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321 results on '"Signorelli D."'

1. Activity of osimeRTInib in non-small-cell lung Cancer with UNcommon epidermal growth factor receptor mutations: retrospective Observational multicenter study (ARTICUNO)

Author

Pizzutilo, E.G., Agostara, A.G., Oresti, S., Signorelli, D., Stabile, S., Lauricella, C., Motta, V., Amatu, A., Ruggieri, L., Brambilla, M., Occhipinti, M., Proto, C., Giusti, R., Filetti, M., Genova, C., Barletta, G., Gelsomino, F., Bennati, C., Siringo, M., Di Fazio, G.R., Russano, M., Montrone, M., Gariazzo, E., Roca, E., Bordi, P., Delmonte, A., Scimone, A., Belluomini, L., Mazzoni, F., Carta, A., Pelizzari, G., Viscardi, G., Morgillo, F., Gelibter, A., Gori, S., Berardi, R., Cortinovis, D., Ardizzoni, A., Veronese, S.M., Sartore-Bianchi, A., Giannetta, L.G., Cerea, G., and Siena, S.

Published
2024
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2. PEOPLE (NCT03447678), a first-line phase II pembrolizumab trial, in negative and low PD-L1 advanced NSCLC: clinical outcomes and association with circulating immune biomarkers

Author

Lo Russo, G., Sgambelluri, F., Prelaj, A., Galli, F., Manglaviti, S., Bottiglieri, A., Di Mauro, R.M., Ferrara, R., Galli, G., Signorelli, D., De Toma, A., Occhipinti, M., Brambilla, M., Rulli, E., Triulzi, T., Torelli, T., Agnelli, L., Brich, S., Martinetti, A., Dumitrascu, A.D., Torri, V., Pruneri, G., Fabbri, A., de Braud, F., Anichini, A., Proto, C., Ganzinelli, M., Mortarini, R., and Garassino, M.C.

Published
2022
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3. Evaluation of COVID-19 impact on DELAYing diagnostic-therapeutic pathways of lung cancer patients in Italy (COVID-DELAY study): fewer cases and higher stages from a real-world scenario

Author

Cantini, L., Mentrasti, G., Russo, G.L., Signorelli, D., Pasello, G., Rijavec, E., Russano, M., Antonuzzo, L., Rocco, D., Giusti, R., Adamo, V., Genova, C., Tuzi, A., Morabito, A., Gori, S., Verde, N. La, Chiari, R., Cortellini, A., Cognigni, V., Pecci, F., Indini, A., De Toma, A., Zattarin, E., Oresti, S., Pizzutilo, E.G., Frega, S., Erbetta, E., Galletti, A., Citarella, F., Fancelli, S., Caliman, E., Della Gravara, L., Malapelle, U., Filetti, M., Piras, M., Toscano, G., Zullo, L., De Tursi, M., Di Marino, P., D’Emilio, V., Cona, M.S., Guida, A., Caglio, A., Salerno, F., Spinelli, G., Bennati, C., Morgillo, F., Russo, A., Dellepiane, C., Vallini, I., Sforza, V., Inno, A., Rastelli, F., Tassi, V., Nicolardi, L., Pensieri, V., Emili, R., Roca, E., Migliore, A., Galassi, T., Rocchi, M. L. Bruno, and Berardi, R.

Published
2022
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6. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G.L., Cortellini, A., Cortinovis, D.L., Tiseo, M., Aerts, J.G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021
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7. EP17.06-01 COVID-19 Long-Lasting Effect on Lung Cancer Diagnoses in Italy: Update of the Real-World Multicenter COVID-DELAY Study

Author

Mentrasti, G., primary, Cognigni, V., additional, Galassi, T., additional, Signorelli, D., additional, Pizzutilo, E.G., additional, Martinelli, F., additional, Lo Russo, G., additional, Leporati, R., additional, Ambrosini, P., additional, Giusti, R., additional, D'Amuri, S., additional, Rocco, D., additional, Della Gravara, L., additional, Antonuzzo, L., additional, Fancelli, S., additional, Gori, S., additional, Sernia, S., additional, Ferrari, M., additional, De Tursi, M., additional, Di Marino, P., additional, Di Maio, M., additional, Salerno, F., additional, Zumstein, L., additional, Russano, M., additional, Citarella, F., additional, Adamo, V., additional, Russo, A., additional, Scimone, C., additional, Sforza, V., additional, Morabito, A., additional, La Verde, N., additional, Cona, M.S., additional, Catalano, V., additional, Emili, R., additional, Sarti, D., additional, Morgillo, F., additional, Di Guida, G., additional, Rocchi, M.B.L., additional, Parisi, A., additional, and Berardi, R., additional

Published
2023
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8. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer

Author

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

Abstract

BACKGROUND Among patients with resectable early-stage non-small-cell lung cancer (NSCLC), a perioperative approach that includes both neoadjuvant and adjuvant immune checkpoint inhibition may provide benefit beyond either approach alone. METHODS We conducted a randomized, double-blind, phase 3 trial to evaluate perioperative pembrolizumab in patients with early-stage NSCLC. Participants with resectable stage II, IIIA, or IIIB (N2 stage) NSCLC were assigned in a 1:1 ratio to receive neoadjuvant pembrolizumab (200 mg) or placebo once every 3 weeks, each of which was given with cisplatin-based chemotherapy for 4 cycles, followed by surgery and adjuvant pembrolizumab (200 mg) or placebo once every 3 weeks for up to 13 cycles. The dual primary end points were event-free survival (the time from randomization to the first occurrence of local progression that precluded the planned surgery, unresectable tumor, progression or recurrence, or death) and overall survival. Secondary end points included major pathological response, pathological complete response, and safety. RESULTS A total of 397 participants were assigned to the pembrolizumab group, and 400 to the placebo group. At the prespecified first interim analysis, the median follow-up was 25.2 months. Event-free survival at 24 months was 62.4% in the pembrolizumab group and 40.6% in the placebo group (hazard ratio for progression, recurrence, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.72; P<0.001). The estimated 24-month overall survival was 80.9% in the pembrolizumab group and 77.6% in the placebo group (P = 0.02, which did not meet the significance criterion). A major pathological response occurred in 30.2% of the participants in the pembrolizumab group and in 11.0% of those in the placebo group (difference, 19.2 percentage points; 95% CI, 13.9 to 24.7; P<0.0001; threshold, P = 0.0001), and a pathological complete response occurred in 18.1% and 4.0%, respectively (difference, 14.2 percentage points

