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2. Feasibility and Acute Toxicity of Hypo-Fractionated Radiotherapy on 0.35T MR-LINAC: The First Prospective Study in Spain

Author

Gonsalves, Daniela, primary, Ocanto, Abrahams, additional, Meilan, Eduardo, additional, Gomez, Alberto, additional, Dominguez, Jesus, additional, Torres, Lisselott, additional, Pascual, Castalia, additional, Teja, Macarena, additional, Linde, Miguel Montijano, additional, Guijarro, Marcos, additional, Rivas, Daniel, additional, Begara, Jose, additional, González, Jose, additional, Andreescu, Jon, additional, Holgado, Esther, additional, Alcaraz, Diego, additional, López, Escarlata, additional, Dzhugashvli, Maia, additional, Lopez-Campos, Fernando, additional, Alongi, Filippo, additional, and Couñago, Felipe, additional

Published
2024
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3. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial

Author

Luis, Fein, Gonzalo, Gomez Abuin, Diego, Kaen, Ruben, Kowalwszyn, Matias, Molina, Mirta, Varela, Sally, Baron-Hay, Stephen, Begbie, Philip, Clingan, Sherene, Loi, Dhanusha, Sabanathan, Andrea, Gombos, Donatienne, Taylor, Carlos, Barrios, Leandro, Brust, Fabiano, Costa, Ruffo, de Freitas Junior, Roberto, Hegg, Domicio Carvalho, Lacerda, Fernando Cezar Toniazzi, Lissa, Roberto Odebrecht, Rocha, Antonio Orlando, Scalabrini Neto, Felipe, Silva, David, Cescon, Danielle, Charpentier, Cristiano, Ferrario, Xinni, Song, Joanne, Yu, Alejandro, Acevedo, Carlos, Gallardo, Claudio, Salas, Cesar, Sanchez, Eduardo, Yanez, Alvaro, Gomez Diaz, Jesus, Sanchez, Petra, Holeckova, Zdenek, Kral, Bohuslav, Melichar, Katarina, Petrakova, Jana, Prausova, Vesna, Glavicic, Erik, Jakobsen, Jeanette, Jensen, Soren, Linnet, Tamas, Lorincz, Herve, Bonnefoi, Isabelle, Desmoulins, Anthony, Goncalves, Anne-Claire, Hardy-Bessard, Luis, Teixeira, Jens-Uwe, Blohmer, Peter, Fasching, Dirk, Forstmeyer, Nadia, Harbeck, Jens, Huober, Anna, Kaczerowsky Flores de Sousa, Christian, Kurbacher, Sibylle, Loibl, Diana, Lueftner, Tjoung-Won, Park-Simon, Raquel Von, Schumann, Pauline, Wimberger, Louis, Chow, Ava, Kwong, Kai Cheong Roger, Ngan, Peter, Arkosy, Tibor, Csoszi, Zsuzsanna, Kahan, Laszlo, Landherr, Karoly, Mahr, Gabor, Rubovszky, John, Crown, Catherine, Kelly, Seamus, O'Reilly, Saverio, Cinieri, Antonietta, DAlessio, Enrico, Ricevuto, Tomoyuki, Aruga, Takaaki, Fujii, Kenichi, Inoue, Takashi, Ishikawa, Yoshinori, Ito, Tsutomu, Iwasa, Hiroji, Iwata, Yoshimasa, Kosaka, Koji, Matsumoto, Yasuo, Miyoshi, Hirofumi, Mukai, Seigo, Nakamura, Naoki, Niikura, Shoichiro, Ohtani, Akihiko, Osaki, Yasuaki, Sagara, Eiji, Suzuki, Masato, Takahashi, Yuko, Tanabe, Kenji, Tamura, Koichiro, Tsugawa, Junichiro, Watanabe, Naohito, Yamamoto, Yutaka, Yamamoto, Teruo, Yamauchi, Anita, Bustam, Mastura, Md Yusof, Angel, Gomez Villanueva, Alejandro, Juarez Ramiro, Jorge, Martinez Rodriguez, Flavia, Morales-Vasquez, Jessica, Reyes Contreras, Karin, Beelen, Vivianne, Tjan-Heijnen, David, Porter, Ewa, Chmielowska, Ewa, Nowakowska-Zajdel, Zbigniew, Nowecki, Barbara, Radecka, Joanna, Streb, Cezary, Szczylik, Rafal, Tarnawski, Bogdan, Zurawski, Alexander, Arkhipov, Natalia, Fadeeva, Oleg, Lipatov, Andrey, Meshcheryakov, Vladimir, Moiseyenko, Guzel, Mukhametshina, Jin Hee, Ahn, Seock-Ah, Im, Keun Seok, Lee, Kwong Hwa, Park, Yeon Hee, Park, Begona, Bermejo de las Heras, Javier, Cortes, Josefina, Cruz Jurado, Luis, de la Cruz Merino, Jose, Garcia Saenz, Maria, Gion, Esther, Holgado, Esther, Zamora Adelantado, Chien-Ting, Liu, Mei-Ching, Liu, Chiun-Sheng, Huang, Chao-Jung, Tsao, Ling-Ming, Tseng, Cagatay, Arslan, Gul, Basaran, Irfan, Cicin, Erhan, Gokmen, Seyda, Gunduz, Nil, Molinas Mandel, Mustafa, Ozguroglu, Ozgur, Ozyilkan, Sinan, Yavuz, Steve, Chan, Janine, Graham, Iain, MacPherson, Peter, Schmid, Nicholas, Turner, Mark, Tuthill, Christopher, Twelves, Duncan, Wheatley, Hryhoriy, Adamchuk, Oleksandr, Berzoy, Igor, Bondarenko, Oleksii, Kolesnik, Olena, Kolesnik, Hanna, Komisarenko, Anna, Kryzhanivska, Iurii, Leshchenko, Alla, Nasonova, Natalya, Otchenash, Olga, Ponomarova, Andrii, Rusyn, Sergii, Shevnya, Yaroslav, Shparyk, Dmytro, Trukhin, Grygorii, Ursol, Ihor, Vynnychenko, Sibel, Blau, Madhu, Chaudhry, Michael, Chung, Patrick, Cobb, Scott, Cole, Jennifer, Diamond, Keerthi, Gogineni, Jeffrey, Hargis, Kent, Hoskins, William, Irvin, Randa, Loutfi, Janice, Lu, Raul, Mena, Susan, Moore, Rita, Nanda, Ira, Oliff, Coral, Omene, Timothy, Panella, Amit, Panwalkar, Brian, Patson, Hope, Rugo, Irina, Rybalova, Michael, Schleider, Robert, Siegel, Michael, Simon, Laura, Stampleman, Bradley, Sumrall, Michaela, Tsai, Frances, Valdes-Albini, Cortes, Javier, Cescon, David W, Rugo, Hope S, Nowecki, Zbigniew, Im, Seock-Ah, Yusof, Mastura Md, Gallardo, Carlos, Lipatov, Oleg, Barrios, Carlos H, Holgado, Esther, Iwata, Hiroji, Masuda, Norikazu, Otero, Marco Torregroza, Gokmen, Erhan, Loi, Sherene, Guo, Zifang, Zhao, Jing, Aktan, Gursel, Karantza, Vassiliki, and Schmid, Peter

Published
2020
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7. Immuno-priming durvalumab with bevacizumab in HER2-negative advanced breast cancer: a pilot clinical trial

Author

Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramon, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martinez, Mario, Dominguez, Orlando, Hornedo, Javier, Gonzalez-Cortijo, Lucia, Cortes, Javier, Gasol Cudos, Ariadna, Malon, Diego, Lopez-Alonso, Antonio, Moreno-Ortíz, María C., Mouron, Silvana, and Mañes, Santos

Published
2020
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8. Spine Instability Neoplastic Score: agreement across different medical and surgical specialties

