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2. Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor[FIGURE DASH]Resistant, EGFR–Mutant, Metastatic Nonsquamous Non–Small Cell Lung Cancer

Author

Yang, James Chih-Hsin, Lee, Dae Ho, Lee, Jong-Seok, Fan, Yun, de Marinis, Filippo, Iwama, Eiji, Inoue, Takako, Rodríguez-Cid, Jerónimo, Zhang, Li, Yang, Cheng-Ta, de la Mora Jimenez, Emmanuel, Zhou, Jianying, Pérol, Maurice, Lee, Ki Hyeong, Vicente, David, Ichihara, Eiki, Riely, Gregory J., Luo, Yiwen, Chirovsky, Diana, Pietanza, M. Catherine, Bhagwati, Niyati, Lu, Shun, Joseph Boyer, Michael, Hui, Rina, Wong, Mark, Mant, Andrew, Parente, Phillip, John, Thomas, Parakh, Sagun, Castro, Gilberto, Jr, Werutsky, Gustavo, de Azevedo, Sergio Jobim, Andre Franke, Fabio, De Almeida Rego, Joilda Batista, Martins De Marchi, Pedro Rafael, Dix Junqueira, Gustavo, Maris Peria, Fernanda, Brust, Leandro, Cheema, Parneet, Doherty, Mark, Parmar, Ambika, Menjak, Ines B., Leighl, Natasha B., Agulnik, Jason, Lu, Shun, Han, Zhigang, Cui, Jiuwei, Zhang, Li, Cheng, Ying, Chen, Gongyan, Zhang, Helong, Yao, Yu, Hu, Chengping, Wang, Qiming, Zhang, Xin, Zhang, Yong, Zhou, Jianying, Ying, Kejing, Fan, Yun, Wang, Yan, Wang, Ziping, Feng, Jifeng, Du, YingYing, Wu, Lin, Huang, Cheng, Zhou, Xiangdong, Perol, Maurice, Domont, Julien, Lamour, Corinne, Dutilh, Julien, Oulkhouir, Youssef, Westeel, Virginie, Carmier, Delphine, Coudert, Bruno, Lagrange, Aurelie, Spaeth, Dominique, Ropert, Stanislas, Christoph, Daniel C., Kern, Jens, Kopp, Hans-Georg, Griesinger, Frank, Wiewrodt, Rainer, Wermke, Martin, Wesseler, Claas, Mueller, Annette, Vogel, Gunther, Lee, Victor, James Ho, Chung Man, Oscar Chan, Siu Hong, Hung Lo, Sing, Jonathan Nyaw, Shi Feng, Jacky Li, Yu Chung, Bar, Jair, Gottfried, Maya, Dudnik, Julia, Zer, Alona, Moskovitz, Mor, Wollner, Mirjana, Rotem, Ofer, Shamai, Sivan, Asna, Noam, Kamel, Mhameed, Novello, Silvia, Di Costanzo, Francesco, Doni, Laura, Mazzoni, Francesca, Ferrau, Francesco, de Marinis, Filippo, Tonini, Giuseppe, Galetta, Domenico, Piantedosi, Francovito, Vitiello, Fabiana, Kirita, Keisuke, Yoh, Kiyotaka, Takahashi, Toshiaki, Ohe, Yuichiro, Hattori, Yoshihiro, Okamoto, Isamu, Kurata, Takayasu, Yoshioka, Hiroshige, Saka, Hideo, Oki, Masahide, Kato, Terufumi, Tanaka, Hiroshi, Kumagai, Toru, Inoue, Takako, Hida, Toyoaki, Horio, Yoshitsugu, Teraoka, Shunsuke, Ichihara, Eiki, Kishi, Kazuma, Takaya, Hisashi, Takai, Daiya, Kozuki, Toshiyuki, Kasahara, Kazuo, Tambo, Yuichi, Hosomi, Yukio, Kondo, Masashi, Ichiki, Masao, Takeoka, Hiroaki, de la Mora Jimenez, Emmanuel, Hernandez, Carlos Alberto, Rodriguez Cid, Jeronimo Rafael, Rodriguez, Oscar Gerardo Arrieta, Han, Ji-Youn, Min, Young Joo, Kim, Dong-Wan, Park, Keunchil, Lee, Se-Hoon, Lee, Ki Hyeong, Lee, Jong-Seok, Kang, Jin Hyoung, Lee, Dae Ho, Cho, Eun Kyung, Carcereny, Enric, Lopez, Pilar Garrido, Tarruella, Margarita Majem, Rodriguez, Luis Paz-Ares, Vicente Baz, David, Font, Enriqueta Felip, Cobo-Dols, Manuel, Ekman, Simon, Bergman, Bengt, Ohman, Ronny, Vikstrom, Anders, Yang, Chih-Hsin, Chiu, Chao-Hua, Huang, Hsu-Ching, Yang, Cheng-Ta, Su, Jian, Chang, Gee-Chen, Yang, Tsung-Ying, Hsia, Te-Chun, Su, Wu-Chou, Wu, Shang-Yin, Wang, Chin-Chou, Lee, Kang-Yun, Lin, Sheng-Hao, Lin, Chih-Bin, Lee, Jih-Hsiang, Huang, Chun-Yao, Ahmed, Samreen, Newsom-Davis, Thomas, Baijal, Shobhit, Brock, Juliet, Zaki, Kam, Shamash, Jonathan, Papadatos-Pastos, Dionysis, Jain, Pooja, Jane Mackean, Melanie, Kendall, Stephan DiSean, Anderson, Ian, Costin, Dan, Hall, Richard, Campbell, Nicholas, Khan, Saad, Dowell, Jonathan, Mashru, Sandeep, Menon, Smitha, Raza, Ahmad, Ge, Li, Riely, Gregory J., Seetharamu, Nagashree, Stampleman, Laura, Subramanian, Janakiraman, Wender, Donald B., Natale, Ronald B., Zhu, Viola, Ignatius Ou, Sai-Hong, Sanborn, Rachel, and Evangelist, Makenzi C.

Published
2024
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4. Application of the nnU-Net for automatic segmentation of lung lesion on CT images, and implication on radiomic models

Author

Ferrante, Matteo, Rinaldi, Lisa, Botta, Francesca, Hu, Xiaobin, Dolp, Andreas, Minotti, Marta, De Piano, Francesca, Funicelli, Gianluigi, Volpe, Stefania, Bellerba, Federica, De Marco, Paolo, Raimondi, Sara, Rizzo, Stefania, Shi, Kuangyu, Cremonesi, Marta, Jereczek-Fossa, Barbara A., Spaggiari, Lorenzo, De Marinis, Filippo, Orecchia, Roberto, and Origgi, Daniela

Subjects
Electrical Engineering and Systems Science - Image and Video Processing, Computer Science - Computer Vision and Pattern Recognition
Abstract

