110 results on '"Soria, Ainara"'
Search Results
2. Access to systemic treatment of non-melanoma skin cancer in Spain: a survey analysis
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Cerezuela-Fuentes, Pablo, Gonzalez-Cao, Maria, Puertolas, Teresa, Manzano, Jose Luis, Maldonado, Cayetana, Yelamos, Oriol, Berciano-Guerrero, Miguel A., Martin-Liberal, Juan, Muñoz-Couselo, Eva, Espinosa, Enrique, Drozdowskyj, Ana, Berrocal, Alfonso, Soria, Ainara, Marquez-Rodas, Ivan, Martin-Algarra, Salvador, Quindos, Maria, and Puig, Susana
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- 2024
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3. Negative association of steroids with immunotherapy efficacy in a multi-tumor cohort: time and dose-dependent
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Albarrán, Víctor, Guerrero, Patricia, de Quevedo, Coral García, González, Carlos, Chamorro, Jesús, Rosero, Diana Isabel, Moreno, Jaime, Calvo, Juan Carlos, de Aguado, Patricia Pérez, Alía, Víctor, Sotoca, Pilar, Barrill, Ana María, Román, María San, Álvarez-Ballesteros, Pablo, Serrano, Juan José, Soria, Ainara, Olmedo, María Eugenia, Saavedra, Cristina, Cortés, Alfonso, Gómez, Ana, Lage, Yolanda, Ruiz, Álvaro, Ferreiro, María Reyes, Longo, Federico, Garrido, Pilar, and Gajate, Pablo
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- 2024
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4. SARS-CoV-2 infection in patients with melanoma: results of the Spanish Melanoma Group registry
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Gonzalez-Cao, Maria, Puertolas, Teresa, Martinez-Vila, Clara, Carrera, Cristina, Maldonado Seral, Cayetana, Rodríguez-Jiménez, Pedro, Sequero, Silvia, Cerezuela-Fuentes, Pablo, Feltes Ochoa, Rosa, Muñoz, Eva, Antoñanzas Basa, Mónica, Martín-Liberal, Juan, Soria, Ainara, Francisco Rodriguez Moreno, Juan, Marquez-Rodas, Ivan, Lopez Criado, Pilar, Luis Manzano, José, Lopez-Castro, Rafael, Ayala de Miguel, Pablo, Villalobos, Laura, Martin Algarra, Salvador, Gonzalez-Barrallo, Ines, Boada, Aram, García Castaño, Almudena, Puig, Susana, Crespo, Guillermo, Luna Fra, Pablo, Aguayo Zamora, Cristina, Feito Rodríguez, Marta, Valles, Lara, Drozdowskyj, Ana, Gardeazabal, Jesús, Antonio Fernandez-Morales, Luis, Rodrigo, Alberto, Cruz, Raquel, Yelamos, Oriol, Rubio, Belen, Mujica, Karmele, Provencio, Mariano, and Berrocal, Alfonso
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- 2023
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5. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040.
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Harrington, Kevin J, Soulières, Denis, Le Tourneau, Christophe, Dinis, Jose, Licitra, Lisa F, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal H, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Ellison, Misoo C, Cheng, Jonathan D, Chirovsky, Diana Romana, Swaby, Ramona F, and Cohen, Ezra EW
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Clinical Research ,Rare Diseases ,Cancer ,Dental/Oral and Craniofacial Disease ,Good Health and Well Being ,Adult ,Aged ,Aged ,80 and over ,Antibodies ,Monoclonal ,Humanized ,Antineoplastic Combined Chemotherapy Protocols ,Cetuximab ,Disease-Free Survival ,Docetaxel ,Humans ,Male ,Middle Aged ,Neoplasm Metastasis ,Neoplasm Recurrence ,Local ,Patient Reported Outcome Measures ,Quality of Life ,Squamous Cell Carcinoma of Head and Neck ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
BackgroundHead and neck squamous cell carcinoma (HNSCC) affects health-related quality of life (HRQoL); few treatments have demonstrated clinically meaningful HRQoL benefit. KEYNOTE-040 evaluated pembrolizumab vs standard of care (SOC) in patients with recurrent and/or metastatic HNSCC whose disease recurred or progressed after platinum-containing regimen.MethodsPatients received pembrolizumab 200 mg or SOC (methotrexate, docetaxel, or cetuximab). Exploratory HRQoL analyses used European Organisation for Research and Treatment of Cancer (EORTC) 30 quality-of-life, EORTC 35-question quality-of-life head and neck cancer-specific module, and EuroQoL 5-dimensions questionnaires.ResultsThe HRQoL population comprised 469 patients (pembrolizumab = 241, SOC = 228). HRQoL compliance for patients in the study at week 15 was 75.3% (116 of 154) for pembrolizumab and 74.6% (85 of 114) for SOC. The median time to deterioration in global health status (GHS) and QoL scores were 4.8 months with pembrolizumab and 2.8 months with SOC (hazard ratio = 0.79, 95% confidence interval [CI] = 0.59 to 1.05). At week 15, GHS / QoL scores were stable for pembrolizumab (least squares mean [LSM] = 0.39, 95% CI = -3.00 to 3.78) but worsened for SOC (LSM = -5.86, 95% CI = -9.68 to -2.04); the LSM between-group difference was 6.25 points (95% CI = 1.32 to 11.18; nominal 2-sided P = .01). A greater difference in the LSM for GHS / QoL score occurred with pembrolizumab vs docetaxel (10.23, 95% CI = 3.15 to 17.30) compared with pembrolizumab vs methotrexate (6.21, 95% CI = -4.57 to 16.99) or pembrolizumab vs cetuximab (-1.44, 95% CI = -11.43 to 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC.ConclusionsGHS / QoL scores were stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in recurrent and/or metastatic HNSCC.