Published
2023

9. EP08.02-046 Activity of OsimeRTInib in NSCLC with Uncommon EGFR Mutations: Retrospective Observational Multicenter Study (ARTICUNO)

Author

Pizzutilo, E.G., primary, Agostara, A.G., additional, Oresti, S., additional, Signorelli, D., additional, Giannetta, L.G., additional, Stabile, S., additional, Lauricella, C., additional, Amatu, A., additional, Brambilla, M., additional, Lo Russo, G., additional, Proto, C., additional, Mazzeo, L., additional, Beninato, T., additional, Siringo, M., additional, Giusti, R., additional, Filetti, M., additional, Genova, C., additional, Barletta, G., additional, Russano, M., additional, Di Fazio, G.R., additional, Tosoni, E., additional, Metro, G., additional, Pilotto, S., additional, Carta, A., additional, Mazzoni, F., additional, Roca, E., additional, Gelibter, A.J., additional, Gori, S., additional, Berardi, R., additional, Cerea, G., additional, Sartore-Bianchi, A., additional, and Siena, S., additional

Published
2022
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10. 996P Activity of OsimeRTInib in NSCLC with UNcommon EGFR Mutations: Retrospective observational multicenter study (ARTICUNO)

Author

Pizzutilo, E.G., primary, Cerea, G., additional, Oresti, S., additional, Agostara, A.G., additional, Signorelli, D., additional, Stabile, S., additional, Lauricella, C., additional, Brambilla, M., additional, Mazzeo, L., additional, Giusti, R., additional, Montrone, M., additional, Russano, M., additional, Bennati, C., additional, Russo, A., additional, Viscardi, G., additional, Roca, E., additional, Gelibter, A.J., additional, Cortinovis, D.L., additional, Sartore Bianchi, A., additional, and Siena, S., additional

Published
2022
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11. Erratum to ‘Evaluation of COVID-19 impact on DELAYing diagnostic-therapeutic pathways of lung cancer patients in Italy (COVID-DELAY study): fewer cases and higher stages from a real-world scenario’: [ESMO Open Volume 7, Issue 2, April 2022, 100406](S2059702922000278)(10.1016/j.esmoop.2022.100406)

Author

Cantini L., Mentrasti G., Lo Russo G., Signorelli D., Pasello G., Rijavec E., Russano M., Antonuzzo L., Rocco D., Giusti R., Adamo V., Genova C., Tuzi A., Morabito A., Gori S., La Verde N., Chiari R., Cortellini A., Cognigni V., Pecci F., Indini A., De Toma A., Zattarin E., Oresti S., Pizzutilo E. G., Frega S., Erbetta E., Galletti A., Citarella F., Fancelli S., Caliman E., Della Gravara L., Malapelle U., Filetti M., Piras M., Toscano G., Zullo L., De Tursi M., Di Marino P., D'Emilio V., Cona M. S., Guida A., Caglio A., Salerno F., Spinelli G. P., Bennati C., Morgillo F., Russo A., Dellepiane C., Vallini I., Sforza V., Inno A., Rastelli F., Tassi V., Nicolardi L., Pensieri M. V., Emili R., Roca E., Migliore A., Galassi T., Rocchi M. B. L., Berardi R., Cantini, L., Mentrasti, G., Lo Russo, G., Signorelli, D., Pasello, G., Rijavec, E., Russano, M., Antonuzzo, L., Rocco, D., Giusti, R., Adamo, V., Genova, C., Tuzi, A., Morabito, A., Gori, S., La Verde, N., Chiari, R., Cortellini, A., Cognigni, V., Pecci, F., Indini, A., De Toma, A., Zattarin, E., Oresti, S., Pizzutilo, E. G., Frega, S., Erbetta, E., Galletti, A., Citarella, F., Fancelli, S., Caliman, E., Della Gravara, L., Malapelle, U., Filetti, M., Piras, M., Toscano, G., Zullo, L., De Tursi, M., Di Marino, P., D'Emilio, V., Cona, M. S., Guida, A., Caglio, A., Salerno, F., Spinelli, G. P., Bennati, C., Morgillo, F., Russo, A., Dellepiane, C., Vallini, I., Sforza, V., Inno, A., Rastelli, F., Tassi, V., Nicolardi, L., Pensieri, M. V., Emili, R., Roca, E., Migliore, A., Galassi, T., Rocchi, M. B. L., and Berardi, R.

Abstract

The publisher regrets that at the time the article was published the name of the author N. La Verde was mistakenly abbreviated as N.L. Verde. This has now been corrected. The publisher would like to apologise for any inconvenience caused.

Published
2022

12. Predictive ability of a drug-based score in patients with advanced non-small-cell lung cancer receiving first-line immunotherapy

Author

Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, Cortellini A, Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, and Cortellini A

Abstract

Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This ‘drug score’ was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1–2 and poor risk with score 3–4. Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non–small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy). Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab coh

Published
2021

13. Differential influence of antibiotic therapy and other medications on oncological outcomes of patients with non-small cell lung cancer treated with first-line pembrolizumab versus cytotoxic chemotherapy

Author

Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, Pinato DJ, Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, and Pinato DJ

