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1. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, Zurawski, Bogdan, Spicer, Jonathan D, Garassino, Marina C, Majem, Margarita, Martinengo, Gastón L, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, and Samkari, Ayman

Published
2024
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2. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer

Author

Abdel-Karim, Isam, Abdelsalam, Mahmoud, Addeo, Alfredo, Aguado, Carlos, Alexander, Patrick, Alt, Jürgen, Azzi, Georges, Balaraman, Rama, Biesma, Bonne, Blackhall, Fiona, Bohnet, Sabine, Boleti, Ekaterini, Borghaei, Hossein, Bradbury, Penelope, Brighenti, Matteo, Campbell, Nicholas, Campbell, Toby, Canon, Jean-Luc, Cappuzzo, Federico, Costa, Enric Carcereny, Cavanna, Luigi, Cetnar, Jeremy, Chella, Antonio, Chouaid, Christos, Christoph, Daniel, Castán, Javier Cortés, Dakhil, Shaker, de Castro Carpeño, Francisco Javier, de Marinis, Filippo, Delmonte, Angelo, Demedts, Ingel, Demey, Wim, Dits, Joyce, del Pilar Diz Taín, Maria, Gómez, Manuel Dómine, Dorius, Timothy, Dumoulin, Daphne, Duruisseaux, Michaël, Eaton, Keith, González, Emilio Esteban, Evans, Devon, Faehling, Martin, Farrell, Nicholas, Feinstein, Trevor, Font, Enriqueta Felip, Garcia Campelo, Maria Rosario, Garon, Edward, Garrido López, María Pilar, Germonpré, Paul, Gersten, Todd, Cao, Maria Gonzalez, Gopaluni, Srivalli, Greillier, Laurent, Grossi, Francesco, Guisier, Florian, Gurubhagavatula, Sarada, Calderón, Vanesa Gutiérrez, Hakimian, David, Hall, Richard, Jr., Hao, Desirée, Harris, Ronald, Hashemi, Sayed, He, Kai, Hendriks, Lizza, Huang, Chao, Ibrahim, Emad, Jain, Sharad, Johnson, Melissa, Jones, Benjamin, Jones, Monte, Juan Vidal, Óscar José, Juergens, Rosalyn, Kaderbhai, Courèche, Kastelijn, Elisabeth A (Lisanne), Keresztes, Roger, Kio, Ebenezer, Kokowski, Konrad, Konduri, Kartik, Kulkarni, Swati, Kuon, Jonas, Kurkjian, Carla, Labbé, Catherine, Lerner, Rachel, Lim, Farah, Madroszyk-Flandin, Anne, Marathe, Omkar, Martincic, Danko, McClay, Edward, McIntyre, Kristi, Mekhail, Tarek, Misino, Andrea, Molinier, Olivier, Morabito, Alessandro, Morócz, Éva, Müller, Veronika, Nagy, Tünde, Nguyen, Anthony V., Nidhiry, Emmanuel, Okazaki, Ian, Ortega-Granados, Ana Laura, Ostoros, Gyula, Oubre, David, Owen, Scott, Pachipala, Krishna, Park, David, Patel, Pareshkumar, Percent, Ivor, Pérol, Maurice, Peters, Solange, Piet, Berber, Planchard, David, Polychronis, Andreas, Aix, Santiago Ponce, Pons-Tostivint, Elvire, Popat, Sanjaykumar, Pulla, Mariano Provencio, Quantin, Xavier, Quéré, Gilles, Rafique, Noman, Ramaekers, Ryan, Reck, Martin, Reiman, Anthony, Reinmuth, Niels, Reynolds, Craig, Rodríguez-Abreu, Delvys, Romano, Gianpiero, Roque, Tammy, Salzberg, Matthew, Sanborn, Rachel, Sandiego, Sergio, Schaefer, Eric, Schreeder, Marshall, Seetharamu, Nagashree, Seneviratne, Lasika, Shah, Purvi, Shunyakov, Leonid, Slater, Dennis, Parra, Hector Soto, Stigt, Johannes, Stilwill, Joseph, Su, Jingdong, Surmont, Veerle, Swink, Alicia, Szalai, Zsuzsanna, Talbot, Toby, Garcia, Alvaro Taus, Theelen, Willemijn, Thompson, Jonathan, Tiseo, Marcello, Uprety, Dipesh, Uyeki, James, van der Leest, Kornelius Cor, Van Ho, Anthony, van Putten, John, Estévez, Sergio Vázquez, Veatch, Andrea, Vergnenègre, Alain, Ward, Patrick, Weise, Amy, Weiss, Matthias, Whitehurst, Matthew, Zai, Silvia, Zalcman, Gérard, Zuniga, Richard, Borghaei, H., de Marinis, F., Dumoulin, D., Reynolds, C., Theelen, W.S.M.E., Percent, I., Gutierrez Calderon, V., Johnson, M.L., Madroszyk-Flandin, A., Garon, E.B., He, K., Planchard, D., Reck, M., Popat, S., Herbst, R.S., Leal, T.A., Shazer, R.L., Yan, X., Harrigan, R., and Peters, S.

