia ES, Deben G, Alvarez-Larran A, Barca EG, Sancho JM, Penarrubia MJ, Garcia-Cerecedo T, and Garcia Vela JA

Subjects
Adult, Aged, Cytarabine administration & dosage, Cytarabine adverse effects, Drug Evaluation, Female, Humans, Injections, Spinal, Male, Middle Aged, Quality of Life, Retrospective Studies, Cytarabine therapeutic use, Liposomes, Lymphoma drug therapy, Lymphoma pathology, Meningeal Carcinomatosis drug therapy, Meningeal Carcinomatosis secondary
Abstract

Background: : Standard intrathecal chemotherapy for lymphomatous meningitis (LM) is limited by the short cerebrospinal half-lives of the agents used, necessitating frequent administration. Liposomal cytarabine (DepoCyte) has an extended half-life that permits administration at 2- to 4-weekly intervals., Methods: : Patients with LM who underwent treatment with liposomal cytarabine at treatment centers in Spain between 2004 and 2007 were identified. Data on demographics, treatment, and outcomes were extracted from medical notes and entered, retrospectively, into a database for analysis., Results: : Data on 55 patients with lymphoma (mainly stage IV) and LM were entered into the database. Most patients (n = 36) had diffuse large B-cell lymphoma. The median number of cycles of liposomal cytarabine received was 4 (range, 1-10), and the median follow-up period was 124 days. Complete and partial neurologic responses were achieved in 27 and 12 patients, respectively (overall response rate, 72%), all of whom also showed a cytological response, except for 5 with initially negative cytology. Median time to neurologic progression among responders was 105.5 days. Liposomal cytarabine was generally well tolerated; headache was the most commonly reported adverse effect (n = 17)., Conclusions: : Liposomal cytarabine is effective and well tolerated in the treatment of LM, and should be considered as an agent of choice for the treatment of this complication. Cancer 2009. (c) 2009 American Cancer Society.

Published
2009
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33. Prospective study on the practice of central nervous system prophylaxis and treatment in non-Hodgkin's lymphoma in Spain.

Author

Sancho JM, Morgades M, Alonso N, Deben G, Fernández de Sevilla A, Vázquez L, Nicolás C, García Vela JA, Arranz R, Abella E, Canales MA, Miralles P, Sánchez E, Hermosilla M, Conde E, Rueda A, and Ribera JM

Subjects
Central Nervous System Neoplasms etiology, Central Nervous System Neoplasms therapy, Female, Humans, Lymphoma, Non-Hodgkin complications, Male, Prospective Studies, Spain, Central Nervous System Neoplasms prevention & control, Lymphoma, Non-Hodgkin therapy
Abstract

Background and Objective: Central nervous system (CNS) involvement in patients diagnosed with non-Hodgkin's lymphoma (NHL) or other lymphoproliferative disorders is an infrequent complication with a poor prognosis. The prophylaxis and treatment of CNS involvement in these patients are not homogenous. The aim of this prospective longitudinal study was to report the current practice of CNS prophylaxis and treatment in patients with lymphoproliferative disorders in Spain., Methods: Prospective study conducted from June 2005 to June 2006. Adult patients (> or = 18 yr) diagnosed with NHL or other lymphoproliferative disorders who received CNS prophylaxis or treatment were consecutively included through online registration., Results: 228 patients from 33 hospitals were included. The mean (SD) age was 52 (16) yr and 144 (63%) were males. CNS therapy was given to 41 cases and consisted of triple intrathecal (IT) therapy (TIT, methotrexate, cytarabine and hydrocortisone) in 22, liposomal depot cytarabine in 18 and methotrexate in one. In addition, 4 patients received cranial radiotherapy. CNS prophylaxis (n = 187) consisted of TIT (166 cases), IT methotrexate (17), IT liposomal depot cytarabine (3) and IT cytarabine (1), whereas cranial or craniospinal radiotherapy was administered to 2 patients. The main reasons for CNS prophylaxis cited by the investigators included extranodal involvement (89 patients), raised serum lactate dehydrogenase level (87), IPI score > 2 (62), bulky mass (43), extranodal involvement in more than one organ (33), age over 60 yr (28) and human immunodeficiency virus infection (13)., Conclusions: The results of this study point out the generalized use of TIT therapy both for CNS prophylaxis and therapy in patients with lymphoproliferative disorders in Spain. The introduction of the new formulations of drugs, especially liposomal depot cytarabine for CNS involvement, and the scarce use of radiotherapy are also of note. Similar to other studies, the absence of homogeneous criteria for CNS prophylaxis is of note.

Published
2008
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34. Practice of central nervous system prophylaxis and treatment in acute leukemias in Spain. Prospective registry study.