Author

Abraira, Víctor, Alcázar, Lucía, Alonso, Ana, Álvarez, Luis, Álvarez, Marco Antonio, Amengual, Guillermo, Antuña, Aida, Aparici, Fernando, Bagó, Joan, Barriga, Andrés, Barrios, María, Bas, Paloma, Begara, José, Bravo-Rodríguez, Francisco, Cabrera, Alberto, Casillas, Carlos, Catalán, Gregorio, Conde, Antonio José, de las Peñas, Ramón, Díaz, Laura, Dualde, Diego, Estremera, Ana, Fenollosa, Joaquín, Fernández, Carlos, Fernández, Eva, Fernández-Baillo, Nicomedes, Ferrer, Pilar, Fuster, Salvador, Galarraga, María Isabel, García-Villar, Cristina, García-Ferrer, Luis, García, María Isabel, García-Duque, Sara, Garde, Javier, González, Andrés, González-Díaz, Rafael, Hernández-Fernández, Alberto, Hernando, Ovidio, Hernanz, Raúl, Hervás, Asunción, Holgado, Esther, Juan, María José, Lavernia, Javier, Lazo, Antonio, Lersundi, Ana, López, Escarlata, Magallón, Rosa, Majem, Margarita, Martín, Antonio, Martín, María Isabel, Martínez, Javier, Montoya, Julia, Moreno, Paloma, Navarro, Arturo, Noguerón, Esther, de Mendivil, Ana Ortiz, Palomino, Julio César, Paniagua, Juan Carlos, Pereira, David, Pérez-Romasanta, Luis A., Pérez, Rocío, Piñera, Ángel Ramón, Piñero, Pilar, Plata-Bello, Julio, Poblete, José, Ramírez, José, Repetto, Juan Antonio, Rivas, Daniel, Roldán, Héctor, Ruiz, Fernando, Sánchez, José Miguel, Sancho, Sonsoles, Sarasíbar, Helena, Sepúlveda, Juan Manuel, Silvestre, Antonio, Sobrino, Beatriz, Tomé-Bermejo, Félix, Tovar, Isabel, Vallejo, María del Carmen, Vanaclocha, Vicente, Villanueva, Asunción, Zamarro, Joaquín, Zazpe, Idoya, Arana, Estanislao, Kovacs, Francisco M., Royuela, Ana, Asenjo, Beatriz, Pérez-Ramírez, Úrsula, and Zamora, Javier

Published
2016
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9. Agreement in the assessment of metastatic spine disease using scoring systems

Author

Abraira, Víctor, Alcázar, Lucía, Alonso, Ana, Álvarez, Luis, Álvarez, Marco Antonio, Amengual, Guillermo, Antuña, Aida, Aparici, Fernando, Bagó, Joan, Barriga, Andrés, Barrios, María, Bas, Paloma, Begara, José, Bravo-Rodríguez, Francisco, Cabrera, Alberto, Casillas, Carlos, Catalán, Gregorio, Conde, Antonio José, Peñas, Ramón de las, Díaz, Laura, Dualde, Diego, Estremera, Ana, Fenollosa, Joaquín, Fernández, Carlos, Fernández, Eva, Fernández-Baillo, Nicomedes, Ferrer, Pilar, Fuster, Salvador, Galarraga, María Isabel, García-Villar, Cristina, García-Ferrer, Luis, García, María Isabel, García-Duque, Sara, Garde, Javier, González, Andrés, González, Rafael, Hernández-Fernández, Alberto, Hernando, Ovidio, Hernanz, Raúl, Hervás, Asunción, Holgado, Esther, Juan, María José, Lavernia, Javier, Lazo, Antonio, Lersundi, Ana, López, Escarlata, Magallón, Rosa, Majem, Margarita, Martín, Antonio, Martín, María Isabel, Martínez, Javier, Montoya, Julia, Moreno, Paloma, Navarro, Arturo, Noguerón, Esther, Mendivil, Ana Ortiz de, Palomino, Julio César, Paniagua, Juan Carlos, Pereira, David, Pérez-Romasanta, Luis A., Pérez, Rocío, Piñera, Ángel Ramón, Piñero, Pilar, Plata-Bello, Julio, Poblete, José, Ramírez, José, Rivas, Daniel, Roldán, Héctor, Ruiz, Fernando, Sánchez, José Miguel, Sancho, Sonsoles, Sarasíbar, Helena, Sepúlveda, Juan Manuel, Silvestre, Antonio, Sobrino, Beatriz, Tomé-Bermejo, Félix, Tovar, Isabel, Vallejo, María del Carmen, Vanaclocha, Vicente, Villanueva, Asunción, Zamarro, Joaquín, Zazpe, Idoya, Arana, Estanislao, Kovacs, Francisco M., Royuela, Ana, Asenjo, Beatriz, Pérez-Ramírez, Ursula, and Zamora, Javier

Published
2015
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11. Pembrolizumab in combination with gemcitabine for patients with HER2-negative advanced breast cancer: GEICAM/2015-04 (PANGEA-Breast) study

Author

Cruz-Merino, Luis de la, primary, Gion, María, additional, Cruz, Josefina, additional, Alonso-Romero, Jose Luis, additional, Quiroga, Vanesa, additional, Moreno, Fernando, additional, Andrés, Raquel, additional, Santisteban, Marta, additional, Ramos, Manuel, additional, Holgado, Esther, additional, Cortés, Javier, additional, López-Miranda, Elena, additional, Cortés, Alfonso, additional, Henao, Fernando, additional, Palazón-Carrión, Natalia, additional, Rodriguez, Luz Milva, additional, Ceballos, Isaac, additional, Soto, Asunción, additional, Puertes, Ana, additional, Casas, Maribel, additional, Benito, Sara, additional, Chiesa, Massimo, additional, Bezares, Susana, additional, Caballero, Rosalía, additional, Jiménez-Cortegana, Carlos, additional, Sánchez-Margalet, Víctor, additional, and Rojo, Federico, additional

Published
2022
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12. Supplement to: Nivolumab versus docetaxel in advanced squamous-cell non--small-cell lung cancer.

Author

Brahmer, Julie, Reckamp, Karen L., Baas, Paul, Crinò, Lucio, Eberhardt, Wilfried E. E., Poddubskaya, Elena, Antonia, Scott, Pluzanski, Adam, Vokes, Everett E., Holgado, Esther, Waterhouse, David, Ready, Neal, Gainor, Justin, Frontera, Osvaldo Arén, Havel, Libor, Steins, Martin, Garassino, Marina C., Aerts, Joachim G., Domine, Manuel, Paz-Ares, Luis, Reck, Martin, Baudelet, Christine, Harbison, Christopher T., Lestini, Brian, and Spigel, David R.

Published
2015

13. 338 Effects of pembrolizumab on the tumor microenvironment (TME) after one presurgery treatment cycle in patients with triple-negative breast cancer (TNBC): phase 1b KEYNOTE-173 study

Author

Schmid, Peter, primary, Park, Yeon Hee, additional, Muñoz-Couselo, Eva, additional, Kim, Sung-Bae, additional, Sohn, Joohyuk, additional, Im, Seock-Ah, additional, Holgado, Esther, additional, Foukakis, Theodoros, additional, Kümmel, Sherko, additional, Dent, Rebecca, additional, Sun, Yuan, additional, Huang, Lingkang, additional, Yearley, Jennifer, additional, Jelinic, Petar, additional, Karantza, Vassiliki, additional, and Cortés, Javier, additional

Published
2021
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14. Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

Author

de la Cruz-Merino, Luis, primary, Gion, María, additional, Cruz-Jurado, Josefina, additional, Quiroga, Vanesa, additional, Andrés, Raquel, additional, Moreno, Fernando, additional, Alonso-Romero, Jose, additional, Ramos, Manuel, additional, Holgado, Esther, additional, Cortés, Javier, additional, López-Miranda, Elena, additional, Henao-Carrasco, Fernando, additional, Palazón-Carrión, Natalia, additional, Rodríguez, Luz, additional, Ceballos, Isaac, additional, Casas, Maribel, additional, Benito, Sara, additional, Chiesa, Massimo, additional, Bezares, Susana, additional, Caballero, Rosalia, additional, Jiménez-Cortegana, Carlos, additional, Sánchez-Margalet, Víctor, additional, and Rojo, Federico, additional

Published
2021
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15. Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

Author

Borghaei, Hossein, Paz-Ares, Luis, Horn, Leora, Spigel, David R., Steins, Martin, Ready, Neal E., Chow, Laura Q., Vokes, Everett E., Felip, Enriqueta, Holgado, Esther, Barlesi, Fabrice, Kohlhäufl, Martin, Arrieta, Oscar, Burgio, Marco Angelo, Fayette, Jérôme, Lena, Hervé, Poddubskaya, Elena, Gerber, David E., Gettinger, Scott N., Rudin, Charles M., Rizvi, Naiyer, Crinò, Lucio, Blumenschein, George R., Jr., Antonia, Scott J., Dorange, Cécile, Harbison, Christopher T., Graf Finckenstein, Friedrich, and Brahmer, Julie R.

Published
2015
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16. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer

Author

Brahmer, Julie, Reckamp, Karen L., Baas, Paul, Crinò, Lucio, Eberhardt, Wilfried E.E., Poddubskaya, Elena, Antonia, Scott, Pluzanski, Adam, Vokes, Everett E., Holgado, Esther, Waterhouse, David, Ready, Neal, Gainor, Justin, Frontera, Osvaldo Arén, Havel, Libor, Steins, Martin, Garassino, Marina C., Aerts, Joachim G., Domine, Manuel, Paz-Ares, Luis, Reck, Martin, Baudelet, Christine, Harbison, Christopher T., Lestini, Brian, and Spigel, David R.