Abstract

Background Some concomitant medications including antibiotics (ATB) have been reproducibly associated with worse survival following immune checkpoint inhibitors (ICIs) in unselected patients with non-small cell lung cancer (NSCLC) (according to programmed death-ligand 1 (PD-L1) expression and treatment line). Whether such relationship is causative or associative is matter of debate. Methods We present the outcomes analysis according to concomitant baseline medications (prior to ICI initiation) with putative immune-modulatory effects in a large cohort of patients with metastatic NSCLC with a PD-L1 expression >= 50%, receiving first-line pembrolizumab monotherapy. We also evaluated a control cohort of patients with metastatic NSCLC treated with first-line chemotherapy. The interaction between key medications and therapeutic modality (pembrolizumab vs chemotherapy) was validated in pooled multivariable analyses. Results 950 and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Corticosteroid and proton pump inhibitor (PPI) therapy but not ATB therapy was associated with poorer performance status at baseline in both the cohorts. No association with clinical outcomes was found according to baseline statin, aspirin, beta-blocker and metformin within the pembrolizumab cohort. On the multivariable analysis, ATB emerged as a strong predictor of worse overall survival (OS) (HR=1.42 (95% CI 1.13 to 1.79); p=0.0024), and progression free survival (PFS) (HR=1.29 (95% CI 1.04 to 1.59); p=0.0192) in the pembrolizumab but not in the chemotherapy cohort. Corticosteroids were associated with shorter PFS (HR=1.69 (95% CI 1.42 to 2.03); p<0.0001), and OS (HR=1.93 (95% CI 1.59 to 2.35); p<0.0001) following pembrolizumab, and shorter PFS (HR=1.30 (95% CI 1.08 to 1.56), p=0.0046) and OS (HR=1.58 (95% CI 1.29 to 1.94), p<0.0001), following chemotherapy. PPIs were associated with worse OS (HR=1.49 (95% CI 1.26 to 1.77); p<0.0001) with pem

Published
2021

14. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case-control matched analysis from a large multicenter study

Author

Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, Porzio G, Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, and Porzio G

Abstract

Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat

Published
2021

15. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, Addeo A., Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, and Addeo A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

16. Post-progression outcomes of NSCLC patients with PD-L1 expression ≥ 50% receiving first-line single-agent pembrolizumab in a large multicentre real-world study

Author

Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, Porzio G, Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, and Porzio G

Abstract

Background: Treatment sequencing with first-line immunotherapy, followed by second-line chemotherapy, is still a viable option for NSCLC patients with PD-L1 expression ≥50%. Methods: We evaluated post-progression treatment pathways in a large real-world cohort of metastatic NSCLC patients with PD-L1 expression ≥ 50% treated with first-line pembrolizumab monotherapy. Results: Overall, 974 patients were included. With a median follow-up of 22.7 months (95%CI: 21.6–38.2), the median overall survival (OS) of the entire population was 15.8 months (95%CI: 13.5–17.5; 548 events). At the data cutoff, among the 678 patients who experienced disease progression, 379 (55.9%) had not received any further treatment, and 359 patients (52.9%) had died. Patients who did not receive post-progression therapies were older (p = 0.0011), with a worse ECOG-PS (p < 0.0001) and were on corticosteroids prior to pembrolizumab (p = 0.0024). At disease progression, 198 patients (29.2%) received a switched approach and 101 (14.9%) received pembrolizumab ByPD either alone (64 [9.4%]) or in combination with local ablative treatments (37 [5.5%]) (LATs). After a random-case control matching according to ECOG-PS, CNS metastases, bone metastases, and (previous) best response to pembrolizumab, patients receiving pembrolizumab ByPD plus LATs were confirmed to have a significantly longer post-progression OS compared to patients receiving pembrolizumab ByPD alone 13.9 months versus 7.8 months (p = 0.0179) 241 patients (35.5%) among the 678 who had experienced PD, received a second-line systemic treatment (regardless of previous treatment beyond PD). As compared to first-line treatment commencement, patients’ features at the moment of second-line initiation showed a significantly higher proportion of patients aged under 70 years (p = 0.0244), with a poorer ECOG-PS (p < 0.0001) and having CNS (p = 0.0001), bone (p = 0.0266) and liver metastases (p = 0.0148). Conclusions: In the real-world scenario NSC

Published
2021

17. Skip pattern approach toward the early access of innovative anticancer drugs

Author

Apolone, G, Ardizzoni, A, Biondi, A, Bortolami, A, Cardone, C, Ciniselli, C, Conte, P, Crippa, C, de Braud, F, Duca, M, Gori, S, Gritti, G, Inno, A, Luksch, R, Lussana, F, Maio, M, Pasello, G, Perrone, F, Rambaldi, A, Rossi, G, Signorelli, D, Soverini, G, Valente, M, Verderio, P, Buzzetti, G, Apolone G., Ardizzoni A., Biondi A., Bortolami A., Cardone C., Ciniselli C. M., Conte P., Crippa C., de Braud F., Duca M., Gori S., Gritti G., Inno A., Luksch R., Lussana F., Maio M., Pasello G., Perrone F., Rambaldi A., Rossi G., Signorelli D., Soverini G., Valente M., Verderio P., Buzzetti G., Apolone, G, Ardizzoni, A, Biondi, A, Bortolami, A, Cardone, C, Ciniselli, C, Conte, P, Crippa, C, de Braud, F, Duca, M, Gori, S, Gritti, G, Inno, A, Luksch, R, Lussana, F, Maio, M, Pasello, G, Perrone, F, Rambaldi, A, Rossi, G, Signorelli, D, Soverini, G, Valente, M, Verderio, P, Buzzetti, G, Apolone G., Ardizzoni A., Biondi A., Bortolami A., Cardone C., Ciniselli C. M., Conte P., Crippa C., de Braud F., Duca M., Gori S., Gritti G., Inno A., Luksch R., Lussana F., Maio M., Pasello G., Perrone F., Rambaldi A., Rossi G., Signorelli D., Soverini G., Valente M., Verderio P., and Buzzetti G.