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- 2021
6. Negative impact of steroids on the efficacy of immunotherapy in a multi- tumor cohort: time and dose-dependent
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Albarrán, Víctor, primary, Guerrero, Patricia, additional, de Quevedo, Coral García, additional, González, Carlos, additional, Chamorro, Jesús, additional, Rosero, Diana Isabel, additional, Moreno, Jaime, additional, Calvo, Juan Carlos, additional, de Aguado, Patricia Pérez, additional, Alía, Víctor, additional, Sotoca, Pilar, additional, Barrill, Ana María, additional, Román, María San, additional, Álvarez-Ballesteros, Pablo, additional, Serrano, Juan José, additional, Soria, Ainara, additional, Olmedo, María Eugenia, additional, Saavedra, Cristina, additional, Cortés, Alfonso, additional, Gómez, Ana, additional, Lage, Yolanda, additional, Ruiz, Álvaro, additional, Ferreiro, María Reyes, additional, Longo, Federico, additional, Garrido, Pilar, additional, and Gajate, Pablo, additional
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- 2024
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7. Adoptive T cell therapy for solid tumors: current landscape and future challenges
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Albarrán, Víctor, primary, San Román, María, additional, Pozas, Javier, additional, Chamorro, Jesús, additional, Rosero, Diana Isabel, additional, Guerrero, Patricia, additional, Calvo, Juan Carlos, additional, González, Carlos, additional, García de Quevedo, Coral, additional, Pérez de Aguado, Patricia, additional, Moreno, Jaime, additional, Cortés, Alfonso, additional, and Soria, Ainara, additional
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- 2024
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8. Cancer Stem Cells in Melanoma
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Soria, Ainara, del Toro, Jacobo Muñoz, Fuentes, Raquel, Cortés, Alfonso, Grande, Enrique, editor, and Antón Aparicio, Luis, editor
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- 2014
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9. Melanoma proteomics suggests functional differences related to mutational status
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Trilla-Fuertes, Lucía, Gámez-Pozo, Angelo, Prado-Vázquez, Guillermo, Zapater-Moros, Andrea, Díaz-Almirón, Mariana, Fortes, Claudia, Ferrer-Gómez, María, López-Vacas, Rocío, Parra Blanco, Verónica, Márquez-Rodas, Iván, Soria, Ainara, Fresno Vara, Juan Ángel, and Espinosa, Enrique
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- 2019
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10. Dabrafenib plus trametinib for compassionate use in metastatic melanoma: A STROBE-compliant retrospective observational postauthorization study
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Martín Algarra, Salvador, Soriano, Virtudes, Fernández-Morales, Luis, Berciano-Guerrero, Miguel-Ángel, Mujika, Karmele, Manzano, José Luis, Puértolas Hernández, Teresa, Soria, Ainara, Rodríguez-Abreu, Delvys, Espinosa Arranz, Enrique, Medina Martínez, Javier, Márquez-Rodas, Ivan, Rubió-Casadevall, Jordi, Ortega, María Eugenia, Jurado García, José Miguel, Lecumberri Biurrun, María José, Palacio, Isabel, Rodríguez de la Borbolla Artacho, María, Altozano, Javier Pérez, Castellón Rubio, Victoria Eugenia, García, Almudena, Luna, Pablo, Ballesteros, Anabel, Fernández, Ovidio, López Martín, Jose Antonio, Berrocal, Alfonso, and Arance, Ana
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- 2017
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11. Neurologic Toxicity of Immune Checkpoint Inhibitors: A Review of Literature
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Albarrán, Víctor, primary, Chamorro, Jesús, additional, Rosero, Diana Isabel, additional, Saavedra, Cristina, additional, Soria, Ainara, additional, Carrato, Alfredo, additional, and Gajate, Pablo, additional
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- 2022
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12. 473 Immune profiling of patients with advanced solid tumors treated with intratumorally administered CV8102 as a single-agent or in combination with anti-PD-1 antibodies in phase I clinical trial
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Codó, Paula, primary, Eigentler, Thomas, additional, Heinzerling, Lucie, additional, Krauss, Juergen, additional, Weishaupt, Carsten, additional, Ochsenreither, Sebastian, additional, Lebbe, Celeste, additional, Mohr, Peter, additional, Oliva, Marc, additional, Oberoi, Honey, additional, Terheyden, Patrick, additional, Pérez, José Trigo, additional, Bauernfeind, Franz-Georg, additional, Fluck, Michael, additional, Richtig, Erika, additional, Soria, Ainara, additional, Gonzalez, Marina, additional, Funkner, Fatma, additional, Wengenmayer, Peter, additional, Vahrenhorst, Dominik, additional, Seibel, Tobias, additional, Quintini, Gianluca, additional, Schmitt-Bormann, Beate, additional, Scheel, Birgit, additional, Falk, Martin, additional, and Gnad-Vogt, Ulrike, additional
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- 2021
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13. COVID-19 in melanoma patients: Results of the Spanish Melanoma Group Registry, GRAVID study
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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
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- 2021
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14. Acute anti-Ma2 paraneoplastic encephalitis associated to pembrolizumab: a case report and review of literature
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Albarrán, Víctor, primary, Pozas, Javier, additional, Rodríguez, Fernando, additional, Carrasco, Ángela, additional, Corral, Elena, additional, Lage, Yolanda, additional, Álvarez-Ballesteros, Pablo, additional, Soria, Ainara, additional, and Garrido, Pilar, additional
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- 2021
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15. Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and Granulocyte Macrophage Colony-Stimulating Factor in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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Babiker, Hani, primary, Brana, Irene, additional, Mahadevan, Daruka, additional, Owonikoko, Taofeek, additional, Calvo, Emiliano, additional, Rischin, Danny, additional, Moreno, Victor, additional, Papadopoulos, Kyriakos P., additional, Crittenden, Marka, additional, Formenti, Silvia, additional, Giralt, Jordi, additional, Garrido, Pilar, additional, Soria, Ainara, additional, Hervás-Morón, Asunción, additional, Mohan, Kosalai Kal, additional, Fury, Matthew, additional, Lowy, Israel, additional, Mathias, Melissa, additional, Feng, Minjie, additional, Li, Jingjin, additional, and Stankevich, Elizabeth, additional
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- 2021
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16. Cancer immunotherapy in special challenging populations: recommendations of the Advisory Committee of Spanish Melanoma Group (GEM)
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Gonzalez Cao, Maria, Puertolas, Teresa, Riveiro, Mar, Muñoz Couselo, Eva, Ortiz, Carolina, Paredes, Roger, Podzamczer Palter, Daniel, Manzano, Jose Luis, Molto, Jose, Revollo, Boris, Carrera Álvarez, Cristina, Mateu, Lourdes, Fancelli, Sara, Espinosa, Enrique, Clotet, Bonaventura, 1953, Martinez Picado, Javier, Cerezuela, Pablo, Soria, Ainara, Marquez, Ivan, Mandala, Mario, Berrocal, Alfonso, Spanish Melanoma Group (GEM)., Institut Català de la Salut, [Gonzalez-Cao M] Translational Cancer Research Unit, Instituto Oncologico Dr Rosell, Dexeus University Hospital, Barcelona, Spain. [Puertolas T] Oncology Department, Hospital Universitario Miguel Servet, Zaragoza, Aragón, Spain. [Riveiro M] Unitat del Fetge, Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Muñoz-Couselo E, Ortiz C] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Paredes R] IrsiCaixa AIDS Research Institute, Badalona, Catalunya, Spain. Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Catalunya, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Oncology ,Cancer Research ,Skin Neoplasms ,Advisory committee ,medicine.medical_treatment ,Immunoteràpia ,Comorbidity ,Medical Oncology ,0302 clinical medicine ,Cancer immunotherapy ,Risk Factors ,Immunology and Allergy ,030212 general & internal medicine ,Càncer ,Immune Checkpoint Inhibitors ,Melanoma ,Otros calificadores::/terapia [Otros calificadores] ,RC254-282 ,Cancer ,Evidence-Based Medicine ,Latent tuberculosis ,terapéutica::terapia biológica::inmunomodulación::inmunoterapia [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Immunosuppression ,Treatment Outcome ,030220 oncology & carcinogenesis ,Molecular Medicine ,immunotherapy ,Viral hepatitis ,medicine.medical_specialty ,Consensus ,Immunology ,Immunotheraphy ,Communicable Diseases ,Risk Assessment ,neoplasias [ENFERMEDADES] ,Immunocompromised Host ,03 medical and health sciences ,Internal medicine ,Position Article and Guidelines ,medicine ,Humans ,In patient ,Pharmacology ,Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,business.industry ,Other subheadings::/therapy [Other subheadings] ,Immunotherapy ,medicine.disease ,Neoplasms [DISEASES] ,Càncer - Immunoteràpia ,business - Abstract
Immunoteràpia Inmunoterapia Immunotherapy Cancer immunotherapy based on the use of antibodies targeting the so-called checkpoint inhibitors, such as programmed cell death-1 receptor, its ligand, or CTLA-4, has shown durable clinical benefit and survival improvement in melanoma and other tumors. However, there are some special situations that could be a challenge for clinical management. Persons with chronic infections, such as HIV-1 or viral hepatitis, latent tuberculosis, or a history of solid organ transplantation, could be candidates for cancer immunotherapy, but their management requires a multidisciplinary approach. The Spanish Melanoma Group (GEM) panel in collaboration with experts in virology and immunology from different centers in Spain reviewed the literature and developed evidence-based guidelines for cancer immunotherapy management in patients with chronic infections and immunosuppression. These are the first clinical guidelines for cancer immunotherapy treatment in special challenging populations. Cancer immunotherapy in chronically infected or immunosuppressed patients is feasible but needs a multidisciplinary approach in order to decrease the risk of complications related to the coexistent comorbidities. This work was supported by the Spanish Melanoma Group (GEM).
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- 2021
17. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040.