Lesion segmentation is a crucial step of the radiomic workflow. Manual segmentation requires long execution time and is prone to variability, impairing the realisation of radiomic studies and their robustness. In this study, a deep-learning automatic segmentation method was applied on computed tomography images of non-small-cell lung cancer patients. The use of manual vs automatic segmentation in the performance of survival radiomic models was assessed, as well. METHODS A total of 899 NSCLC patients were included (2 proprietary: A and B, 1 public datasets: C). Automatic segmentation of lung lesions was performed by training a previously developed architecture, the nnU-Net, including 2D, 3D and cascade approaches. The quality of automatic segmentation was evaluated with DICE coefficient, considering manual contours as reference. The impact of automatic segmentation on the performance of a radiomic model for patient survival was explored by extracting radiomic hand-crafted and deep-learning features from manual and automatic contours of dataset A, and feeding different machine learning algorithms to classify survival above/below median. Models' accuracies were assessed and compared. RESULTS The best agreement between automatic and manual contours with DICE=0.78 +(0.12) was achieved by averaging predictions from 2D and 3D models, and applying a post-processing technique to extract the maximum connected component. No statistical differences were observed in the performances of survival models when using manual or automatic contours, hand-crafted, or deep features. The best classifier showed an accuracy between 0.65 and 0.78. CONCLUSION The promising role of nnU-Net for automatic segmentation of lung lesions was confirmed, dramatically reducing the time-consuming physicians' workload without impairing the accuracy of survival predictive models based on radiomics.

Published
2022

8. Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial

Author

Wu, Yi-Long, Guarneri, Valentina, Voon, Pei Jye, Lim, Boon Khaw, Yang, Jin-Ji, Wislez, Marie, Huang, Cheng, Liam, Chong Kin, Mazieres, Julien, Tho, Lye Mun, Hayashi, Hidetoshi, Nhung, Nguyen Viet, Chia, Puey Ling, de Marinis, Filippo, Raskin, Jo, Zhou, Qinghua, Finocchiaro, Giovanna, Le, Anh Tuan, Wang, Jialei, Dooms, Christophe, Kato, Terufumi, Nadal, Ernest, Hin, How Soon, Smit, Egbert F, Wermke, Martin, Tan, Daniel, Morise, Masahiro, O'Brate, Aurora, Adrian, Svenja, Pfeiffer, Boris M, Stroh, Christopher, Juraeva, Dilafruz, Strotmann, Rainer, Goteti, Kosalaram, Berghoff, Karin, Ellers-Lenz, Barbara, Karachaliou, Niki, Le, Xiuning, and Kim, Tae Min

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

Author

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

Published
2024
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12. Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial

Author

Lim, Sun Min, Peters, Solange, Ortega Granados, Ana Laura, Pinto, Gustavo dix Junqueira, Fuentes, Christian Sebastián, Lo Russo, Giuseppe, Schenker, Michael, Ahn, Jin Seok, Reck, Martin, Szijgyarto, Zsolt, Huseinovic, Neda, Zografos, Eleftherios, Buss, Elena, Stjepanovic, Neda, O’Donnell, Sean, and de Marinis, Filippo

Published
2023
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13. Author Correction: BIM and mTOR expression levels predict outcome to erlotinib in EGFR-mutant non-small-cell lung cancer

Author

Karachaliou, Niki, Codony-Servat, Jordi, Teixidó, Cristina, Pilotto, Sara, Drozdowskyj, Ana, Codony-Servat, Carles, Giménez-Capitán, Ana, Molina-Vila, Miguel Angel, Bertrán-Alamillo, Jordi, Gervais, Radj, Massuti, Bartomeu, Morán, Teresa, Majem, Margarita, Felip, Enriqueta, Carcereny, Enric, García-Campelo, Rosario, Viteri, Santiago, González-Cao, María, Morales-Espinosa, Daniela, Verlicchi, Alberto, Crisetti, Elisabetta, Chaib, Imane, Santarpia, Mariacarmela, Luis Ramírez, José, Bosch-Barrera, Joaquim, Felipe Cardona, Andrés, de Marinis, Filippo, López-Vivanco, Guillermo, Miguel Sánchez, José, Vergnenegre, Alain, Sánchez Hernández, José Javier, Sperduti, Isabella, Bria, Emilio, and Rosell, Rafael

Published
2023
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14. Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial

Author

John, Thomas, Grohé, Christian, Goldman, Jonathan W., Shepherd, Frances A., de Marinis, Filippo, Kato, Terufumi, Wang, Qun, Su, Wu-Chou, Choi, Jin Hyuk, Sriuranpong, Virote, Melotti, Barbara, Fidler, Mary J., Chen, Jun, Albayaty, Muna, Stachowiak, Marta, Taggart, Sarah, Wu, Yi-Long, Tsuboi, Masahiro, Herbst, Roy S., and Majem, Margarita

Published
2023
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16. Salvage Surgery After First-Line Alectinib for Locally-Advanced/Metastatic ALK-Rearranged NSCLC: Pathological Response and Perioperative Results

Author

Lococo, Filippo, Cancellieri, Alessandra, Chiappetta, Marco, Leonetti, Alessandro, Cardillo, Giuseppe, Zanelli, Francesca, Mangiameli, Giuseppe, Toschi, Luca, Guggino, Gianluca, Romano, Francesco Jacopo, Leuzzi, Giovanni, Proto, Claudia, Spaggiari, Lorenzo, De Marinis, Filippo, Vita, Emanuele, Ampollini, Luca, Margaritora, Stefano, Tiseo, Marcello, and Bria, Emilio

Published
2023
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17. Brain metastases from NSCLC treated with stereotactic radiotherapy: prediction mismatch between two different radiomic platforms

Author

Carloni, Gianluca, Garibaldi, Cristina, Marvaso, Giulia, Volpe, Stefania, Zaffaroni, Mattia, Pepa, Matteo, Isaksson, Lars Johannes, Colombo, Francesca, Durante, Stefano, Lo Presti, Giuliana, Raimondi, Sara, Spaggiari, Lorenzo, de Marinis, Filippo, Piperno, Gaia, Vigorito, Sabrina, Gandini, Sara, Cremonesi, Marta, Positano, Vincenzo, and Jereczek-Fossa, Barbara Alicja

Published
2023
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19. Pralsetinib in RET fusion-positive non-small-cell lung cancer: A real-world data (RWD) analysis from the Italian expanded access program (EAP)

Author

Passaro, Antonio, Russo, Giuseppe Lo, Passiglia, Francesco, D'Arcangelo, Manolo, Sbrana, Andrea, Russano, Marco, Bonanno, Laura, Giusti, Raffaele, Metro, Giulio, Bertolini, Federica, Grisanti, Salvatore, Carta, Annamaria, Cecere, Fabiana, Montrone, Michele, Massa, Giacomo, Perrone, Fabiana, Simionato, Francesca, Guaitoli, Giorgia, Scotti, Vieri, Genova, Carlo, Lugini, Antonio, Bonomi, Lucia, Attili, Ilaria, and de Marinis, Filippo

Published
2022
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21. Addition of Bevacizumab to Erlotinib as First-Line Treatment of Patients With EGFR-Mutated Advanced Nonsquamous NSCLC: The BEVERLY Multicenter Randomized Phase 3 Trial

Author

Piccirillo, Maria Carmela, Bonanno, Laura, Garassino, Marina Chiara, Esposito, Giovanna, Dazzi, Claudio, Cavanna, Luigi, Burgio, Marco Angelo, Rosetti, Francesco, Rizzato, Simona, Morgillo, Floriana, Cinieri, Saverio, Veccia, Antonello, Papi, Maximilan, Tonini, Giuseppe, Gebbia, Vittorio, Ricciardi, Serena, Pozzessere, Daniele, Ferro, Alessandra, Proto, Claudia, Costanzo, Raffaele, D’Arcangelo, Manolo, Proietto, Manuela, Gargiulo, Piera, Di Liello, Raimondo, Arenare, Laura, De Marinis, Filippo, Crinò, Lucio, Ciardiello, Fortunato, Normanno, Nicola, Gallo, Ciro, Perrone, Francesco, Gridelli, Cesare, and Morabito, Alessandro

Published
2022
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23. Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor‒Resistant, EGFR –Mutant, Metastatic Nonsquamous Non–Small Cell Lung Cancer.

