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2. Preclinical and randomized phase I studies of plitidepsin in adults hospitalized with COVID-19

Author

Varona, Jose F, Landete, Pedro, Lopez-Martin, Jose A, Estrada, Vicente, Paredes, Roger, Guisado-Vasco, Pablo, de Orueta, Lucia Fernandez, Torralba, Miguel, Fortun, Jesus, Vates, Roberto, Barberan, Jose, Clotet, Bonaventura, Ancochea, Julio, Carnevali, Daniel, Cabello, Noemi, Porras, Lourdes, Gijon, Paloma, Monereo, Alfonso, Abad, Daniel, Zuñiga, Sonia, Sola, Isabel, Rodon, Jordi, Vergara-Alert, Julia, Izquierdo-Useros, Nuria, Fudio, Salvador, Pontes, Maria Jose, de Rivas, Beatriz, de Velasco, Patricia Giron, Nieto, Antonio, Gomez, Javier, Aviles, Pablo, Lubomirov, Rubin, Belgrano, Alvaro, Sopesen, Belen, White, Kris M, Rosales, Romel, Yildiz, Soner, Reuschl, Ann-Kathrin, Thorne, Lucy G, Jolly, Clare, Towers, Greg J, Zuliani-Alvarez, Lorena, Bouhaddou, Mehdi, Obernier, Kirsten, McGovern, Briana L, Rodriguez, M Luis, Enjuanes, Luis, Fernandez-Sousa, Jose M, Krogan, Nevan J, Jimeno, Jose M, and Garcia-Sastre, Adolfo

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Infectious Diseases, Cancer, Lung, Clinical Trials and Supportive Activities, Patient Safety, Prevention, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Aged, COVID-19, Cell Line, Tumor, Depsipeptides, Drug Evaluation, Preclinical, Female, Hospitalization, Humans, Kaplan-Meier Estimate, Length of Stay, Male, Middle Aged, Neutropenia, Peptides, Cyclic, SARS-CoV-2, Treatment Outcome, Viral Load, COVID-19 Drug Treatment, Biological sciences, Biomedical and clinical sciences
Abstract

Plitidepsin, a marine-derived cyclic-peptide, inhibits SARS-CoV-2 replication at nanomolar concentrations by targeting the host protein eukaryotic translation elongation factor 1A. Here, we show that plitidepsin distributes preferentially to lung over plasma, with similar potency against across several SARS-CoV-2 variants in preclinical studies. Simultaneously, in this randomized, parallel, open-label, proof-of-concept study (NCT04382066) conducted in 10 Spanish hospitals between May and November 2020, 46 adult hospitalized patients with confirmed SARS-CoV-2 infection received either 1.5 mg (n = 15), 2.0 mg (n = 16), or 2.5 mg (n = 15) plitidepsin once daily for 3 d. The primary objective was safety; viral load kinetics, mortality, need for increased respiratory support, and dose selection were secondary end points. One patient withdrew consent before starting procedures; 45 initiated treatment; one withdrew because of hypersensitivity. Two Grade 3 treatment-related adverse events were observed (hypersensitivity and diarrhea). Treatment-related adverse events affecting more than 5% of patients were nausea (42.2%), vomiting (15.6%), and diarrhea (6.7%). Mean viral load reductions from baseline were 1.35, 2.35, 3.25, and 3.85 log10 at days 4, 7, 15, and 31. Nonmechanical invasive ventilation was required in 8 of 44 evaluable patients (16.0%); six patients required intensive care support (13.6%), and three patients (6.7%) died (COVID-19-related). Plitidepsin has a favorable safety profile in patients with COVID-19.

Published
2022

3. SARS-CoV-2 variants evolve convergent strategies to remodel the host response

Author

Bouhaddou, Mehdi, Reuschl, Ann-Kathrin, Polacco, Benjamin J., Thorne, Lucy G., Ummadi, Manisha R., Ye, Chengjin, Rosales, Romel, Pelin, Adrian, Batra, Jyoti, Jang, Gwendolyn M., Xu, Jiewei, Moen, Jack M., Richards, Alicia L., Zhou, Yuan, Harjai, Bhavya, Stevenson, Erica, Rojc, Ajda, Ragazzini, Roberta, Whelan, Matthew V.X., Furnon, Wilhelm, De Lorenzo, Giuditta, Cowton, Vanessa, Syed, Abdullah M., Ciling, Alison, Deutsch, Noa, Pirak, Daniel, Dowgier, Giulia, Mesner, Dejan, Turner, Jane L., McGovern, Briana L., Rodriguez, M. Luis, Leiva-Rebollo, Rocio, Dunham, Alistair S., Zhong, Xiaofang, Eckhardt, Manon, Fossati, Andrea, Liotta, Nicholas F., Kehrer, Thomas, Cupic, Anastasija, Rutkowska, Magdalena, Mena, Ignacio, Aslam, Sadaf, Hoffert, Alyssa, Foussard, Helene, Olwal, Charles Ochieng’, Huang, Weiqing, Zwaka, Thomas, Pham, John, Lyons, Molly, Donohue, Laura, Griffin, Aliesha, Nugent, Rebecca, Holden, Kevin, Deans, Robert, Aviles, Pablo, Lopez-Martin, Jose A., Jimeno, Jose M., Obernier, Kirsten, Fabius, Jacqueline M., Soucheray, Margaret, Hüttenhain, Ruth, Jungreis, Irwin, Kellis, Manolis, Echeverria, Ignacia, Verba, Kliment, Bonfanti, Paola, Beltrao, Pedro, Sharan, Roded, Doudna, Jennifer A., Martinez-Sobrido, Luis, Patel, Arvind H., Palmarini, Massimo, Miorin, Lisa, White, Kris, Swaney, Danielle L., Garcia-Sastre, Adolfo, Jolly, Clare, Zuliani-Alvarez, Lorena, Towers, Greg J., and Krogan, Nevan J.