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UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'oto-rhino-laryngologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Harrington, Kevin J, Soulières, Denis, Le Tourneau, Christophe, Dinis, Jose, Licitra, Lisa F, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Ellison, Misoo C, Cheng, Jonathan D, Chirovsky, Diana Romana, Swaby, Ramona F, Cohen, Ezra E W, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'oto-rhino-laryngologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Harrington, Kevin J, Soulières, Denis, Le Tourneau, Christophe, Dinis, Jose, Licitra, Lisa F, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Ellison, Misoo C, Cheng, Jonathan D, Chirovsky, Diana Romana, Swaby, Ramona F, and Cohen, Ezra E W
- Abstract
Head and neck squamous cell carcinoma (HNSCC) affects health-related quality of life (HRQoL); few treatments have demonstrated clinically meaningful HRQoL benefit. KEYNOTE-040 evaluated pembrolizumab vs standard of care (SOC) in patients with recurrent and/or metastatic HNSCC whose disease recurred or progressed after platinum-containing regimen. Patients received pembrolizumab 200 mg or SOC (methotrexate, docetaxel, or cetuximab). Exploratory HRQoL analyses used European Organisation for Research and Treatment of Cancer (EORTC) 30 quality-of-life, EORTC 35-question quality-of-life head and neck cancer-specific module, and EuroQoL 5-dimensions questionnaires. The HRQoL population comprised 469 patients (pembrolizumab = 241, SOC = 228). HRQoL compliance for patients in the study at week 15 was 75.3% (116 of 154) for pembrolizumab and 74.6% (85 of 114) for SOC. The median time to deterioration in global health status (GHS) and QoL scores were 4.8 months with pembrolizumab and 2.8 months with SOC (hazard ratio = 0.79, 95% confidence interval [CI] = 0.59 to 1.05). At week 15, GHS / QoL scores were stable for pembrolizumab (least squares mean [LSM] = 0.39, 95% CI = -3.00 to 3.78) but worsened for SOC (LSM = -5.86, 95% CI = -9.68 to -2.04); the LSM between-group difference was 6.25 points (95% CI = 1.32 to 11.18; nominal 2-sided P = .01). A greater difference in the LSM for GHS / QoL score occurred with pembrolizumab vs docetaxel (10.23, 95% CI = 3.15 to 17.30) compared with pembrolizumab vs methotrexate (6.21, 95% CI = -4.57 to 16.99) or pembrolizumab vs cetuximab (-1.44, 95% CI = -11.43 to 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC. GHS / QoL scores were stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in recurrent and/or metastatic HNSCC.
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- 2021
18. Nutritional support in patients with head and neck cancer during radiotherapy alone or combined chemoradiotherapy
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Soria, Ainara, Galdón, Alba, Chacín, Juan, Secos, Jessica, Hervás, Asunción, Vallejo, Carmen, Arrieta, Francisco, Calañas, Alfonso, Zamarrón, Isabel, Vázquez, Clotilde, and Botella-Carretero, José I.
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- 2013
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19. Abstract PO-059: COVID-19 in melanoma patients: Spanish register
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Gonzalez-Cao, Maria, primary, Carrera, Cristina, additional, Moreno, Juan Francisco Rodriguez, additional, Rodriguez-Jiménez, Pedro, additional, Basa, Mónica Antoñanzas, additional, Rodríguez, Marta Feito, additional, Puertolas, Teresa, additional, Muñoz, Eva, additional, Manzano, José Luis, additional, Marquez-Rodas, Ivan, additional, Martín-Liberal, Juan, additional, Soria, Ainara, additional, Criado, Pilar Lopez, additional, Castaño, Almudena García, additional, Boada, Aram, additional, de Miguel, Pablo Ayala, additional, Puig, Susana, additional, Crespo, Guillermo, additional, Fra, Pablo Luna, additional, Zamora, Cristina Aguayo, additional, Gardeazabal, Jesús, additional, Seral, Cayetana Maldonado, additional, Drozdowskyj, Ana, additional, Provencio, Mariano, additional, and Berrocal, Alfonso, additional
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- 2020
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20. Cancer immunotherapy does not increase the risk of death by COVID-19 in melanoma patients
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Gonzalez-Cao, Maria, primary, Antonazas-Basa, Monica, additional, Puertolas, Teresa, additional, Munoz-Couselo, Eva, additional, Manzano, Jose Luis, additional, Carrera, Cristina, additional, Marquez-Rodas, Ivan, additional, Lopez-Criado, Pilar, additional, Rodriguez-Moreno, Juan Francisco, additional, Garcia-Castano, Almudena, additional, Martin-Liberal, Juan, additional, Rodriguez-Jimenez, Pedro, additional, Puig, Susana, additional, Cerezuela, Pablo, additional, Feito-Rodriguez, Marta, additional, Rubio-Viqueira, Belen, additional, Crespo, Guillermo, additional, Luna-Fra, Pablo, additional, Aguayo, Cristina, additional, Ayala de Miguel, Pablo, additional, Feltes, Rosa, additional, Valles, Lara, additional, Drozdowskyj, Ana, additional, Soria, Ainara, additional, Maldonado, Cayetana, additional, Fernandez-Morales, Luis, additional, Rosell, Rafael, additional, Provencio, Mariano, additional, and Berrocal, Alfonso, additional
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- 2020
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21. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040
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Harrington, Kevin J, primary, Soulières, Denis, additional, Le Tourneau, Christophe, additional, Dinis, Jose, additional, Licitra, Lisa F, additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal H, additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Ellison, Misoo C, additional, Cheng, Jonathan D, additional, Chirovsky, Diana Romana, additional, Swaby, Ramona F, additional, and Cohen, Ezra E W, additional
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- 2020
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22. Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck : a randomized clinical trial
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Burtness, Barbara, Haddad, Robert, Dinis, Jose, Trigo, Jose, Yokota, Tomoya, de Viana, Luciano Souza, Romanov, Ilya, Vermorken, Jan Baptist, Bourhis, Jean, Tahara, Makoto, Martins Segalla, Jose Getulio, Psyrri, Amanda, Vasilevskaya, Irina, Nangia, Chaitali Singh, Chaves-Conde, Manuel, Kiyota, Naomi, Homma, Akihiro, Holeckova, Petra, Del Campo, Josep Maria, Asarawala, Nirav, Nicolau, Ulisses Ribaldo, Rauch, Daniel, Even, Caroline, Wang, Bushi, Gibson, Neil, Ehrnrooth, Eva, Harrington, Kevin, Cohen, Ezra E. W., Eduardo Giglio, Raul, Raul Blajman, Cesar, Mario Freue, Jose, Graciela Pilnik, Norma, Salvador Palazzo, Felipe, McGrath, Margaret, Fureder, Thorsten, Kornek, Gabriela, Pichler, Angelika, Bauernhofer, Thomas, Tinchon, Christoph, Greil, Richard, Burian, Martin, Kienzer, Heinz, Specenier, Pol, Sautois, Brieuc, Debruyne, Philip, Graas, Marie-Pascale, Maes, Annelies, Lonchay, Christophe, Daisne, Jean-Francois, Fontaine, Christel, Castro Junior, Gilberto, de Oliveira, Frias, Pereira, Rodrigo Perez, Martins De Marchi, Pedro Rafael, Lazaretti, Nicolas Silva, Kulkarni, Swati, Alam, Yasmin, Ho, Cheryl, Shenouda, George, Soulieres, Denis, Sultanem, Khalil, Singh, Simron, Gonzalez Mella, Pablo, Solis Campos, Jose Antonio, Prausova, Jana, Obermannova, Radka, Friborg, Jeppe, Specht, Lena, Elsaid, Amr Abdelaziz, Minn, Heikki, Martin, Laurent, Rolland, Frederic, Ceruse, Philippe, Calais, Gilles, Guigay, Joe, Ferte, Charles, Peyrade, Frederic, Duffaud, Florence, Champeaux-Orange, Elise, Coutte, Alexandre, Clatot, Florian, Fournel, Pierre, Le