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1. Multi-omics Characterization of Response to PD-1 Inhibitors in Advanced Melanoma

Author

Trilla-Fuertes, Lucía, primary, Gámez-Pozo, Angelo, additional, Prado-Vázquez, Guillermo, additional, López-Vacas, Rocío, additional, Soriano, Virtudes, additional, Garicano, Fernando, additional, Lecumberri, M. José, additional, Rodríguez de la Borbolla, María, additional, Majem, Margarita, additional, Pérez-Ruiz, Elisabeth, additional, González-Cao, María, additional, Oramas, Juana, additional, Magdaleno, Alejandra, additional, Fra, Joaquín, additional, Martín-Carnicero, Alfonso, additional, Corral, Mónica, additional, Puértolas, Teresa, additional, Ramos-Ruiz, Ricardo, additional, Dittmann, Antje, additional, Nanni, Paolo, additional, Fresno Vara, Juan Ángel, additional, and Espinosa, Enrique, additional

Published
2023
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2. Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study

Author

Manzano, José L., primary, Martin-Liberal, Juan, additional, Fernández-Morales, Luis A., additional, Benítez, Gretel, additional, Medina Martínez, Javier, additional, Quindós, María, additional, García-Castaño, Almudena, additional, Fernández, Ovidio, additional, Simo, Rocío V., additional, Majem, Margarita, additional, Bellido, Lorena, additional, Ayala de Miguel, Pablo, additional, Campos, Begoña, additional, Espinosa, Enrique, additional, Macías Cerrolaza, José A., additional, Gil-Arnaiz, Irene, additional, Lorente, David, additional, Rodriguez-Lescure, Alvaro, additional, Perez, Victor N., additional, López Castro, Rafael, additional, Gramaje, María G., additional, Puértolas, Teresa, additional, Rodriguez Moreno, Juan F., additional, Espasa Font, Laia, additional, Belaustegui Ferrández, Guillermo, additional, and Cerezuela-Fuentes, Pablo, additional

Published
2023
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3. Impact of the 21-Gene Assay in Patients with High-Clinical Risk ER-Positive and HER2-Negative Early Breast Cancer: Results of the KARMA Dx Study

Author

Llombart-Cussac, Antonio, primary, Anton-Torres, Antonio, additional, Rojas, Beatriz, additional, Andrés, Raquel, additional, Martinez, Noelia, additional, Rodríguez, César A., additional, Marin, Sara, additional, Puértolas, Teresa, additional, González, Alejandro Falcón, additional, Fernández-Murga, María Leonor, additional, Hagen, Carlos, additional, and Ruiz-Borrego, Manuel, additional

Published
2023
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4. Sorting Transcriptomics Immune Information from Tumor Molecular Features Allows Prediction of Response to Anti-PD1 Therapy in Patients with Advanced Melanoma

Author

Trilla-Fuertes, Lucía, primary, Gámez-Pozo, Angelo, additional, Prado-Vázquez, Guillermo, additional, López-Vacas, Rocío, additional, Zapater-Moros, Andrea, additional, López-Camacho, Elena, additional, Lumbreras-Herrera, María I., additional, Soriano, Virtudes, additional, Garicano, Fernando, additional, Lecumberri, Mª José, additional, Rodríguez de la Borbolla, María, additional, Majem, Margarita, additional, Pérez-Ruiz, Elisabeth, additional, González-Cao, María, additional, Oramas, Juana, additional, Magdaleno, Alejandra, additional, Fra, Joaquín, additional, Martín-Carnicero, Alfonso, additional, Corral, Mónica, additional, Puértolas, Teresa, additional, Ramos, Ricardo, additional, Fresno Vara, Juan Ángel, additional, and Espinosa, Enrique, additional

Published
2023
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5. Association of TYR SNP rs1042602 with Melanoma Risk and Prognosis

Author

Sevilla, Arrate, primary, Sánchez-Diez, Ana, additional, Cobo, Sofía, additional, Izagirre, Neskuts, additional, Martinez-Cadenas, Conrado, additional, Martí, Rosa M., additional, Puértolas, Teresa, additional, de Unamuno, Blanca, additional, Bañuls, José, additional, Izu, Rosa, additional, Gardeazabal, Jesús, additional, Asumendi, Aintzane, additional, Boyano, María D., additional, and Alonso, Santos, additional