Published
2023
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5. A phase II trial of weekly nab-paclitaxel for progressive and symptomatic desmoid tumors

Author

Martin-Broto, Javier, Redondo, Andres, Moura, David S., Valverde, Claudia, Morales, Jose Manuel, Lopez-Pousa, Antonio, Martinez-Trufero, Javier, Gutierrez, Antonio, Díaz-Beveridge, Roberto, Luna, Pablo, Martinez-Marin, Virginia, Marcilla, David, Arribas, Ivan, Ledesma, Patricio, Lopez-Martin, Jose Antonio, Di Lernia, Davide, Zamora, Jorge, and Hindi, Nadia

Published
2022
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6. Dabrafenib plus trametinib in patients with BRAFV600E-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial

Author

Wen, Patrick Y, Stein, Alexander, van den Bent, Martin, De Greve, Jacques, Wick, Antje, de Vos, Filip Y F L, von Bubnoff, Nikolas, van Linde, Myra E, Lai, Albert, Prager, Gerald W, Campone, Mario, Fasolo, Angelica, Lopez-Martin, Jose A, Kim, Tae Min, Mason, Warren P, Hofheinz, Ralf-Dieter, Blay, Jean-Yves, Cho, Daniel C, Gazzah, Anas, Pouessel, Damien, Yachnin, Jeffrey, Boran, Aislyn, Burgess, Paul, Ilankumaran, Palanichamy, Gasal, Eduard, and Subbiah, Vivek

Published
2022
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7. Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors

Author

Von Hoff, Daniel D, Rasco, Drew W, Heath, Elisabeth I, Munster, Pamela N, Schellens, Jan HM, Isambert, Nicolas, Le Tourneau, Christophe, O'Neil, Bert, Mathijssen, Ron HJ, Lopez-Martin, Jose A, Edenfield, W Jeff, Martin, Miguel, LoRusso, Patricia M, Bray, Gordon L, DiMartino, Jorge, Nguyen, Aaron, Liu, Kejian, Laille, Eric, and Bendell, Johanna C

Subjects
Cancer, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Aged, Albumins, Antineoplastic Combined Chemotherapy Protocols, Azacitidine, Carboplatin, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Male, Maximum Tolerated Dose, Middle Aged, Neoplasms, Paclitaxel, Treatment Outcome, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Purpose: This large two-part, three-arm phase I study examined the safety and tolerability of CC-486 (an oral formulation of azacitidine, a hypomethylating agent) alone or in combination with the cytotoxic agents, carboplatin or nab-paclitaxel, in patients with advanced unresectable solid tumors.Patients and Methods: Part 1 (n = 57) was a dose escalation of CC-486 alone (arm C) or with carboplatin (arm A) or nab-paclitaxel (arm B). The primary endpoint was safety, MTD, and recommended part 2 dose (RP2D) of CC-486. In part 2 (n = 112), the primary endpoint was the safety and tolerability of CC-486 administered at the RP2D for each treatment arm, in tumor-specific expansion cohorts. Secondary endpoints included pharmacokinetics, pharmacodynamics, and antitumor activity of CC-486.Results: At pharmacologically active doses CC-486 in combination with carboplatin or nab-paclitaxel had a tolerable safety profile and no drug-drug interactions. The CC-486 RP2D was determined as 300 mg (every day, days 1-14/21) in combination with carboplatin (arm A) or as monotherapy (arm C); and 200 mg in the same dosing regimen in combination with nab-paclitaxel (arm B). Albeit limited by the small sample size, CC-486 monotherapy resulted in partial responses (three/eight) and stable disease (four/eight) in patients with nasopharyngeal cancer. Three of the stable disease responses lasted more than 150 days.Conclusions: CC-486 is well tolerated alone or in combination with carboplatin or nab-paclitaxel. Exploratory analyses suggest clinical activity of CC-486 monotherapy in nasopharyngeal cancer and provided the basis for an ongoing phase II clinical trial (ClinicalTrials.gov identifier: NCT02269943). Clin Cancer Res; 24(17); 4072-80. ©2018 AACR.

Published
2018

8. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study

Author

Marabelle, Aurélien, Fakih, Marwan, Lopez, Juanita, Shah, Manisha, Shapira-Frommer, Ronnie, Nakagawa, Kazuhiko, Chung, Hyun Cheol, Kindler, Hedy L, Lopez-Martin, Jose A, Miller, Wilson H, Jr, Italiano, Antoine, Kao, Steven, Piha-Paul, Sarina A, Delord, Jean-Pierre, McWilliams, Robert R, Fabrizio, David A, Aurora-Garg, Deepti, Xu, Lei, Jin, Fan, Norwood, Kevin, and Bang, Yung-Jue

Published
2020
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9. Pembrolizumab After Two or More Lines of Previous Therapy in Patients With Recurrent or Metastatic SCLC: Results From the KEYNOTE-028 and KEYNOTE-158 Studies

Author

Chung, Hyun Cheol, Piha-Paul, Sarina A., Lopez-Martin, Jose, Schellens, Jan H.M., Kao, Steven, Miller, Wilson H., Jr., Delord, Jean-Pierre, Gao, Bo, Planchard, David, Gottfried, Maya, Zer, Alona, Jalal, Shadia I., Penel, Nicolas, Mehnert, Janice M., Matos, Ignacio, Bennouna, Jaafar, Kim, Dong-Wan, Xu, Lei, Krishnan, Suba, Norwood, Kevin, and Ott, Patrick A.