Published
2024
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3. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Spicer, Jonathan D, Garassino, Marina C, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, Samkari, Ayman, Gao, Shugeng, Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, and Zurawski, Bogdan

Abstract

At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis.

Published
2024
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5. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer

Author

Borghaei, H., primary, de Marinis, F., additional, Dumoulin, D., additional, Reynolds, C., additional, Theelen, W.S.M.E., additional, Percent, I., additional, Gutierrez Calderon, V., additional, Johnson, M.L., additional, Madroszyk-Flandin, A., additional, Garon, E.B., additional, He, K., additional, Planchard, D., additional, Reck, M., additional, Popat, S., additional, Herbst, R.S., additional, Leal, T.A., additional, Shazer, R.L., additional, Yan, X., additional, Harrigan, R., additional, Peters, S., additional, Abdel-Karim, Isam, additional, Abdelsalam, Mahmoud, additional, Addeo, Alfredo, additional, Aguado, Carlos, additional, Alexander, Patrick, additional, Alt, Jürgen, additional, Azzi, Georges, additional, Balaraman, Rama, additional, Biesma, Bonne, additional, Blackhall, Fiona, additional, Bohnet, Sabine, additional, Boleti, Ekaterini, additional, Borghaei, Hossein, additional, Bradbury, Penelope, additional, Brighenti, Matteo, additional, Campbell, Nicholas, additional, Campbell, Toby, additional, Canon, Jean-Luc, additional, Cappuzzo, Federico, additional, Costa, Enric Carcereny, additional, Cavanna, Luigi, additional, Cetnar, Jeremy, additional, Chella, Antonio, additional, Chouaid, Christos, additional, Christoph, Daniel, additional, Castán, Javier Cortés, additional, Dakhil, Shaker, additional, de Castro Carpeño, Francisco Javier, additional, de Marinis, Filippo, additional, Delmonte, Angelo, additional, Demedts, Ingel, additional, Demey, Wim, additional, Dits, Joyce, additional, del Pilar Diz Taín, Maria, additional, Gómez, Manuel Dómine, additional, Dorius, Timothy, additional, Dumoulin, Daphne, additional, Duruisseaux, Michaël, additional, Eaton, Keith, additional, González, Emilio Esteban, additional, Evans, Devon, additional, Faehling, Martin, additional, Farrell, Nicholas, additional, Feinstein, Trevor, additional, Font, Enriqueta Felip, additional, Garcia Campelo, Maria Rosario, additional, Garon, Edward, additional, Garrido López, María Pilar, additional, Germonpré, Paul, additional, Gersten, Todd, additional, Cao, Maria Gonzalez, additional, Gopaluni, Srivalli, additional, Greillier, Laurent, additional, Grossi, Francesco, additional, Guisier, Florian, additional, Gurubhagavatula, Sarada, additional, Calderón, Vanesa Gutiérrez, additional, Hakimian, David, additional, Hall, Richard, additional, Hao, Desirée, additional, Harris, Ronald, additional, Hashemi, Sayed, additional, He, Kai, additional, Hendriks, Lizza, additional, Huang, Chao, additional, Ibrahim, Emad, additional, Jain, Sharad, additional, Johnson, Melissa, additional, Jones, Benjamin, additional, Jones, Monte, additional, Juan Vidal, Óscar José, additional, Juergens, Rosalyn, additional, Kaderbhai, Courèche, additional, Kastelijn, Elisabeth