Published
2022
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6. Association of TYR SNP rs1042602 with Melanoma Risk and Prognosis

Author

Genética, antropología física y fisiología animal, Dermatología, oftalmología y otorrinolaringología, Biología celular e histología, Genetika,antropologia fisikoa eta animalien fisiologia, Dermatologia, oftalmologia eta otorrinolaringologia, Zelulen biologia eta histologia, Sevilla Mambrilla, Arrate, Sánchez Díez, Ana, Cobo, Sofía, Izagirre Arribalzaga, Neskuts, Martínez Cadenas, Conrado, Martí Laborda, Rosa María, Puértolas, Teresa, de Unamuno, Blanca, Bañuls, José, Izu Belloso, Rosa María, Gardeazabal García, Jesús, Asumendi Mallea, Aintzane, Boyano López, María Dolores, Alonso Alegre, Santos, Genética, antropología física y fisiología animal, Dermatología, oftalmología y otorrinolaringología, Biología celular e histología, Genetika,antropologia fisikoa eta animalien fisiologia, Dermatologia, oftalmologia eta otorrinolaringologia, Zelulen biologia eta histologia, Sevilla Mambrilla, Arrate, Sánchez Díez, Ana, Cobo, Sofía, Izagirre Arribalzaga, Neskuts, Martínez Cadenas, Conrado, Martí Laborda, Rosa María, Puértolas, Teresa, de Unamuno, Blanca, Bañuls, José, Izu Belloso, Rosa María, Gardeazabal García, Jesús, Asumendi Mallea, Aintzane, Boyano López, María Dolores, and Alonso Alegre, Santos

Abstract

Cutaneous melanoma is the most aggressive of skin tumors. In order to discover new biomarkers that could help us improve prognostic prediction in melanoma patients, we have searched for germline DNA variants associated with melanoma progression. Thus, after exome sequencing of a set of melanoma patients and healthy control individuals, we identified rs1042602, an SNP within TYR, as a good candidate. After genotyping rs1042602 in 1025 patients and 773 healthy donors, we found that the rs1042602-A allele was significantly associated with susceptibility to melanoma (CATT test: p = 0.0035). Interestingly, we also observed significant differences between patients with good and bad prognosis (5 years of follow-up) (n = 664) (CATT test for all samples p = 0.0384 and for men alone p = 0.0054). Disease-free-survival (DFS) analyses also showed that patients with the A allele had shorter DFS periods. In men, the association remained significant even in a multivariate Cox Proportional-hazards model, which was adjusted for age at diagnosis, Breslow thickness, ulceration and melanoma subtype (HR 0.4; 95% confidence interval (CI) 0.20–0.83; p = 0.0139). Based on our results, we propose that rs1042602-A is a risk allele for melanoma, which also seems to be responsible for a poorer prognosis of the disease, particularly in men.

Published
2022

7. COVID-19 in melanoma patients: Results of the Spanish Melanoma Group Registry, GRAVID study

Author

Gonzalez-Cao, Maria, Carrera, Cristina, Rodriguez Moreno, Juan Francisco, Rodríguez-Jiménez, Pedro, Basa, Mónica Antoñanzas, Ochoa, Rosa Feltes, Puertolas, Teresa, Muñoz-Couselo, Eva, Manzano, José Luis, Marquez-Rodas, Ivan, Martín-Liberal, Juan, Soria, Ainara, Criado, Pilar Lopez, Garcia-Castaño, Almudena, Boada, Aram, Ayala de Miguel, Pablo, Puig, Susana, Crespo, Guillermo, Fra, Pablo Luna, Zamora, Cristina Aguayo, Rodríguez, Marta Feito, Valles, Lara, Drozdowskyj, Ana, Maldonado-Seral, Cayetana, Gardeazabal, Jesús, Villalobos, Laura, Rosell, Rafael, Fernandez-Morales, Luis Antonio, Rodrigo, Alberto, Viteri, Santiago, Provencio, Mariano, and Berrocal, Alfonso