Published
2020
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10. Intermittent BRAF inhibition in advanced BRAF mutated melanoma results of a phase II randomized trial

Author

Gonzalez-Cao, Maria, Mayo de las Casas, Clara, Oramas, Juana, Berciano-Guerrero, Miguel A., de la Cruz, Luis, Cerezuela, Pablo, Arance, Ana, Muñoz-Couselo, Eva, Espinosa, Enrique, Puertolas, Teresa, Diaz Beveridge, Roberto, Ochenduszko, Sebastian, Villanueva, Maria-Jose, Basterretxea, Laura, Bellido, Lorena, Rodriguez, Delvys, Campos, Begoña, Montagut, Clara, Drozdowskyj, Ana, Molina, Miguel A., Lopez-Martin, Jose Antonio, and Berrocal, Alfonso

Published
2021
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12. Phase Ib study evaluating safety and clinical activity of the anti-HER3 antibody lumretuzumab combined with the anti-HER2 antibody pertuzumab and paclitaxel in HER3-positive, HER2-low metastatic breast cancer

Author

Schneeweiss, Andreas, Park-Simon, Tjoung-Won, Albanell, Joan, Lassen, Ulrik, Cortés, Javier, Dieras, Veronique, May, Marcus, Schindler, Christoph, Marmé, Frederik, Cejalvo, Juan Miguel, Martinez-Garcia, Maria, Gonzalez, Iria, Lopez-Martin, Jose, Welt, Anja, Levy, Christelle, Joly, Florence, Michielin, Francesca, Jacob, Wolfgang, Adessi, Céline, Moisan, Annie, Meneses-Lorente, Georgina, Racek, Tomas, James, Ian, Ceppi, Maurizio, Hasmann, Max, Weisser, Martin, and Cervantes, Andrés

Published
2018
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14. Outcomes and clinical characteristics of the compassionate use of plitidepsin for immunocompromised adult patients with COVID-19

Author

Aguareles, José, Fernández, Paula Villares, Carralón-González, María Maravillas, Izquierdo, Carles Forné, Martí-Ballesteros, Eva María, Fernández, Virginia Pradillo, Sotres-Fernandez, Gabriel, García-Delangue, Teresa, LaPetra, Rocío García de Viedma, Sánchez-Manzano, María Dolores, Gutiérrez, Carolina, García-Coca, Marta, Carnevali-Ruiz, Daniel, Barrena-Puertas, Ruth, Luque-Pinilla, José Manuel, Lloris, Raquel, Luepke-Estefan, Xavier Erik, López-Martín, José Antonio, Jimeno, José María, and Guisado-Vasco, Pablo

Published
2023
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15. Supplementary Figure 1 from Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors

Author

Von Hoff, Daniel D., primary, Rasco, Drew W., primary, Heath, Elisabeth I., primary, Munster, Pamela N., primary, Schellens, Jan H.M., primary, Isambert, Nicolas, primary, Tourneau, Christophe Le, primary, O'Neil, Bert, primary, Mathijssen, Ron H.J., primary, Lopez-Martin, Jose A., primary, Edenfield, W. Jeff, primary, Martin, Miguel, primary, LoRusso, Patricia M., primary, Bray, Gordon L., primary, DiMartino, Jorge, primary, Nguyen, Aaron, primary, Liu, Kejian, primary, Laille, Eric, primary, and Bendell, Johanna C., primary

Published
2023
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16. Supplementary Tables 1-8 from Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors

Author

Von Hoff, Daniel D., primary, Rasco, Drew W., primary, Heath, Elisabeth I., primary, Munster, Pamela N., primary, Schellens, Jan H.M., primary, Isambert, Nicolas, primary, Tourneau, Christophe Le, primary, O'Neil, Bert, primary, Mathijssen, Ron H.J., primary, Lopez-Martin, Jose A., primary, Edenfield, W. Jeff, primary, Martin, Miguel, primary, LoRusso, Patricia M., primary, Bray, Gordon L., primary, DiMartino, Jorge, primary, Nguyen, Aaron, primary, Liu, Kejian, primary, Laille, Eric, primary, and Bendell, Johanna C., primary

Published
2023
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17. Supplementary Figure 1 from A Phase I/II, Multiple-Dose, Dose-Escalation Study of Siltuximab, an Anti-Interleukin-6 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Author

Angevin, Eric, primary, Tabernero, Josep, primary, Elez, Elena, primary, Cohen, Steven J., primary, Bahleda, Rastilav, primary, van Laethem, Jean-Luc, primary, Ottensmeier, Christian, primary, Lopez-Martin, Jose A., primary, Clive, Sally, primary, Joly, Florence, primary, Ray-Coquard, Isabelle, primary, Dirix, Luc, primary, Machiels, Jean-Pascal, primary, Steven, Neil, primary, Reddy, Manjula, primary, Hall, Brett, primary, Puchalski, Thomas A., primary, Bandekar, Rajesh, primary, van de Velde, Helgi, primary, Tromp, Brenda, primary, Vermeulen, Jessica, primary, and Kurzrock, Razelle, primary

Published
2023
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18. Supplementary Methods, Table 1 from A Phase I/II, Multiple-Dose, Dose-Escalation Study of Siltuximab, an Anti-Interleukin-6 Monoclonal Antibody, in Patients with Advanced Solid Tumors

Author

Angevin, Eric, primary, Tabernero, Josep, primary, Elez, Elena, primary, Cohen, Steven J., primary, Bahleda, Rastilav, primary, van Laethem, Jean-Luc, primary, Ottensmeier, Christian, primary, Lopez-Martin, Jose A., primary, Clive, Sally, primary, Joly, Florence, primary, Ray-Coquard, Isabelle, primary, Dirix, Luc, primary, Machiels, Jean-Pascal, primary, Steven, Neil, primary, Reddy, Manjula, primary, Hall, Brett, primary, Puchalski, Thomas A., primary, Bandekar, Rajesh, primary, van de Velde, Helgi, primary, Tromp, Brenda, primary, Vermeulen, Jessica, primary, and Kurzrock, Razelle, primary