A (Lisanne), additional, Keresztes, Roger, additional, Kio, Ebenezer, additional, Kokowski, Konrad, additional, Konduri, Kartik, additional, Kulkarni, Swati, additional, Kuon, Jonas, additional, Kurkjian, Carla, additional, Labbé, Catherine, additional, Lerner, Rachel, additional, Lim, Farah, additional, Madroszyk-Flandin, Anne, additional, Marathe, Omkar, additional, Martincic, Danko, additional, McClay, Edward, additional, McIntyre, Kristi, additional, Mekhail, Tarek, additional, Misino, Andrea, additional, Molinier, Olivier, additional, Morabito, Alessandro, additional, Morócz, Éva, additional, Müller, Veronika, additional, Nagy, Tünde, additional, Nguyen, Anthony V., additional, Nidhiry, Emmanuel, additional, Okazaki, Ian, additional, Ortega-Granados, Ana Laura, additional, Ostoros, Gyula, additional, Oubre, David, additional, Owen, Scott, additional, Pachipala, Krishna, additional, Park, David, additional, Patel, Pareshkumar, additional, Percent, Ivor, additional, Pérol, Maurice, additional, Peters, Solange, additional, Piet, Berber, additional, Planchard, David, additional, Polychronis, Andreas, additional, Aix, Santiago Ponce, additional, Pons-Tostivint, Elvire, additional, Popat, Sanjaykumar, additional, Pulla, Mariano Provencio, additional, Quantin, Xavier, additional, Quéré, Gilles, additional, Rafique, Noman, additional, Ramaekers, Ryan, additional, Reck, Martin, additional, Reiman, Anthony, additional, Reinmuth, Niels, additional, Reynolds, Craig, additional, Rodríguez-Abreu, Delvys, additional, Romano, Gianpiero, additional, Roque, Tammy, additional, Salzberg, Matthew, additional, Sanborn, Rachel, additional, Sandiego, Sergio, additional, Schaefer, Eric, additional, Schreeder, Marshall, additional, Seetharamu, Nagashree, additional, Seneviratne, Lasika, additional, Shah, Purvi, additional, Shunyakov, Leonid, additional, Slater, Dennis, additional, Parra, Hector Soto, additional, Stigt, Johannes, additional, Stilwill, Joseph, additional, Su, Jingdong, additional, Surmont, Veerle, additional, Swink, Alicia, additional, Szalai, Zsuzsanna, additional, Talbot, Toby, additional, Garcia, Alvaro Taus, additional, Theelen, Willemijn, additional, Thompson, Jonathan, additional, Tiseo, Marcello, additional, Uprety, Dipesh, additional, Uyeki, James, additional, van der Leest, Kornelius Cor, additional, Van Ho, Anthony, additional, van Putten, John, additional, Estévez, Sergio Vázquez, additional, Veatch, Andrea, additional, Vergnenègre, Alain, additional, Ward, Patrick, additional, Weise, Amy, additional, Weiss, Matthias, additional, Whitehurst, Matthew, additional, Zai, Silvia, additional, Zalcman, Gérard, additional, and Zuniga, Richard, additional

Published
2023
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11. Phase II trial of bortezomib alone or in combination with irinotecan in patients with adenocarcinoma of the gastroesophageal junction or stomach

Author

Ocean, Allyson J., Christos, Paul, Sparano, Joseph A., Shah, Manish A., Yantiss, Rhonda K., Cheng, Jonathan, Lin, Juan, Papetti, Michael, Matulich, Dan, Schnoll-Sussman, Felice, Besanceney-Webler, Christen, Xiang, Jenny, Ward, Maureen, Dilts, Kaili Temple, Keresztes, Roger, Holloway, Shannon, Chen, Eric X., Wright, John J., and Lane, Maureen E.