Published
2015
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17. Additional file 2 of Immuno-priming durvalumab with bevacizumab in HER2-negative advanced breast cancer: a pilot clinical trial

Author

Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramon, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martinez, Mario, Dominguez, Orlando, Hornedo, Javier, Gonzalez-Cortijo, Lucia, Cortes, Javier, Cudos, Ariadna Gasol, Malon, Diego, Lopez-Alonso, Antonio, Moreno-Ortíz, María C., Mouron, Silvana, and Mañes, Santos

Subjects
hemic and immune systems, chemical and pharmacologic phenomena
Abstract

Additional file 2 : Supplementary Figure S2: Flow cytometry gating strategy for Treg cells. Representative gating strategy used in Treg cell immunophenotyping based on the exclusion of dead cells, the selection of the lymphoid cells by size and complexity, and then the surface expression of CD3, CD4, CD25, CD127, CCR4, HLA-DR and CD45RO markers. After the initial selection of CD4+ T cells (CD3+CD4+), Treg cells were identified as CD25+CD127low double positive cells. The combination of CCR4 and CD45RO markers allowed the identification of naïve Treg (CCR4+,CD45RO−) and memory Treg (CCR4+CD45RO+), whereas HLA-DR positivity identified activated cells in these Treg subpopulations.

Published
2020
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18. Additional file 6 of Immuno-priming durvalumab with bevacizumab in HER2-negative advanced breast cancer: a pilot clinical trial

Author

Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramon, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martinez, Mario, Dominguez, Orlando, Hornedo, Javier, Gonzalez-Cortijo, Lucia, Cortes, Javier, Cudos, Ariadna Gasol, Malon, Diego, Lopez-Alonso, Antonio, Moreno-Ortíz, María C., Mouron, Silvana, and Mañes, Santos

Abstract

Additional file 6 : Supplementary Table 1: Antibodies used for immunophenotyping in peripheral blood.

Published
2020
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19. Additional file 4 of Immuno-priming durvalumab with bevacizumab in HER2-negative advanced breast cancer: a pilot clinical trial

Author

Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramon, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martinez, Mario, Dominguez, Orlando, Hornedo, Javier, Gonzalez-Cortijo, Lucia, Cortes, Javier, Cudos, Ariadna Gasol, Malon, Diego, Lopez-Alonso, Antonio, Moreno-Ortíz, María C., Mouron, Silvana, and Mañes, Santos

Abstract

Additional file 4 : Supplementary Figure 4: Immunophenotyping of leukocyte populations in the baseline sample of responders and non-responder patients. (A-D) Analysis of the indicated leukocyte subtypes in the baseline blood sample of the patients stratified according to their clinical response. The percentages of the main leukocyte subtypes (A), CD4+ and CD8+ T cells (B), monocyte subtypes (C) and DC subtypes (D) are shown.

Published
2020
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20. Additional file 3 of Immuno-priming durvalumab with bevacizumab in HER2-negative advanced breast cancer: a pilot clinical trial

Author

Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramon, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martinez, Mario, Dominguez, Orlando, Hornedo, Javier, Gonzalez-Cortijo, Lucia, Cortes, Javier, Cudos, Ariadna Gasol, Malon, Diego, Lopez-Alonso, Antonio, Moreno-Ortíz, María C., Mouron, Silvana, and Mañes, Santos

Subjects
immune system diseases, chemical and pharmacologic phenomena, hemic and immune systems
Abstract

Additional file 3 : Supplementary Figure S3: Flow cytometry gating strategy for innate cell populations. Representative example of the gating strategy used for immunophenotyping of the indicated innate subpopulations. After the exclusion of dead cells, monocytes were selected by size and complexity; subtypes were identified by CD14 and CD16 staining, allowing the identification of classical monocytes (CD14+ CD16−), alternative monocytes (CD14−CD16+) and intermediate monocytes. For DC and NK, leukocytes were selected by size and complexity in the live cells, and T- and B-lymphocytes excluded by staining with lineage-specific antibodies. Dendritic cells (DC) and NK cells were selected within the CD20− and CD14− population; NK cells were identified as CD56+ cells (both CD16+ and CD16−) and DC as HLA-DR+CD16− cells. DC subtypes were further defined by CD11c+ (myeloid DC) or CD123+ (plasmacytoid DC).

Published
2020
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21. Additional file 1 of Immuno-priming durvalumab with bevacizumab in HER2-negative advanced breast cancer: a pilot clinical trial

Author

Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramon, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martinez, Mario, Dominguez, Orlando, Hornedo, Javier, Gonzalez-Cortijo, Lucia, Cortes, Javier, Cudos, Ariadna Gasol, Malon, Diego, Lopez-Alonso, Antonio, Moreno-Ortíz, María C., Mouron, Silvana, and Mañes, Santos

Subjects
immune system diseases, virus diseases, chemical and pharmacologic phenomena, hemic and immune systems, circulatory and respiratory physiology
Abstract

Additional file 1 : Supplementary Figure S1: Flow cytometry gating strategy for T cells. Representative gating strategy used in T cell immunophenotyping based on the exclusion of dead cells, the selection of the lymphoid cells by size and complexity, and then the surface expression of CD3, CD4, CD8, CCR7 and CD45RA. The combination of these markers allowed the identification of naïve cells (CCR7+CD45RA+), Teff (CCR7−,CD45RA+), TCM (CCR7+CD45RA−), and TEM (CCR7−CD45RA−). Staining with the CD38 marker allowed the identification of activated cells, which were minimally detected only in Teff and TEM subpopulations.

Published
2020
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22. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial

Author

Vassiliki Karantza, Shparyk Yaroslav, Sumrall Bradley, Javier Cortes, Iwata Hiroji, Kolesnik Oleksii, Ahn Jin Hee, Harbeck Nadia, Prausova Jana, Song Xinni, Berzoy Oleksandr, Mena Raul, Osaki Akihiko, Kahan Zsuzsanna, Simon Michael, Ozguroglu Mustafa, Chmielowska Ewa, Tsugawa Koichiro, Tsao Chao-Jung, Ozyilkan Ozgur, Nowecki Zbigniew, Fadeeva Natalia, Kaen Diego, Garcia Saenz Jose, Porter David, Ngan Kai Cheong Roger, Sherene Loi, Bermejo de las Heras Begona, Turner Nicholas, David W. Cescon, Hope S. Rugo, Oliff Ira, Kelly Catherine, Barrios Carlos, Cole Scott, Shevnya Sergii, Seock-Ah Im, Hoskins Kent, Komisarenko Hanna, Yavuz Sinan, Chaudhry Madhu, Sagara Yasuaki, Brust Leandro, Chan Steve, Gomez Villanueva Angel, Gallardo Carlos, Watanabe Junichiro, Ishikawa Takashi, Schleider Michael, Salas Claudio, Hardy-Bessard Anne-Claire, Erhan Gokmen, Adamchuk Hryhoriy, Beelen Karin, Holeckova Petra, Szczylik Cezary, Fujii Takaaki, Nakamura Seigo, Aruga Tomoyuki, Gokmen Erhan, Jing Zhao, Hiroji Iwata, Molinas Mandel Nil, Gogineni Keerthi, Im Seock-Ah, Zifang Guo, Loi Sherene, Costa Fabiano, Forstmeyer Dirk, Kosaka Yoshimasa, Gomez Diaz Alvaro, Ponomarova Olga, Wimberger Pauline, DAlessio Antonietta, Suzuki Eiji, Blohmer Jens-Uwe, Kowalwszyn Ruben, Molina Matias, Clingan Philip, Yamamoto Yutaka, Sabanathan Dhanusha, Gursel Aktan, Vynnychenko Ihor, Ferrario Cristiano, Schumann Raquel Von, Trukhin Dmytro, Arkosy Peter, Tseng Ling-Ming, Moore Susan, Gunduz Seyda, Stampleman Laura, de Freitas Junior Ruffo, Acevedo Alejandro, Lipatov Oleg, Niikura Naoki, Norikazu Masuda, Rusyn Andrii, Kral Zdenek, Crown John, Yamamoto Naohito, Jakobsen Erik, Blau Sibel, Bustam Anita, Zamora Adelantado Esther, Nanda Rita, Omene Coral, Arslan Cagatay, Kwong Ava, Teixeira Luis, Jensen Jeanette, Ito Yoshinori, Siegel Robert, Mastura Md Yusof, Nowakowska-Zajdel Ewa, Miyoshi Yasuo, Yu Joanne, Tuthill Mark, Mukhametshina Guzel, Matsumoto Koji, Gion Maria, Melichar Bohuslav, Desmoulins Isabelle, Moiseyenko Vladimir, Zurawski Bogdan, Carlos Gallardo, Lorincz Tamas, Cruz Jurado Josefina, Bondarenko Igor, Kaczerowsky Flores de Sousa Anna, Yamauchi Teruo, Loutfi Randa, Esther Holgado, Holgado Esther, Twelves Christopher, Streb Joanna, Tanabe Yuko, Tarnawski Rafal, Morales-Vasquez Flavia, Park Kwong Hwa, Csoszi Tibor, Meshcheryakov Andrey, Scalabrini Neto Antonio Orlando, Oleg Lipatov, Iwasa Tsutomu, Ricevuto Enrico, Tamura Kenji, Patson Brian, Liu Mei-Ching, Cinieri Saverio, Loibl Sibylle, Tjan-Heijnen Vivianne, Glavicic Vesna, Panwalkar Amit, Hargis Jeffrey, Kryzhanivska Anna, Yusof Mastura, O'Reilly Seamus, Rubovszky Gabor, Irvin William, Takahashi Masato, Ohtani Shoichiro, Peter Schmid, Carlos H. Barrios, Sanchez Cesar, Zbigniew Nowecki, Arkhipov Alexander, Chung Michael, Liu Chien-Ting, Mukai Hirofumi, Marco Torregroza Otero, Charpentier Danielle, Park-Simon Tjoung-Won, Lee Keun Seok, Leshchenko Iurii, Huang Chiun-Sheng, Tsai Michaela, Panella Timothy, Petrakova Katarina, MacPherson Iain, Schmid Peter, Baron-Hay Sally, Ursol Grygorii, Lacerda Domicio Carvalho, Cobb Patrick, Sanchez Jesus, Park Yeon Hee, Reyes Contreras Jessica, Fein Luis, Hegg Roberto, Diamond Jennifer, Huober Jens, Rugo Hope, Rybalova Irina, de la Cruz Merino Luis, Linnet Soren, Inoue Kenichi, Wheatley Duncan, Cescon David, Cicin Irfan, Gombos Andrea, Bonnefoi Herve, Nasonova Alla, Taylor Donatienne, Martinez Rodriguez Jorge, Valdes-Albini Frances, Juarez Ramiro Alejandro, Cortes Javier, Lu Janice, Silva Felipe, Lueftner Diana, Landherr Laszlo, Gomez Abuin Gonzalo, Yanez Eduardo, Rocha Roberto Odebrecht, Chow Louis, Otchenash Natalya, Radecka Barbara, Kolesnik Olena, Basaran Gul, Kurbacher Christian, Mahr Karoly, Goncalves Anthony, Begbie Stephen, Graham Janine, Fasching Peter, Varela Mirta, and Lissa Fernando Cezar Toniazzi