Published
2023
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19. Supplementary Table 1 from Phase I Study of Dovitinib (TKI258), an Oral FGFR, VEGFR, and PDGFR Inhibitor, in Advanced or Metastatic Renal Cell Carcinoma

Author

Angevin, Eric, primary, Lopez-Martin, Jose A., primary, Lin, Chia-Chi, primary, Gschwend, Jürgen E., primary, Harzstark, Andrea, primary, Castellano, Daniel, primary, Soria, Jean-Charles, primary, Sen, Paramita, primary, Chang, Julie, primary, Shi, Michael, primary, Kay, Andrea, primary, and Escudier, Bernard, primary

Published
2023
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20. Supplementary Table 1 from A Phase I First-in-Human Pharmacokinetic and Pharmacodynamic Study of Serdemetan in Patients with Advanced Solid Tumors

Author

Tabernero, Josep, primary, Dirix, Luc, primary, Schöffski, Patrick, primary, Cervantes, Andrés, primary, Lopez-Martin, Jose Antonio, primary, Capdevila, Jaume, primary, van Beijsterveldt, Ludy, primary, Platero, Suso, primary, Hall, Brett, primary, Yuan, Zhilong, primary, Knoblauch, Roland, primary, and Zhuang, Sen Hong, primary

Published
2023
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21. Data from A Phase I First-in-Human Pharmacokinetic and Pharmacodynamic Study of Serdemetan in Patients with Advanced Solid Tumors

Author

Tabernero, Josep, primary, Dirix, Luc, primary, Schöffski, Patrick, primary, Cervantes, Andrés, primary, Lopez-Martin, Jose Antonio, primary, Capdevila, Jaume, primary, van Beijsterveldt, Ludy, primary, Platero, Suso, primary, Hall, Brett, primary, Yuan, Zhilong, primary, Knoblauch, Roland, primary, and Zhuang, Sen Hong, primary

Published
2023
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22. Supplementary Methods Data from Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors

Author

Von Hoff, Daniel D., primary, Rasco, Drew W., primary, Heath, Elisabeth I., primary, Munster, Pamela N., primary, Schellens, Jan H.M., primary, Isambert, Nicolas, primary, Tourneau, Christophe Le, primary, O'Neil, Bert, primary, Mathijssen, Ron H.J., primary, Lopez-Martin, Jose A., primary, Edenfield, W. Jeff, primary, Martin, Miguel, primary, LoRusso, Patricia M., primary, Bray, Gordon L., primary, DiMartino, Jorge, primary, Nguyen, Aaron, primary, Liu, Kejian, primary, Laille, Eric, primary, and Bendell, Johanna C., primary

Published
2023
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23. Supplementary Figure 3 from Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors

Author

Von Hoff, Daniel D., primary, Rasco, Drew W., primary, Heath, Elisabeth I., primary, Munster, Pamela N., primary, Schellens, Jan H.M., primary, Isambert, Nicolas, primary, Tourneau, Christophe Le, primary, O'Neil, Bert, primary, Mathijssen, Ron H.J., primary, Lopez-Martin, Jose A., primary, Edenfield, W. Jeff, primary, Martin, Miguel, primary, LoRusso, Patricia M., primary, Bray, Gordon L., primary, DiMartino, Jorge, primary, Nguyen, Aaron, primary, Liu, Kejian, primary, Laille, Eric, primary, and Bendell, Johanna C., primary

Published
2023
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24. Supplementary Figure 2 from Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors

Author

Von Hoff, Daniel D., primary, Rasco, Drew W., primary, Heath, Elisabeth I., primary, Munster, Pamela N., primary, Schellens, Jan H.M., primary, Isambert, Nicolas, primary, Tourneau, Christophe Le, primary, O'Neil, Bert, primary, Mathijssen, Ron H.J., primary, Lopez-Martin, Jose A., primary, Edenfield, W. Jeff, primary, Martin, Miguel, primary, LoRusso, Patricia M., primary, Bray, Gordon L., primary, DiMartino, Jorge, primary, Nguyen, Aaron, primary, Liu, Kejian, primary, Laille, Eric, primary, and Bendell, Johanna C., primary

Published
2023
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25. Plitidepsin in adult patients with COVID-19 requiring hospital admission: A long-term follow-up analysis

Author

Varona, Jose F., primary, Landete, Pedro, additional, Paredes, Roger, additional, Vates, Roberto, additional, Torralba, Miguel, additional, Guisado-Vasco, Pablo, additional, Porras, Lourdes, additional, Muñoz, Patricia, additional, Gijon, Paloma, additional, Ancochea, Julio, additional, Saiz, Elena, additional, Meira, Fernanda, additional, Jimeno, Jose M., additional, Lopez-Martin, Jose A., additional, and Estrada, Vicente, additional

Published
2023
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27. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial

Author

Antonia, Scott J, López-Martin, José A, Bendell, Johanna, Ott, Patrick A, Taylor, Matthew, Eder, Joseph Paul, Jäger, Dirk, Pietanza, M Catherine, Le, Dung T, de Braud, Filippo, Morse, Michael A, Ascierto, Paolo A, Horn, Leora, Amin, Asim, Pillai, Rathi N, Evans, Jeffry, Chau, Ian, Bono, Petri, Atmaca, Akin, Sharma, Padmanee, Harbison, Christopher T, Lin, Chen-Sheng, Christensen, Olaf, and Calvo, Emiliano