Published
2014
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13. Risk of venous thromboembolism with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis

Author

Nalluri, Shobha Rani, Chu, David, Keresztes, Roger, Xiaolei Zhu, and Shenhong Wu

Subjects
Thromboembolism -- Causes of, Cancer -- Risk factors
Abstract

A study was conducted to determine the risk of venous thromboembolism due to the prescription of bevacizumab among cancer patients. Results revealed that use of the drug raised the chances of cancer patients developing venous thromboembolism.

Published
2008

14. Risk Stratification of Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated with Chemo-Radiotherapy: An Institutional Analysis

Author

Sher,Amna, Medavaram,Sowmini, Nemesure,Barbara, Clouston,Sean, and Keresztes,Roger

Subjects
prediction model, Cancer Management and Research, locally advanced, NSCLC, survival, Original Research
Abstract

Amna Sher,1 Sowmini Medavaram,1 Barbara Nemesure,2 Sean Clouston,2 Roger Keresztes1 1Department of Medicine, Stony Brook University Hospital, Stony Brook, NY, USA; 2Department of Family, Population and Preventive Medicine, Stony Brook University Hospital, Stony Brook, NY, USACorrespondence: Amna Sher Email Amna.Sher@Stonybrookmedicine.eduBackground: The purpose of this study was to determine which factors predicted survival and to derive a risk prediction model for patients with locally advanced non-small cell lung cancer (NSCLC) receiving concurrent chemo-radiotherapy (cCRT).Methods: This investigation included 149 patients with locally advanced NSCLC who were treated with cCRT at Stony Brook University Hospital between 2007 and 2015. A finite set of demographic, clinical, and treatment variables were evaluated as independent prognostic factors. Kaplan–Meier survival curves were generated, and log rank tests were used to evaluate difference in survival between groups. To derive a risk score for mortality, a machine learning approach was utilized. To maximize statistical power while examining replicability, the sample was split into discovery (n=99) and replication (n=50) subsamples. Elastic-net regression was used to identify a linear prediction model. Youden’s index was used to identify appropriate cutoffs. Cox proportional hazards regression was used to examine mortality risk; model concordance and hazards ratios were reported.Results: One-quarter of the patients survived for three years after initiation of cCRT. Prognostic factors for survival in the discovery group included age, sex, smoking status, albumin, histology, largest tumor size, number of nodal stations, stage, induction therapy, and radiation dose. The derived model had good risk predictive accuracy (C=0.70). Median survival time was shorter in the high-risk group (0.93 years) vs the low-risk group (2.40 years). Similar findings were noted in the replication sample with strong model accuracy (C=0.69) and median survival time of 0.93 years and 2.03 years for the high- and low-risk groups, respectively.Conclusion: This novel risk prediction model for overall survival in patients with stage III NSCLC highlights the importance of integrating patient, clinical, and treatment variables for accurately predicting outcomes. Clinicians can use this tool to make personalized treatment decisions for patients with locally advanced NSCLC treated with concurrent chemo-radiation.Keywords: prediction model, survival, locally advanced, NSCLC

Published
2020

17. Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck : a randomized clinical trial