Moal, Laurence Bozec, Dietz, Andreas, Gruenwald, Viktor, Gauler, Thomas, Guntinas-Lichius, Orlando, Hildebrandt, Guido, Kuhnt, Thomas, Schmidt, Horst-Juergen, Henke, Michael, Rueckert, Anja, Brugger, Wolfram, Rotter, Nicole, Mahlberg, Rolf, Karavasilis, Vasilios, Fountzilas, Georgios, Psyrri, Diamanto, Lang, Istvan, Boer, Andras, Kocsis, Judit, Pajkos, Gabor, Tamas, Laszlo, Anand, A. L., Sharma, Ajay, Sharma, Voona, Murali, Pandy, Ananda Selvakumar, Kumar, Kirushna, Nathan, Raj Kumar Poovna, Srinivasan, Venkatesan, Zade, Bhooshan, Jain, Minish, Srinivasa, B. J., Naik, Radheshyam, Mohanty, B. K., Charas, Tomer, Billan, Salem, Popovtzer, Aron, Licitra, Lisa, Ferrari, Daris, Fao, Paolo, Merlano, Marco, Rocca, Maria Cossu, Fujii, Hirofumi, Minami, Syujiro, Fujii, Masato, Kadowaki, Shigenori, Muro, Kei, Okami, Kenji, Yagi, Toshinari, Yoshino, Kunitoshi, Matsumoto, Koji, Takahashi, Shunji, Matsuura, Kazuto, Alvarez Avitia, Miguel Angel, Gonzalez Riestra, Hector Jorge, van Meerten, E., Buter, J., Gelderblom, A. J., Kawecki, Andrzej, Golusinski, Wojciech, Dinis, Rui, Ribeiro, Leonor, Silva, Regina, Mansinho, Helder, Selezneva, Irina, Biakhov, Mikhail, Galiulin, Rinat, Izmailov, Adel, Vladimirov, Vladimir, Vinogradov, Valery, Mufazalov, Fagim, Baste, Neus, Ma del Campo, Josep, Mesia Nin, Ricard, Lopez Pousa, Antonio, Jose Grau de Castro, Juan, Reig, Oscar, Vera, Ruth, Trigo, JoseManuel, Iglesias, Lara, Martinez Trufero, Javier, Vazquez, Sergio, Rubio, Belen, Enrique Ales, Jose, Villar, Esther, Rubio, Jordi, Escobar, Yolanda, Soria, Ainara, Chaves, Mauel, Johansson, Gun Wickart, Friesland, Signe, Tell, Roger, Nyman, Jan, Rothschild, Sacha, Zippelius, Alfred, Usluoglu, Nurguel, Gogunska, Inna, Zabolotniy, Dmytro, Vinnyk, Yuriy, Burian, Oleksandr, Sykes, Andrew, Peel, David, Lester, James, Robinson, Martin, Srinivasan, Devraj, Fragkandrea-Nixon, Ioanna, Junor, Elizabeth, Gollins, Simon, Evans, Mererid, Newbold, Kate, Hwang, David, Schipani, Stefano, Rizwanullah, Mohammed, Atiq, Omar, Arnaoutakis, Konstantinos, Bauman, Jessica, Mehra, Ranee, Kang, Hyunseok, Chung, Christine, Davis, Thomas, Jimeno, Antonio, Keresztes, Roger, Nangia, Chaitali, Ignatius, Sai-Hong, Su, Yungpo Bernard, Overton, Lindsay Carol, Garrison, Mitchell A., Jeong, Woondong, Wehbe, Ahmad, Argiris, Athanassios, Chiang, Anne, Morgensztern, Daniel, Haigentz, Missak, Jr., Martincic, Danko, Porosnicu, Mercedes, LUX-HEAD & Neck 2 Investigators, Medical Oncology, and Boehringer Ingelheim Fonds
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Oncology ,Cancer Research ,medicine.medical_specialty ,animal structures ,Afatinib ,Population ,Medizin ,Placebo ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,mental disorders ,medicine ,Adjuvant therapy ,Clinical endpoint ,030212 general & internal medicine ,education ,610 Medicine & health ,Original Investigation ,education.field_of_study ,business.industry ,food and beverages ,medicine.disease ,Head and neck squamous-cell carcinoma ,030220 oncology & carcinogenesis ,bacteria ,sense organs ,Human medicine ,business ,Chemoradiotherapy ,medicine.drug - Abstract
LUX-Head & Neck 2 investigators., [Importance] Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC., [Objective] To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC., [Design, Setting, and Participants] This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population., [Interventions] Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal., [Main Outcomes and Measures] The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life., [Results] A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group)., [Conclusions and Relevance] This study’s findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended., [Trial Registration] ClinicalTrials.gov identifier: NCT01345669., The study was funded by Boehringer Ingelheim.
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- 2019
23. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study.
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UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Cohen, Ezra E W, Soulières, Denis, Le Tourneau, Christophe, Dinis, José, Licitra, Lisa, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Zhang, Pingye, Cheng, Jonathan, Swaby, Ramona F, Harrington, Kevin J, KEYNOTE-040 investigators, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Cohen, Ezra E W, Soulières, Denis, Le Tourneau, Christophe, Dinis, José, Licitra, Lisa, Ahn, Myung-Ju, Soria, Ainara, Machiels, Jean-Pascal, Mach, Nicolas, Mehra, Ranee, Burtness, Barbara, Zhang, Pingye, Cheng, Jonathan, Swaby, Ramona F, Harrington, Kevin J, and KEYNOTE-040 investigators
- Abstract
BACKGROUND: There are few effective treatment options for patients with recurrent or metastatic head-and-neck squamous cell carcinoma. Pembrolizumab showed antitumour activity and manageable toxicity in early-phase trials. We aimed to compare the efficacy and safety of pembrolizumab versus standard-of-care therapy for the treatment of head-and-neck squamous cell carcinoma. METHODS: We did a randomised, open-label, phase 3 study at 97 medical centres in 20 countries. Patients with head-and-neck squamous cell carcinoma that progressed during or after platinum-containing treatment for recurrent or metastatic disease (or both), or whose disease recurred or progressed within 3-6 months of previous multimodal therapy containing platinum for locally advanced disease, were randomly assigned (1:1) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive pembrolizumab 200 mg every 3 weeks intravenously or investigator's choice of standard doses of methotrexate, docetaxel, or cetuximab intravenously (standard-of-care group). The primary endpoint was overall survival in the intention-to-treat population. Safety was analysed in the as-treated population. This trial is registered with ClinicalTrials.gov, number NCT02252042, and is no longer enrolling patients. FINDINGS: Between Dec 24, 2014, and May 13, 2016, 247 patients were randomly allocated to pembrolizumab and 248 were randomly allocated to standard of care. As of May 15, 2017, 181 (73%) of 247 patients in the pembrolizumab group and 207 (83%) of 248 patients in the standard-of-care group had died. Median overall survival in the intention-to-treat population was 8·4 months (95% CI 6·4-9·4) with pembrolizumab and 6·9 months (5·9-8·0) with standard of care (hazard ratio 0·80, 0·65-0·98; nominal p=0·0161). Fewer patients treated with pembrolizumab than with standard of care had grade 3 or worse treatment-related adverse events (33 [13%] of 246 vs 85 [36%] of 234). The most
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- 2019
24. Pembrolizumab (pembro) for recurrent head and neck squamous cell carcinoma (HNSCC): Post hoc analyses of phase 3 KEYNOTE-040 prior radiation treatment (RT) and disease state.
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Harrington, Kevin J., primary, Cohen, Ezra E.W., additional, Soulieres, Denis, additional, Dinis, José, additional, Licitra, Lisa F., additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal H., additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Lin, Jianxin, additional, Cheng, Jonathan D., additional, Swaby, Ramona F., additional, and Le Tourneau, Christophe, additional
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- 2019
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25. A phase I study (E011-MEL) of a TriMix-based mRNA immunotherapy (ECI-006) in resected melanoma patients: Analysis of safety and immunogenicity.