Author

Yang, James Chih-Hsin, Lee, Dae Ho, Lee, Jong-Seok, Fan, Yun, de Marinis, Filippo, Iwama, Eiji, Inoue, Takako, Rodríguez-Cid, Jerónimo, Zhang, Li, Yang, Cheng-Ta, de la Mora Jimenez, Emmanuel, Zhou, Jianying, Pérol, Maurice, Lee, Ki Hyeong, Vicente, David, Ichihara, Eiki, Riely, Gregory J., Luo, Yiwen, Chirovsky, Diana, and Pietanza, M. Catherine

Published
2024
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24. Lorlatinib Versus Crizotinib in Patients With Advanced ALK -Positive Non–Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study.

Author

Solomon, Benjamin J., Liu, Geoffrey, Felip, Enriqueta, Mok, Tony S.K., Soo, Ross A., Mazieres, Julien, Shaw, Alice T., de Marinis, Filippo, Goto, Yasushi, Wu, Yi-Long, Kim, Dong-Wan, Martini, Jean-François, Messina, Rossella, Paolini, Jolanda, Polli, Anna, Thomaidou, Despina, Toffalorio, Francesca, and Bauer, Todd M.

Published
2024
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25. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC

Author

Wu, Yi-Long, John, Thomas, Grohe, Christian, Majem, Margarita, Goldman, Jonathan W., Kim, Sang-We, Kato, Terufumi, Laktionov, Konstantin, Vu, Huu Vinh, Wang, Zhijie, Lu, Shun, Lee, Kye Young, Akewanlop, Charuwan, Yu, Chong-Jen, de Marinis, Filippo, Bonanno, Laura, Domine, Manuel, Shepherd, Frances A., Zeng, Lingmin, Atasoy, Ajlan, Herbst, Roy S., and Tsuboi, Masahiro

Published
2022
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26. Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study.

Author

Paz-Ares, Luis G., primary, Juan-Vidal, Oscar, additional, Mountzios, Giannis Socrates, additional, Felip, Enriqueta, additional, Reinmuth, Niels, additional, de Marinis, Filippo, additional, Girard, Nicolas, additional, Patel, Vipul M., additional, Takahama, Takayuki, additional, Owen, Scott Peter, additional, Reznick, Douglas, additional, Badin, Firas Benyamine, additional, Cicin, Irfan, additional, Mekan, Sabeen Fatima, additional, Patel, Riddhi, additional, Zhang, Eric, additional, Karumanchi, Divyadeep, additional, and Garassino, Marina Chiara, additional

Published
2024
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27. KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation.

Author

Mok, Tony S. K., primary, Yao, Wenxiu, additional, Duruisseaux, Michaël, additional, Doucet, Ludovic, additional, Azkárate Martínez, Aitor, additional, Gregorc, Vanesa, additional, Juan-Vidal, Oscar, additional, Lu, Shun, additional, De Bondt, Charlotte, additional, de Marinis, Filippo, additional, Linardou, Helena, additional, Kim, Young-Chul, additional, Jotte, Robert M., additional, Felip, Enriqueta, additional, Lo Russo, Giuseppe, additional, Reck, Martin, additional, Michenzie, Mary F., additional, Yang, Wenjing, additional, Meade, Julie N., additional, and Barlesi, Fabrice, additional

Published
2024
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28. Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study.

Author

Solomon, Benjamin J., primary, Liu, Geoffrey, additional, Felip, Enriqueta, additional, Mok, Tony S. K., additional, Soo, Ross Andrew, additional, Mazieres, Julien, additional, Shaw, Alice Tsang, additional, de Marinis, Filippo, additional, Goto, Yasushi, additional, Wu, Yi-Long, additional, Kim, Dong-Wan, additional, Martini, Jean-Francois, additional, Messina, Rossella, additional, Paolini, Jolanda, additional, Polli, Anna, additional, Thomaidou, Despina, additional, Toffalorio, Francesca, additional, and Bauer, Todd Michael, additional

Published
2024
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29. Alectinib in Resected ALK -Positive Non–Small-Cell Lung Cancer

Author

Wu, Yi-Long, primary, Dziadziuszko, Rafal, additional, Ahn, Jin Seok, additional, Barlesi, Fabrice, additional, Nishio, Makoto, additional, Lee, Dae Ho, additional, Lee, Jong-Seok, additional, Zhong, Wenzhao, additional, Horinouchi, Hidehito, additional, Mao, Weimin, additional, Hochmair, Maximilian, additional, de Marinis, Filippo, additional, Migliorino, M. Rita, additional, Bondarenko, Igor, additional, Lu, Shun, additional, Wang, Qun, additional, Ochi Lohmann, Tania, additional, Xu, Tingting, additional, Cardona, Andres, additional, Ruf, Thorsten, additional, Noe, Johannes, additional, and Solomon, Benjamin J., additional

Published
2024
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30. Blood First Assay Screening Trial (BFAST) in Treatment-Naive Advanced or Metastatic NSCLC: Initial Results of the Phase 2 ALK-Positive Cohort

Author

Dziadziuszko, Rafal, Mok, Tony, Peters, Solange, Han, Ji-Youn, Alatorre-Alexander, Jorge, Leighl, Natasha, Sriuranpong, Virote, Pérol, Maurice, de Castro Junior, Gilberto, Nadal, Ernest, de Marinis, Filippo, Frontera, Osvaldo Arén, Tan, Daniel S.W., Lee, Dae Ho, Kim, Hye Ryun, Yan, Mark, Riehl, Todd, Schleifman, Erica, Paul, Sarah M., Mocci, Simonetta, Patel, Rajesh, Assaf, Zoe June, Shames, David S., Mathisen, Michael S., and Gadgeel, Shirish M.

Published
2021
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31. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1–Selected NSCLC

Author

Jassem, Jacek, de Marinis, Filippo, Giaccone, Giuseppe, Vergnenegre, Alain, Barrios, Carlos H., Morise, Masahiro, Felip, Enriqueta, Oprean, Cristina, Kim, Young-Chul, Andric, Zoran, Mocci, Simonetta, Enquist, Ida, Komatsubara, Kimberly, McCleland, Mark, Kuriki, Hiroshi, Villalobos, Monette, Phan, See, Spigel, David R., and Herbst, Roy S.