Abstract

BACKGROUND: With the rapid development of innovative anticancer treatments, the optimization of tools able to accelerate the access of new drugs to the market by the regulatory authority is a major issue. The aim of the project was to propose a reliable methodological pathway for the assessment of clinical value of new therapeutic innovative options, to objectively identify drugs which deserve early access (EA) priority for solid and possibly in other cancer scenarios, such as the hematological ones. MATERIALS AND METHODS: After a comprehensive review of the European Public Assessment Report of 21 drugs, to which innovation had previously been attributed by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA), an expert panel formulated an algorithm for the balanced use of three parameters: Unmet Medical Need (UMN) according to AIFA criteria, Added Benefit (AB) according to the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale (ESMO-MCBS) criteria and Quality of Evidence (QE) assessed by the Grades of Recommendation Assessment, Development and Evaluation (GRADE) method. By sequentially combining the above indicators, a final priority status (i.e. EA or not) was obtained using the skip pattern approach (SPA). RESULTS: By applying the SPA to the non-curative setting in solid cancers, the EA status was obtained by 5 out of 14 investigated drugs (36%); by enhancing the role of some categories of the UMN, additional 4 drugs, for a total of 9 (64%), reached the EA status: 2 and 3 drugs were excluded for not achieving an adequate score according to AB and QE criteria, respectively. For hematology cancer, only the UMN criteria were found to be adequate. CONCLUSIONS: The use of this model may represent a reliable tool for assessment available to the various stakeholders involved in the EA process and may help regulatory agencies in a more comprehensive and objective definition of new treatments' value in these contexts. Its generalizabi

Published
2021

18. High Prevalence and Early Occurrence of Skeletal Complications in EGFR Mutated NSCLC Patients With Bone Metastases

Author

Lagana, M, Gurizzan, C, Roca, E, Cortinovis, D, Signorelli, D, Pagani, F, Bettini, A, Bonomi, L, Rinaldi, S, Berardi, R, Filetti, M, Giusti, R, Pilotto, S, Milella, M, Intagliata, S, Baggi, A, Cortellini, A, Soto Parra, H, Brighenti, M, Petrelli, F, Bennati, C, Bidoli, P, Garassino, M, Berruti, A, Lagana M., Gurizzan C., Roca E., Cortinovis D., Signorelli D., Pagani F., Bettini A., Bonomi L., Rinaldi S., Berardi R., Filetti M., Giusti R., Pilotto S., Milella M., Intagliata S., Baggi A., Cortellini A., Soto Parra H., Brighenti M., Petrelli F., Bennati C., Bidoli P., Garassino M. C., Berruti A., Lagana, M, Gurizzan, C, Roca, E, Cortinovis, D, Signorelli, D, Pagani, F, Bettini, A, Bonomi, L, Rinaldi, S, Berardi, R, Filetti, M, Giusti, R, Pilotto, S, Milella, M, Intagliata, S, Baggi, A, Cortellini, A, Soto Parra, H, Brighenti, M, Petrelli, F, Bennati, C, Bidoli, P, Garassino, M, Berruti, A, Lagana M., Gurizzan C., Roca E., Cortinovis D., Signorelli D., Pagani F., Bettini A., Bonomi L., Rinaldi S., Berardi R., Filetti M., Giusti R., Pilotto S., Milella M., Intagliata S., Baggi A., Cortellini A., Soto Parra H., Brighenti M., Petrelli F., Bennati C., Bidoli P., Garassino M. C., and Berruti A.

Abstract

Objectives: The prevalence of Skeletal Related Adverse Events (SREs) in EGFR mutated non-small cell lung cancer (NSCLC) patients with bone metastases, treated with modern tyrosine kinase inhibitors (TKIs), has been scarcely investigated. Materials and Methods: We retrospectively evaluated the data of EGFR mutated NSCLC patients with bone metastases treated with TKIs in 12 Italian centers from 2014 to 2019, with the primary aim to explore type and frequency of SREs. Results: Seventy-seven out of 274 patients enrolled (28%) developed at least one major SRE: 55/274 (20%) bone fractures, 30/274 (11%) spinal cord compression, 5/274 (2%) hypercalcemia. Median time to the onset of SRE was 3.63 months. Nine patients (3%) underwent bone surgery and 150 (55%) radiation therapy on bone. SREs were more frequently observed within the 12 months from TKI start than afterwards (71 vs 29%, p 0.000). Patient Performance Status and liver metastases where independently associated with the risk of developing SREs. Median TKI exposure and overall survival were 11 and 28 months, respectively. Bone resorption inhibitors were associated with a lower risk of death (HR 0.722, 95% CI: 0.504–1.033, p = 0.075) although not statistically significant at multivariate analysis. Conclusion: Bone metastatic NSCLC patients with EGFR mutated disease, treated with EGFR TKIs, have a relatively long survival expectancy and are at high risk to develop SREs. The early SRE occurrence after the TKI start provides the rationale to administer bone resorption inhibitors.

Published
2020

19. Immune-related Adverse Events of Pembrolizumab in a Large Real-world Cohort of Patients With NSCLC With a PD-L1 Expression ≥ 50% and Their Relationship With Clinical Outcomes

Author

Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, Cannita K., Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, and Cannita K.

Abstract

Background: The role of immune-related adverse events (irAEs), as a surrogate predictor of the efficacy of checkpoint inhibitors, has not yet been described in the setting of first-line, single-agent pembrolizumab for patients with metastatic non-small-cell lung-cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of ≥ 50%. Patients and methods: We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50% receiving first-line pembrolizumab. Here, we report the results of the irAE analysis and the potential correlation between irAEs and clinical outcomes. Results: A total of 1010 patients were included in this analysis; after a 6-week landmark selection, 877 (86.8%) patients were included in the efficacy analysis. Any grade irAEs (P < .0001), grade 3/4 irAEs (P = .0025), leading to discontinuation irAEs (P = .0144), multiple-site and single-site irAEs (P < .0001), cutaneous irAEs (P = .0001), endocrine irAEs (P = .0227), pulmonary irAEs (P = .0479), and rheumatologic irAEs (P = .0018) were significantly related to a higher objective response rate. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0005), cutaneous irAEs (P = .0042), endocrine irAEs (P < .0001), gastrointestinal irAEs (P = .0391), and rheumatologic irAEs (P = .0086) were significantly related to progression-free survival. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0003), cutaneous irAEs (P = .0002), endocrine irAEs (P = .0001), and rheumatologic irAEs (P = .0214) were significantly related to overall survival. Conclusions: This study confirms the feasibility and the safety of first-line, single-agent pembrolizumab, in a large, real-world cohort of patients with NSCLC with PD-L1 expression ≥ 50%. The occurrence of irAEs may be a surrogate of clinical activity and improved outcomes in this setting.