Author

Burtness, Barbara, Haddad, Robert, Dinis, Jose, Trigo, Jose, Yokota, Tomoya, de Viana, Luciano Souza, Romanov, Ilya, Vermorken, Jan Baptist, Bourhis, Jean, Tahara, Makoto, Martins Segalla, Jose Getulio, Psyrri, Amanda, Vasilevskaya, Irina, Nangia, Chaitali Singh, Chaves-Conde, Manuel, Kiyota, Naomi, Homma, Akihiro, Holeckova, Petra, Del Campo, Josep Maria, Asarawala, Nirav, Nicolau, Ulisses Ribaldo, Rauch, Daniel, Even, Caroline, Wang, Bushi, Gibson, Neil, Ehrnrooth, Eva, Harrington, Kevin, Cohen, Ezra E. W., Eduardo Giglio, Raul, Raul Blajman, Cesar, Mario Freue, Jose, Graciela Pilnik, Norma, Salvador Palazzo, Felipe, McGrath, Margaret, Fureder, Thorsten, Kornek, Gabriela, Pichler, Angelika, Bauernhofer, Thomas, Tinchon, Christoph, Greil, Richard, Burian, Martin, Kienzer, Heinz, Specenier, Pol, Sautois, Brieuc, Debruyne, Philip, Graas, Marie-Pascale, Maes, Annelies, Lonchay, Christophe, Daisne, Jean-Francois, Fontaine, Christel, Castro Junior, Gilberto, de Oliveira, Frias, Pereira, Rodrigo Perez, Martins De Marchi, Pedro Rafael, Lazaretti, Nicolas Silva, Kulkarni, Swati, Alam, Yasmin, Ho, Cheryl, Shenouda, George, Soulieres, Denis, Sultanem, Khalil, Singh, Simron, Gonzalez Mella, Pablo, Solis Campos, Jose Antonio, Prausova, Jana, Obermannova, Radka, Friborg, Jeppe, Specht, Lena, Elsaid, Amr Abdelaziz, Minn, Heikki, Martin, Laurent, Rolland, Frederic, Ceruse, Philippe, Calais, Gilles, Guigay, Joe, Ferte, Charles, Peyrade, Frederic, Duffaud, Florence, Champeaux-Orange, Elise, Coutte, Alexandre, Clatot, Florian, Fournel, Pierre, Le Moal, Laurence Bozec, Dietz, Andreas, Gruenwald, Viktor, Gauler, Thomas, Guntinas-Lichius, Orlando, Hildebrandt, Guido, Kuhnt, Thomas, Schmidt, Horst-Juergen, Henke, Michael, Rueckert, Anja, Brugger, Wolfram, Rotter, Nicole, Mahlberg, Rolf, Karavasilis, Vasilios, Fountzilas, Georgios, Psyrri, Diamanto, Lang, Istvan, Boer, Andras, Kocsis, Judit, Pajkos, Gabor, Tamas, Laszlo, Anand, A. L., Sharma, Ajay, Sharma, Voona, Murali, Pandy, Ananda Selvakumar, Kumar, Kirushna, Nathan, Raj Kumar Poovna, Srinivasan, Venkatesan, Zade, Bhooshan, Jain, Minish, Srinivasa, B. J., Naik, Radheshyam, Mohanty, B. K., Charas, Tomer, Billan, Salem, Popovtzer, Aron, Licitra, Lisa, Ferrari, Daris, Fao, Paolo, Merlano, Marco, Rocca, Maria Cossu, Fujii, Hirofumi, Minami, Syujiro, Fujii, Masato, Kadowaki, Shigenori, Muro, Kei, Okami, Kenji, Yagi, Toshinari, Yoshino, Kunitoshi, Matsumoto, Koji, Takahashi, Shunji, Matsuura, Kazuto, Alvarez Avitia, Miguel Angel, Gonzalez Riestra, Hector Jorge, van Meerten, E., Buter, J., Gelderblom, A. J., Kawecki, Andrzej, Golusinski, Wojciech, Dinis, Rui, Ribeiro, Leonor, Silva, Regina, Mansinho, Helder, Selezneva, Irina, Biakhov, Mikhail, Galiulin, Rinat, Izmailov, Adel, Vladimirov, Vladimir, Vinogradov, Valery, Mufazalov, Fagim, Baste, Neus, Ma del Campo, Josep, Mesia Nin, Ricard, Lopez Pousa, Antonio, Jose Grau de Castro, Juan, Reig, Oscar, Vera, Ruth, Trigo, JoseManuel, Iglesias, Lara, Martinez Trufero, Javier, Vazquez, Sergio, Rubio, Belen, Enrique Ales, Jose, Villar, Esther, Rubio, Jordi, Escobar, Yolanda, Soria, Ainara, Chaves, Mauel, Johansson, Gun Wickart, Friesland, Signe, Tell, Roger, Nyman, Jan, Rothschild, Sacha, Zippelius, Alfred, Usluoglu, Nurguel, Gogunska, Inna, Zabolotniy, Dmytro, Vinnyk, Yuriy, Burian, Oleksandr, Sykes, Andrew, Peel, David, Lester, James, Robinson, Martin, Srinivasan, Devraj, Fragkandrea-Nixon, Ioanna, Junor, Elizabeth, Gollins, Simon, Evans, Mererid, Newbold, Kate, Hwang, David, Schipani, Stefano, Rizwanullah, Mohammed, Atiq, Omar, Arnaoutakis, Konstantinos, Bauman, Jessica, Mehra, Ranee, Kang, Hyunseok, Chung, Christine, Davis, Thomas, Jimeno, Antonio, Keresztes, Roger, Nangia, Chaitali, Ignatius, Sai-Hong, Su, Yungpo Bernard, Overton, Lindsay Carol, Garrison, Mitchell A., Jeong, Woondong, Wehbe, Ahmad, Argiris, Athanassios, Chiang, Anne, Morgensztern, Daniel, Haigentz, Missak, Jr., Martincic, Danko, Porosnicu, Mercedes, LUX-HEAD & Neck 2 Investigators, Medical Oncology, and Boehringer Ingelheim Fonds