Published
2021
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32. Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial

Author

Pinto, Carmine, Zucali, Paolo Andrea, Pagano, Maria, Grosso, Federica, Pasello, Giulia, Garassino, Marina Chiara, Tiseo, Marcello, Soto Parra, Hector, Grossi, Francesco, Cappuzzo, Federico, de Marinis, Filippo, Pedrazzoli, Paolo, Bonomi, Maria, Gianoncelli, Letizia, Perrino, Matteo, Santoro, Armando, Zanelli, Francesca, Bonelli, Candida, Maconi, Antonio, Frega, Stefano, Gervasi, Erika, Boni, Luca, and Ceresoli, Giovanni Luca

Published
2021
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33. Avelumab Versus Docetaxel in Patients With Platinum-Treated Advanced NSCLC: 2-Year Follow-Up From the JAVELIN Lung 200 Phase 3 Trial

Author

Park, Keunchil, Özgüroğlu, Mustafa, Vansteenkiste, Johan, Spigel, David, Yang, James C.H., Ishii, Hidenobu, Garassino, Marina, de Marinis, Filippo, Szczesna, Aleksandra, Polychronis, Andreas, Uslu, Ruchan, Krzakowski, Maciej, Lee, Jong-Seok, Calabrò, Luana, Arén Frontera, Osvaldo, Xiong, Huiling, Bajars, Marcis, Ruisi, Mary, and Barlesi, Fabrice

Published
2021
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36. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial

Author

Rittmeyer, Achim, Barlesi, Fabrice, Waterkamp, Daniel, Park, Keunchil, Ciardiello, Fortunato, von Pawel, Joachim, Gadgeel, Shirish M, Hida, Toyoaki, Kowalski, Dariusz M, Dols, Manuel Cobo, Cortinovis, Diego L, Leach, Joseph, Polikoff, Jonathan, Barrios, Carlos, Kabbinavar, Fairooz, Frontera, Osvaldo Arén, De Marinis, Filippo, Turna, Hande, Lee, Jong-Seok, Ballinger, Marcus, Kowanetz, Marcin, He, Pei, Chen, Daniel S, Sandler, Alan, Gandara, David R, and Group, OAK Study

Subjects
Clinical Research, Cancer, Clinical Trials and Supportive Activities, Lung, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Disease-Free Survival, Docetaxel, Drug Administration Schedule, Female, Humans, Infusions, Intravenous, Kaplan-Meier Estimate, Lung Neoplasms, Male, Middle Aged, Taxoids, Treatment Outcome, OAK Study Group, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundAtezolizumab is a humanised antiprogrammed death-ligand 1 (PD-L1) monoclonal antibody that inhibits PD-L1 and programmed death-1 (PD-1) and PD-L1 and B7-1 interactions, reinvigorating anticancer immunity. We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer.MethodsWe did a randomised, open-label, phase 3 trial (OAK) in 194 academic or community oncology centres in 31 countries. We enrolled patients who had squamous or non-squamous non-small-cell lung cancer, were 18 years or older, had measurable disease per Response Evaluation Criteria in Solid Tumors, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients had received one to two previous cytotoxic chemotherapy regimens (one or more platinum based combination therapies) for stage IIIB or IV non-small-cell lung cancer. Patients with a history of autoimmune disease and those who had received previous treatments with docetaxel, CD137 agonists, anti-CTLA4, or therapies targeting the PD-L1 and PD-1 pathway were excluded. Patients were randomly assigned (1:1) to intravenously receive either atezolizumab 1200 mg or docetaxel 75 mg/m2 every 3 weeks by permuted block randomisation (block size of eight) via an interactive voice or web response system. Coprimary endpoints were overall survival in the intention-to-treat (ITT) and PD-L1-expression population TC1/2/3 or IC1/2/3 (≥1% PD-L1 on tumour cells or tumour-infiltrating immune cells). The primary efficacy analysis was done in the first 850 of 1225 enrolled patients. This study is registered with ClinicalTrials.gov, number NCT02008227.FindingsBetween March 11, 2014, and April 29, 2015, 1225 patients were recruited. In the primary population, 425 patients were randomly assigned to receive atezolizumab and 425 patients were assigned to receive docetaxel. Overall survival was significantly longer with atezolizumab in the ITT and PD-L1-expression populations. In the ITT population, overall survival was improved with atezolizumab compared with docetaxel (median overall survival was 13·8 months [95% CI 11·8-15·7] vs 9·6 months [8·6-11·2]; hazard ratio [HR] 0·73 [95% CI 0·62-0·87], p=0·0003). Overall survival in the TC1/2/3 or IC1/2/3 population was improved with atezolizumab (n=241) compared with docetaxel (n=222; median overall survival was 15·7 months [95% CI 12·6-18·0] with atezolizumab vs 10·3 months [8·8-12·0] with docetaxel; HR 0·74 [95% CI 0·58-0·93]; p=0·0102). Patients in the PD-L1 low or undetectable subgroup (TC0 and IC0) also had improved survival with atezolizumab (median overall survival 12·6 months vs 8·9 months; HR 0·75 [95% CI 0·59-0·96]). Overall survival improvement was similar in patients with squamous (HR 0·73 [95% CI 0·54-0·98]; n=112 in the atezolizumab group and n=110 in the docetaxel group) or non-squamous (0·73 [0·60-0·89]; n=313 and n=315) histology. Fewer patients had treatment-related grade 3 or 4 adverse events with atezolizumab (90 [15%] of 609 patients) versus docetaxel (247 [43%] of 578 patients). One treatment-related death from a respiratory tract infection was reported in the docetaxel group.InterpretationTo our knowledge, OAK is the first randomised phase 3 study to report results of a PD-L1-targeted therapy, with atezolizumab treatment resulting in a clinically relevant improvement of overall survival versus docetaxel in previously treated non-small-cell lung cancer, regardless of PD-L1 expression or histology, with a favourable safety profile.FundingF. Hoffmann-La Roche Ltd, Genentech, Inc.

Published
2017

37. Afatinib in EGFR TKI-naïve patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer: Interim analysis of a Phase 3b study

Author

de Marinis, Filippo, Laktionov, Konstantin K., Poltoratskiy, Artem, Egorova, Inna, Hochmair, Maximilian, Passaro, Antonio, Migliorino, Maria Rita, Metro, Giulio, Gottfried, Maya, Tsoi, Daphne, Ostoros, Gyula, Rizzato, Simona, Mukhametshina, Guzel Z., Schumacher, Michael, Novello, Silvia, Dziadziuszko, Rafal, Tang, Wenbo, Clementi, Laura, Cseh, Agnieszka, and Kowalski, Dariusz

Published
2021
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39. Pegargiminase Plus First-Line Chemotherapy in Patients With Nonepithelioid Pleural Mesothelioma