Author

Sancho JM, Morgades M, Arranz R, Fernández-Abellán P, Deben G, Alonso N, Blanes M, Rodríguez MJ, Nicolás C, Sánchez E, Fernández de Sevilla A, Conde E, and Ribera JM

Subjects
Adolescent, Adult, Anti-Inflammatory Agents administration & dosage, Antimetabolites, Antineoplastic administration & dosage, Cytarabine administration & dosage, Drug Therapy, Combination, Female, Humans, Hydrocortisone administration & dosage, Injections, Spinal, Liposomes, Longitudinal Studies, Male, Methotrexate administration & dosage, Middle Aged, Prospective Studies, Spain, Central Nervous System Neoplasms prevention & control, Leukemia, Myeloid, Acute drug therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Registries
Abstract

Background and Objective: Central nervous system (CNS) involvement in patients diagnosed with acute leukemias (AL) is an uncommon complication with poor prognosis. The indication and the schedules of prophylaxis and treatment of CNS involvement in AL are not homogenous among countries and within the same country. The aim of this prospective longitudinal study was to analyze and report the practice of CNS prophylaxis and treatment in patients with AL in Spain., Patients and Method: Prospective study conducted from June 2005 to June 2006. Adult patients (> or = 18 yr.) diagnosed with AL who received CNS prophylaxis or treatment were consecutively included through online registration., Results: 265 patients from 32 hospitals were included. Mean (standard deviation) age was 44 (16) yr. and 133 (50%) were males. For acute lymphoblastic leukemia patients (n = 158), CNS therapy was given to 12 cases (10 at diagnosis and 2 at relapse) and consisted of triple intrathecal therapy (TIT, methotrexate, cytarabine and hydrocortisone) in 11 and liposomal depot cytarabine in one. CNS prophylaxis (n = 146) consisted of TIT in 135 cases, intrathecal methotrexate in 7, intrathecal cytarabine in 2 and intrathecal liposomal depot cytarabine in 2. No cranial irradiation either for prophylaxis or therapy was given in any case. In acute myeloblastic leukemia patients (n = 107), CNS therapy was administered to 17 cases (9 at diagnosis and 8 at relapse). Intrathecal therapy consisted of TIT in 11, intrathecal liposomal depot cytarabine in 5 and intrathecal cytarabine in one. One patient also received craniospinal irradiation. CNS prophylaxis (n = 90) consisted of TIT in 68 cases and intrathecal methotrexate in 22., Conclusions: In Spain, the patterns of CNS prophylaxis and therapy for AL are homogeneous. TIT was the most frequent schedule for CNS prophylaxis and therapy. The lack of use of cranial or craniospinal irradiation and the administration of new drugs (i.e.: liposomal depot cytarabine) for CNS therapy and prophylaxis is of note.

Published
2008
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35. Results of compassionate therapy with intrathecal depot liposomal cytarabine in acute myeloid leukemia meningeosis.

Author

Sancho JM, Deben G, Parker A, Piñana JL, Bolam S, Sánchez-García E, Giménez E, Pascual T, Fernández-Abellán P, Palomera L, and Ribera JM

Subjects
Adult, Female, Humans, Injections, Spinal, Leukemic Infiltration complications, Liposomes, Male, Middle Aged, Retrospective Studies, Spain, United Kingdom, Antimetabolites, Antineoplastic administration & dosage, Cytarabine administration & dosage, Leukemia, Myeloid, Acute complications, Leukemia, Myeloid, Acute drug therapy, Leukemic Infiltration drug therapy, Meninges pathology
Abstract

Intrathecal (IT) depot liposomal cytarabine is useful in solid tumors or lymphomatous meningitis, but has scarcely been used in central nervous system (CNS) involvement in acute leukemia. We report the results of compassionate therapy with IT depot liposomal cytarabine in 10 patients with acute myeloid leukemia with CNS involvement. Five of 6 cases receiving this drug as the only IT therapy and the remaining 4 receiving it as adjuvant therapy to other CNS-directed therapies showed clearance of cerebrospinal fluid blast cells, with sustained response in 5 and mild side effects. Systemic therapy was given concomitantly in all cases, with high-dose cytarabine in 6. Clinical trials should establish the role of IT liposomal cytarabine in leukemic meningitis.

Published
2007
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36. Comparison of intensive chemotherapy, allogeneic, or autologous stem-cell transplantation as postremission treatment for children with very high risk acute lymphoblastic leukemia: PETHEMA ALL-93 Trial.

Author

Ribera JM, Ortega JJ, Oriol A, Bastida P, Calvo C, Pérez-Hurtado JM, González-Valentín ME, Martín-Reina V, Molinés A, Ortega-Rivas F, Moreno MJ, Rivas C, Egurbide I, Heras I, Poderós C, Martínez-Revuelta E, Guinea JM, del Potro E, and Deben G

Subjects
Antineoplastic Agents therapeutic use, Child, Child, Preschool, Disease-Free Survival, Female, Humans, Infant, Male, Remission Induction, Risk, Transplantation, Autologous, Transplantation, Homologous, Treatment Outcome, Precursor Cell Lymphoblastic Leukemia-Lymphoma therapy, Stem Cell Transplantation methods
Abstract