Published
2021
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9. Immunotherapy Bridge 2017 and Melanoma Bridge 2017: meeting abstracts

Author

Carbone, David, primary, Sharpnack, Michael, additional, He, Kai, additional, Butterfield, Lisa H., additional, Eggermont, Alexander M. M., additional, Gonzalez-Cao, Maria, additional, Karachaliou, Niki, additional, Crespo, Guillermo, additional, Aldeguer, Erika, additional, Drozdowskyj, Ana, additional, Giménez-Capitán, Ana, additional, Teixidó, Cristina, additional, Molina-Vila, Miguel Angel, additional, Ramírez, Santiago Viteri, additional, Algarra, Salvador Martin, additional, Pérez-Ruiz, Elisabeth, additional, Márquez-Rodas, Iván, additional, Rodriguez-Abreu, Delvys, additional, Blanco, Remei, additional, Puértolas, Teresa, additional, Royo, Maria Angeles, additional, Rosell, Rafael, additional, Ascierto, Maria Libera, additional, Hamm, Svetlana, additional, Wulff, Tanja, additional, Kronthaler, Kerstin, additional, Schrepfer, Sabine, additional, Parnitzke, Ulrike, additional, Bretz, Anne Catherine, additional, Baumgartner, Roland, additional, Ferrucci, Veronica, additional, Pennino, Francesco Paolo, additional, Dassi, Luisa, additional, Asadzadeh, Fatemeh, additional, Siciliano, Roberto, additional, Carotenuto, Marianeve, additional, Spano, Daniela, additional, Chiarolla, Cristina Maria, additional, Greco, Adelaide, additional, Cantile, Monica, additional, Di Bonito, Maurizio, additional, Botti, Gerardo, additional, Jonathan, Vandenbussche, additional, Kris, Gevaert, additional, Zollo, Massimo, additional, Amaral, Teresa, additional, Tampouri, Ioanna, additional, Keim, Ulrike, additional, Eigentler, Thomas, additional, Garbe, Claus, additional, Forschner, Andrea, additional, Cesano, Alessandra, additional, Warren, Sarah, additional, Moogk, Duane, additional, Li, Kaitao, additional, Yuan, Zhou, additional, Zhong, Shi, additional, Yu, Zhiya, additional, Liadi, Ivan, additional, Rittase, William, additional, Fang, Victoria, additional, Dougherty, Janna, additional, Perez-Garcia, Arianne, additional, Osman, Iman, additional, Varadarajan, Navin, additional, Restifo, Nicholas P., additional, Frey, Alan, additional, Zhu, Cheng, additional, Krogsgaard, Michelle, additional, Vanpouille-Box, Claire, additional, Formenti, Silvia C., additional, Demaria, Sandra, additional, Nigro, Cristiana Lo, additional, Renziehausen, Alexander, additional, Tzakos, Andreas G., additional, Wang, Hexiao, additional, Rao, Bhavya, additional, Matin, Rubeta, additional, Harwood, Catherine, additional, Vivenza, Daniela, additional, Tonissi, Federica, additional, Occelli, Marcella, additional, Weir, Lynda, additional, Li, Su, additional, Sim, Van Ren, additional, O’Neill, Kevin, additional, Evans, Alan, additional, Thompson, Alastair, additional, Szlosarek, Peter, additional, Fleming, Colin, additional, Proby, Charlotte, additional, Syed, Nelofer, additional, Merlano, Marco, additional, Crook, Tim, additional, Ferguson, Robert, additional, Simpson, Danny, additional, Martinez, Carlos, additional, Vogelsang, Matjaz, additional, Kazlow, Esther, additional, Wilson, Melissa, additional, Pavlick, Anna, additional, Weber, Jeffrey, additional, Sullivan, Ryan, additional, Flaherty, Keith, additional, Ribas, Antoni, additional, Kirchhoff, Tomas, additional, D’Avino, Antonio, additional, Guida, Licia, additional, Cosacco, Augusto, additional, D’Aniello, Roberta, additional, Maiolino, Piera, additional, Tramontano, Teresa, additional, Sarno, Maria