Author

Szlosarek, P, Creelan, B, Sarkodie, T, Nolan, L, Taylor, P, Olevsky, O, Grosso, F, Cortinovis, D, Chitnis, M, Roy, A, Gilligan, D, Kindler, H, Papadatos-Pastos, D, Ceresoli, G, Mansfield, A, Tsao, A, O’Byrne, K, Nowak, A, Steele, J, Sheaff, M, Shiu, C, Kuo, C, Johnston, A, Bomalaski, J, Zauderer, M, Fennell, D, Rybkin, I, Rolfo, C, Mackean, M, Steele, N, Franks, K, Shaw, P, Lind, M, Upadhyay, S, John, T, Karapetis, C, Srivastav, R, Mencoboni, M, Chella, A, Zilembo, N, de Marinis, F, Stella, M, Chong, I, Wang, C, Null, N, Szlosarek, Peter W., Creelan, Benjamin C., Sarkodie, Thomas, Nolan, Luke, Taylor, Paul, Olevsky, Olga, Grosso, Federica, Cortinovis, Diego, Chitnis, Meenali, Roy, Amy, Gilligan, David, Kindler, Hedy, Papadatos-Pastos, Dionysis, Ceresoli, Giovanni L., Mansfield, Aaron S., Tsao, Anne, O’Byrne, Kenneth J., Nowak, Anna K., Steele, Jeremy, Sheaff, Michael, Shiu, Chiung-Fang, Kuo, Chih-Ling, Johnston, Amanda, Bomalaski, John, Zauderer, Marjorie G., Fennell, Dean A., Rybkin, Igor I., Rolfo, Christian D., MacKean, Melanie, Steele, Nicola, Franks, Kevin, Shaw, Paul, Lind, Michael J., Upadhyay, Sunil, John, Thomas, Karapetis, Christos, Srivastav, Ratnesh, Mencoboni, Manlio, Chella, Antonio, Zilembo, Nicoletta, de Marinis, Filippo, Stella, Maria Giulia, Chong, Inn-Wen, Wang, Chin-Chou, null, null, Szlosarek, P, Creelan, B, Sarkodie, T, Nolan, L, Taylor, P, Olevsky, O, Grosso, F, Cortinovis, D, Chitnis, M, Roy, A, Gilligan, D, Kindler, H, Papadatos-Pastos, D, Ceresoli, G, Mansfield, A, Tsao, A, O’Byrne, K, Nowak, A, Steele, J, Sheaff, M, Shiu, C, Kuo, C, Johnston, A, Bomalaski, J, Zauderer, M, Fennell, D, Rybkin, I, Rolfo, C, Mackean, M, Steele, N, Franks, K, Shaw, P, Lind, M, Upadhyay, S, John, T, Karapetis, C, Srivastav, R, Mencoboni, M, Chella, A, Zilembo, N, de Marinis, F, Stella, M, Chong, I, Wang, C, Null, N, Szlosarek, Peter W., Creelan, Benjamin C., Sarkodie, Thomas, Nolan, Luke, Taylor, Paul, Olevsky, Olga, Grosso, Federica, Cortinovis, Diego, Chitnis, Meenali, Roy, Amy, Gilligan, David, Kindler, Hedy, Papadatos-Pastos, Dionysis, Ceresoli, Giovanni L., Mansfield, Aaron S., Tsao, Anne, O’Byrne, Kenneth J., Nowak, Anna K., Steele, Jeremy, Sheaff, Michael, Shiu, Chiung-Fang, Kuo, Chih-Ling, Johnston, Amanda, Bomalaski, John, Zauderer, Marjorie G., Fennell, Dean A., Rybkin, Igor I., Rolfo, Christian D., MacKean, Melanie, Steele, Nicola, Franks, Kevin, Shaw, Paul, Lind, Michael J., Upadhyay, Sunil, John, Thomas, Karapetis, Christos, Srivastav, Ratnesh, Mencoboni, Manlio, Chella, Antonio, Zilembo, Nicoletta, de Marinis, Filippo, Stella, Maria Giulia, Chong, Inn-Wen, Wang, Chin-Chou, and null, null

Abstract

IMPORTANCE Arginine deprivation using ADI-PEG20 (pegargiminase) combined with chemotherapy is untested in a randomized study among patients with cancer. ATOMIC-Meso (ADI-PEG20 Targeting of Malignancies Induces Cytotoxicity-Mesothelioma) is a pivotal trial comparing standard first-line chemotherapy plus pegargiminase or placebo in patients with nonepithelioid pleural mesothelioma. OBJECTIVE To determine the effect of pegargiminase-based chemotherapy on survival in nonepithelioid pleural mesothelioma, an arginine-auxotrophic tumor. DESIGN, SETTING, AND PARTICIPANTS Thiswas a phase 2-3, double-blind randomized clinical trial conducted at 43 centers in 5 countries that included patients with chemotherapy-naive nonepithelioid pleural mesothelioma from August 1, 2017, to August 15, 2021, with at least 12 months' follow-up. Final follow-up was on August 15, 2022. Data analysis was performed from March 2018 to June 2023. INTERVENTION Patients were randomly assigned (1:1) to receive weekly intramuscular pegargiminase (36.8mg/m2) or placebo. All patients received intravenous pemetrexed (500mg/m2) and platinum (75-mg/m2 cisplatin or carboplatin area under the curve 5) chemotherapy every 3 weeks up to 6 cycles. Pegargiminase or placebo was continued until progression, toxicity, or 24 months. MAIN OUTCOMES AND MEASURES The primary end pointwas overall survival, and secondary end points were progression-free survival and safety. Response rate by blinded independent central review was assessed in the phase 2 portion only. RESULTS Among 249 randomized patients (mean [SD] age, 69.5 [7.9] years; 43 female individuals [17.3%] and 206 male individuals [82.7%]), all were included in the analysis. The median overall survival was 9.3 months (95%CI, 7.9-11.8 months) with pegargiminase-chemotherapy as compared with 7.7 months (95%CI, 6.1-9.5 months) with placebo-chemotherapy (hazard ratio [HR] for death, 0.71; 95%CI, 0.55-0.93; P = .02). The median progression-free survival was 6.2 months (

Published
2024

40. Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial

Author

Bria, Emilio, Morgillo, Floriana, Garassino, Marina Chiara, Ciardiello, Fortunato, Ardizzoni, Andrea, Stefani, Alessio, Verderame, Francesco, Morabito, Alessandro, Chella, Antonio, Tonini, Giuseppe, Gilli, Marina, Del Signore, Ester, Berardi, Rossana, Mencoboni, Manlio, Bearz, Alessandra, Delmonte, Angelo, Migliorino, Marta Rita, Gridelli, Cesare, Pazzola, Antonio, Iero, Manuela, De Marinis, Filippo, Bria, Emilio (ORCID:0000-0002-2333-704X), Bria, Emilio, Morgillo, Floriana, Garassino, Marina Chiara, Ciardiello, Fortunato, Ardizzoni, Andrea, Stefani, Alessio, Verderame, Francesco, Morabito, Alessandro, Chella, Antonio, Tonini, Giuseppe, Gilli, Marina, Del Signore, Ester, Berardi, Rossana, Mencoboni, Manlio, Bearz, Alessandra, Delmonte, Angelo, Migliorino, Marta Rita, Gridelli, Cesare, Pazzola, Antonio, Iero, Manuela, De Marinis, Filippo, and Bria, Emilio (ORCID:0000-0002-2333-704X)

