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191 results on '"de Marinis, F."'

1. 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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6. 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

7. LBA2 First-line (1L) durvalumab (D) + platinum-etoposide (EP) for patients (pts) with extensive-stage SCLC (ES-SCLC): Primary results from the phase IIIb LUMINANCE study

Author

Reinmuth, N., primary, Özgüroğlu, M., additional, Leighl, N.B., additional, Galetta, D., additional, Hacibekiroglu, I., additional, Roubec, J., additional, Sendur, M.A.N., additional, Bria, E., additional, Cicin, I., additional, Grohé, C., additional, Harputluoglu, H., additional, Kilickap, S., additional, Novello, S., additional, Opalka, P., additional, Riccardi, F., additional, Ruseva, R.K., additional, Lang, S., additional, Hodari, M., additional, Donner, N., additional, and de Marinis, F., additional

Published
2023
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8. 3P Exploratory efficacy analysis by smoking status in PD-L1 high patients in the phase III, non-small cell lung cancer (NSCLC) IMpower110 study

Author

Paz-Ares, L., primary, García-Campelo, M.R., additional, Isla Casado, M.D., additional, Carcereny, E., additional, Abreu, D. Rodriguez, additional, Gonzalez, J.J. Garcia, additional, Parente, D. Perez, additional, Mancha, N. Gonzalez, additional, Vilas, E., additional, Gracia, P. Ruiz, additional, Greco, A., additional, Spigel, D.R., additional, de Marinis, F., additional, and Jassem, J., additional

Published
2023
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9. EP07.04-06 ALK Rearrangement Is Associated with Early Lymphatic Spread in Resected LUAD with Negative Preoperative Mediastinal Staging

Author

Gallina, F.T., primary, Tajè, R., additional, Cecere, F.L., additional, Melis, E., additional, Bertolaccini, L., additional, Spaggiari, L., additional, de Marinis, F., additional, Cannone, G., additional, Busetto, A., additional, Rea, F., additional, Martucci, N., additional, Mercadante, E., additional, Normanno, N., additional, Mazzoni, F., additional, Bongiolatti, S., additional, Voltolini, L., additional, Sperduti, I., additional, Cappuzzo, F., additional, and Facciolo, F., additional

Published
2023
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10. OA15.04 Comparison of Digital Vs Manual PD-L1 Tumour Cell Scoring on SP263-Stained Whole Imaging Slides from IMpower110

Author

Herbst, R.S., primary, Ruderman, D., additional, Conway, J., additional, Prizant, H., additional, Hennek, S., additional, Shamshoian, J., additional, Abel, J., additional, Montalto, M., additional, Beck, A., additional, Wapinski, I., additional, Molinero, L., additional, Amin, R., additional, Hoang, T., additional, Ballinger, M., additional, de Marinis, F., additional, Giaccone, G., additional, Jassem, J., additional, Giltnane, J., additional, Srivastava, M.K., additional, and Spigel, D.R., additional

Published
2023
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12. OA21.05 Tepotinib + Osimertinib in EGFR-mutant NSCLC with MET Amplification Following 1L Osimertinib: INSIGHT 2 Primary Analysis

Author

Kim, T.M., primary, Guarneri, V., additional, Jye, V.P., additional, Khaw, L.B., additional, Yang, J.-J., additional, Wislez, M., additional, Huang, C., additional, Chong Kin, L., additional, Mazieres, J., additional, Tho, L.M., additional, Hayashi, H., additional, Nhung, N., additional, Chia, P.L., additional, De Marinis, F., additional, Raskin, J., additional, Zhou, Q., additional, Finochhiaro, G., additional, Le, X., additional, Tan, D., additional, Brutlach, S., additional, O'Brate, A., additional, Adrian, S., additional, Berghoff, K., additional, Ellers-Lenz, B., additional, Karachaliou, N., additional, and Wu, Y.-L., additional

Published
2023
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13. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer

Author

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

Published
2023
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14. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer.