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Arance Fernandez, ANA Maria, primary, Baurain, Jean-Francois, additional, Vulsteke, Christof, additional, Rutten, Annemie, additional, Soria, Ainara, additional, Carrasco, Javier, additional, Neyns, Bart, additional, De Keersmaecker, Brenda, additional, Van Assche, Tim, additional, and Lindmark, Bertil, additional
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- 2019
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26. Tumores indiferenciados de senos paranasales. Experiencia del Hospital Universitario Ramón y Cajal a propósito de un caso y revisión de la literatura
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Molina-Cerrillo, Javier, primary, Garrido, Pilar, additional, Soria, Ainara, additional, and Alonso-Gordoa, Teresa, additional
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- 2019
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27. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study
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Cohen, Ezra E W, primary, Soulières, Denis, additional, Le Tourneau, Christophe, additional, Dinis, José, additional, Licitra, Lisa, additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal, additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Zhang, Pingye, additional, Cheng, Jonathan, additional, Swaby, Ramona F, additional, Harrington, Kevin J, additional, Acosta-Rivera, Mirelis, additional, Adkins, Douglas R., additional, Aghmesheh, Morteza, additional, Airoldi, Mario, additional, Aleknavicius, Eduardas, additional, Al-Farhat, Yousuf, additional, Algazi, Alain P., additional, Almokadem, Salah, additional, Alyasova, Anna, additional, Bauman, Jessica R., additional, Benasso, Marco, additional, Berrocal, Alfonso, additional, Bray, Victoria, additional, Burtness, Barbara Ann, additional, Caponigro, Francesco, additional, Castro, Ana, additional, Cescon, Terrence P., additional, Chan, Kelvin, additional, Chaudhry, Arvind, additional, Chauffert, Bruno, additional, Cohen, Ezra, additional, Csoszi, Tibor, additional, De Boer, J.P., additional, Delord, Jean-Pierre, additional, Dietz, Andreas, additional, Dinis, Jose, additional, Dupuis, Charlotte, additional, Digue, Laurence, additional, Erfan, Jozsef, additional, Escobar Alvarez, Yolanda, additional, Evans, Mererid, additional, Fidler, Mary Jo, additional, Forster, Martin David, additional, Friesland, Signe, additional, Ganti, Apar K., additional, Geoffrois, Lionnel, additional, Grant, Cliona, additional, Gruenwald, Viktor, additional, Harrington, Kevin, additional, Hoffmann, Thomas, additional, Horvai, Geza, additional, Inciura, Arturas, additional, Jang, Raymond, additional, Jankowska, Petra, additional, Jimeno, Antonio, additional, Joseph, Mano, additional, Juarez Ramiro, Alejandro, additional, Karaszewska, Boguslawa, additional, Kawecki, Andrzej, additional, Keilholz, Ulrich, additional, Keller, Ulrich, additional, Kim, Sung-Bae, additional, Kocsis, Judit, additional, Kotecki, Nuria, additional, Kozloff, Mark F., additional, Lambea, Julio, additional, Landherr, Laszlo, additional, Lantsukhay, Yuri, additional, Lazarev, Sergey Alexandrovich, additional, Lee, Lip Way, additional, Lifirenko, Igor Dmitrievich, additional, Martincic, Danko, additional, Matorin, Oleg Vladmirovhich, additional, McGrath, Margaret, additional, Misiukiewicz, Krzysztof, additional, Morris, John C., additional, Mufazalov, Fagim Fanisovich, additional, Niu, Jiaxin, additional, Pamoorthy Srinivasan, Devraj, additional, Perez Segura, Pedro, additional, Rauch, Daniel, additional, Ribeiro, Maria Leonor, additional, Rodriguez, Cristina, additional, Rolland, Frederic, additional, Russo, Antonio, additional, Ruzsa, Agnes, additional, Sanches, Frederico, additional, Shin, Sang-Won, additional, Shtiveland, Mikhail, additional, Soulieres, Denis, additional, Specenier, Pol, additional, Szekanecz, Eva, additional, Szota, Judit, additional, van Herpen, Carla M.L., additional, Velez-Cortes, Hector A., additional, Walsh, William V., additional, Wilop, Stefan, additional, Winterhalder, Ralph, additional, Wojtukiewicz, Marek, additional, Wong, Deborah, additional, and Zandberg, Dan, additional
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- 2019
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28. Gastrostomy vs nasogastric tube feeding in patients with head and neck cancer during radiotherapy alone or combined chemoradiotherapy
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Soria, Ainara, Santacruz, Elisa, Vega-Piñero, Belén, Gión, María, Molina, Javier, Villamayor, María, Mateo, Raquel, Riveiro, Javier, Nattero, Lia, and Botella-Carretero, José-I.
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Gastrostomy ,Nasogastric tube ,Desnutrición ,Sonda nasogástrica ,Malnutrition ,Cáncer de cabeza y cuello ,Nutrición enteral ,Gastrostomía ,Chemoradiotherapy ,Head and neck cancer ,Enteral nutrition ,Quimiorradioterapia - Abstract
Introduction: Patients with head and neck cancer (HNC) submitted to radiotherapy alone or combined chemoradiotherapy present a high prevalence of malnutrition at baseline. Prophylactic use of gastrostomy has been suggested for these patients for delivering enteral nutrition. On the other hand, other authors have failed to demonstrate the effectiveness of this measure over nasogastric tube feeding. Material and methods: We studied 40 patients with HNC with moderate or severe malnutrition who were offered either prophylactic percutaneous gastrostomy before starting oncologic treatment or close follow-up with nutritional counseling with the placement of a nasogastric tube when necessary. Results: There were no significant changes throughout the study period in weight (p = 0.338), body mass index (BMI) (p = 0.314) or serum proteins (p = 0.729), and these changes showed no differences between the gastrostomy vs nasogastric tube feeding groups. The amount of delivered energy was above the estimated energy needs with both gastrostomy and nasogastric tube feeding, but there were no differences in the total energy provided by enteral nutrition between groups. Patients in the gastrostomy group received enteral nutrition support for a longer period of time (p = 0.007). Conclusions: Both gastrostomy and nasogastric tube feeding are effective methods of delivering enteral nutrition in patients with HNC submitted to radiotherapy alone or combined chemoradiotherapy, with no differences between them in terms of avoiding further nutritional deterioration. Resumen Introducción: los pacientes con cáncer de cabeza y cuello (CCC) que reciben radioterapia o tratamiento combinado con radioterapia y quimioterapia presentan una elevada prevalencia de desnutrición. El uso profiláctico de la gastrostomía se ha sugerido para el soporte nutricional enteral en estos pacientes. Sin embargo, otros autores no han demostrado un beneficio claro de esta medida frente al uso de la sonda nasogástrica. Material y métodos: se realizó el estudio en cuarenta pacientes con CCC con desnutrición moderada o grave, a los cuales se les ofreció la gastrostomía percutánea antes de empezar el tratamiento oncológico o bien seguimiento estrecho mediante consejo nutricional y la colocación de una sonda nasogástrica en el momento necesario. Resultados: no se encontraron cambios significativos en cuanto a peso, (p = 0,338), índice de masa corporal (p = 0,314) o proteínas séricas (p = 0,729) durante el seguimiento, y estos cambios tampoco fueron diferentes entre los pacientes con gastrostomía o con sonda nasogástrica. Las calorías recibidas fueron superiores a los requerimientos estimados en ambos grupos, pero no existieron diferencias entre ellos. Los pacientes con gastrostomía recibieron nutrición enteral durante más tiempo (p = 0,007). Conclusiones: tanto la gastrostomía como la sonda nasogástrica son eficaces para el soporte nutricional enteral en pacientes con CCC que reciben radioterapia o tratamiento combinado con quimioterapia y radioterapia, sin mostrar diferencias en la evolución nutricional entre ambas.
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- 2017
29. Predictive factors of response to immunotherapy-a review from the Spanish Melanoma Group (GEM)
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Espinosa, Enrique, Márquez-Rodas, Ivan, Soria, Ainara, Berrocal, Alfonso, Manzano, Jose Luis, Gonzalez-Cao, Maria, and Martin-Algarra, Salvador
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predictive factors ,PD-1 ,melanoma ,CTLA-4 - Abstract
Immunotherapy has become a key element in the treatment of several tumors, such as lung carcinoma and melanoma. Immunotherapy, unlike classical chemotherapy and targeted drugs, may yield long-term survival, even in patients who stop treatment due to toxicity. This fact has generated considerable excitement and a real shift in the paradigm of cancer treatment. However, only a small subset of patients benefit from immunotherapy. Survival curves show that most patients have progression of the disease in the first months after starting immunotherapy, followed by a slower decrease over the first 3 years, until curves reach a plateau. This early progression suggests the presence of mechanisms for primary resistance. In addition, some patients have tumor relapse after years of response, suggesting that there is also acquired resistance in a small subset of patients. Resistance mechanisms are now being elucidated. PD-L1 expression in tumor and immune cells correlates with higher chances of response, but melanoma patients with PD-L1 negative tumors can also respond. Several studies have demonstrated an increased probability of clinical benefit when tumors are infiltrated by CD8 T cells, have a high mutation burden or have an interferon gamma signature. But none of these factors has been implemented in the clinical practice, since more studies confirming their value are needed, as well as the development of standardized techniques.