Purpose: The optimal postremission therapy for children with very high-risk (VHR) acute lymphoblastic leukemia (ALL) is not well established. This randomized trial compared three options of postremission therapy: chemotherapy and allogeneic or autologous stem-cell transplantation (SCT)., Patients and Methods: All 106 VHR-ALL patients received induction with five drugs followed by intensification with three cycles of chemotherapy. Patients in complete remission (CR) with an HLA-identical family donor were assigned to allogeneic SCT (n = 24) and the remaining were randomly assigned to autologous SCT (n = 38) or to delayed intensification followed by maintenance chemotherapy up to 2 years in CR (n = 38)., Results: Overall, 100 patients achieved CR (94%). With a median follow-up of 6.5 years, 5-year disease-free survival (DFS) and overall survival (OS) probabilities were 45% (95% CI, 37% to 54%) and 48% (95% CI, 40% to 57%), respectively. The three groups were comparable in the main pretreatment ALL characteristics. Intention-to-treat analysis showed no differences for donor versus no donor in DFS (45%; 95% CI, 27% to 65% v 45%; 95% CI, 37% to 55%) and OS (48%; 95% CI, 30% to 67% v 51%; 95% CI, 43% to 61%), as well as for autologous SCT versus chemotherapy comparisons (DFS: 44%; 95% CI, 29% to 60% v 46%; 95% CI, 32% to 62%; OS: 45%; 95% CI, 31% to 62% v 57%; 95% CI, 43% to 73%). No differences were found within the different subgroups of ALL and neither were differences observed when the analysis was made by treatment actually performed., Conclusion: This study failed to prove that, when a family donor is available, allogeneic SCT produces a better outcome than autologous SCT or chemotherapy in children with VHR-ALL.

Published
2007
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37. Central nervous system recurrence in adult patients with acute lymphoblastic leukemia: frequency and prognosis in 467 patients without cranial irradiation for prophylaxis.

Author

Sancho JM, Ribera JM, Oriol A, Hernandez-Rivas JM, Rivas C, Bethencourt C, Parody R, Deben G, Bello JL, and Feliu E

Subjects
Adolescent, Adult, Aged, Antimetabolites, Antineoplastic administration & dosage, Central Nervous System Neoplasms prevention & control, Combined Modality Therapy, Cranial Irradiation, Cytarabine administration & dosage, Female, Humans, Hydrocortisone administration & dosage, Incidence, Lactate Dehydrogenases analysis, Male, Methotrexate administration & dosage, Middle Aged, Multivariate Analysis, Neoplasm Recurrence, Local prevention & control, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma radiotherapy, Predictive Value of Tests, Prognosis, Retrospective Studies, Risk Factors, Survival Analysis, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Central Nervous System Neoplasms pathology, Neoplasm Recurrence, Local pathology, Precursor Cell Lymphoblastic Leukemia-Lymphoma pathology
Abstract

Recurrence of acute lymphoblastic leukemia (ALL) in the central nervous system (CNS) confers a poor prognosis, although to the authors' knowledge, only a few studies have analyzed this issue in adults. For the current study, the authors analyzed the frequency, predictive factors, and prognosis of CNS involvement and recurrence in adult patients with ALL who did not receive cranial irradiation for CNS prophylaxis. Four hundred sixty-seven adult patients (age > or = 15 years) with ALL were treated on 4 protocols: ALL-89 (standard-risk and high-risk ALL; n = 108 patients), ALL-93 (high-risk ALL; n = 222 patients), ALL-96 (standard-risk ALL; n = 84 patients), and ALL3-97 (Burkitt leukemia; n = 53 patients). CNS prophylaxis consisted of intrathecal methotrexate, cytarabine, and hydrocortisone together with high-dose systemic methotrexate and cytarabine. The mean age (+/- standard deviation) was 33 years (+/- 16 years), and 272 patients were males. ALL subtypes included an early pre-B phenotype (15%), a common phenotype (45%), a pre-B phenotype (5%), a mature B phenotype (11%), and a T phenotype (24%). CNS involvement at diagnosis was observed in 18 patients (3.9%). Of 159 recurrences, 22 occurred (5.8%) in the CNS (14 isolated and 8 combined). A lactate dehydrogenase level > 1000 U/L was the only factor associated with the risk of CNS recurrence. A complete remission was attained in 7 of 22 patients (32%). The median overall survival after recurrence was 0.7 years for patients with isolated CNS recurrence, 0.13 years for patients with combined recurrence, and 0.41 years for patients with bone marrow recurrence (P = .11). The only 2 survivors underwent stem cell transplantation. The frequency of CNS recurrence in adult patients with ALL who do not receive radiotherapy for CNS prophylaxis was similar to the frequency observed in protocols that included cranial irradiation. A lactate dehydrogenase value >1000 U/L was the only factor found to be associated with CNS recurrence. The prognosis for patients who develop CNS recurrence is poor, identical to that for patients who develop bone marrow recurrence., (Copyright 2006 American Cancer Society.)

Published
2006
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