Author

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.

Subjects
*NON-small-cell lung carcinoma, *DOCETAXEL, *NIVOLUMAB, *CLINICAL trials, *ADVERSE health care events
Abstract

Checkpoint inhibitor (CPI) therapy revolutionized treatment for advanced non-small-cell lung cancer (NSCLC); however, most patients progress due to primary or acquired resistance. Sitravatinib is a receptor tyrosine kinase inhibitor that can shift the immunosuppressive tumor microenvironment toward an immunostimulatory state. Combining sitravatinib with nivolumab (sitra + nivo) may potentially overcome initial CPI resistance. In the phase III SAPPHIRE study, patients with advanced non-oncogenic driven, nonsquamous NSCLC who initially benefited from (≥4 months on CPI without progression) and subsequently experienced disease progression on or after CPI combined with or following platinum-based chemotherapy were randomized 1 : 1 to sitra (100 mg once daily administered orally) + nivo (240 mg every 2 weeks or 480 mg every 4 weeks administered intravenously) or docetaxel (75 mg/m2 every 3 weeks administered intravenously). The primary endpoint was overall survival (OS). The secondary endpoints included progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR; all assessed by blinded independent central review), and safety. A total of 577 patients included randomized: sitra + nivo, n = 284; docetaxel, n = 293 (median follow-up, 17.1 months). Sitra + nivo did not significantly improve OS versus docetaxel [median, 12.2 versus 10.6 months; hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.70-1.05; P = 0.144]. The median PFS was 4.4 versus 5.4 months, respectively (HR 1.08, 95% CI 0.89-1.32; P = 0.452). The ORR was 15.6% for sitra + nivo and 17.2% for docetaxel (P = 0.597); CBR was 75.5% and 64.5%, respectively (P = 0.004); median DOR was 7.4 versus 7.1 months, respectively (P = 0.924). Grade ≥3 treatment-related adverse events were observed in 53.0% versus 66.7% of patients receiving sitra + nivo versus docetaxel, respectively. Although median OS was numerically longer with sitra + nivo, the primary endpoint was not met in patients with previously treated advanced nonsquamous NSCLC. The safety profiles demonstrated were consistent with previous reports. • Phase III trial of sitra + nivo compared with docetaxel in patients with advanced nonsquamous NSCLC. • The study evaluated whether CPI resistance can be overcome in patients treated with platinum-based chemotherapy and CPI. • The primary endpoint of improved OS with sitra + nivo versus docetaxel was not met. • The safety profiles of both regimens were consistent with previous reports, with no new safety signals. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Osimertinib as adjuvant therapy in patients with resected EGFRm stage IB-IIIA NSCLC: updated results from ADAURA

Author

Grohé, C, additional, Tsuboi, M, additional, Wu, Y, additional, John, T, additional, Majem, M, additional, Wang, J, additional, Kato, T, additional, Goldman, J, additional, Kim, S, additional, Yu, C, additional, Vu, H, additional, Mukhametshina, G, additional, Akewanlop, C, additional, de Marinis, F, additional, Shepherd, F, additional, Urban, D, additional, Stachowiak, M, additional, Balanos, A, additional, Huang, X, additional, Herbst, R, additional, and Kern, J, additional

Published
2023
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17. OA01.09 Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB–IIIA Non-Small Cell Lung Cancer: Updated ADAURA Results

Author

Herbst, R.S., primary, Wu, Y.-L., additional, Grohe, C., additional, John, T., additional, Majem, M., additional, Wang, J., additional, Kato, T., additional, Goldman, J.W., additional, Kim, S.-W., additional, Yu, C.-J., additional, Vu, H.V., additional, Mukhametshina, G., additional, Akewanlop, C., additional, de Marinis, F., additional, Shepherd, F.A., additional, Urban, D., additional, Stachowiak, M., additional, Bolanos, A., additional, Huang, X., additional, and Tsuboi, M., additional