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- 2017
30. Abstract CT115: Updated survival results of the KEYNOTE-040 study of pembrolizumab vs standard-of-care chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma
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Soulieres, Denis, primary, Cohen, Ezra, additional, Tourneau, Christophe Le, additional, Dinis, Jose, additional, Licitra, Lisa, additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal, additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Zhang, Pingye, additional, Cheng, Jonathan, additional, Swaby, Ramona, additional, and Harrington, Kevin J., additional
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- 2018
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31. Early evolution of BRAFV600 status in the blood of melanoma patients correlates with clinical outcome and identifies patients refractory to therapy
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Gonzalez-Cao, Maria, primary, Mayo de las Casas, Clara, additional, Jordana Ariza, Nuria, additional, Manzano, Jose L., additional, Molina-Vila, Miguel Á., additional, Soriano, Virtudes, additional, Puertolas, Teresa, additional, Balada, Ariadna, additional, Soria, Ainara, additional, Majem, Margarita, additional, Montagut, Clara, additional, Muñoz, Eva, additional, Rodriguez-Abreu, Delvys, additional, Perez, Elisabeth, additional, Garcia, Almudena, additional, Cortes, Javier, additional, Drozdowskyj, Ana, additional, Karachaliou, Niki, additional, and Rosell, Rafael, additional
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- 2018
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32. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040.
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Cohen, Ezra E.W., primary, Soulieres, Denis, additional, Le Tourneau, Christophe, additional, Dinis, Jose, additional, Licitra, Lisa F., additional, Ahn, Myung-Ju, additional, Soria, Ainara, additional, Machiels, Jean-Pascal H., additional, Mach, Nicolas, additional, Mehra, Ranee, additional, Burtness, Barbara, additional, Ellison, Misoo C., additional, Cheng, Jonathan D., additional, Chirovsky, Diana Romana, additional, Swaby, Ramona F., additional, and Harrington, Kevin J., additional
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- 2018
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33. Autoimmune endocrinopathies induced by immunomodulating antibodies in the treatment of cancer
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Iglesias, Pedro, Soria, Ainara, and Díez, Juan José
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- 2015
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34. Melanoma proteomics unravels major differences related to mutational status
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Trilla-Fuertes, Lucía, primary, Gámez-Pozo, Angelo, additional, Prado-Vázquez, Guillermo, additional, Zapater-Moros, Andrea, additional, Díaz-Almirón, Mariana, additional, Fortes, Claudia, additional, López-Vacas, Rocío, additional, Márquez-Rodas, Iván, additional, Soria, Ainara, additional, Fresno Vara, Juan Ángel, additional, and Espinosa, Enrique, additional
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- 2017
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35. Infomelanoma 2020: an online digital application designed to assist health professionals for melanoma treatment
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González-Cao, Maria, primary, Carrasco-Calvo, Mar, additional, Soria, Ainara, additional, Berrocal, Alfonso, additional, Arance, Ana, additional, Puig, Susana, additional, Alós, Laura, additional, Viteri, Santiago, additional, Cerezuela, Pablo, additional, and Martín-Algarra, Salvador, additional
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- 2017
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36. Gastrostomy vsnasogastric tube feeding in patients with head and neck cancer during radiotherapy alone or combined chemoradiotherapy
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Soria, Ainara, primary, Santacruz, Elisa, additional, Vega-Piñeiro, Belén, additional, Gión, María, additional, Molina, Javier, additional, Villamayor, María, additional, Mateo, Raquel, additional, Riveiro, Javier, additional, Nattero, Lia, additional, and Botella-Carretero, José I., additional
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- 2017
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37. P3.02c-079 Immunotherapy in Non-Small Cell Lung Cancer (NSCLC): Biomarkers Associated with Early Death
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Del Toro, Jacobo Muñoz, primary, Olmedo, Eugenia, additional, Gomez, Ana, additional, Madariaga, Ainhoa, additional, Templado, Josefa Perez, additional, Gorospe, Luis, additional, Reguera, Pablo, additional, Soria, Ainara, additional, Gión, María, additional, Martínez, Olga, additional, Molina, Javier, additional, Villamayor, María, additional, Saavedra, Cristina, additional, Muñoz, Gema, additional, Albarrán, Victor, additional, Benito, Amparo, additional, Barquin, Arantzazu, additional, Cabañero, Alberto, additional, Alonso, Teresa, additional, Gajate, Pablo, additional, Grande, Enrique, additional, and Garrido, Pilar, additional
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- 2017
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38. P3.02c-075 Could Blood Levels of Lymphocytes and Eosinophils Help Us to Identify the Efficacy or Toxicity of Immunotherapy?
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Olmedo, Eugenia, primary, Del Toro, Jacobo Muñoz, additional, Gorospe, Luis, additional, Templado, Josefa Perez, additional, Gomez, Ana, additional, Reguera, Pablo, additional, Gión, María, additional, Madariaga, Ainhoa, additional, Martínez, Olga, additional, Molina, Javier, additional, Villamayor, María, additional, Albarrán, Victor, additional, Barquin, Arantzazu, additional, Saavedra, Cristina, additional, Soria, Ainara, additional, Alonso, Teresa, additional, Gajate, Pablo, additional, Grande, Enrique, additional, and Garrido, Pilar, additional
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- 2017
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39. Immune checkpoint inhibitors: therapeutic advances in melanoma
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Márquez-Rodas, Ivan, Cerezuela, Pablo, Soria, Ainara, Berrocal, Alfonso, Riso, Aldo, González-Cao, María, and Martín-Algarra, Salvador
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programmed cell death protein 1 (PD-1) ,melanoma ,immunotherapy ,Checkpoint inhibitors - Abstract
In recent years, new strategies for treating melanoma have been introduced, improving the outlook for this challenging disease. One of the most important advances has been the development of immunotherapy. The better understanding of the role of the immunological system in tumor control has paved the way for strategies to enhance the immune response against cancer cells. Monoclonal antibodies (mAbs) against the immune checkpoints cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death protein 1 (PD-1) and its ligand (PD-L1) have demonstrated high activity in melanoma and other tumors. Ipilimumab, an anti CTLA-4 antibody, was the first drug of this class that was approved. Although the response rate with ipilimumab is low (less than 20% of patients have objective responses), 20% of patients have long survival, with similar results in the first and second line settings. Nivolumab and pembrolizumab, both anti PD-1 inhibitors, have been approved for the treatment of melanoma, with response rates of 40% and a demonstrated survival advantage in phase III trials. This has marked a new era in the treatment of metastatic melanoma and much research is now ongoing with other drugs targeting checkpoint inhibitors. In addition, the agonist of activating molecules on T cells and their combinations are being investigated. Herein we review the clinical development of checkpoint inhibitors and their approval for treatment of metastatic melanoma.