Abstract

Background MAURIS is an Italian multicenter, open-label, phase IIIb ongoing trial, aiming at evaluating the safety and effectiveness of atezolizumab + carboplatin/etoposide in patients with newly diagnosed, extensive-stage small-cell lung cancer (ES-SCLC). The primary objective is the safety evaluation.Materials and Methods Patients received atezolizumab + carboplatin/etoposide Q3W for 4-6 cycles in the induction phase, followed by atezolizumab maintenance Q3W. We presented the interim analysis on safety (referring to the induction phase) and clinical effectiveness, in all patients (N = 154) and in subgroups that received <= 3 (N = 23), 4 (N = 43), and 5-6 cycles (N = 89) of induction.Results At a median follow-up of 10.5 months, 139 patients (90.3%) discontinued treatment. Serious adverse events occurred in 29.9% of patients overall, and the rate was lower in patients with 5-6 cycles (19.1%) than in those with 4 (34.9%) or <= 3 (63.6%) cycles. Immune-mediated adverse events were reported in 14.9%, 15.7%, 11.6%, and 18.2% of patients, overall and by subgroup, respectively. The median overall survival and progression-free survival were 10.7 and 5.5 months, respectively. Overall, 111 patients (71.6%) had a tumor response.Conclusions Interim results provide further evidences about safety and efficacy profile of atezolizumab + carboplatin/etoposide treatment in a ES-SCLC patient population closer to that observed in clinical practice.Clinical Trial Registration Eudract No. 2019-001146-17, NCT04028050.This analysis is based on interim data from the MAURIS study, an Italian multicenter, phase IIIb ongoing trial to evaluate treatment with atezolizumab plus carboplatin/etoposide in patients with newly diagnosed extensive-stage small-cell lung cancer.

Published
2024

41. Management of Non-Metastatic Non-Small Cell Lung Cancer (NSCLC) with Driver Gene Alterations: An Evolving Scenario.

Author

Fuorivia, Valeria, Attili, Ilaria, Corvaja, Carla, Asnaghi, Riccardo, Carnevale Schianca, Ambra, Trillo Aliaga, Pamela, Del Signore, Ester, Spitaleri, Gianluca, Passaro, Antonio, and de Marinis, Filippo

Subjects
NON-small-cell lung carcinoma, PROTEIN-tyrosine kinase inhibitors, GENE rearrangement, MOLECULAR biology, ADJUVANT chemotherapy
Abstract

The ever-growing knowledge regarding NSCLC molecular biology has brought innovative therapies into clinical practice; however, the treatment situation in the non-metastatic setting is rapidly evolving. Indeed, immunotherapy-based perioperative treatments are currently considered the standard of care for patients with resectable NSCLC in the absence of EGFR mutations or ALK gene rearrangements. Recently, data have been presented on the use of tyrosine kinase inhibitors (TKIs) in the adjuvant and locally advanced setting for patients with NSCLC harboring such driver gene alterations. The aim of the current work is to review the available evidence on the use of targeted treatments in the non-metastatic setting, together with a summary of the ongoing trials designed for actionable gene alterations other than EGFR and ALK. To date, 3-year adjuvant osimertinib treatment has been demonstrated to improve DFS and OS and to reduce CNS recurrence in resected EGFR-mutated NSCLC in stage IB–IIIA (TNM 7th edition). The use of osimertinib after chemo-radiation in stage III unresectable EGFR-mutated NSCLC showed the relevant PFS improvement. In the ALK-positive setting, 2-year alectinib treatment was shown to clearly improve DFS compared to adjuvant standard chemotherapy in resected NSCLC with stage IB (≥4 cm)–IIIA (TNM 7th edition). Several trials are ongoing to establish the optimal adjuvant TKI treatment duration, as well as neoadjuvant TKI strategies in EGFR- and ALK-positive disease, and (neo)adjuvant targeted treatments in patients with actionable gene alterations other than EGFR or ALK. In conclusion, our review depicts how the current treatment scenario is expected to rapidly change in the context of non-metastatic NSCLC with actionable gene alterations, hence appropriate molecular testing from the early stages has become crucial to establish the most adequate approaches both in the perioperative and the locally advanced disease. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study.

Author

Paz-Ares, Luis G., Juan-Vidal, Oscar, Mountzios, Giannis S., Felip, Enriqueta, Reinmuth, Niels, de Marinis, Filippo, Girard, Nicolas, Patel, Vipul M., Takahama, Takayuki, Owen, Scott P., Reznick, Douglas M., Badin, Firas B., Cicin, Irfan, Mekan, Sabeen, Patel, Riddhi, Zhang, Eric, Karumanchi, Divyadeep, and Garassino, Marina Chiara

Published
2024
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43. Non-Small-Cell Lung Cancers (NSCLCs) Harboring RET Gene Fusion, from Their Discovery to the Advent of New Selective Potent RET Inhibitors: "Shadows and Fogs".

Author

Spitaleri, Gianluca, Trillo Aliaga, Pamela, Attili, Ilaria, Del Signore, Ester, Corvaja, Carla, Pellizzari, Gloria, Katrini, Jalissa, Passaro, Antonio, and de Marinis, Filippo

Subjects
THERAPEUTIC use of antineoplastic agents, DRUG toxicity, DRUG resistance in cancer cells, GENE rearrangement, PROTEIN-tyrosine kinase inhibitors, IMMUNOTHERAPY, IMMUNE checkpoint inhibitors, CANCER chemotherapy, DRUG efficacy, LUNG cancer, PHARMACODYNAMICS
Abstract

Simple Summary: RET fusions are relatively rare in Non-Small-Cell Lung Cancers (NSCLCs), being around 1–2% of all NSCLCs. Chemotherapy and immunotherapy have a low impact on the prognosis of patients with RET fusions positive NSCLC. Multitargeted RET inhibitors have shown modest activity jeopardized by high toxicity. New potent and selective RET inhibitors (RET-Is) (pralsetinib and selpercatinib) have achieved a higher efficacy in minimizing the known toxicities of the old drugs. This review will focus on the advent of new potent and selective RET-Is. We will describe their efficacy as well as the main mechanisms of resistance to them. We will further proceed to deal with new drugs and strategies proposed to overcome the resistance to RET-Is. In the last section, we will also focus on the safety profile of RET-Is, dealing with the main toxicities as well as the rare but severe adverse events. RET fusions are relatively rare in Non-Small-Cell Lung Cancers (NSCLCs), being around 1–2% of all NSCLCs. They share the same clinical features as the other fusion-driven NSCLC patients, as follows: younger age, adenocarcinoma histology, low exposure to tobacco, and high risk of spreading to the brain. Chemotherapy and immunotherapy have a low impact on the prognosis of these patients. Multitargeted RET inhibitors have shown modest activity jeopardized by high toxicity. New potent and selective RET inhibitors (RET-Is) (pralsetinib and selpercatinib) have achieved a higher efficacy minimizing the known toxicities of the multitargeted agents. This review will describe the sensitivity of immune-checkpoint inhibitors (ICIs) in RET fusion + NSCLC patients, as well their experiences with the 'old' multi-targeted RET inhibitors. This review will focus on the advent of new potent and selective RET-Is. We will describe their efficacy as well as the main mechanisms of resistance to them. We will further proceed to deal with the new drugs and strategies proposed to overcome the resistance to RET-Is. In the last section, we will also focus on the safety profile of RET-Is, dealing with the main toxicities as well as the rare but severe adverse events. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Revamping Non-Small Cell Lung Cancer Treatments in Stages II and III: Preparing Healthcare for Cutting-Edge Immuno-Oncology Regimens.