Subjects
Oncology, Cancer Research, medicine.medical_specialty, animal structures, Afatinib, Population, Medizin, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, mental disorders, medicine, Adjuvant therapy, Clinical endpoint, 030212 general & internal medicine, education, 610 Medicine & health, Original Investigation, education.field_of_study, business.industry, food and beverages, medicine.disease, Head and neck squamous-cell carcinoma, 030220 oncology & carcinogenesis, bacteria, sense organs, Human medicine, business, Chemoradiotherapy, medicine.drug
Abstract

LUX-Head & Neck 2 investigators., [Importance] Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC., [Objective] To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC., [Design, Setting, and Participants] This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population., [Interventions] Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal., [Main Outcomes and Measures] The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life., [Results] A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group)., [Conclusions and Relevance] This study’s findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended., [Trial Registration] ClinicalTrials.gov identifier: NCT01345669., The study was funded by Boehringer Ingelheim.

Published
2019

23. A Phase II trial of interferon alpha-2A, 5-fluorouracil, and cisplatin in patients with advanced esophageal carcinoma

Author

Ilson, David H., Sirott, Matthew, Saltz, Leonard, Heelan, Robert, Huang, Ying, Keresztes, Roger, and Kelsen, David P.

Subjects
Esophageal cancer, Interferon alpha -- Evaluation, Fluorouracil -- Evaluation, Cisplatin -- Evaluation, Health
Abstract