Published
2016
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28. Efficacy and safety of pembrolizumab for patients with previously treated advanced vulvar squamous cell carcinoma: Results from the phase 2 KEYNOTE-158 study

Author

Shapira-Frommer, Ronnie, primary, Mileshkin, Linda, additional, Manzyuk, Ludmila, additional, Penel, Nicolas, additional, Burge, Matthew, additional, Piha-Paul, Sarina A., additional, Girda, Eugenia, additional, Lopez Martin, Jose A., additional, van Dongen, Marloes G.J., additional, Italiano, Antoine, additional, Xu, Lei, additional, Jin, Fan, additional, Norwood, Kevin, additional, and Ott, Patrick A., additional

Published
2022
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30. Recomendaciones para la determinación de biomarcadores en el melanoma metastásico. Consenso Nacional de la Sociedad Española de Anatomía Patológica y de la Sociedad Española de Oncología Médica

Author

Rodríguez-Peralto, José Luis, Espinosa, Enrique, Ríos-Martín, Juan José, Berrocal, Alfonso, Lozano, María Dolores, Arance, Ana, Santos-Briz, Angel, López-Martín, José Antonio, Fernández-Figueras, María Teresa, and Martín-Algarra, Salvador

Published
2014
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31. Dabrafenib plus trametinib in patients with BRAFV600E-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial

Author

MS Medische Oncologie, Cancer, Wen, Patrick Y, Stein, Alexander, van den Bent, Martin, De Greve, Jacques, Wick, Antje, de Vos, Filip Y F L, von Bubnoff, Nikolas, van Linde, Myra E, Lai, Albert, Prager, Gerald W, Campone, Mario, Fasolo, Angelica, Lopez-Martin, Jose A, Kim, Tae Min, Mason, Warren P, Hofheinz, Ralf-Dieter, Blay, Jean-Yves, Cho, Daniel C, Gazzah, Anas, Pouessel, Damien, Yachnin, Jeffrey, Boran, Aislyn, Burgess, Paul, Ilankumaran, Palanichamy, Gasal, Eduard, Subbiah, Vivek, MS Medische Oncologie, Cancer, Wen, Patrick Y, Stein, Alexander, van den Bent, Martin, De Greve, Jacques, Wick, Antje, de Vos, Filip Y F L, von Bubnoff, Nikolas, van Linde, Myra E, Lai, Albert, Prager, Gerald W, Campone, Mario, Fasolo, Angelica, Lopez-Martin, Jose A, Kim, Tae Min, Mason, Warren P, Hofheinz, Ralf-Dieter, Blay, Jean-Yves, Cho, Daniel C, Gazzah, Anas, Pouessel, Damien, Yachnin, Jeffrey, Boran, Aislyn, Burgess, Paul, Ilankumaran, Palanichamy, Gasal, Eduard, and Subbiah, Vivek

Published
2022

32. Phase II trial of palbociclib in advanced sarcoma overexpressing CDK4 gene excluding dedifferentiated liposarcoma (DD LPS): A study from the Spanish Group for Research on Sarcoma (GEIS).

Author

Martin Broto, Javier, primary, Martinez Garcia, Jeronimo, additional, Moura, David Silva, additional, Redondo, Andres, additional, Gutierrez, Antonio, additional, Lopez-Pousa, Antonio, additional, Martinez-Trufero, Javier, additional, Sevilla, Isabel, additional, Diaz Beveridge, Robert, additional, Solis-Hernandez, Maria Pilar, additional, Carnero, Amancio, additional, Perez, Marco, additional, Marcilla, David, additional, Lopez-Martin, Jose A., additional, Casado Herraez, Antonio, additional, Alvarez Alvarez, Rosa Maria, additional, Cruz Jurado, Josefina, additional, Estival-Gonzalez, Anna, additional, Ledesma, Patricio, additional, and Hindi, Nadia, additional

Published
2022
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33. Prognostic value of EZH2 expression for immunotherapy-based schemes in advanced soft-tissue sarcoma: A translational research from Spanish Group of Research on Sarcoma (GEIS).

Author

Moura, David Silva, primary, Zamora, Jorge, additional, Hindi, Nadia, additional, Lopez-Alvarez, Maria, additional, Lacerenza, Serena, additional, Grignani, Giovanni, additional, Martinez-Trufero, Javier, additional, Redondo, Andres, additional, Valverde Morales, Claudia Maria, additional, Stacchiotti, Silvia, additional, Lopez-Pousa, Antonio, additional, Gutierrez, Antonio, additional, Lopez-Martin, Jose A., additional, and Martin Broto, Javier, additional

Published
2022
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35. sj-docx-2-tam-10.1177_17588359221086911 – Supplemental material for Topical heparin as an effective and safe treatment for patients with capecitabine-induced hand-foot syndrome: results of a phase IIA trial supported by proteomic profiling of skin biopsies

Author

Rodríguez-Garzotto, Analia, Iglesias-Docampo, Lara, Díaz-García, C. Vanesa, Ruppen, Isabel, Ximénez-Embún, Pilar, Gómez, Carlos, Rodríguez-Peralto, J. Luis, de Frutos, Javier Ortiz, Lopez-Martin, Jose A., Grávalos, Cristina, Cortés-Funes, Hernán, and Agulló-Ortuño, M. Teresa

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-2-tam-10.1177_17588359221086911 for Topical heparin as an effective and safe treatment for patients with capecitabine-induced hand-foot syndrome: results of a phase IIA trial supported by proteomic profiling of skin biopsies by Analia Rodríguez-Garzotto, Lara Iglesias-Docampo, C. Vanesa Díaz-García, Isabel Ruppen, Pilar Ximénez-Embún, Carlos Gómez, J. Luis Rodríguez-Peralto, Javier Ortiz de Frutos, Jose A. Lopez-Martin, Cristina Grávalos, Hernán Cortés-Funes and M. Teresa Agulló-Ortuño in Therapeutic Advances in Medical Oncology