R., additional, Palazzo, Ida, additional, Di Napoli, Angela, additional, Acunzo, Gianclaudio, additional, De Fina, Mariarosanna, additional, Silvestri, Antonia, additional, Specchia, Monica, additional, Musacchio, Michela, additional, Giglio, Gianfranco, additional, Carrozza, Francesco, additional, Di Lullo, Liberato, additional, De Maddi, Gian Marco, additional, Venturelli, Adele, additional, Gambale, Elisabetta, additional, Gatta, Alessia, additional, Brocco, Davide, additional, Carella, Consiglia, additional, De Tursi, Michele, additional, Gajewski, Thomas F., additional, Cristiani, Costanza M., additional, Tallerico, Rossana, additional, Ventura, Valeria, additional, Capone, Mariaelena, additional, Madonna, Gabriele, additional, Mallardo, Domenico, additional, Selinger, Eliska, additional, Garofalo, Cinzia, additional, Staaf, Elina, additional, Simeone, Ester, additional, Grimaldi, Antonio M., additional, del Zotto, Genny, additional, Gulletta, Elio, additional, Ciliberto, Gennaro, additional, Moretta, Alessandro, additional, Ascierto, Paolo A., additional, Carbone, Ennio, additional, Costantini, Susan, additional, Sorice, Angela, additional, Capone, Francesca, additional, Budillon, Alfredo, additional, Cauchi, Carolina, additional, Sciancalepore, Grazia, additional, Rovera, Michela, additional, Varamo, Chiara, additional, Seia, Zelda, additional, Palazzini, Stefania, additional, Errico, Fabiana, additional, Basso, Davide, additional, Quaranta, Laura, additional, Forte, Giuseppe, additional, Lavagna, Fulvio, additional, Violante, Silvia, additional, Bosio, Paolo, additional, Lattanzio, Laura, additional, Merlano, Marco C, additional, Gowen, Mike, additional, Tchack, Jeremy, additional, Zhou, Hua, additional, Giles, Keith, additional, Paschke, Scott, additional, Moran, Una, additional, Fenyo, David, additional, Tsirigos, Aris, additional, Pacold, Michael, additional, Morello, Silvana, additional, Sorrentino, Claudia, additional, Giannarelli, Diana, additional, Pinto, Aldo, additional, Fratangelo, Federica, additional, Falcone, Rosaria, additional, Vanella, Vito, additional, Schadendorf, Dirk, additional, Lewis, Karl, additional, Maio, Michele, additional, Demidov, Lev, additional, Mandalà, Mario, additional, Bondarenko, Igor, additional, Herbert, Christopher, additional, Mackiewicz, Andrzej, additional, Rutkowski, Piotr, additional, Guminski, Alexander, additional, Goodman, Grant, additional, Simmons, Brian, additional, Ye, Chenglin, additional, Hooper, Gregory, additional, Wongchenko, Matthew J., additional, Yan, Yibing, additional, Hermann, Frank, additional, Ammendola, Astrid, additional, Bartz, René, additional, Alessandra, Bulotta, additional, Letizia, Colombo, additional, Aurora, Mirabile, additional, Chiara, Lazzari, additional, Raffaele, Mercuri Santo, additional, Danilo, Parolini, additional, Nathalie, Rizzo, additional, Stefano, Martella, additional, Giulio, Modorati, additional, Pina, Brianti, additional, Enza, Cestone, additional, Federica, Bellinzona, additional, Elisabetta, Miserocchi, additional, Luca, Gianni, additional, Vanesa, Gregorc, additional, Agarwala, Sanjiv, additional, Mark Smithers, B., additional, Haushild, Axel, additional, Watcher, Eric, additional, Fattore, Luigi, additional, Ruggiero, Ciro Francesco, additional, Liguoro, Domenico, additional, Cerri, Andrea, additional, Pisanu, Maria Elena, additional, and Mancini, Rita, additional