Subjects
Oncology, double blind procedure, pharmacist, CD274 protein, human, hazard ratio, 0302 clinical medicine, middle aged, Antineoplastic Combined Chemotherapy Protocols, cancer survival, comparative study, education.field_of_study, progression free survival, adult, drug effect, gemcitabine, clinical trial, General Medicine, nausea, anemia, Progression-Free Survival, priority journal, immunological antineoplastic agent, thyroiditis, pembrolizumab, metastatic breast cancer, neoadjuvant chemotherapy, medicine.medical_specialty, Antineoplastic Agents, intention to treat analysis, Article, skin manifestation, 03 medical and health sciences, Breast cancer, cancer combination chemotherapy, neutropenia, Humans, Progression-free survival, human, education, protein expression, cancer immunotherapy, treatment response, Interim analysis, medicine.disease, major clinical study, tumor recurrence, Carboplatin, programmed death 1 ligand 1, drug efficacy, multicenter study, chemistry, monoclonal antibody, randomized controlled trial, fatigue, drug tolerability, cancer patient, age distribution, drug safety, colitis, clinical outcome, Triple Negative Breast Neoplasms, Pembrolizumab, 030204 cardiovascular system & hematology, B7-H1 Antigen, Placebos, chemistry.chemical_compound, paclitaxel, Antineoplastic Agents, Immunological, Outcome Assessment, Health Care, 030212 general & internal medicine, antineoplastic agent, cancer adjuvant therapy, Eastern Cooperative Oncology Group performance status, female, carboplatin, sodium chloride, immunohistochemistry, medicine.drug, interactive voice response system, alanine aminotransferase, overall survival, Population, Antibodies, Monoclonal, Humanized, Double-Blind Method, Internal medicine, medicine, follow up, hyperthyroidism, pneumonia, controlled study, Taxane, phase 3 clinical trial, business.industry, hypertransaminasemia, alopecia, Gemcitabine, human tissue, cancer recurrence, functional status assessment, triple negative breast cancer, placebo, inoperable cancer, pathology, hypothyroidism, Neoplasm Recurrence, Local, business, metabolism, Follow-Up Studies
Abstract

Background: Pembrolizumab monotherapy showed durable antitumour activity and manageable safety in patients with metastatic triple-negative breast cancer. We aimed to examine whether the addition of pembrolizumab would enhance the antitumour activity of chemotherapy in patients with metastatic triple-negative breast cancer. Methods: In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 209 sites in 29 countries, we randomly assigned patients 2:1 with untreated locally recurrent inoperable or metastatic triple-negative breast cancer using a block method (block size of six) and an interactive voice-response system with integrated web-response to pembrolizumab (200 mg) every 3 weeks plus chemotherapy (nab-paclitaxel; paclitaxel; or gemcitabine plus carboplatin) or placebo plus chemotherapy. Randomisation was stratified by type of on-study chemotherapy (taxane or gemcitabine–carboplatin), PD-L1 expression at baseline (combined positive score [CPS] ?1 or, Breast Cancer Research Foundation, BCRF; Pfizer; AstraZeneca; Merck; Roche; Samsung; Merck Sharp and Dohme, MSD; Eisai, JC reports personal fees and research funding paid to his institution from Roche, AstraZeneca, Merck Sharp & Dohme, and Eisai; personal fees from Celgene, Cellestia, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, GlaxoSmithKline, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Kyowa Kirin, Novartis, Pfizer, Samsung Bioepis; research funding paid to his institution from Ariad Pharmaceuticals, Bayer Healthcare, F Hoffman-La Roche, Guardanth Health, Piqur Therapeutics, Puma C, and Queen Mary University of London, outside the submitted work. In addition, JC has a MedSIR patent pending. DWC reports research support from Merck during the conduct of the study; research support paid to his institution from Merck, Pfizer, and GlaxoSmithKline; personal fees from Merck, Roche–Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Puma, Agenda, Exact Sciences, and Dynamo Therapeutics, outside the submitted work. In addition, DWC has a Biomarkers of TTK inhibitors patent pending. HSR reports funding for sponsored studies paid to the University of California San Francisco from Pfizer, Novartis, Lilly, Roche–Genentech, Macrogenics, OBI, Merck, Eisai, Immunomedics, Daiichi Sankyo, Seattle Genetics, and Odonate; travel support for educational meetings from Daiichi Sankyo, Mylan, Pfizer, Merck, AstraZeneca, Novartis, and Macrogenics; and consulting fees from Samsung and Puma, outside the submitted work. S-AI reports grants from AstraZeneca, Eisai, Pfizer, Roche, and Daewoong; an advisory role for AstraZeneca, Amgen, Eisai, Hanmi, Novartis, Lily, MedPacto, Pfizer, and Roche; and travel expenses for presentation from Novartis, outside the submitted work. CG reports Advisory Board fees from Merck Sharp & Dohme and Roche; and speaker's bureau fees from Bristol Myers Squibb and AstraZeneca, outside the submitted work. CHB reports grants and fees from Merck Sharp & Dohme for clinical research consulting during the conduct of the study; consulting–advisory role fees from Boehringer Ingelheim, GlaxoSmithKline, and Bayer; consulting–advisory role fees and grants for clinical research from Novartis, Pfizer, Roche–Genentech, Eisai, Merck Sharp & Dohme, and AstraZeneca; grants for clinical research from Abbvie, Amgen, Astellas Pharma, Bristol Myers Squibb, Celgene, Covance, Lilly, Medication, Merck Serono, and PharmaMar; grants for academic research projects from CPO, Pontificia Universidade Católica do Rio Grande do Sul, Latin American Cooperative Oncology Group, Grupo Brasileiro Estudos Câncer Mama, and Instituto Nacional de Câncer-Brazil, outside the submitted work. HI reports a grant from Merck Sharp & Dohme during the conduct of the study; honoraria and consulting fees from Novartis, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, Eisai, and Chugai; and a grant from Chugai, outside the submitted work. NM reports honoraria and research funding paid to his institution from Chugai, AstraZeneca, Pfizer, Eli-Lilly, Eisai, Takeda, Kyowa-Kirin, Merck Sharp & Dohme, Novartis, and Daiichi Sankyo, outside the submitted work. EG reports non-financial support from Merck Sharp & Dohme during the conduct of the study; honoraria, consulting–advisory fees and meeting support from Novartis, Roche, Bristol Myers Squibb, and Pfizer; and honoraria from AstraZeneca and Astellas, outside the submitted work. SL reports research funding or consulting fees paid to her institution from Bristol Myers Squibb, Roche–Genentech, Puma Biotechnology, Pfizer, Seattle Genetics, Novartis, Merck Sharp & Dohme, Eli Lilly, Aduro Biotech, GI Therapeutics, AstraZeneca, and GlaxoSmithKline; and non-remunerated consultancy for Bristol Myers Squibb, Roche–Genentech, Pfizer, Seattle Genetics, Novartis, Merck Sharp & Dohme, and AstraZeneca, outside the submitted work. In addition, SL is supported by the National Breast Cancer Foundation of Australia Endowed Chair and the Breast Cancer Research Foundation, New York. ZG, JZ, GA, and VK are employees of Merck Sharp & Dohme and own stock or stock options in Merck. PS reports consultancy fees from Pfizer, AstraZeneca, Novartis, Roche, Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Eisai, Celgene, and Puma; consultancy fees to his spouse from Genentech and Roche; and grants or funding to his institution from Roche, Genentech, Oncogenex, Novartis, Astellas, and AstraZeneca, outside the submitted work. All other authors declare no competing interests., The authors thank the patients, their families and caregivers for participating in this trial, all of the investigators and site personnel, and the following employees of Merck Sharp & Dohme: Wilbur Pan, Deborah Card, Eleanor Readinger, Shana Hamm, Roger Maxwell, and Krystal Bourdon, for collection of data, supervision of research, provision of study materials or patients or administrative or logistical support; Aline Galvao, for collection of data, supervision of research, administrative or logistical support, and review of imaging data related to the primary end point; Donna Letizia, for collection of data and imaging expertise; Jennifer Kimmel, for study management; Mercedes Bustamante, for data collection and management; Xuan Zhou and Madhusudhan Reddy Papasani, for statistical expertise; Christine McCrary Sisk, for medical writing and editorial assistance; and Joseph C Naggar and Michele McColgan, for administrative or logistical support.