Published
2023
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18. Sharing Experience with Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors in Lung Cancer: An Italian Expert Panel Discussion

Author

Gridelli, C, Tiseo, M, Cortinovis, D, Migliorino, M, Barbieri, V, Bironzo, P, Bearz, A, Attili, I, de Marinis, F, Cortinovis, DL, Migliorino, MR, Gridelli, C, Tiseo, M, Cortinovis, D, Migliorino, M, Barbieri, V, Bironzo, P, Bearz, A, Attili, I, de Marinis, F, Cortinovis, DL, and Migliorino, MR

Abstract

Background: ALK tyrosine kinase inhibitors (TKIs) have revolutionized the treatment and largely improved the survival outcomes of patients with NSCLC harboring ALK rearrangements. Different ALK TKI compounds have demonstrated antitumor activity in these patients and are available in clinical practice. However, clinical expertise across countries varies according to local regulatory approval of different drugs, identifying multiple treatment scenarios to comply with international guidelines and clinical practice. Methods: A virtual webinar was held on July 2023 to discuss the state of the art and future perspectives in the treatment of ALK rearrangement in advanced NSCLC in Italy. The faculty hosting the webinar was composed of eight medical oncologists from different regions of Italy with clinical expertise in treating patients with lung cancer. Live-shared notes were used to produce a report to serve as the basis of a review manuscript on the topic. Results: Alectinib and brigatinib are the preferred front-line treatment options in Italy, pending approval of the front-line medicine lorlatinib, which would be considered among the choices. Due to a local regulatory limitation of second-line lorlatinib, which is not allowed after front-line brigatinib, alectinib is commonly the preferred front-line choice to follow a sequence of alectinib, followed by lorlatinib, followed by platinum plus pemetrexed chemotherapy. Age and performance status were not considered per se as clinical features influencing treatment choice. However, treatment compliance is deemed a relevant factor in decision making with regard to the number of pills to be administered. In general, given the availability of alternative choices, the spectrum of patients’ comorbidities and polypharmacotherapy interactions should be taken into account in treatment selection according to the toxicity profile of each compound. In addition, several issues were debated with regard to improving treatment outcomes, in

Published
2023

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

Author

Lococo, Filippo, Cancellieri, Alessandra, Chiappetta, M., Leonetti, A., Cardillo, G., Zanelli, F., Mangiameli, G., Toschi, L., Guggino, G., Romano, F. J., Leuzzi, G., Proto, C., Spaggiari, L., De Marinis, F., Vita, Emanuele, Ampollini, L., Margaritora, Stefano, Tiseo, M., Bria, Emilio, Lococo,F. (ORCID:0000-0002-9383-5554), Cancellieri,A., Vita, E., Margaritora, S. (ORCID:0000-0002-9796-760X), Bria, E. (ORCID:0000-0002-2333-704X), Lococo, Filippo, Cancellieri, Alessandra, Chiappetta, M., Leonetti, A., Cardillo, G., Zanelli, F., Mangiameli, G., Toschi, L., Guggino, G., Romano, F. J., Leuzzi, G., Proto, C., Spaggiari, L., De Marinis, F., Vita, Emanuele, Ampollini, L., Margaritora, Stefano, Tiseo, M., Bria, Emilio, Lococo,F. (ORCID:0000-0002-9383-5554), Cancellieri,A., Vita, E., Margaritora, S. (ORCID:0000-0002-9796-760X), and Bria, E. (ORCID:0000-0002-2333-704X)