Background. The combination of 5-fiuorouracil (5FU) and cisplatin has moderate antitumor activity in the treatment of metastatic epidermoid carcinoma of the esophagus. The authors have recently shown activity for the combination of 5-FU and interferon-alpha 2a (IFN-alpha) in both esophageal epidermoid and adenocarcinoma. A Phase II trial, therefore, was undertaken to evaluate the antitumor activity of the three-drug combination of IFN-alpha, 5-FU, and cisplatin in unresectable or metastatic esophageal carcinoma. Methods. Twenty-seven patients with locally advanced or metastatic carcinoma of the esophagus were treated. No prior chemotherapy was allowed. Twelve patients had epidermoid carcinoma (44%) and 15 patients had adenocarcinoma (56%). Patients received IFN-alpha at a dose of 3 X 108 units/day given daily by subcutaneous injection on days I to 28, 5-FU at a dose of 750 mg/m2/day for 5 days by continuous intravenous infusion on days 1 to 5, and cisplatin at a dose of 100 mg/m2 on day 1. Treatment was recycled every 28 days, and after the first three cycles, cisplatin was administered only on alternate cycles. Twenty-seven patients completed a median of 4 cycles (range, 1-13 cycles), and 26 patients were evaluable for response. Results. Major responses were observed in 13 patients (50%, 95% confidence intervals, 31-69%), including two complete responses (8%). The response proportion in epidermoid carcinoma (8 of 11 patients, 73%) was higher than the response proportion in adenocarcinoma (5 of 15 patients, 33%). The median duration of response was 29 weeks (range', 11-74 weeks), similar in epidermoid carcinoma and adenocarcinoma. Toxicity was moderately severe but manageable with dose attenuations. Grade 3/4 hematologic toxicity was observed in 41% of patients and grade 3/4 nonhematologic toxicity was observed in 26% of patients. IFN-alpha was reduced to either a 3- or 5-day a week schedule because of fatigue and/or myelosuppression in 12 patients (44%). There were two treatment- related deaths (7%). Conclusions. In this Phase II trial, the combination of IFN- alpha, 5-FU, and cisplatin had substantial antitumor activity in esophageal carcinoma with apparently greater antitumor activity in epidermoid carcinoma than adenocarcinoma. A larger confirmatory trial comparing this treatment to conventional 5-FU and cisplatin is warranted for epidermoid carcinoma. In future chemotherapy trials, the response assessment for epidermoid and adenocarcinoma should continue to be stratified. Cancer 1995; 75:2197-202. Key words: esophageal cancer, metastatic, unresectable, cisplatin, fiuorouracil, interferon-alpha.

Published
1995

28. Severe immune thrombocy-topenia induced by a single dose of nivolumab in a patient with advanced non-small cell lung cancer.

Author

Khorasanchi, Adam and Keresztes, Roger

Subjects
*NON-small-cell lung carcinoma, *MOUTH, *IMMUNE checkpoint inhibitors, *IDIOPATHIC thrombocytopenic purpura, *THROMBOCYTOPENIA, *BLOOD platelet disorders
Abstract

Nivolumab-induced immune thrombocytopenia (ITP) is a rare process with few reported cases. We present a 67-year-old man with advanced non-small cell lung cancer who was hospitalized with severe thrombocytopenia. Physical exam was notable for petechiae across his chest and extremities as well as bullae in his oral cavity. The patient initially received high-dose glucocorticoids and intravenous immuno - globulin, but did not respond to treatment. He was then started on weekly rituximab and after three doses, there was complete resolution of his thrombocytopenia. Altogether, his presentation was an extreme case and rare side effect of immune checkpoint therapy, known as nivolumab-induced ITP. Diagnosis of nivolumab-induced ITP is challenging given the lack of specific testing and a wide differential diagnosis. There are few cases reporting severe ITP following nivolumab treatment. We highlight the importance of recognizing and treating this rare complication of immunotherapy. [ABSTRACT FROM AUTHOR]

Published
2020
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29. Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of the Efficacy and Safety of Apricoxib in Combination With Either Docetaxel or Pemetrexed in Patients With Biomarker-Selected Non–Small-Cell Lung Cancer

Author

Edelman, Martin J., primary, Tan, Ming T., additional, Fidler, Mary J., additional, Sanborn, Rachel E., additional, Otterson, Greg, additional, Sequist, Lecia V., additional, Evans, Tracey L., additional, Schneider, Bryan J., additional, Keresztes, Roger, additional, Rogers, John S., additional, de Mayolo, Jorge Antunez, additional, Feliciano, Josephine, additional, Yang, Yang, additional, Medeiros, Michelle, additional, and Zaknoen, Sara L., additional

Published
2015
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31. A randomized, double-blind, placebo-controlled multicenter phase II study of the COX-2 inhibitor apricoxib (A) in combination with either docetaxel (doc) or pemetrexed (pem) in advanced non-small cell lung cancer (NSCLC) patients (pts) selected by urinary PGE-m suppression.