Published
2020

23. Immuno-priming durvalumab with bevacizumab in HER2-negative advanced breast cancer: a pilot clinical trial

Author

Instituto de Salud Carlos III, Comunidad de Madrid, Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramón, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martínez, Mario, Domínguez, Orlando, Hornedo, Javier, González-Cortijo, Lucía, Instituto de Salud Carlos III, Comunidad de Madrid, Quintela-Fandino, Miguel, Holgado, Esther, Manso, Luis, Morales, Serafin, Bermejo, Begoña, Colomer, Ramón, Apala, Juan V., Blanco, Raquel, Muñoz, Manuel, Caleiras, Eduardo, Iranzo, Vega, Martínez, Mario, Domínguez, Orlando, Hornedo, Javier, and González-Cortijo, Lucía

Abstract

[Background]: Preclinical research suggests that the efficacy of immune checkpoint inhibitors in breast cancer can be enhanced by combining them with antiangiogenics, particularly in a sequential fashion. We sought to explore the efficacy and biomarkers of combining the anti-PD-L1 durvalumab plus the antiangiogenic bevacizumab after bevacizumab monotherapy for advanced HER2-negative breast cancer. [Methods]: Patients had advanced HER2-negative disease that progressed while receiving single-agent bevacizumab maintenance as a part of a previous chemotherapy plus bevacizumab regimen. Treatment consisted of bi-weekly durvalumab plus bevacizumab (10 mg/kg each i.v.). Peripheral-blood mononuclear cells (PBMCs) were obtained before the first durvalumab dose and every 4 weeks and immunophenotyped by flow-cytometry. A fresh pre-durvalumab tumor biopsy was obtained; gene-expression studies and immunohistochemical staining to assess vascular normalization and characterize the immune infiltrate were conducted. Patients were classified as “non-progressors” if they had clinical benefit (SD/PR/CR) at 4 months. The co-primary endpoints were the changes in the percentage T cell subpopulations in PBMCs in progressors versus non-progressors, and PFS/OS time. [Results]: Twenty-six patients were accrued. Median PFS and OS were 3.5 and 11 months; a trend for a longer OS was detected for the hormone-positive subset (19.8 versus 7.4 months in triple-negatives; P = 0.11). Clinical benefit rate at 2 and 4 months was 60% and 44%, respectively, without significant differences between hormone-positive and triple-negative (P = 0.73). Non-progressors’ tumors displayed vascular normalization features as a result of previous bevacizumab, compared with generally abnormal patterns observed in progressors. Non-progressors also showed increased T-effector and T-memory signatures and decreased TREG signatures in gene expression studies in baseline—post-bevacizumab—tumors compared with progressors. Notab

Published
2020

25. Abstract PS4-38: Association of tumor infiltrating lymphocytes (TILs) density and PD-L1 expression with pembrolizumab (P) plus gemcitabine (Gem) efficacy in patients with HER2-negative advanced breast cancer (ABC) from the GEICAM/2015-04 (PANGEA-Breast) study

Author

De la Cruz, Luis, primary, Gion, María, additional, Cruz, Josefina, additional, Alonso, Jose Luis, additional, Quiroga, Vanesa, additional, Moreno, Fernando, additional, Santisteban, Marta, additional, Andrés, Raquel, additional, Holgado, Esther, additional, Palazón, Natalia, additional, Rodríguez, Luz Milva, additional, Soto, Asunción, additional, Cortés, Javier, additional, Cortés, Alfonso, additional, Ramos, Manuel, additional, Casas, Maribel, additional, Chiesa, Massimo, additional, Bezares, Susana, additional, Caballero, Rosalía, additional, and Rojo, Federico, additional

Published
2021
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26. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial

Author

Cortes, Javier, primary, Cescon, David W, additional, Rugo, Hope S, additional, Nowecki, Zbigniew, additional, Im, Seock-Ah, additional, Yusof, Mastura Md, additional, Gallardo, Carlos, additional, Lipatov, Oleg, additional, Barrios, Carlos H, additional, Holgado, Esther, additional, Iwata, Hiroji, additional, Masuda, Norikazu, additional, Otero, Marco Torregroza, additional, Gokmen, Erhan, additional, Loi, Sherene, additional, Guo, Zifang, additional, Zhao, Jing, additional, Aktan, Gursel, additional, Karantza, Vassiliki, additional, Schmid, Peter, additional, Luis, Fein, additional, Gonzalo, Gomez Abuin, additional, Diego, Kaen, additional, Ruben, Kowalwszyn, additional, Matias, Molina, additional, Mirta, Varela, additional, Sally, Baron-Hay, additional, Stephen, Begbie, additional, Philip, Clingan, additional, Sherene, Loi, additional, Dhanusha, Sabanathan, additional, Andrea, Gombos, additional, Donatienne, Taylor, additional, Carlos, Barrios, additional, Leandro, Brust, additional, Fabiano, Costa, additional, Ruffo, de Freitas Junior, additional, Roberto, Hegg, additional, Domicio Carvalho, Lacerda, additional, Fernando Cezar Toniazzi, Lissa, additional, Roberto Odebrecht, Rocha, additional, Antonio Orlando, Scalabrini Neto, additional, Felipe, Silva, additional, David, Cescon, additional, Danielle, Charpentier, additional, Cristiano, Ferrario, additional, Xinni, Song, additional, Joanne, Yu, additional, Alejandro, Acevedo, additional, Carlos, Gallardo, additional, Claudio, Salas, additional, Cesar, Sanchez, additional, Eduardo, Yanez, additional, Alvaro, Gomez Diaz, additional, Jesus, Sanchez, additional, Petra, Holeckova, additional, Zdenek, Kral, additional, Bohuslav, Melichar, additional, Katarina, Petrakova, additional, Jana, Prausova, additional, Vesna, Glavicic, additional, Erik, Jakobsen, additional, Jeanette, Jensen, additional, Soren, Linnet, additional, Tamas, Lorincz, additional, Herve, Bonnefoi, additional, Isabelle, Desmoulins, additional, Anthony, Goncalves, additional, Anne-Claire, Hardy-Bessard, additional, Luis, Teixeira, additional, Jens-Uwe, Blohmer, additional, Peter, Fasching, additional, Dirk, Forstmeyer, additional, Nadia, Harbeck, additional, Jens, Huober, additional, Anna, Kaczerowsky Flores de Sousa, additional, Christian, Kurbacher, additional, Sibylle, Loibl, additional, Diana, Lueftner, additional, Tjoung-Won, Park-Simon, additional, Raquel Von, Schumann, additional, Pauline, Wimberger, additional, Louis, Chow, additional, Ava, Kwong, additional, Kai Cheong Roger, Ngan, additional, Peter, Arkosy, additional, Tibor, Csoszi, additional, Zsuzsanna, Kahan, additional, Laszlo, Landherr, additional, Karoly, Mahr, additional, Gabor, Rubovszky, additional, John, Crown, additional, Catherine, Kelly, additional, Seamus, O'Reilly, additional, Saverio, Cinieri, additional, Antonietta, DAlessio, additional, Enrico, Ricevuto, additional, Tomoyuki, Aruga, additional, Takaaki, Fujii, additional, Kenichi, Inoue, additional, Takashi, Ishikawa, additional, Yoshinori, Ito, additional, Tsutomu, Iwasa, additional, Hiroji, Iwata, additional, Yoshimasa, Kosaka, additional, Koji, Matsumoto, additional, Yasuo, Miyoshi, additional, Hirofumi, Mukai, additional, Seigo, Nakamura, additional, Naoki, Niikura, additional, Shoichiro, Ohtani, additional, Akihiko, Osaki, additional, Yasuaki, Sagara, additional, Eiji, Suzuki, additional, Masato, Takahashi, additional, Yuko, Tanabe, additional, Kenji, Tamura, additional, Koichiro, Tsugawa, additional, Junichiro, Watanabe, additional, Naohito, Yamamoto, additional, Yutaka, Yamamoto, additional, Teruo, Yamauchi, additional, Anita, Bustam, additional, Mastura, Md Yusof, additional, Angel, Gomez Villanueva, additional, Alejandro, Juarez Ramiro, additional, Jorge, Martinez Rodriguez, additional, Flavia, Morales-Vasquez, additional, Jessica, Reyes Contreras, additional, Karin, Beelen, additional, Vivianne, Tjan-Heijnen, additional, David, Porter, additional, Ewa, Chmielowska, additional, Ewa, Nowakowska-Zajdel, additional, Zbigniew, Nowecki, additional, Barbara, Radecka, additional, Joanna, Streb, additional, Cezary, Szczylik, additional, Rafal, Tarnawski, additional, Bogdan, Zurawski, additional, Alexander, Arkhipov, additional, Natalia, Fadeeva, additional, Oleg, Lipatov, additional, Andrey, Meshcheryakov, additional, Vladimir, Moiseyenko, additional, Guzel, Mukhametshina, additional, Jin Hee, Ahn, additional, Seock-Ah, Im, additional, Keun Seok, Lee, additional, Kwong Hwa, Park, additional, Yeon Hee, Park, additional, Begona, Bermejo de las Heras, additional, Javier, Cortes, additional, Josefina, Cruz Jurado, additional, Luis, de la Cruz Merino, additional, Jose, Garcia Saenz, additional, Maria, Gion, additional, Esther, Holgado, additional, Esther, Zamora Adelantado, additional, Chien-Ting, Liu, additional, Mei-Ching, Liu, additional, Chiun-Sheng, Huang, additional, Chao-Jung, Tsao, additional, Ling-Ming, Tseng, additional, Cagatay, Arslan, additional, Gul, Basaran, additional, Irfan, Cicin, additional, Erhan, Gokmen, additional, Seyda, Gunduz, additional, Nil, Molinas Mandel, additional, Mustafa, Ozguroglu, additional, Ozgur, Ozyilkan, additional, Sinan, Yavuz, additional, Steve, Chan, additional, Janine, Graham, additional, Iain, MacPherson, additional, Peter, Schmid, additional, Nicholas, Turner, additional, Mark, Tuthill, additional, Christopher, Twelves, additional, Duncan, Wheatley, additional, Hryhoriy, Adamchuk, additional, Oleksandr, Berzoy, additional, Igor, Bondarenko, additional, Oleksii, Kolesnik, additional, Olena, Kolesnik, additional, Hanna, Komisarenko, additional, Anna, Kryzhanivska, additional, Iurii, Leshchenko, additional, Alla, Nasonova, additional, Natalya, Otchenash, additional, Olga, Ponomarova, additional, Andrii, Rusyn, additional, Sergii, Shevnya, additional, Yaroslav, Shparyk, additional, Dmytro, Trukhin, additional, Grygorii, Ursol, additional, Ihor, Vynnychenko, additional, Sibel, Blau, additional, Madhu, Chaudhry, additional, Michael, Chung, additional, Patrick, Cobb, additional, Scott, Cole, additional, Jennifer, Diamond, additional, Keerthi, Gogineni, additional, Jeffrey, Hargis, additional, Kent, Hoskins, additional, William, Irvin, additional, Randa, Loutfi, additional, Janice, Lu, additional, Raul, Mena, additional, Susan, Moore, additional, Rita, Nanda, additional, Ira, Oliff, additional, Coral, Omene, additional, Timothy, Panella, additional, Amit, Panwalkar, additional, Brian, Patson, additional, Hope, Rugo, additional, Irina, Rybalova, additional, Michael, Schleider, additional, Robert, Siegel, additional, Michael, Simon, additional, Laura, Stampleman, additional, Bradley, Sumrall, additional, Michaela, Tsai, additional, and Frances, Valdes-Albini, additional

Published
2020
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27. KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer.

Author

Cortes, Javier, primary, Cescon, David W., additional, Rugo, Hope S., additional, Nowecki, Zbigniew, additional, Im, Seock-Ah, additional, Yusof, Mastura Md, additional, Gallardo, Carlos, additional, Lipatov, Oleg, additional, Barrios, Carlos Henrique, additional, Holgado, Esther, additional, Iwata, Hiroji, additional, Masuda, Norikazu, additional, Torregroza Otero, Marco, additional, Gokmen, Erhan, additional, Loi, Sherene, additional, Guo, Zifang, additional, Zhao, Jing, additional, Aktan, Gursel, additional, Karantza, Vassiliki, additional, and Schmid, Peter, additional

Published
2020
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28. Abstract P3-09-03: A phase II study of pembrolizumab and eribulin in patients with HR-positive/HER2-negative metastatic breast cancer previously treated with anthracyclines and taxanes (KELLY study)

Author

Pérez-García, José Manuel, primary, Llombart-Cussac, Antonio, additional, Holgado, Esther, additional, Curigliano, Giuseppe, additional, Miranda, Elena López, additional, Alonso-Romero, José Luis, additional, Bermejo, Begoña, additional, Calvo, Lourdes, additional, Carañana, Vicente, additional, de la Cruz Sánchez, Susana, additional, Cortés, María Gión, additional, Vázquez, Raúl Márquez, additional, Prat, Aleix, additional, Borrego, Manuel Ruiz, additional, Sampayo, Miguel, additional, Seguí, Miguel Àngel, additional, Soberino, Jesus, additional, Malfettone, Andrea, additional, Schmid, Peter, additional, and Cortés, Javier, additional

Published
2020
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30. Inclusion of non-inferiority analysis in superiority-based clinical trials with single-arm, two-stage Simon’s design

Author

Sampayo-Cordero, Miguel, primary, Miguel-Huguet, Bernat, additional, Pérez-García, José, additional, Páez, David, additional, Guerrero-Zotano, Ángel, additional, Noguera, Javier Garde, additional, Aguirre, Elena, additional, Holgado, Esther, additional, López-Miranda, Elena, additional, Huang, Xin, additional, Llombart-Cussac, Antonio, additional, Malfettone, Andrea, additional, and Cortés, Javier, additional

Published
2019
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31. Abstract CT195: Long-term survival outcomes with nivolumab (NIVO) in pts with previously treated advanced non-small cell lung cancer (NSCLC): Impact of early disease control and response

Author

Brahmer, Julie, primary, Borghaei, Hossein, additional, Ramalingam, Suresh S., additional, Horn, Leora, additional, Holgado, Esther, additional, Pluzanski, Adam, additional, Burgio, Marco A., additional, Garassino, Marina, additional, Chow, Laura Q., additional, Gettinger, Scott, additional, Crino, Lucio, additional, Planchard, David, additional, Butts, Charles, additional, Drilon, Alexander, additional, Wojcik-Tomaszewska, Joanna, additional, Otterson, Gregory, additional, Hayreh, Vinny, additional, Li, Ang, additional, Penrod, John R., additional, and Antonia, Scott J., additional

Published
2019
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32. Evolution of the myeloid-derived suppressor cells in advanced breast cancer and comparative analysis with a healthy population cohort.