Published
2022
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36. sj-docx-1-tam-10.1177_17588359221086911 – Supplemental material for Topical heparin as an effective and safe treatment for patients with capecitabine-induced hand-foot syndrome: results of a phase IIA trial supported by proteomic profiling of skin biopsies

Author

Rodríguez-Garzotto, Analia, Iglesias-Docampo, Lara, Díaz-García, C. Vanesa, Ruppen, Isabel, Ximénez-Embún, Pilar, Gómez, Carlos, Rodríguez-Peralto, J. Luis, de Frutos, Javier Ortiz, Lopez-Martin, Jose A., Grávalos, Cristina, Cortés-Funes, Hernán, and Agulló-Ortuño, M. Teresa

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-1-tam-10.1177_17588359221086911 for Topical heparin as an effective and safe treatment for patients with capecitabine-induced hand-foot syndrome: results of a phase IIA trial supported by proteomic profiling of skin biopsies by Analia Rodríguez-Garzotto, Lara Iglesias-Docampo, C. Vanesa Díaz-García, Isabel Ruppen, Pilar Ximénez-Embún, Carlos Gómez, J. Luis Rodríguez-Peralto, Javier Ortiz de Frutos, Jose A. Lopez-Martin, Cristina Grávalos, Hernán Cortés-Funes and M. Teresa Agulló-Ortuño in Therapeutic Advances in Medical Oncology

Published
2022
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37. sj-docx-3-tam-10.1177_17588359221086911 – Supplemental material for Topical heparin as an effective and safe treatment for patients with capecitabine-induced hand-foot syndrome: results of a phase IIA trial supported by proteomic profiling of skin biopsies

Author

Rodríguez-Garzotto, Analia, Iglesias-Docampo, Lara, Díaz-García, C. Vanesa, Ruppen, Isabel, Ximénez-Embún, Pilar, Gómez, Carlos, Rodríguez-Peralto, J. Luis, de Frutos, Javier Ortiz, Lopez-Martin, Jose A., Grávalos, Cristina, Cortés-Funes, Hernán, and Agulló-Ortuño, M. Teresa

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-3-tam-10.1177_17588359221086911 for Topical heparin as an effective and safe treatment for patients with capecitabine-induced hand-foot syndrome: results of a phase IIA trial supported by proteomic profiling of skin biopsies by Analia Rodríguez-Garzotto, Lara Iglesias-Docampo, C. Vanesa Díaz-García, Isabel Ruppen, Pilar Ximénez-Embún, Carlos Gómez, J. Luis Rodríguez-Peralto, Javier Ortiz de Frutos, Jose A. Lopez-Martin, Cristina Grávalos, Hernán Cortés-Funes and M. Teresa Agulló-Ortuño in Therapeutic Advances in Medical Oncology

Published
2022
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38. Topical heparin as an effective and safe treatment for patients with capecitabine-induced hand-foot syndrome: results of a phase IIA trial supported by proteomic profiling of skin biopsies

Author

Rodríguez-Garzotto, Analia, primary, Iglesias-Docampo, Lara, additional, Díaz-García, C. Vanesa, additional, Ruppen, Isabel, additional, Ximénez-Embún, Pilar, additional, Gómez, Carlos, additional, Rodríguez-Peralto, J. Luis, additional, de Frutos, Javier Ortiz, additional, Lopez-Martin, Jose A., additional, Grávalos, Cristina, additional, Cortés-Funes, Hernán, additional, and Agulló-Ortuño, M. Teresa, additional

Published
2022
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41. Abstract CT025: Dabrafenib plus trametinib in BRAF V600E-mutant high-grade (HGG) and low-grade glioma (LGG)

Author

Subbiah, Vivek, primary, Stein, Alexander, additional, van den Bent, Martin, additional, Wick, Antje, additional, de Vos, Filip Y., additional, von Bubnoff, Nikolas, additional, van Linde, Myra E., additional, Lai, Albert, additional, Prager, Gerald W., additional, Campone, Mario, additional, Fasolo, Angelica, additional, Lopez-Martin, Jose A., additional, Kim, Tae Min, additional, Hofheinz, Ralf-Dieter, additional, Blay, Jean-Yves, additional, Cho, Daniel C., additional, Gazzah, Anas, additional, Pouessel, Damien, additional, Yachnin, Jeffrey, additional, Boran, Aislyn, additional, Burgess, Paul, additional, Ilankumaran, Palanichamy, additional, Gasal, Eduard, additional, and Wen, Patrick Y., additional

Published
2021
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42. GEIS 39: Phase II trial of nabpaclitaxel for the treatment of patient with multiply relapsed/refractory desmoplastic small round cell tumor (DSRCT) and Ewing sarcoma (EwS).

Author

Mora, Jaume, primary, Suñol, Mariona, additional, Hindi, Nadia, additional, Castañeda, Alicia, additional, Redondo, Andrés, additional, Sirvent, Francisco José Bautista, additional, Diaz Beveridge, Robert, additional, Lopez-Pousa, Antonio, additional, Lopez-Martin, Jose A., additional, and Martin Broto, Javier, additional

Published
2021
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43. Retrospective world-wide registry on the efficacy of immune checkpoint inhibitors in alveolar soft part sarcoma: Updated results from sixty patients.