Published
2018
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11. Estudio de catalizadores de Ni-Fe-Mg-Al dopados con Na, utilizados en la obtención de materiales nanocarbonosos mediante la descomposición catalítica de metano

Author

París Garcés, Jesús, Royo Pascual, Carlos, and Ubieto Puértolas, Teresa

Abstract

La descomposición catalítica de metano, además de ser una vía de obtención de hidrógeno más económica y más eficiente, tiene como ventaja la obtención de materiales nanocarbonosos como co-producto de la reacción. Estos materiales pueden ser nanotubos y/o nanofibras de carbono, que poseen extraordinarias propiedades físicas y químicas, además de amplias y versátiles aplicaciones potenciales. Este proyecto fin de carrera pretende estudiar la actividad y estabilidad de un catalizador Ni-Fe-Mg-Al dopado con diferentes cantidades de Na, en la reacción de descomposición de metano. Se pretende relacionar la composición de los catalizadores con las propiedades que estos presentan durante la reacción, y con las condiciones elegidas para los ensayos. En este trabajo se propone variar la cantidad de agua de lavado en la preparación para obtener una serie de catalizadores NiFeMgAl que incorporen distintas cantidades de Na. Se parte de un catalizador sintetizado por el método de coprecipitación, que está formado por un soporte (Mg, Al) y una parte activa metálica (Ni, Fe). Los experimentos se realizan en un sistema termogravimétrico que recoge datos de peso de carbón producido, temperatura y tiempo durante el transcurso de la reacción. Estos datos permiten analizar la influencia de diferentes condiciones de operación como la temperatura de reacción, la composición de la alimentación sobre la actividad y la formación de carbono. Se utilizan las siguientes técnicas de caracterización con los catalizadores antes de reacción: Determinación de la superficie especifica por adsorción de N2 (BET), Reducción a temperatura programada (TPR), Difracción de rayos X (XRD), Absorción atómica (AAS). Con el fin de obtener información sobre las características del carbono formado durante la reacción, se utilizan las siguientes técnicas: Difracción de rayos X (XRD), Oxidación a temperatura programada (TPO), Microscopía electrónica de barrido (SEM), Microscopía electrónica de transmisión (TEM).

Published
2015

13. Treatment patterns of adjuvant interferon-α2b for high-risk melanoma: a retrospective study of the Grupo Español Multidisciplinar de Melanoma – Prima study

Author

Espinosa, Enrique, primary, Soriano, Virtudes, additional, Malvehy, Josep, additional, Berrocal, Alfonso, additional, Martínez de Prado, Purificación, additional, Quindós, María, additional, Soria, Ainara, additional, Márquez-Rodas, Iván, additional, Palacio, Isabel, additional, Cerezuela, Pablo, additional, López-Vivanco, Guillermo, additional, Alonso, Lorenzo, additional, Samaniego, Elia, additional, Ballesteros, Ana, additional, Puértolas, Teresa, additional, Díaz-Beveridge, Rodrigo, additional, de la Cruz-Merino, Luis, additional, López Castro, Rafael, additional, López López, Rafael, additional, Stevinson, Kendall, additional, del Barrio, Patricia, additional, Tornamira, Maria V., additional, Guillém, Vicente, additional, and Martín-Algarra, Salvador, additional

Published
2016
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14. Liposomal Doxorubicin in the Treatment of Breast Cancer Patients: A Review

Author

Lao, Juan, Madani, Julia, Puértolas, Teresa, Álvarez, María, Hernández, Alba, Pazo-Cid, Roberto, Artal, Ángel, and Antón Torres, Antonio

Subjects
Article Subject, skin and connective tissue diseases
Abstract

Drug delivery systems can provide enhanced efficacy and/or reduced toxicity for anticancer agents. Liposome drug delivery systems are able to modify the pharmacokinetics and biodistribution of cytostatic agents, increasing the concentration of the drug released to neoplastic tissue and reducing the exposure of normal tissue. Anthracyclines are a key drug in the treatment of both metastatic and early breast cancer, but one of their major limitations is cardiotoxicity. One of the strategies designed to minimize this side effect is liposome encapsulation. Liposomal anthracyclines have achieved highly efficient drug encapsulation and they have proven to be effective and with reduced cardiotoxicity, as a single agent or in combination with other drugs for the treatment of either anthracyclines-treated or naïve metastatic breast cancer patients. Of particular interest is the use of the combination of liposomal anthracyclines and trastuzumab in patients with HER2-overexpressing breast cancer. In this paper, we discuss the different studies on liposomal doxorubicin in metastatic and early breast cancer therapy.