Author

Bertolaccini, Luca, Casiraghi, Monica, Bardoni, Claudia, Diotti, Cristina, Chiari, Matteo, Mazzella, Antonio, de Marinis, Filippo, and Spaggiari, Lorenzo

Subjects
THERAPEUTICS, SURVIVAL rate, INTERPROFESSIONAL relations, CANCER patient medical care, PROGRAMMED death-ligand 1, MICROMETASTASIS, IMMUNOLOGY, CANCER patients, TREATMENT effectiveness, PATIENT care, EVALUATION of medical care, GENE expression, COMBINED modality therapy, QUALITY of life, LUNG cancer, TUMOR classification, GENETIC mutation, PROGRESSION-free survival, INDIVIDUALIZED medicine, NEEDS assessment, BIOMARKERS, EPIDERMAL growth factor receptors, OVERALL survival, HEALTH care teams, MANAGEMENT
Abstract

Simple Summary: Non-small cell lung cancer in stages II and III is a significant health challenge, requiring ongoing improvements in treatment strategies. One promising approach is neoadjuvant therapy, which is given before surgery to shrink tumours and treat unseen cancer spread. This early treatment can help doctors see how well the tumour responds, which can guide further therapy after surgery. Testing for specific markers in the tumour, like certain gene mutations and protein levels, helps doctors choose the most effective treatments for each patient. By doing this, the chances of successful surgery and long-term survival improve. Managing this type of cancer requires a team of specialists working together to create personalised treatment plans. Despite its promise, neoadjuvant therapy comes with challenges, such as determining which tumours can be removed after treatment and recognising if a tumour appears larger due to treatment effects rather than actual growth. However, the medical community's ongoing research and dedication are essential to overcoming these obstacles and enhancing the benefits of neoadjuvant therapy. This approach aims to increase survival rates and improve the quality of life for patients with non-small cell lung cancer, making it a valuable advancement for society. Non-small cell lung cancer (NSCLC) poses a significant challenge in clinical oncology, necessitating continual refinement of treatment approaches in stages II and III. Recent advancements have highlighted the potential of neoadjuvant therapy in optimising patient outcomes. Biomarker testing guides neoadjuvant therapy decisions, including epidermal growth factor receptor (EGFR) mutation and programmed death-ligand 1 (PD-L1) expression testing. Neoadjuvant therapy aims to improve oncological outcomes by treating micrometastatic disease and assessing tumour response before surgery. Disease-free survival is a surrogate endpoint for overall survival in both neoadjuvant and adjuvant settings. Multidisciplinary collaboration is crucial for individualised treatment planning and optimising patient care. The management of NSCLC requires a comprehensive approach, integrating expertise across disciplines and tailoring treatment strategies to individual patient needs. Neoadjuvant therapy shows promise in improving long-term outcomes, with biomarker testing guiding treatment decisions. Challenges such as defining borderline resectability and differentiating pseudoprogression highlight the need for ongoing research and collaboration. [ABSTRACT FROM AUTHOR]

Published
2024
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45. Co-Occurring Driver Genomic Alterations in Advanced Non-Small-Cell Lung Cancer (NSCLC): A Retrospective Analysis.

Author

Attili, Ilaria, Asnaghi, Riccardo, Vacirca, Davide, Adorisio, Riccardo, Rappa, Alessandra, Ranghiero, Alberto, Lombardi, Mariano, Corvaja, Carla, Fuorivia, Valeria, Carnevale Schianca, Ambra, Trillo Aliaga, Pamela, Spitaleri, Gianluca, Del Signore, Ester, Guarize, Juliana, Spaggiari, Lorenzo, Guerini-Rocco, Elena, Fusco, Nicola, de Marinis, Filippo, and Passaro, Antonio

Subjects
NON-small-cell lung carcinoma, PROTEIN-tyrosine kinase inhibitors, NUCLEOTIDE sequencing, TREATMENT effectiveness, GENETIC mutation
Abstract

Background: Actionable driver mutations account for 40–50% of NSCLC cases, and their identification clearly affects treatment choices and outcomes. Conversely, non-actionable mutations are genetic alterations that do not currently have established treatment implications. Among co-occurring alterations, the identification of concurrent actionable genomic alterations is a rare event, potentially impacting prognosis and treatment outcomes. Methods: We retrospectively evaluated the prevalence and patterns of concurrent driver genomic alterations in a large series of NSCLCs to investigate their association with clinicopathological characteristics, to assess the prognosis of patients whose tumor harbors concurrent alterations in the genes of interest and to explore their potential therapeutic implications. Results: Co-occurring driver alterations were identified in 26 out of 1520 patients with at least one gene alteration (1.7%). Within these cases, the incidence of concurrent actionable gene alterations was 39% (0.7% of the overall cohort). Among compound actionable gene mutations, EGFR was the most frequently involved gene (70%). The most frequent association was EGFR mutations with ROS1 rearrangement. Front-line targeted treatments were the preferred approach in patients with compound actionable mutations, with dismal median PFS observed (6 months). Conclusions: Advances in genomic profiling technologies are facilitating the identification of concurrent mutations. In patients with concurrent actionable gene alterations, integrated molecular and clinical data should be used to guide treatment decisions, always considering rebiopsy at the moment of disease progression. [ABSTRACT FROM AUTHOR]

Published
2024
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46. Post-Progression Analysis of EGFR -Mutant NSCLC Following Osimertinib Therapy in Real-World Settings.

Author

Attili, Ilaria, Corvaja, Carla, Spitaleri, Gianluca, Trillo Aliaga, Pamela, Del Signore, Ester, Passaro, Antonio, and de Marinis, Filippo

Subjects
HEALTH services accessibility, RESEARCH funding, PROTEIN-tyrosine kinase inhibitors, BRAIN, RETROSPECTIVE studies, TREATMENT effectiveness, DESCRIPTIVE statistics, TREATMENT duration, CANCER chemotherapy, LUNG cancer, GENETIC mutation, CENTRAL nervous system diseases, CONFIDENCE intervals, PROGRESSION-free survival, EPIDERMAL growth factor receptors, DISEASE progression, PLATINUM, OVERALL survival
Abstract