Author

Hindi, Nadia, primary, Rosenbaum, Evan, additional, Jonczak, Emily, additional, Hamacher, Rainer, additional, Rutkowski, Piotr, additional, Skryd, Anthony, additional, Connolly, Elizabeth, additional, Blay, Jean-Yves, additional, Gutierrez, Antonio, additional, Bogefors, Carolina, additional, Gelderblom, Hans, additional, Boye, Kjetil, additional, Henon, Clemence, additional, Martinez-Trufero, Javier, additional, Lopez-Martin, Jose A., additional, Redondo, Andrés, additional, Valverde, Claudia, additional, Vincenzi, Bruno, additional, Tap, William D., additional, and Martin Broto, Javier, additional

Published
2021
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44. MEDDOCAN guidelines: Medical Document Anonymization

Author

Marimon, Montserrat, Gonzalez-Agirre, Aitor, Intxaurrondo, Ander, Rodríguez, Heidy, Lopez Martin, Jose Antonio, Villegas, Marta, and Krallinger, Martin

Subjects
anonimization, clinical NLP, NLP, medical NLP, guideline
Abstract

Spanish-only document The MEDDOCAN corpus was manually annotated by clinical experts following the MEDDOCAN guidelines. The MEDDOCAN annotation scheme defines a total of 29 granular entity types grouped into more general parent classes. For further information, visit the track webpage: https://temu.bsc.es/meddocan Resources: Web Citation: Montserrat Marimon et al. “Automatic De-identification of Medical Texts in Spanish: the MEDDOCAN Track, Corpus, Guidelines, Methods and Evaluation of Results.” In: IberLEF@ SEPLN. 2019, pp. 618–638. Silver Standard corpus Gold Standard corpus For further information, please visit https://temu.bsc.es/meddocan/ or email us at encargo-pln-life@bsc.es Copyright (c) 2019 Secretaría de Estado para el Avance Digital (SEAD), Funded by the Plan de Impulso de las Tecnologías del Lenguaje (Plan TL).

Published
2020
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45. Frequency and Clinicopathological Profile Associated with Braf Mutations in Patients with Advanced Melanoma in Spain

Author

Lopez-Martin, Jose A, Arance Fernández, Ana, Ríos-Martín, Juan José, Hernández-Losa, Javier, Alós Hernández, Lucía, Cerezuela Fuentes, Pablo, Ortiz Reina, Sebastián, Ortega Izquierdo, Eugenia, Martí, Rosa M, Soberino García, Jesús, Ferrer Fábrega, Berta, Rodríguez Peralto, José Luis, and ABSOLUT-BRAF Study Group

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Original article, medicine.disease_cause, lcsh:RC254-282, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Epidemiology, medicine, Stage IIIC, Stage (cooking), Mutation frequency, Melanoma, neoplasms, Mutation, business.industry, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, digestive system diseases, Superficial spreading melanoma, 030104 developmental biology, 030220 oncology & carcinogenesis, Mutation testing, business
Abstract

Real-world data on BRAF mutation frequency in advanced melanoma are lacking in Spain. Moreover, data available on clinicopathological profile of patients with advanced BRAF-mutant melanoma are currently limited. This study aimed to assess the frequency of BRAF V600 mutations in Spanish patients with advanced or metastatic melanoma and to identify clinical and histopathological features associated with BRAF-mutated tumors. A multicenter, cross-sectional epidemiological study was conducted in 33 Spanish hospitals in adult patients with stage IIIc/IV melanoma. A total of 264 patients were included. The median age was 68 years and 57% were male. Melanoma mainly involved skin with intermittent (40.4%) and low or no sun exposure (43.5%). Most patients (85.6%) had stage IV disease (M1a: 19.3%; M1b: 13.3%; M1c: 22.7%). Serum lactate dehydrogenase levels were elevated in 20% of patients. Superficial spreading melanoma was the most frequent histological type (29.9%). Samples were predominantly obtained from metastases (62.7%), mostly from skin and soft tissues (80%). BRAF mutation analysis was primarily performed using the Cobas 4800 BRAF V600 Mutation Test (92.8%) on formalin-fixed, paraffin-embedded tissue (95.8%). BRAF mutations were detected in 41.3% of samples. Multivariate analysis identified age (odd ratio [OR] 0.975) and stage IV M1a (OR 2.716) as independent factors associated with BRAF mutation. The frequency of BRAF mutations in tumor samples from patients with advanced or metastatic melanoma in Spain was 41.3%. BRAF mutations seem to be more frequent in younger patients and stage M1a patients. This study provides the basis for further investigation regarding BRAF-mutated advanced melanoma in larger cohorts. This study was sponsored by Roche Farma S.A.

Published
2020

46. Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier.

Author

UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, UCL - (SLuc) Service d'hématologie, Carpio, Cecilia, Bouabdallah, Reda, Ysebaert, Loïc, Sancho, Juan-Manuel, Salles, Gilles, Cordoba, Raul, Pinto, Antonio, Gharibo, Mecide, Rasco, Drew, Panizo, Carlos, Lopez-Martin, Jose A, Santoro, Armando, Salar, Antonio, Damian, Silvia, Martin, Alejandro, Verhoef, Gregor, Van Den Neste, Eric, Wang, Maria, Couto, Suzana, Carrancio, Soraya, Weng, Andrew, Wang, Xuehai, Schmitz, Frank, Wei, Xin, Hege, Kristen, Trotter, Matthew W B, Risueño, Alberto, Buchholz, Tonia J, Hagner, Patrick R, Gandhi, Anita K, Pourdehnad, Michael, Ribrag, Vincent, UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, UCL - (SLuc) Service d'hématologie, Carpio, Cecilia, Bouabdallah, Reda, Ysebaert, Loïc, Sancho, Juan-Manuel, Salles, Gilles, Cordoba, Raul, Pinto, Antonio, Gharibo, Mecide, Rasco, Drew, Panizo, Carlos, Lopez-Martin, Jose A, Santoro, Armando, Salar, Antonio, Damian, Silvia, Martin, Alejandro, Verhoef, Gregor, Van Den Neste, Eric, Wang, Maria, Couto, Suzana, Carrancio, Soraya, Weng, Andrew, Wang, Xuehai, Schmitz, Frank, Wei, Xin, Hege, Kristen, Trotter, Matthew W B, Risueño, Alberto, Buchholz, Tonia J, Hagner, Patrick R, Gandhi, Anita K, Pourdehnad, Michael, and Ribrag, Vincent