Abstract

Background: The role of salvage surgery after tyrosine kinase inhibitors in advanced oncogene-addicted non-small cell lung cancer is largely unexplored. Patients: We aimed to describe the pathological features and surgical early-outcomes of Anaplastic Lymphome Kinase anaplastic lymphome kinase positive non-small cell lung cancer patients undergoing surgery after first-line alectinib treatment. We retrospectively collected and analyzed multicentric data of 10 patients treated with alectinib for advanced-stage anaplastic lymphome kinase positive lung adenocarcinoma who underwent anatomical surgical resection from January 2020 to Decemeber 2021. All patients were treatment naive and received alectinib (600 mg twice daily). Surgery was always proposed after multidisciplinary discussion. The primary endpoints were pathological response and surgical feasibility (technical intraoperative complications, postoperative outcomes). Results: Alectinib was received for a mean of 212 days before surgery (42-415 days) and was generally interrupted about one week before surgery (range: 0-32 days) with no patient experienced grade 4 toxicity. All patients received an R0 resection with surgery consisting of lobectomy in 8 cases with bilobectomy and (left) pneumonectomy in 1 case each. Intra-operative difficulties were described in 7 cases (70%), mostly due to perivascular fibrosis or thickening of mediastinal lymph nodal tissues. Major and minor complications occurred in 0 and 3 cases (30%), respectively. A pathological complete response and major pathological response (defined as 0% and < 10% viable tumor cells, respectively) were observed in 50% and 90% of cases, respectively. Despite short follow-up, only one tumor recurrence was observed (in the only patient who did not resume alectinib after surgery). Interpretation: Despite some technical intraoperative difficulties, salvage surgery was safe and feasible after Alectinib for advanced lung adenocarcinoma.

Published
2023

20. Upfront Advanced Radiotherapy and New Drugs for NSCLC Patients with Synchronous Brain Metastases: Is the Juice Worth the Squeeze? A Real-World Analysis from Lombardy, Italy

Author

Corrao, G, Franchi, M, Zaffaroni, M, Vincini, M, de Marinis, F, Spaggiari, L, Orecchia, R, Marvaso, G, Jereczek-Fossa, B, Vincini, MG, Jereczek-Fossa, BA, Corrao, G, Franchi, M, Zaffaroni, M, Vincini, M, de Marinis, F, Spaggiari, L, Orecchia, R, Marvaso, G, Jereczek-Fossa, B, Vincini, MG, and Jereczek-Fossa, BA

Abstract

Aim: Healthcare administrative databases represent a valuable source for real-life data analysis. The primary aim of this study is to compare effectiveness and cost profile in non-small-cell lung cancer (NSCLC) patients harboring synchronous brain metastases (BMs) who received non-chemo first-line systemic therapy with or without advanced radiotherapy (aRT). Methods: Diagnostic ICD-9-CM codes were used for identifying all patients with a new diagnosis of lung cancer between 2012 and 2019. Among these, patients who had started a first-line systemic treatment with either TKIs or pembrolizumab, alone or in combination with intensity-modulated or stereotactic RT, were selected. Clinical outcomes investigated included overall survival (OS), progression-free survival (PFS), and time-to-treatment failure (TTF). The cost outcome was defined as the average per capita cumulative healthcare direct costs of the treatment, including all inpatient and outpatient costs. Results: The final cohort included 177 patients, of whom 58 were treated with systemic treatment plus aRT (STRT) and 119 with systemic treatment alone. The addition of aRT to systemic treatment was associated with a significantly better OS (p = 0.020) and PFS (p = 0.041) than systemic therapy alone. The ICER (incremental cost-effectiveness ratio) value indicated an average cost of €3792 for each month of survival after STRT treatment and confirmed clinical effectiveness but higher healthcare costs. Conclusions: This real-world study suggests that upfront aRT for NCLSC patients with synchronous BMs represents a valid treatment strategy, boosting the efficacy of novel and emerging drug classes with sustainable costs for the health service. Translational relevance: The present real-world study reports that the use of upfront advanced radiotherapyaRT and new-generation systemic agents, such as TKIs and pembrolizumab, may have higher oncological control and an improved cost-effectiveness profile than the use of new-gene

Published
2023

21. LBA4 Preliminary safety and efficacy of adagrasib with pembrolizumab in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation

Author

Jänne, P.A., primary, Smit, E.F., additional, de Marinis, F., additional, Laskin, J., additional, Gomez, M. Domine, additional, Gadgeel, S., additional, Garassino, M.C., additional, Lu, S., additional, Spira, A.S., additional, Kang, V., additional, Roshan, S., additional, Yan, X., additional, and Felip, E., additional

Published
2022
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22. 57O Randomized double-blind phase II trial (PERLA) of dostarlimab (dostar) + chemotherapy (CT) vs pembrolizumab (pembro) + CT in metastatic non-squamous NSCLC: Primary results

Author

Peters, S., primary, Lim, S.M., additional, Ortega Granados, A.L.O., additional, Pinto, G.D.J., additional, Fuentes, C.S., additional, Lo Russo, G., additional, Schenker, M., additional, Ahn, J.S., additional, Reck, M., additional, Szijgyarto, Z., additional, Huseinovic, N., additional, Zografos, E., additional, O’Donnell, S., additional, and de Marinis, F., additional

Published
2022
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23. 296P Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA

Author

Wu, Y-L., primary, Tsuboi, M., additional, Grohe, C., additional, John, T., additional, Majem Tarruella, M., additional, Wang, J., additional, Kato, T., additional, Goldman, J.W., additional, Kim, S-W., additional, Yu, C-J., additional, Vinh Vu, H., additional, Mukhametshina, G., additional, Akewanlop, C., additional, de Marinis, F., additional, Shepherd, F.A., additional, Urban, D., additional, Stachowiak, M., additional, Bolanos, A., additional, Huang, X., additional, and Herbst, R.S., additional

Published
2022
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24. LBA5 Long-term tolerability of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC) from ADAURA

Author

John, T., primary, Grohe, C., additional, Goldman, J., additional, De Marinis, F., additional, Kato, T., additional, Wang, Q., additional, Choi, J-H., additional, Melotti, B., additional, Fidler, M., additional, Sainsbury, L., additional, Stachowiak, M., additional, Taggart, S., additional, Wu, Y-L., additional, Tsuboi, M., additional, Herbst, R.S., additional, and Majem Tarruella, M., additional

Published
2022
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25. EP08.02-140 MET Biomarker-based Preliminary Efficacy Analysis in SAVANNAH: savolitinib+osimertinib in EGFRm NSCLC Post-Osimertinib

Author

Ahn, M-j., primary, De Marinis, F., additional, Bonanno, L., additional, Cho, B.C., additional, Kim, T.-M., additional, Cheng, S., additional, Novello, S., additional, Proto, C., additional, Kim, S.-W., additional, Lee, J.S., additional, Metro, G., additional, Yang, J.C., additional, Xu, W., additional, Hartmaier, R., additional, Telaranta-Keerie, A., additional, Poole, L., additional, and Sequist, L., additional

Published
2022
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27. P2.14-02 TP53 Mutations Affect Sensitivity to Lorlatinib in ROS1 Positive NSCLC: Final Results of the PFROST Trial

Author

Landi, L., primary, Tiseo, M., additional, Heukamp, L.C., additional, Menon, R., additional, de Marinis, F., additional, Minuti, G., additional, Cortinovis, D.L., additional, Delmonte, A., additional, Galetta, D., additional, Bertrand, M., additional, Zacher, A., additional, Gridelli, C., additional, Jacobs, F., additional, Chiari, R., additional, Verusio, C., additional, Giannarelli, D., additional, Crinò, L., additional, and Cappuzzo, F., additional

Published
2022
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28. 1124P 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, A., primary, Lo Russo, G., additional, Passiglia, F., additional, D'Arcangelo, M., additional, Sbrana, A., additional, Russano, M., additional, Bonanno, L., additional, Giusti, R., additional, Metro, G., additional, Bertolini, F., additional, Grisanti, S., additional, Carta, A., additional, Cecere, F.L., additional, Montrone, M., additional, Massa, G., additional, Attili, I., additional, and de Marinis, F., additional