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- 2015
40. Abstract 468: BRAF mutation analysis in cell free tumoral DNA (cfDNA) of melanoma patients: results from the prospective study GEM1304 (Spanish Melanoma Group)
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Gonzalez Cao, Maria, primary, Manzano, Jose Luis, additional, Soriano, Virtudes, additional, Puertolas, Teresa, additional, Soria, Ainara, additional, Mayo, Clara, additional, Magem, Margarita, additional, Molina, Miguel Angel, additional, Montagut, Clara, additional, Muñoz, Eva, additional, Rodriguez, Delvys, additional, Perez, Elizabeth, additional, Garcia, Almudena, additional, Cortes, Javier, additional, Jordana, Nuria, additional, Rodon, Jordi, additional, Karachaliou, Niki, additional, and Rosell, Rafael, additional
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- 2016
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41. Treatment patterns of adjuvant interferon-α2b for high-risk melanoma: a retrospective study of the Grupo Español Multidisciplinar de Melanoma – Prima study
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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
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- 2016
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42. Ipilimumab-induced colitis: A new challenge for gastroenterologists
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Mesonero, Francisco, primary, López-Sanromán, Antonio, additional, Madariaga, Ainhoa, additional, and Soria, Ainara, additional
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- 2016
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43. Colitis secundaria a ipilimumab: un nuevo reto para el gastroenterólogo
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Mesonero, Francisco, primary, López-Sanromán, Antonio, additional, Madariaga, Ainhoa, additional, and Soria, Ainara, additional
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- 2016
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44. Dabrafenib plus trametinib for compassionate use in metastatic melanoma: A STROBE-compliant retrospective observational postauthorization study.
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Algarra, Salvador Martín, Soriano, Virtudes, Fernández-Morales, Luis, Berciano-Guerrero, Miguel-Ángel, Mujika, Karmele, Manzano, José Luis, Hernández, Teresa Puértolas, Soria, Ainara, Rodríguez-Abreu, Delvys, Arranz, Enrique Espinosa, Martínez, Javier Medina, Márquez-Rodas, Ivan, Rubió-Casadevall, Jordi, Ortega, María Eugenia, Jurado García, José Miguel, Lecumberri Biurrun, María José, Palacio, Isabel, de la Borbolla Artacho, María Rodríguez, Altozano, Javier Pérez, and Castellón Rubio, Victoria Eugenia
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- 2017
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45. Endocrinopatías autoinmunitarias inducidas por anticuerpos inmunomoduladores en el tratamiento del cáncer
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Iglesias, Pedro, primary, Soria, Ainara, additional, and Díez, Juan José, additional
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- 2015
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46. Ipilimumab-induced hypophysitis in cancer patients
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Lafuente, Christian, primary, Arcano, Karina, additional, Guerrero, Fernando, additional, Marengo, A, additional, Peiro, I, additional, Soria, Ainara, additional, Diez, Juan Jose, additional, Villabona, Carlos, additional, and Iglesias, Pedro, additional
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- 2015
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47. Early evolution of BRAFV600status in the blood of melanoma patients correlates with clinical outcome and identifies patients refractory to therapy
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Gonzalez-Cao, Maria, Mayo de las Casas, Clara, Jordana Ariza, Nuria, Manzano, Jose L., Molina-Vila, Miguel Á., Soriano, Virtudes, Puertolas, Teresa, Balada, Ariadna, Soria, Ainara, Majem, Margarita, Montagut, Clara, Muñoz, Eva, Rodriguez-Abreu, Delvys, Perez, Elisabeth, Garcia, Almudena, Cortes, Javier, Drozdowskyj, Ana, Karachaliou, Niki, and Rosell, Rafael
- Abstract
Supplemental Digital Content is available in the text.Serial analysis of BRAFmutations in circulating-free DNA (cfDNA) could be of prognostic value in melanoma patients. We collected blood samples from 63 advanced BRAFV600E/Kmelanoma patients and determined BRAFV600E/Kstatus in cfDNA using a quantitative 5′-nuclease PCR-based assay. Levels of BRAFmutation in pre-cfDNAs were associated significantly with tumour burden, progression-free survival and overall survival. Changes in BRAFstatus in cfDNA after initiation of treatment (early-cfDNA) had a significant correlation with outcome. In patients with persistent BRAFmutations (n=12), progression-free survival and overall survival were 3.5 months [95% confidence interval (CI): 1.6–4.6] and 5.3 months (95% CI: 3.4–8.1) compared with 16.6 months (95% CI: 8.2–22.3) and 21.9 months (95% CI: 10.2–NR) in patients with BRAFnegativization (n=16), and 15.1 months (95% CI: 2.3–NR) and NR (95% CI: 5.1–NR) in patients who maintained their initial negative status (n=12) (P<0.0001). The median duration of response in patients with radiological response, but persistence of BRAFV600in early-cfDNA (n=5) was 4 months. Our study indicates that serial BRAFtesting in the blood of advanced melanoma identifies patients refractory to therapy.
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- 2018
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48. Frequency and Characteristics of Familial Melanoma in Spain: The FAM-GEM-1 Study.
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Márquez-Rodas, Iván, Martín González, Manuel, Nagore, Eduardo, Gómez-Fernández, Cristina, Avilés-Izquierdo, Jose Antonio, Maldonado-Seral, Cayetana, Soriano, Virtudes, Majem-Tarruella, Margarita, Palomar, Virginia, Maseda, Rocio, Martín-Carnicero, Alfonso, Puertolas, Teresa, Godoy, Elena, Cerezuela, Pablo, Ochoa de Olza, Maria, Campos, Begoña, Perez-Ruiz, Elisabeth, Soria, Ainara, Gil-Arnaiz, Irene, and Gonzalez-Cao, Maria
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FAMILY history (Medicine) ,MELANOMA ,DERMATOLOGY ,ONCOLOGY ,PATIENTS ,CANCER risk factors - Abstract
Introduction: Familial history of melanoma is a well-known risk factor for the disease, and 7% melanoma patients were reported to have a family history of melanoma. Data relating to the frequency and clinical and pathological characteristics of both familial and non-familial melanoma in Spain have been published, but these only include patients from specific areas of Spain and do not represent the data for the whole of Spain. Patients and methods: An observational study conducted by the Spanish Group of Melanoma (GEM) analyzed the family history of patients diagnosed with melanoma between 2011 and 2013 in the dermatology and oncology departments. Results: In all, 1047 patients were analyzed, and 69 (6.6%) fulfilled criteria for classical familial melanoma (two or more first-degree relatives diagnosed with melanoma). Taking into account other risk factors for familial melanoma, such as multiple melanoma, pancreatic cancer in the family or second-degree relatives with melanoma, the number of patients fulfilling the criteria increased to 165 (15.8%). Using a univariate analysis, we determined that a Breslow index of less than 1 mm, negative mitosis, multiple melanoma, and a history of sunburns in childhood were more frequent in familial melanoma patients, but a multivariate analysis revealed no differences in any pathological or clinical factor between the two groups. Conclusions: Similar to that observed in other countries, familial melanoma accounts for 6.6% of melanoma diagnoses in Spain. Although no differences in the multivariate analysis were found, some better prognosis factors, such as Breslow index, seem more frequent in familial melanoma, which reflect a better early detection marker and/or a different biological behavior. [ABSTRACT FROM AUTHOR]
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- 2015