Published
2020

20. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation

Author

Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, Ficorella C., Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, and Ficorella C.

Abstract

Background The association between obesity and outcomes in patients receiving programmed death-1/programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04-2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37-0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45-0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01-1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49-0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.

Published
2020

21. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50

Author

Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, Porzio G., Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, and Porzio G.

Abstract

Background: Single-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%. Methods: We conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%. Results: One thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2–49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9–9.5; 599 events) and 17.2 months (95% CI 15.3–22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis. Conclusion: Pembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effe

Published
2020

22. Chemotherapy in non-small cell lung cancer patients after prior immunotherapy: The multicenter retrospective CLARITY study

Author

Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., Tiseo M., Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., and Tiseo M.

Abstract

Objectives: In the most of cases, for non-small cell lung cancer (NSCLC) patients who progressed to previous immune checkpoint inhibitors (CKI) administered as first- or as second-line therapy, chemotherapy (CT) remains the only viable options in the absence of “druggable” mutations. We aimed to explore the efficacy of salvage chemotherapy after immunotherapy (SCAI) in advanced NSCLC patients. Materials and Methods: We designed a retrospective, multicenter study, involving 20 Italian centers, with the primary objective of describing the clinical outcome of advanced NSCLC patients treated with SCAI at the participating institutions from November 2013 to July 2019. The primary endpoint of the study was represented by overall survival (OS), defined as the time from CT initiation to death. Secondary outcome endpoints of the SCAI (progression free survival, PFS, objective response rate, ORR and toxicity) and explorative biomarkers (lactate dehydrogenase, LDH, and neutrophil-to-lymphocyte ratio, NLR during immunotherapy) were also analyzed. Results: In our study population of 342 NSCLC patients, SCAI obtained a median OS of 6.8 months (95 % confidence interval, CI 5.5–8.1), median PFS of 4.1 months (95 % CI 3.4−4.8) and ORR of 22.8 %. A “Post-CKI score” was constructed by combining significant predictors of OS at the multivariate analyses (sex, ECOG PS, disease control with prior immunotherapy), Harrell'C was 0.65, (95 % CI:0.59−0.71). Conclusions: Despite the late-line settings, our findings support the hypothesis that previous immunotherapy might increase the sensitivity of the tumor to the subsequent chemotherapy. The “Post-CKI score” was clinically effective in successfully discriminating three distinct prognostic subgroups of patients after the failure of CKI, representing a possibly useful tool for the tailored decision-making process of advanced treatment-line settings in NSCLC.

Published
2020

23. Erratum to ‘Evaluation of COVID-19 impact on DELAYing diagnostic-therapeutic pathways of lung cancer patients in Italy (COVID-DELAY study): fewer cases and higher stages from a real-world scenario’: [ESMO Open Volume 7, Issue 2, April 2022, 100406]

Author

Cantini, L., Mentrasti, G., Lo Russo, G., Signorelli, D., Pasello, G., Rijavec, E., Russano, M., Antonuzzo, L., Rocco, D., Giusti, R., Adamo, V., Genova, C., Tuzi, A., Morabito, A., Gori, S., La Verde, N., Chiari, R., Cortellini, A., Cognigni, V., Pecci, F., Indini, A., De Toma, A., Zattarin, E., Oresti, S., Pizzutilo, E.G., Frega, S., Erbetta, E., Galletti, A., Citarella, F., Fancelli, S., Caliman, E., Della Gravara, L., Malapelle, U., Filetti, M., Piras, M., Toscano, G., Zullo, L., De Tursi, M., Di Marino, P., D’Emilio, V., Cona, M.S., Guida, A., Caglio, A., Salerno, F., Spinelli, G.P., Bennati, C., Morgillo, F., Russo, A., Dellepiane, C., Vallini, I., Sforza, V., Inno, A., Rastelli, F., Tassi, V., Nicolardi, L., Pensieri, M.V., Emili, R., Roca, E., Migliore, A., Galassi, T., Rocchi, M.B.L., and Berardi, R.

Published
2022
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25. Bone metastases and immunotherapy in patients with advanced non-small-cell lung cancer

Author

Landi, L, D'Inca, F, Gelibter, A, Chiari, R, Grossi, F, Delmonte, A, Passaro, A, Signorelli, D, Gelsomino, F, Galetta, D, Giannarelli, D, Soto Parra, H, Minuti, G, Tiseo, M, Migliorino, M, Cognetti, F, Toschi, L, Bidoli, P, Piantedosi, F, Calabro', L, Cappuzzo, F, Landi L., D'Inca F., Gelibter A., Chiari R., Grossi F., Delmonte A., Passaro A., Signorelli D., Gelsomino F., Galetta D., Giannarelli D., Soto Parra H., Minuti G., Tiseo M., Migliorino M. R., Cognetti F., Toschi L., Bidoli P., Piantedosi F., Calabro' L., Cappuzzo F., Landi, L, D'Inca, F, Gelibter, A, Chiari, R, Grossi, F, Delmonte, A, Passaro, A, Signorelli, D, Gelsomino, F, Galetta, D, Giannarelli, D, Soto Parra, H, Minuti, G, Tiseo, M, Migliorino, M, Cognetti, F, Toschi, L, Bidoli, P, Piantedosi, F, Calabro', L, Cappuzzo, F, Landi L., D'Inca F., Gelibter A., Chiari R., Grossi F., Delmonte A., Passaro A., Signorelli D., Gelsomino F., Galetta D., Giannarelli D., Soto Parra H., Minuti G., Tiseo M., Migliorino M. R., Cognetti F., Toschi L., Bidoli P., Piantedosi F., Calabro' L., and Cappuzzo F.