Author

Edelman, Martin J., primary, Tan, Ming Tony, additional, Fidler, Mary J., additional, Sanborn, Rachel E., additional, Otterson, Gregory Alan, additional, Sequist, Lecia V., additional, Evans, Tracey L., additional, Schneider, Bryan J., additional, Keresztes, Roger, additional, Rogers, John S., additional, Antunez de Mayolo, Jorge, additional, Medeiros, Michelle, additional, and Zaknoen, Sara L., additional

Published
2012
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36. Antiangiogenic Agents for the Treatment of Nonsmall Cell Lung Cancer: Characterizing the Molecular Basis for Serious Adverse Events.

Author

Wu, Shenhong and Keresztes, Roger S.

Subjects
*NEOVASCULARIZATION, *LUNG cancer treatment, *DRUG side effects, *VASCULAR endothelial growth factors, *TARGETED drug delivery, *PROTEIN-tyrosine kinase inhibitors, *CELLULAR signal transduction, *HEMORRHAGE
Abstract

Novel agents to reduce angiogenesis by targeting vascular endothelial growth factor and other proangiogenic signaling pathways are being developed for advanced nonsmall cell lung cancer. Antibody-based therapies (e.g., aflibercept) and multitargeted tyrosine kinase inhibitors (e.g., sorafenib, sunitinib, and BIBF 1120) are being evaluated in phase III clinical trials. Some antiangiogenic agents have demonstrated distinct profiles in producing a variety of nonhematologic toxicities, including bleeding/hemorrhage, venous and arterial thromboembolic events, gastrointestinal perforation, hypertension, and proteinuria. Elucidating the molecular basis of these toxicities may lead to clinical benefits by improving patient selection and allowing for the development of effective prevention and management strategies. [ABSTRACT FROM AUTHOR]

Published
2011
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37. Surgical Resection for Residual N2 Disease After Induction Chemotherapy.

Author

Port, Jeffrey L., Korst, Robert J., Lee, Paul C., Levin, Matthew A., Becker, David E., Keresztes, Roger, and Altorki, Nasser K.

Subjects
LUNG cancer, CANCER treatment, DRUG therapy, THERAPEUTICS
Abstract

Background: Induction therapy is a common treatment modality for patients with stage IIIA non-small cell lung cancer (NSCLC). Although mediastinal nodal downstaging after induction therapy is generally considered a favorable prognostic feature, the benefit of resection in the presence of residual N2 disease is controversial. In this study we analyzed our experience with resection after induction chemotherapy in patients with residual N2 disease to more precisely define the role of surgical resection in this group of patients. Methods: In this retrospective analysis, we reviewed the records of 78 patients with N2 disease who received induction therapy with preoperative intent between 1990 and 2003. All patients had potentially resectable disease. Survival analysis was performed using the Kaplan-Meier method. A Cox proportional hazards regression model was used to evaluate multiple prognostic factors. Results: There were 78 patients (39 men) with a median age of 64 years. Sixty had nonsquamous histology. Resection was performed in 52 patients (47 R0). Hospital mortality was 1.9%. A complete pathologic response occurred in 2 of 52 (3.8%) patients and 19 of 52 (36%) patients had no residual N2 disease. Overall 5-year survival for resected patients was 23%. Overall 5-year survival was 30% for N0-N1 patients and 19% for those with residual N2 disease. Multivariable analysis identified clinical response to therapy (p = 0.0007) and histology (p = 0.01), but not residual N2 disease (p = 0.65), as important prognostic variables. Conclusions: Surgical resection may be a viable option for patients with residual N2 disease after induction chemotherapy, provided an R0 resection can be performed. [Copyright &y& Elsevier]

Published
2005
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