Published
2013
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15. Desarrollo de herramientas didácticas para la plataforma Ibercivis

Author

Ubieto Puértolas, Teresa, Cano de Escoriaza, Jacobo, and Clemente Gallardo, Jesús

Subjects
ibercivis, acercamiento de la ciencia, fusión nuclear, computación ciudadana, estudiantes de bachillerato
Abstract

La siguiente memoria sintetiza el trabajo de inicio en la investigación educativa integrado en la línea “Desarrollo de herramientas didácticas para la plataforma Ibercivis”, propuesta para la especialidad de Física y Química del Máster Universitario en Profesorado de Educación Secundaria Obligatoria, Bachillerato, Formación Profesional y Enseñanzas de Idiomas, Artísticas y Deportivas. El objeto de la investigación es acercar algunos proyectos de investigación científica de primera línea a los estudiantes de Bachillerato. Para ello se va a desarrollar la programación y la evaluación de la unidad didáctica “Fusión nuclear”, y se va a ensayar de forma preliminar con los alumnos de 1º de Bachiller del IES Élaios durante las asignaturas Practicum II y Practicum III del Máster de Formación del Profesorado. Si bien este ensayo se ha realizado con un grupo pequeño de estudiantes, los datos disponibles indican que la respuesta del alumnado ha sido muy positiva. Enfrentados a un tema científico de gran complejidad, el uso de las TICs, la novedad de la plataforma y la posibilidad de aproximarse a la Ciencia de forma más directa, ha posibilitado una aceptación mayor que la esperada. El uso de recursos asociados a la investigación de vanguardia, adecuadamente estructurados, tiene una buena acogida por parte del alumnado y una transmisión de conocimientos adecuada. El siguiente paso en esta investigación es implantar esta u otras unidades didácticas con un grupo de alumnos numeroso, para obtener resultados estadísticamente relevantes. Se ha solicitado financiación para el proyecto “Creando científicos: acercamiento de la Ciencia a estudiantes de Bachillerato” al Programa de Cultura Científica y de la Innovación de la FECYT (referencia del proyecto: FCT-12-3945), con la idea de comenzar a trabajar en él a principios del próximo curso. El objetivo fundamental del proyecto es la incentivación de vocaciones científicas entre los estudiantes de Bachillerato y contribuir a la difusión de la Ciencia entre las generaciones más jóvenes.

Published
2012

16. Retreatment and rechallenge with BRAF/MEK inhibitors in patients with metastatic melanoma: Results from the observational study GEM1801.

Author

Ayala de Miguel, Pablo, Berciano-Guerrero, Miguel-Angel, Muñoz-Couselo, Eva, Manzano, Jose Luis, CEREZUELA Fuentes, Pablo, SORIA RIVAS, AINARA, García Castaño, Almudena, Crespo, Guillermo, Puértolas, Teresa, Aguado De La Rosa, Carlos, Gutiérrez Sanz, Lourdes, López Castro, Rafael, Espinosa, Enrique, Lecumberri, Maria Jose, Majem, Margarita, Medina Martinez, Javier, Bellido, Lorena, Fernandez, Luis Antonio, Martin-Algarra, Salvador, and Marquez-Rodas, Ivan

Published
2023
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17. Role of FDG-PET-CT (PET) in predicting outcome of advanced hepatocellular carcinoma (aHCC) patients (pts) treated with sorafenib (SB): A prospective controlled study.

Author

Pazo Cid, Roberto A., primary, Martinez Trufero, Javier, additional, Lanzuela, M., additional, Fuentes, Javier, additional, Ubieto, Miguel A, additional, Banzo, Javier, additional, Sarriá, Luis, additional, Artigas, José María, additional, Hördnler, Carlos, additional, Artal, Angel, additional, Puértolas, Teresa, additional, Serrablo, Alejandro, additional, Soria, Maite, additional, Barrao, Elena, additional, Cebollero, Ana, additional, Calera, Lourdes, additional, Pajares, Isabel, additional, Hernández García, Alba, additional, Hernando Cubero, Jorge, additional, and Anton, Antonio, additional