Abstract

Background: Bone metastases (BoM) are a negative prognostic factor in non-small-cell lung cancer (NSCLC). Beyond its supportive role, bone is a hematopoietic organ actively regulating immune system. We hypothesized that BoM may influence sensitivity to immunotherapy. Methods: Pretreated non-squamous (cohort A) and squamous (cohort B) NSCLCs included in the Italian Expanded Access Program were evaluated for nivolumab efficacy according to BoM. Results: Cohort A accounted for 1588 patients with non-squamous NSCLC, including 626 (39%) with (BoM+) and 962 (61%) without BoM (BoM-). Cohort B accounted for 371 patients with squamous histology including 120 BoM+ (32%) and 251 (68%) BoM- cases. BoM+ had lower overall response rate (ORR; Cohort A: 12% versus 23%, p < 0.0001; Cohort B: 13% versus 22%, p = 0.04), shorter progression free survival (PFS; Cohort A: 3.0 versus 4.0 months, p < 0.0001; Cohort B: 2.7 versus 5.2 months, p < 0.0001) and overall survival (OS; Cohort A: 7.4 versus 15.3 months, p < 0.0001; Cohort B: 5.0 versus 10.9 months, p < 0.0001). Moreover, BoM negatively affected outcome irrespective of performance status (PS; OS in both cohorts: p < 0.0001) and liver metastases (OS cohort A: p < 0.0001; OS Cohort B: p = 0.48). At multivariate analysis, BoM independently associated with higher risk of death (cohort A: HR 1.50; cohort B: HR 1.78). Conclusions: BoM impairs immunotherapy efficacy. Accurate bone staging should be included in clinical trials with immunotherapy.

Published
2019

26. Corrigendum to ‘The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer’: [ESMO Open Volume 6, Issue 2, April 2021, 100078]

Author

Banna, G.L., Cortellini, A., Cortinovis, D.L., Tiseo, M., Aerts, J.G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021
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27. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078]

Author

Banna, GL, Cortellini, A, Cortinovis, DL, Tiseo, M, Aerts, JGJV, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, and Addeo, A

Abstract

ispartof: ESMO Open vol:6 issue:3 pages:100137- ispartof: location:England status: published

Published
2021

28. P40.08 Bone-Targeted Agents Improve Survival in High Bone Tumor Burden Advanced Non-Small-Cell-Lung Cancer Patients Treated With PD-(L)1 Inhibitors

Author

Manglaviti, S., primary, Bini, M., additional, Apollonio, G., additional, Galli, G., additional, Labianca, A., additional, Zecca, E., additional, Brambilla, M., additional, Occhipinti, M., additional, Proto, C., additional, Prelaj, A., additional, Signorelli, D., additional, De Toma, A., additional, Viscardi, G., additional, Beninato, T., additional, Zattarin, E., additional, Mazzeo, L., additional, Galli, E., additional, Ganzinelli, M., additional, De Braud, F.G.M., additional, Garassino, M.C., additional, Lo Russo, G., additional, and Ferrara, R., additional

Published
2021
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29. 1327P Impact of bone targeted agents (BTA) in advanced non-small cell lung cancer (aNSCLC) patients (pts) with high bone tumor burden (HBTB) treated with PD(L)1 inhibitors (ICIs)

Author

Manglaviti, S., primary, Bini, M., additional, Apollonio, G., additional, Zecca, E., additional, Labianca, A., additional, Galli, G., additional, Brambilla, M., additional, Occhipinti, M., additional, Proto, C., additional, Prelaj, A., additional, Signorelli, D., additional, De Toma, A., additional, Viscardi, G., additional, Beninato, T., additional, Zattarin, E., additional, Galli, E., additional, Garassino, M.C.C., additional, de Braud, F.G.M., additional, Lo Russo, G., additional, and Ferrara, R., additional

Published
2021
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30. 1172MO Durvalumab consolidation in patients with stage III non-resecable NSCLC with driver genomic alterations

Author

Melia, M. Riudavets, primary, Auclin, E., additional, Lamas, M.A. Mosteiro, additional, Dempsey, N., additional, Majem, M., additional, Lobefaro, R., additional, Castro, R. Lopez, additional, Barrera, J. Bosch, additional, Pilotto, S., additional, Martín, E. Escalera, additional, Tagliamento, M., additional, Martinez, J. Mosquera, additional, Zalcman, G., additional, Nadal, E., additional, Lopes, G., additional, Signorelli, D., additional, Campelo, M.R. Garcia, additional, Besse, B., additional, Planchard, D., additional, and Mezquita, L., additional

Published
2021
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31. Immunometabolism of circulating neutrophils in hyperprogressive disease (HPD) upon first-line PD-1/PD-L1 inhibitors (ICI) alone or in combination with platinum-based chemotherapy (PCT) in non-small cell lung cancer (NSCLC) patients (pts)

Author

Ferrara, R, Jachetti, E, Calareso, G, Brambilla, M, Lo Russo, G, Proto, C, Prelaj, A, Signorelli, D, Galli, G, De Toma, A, Occhipinti, M, Manglaviti, S, Labianca, A, Ganzinelli, M, Spano, Sm, Molino, G, Martinetti, A, Greco, Fg, Bini, M, Beninato, T, de Braud, F, Colombo, Mp, Garassino, Mc, and Sangaletti, S

Published
2021

32. LIPI and outcomes of durvalumab as consolidation therapy after ChRT in patients with locally-advanced NSCLC [MA08.04]