Author

Palazón-Carrión, Natalia, primary, Jiménez-Cortegana, Carlos, additional, Holgado, Esther, additional, Jurado, Josefina Cruz, additional, Alonso Romero, Jose Luis, additional, Sánchez Leon, María Luisa, additional, Sanchez Margalet, Victor, additional, Nogales, Esteban, additional, Moreno Anton, Fernando, additional, Quiroga Garcia, Vanesa, additional, Andres, Raquel, additional, Santisteban, Marta, additional, Cortes, Javier, additional, Rodríguez-Rodríguez, Luz Milva, additional, Soto Gutierrez, Asuncion, additional, Cortes, Mana Gion, additional, Nieto Garcia, A., additional, Chiesa, Massimo, additional, Bezares, Susana, additional, and De la Cruz-Merino, Luis, additional

Published
2019
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33. High Frequency of ERBB2 Activating Mutations in Invasive Lobular Breast Carcinoma with Pleomorphic Features

Author

Rosa-Rosa, Juan, primary, Caniego-Casas, Tamara, additional, Leskela, Susanna, additional, Cristobal, Eva, additional, González-Martínez, Silvia, additional, Moreno-Moreno, Esther, additional, López-Miranda, Elena, additional, Holgado, Esther, additional, Pérez-Mies, Belén, additional, Garrido, Pilar, additional, and Palacios, José, additional

Published
2019
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34. Tumor-Infiltrating Lymphocytes in Patients Receiving Trastuzumab/Pertuzumab-Based Chemotherapy: A TRYPHAENA Substudy.

Author

Ignatiadis, Michail, Van den Eynden, Gert, Roberto, Salgado, Fornili, Marco, Bareche, Yacine, Desmedt, Christine, Rothé, Françoise, Maetens, Marion, Venet, David, Holgado, Esther, McNally, Virginia, Kiermaier, Astrid, Savage, Heidi HM, Wilson, Timothy Richard, Cortes, Javier, Schneeweiss, Andreas, Willard-Gallo, Karen, Biganzoli, Elia, Sotiriou, Christos, Ignatiadis, Michail, Van den Eynden, Gert, Roberto, Salgado, Fornili, Marco, Bareche, Yacine, Desmedt, Christine, Rothé, Françoise, Maetens, Marion, Venet, David, Holgado, Esther, McNally, Virginia, Kiermaier, Astrid, Savage, Heidi HM, Wilson, Timothy Richard, Cortes, Javier, Schneeweiss, Andreas, Willard-Gallo, Karen, Biganzoli, Elia, and Sotiriou, Christos

Abstract

There is an urgent requirement to identify biomarkers to tailor treatment in human epidermal growth factor receptor 2 (HER2)-amplified early breast cancer treated with trastuzumab/pertuzumab-based chemotherapy., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2018

36. Abstract CT152: A phase II study of pembrolizumab and eribulin in patients with HR-positive/HER2-negative metastatic breast cancer previously treated with anthracyclines and taxanes (KELLY study)

Author

García, José Manuel Pérez, primary, Llombart, Antonio, additional, Alonso, José Luis, additional, Bermejo, Begoña, additional, Calvo, Lourdes, additional, Carañana, Vicente, additional, Curigliano, Giuseppe, additional, Sánchez, Susana de la Cruz, additional, Cortés, María Gión, additional, Vázquez, Raúl Márquez, additional, Prat, Aleix, additional, Borrego, Manuel Ruiz, additional, Sampayo, Miguel, additional, Schmid, Peter, additional, Seguí, Miguel Ángel, additional, Cortés, Javier, additional, and Holgado, Esther, additional

Published
2018
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37. Tumor-Infiltrating Lymphocytes in Patients Receiving Trastuzumab/Pertuzumab-Based Chemotherapy: A TRYPHAENA Substudy

Author

Ignatiadis, Michail, primary, Van den Eynden, Gert, additional, Roberto, Salgado, additional, Fornili, Marco, additional, Bareche, Yacine, additional, Desmedt, Christine, additional, Rothé, Françoise, additional, Maetens, Marion, additional, Venet, David, additional, Holgado, Esther, additional, McNally, Virginia, additional, Kiermaier, Astrid, additional, Savage, Heidi M, additional, Wilson, Timothy R, additional, Cortes, Javier, additional, Schneeweiss, Andreas, additional, Willard-Gallo, Karen, additional, Biganzoli, Elia, additional, and Sotiriou, Christos, additional

Published
2018
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39. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057)

Author

Horn, Leora, primary, Spigel, David R., additional, Vokes, Everett E., additional, Holgado, Esther, additional, Ready, Neal, additional, Steins, Martin, additional, Poddubskaya, Elena, additional, Borghaei, Hossein, additional, Felip, Enriqueta, additional, Paz-Ares, Luis, additional, Pluzanski, Adam, additional, Reckamp, Karen L., additional, Burgio, Marco A., additional, Kohlhäeufl, Martin, additional, Waterhouse, David, additional, Barlesi, Fabrice, additional, Antonia, Scott, additional, Arrieta, Oscar, additional, Fayette, Jérôme, additional, Crinò, Lucio, additional, Rizvi, Naiyer, additional, Reck, Martin, additional, Hellmann, Matthew D., additional, Geese, William J., additional, Li, Ang, additional, Blackwood-Chirchir, Anne, additional, Healey, Diane, additional, Brahmer, Julie, additional, and Eberhardt, Wilfried E.E., additional

Published
2017
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40. Pembrolizumab (pembro) + chemotherapy (chemo) as neoadjuvant treatment for triple negative breast cancer (TNBC): Preliminary results from KEYNOTE-173.

Author

Schmid, Peter, primary, Park, Yeon Hee, additional, Muñoz-Couselo, Eva, additional, Kim, Sung-Bae, additional, Sohn, Joohyuk, additional, Im, Seock-Ah, additional, Holgado, Esther, additional, Wang, Yang, additional, Dang, Thao, additional, Aktan, Gursel, additional, and Cortés, Javier, additional

Published
2017
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41. Tumor-Infiltrating Lymphocytes in Patients Receiving Trastuzumab/Pertuzumab-Based Chemotherapy: A TRYPHAENA Substudy.

Author

Ignatiadis, Michail, Eynden, Gert Van den, Roberto, Salgado, Fornili, Marco, Bareche, Yacine, Desmedt, Christine, Rothé, Françoise, Maetens, Marion, Venet, David, Holgado, Esther, McNally, Virginia, Kiermaier, Astrid, Savage, Heidi M, Wilson, Timothy R, Cortes, Javier, Schneeweiss, Andreas, Willard-Gallo, Karen, Biganzoli, Elia, Sotiriou, Christos, and Van den Eynden, Gert

Subjects
LYMPHOCYTES, TRASTUZUMAB, CANCER chemotherapy, EPIDERMAL growth factor, PATHOLOGY
Abstract

Background: There is an urgent requirement to identify biomarkers to tailor treatment in human epidermal growth factor receptor 2 (HER2)-amplified early breast cancer treated with trastuzumab/pertuzumab-based chemotherapy.Methods: Among the 225 patients randomly assigned to trastuzumab/pertuzumab concurrently or sequentially with an anthracycline-containing regimen or concurrently with an anthracycline-free regimen in the Tryphaena trial, we determined the percentage of tumor-infiltrating lymphocytes (TILs) at baseline in 213 patients, of which 126 demonstrated a pathological complete response (pCR; ypT0/is ypN0), with 28 demonstrating event-free survival (EFS) events. We investigated associations between baseline TIL percentage and either pCR or EFS after adjusting for clinicopathological characteristics using logistic and Cox regression models, respectively. To understand TIL biology, we evaluated associations between baseline TILs and baseline tumor gene expression data (800 gene set by NanoString) in a subset of 173 patients. All statistical tests were two-sided.Results: Among the patients with measurable TILs at baseline, the median level was 14.1% (interquartile range = 7.1%-32.4%). After adjusting for clinicopathological characteristics, baseline percentage TIL was not associated with pCR (adjusted odds ratio [aOR] for every 10-percentage unit increase in TILs = 1.12, 95% confidence interval [CI] = 0.95 to 1.31, P = .17). At a median follow-up of 4.7 years, for every increase in baseline TILs of 10%, there was a 25% reduction in the hazard for an EFS event (aOR = 0.75, 95% CI = 0.56 to 1.00, P = .05) after adjusting for baseline clinicopathological characteristics and pCR. Additionally, genes associated with epithelial-mesenchymal transition, angiogenesis, and T-cell inhibition such as SNAIL1, ZEB1, NOTCH3, and B7-H3 were statistically significantly inversely correlated with percentage TIL.Conclusions: Baseline TIL percentage provides independent prognostic information in patients treated with trastuzumab/pertuzumab-based neoadjuvant chemotherapy. However, further validation is required. [ABSTRACT FROM AUTHOR]