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49. Dabrafenib plus trametinib for compassionate use in metastatic melanoma
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Karmele Mujika, Pablo Luna, Victoria Eugenia Castellón Rubio, Javier Pérez Altozano, María José Lecumberri Biurrun, Jose Luis Manzano, María Eugenia Ortega, Virtudes Soriano, José Antonio López Martín, Delvys Rodriguez-Abreu, Luis Antonio Fernandez-Morales, Salvador Martin Algarra, Jordi Rubió-Casadevall, Anabel Ballesteros, Almudena Garcia, Ivan Marquez-Rodas, Teresa Puértolas Hernández, María Rodríguez de la Borbolla Artacho, Ainara Soria, Enrique Espinosa Arranz, Javier Martínez, Alfonso Berrocal, José Miguel Jurado García, Isabel Palacio, Ovidio Fernández, Miguel-Ángel Berciano-Guerrero, Ana Arance, [Martin Algarra, Salvador] Clin Univ Navarra, Med Oncol, Pamplona, Spain, [Soriano, Virtudes] Inst Valenciano Oncol, Valencia, Spain, [Fernandez-Morales, Luis] Parc Tauli Sabadell Hosp Univ, Med Oncol, Sabadell, Spain, [Berciano-Guerrero, Miguel-Angel] HURyVV, Oncol Interctr, Malaga, Spain, [Berciano-Guerrero, Miguel-Angel] Inst Invest Biomed Malaga IBIMA, Malaga, Spain, [Mujika, Karmele] Inst Oncol Kutxa, Onkol, San Sebastian, Spain, [Luis Manzano, Jose] Hosp Badalona Germans Trias & Pujol, Inst Catalan Oncol, ICO Badalona, Barcelona, Spain, [Hernandez, Teresa Puertolas] Hosp Univ Miguel Servet, Med Oncol, Zaragoza, Spain, [Soria, Ainara] Hosp Univ Ramon & Cajal, Med Oncol, Madrid, Spain, [Rodriguez-Abreu, Delvys] Complejo Hosp Univ Insular Materno Infantil Gran, Med Oncol, Las Palmas Gran Canaria, Spain, [Espinosa Arranz, Enrique] Hosp Univ La Paz, Med Oncol, Madrid, Spain, [Medina Martinez, Javier] Hosp Virgen de la Salud, Med Oncol, Toledo, Spain, [Marquez-Rodas, Ivan] Hosp Gen Univ Gregorio Maranon, Med Oncol, Madrid, Spain, [Rubio-Casadevall, Jordi] Inst Catalan Oncol Girona, Girona, Spain, [Eugenia Ortega, Maria] Hosp Arnau Vilanova, Med Oncol, Lleida, Spain, [Jurado Garcia, Jose Miguel] Hosp Univ San Cecilio, Med Oncol, Granada, Spain, [Lecumberri Biurrun, Maria Jose] Complejo Hosp Navarra, Med Oncol, Pamplona, Spain, [Palacio, Isabel] Hosp Univ Cent Asturias, Med Oncol, Oviedo, Spain, [de la Borbolla Artacho, Maria Rodriguez] Hosp Univ Nuestra Senora Valme, Med Oncol, Seville, Spain, [Perez Altozano, Javier] Hosp Gen Univ Elche, Med Oncol, Alicante, Spain, [Castellon Rubio, Victoria Eugenia] Complejo Hosp Torrecardenas Almeria, Med Oncol, Almeria, Spain, [Garcia, Almudena] Hosp Marques de Valdecilla, Med Oncol, Santander, Spain, [Luna, Pablo] Hosp Univ Son Espases, Med Oncol, Palma De Mallorca, Spain, [Ballesteros, Anabel] Hosp Univ La Princesa, Med Oncol, Madrid, Spain, [Fernandez, Ovidio] Complejo Hosp Univ Ourense, Med Oncol, Orense, Spain, [Lopez Martin, Jose Antonio] Hosp Univ 12 Octubre, Med Oncol, Madrid, Spain, [Berrocal, Alfonso] Hosp Gen Univ Valencia, Med Oncol, Valencia, Spain, [Arance, Ana] Hosp Clin Barcelona, Med Oncol, Barcelona, Spain, and Novartis
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Compassionate Use Trials ,Male ,Survival ,humanos ,Resistance ,0302 clinical medicine ,Antineoplastic Combined Chemotherapy Protocols ,Oximes ,Medicine ,030212 general & internal medicine ,Neoplasm Metastasis ,Multicenter ,Melanoma ,metástasis neoplásica ,mediana edad ,Aged, 80 and over ,Trametinib ,anciano ,trametinib ,protocolos de quimioterapia antineoplásica combinada ,Imidazoles ,BRAF inhibitors ,General Medicine ,adulto ,análisis de supervivencia ,Middle Aged ,Rash ,030220 oncology & carcinogenesis ,Combination ,Female ,medicine.symptom ,Mutations ,metastatic melanoma ,medicine.drug ,Adult ,medicine.medical_specialty ,Pyridones ,oximas ,compassionate use ,Pyrimidinones ,BRAF ,03 medical and health sciences ,Internal medicine ,melanoma ,Humans ,Stage IIIC ,dabrafenib ,Survival analysis ,Aged ,Retrospective Studies ,business.industry ,estudios retrospectivos ,pirimidinonas ,Dabrafenib ,ensayos clínicos de uso compasivo ,medicine.disease ,Survival Analysis ,Regimen ,Braf inhibition ,Vemurafenib ,Spain ,Therapy ,piridonas ,business ,V600E - Abstract
The main objective of the study was to evaluate the efficacy and safety of dabrafenib alone or combined with trametinib for compassionate use in patients with metastatic melanoma.This retrospective, observational study involved 135 patients with unresectable stage IIIC or stage IV melanoma from an expanded-access program at 30 Spanish centers.Forty-eight patients received dabrafenib monotherapy and 87 received combination dabrafenib and trametinib; 4.4% and 95.6% of the patients had stage IIIC and IV melanoma, respectively. All patients showed BRAF mutations in their primary or metastatic lesions; 3 were positive for V600K while the remainder had V600E or V600+. A positive response to treatment was reported in 89.3% of the patients. Overall survival rates at 12 and 24 months were 59.6% (95% confidence interval [CI], 52.5-68.9%) and 36.4% (95% CI, 27.8-45%), respectively. Progression-free survival rates at 12 and 24 months were 39.3% (95% CI, 31.1-47.5%) and 21.6% (95% CI, 14.5-28.7%), respectively. Fifty-seven patients (42.2%) reported cutaneous toxicity of any type, mainly hyperkeratosis (14.8%) and rash (11.9%). The most frequent adverse events were pyrexia (27.4%), asthenia (19.3%), arthralgia (16.9%), and diarrhoea (13.2%).Our results suggest that both dabrafenib alone or in combination with trametinib are effective for compassionate use in terms of response and/or survival rates. However, differences in patients' prognostic features ought to be considered. No new findings were revealed regarding the safety profiles of either regimen. This is the first study to evaluate the efficacy of these 2 selective BRAF and mitogen-activated extracellular signal-regulated kinase inhibitors in a real-world setting in Spain., Novartis have provided funding for this observational study.
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- 2017
50. Detrimental effect of an early exposure to antibiotics on the outcomes of immunotherapy in a multi-tumor cohort of patients.
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Guerrero P, Albarrán V, González-Merino C, García de Quevedo C, Sotoca P, Chamorro J, Rosero DI, Barrill A, Alía V, Calvo JC, Moreno J, Pérez de Aguado P, Álvarez-Ballesteros P, San Román M, Serrano JJ, Soria A, Olmedo ME, Saavedra C, Cortés A, Gómez A, Lage Y, Ruiz Á, Ferreiro MR, Longo F, Guerra E, Martínez-Delfrade Í, Garrido P, and Gajate P
- Abstract
Background: Immune checkpoint inhibitors (ICI) have changed the therapeutic landscape of many solid tumors. Modulation of the intestinal microbiota by antibiotics (Abx) has been suggested to impact on ICI outcomes., Methods: Retrospective analysis of 475 patients with advanced solid tumors treated with ICI from 2015 to 2022. For each patient, the use of Abx was recorded from 1 month before ICI initiation until disease progression or death. The impact of Abx on objective response rates (ORR), disease control rates (DCR), progression-free survival (PFS), and overall survival (OS) was analyzed. Kaplan-Meier and log-rank tests were used to compare survival outcomes., Results: In total 475 patients with advanced solid tumors were evaluated. Median age was 67.5 years and performance status (PS) was 0-1 in 84.6%. 66.5% of patients received Abx during treatment with ICI, mainly beta-lactams (53.8%) and quinolones (35.9%). The early exposure to Abx (from 60 days before to 42 days after the first cycle of ICI) was associated with a lower ORR (27.4% vs 39.4%; P < .01), a lower DCR (37.3% vs 57.4%; P < .001), lower PFS (16.8 m vs 27.8 m; HR 0.66; P < .001]) and lower OS (2.5 m vs 6.6 m; HR 0.68; P = .001]). The negative impact of Abx on OS and PFS was confirmed by a multivariable analysis. This effect was not observed among patients receiving Abx after 6 weeks from ICI initiation., Conclusions: Our results validate the hypothesis of a detrimental effect of an early exposure to Abxon the efficacy of ICI in a multi-tumor cohort of patients., (© The Author(s) 2024. Published by Oxford University Press.)
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- 2024
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