Simple Summary: This study is a real-world study on a large cohort of patients with EGFR-mutant non-small-cell lung cancer (NSCLC) who progressed on osimertinib, focusing on access to subsequent treatments and progression patterns, including central nervous system (CNS) progression. Almost half of these patients had no access to further treatments due to worsening of clinical conditions or death. The outcomes of standard platinum-based chemotherapy were dismal and in line with those reported in the literature. Notably, intracranial disease progression was a rare event during osimertinib, whereas it occurred in half the patients during standard chemotherapy. Overall, the data highlight the clinical unmet needs in the treatment sequencing of single agent osimertinib and platinum-based chemotherapy alone, confirming the role of combination approaches and treatments in improving CNS control. Background: Platinum-based chemotherapy is the current standard treatment option in patients with EGFR-mutant non-small-cell lung cancer (NSCLC) who progress on osimertinib. However, outcomes with chemotherapy are dismal, and the treatment of central nervous system (CNS) disease is an unmet need in this setting. Methods: Patients with EGFR-mutant NSCLC who were candidates to receive osimertinib in the metastatic setting at our Center from 2015 to 2022 were retrospectively evaluated to identify patients who received standard platinum-based chemotherapy post-osimertinib. Data were collected on treatment outcomes, with a focus on brain metastases and progression patterns. Results: A total of 220 patients received indication for osimertinib in the study period; n = 176 had adequate follow-up data. Overall, n = 117 patients experienced disease progression on osimertinib. The median time to osimertinib progressive disease (PD) was 15 months (95% confidence interval CI 13–18). Of them, 51 patients (45%) had no access to further treatments. Of the remaining patients, n = 8 received experimental treatments, and n = 55 received standard platinum-based chemotherapy and were considered for this study. Median duration of chemotherapy was 3 months (95% CI 2–5); the best responses among 53 evaluable patients were observed as follows: 15% partial response/complete response (PR/CR), 40% stable disease (SD), 45% PD. Median progression-free survival (PFS) and overall survival (OS) were 3 (95% CI 2–5) and 10 (95% CI 6–15) months, respectively. All patients had baseline and follow-up brain radiologic assessments, and n = 23 had brain metastases at the start of chemotherapy. With a median follow-up of 13 months, intracranial PD occurred in 47% patients, being the first site of PD in 59% of cases. The median time for intracranial (IC) PD was 2 months (95% CI 2–7). IC PD occurred as oligometastatic in 29%, whereas in 71% of cases, it was associated with systemic PD. Conclusions: Access to subsequent treatments and CNS progression are confirmed unmet needs in EGFR-mutant NSCLC patients. Clinical and CNS-specific outcomes in patients receiving standard chemotherapy after the failure of osimertinib are dismal. Novel upfront treatment options with demonstrated prolonged PFS and better CNS outcomes may help address this important issue. [ABSTRACT FROM AUTHOR]

Published
2024
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47. Alectinib vs. Lorlatinib in the Front-Line Setting for ALK-Rearranged Non-Small-Cell Lung Cancer (NSCLC): A Deep Dive into the Main Differences across ALEX and CROWN Phase 3 Trials.

Author

Attili, Ilaria, Fuorivia, Valeria, Spitaleri, Gianluca, Corvaja, Carla, Trillo Aliaga, Pamela, Del Signore, Ester, Asnaghi, Riccardo, Carnevale Schianca, Ambra, Passaro, Antonio, and de Marinis, Filippo

Subjects
CHROMONES, DRUG toxicity, PATIENT safety, ANTINEOPLASTIC agents, PROTEIN-tyrosine kinase inhibitors, CANCER chemotherapy, METASTASIS, ANAPLASTIC lymphoma kinase, DRUG efficacy, LUNG cancer, BRAIN tumors, DISEASE progression
Abstract

Simple Summary: This study is an analytic review of the data on the two most used ALK TKIs, alectinib and lorlatinib, used as the first treatment for ALK-positive NSCLC. These drugs have shown promise in separate studies, but there has not been a direct comparison until now. We analyzed data from two major clinical trials that compared these drugs to crizotinib. We found that lorlatinib may be more effective in delaying the progression of the disease compared to alectinib, especially in controlling brain metastases. Although both drugs have side effects, and an alert has been created for the peculiar toxicities of lorlatinib, more people had to stop taking alectinib due to side effects compared to lorlatinib. Overall, the data suggest that lorlatinib might be a better option for patients with this type of lung cancer, but more research is needed to confirm these findings. This information could help clinicians make better treatment decisions for patients with ALK-positive NSCLC. Various next-generation ALK TKIs are available as first-line options for ALK-positive NSCLC, with alectinib and lorlatinib being commonly preferred. However, no direct comparison between them has been conducted, making it impossible to pick a winner. We performed an analytic, 'non-comparative' assessment of the two phase 3 pivotal clinical trials showing superiority of alectinib (ALEX) and lorlatinib (CROWN) in comparison to crizotinib. Overall, the two studies were very similar in the study design and patient characteristics, with the exception of the selection and evaluation of brain metastases. PFS hazard ratios numerically favored lorlatinib, both according to the investigator and to BICR. Notably, the 3-year PFS rate was numerically higher with lorlatinib (64%) than with alectinib (46.4%). Despite similar response rates and overall intracranial response, the rate of complete intracranial response was higher with lorlatinib, with a cumulative incidence risk of CNS disease progression at 12 months of 9.4% with alectinib and 2.8% with lorlatinib. The peculiar toxicities of lorlatinib were related to lipidic profile alterations, peripheral oedema and cognitive effects, with no impact on cardiovascular risk nor impairment in quality of life versus crizotinib. Furthermore, the rate of permanent treatment discontinuation due to adverse events was numerically higher with alectinib (26%) than with lorlatinib (7%). In conclusion, despite the immature OS data for both drugs, the efficacy of lorlatinib appears higher than alectinib while maintaining a manageable toxicity profile. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial

Author

Wu, Yi-Long, Liu, Xiaoqing, Liu, Zhe, Lu, Shun, Chen, Xi, Pan, Hongming, Wang, Mengzhao, Yu, Shiying, Zhang, Helong, Zhang, Yiping, Fang, Jian, Li, Wei, Zhou, Jianying, Zhao, Jun, Cheng, Ying, Yang, Chih-Hsin, Chang, Gee-Chen, Chen, Yuh-Min, Hsia, Te-Chun, Chian, Chih-Feng, Yang, Cheng-Ta, Wang, Chin-Chou, Kim, Sang-We, Park, Keunchil, Kim, Dong-Wan, Cho, Byoung Chul, Lee, Ki Hyeong, Kim, Young-Chul, An, Ho Jung, Woo, In Sook, Cho, Jae Yong, Shin, Sang Won, Lee, Jong-Seok, Kim, Joo-Hang, Yoo, Seung Soo, Kato, Terufumi, Shinagawa, Naofumi, Soo, Ross Andrew, Tan, Shao Weng Daniel, Ngo, Lynette Si-Mien, Ratnavelu, Kananathan, Ahmad, Azura Rozila, Liam, Chong Kin, de Marinis, Filippo, Tassone, Pierfrancesco, Molla, Amelia Insa, Calles Blanco, Antonio, Lazaro Quintela, Martin Emilio, Felip Font, Enriqueta, Dingemans, Anne-Marie, Bui, Lynne, Tan, Daniel Shao Weng, Bruns, Rolf, Straub, Josef, Johne, Andreas, Scheele, Jürgen, and Yang, James Chih-Hsin

Published
2020
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