Author

Riudavets, M., Mezquita, L., Auclin, E., Benitez, J.C., Le Pechoux, C., Majem, M., Dempsey, N., Lobefaro, R., Nadal, E., Amores, A., Menis, J., Tagliamento, M., López-Castro, R., Ponce, S., Bosch-Barrera, J., Aboubakar Nana, Frank, Mosquera, J., Pilotto, S., Reyes, R., Mielgo, X., Duchemann, B., Mosteiro, M., Mussat, E., De Giglio, A., Scheffler, M., Campayo, M., Botticella, A., Naltet, C., Lavaud, P., Lopes, G., Signorelli, D., Garcia-Campelo, R., Besse, B., Planchard, D., 2020 World Conference on Lung Cancer, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, and UCL - (SLuc) Service de pneumologie

Subjects
Pulmonary and Respiratory Medicine, Oncology
Abstract

INTRODUCTION : The lung immune prognostic index (LIPI), which combines pretreatment derived neutrophils/[leukocytes minus neutrophils] ratio (dNLR) >3 and lactate dehydrogenase (LDH) > upper limit of normal (ULN), is associated with outcomes in advanced non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICI). We aimed to assess whether pretreatment LIPI correlates with durvalumab efficacy after concurrent chemoradiotherapy in the locally advanced setting.

Published
2021

33. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case–control matched analysis from a large multicenter study

Author

Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), Porzio, G. (Giampiero), Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), and Porzio, G. (Giampiero)

Abstract

Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat

Published
2021
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34. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Published
2021

35. LIPI and outcomes of durvalumab as consolidation therapy after ChRT in patients with locally-advanced NSCLC [MA08.04]

Author

UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service de pneumologie, Riudavets, M., Mezquita, L., Auclin, E., Benitez, J.C., Le Pechoux, C., Majem, M., Dempsey, N., Lobefaro, R., Nadal, E., Amores, A., Menis, J., Tagliamento, M., López-Castro, R., Ponce, S., Bosch-Barrera, J., Aboubakar Nana, Frank, Mosquera, J., Pilotto, S., Reyes, R., Mielgo, X., Duchemann, B., Mosteiro, M., Mussat, E., De Giglio, A., Scheffler, M., Campayo, M., Botticella, A., Naltet, C., Lavaud, P., Lopes, G., Signorelli, D., Garcia-Campelo, R., Besse, B., Planchard, D., 2020 World Conference on Lung Cancer, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service de pneumologie, Riudavets, M., Mezquita, L., Auclin, E., Benitez, J.C., Le Pechoux, C., Majem, M., Dempsey, N., Lobefaro, R., Nadal, E., Amores, A., Menis, J., Tagliamento, M., López-Castro, R., Ponce, S., Bosch-Barrera, J., Aboubakar Nana, Frank, Mosquera, J., Pilotto, S., Reyes, R., Mielgo, X., Duchemann, B., Mosteiro, M., Mussat, E., De Giglio, A., Scheffler, M., Campayo, M., Botticella, A., Naltet, C., Lavaud, P., Lopes, G., Signorelli, D., Garcia-Campelo, R., Besse, B., Planchard, D., and 2020 World Conference on Lung Cancer

Abstract

INTRODUCTION : The lung immune prognostic index (LIPI), which combines pretreatment derived neutrophils/[leukocytes minus neutrophils] ratio (dNLR) >3 and lactate dehydrogenase (LDH) > upper limit of normal (ULN), is associated with outcomes in advanced non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICI). We aimed to assess whether pretreatment LIPI correlates with durvalumab efficacy after concurrent chemoradiotherapy in the locally advanced setting.

Published
2021

36. The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author

Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.

Abstract

Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.

Published
2021

37. First Case Report of Pregnancy on Alectinib in a Woman With Metastatic ALK-Rearranged Lung Cancer: A Case Report

Author

Scarfone, G., Fumagalli, M., Imbimbo, M., Ceruti, T., Cribiu, F. M., Di Loreto, E., D'Incalci, M., Facchin, Federica, Fontana, Cecilia Alejandra, Garassino, M. C., Peccatori, F. A., Persico, Nicola, Signorelli, D., Zucchetti, M., Facchin F. (ORCID:0000-0001-8944-1440), Fontana C., Persico N., Scarfone, G., Fumagalli, M., Imbimbo, M., Ceruti, T., Cribiu, F. M., Di Loreto, E., D'Incalci, M., Facchin, Federica, Fontana, Cecilia Alejandra, Garassino, M. C., Peccatori, F. A., Persico, Nicola, Signorelli, D., Zucchetti, M., Facchin F. (ORCID:0000-0001-8944-1440), Fontana C., and Persico N.

Abstract

This is the first case report of a patient with ALK-rearranged metastatic lung adenocarcinoma who became pregnant during treatment with alectinib. A multidisciplinary team of gynecologists, neonatologists, oncologists, psychologists, and pharmacologists was set up to handle the case. According to patient's preference, the study drug was continued throughout pregnancy and the woman delivered a healthy baby girl at 35 weeks and 5 days of gestation. Fetal parameters remained normal during pregnancy. At birth, alectinib levels were 14 times higher in maternal plasma than in the fetus (259 versus 18 ng/mL). The average concentration of alectinib in the placenta was 562 ng/g. The baby was followed during her first 20 months, and no developmental anomalies were observed. After 32 months from diagnosis, the mother is well and in partial remission.

Published
2021

39. 184P Bone-targeted agents (BTA) improve survival in advanced non-small cell lung cancer (aNSCLC) patients (pts) with high bone tumor burden (HBTB) treated with PD-(L)-1 inhibitors (ICIs)

Author

Manglaviti, S., primary, Galli, G., additional, Bini, M., additional, Labianca, A., additional, Zecca, E., additional, Brambilla, M., additional, Occhipinti, M., additional, Proto, C., additional, Prelaj, A., additional, Signorelli, D., additional, De Toma, A., additional, Viscardi, G., additional, Beninato, T., additional, Zattarin, E., additional, Ganzinelli, M., additional, de Braud, F.G.M., additional, Garassino, M.C., additional, Lo Russo, G., additional, and Ferrara, R., additional

Published
2021
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40. MA08.04 LIPI and outcomes of durvalumab as consolidation therapy after ChRT in patients with locally-advanced NSCLC