Abstract

Treatment options for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) are limited, with no standard of care; prognosis is poor, with 4- to 6-month median survival. Avadomide (CC-122) is a cereblon-modulating agent with immunomodulatory and direct antitumor activities. This phase 1 dose-expansion study assessed safety and clinical activity of avadomide monotherapy in patients with de novo R/R DLBCL and transformed lymphoma. Additionally, a novel gene expression classifier, which identifies tumors with a high immune cell infiltration, was shown to enrich for response to avadomide in R/R DLBCL. Ninety-seven patients with R/R DLBCL, including 12 patients with transformed lymphoma, received 3 to 5 mg avadomide administered on continuous or intermittent schedules until unacceptable toxicity, disease progression, or withdrawal. Eighty-two patients (85%) experienced ≥1 grade 3/4 treatment-emergent adverse events (AEs), most commonly neutropenia (51%), infections (24%), anemia (12%), and febrile neutropenia (10%). Discontinuations because of AEs occurred in 10% of patients. Introduction of an intermittent 5/7-day schedule improved tolerability and reduced frequency and severity of neutropenia, febrile neutropenia, and infections. Among 84 patients with de novo R/R DLBCL, overall response rate (ORR) was 29%, including 11% complete response (CR). Responses were cell-of-origin independent. Classifier-positive DLBCL patients (de novo) had an ORR of 44%, median progression-free survival (mPFS) of 6 months, and 16% CR vs an ORR of 19%, mPFS of 1.5 months, and 5% CR in classifier-negative patients (P = .0096). Avadomide is being evaluated in combination with other antilymphoma agents. This trial was registered at www.clinicaltrials.gov as #NCT01421524.

Published
2020

47. UPDATED EFFICACY AND SAFETY OF DABRAFENIB PLUS TRAMETINIB IN PATIENTS WITH RECURRENT/REFRACTORY BRAF V600E-MUTATED HIGH-GRADE GLIOMA (HGG) AND LOW-GRADE GLIOMA (LGG)

Author

Wen, Patrick, Stein, Alexander, van den Bent, Martin, De Grève, Jacques, Dietrich, Sascha, De Vos, Filip, von Bubnoff, Nikolas, van Linde, Myra, Lai, Albert, Prager, Gerald, Campone, Mario, Fasolo, Angelica, Lopez-Martin, Jose, Kim, Tae Min, Mason, Warren, Hofheinz, Ralf-Dieter, Blay, Jean-Yves, Cho, Daniel, Gazzah, Anas, Gomez-Roca, Carlos, Yachnin, Jeffrey, Boran, Aislyn, Burgess, Paul, Palanichamy, Ilan, Gasal, Eduard, Subbiah, Vivek, Medical Genetics, Clinical sciences, Laboratory of Molecular and Medical Oncology, and Electronics and Informatics

Abstract

not available

Published
2019

48. Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial

Author

Martin-Broto, Javier, primary, Hindi, Nadia, additional, Grignani, Giovanni, additional, Martinez-Trufero, Javier, additional, Redondo, Andres, additional, Valverde, Claudia, additional, Stacchiotti, Silvia, additional, Lopez-Pousa, Antonio, additional, D'Ambrosio, Lorenzo, additional, Gutierrez, Antonio, additional, Perez-Vega, Herminia, additional, Encinas-Tobajas, Victor, additional, de Alava, Enrique, additional, Collini, Paola, additional, Peña-Chilet, Maria, additional, Dopazo, Joaquin, additional, Carrasco-Garcia, Irene, additional, Lopez-Alvarez, Maria, additional, Moura, David S, additional, and Lopez-Martin, Jose A, additional

Published
2020
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49. Frequency and Clinicopathological Profile Associated with Braf Mutations in Patients with Advanced Melanoma in Spain

Author

Lopez-Martin, Jose A., primary, Arance Fernández, Ana, additional, Ríos-Martín, Juan José, additional, Hernández-Losa, Javier, additional, Alós Hernández, Lucía, additional, Cerezuela Fuentes, Pablo, additional, Ortiz Reina, Sebastián, additional, Ortega Izquierdo, Eugenia, additional, Martí, Rosa M, additional, Soberino García, Jesús, additional, Ferrer Fábrega, Berta, additional, and Rodríguez Peralto, José Luis, additional

Published
2020
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50. IMMUNOSARC: a collaborative Spanish (GEIS) and Italian (ISG) sarcoma groups phase I/II trial of sunitinib and nivolumab in advanced soft tissue and bone sarcoma: Results from the phase II part, bone sarcoma cohort.

Author

Palmerini, Emanuela, primary, Lopez-Pousa, Antonio, additional, Grignani, Giovanni, additional, Redondo, Andres, additional, Hindi, Nadia, additional, Stacchiotti, Silvia, additional, Sebio, Ana, additional, Lopez-Martin, Jose A., additional, Valverde Morales, Claudia Maria, additional, Martinez-Trufero, Javier, additional, Gutierrez, Antonio, additional, de Alava, Enrique, additional, D'Ambrosio, Lorenzo, additional, Collini, Paola, additional, Picci, Piero, additional, Casali, Paolo Giovanni, additional, and Martin Broto, Javier, additional

Published
2020
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