Published
2019
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42. P2.36: Nivolumab (nivo) in Patients (pts) With Advanced (adv) NSCLC and Central Nervous System (CNS) Metastases (mets)

Author

Goldman, Jonathan W., primary, Crino, Lucio, additional, Vokes, Everett E., additional, Holgado, Esther, additional, Reckamp, Karen, additional, Pluzanski, Adam, additional, Spigel, David, additional, Kohlhaeufl, Martin, additional, Garassino, Marina, additional, Chow, Laura Qm, additional, Gettinger, Scott, additional, Gerber, David E., additional, Havel, Libor, additional, Ramalingam, Suresh S., additional, Dy, Grace K., additional, Geese, William J., additional, Li, Ang, additional, Blackwood-Chirchir, Anne, additional, Healey, Diane, additional, Brahmer, Julie, additional, and Lopes, Gilberto, additional

Published
2016
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43. Abstract CT004: KEYNOTE-006: PD-L1 expression and efficacy in patients (Pts) treated with pembrolizumab (pembro) vs ipilimumab (IPI) for advanced melanoma

Author

Carlino, Matteo, primary, Ribas, Antoni, additional, Gonzalez, Rene, additional, Hoeller, Christoph, additional, Bar-Sela, Gil, additional, Barrow, Catherine, additional, Chao, David, additional, Wolter, Pascal, additional, Berking, Carola, additional, Straume, Oddbjørn, additional, Berrocal, Alfonso, additional, Holgado, Esther, additional, Gangadhar, Tara C., additional, Weiss, Geoffrey, additional, Zhou, Honghong, additional, Emancipator, Kenneth, additional, Ibrahim, Nageatte, additional, and Schadendorf, Dirk, additional

Published
2016
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44. Tumor infiltrating lymphocytes before and after dual HER2 blockade in HER2-amplified early breast cancer: A TRYPHAENA substudy.

Author

Ignatiadis, Michail, primary, Van den Eynden, Gert G., additional, Salgado, Roberto, additional, Fornili, Marco, additional, Desmedt, Christine, additional, Holgado, Esther, additional, McNally, V. A., additional, Kiermaier, Astrid Christina, additional, Cortes, Javier, additional, Schneeweiss, Andreas, additional, Willard-Gallo, Karen, additional, Biganzoli, Elia, additional, and Sotiriou, Christos, additional

Published
2016
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45. Nivolumab (nivo) in patients (pts) with advanced (adv) NSCLC and central nervous system (CNS) metastases (mets).

Author

Goldman, Jonathan Wade, primary, Crino, Lucio, additional, Vokes, Everett E., additional, Holgado, Esther, additional, Reckamp, Karen L., additional, Pluzanski, Adam, additional, Spigel, David R., additional, Kohlhaeufl, Martin, additional, Garassino, Marina Chiara, additional, Chow, Laura Quan Man, additional, Gettinger, Scott N., additional, Gerber, David E., additional, Havel, Libor, additional, Ramalingam, Suresh S., additional, Dy, Grace K., additional, Geese, William J., additional, Li, Ang, additional, Blackwood-Chirchir, Anne, additional, Healey, Diane I., additional, and Brahmer, Julie R., additional

Published
2016
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46. Spine Instability Neoplastic Score: agreement across different medical and surgical specialties

Author

Arana, Estanislao, primary, Kovacs, Francisco M., additional, Royuela, Ana, additional, Asenjo, Beatriz, additional, Pérez-Ramírez, Úrsula, additional, Zamora, Javier, additional, Abraira, Víctor, additional, Alcázar, Lucía, additional, Alonso, Ana, additional, Álvarez, Luis, additional, Álvarez, Marco Antonio, additional, Amengual, Guillermo, additional, Antuña, Aida, additional, Aparici, Fernando, additional, Bagó, Joan, additional, Barriga, Andrés, additional, Barrios, María, additional, Bas, Paloma, additional, Begara, José, additional, Bravo-Rodríguez, Francisco, additional, Cabrera, Alberto, additional, Casillas, Carlos, additional, Catalán, Gregorio, additional, Conde, Antonio José, additional, de las Peñas, Ramón, additional, Díaz, Laura, additional, Dualde, Diego, additional, Estremera, Ana, additional, Fenollosa, Joaquín, additional, Fernández, Carlos, additional, Fernández, Eva, additional, Fernández-Baillo, Nicomedes, additional, Ferrer, Pilar, additional, Fuster, Salvador, additional, Galarraga, María Isabel, additional, García-Villar, Cristina, additional, García-Ferrer, Luis, additional, García, María Isabel, additional, García-Duque, Sara, additional, Garde, Javier, additional, González, Andrés, additional, González-Díaz, Rafael, additional, Hernández-Fernández, Alberto, additional, Hernando, Ovidio, additional, Hernanz, Raúl, additional, Hervás, Asunción, additional, Holgado, Esther, additional, Juan, María José, additional, Lavernia, Javier, additional, Lazo, Antonio, additional, Lersundi, Ana, additional, López, Escarlata, additional, Magallón, Rosa, additional, Majem, Margarita, additional, Martín, Antonio, additional, Martín, María Isabel, additional, Martínez, Javier, additional, Montoya, Julia, additional, Moreno, Paloma, additional, Navarro, Arturo, additional, Noguerón, Esther, additional, de Mendivil, Ana Ortiz, additional, Palomino, Julio César, additional, Paniagua, Juan Carlos, additional, Pereira, David, additional, Pérez-Romasanta, Luis A., additional, Pérez, Rocío, additional, Piñera, Ángel Ramón, additional, Piñero, Pilar, additional, Plata-Bello, Julio, additional, Poblete, José, additional, Ramírez, José, additional, Repetto, Juan Antonio, additional, Rivas, Daniel, additional, Roldán, Héctor, additional, Ruiz, Fernando, additional, Sánchez, José Miguel, additional, Sancho, Sonsoles, additional, Sarasíbar, Helena, additional, Sepúlveda, Juan Manuel, additional, Silvestre, Antonio, additional, Sobrino, Beatriz, additional, Tomé-Bermejo, Félix, additional, Tovar, Isabel, additional, Vallejo, María del Carmen, additional, Vanaclocha, Vicente, additional, Villanueva, Asunción, additional, Zamarro, Joaquín, additional, and Zazpe, Idoya, additional

Published
2016
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48. Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC).

Author

Paz-Ares, Luis, primary, Horn, Leora, additional, Borghaei, Hossein, additional, Spigel, David R., additional, Steins, Martin, additional, Ready, Neal, additional, Chow, Laura Quan Man, additional, Vokes, Everett E., additional, Felip, Enriqueta, additional, Holgado, Esther, additional, Barlesi, Fabrice, additional, Kohlhaeufl, Martin, additional, Rodriguez, Oscar, additional, Burgio, Marco Angelo, additional, Fayette, Jerome, additional, Gettinger, Scott N., additional, Harbison, Christopher, additional, Dorange, Cécile, additional, Finckenstein, Friedrich Graf, additional, and Brahmer, Julie R., additional

Published
2015
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49. A phase III study (CheckMate 017) of nivolumab (NIVO; anti-programmed death-1 [PD-1]) vs docetaxel (DOC) in previously treated advanced or metastatic squamous (SQ) cell non-small cell lung cancer (NSCLC).

Author

Spigel, David R., primary, Reckamp, Karen L., additional, Rizvi, Naiyer A., additional, Poddubskaya, Elena, additional, West, Howard Jack, additional, Eberhardt, Wilfried Ernst Erich, additional, Baas, Paul, additional, Antonia, Scott Joseph, additional, Pluzanski, Adam, additional, Vokes, Everett E., additional, Holgado, Esther, additional, Waterhouse, David Michael, additional, Ready, Neal, additional, Gainor, Justin F., additional, Aren, Osvaldo Rudy, additional, Horn, Leora, additional, Paz-Ares, Luis, additional, Baudelet, Christine, additional, Lestini, Brian Joseph, additional, and Brahmer, Julie R., additional

Published
2015
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50. A phase 1b study of the anti-cancer stem cell agent demcizumab (DEM), pemetrexed (PEM) & carboplatin (CARBO) in pts with 1st line non-squamous NSCLC.

Author

Kotasek, Dusan, primary, Hughes, Brett Gordon Maxwell, additional, Markman, Ben, additional, Millward, Michael, additional, Holgado, Esther, additional, Jameson, Michael B., additional, Harris, Dean Laurence, additional, Stagg, Robert J., additional, Kapoun, Ann M., additional, Dupont, Jakob, additional, and McKeage, Mark James, additional

Published
2015
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