Author

Riudavets, M., primary, Mezquita, L., additional, Auclin, E., additional, Benitez, J.C., additional, Le Pechoux, C., additional, Majem, M., additional, Dempsey, N., additional, Lobefaro, R., additional, Nadal, E., additional, Amores, A., additional, Menis, J., additional, Tagliamento, M., additional, López-Castro, R., additional, Ponce, S., additional, Bosch-Barrera, J., additional, Aboubakar, F., additional, Mosquera, J., additional, Pilotto, S., additional, Reyes, R., additional, Mielgo, X., additional, Duchemann, B., additional, Mosteiro, M., additional, Mussat, E., additional, De Giglio, A., additional, Scheffler, M., additional, Campayo, M., additional, Botticella, A., additional, Naltet, C., additional, Lavaud, P., additional, Lopes, G., additional, Signorelli, D., additional, Garcia-Campelo, R., additional, Besse, B., additional, and Planchard, D., additional

Published
2021
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41. P33.01 Circulating Extracellular Vesicles as Biomarkers for Immune-Checkpoint Inhibitors in Advanced NSCLC

Author

Signorelli, D., primary, Fortunato, O., additional, Pontis, F., additional, Capizzuto, V., additional, Ferri, R., additional, Brambilla, M., additional, Ferrara, R., additional, Proto, C., additional, Lo Russo, G., additional, Prelaj, A., additional, Galli, G., additional, De Toma, A., additional, Viscardi, G., additional, Lobefaro, R., additional, Nichetti, F., additional, Ganzinelli, M., additional, Zilembo, N., additional, Colombo, M., additional, Sozzi, G., additional, Garassino, M.C., additional, and Jachetti, E., additional

Published
2021
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43. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression >= 50%: a multicenter study with external validation

Author

Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., Ficorella, C., Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., and Ficorella, C.

Abstract

Background The association between obesity and outcomes in patients receiving programmed death-1/ programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04– 2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37–0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45–0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01–1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49–0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.

Published
2020
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44. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression >= 50%: a multicenter study with external validation

Author

Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, GL, Aerts, Joachim, Barbieri, F, Giusti, R, Cortinovis, DL, Migliorino, MR, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Rastelli, F, Chiari, R, De Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, Luca, Targato, G, Nigro, O, Ferrara, MG, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbo, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, GL, Aerts, Joachim, Barbieri, F, Giusti, R, Cortinovis, DL, Migliorino, MR, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Rastelli, F, Chiari, R, De Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, Luca, Targato, G, Nigro, O, Ferrara, MG, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbo, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, and Ficorella, C

Published
2020

45. 1388P Poziotinib in advanced NSCLC with EGFR or HER2 exon 20 insertion mutation: Initial results from a single site expanded access program

Author

Prelaj, A., primary, Bottiglieri, A., additional, Proto, C., additional, Lo Russo, G., additional, Signorelli, D., additional, Ferrara, R., additional, Galli, G., additional, De Toma, A., additional, Viscardi, G., additional, Brambilla, M., additional, Lobefaro, R., additional, Manglaviti, S., additional, Occhipinti, M., additional, Labianca, A., additional, Gallucci, R., additional, Molino, G., additional, Zilembo, N., additional, Greco, F.G., additional, Torri, V., additional, and Garassino, M.C., additional

Published
2020
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46. 1312P Chemotherapy followed by immunotherapy compared to reverse sequence in NSCLC with PD-L1 low expression: PFS2 analysis

Author

Brambilla, M., primary, Nichetti, F., additional, Loberfaro, R., additional, Galli, G., additional, De Toma, A., additional, Viscardi, G., additional, Prelaj, A., additional, Ferrara, R., additional, Proto, C., additional, Signorelli, D., additional, Bottiglieri, A., additional, Massa, G., additional, Trevisan, B., additional, Ganzinelli, M., additional, Zilembo, N., additional, de Braud, F., additional, Garassino, M.C., additional, and Lo Russo, G., additional

Published
2020
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47. 1278P Hyperprogressive disease (HPD) upon first-line PD-1/PD-L1 inhibitors (ICI) as single agent or in combination with platinum-based chemotherapy in non-small cell lung cancer (NSCLC) patients (pts)

Author

Ferrara, R., primary, Facchinetti, F., additional, Calareso, G., additional, Kasraoui, I., additional, Signorelli, D., additional, Proto, C., additional, Prelaj, A., additional, Naltet, C., additional, Lavaud, P., additional, Desmaris, R., additional, Viscardi, G., additional, Galli, G., additional, De Toma, A., additional, Martinetti, A., additional, Barlesi, F., additional, Planchard, D., additional, Soria, J-C., additional, Garassino, M.C., additional, Besse, B., additional, and Lo Russo, G., additional

Published
2020
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48. 1329P Immune checkpoint inhibitors in advanced NSCLC patients with poor performance status: The role of clinical-pathological variables and inflammatory biomarkers in a real world experience

Author

Lobefaro, R., primary, Viscardi, G., additional, Di Liello, R., additional, Massa, G., additional, Iacovino, M.L., additional, Sparano, F., additional, Della Corte, C.M., additional, Ferrara, R., additional, Signorelli, D., additional, Proto, C., additional, Prelaj, A., additional, Galli, G., additional, De Toma, A., additional, Brambilla, M., additional, Ganzinelli, M., additional, Trevisan, B., additional, De Braud, F.G.M., additional, Morgillo, F., additional, Garassino, M.C., additional, and Lo Russo, G., additional

Published
2020
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50. Baseline neutrophil-to-lymphocyte ratio and PD-L1 expression level or LDH value may predict outcome of patients with high PD-L1 advanced non-small cell lung cancer treated with first-line pembrolizumab

Author

Banna, G., primary, Signorelli, D., additional, Metro, G., additional, Galetta, D., additional, De Toma, A., additional, Cantale, O., additional, Banini, M., additional, Friedlaender, A., additional, Pizzutillo, P., additional, Garassino, M., additional, and Addeo, A., additional

Published
2020
Full Text
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