Published
2014
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18. Serum Markers and Prognosis in Locally Advanced Breast Cancer

Author

Martínez-Trufero, Javier, primary, de Lobera, Abigail Ruíz, additional, Lao, Juan, additional, Puértolas, Teresa, additional, Artal-Cortés, Angel, additional, Zorrilla, Mirian, additional, Alonso, Vicente, additional, Pazo, Roberto, additional, Valero, M. Ignacia, additional, Ríos-Mitchell, M. José, additional, Calderero, Verónica, additional, Herrero, Ana, additional, and Antón, Antonio, additional

Published
2005
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21. Brain Metastases from Colorectal Carcinoma

Author

Zorrilla, Miriam, primary, Alonso, Vicente, additional, Herrero, Ana, additional, Corral, Mónica, additional, Puértolas, Teresa, additional, Trufero, Javier Martínez, additional, Artal, Angel, additional, and Antón, Antonio, additional

Published
2001
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22. Encorafenib and binimetinib followed by radiotherapy for patients with BRAFV600-mutant melanoma and brain metastases (E-BRAIN/GEM1802 phase II study).

Author

Márquez-Rodas I, Álvarez A, Arance A, Valduvieco I, Berciano-Guerrero MÁ, Delgado R, Soria A, Lopez Campos F, Sánchez P, Romero JL, Martin-Liberal J, Lucas A, Díaz-Beveridge R, Conde-Moreno AJ, Álamo de la Gala MDC, García-Castaño A, Prada PJ, González Cao M, Puertas E, Vidal J, Foro P, Aguado de la Rosa C, Corona JA, Cerezuela-Fuentes P, López P, Luna P, Aymar N, Puértolas T, Sanagustín P, and Berrocal A

Subjects
Humans, Male, Female, Middle Aged, Aged, Adult, Prospective Studies, Survival Rate, Chemoradiotherapy methods, Prognosis, Follow-Up Studies, Melanoma pathology, Melanoma drug therapy, Melanoma genetics, Melanoma radiotherapy, Brain Neoplasms secondary, Brain Neoplasms radiotherapy, Brain Neoplasms drug therapy, Brain Neoplasms genetics, Carbamates administration & dosage, Carbamates therapeutic use, Benzimidazoles administration & dosage, Benzimidazoles therapeutic use, Proto-Oncogene Proteins B-raf genetics, Sulfonamides administration & dosage, Sulfonamides therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Mutation
Abstract

Background: Encorafenib plus binimetinib (EB) is a standard-of-care treatment for advanced BRAFV600-mutant melanoma. We assessed the efficacy and safety of encorafenib plus binimetinib in patients with BRAFV600-mutant melanoma and brain metastasis (BM) and explored if radiotherapy improves the duration of response., Methods: E-BRAIN/GEM1802 was a prospective, multicenter, single-arm, phase II trial that enrolled patients with melanoma BRAFV600-mutant and BM. Patients received encorafenib 450 mg once daily plus binimetinib 45 mg BID, and those who achieved a partial response or stable disease at first tumor assessment were offered radiotherapy. Treatment continued until progression. Primary endpoint was intracranial response rate (icRR) after 2 months of EB, establishing a futility threshold of 60%., Results: The study included 25 patients with no BM symptoms and 23 patients with BM symptoms regardless of using corticosteroids. Among them, 31 patients (64.6%) received sequential radiotherapy. After 2 months, icRR was 70.8% (95% CI: 55.9-83.1); 10.4% complete response. Median intracranial progression-free survival (PFS) and OS were 8.5 (95% CI: 6.4-11.8) and 15.9 (95% CI: 10.7-21.4) months, respectively (8.3 months for icPFS and 13.9 months OS for patients receiving RDT). Most common grades 3-4 treatment-related adverse event was alanine aminotransferase (ALT) increased (10.4%)., Conclusions: Encorafenib plus binimetinib showed promising clinical benefit in terms of icRR, and tolerable safety profile with low frequency of high-grade TRAEs, in patients with BRAFV600-mutant melanoma and BM, including those with symptoms and need for steroids. Sequential radiotherapy is feasible but it does not seem to prolong response., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.)

Published
2024
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