Published
2022
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29. EP08.02-048 Crizotinib in ROS1+NSCLC: Long-term OS Analysis in Patients with Brain Metastases Included in the Phase II METROS Trial

Author

Cappuzzo, F., primary, Chiari, R., additional, Tiseo, M., additional, Minotti, V., additional, De Marinis, F., additional, Delmonte, A., additional, Bungaro, M., additional, Cortinovis, D.L., additional, Galetta, D., additional, Bonanno, L., additional, Chella, A., additional, Gridelli, C., additional, Morabito, A., additional, Grossi, F., additional, Bria, E., additional, Giannarelli, D., additional, Fontanini, G., additional, Borra, G., additional, Gori, S., additional, Mazzoni, F., additional, Pilotto, S., additional, and Landi, L., additional

Published
2022
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30. LBA52 Tepotinib + osimertinib for EGFRm NSCLC with MET amplification (METamp) after progression on first-line (1L) osimertinib: Initial results from the INSIGHT 2 study

Author

Mazieres, J., primary, Kim, T.M., additional, Lim, B.K., additional, Wislez, M., additional, Dooms, C., additional, Finocchiaro, G., additional, Hayashi, H., additional, Liam, C.K., additional, Raskin, J., additional, Tho, L.M., additional, de Marinis, F., additional, Nadal, E., additional, Smit, E., additional, Le, X., additional, Brutlach, S., additional, O'Brate Grupp, A.M., additional, Adrian, S., additional, Ellers-Lenz, B., additional, Karachaliou, N., additional, and Wu, Y-L., additional

Published
2022
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31. EP05.03-008 Surgery after First-Line Alectinib for (Locally) Advanced ALK-rearranged NSCLC: Pathological Response and Peri-Operative Results

Author

Lococo, F., primary, Chiappetta, M., additional, Cancellieri, A., additional, Cardillo, G., additional, Zanelli, F., additional, Mangiameli, G., additional, Toschi, L., additional, Guggino, G., additional, Romano, F., additional, Leuzzi, G., additional, Proto, C., additional, Spaggiari, L., additional, De Marinis, F., additional, Vita, E., additional, Menna, E., additional, Margaritora, S., additional, and Bria, E., additional

Published
2022
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33. LBA47 Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA

Author

Tsuboi, M., primary, Wu, Y-L., additional, Grohe, C., additional, John, T., additional, Tarruella, M. Majem, additional, Wang, J., additional, Kato, T., additional, Goldman, J.W., additional, Kim, S-W., additional, Yu, C-J., additional, Vu, H. Vinh, additional, Mukhametshina, G., additional, Akewanlop, C., additional, de Marinis, F., additional, Shepherd, F.A., additional, Urban, D., additional, Stachowiak, M., additional, Bolanos, A.L., additional, Huang, X., additional, and Herbst, R.S., additional

Published
2022
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35. 1206MO ALINA: Exploratory biomarker analyses in patients (pts) with resected ALK+ non-small cell lung cancer (NSCLC) treated with adjuvant alectinib vs chemotherapy (chemo)

Author

Solomon, B.J., Wu, Y-L., Dziadziuszko, R., Barlesi, F., Nishio, M., Ahn, J.S., Horinouchi, H., Hochmair, M.J., de Marinis, F., Migliorino, M.R., Kurochkin, A., Harputluoglu, H., Planchard, D., Korphaisarn, K., Han, J-Y., Lohmann, T., Cardona Gavaldon, A., Archer, V.R., Nowicka, M., and Noe, J.

Published
2024
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36. ESMO expert consensus statements on the management of EGFR mutant non-small-cell lung cancer

Author

Passaro, A., primary, Leighl, N., additional, Blackhall, F., additional, Popat, S., additional, Kerr, K., additional, Ahn, M.J., additional, Arcila, M.E., additional, Arrieta, O., additional, Planchard, D., additional, de Marinis, F., additional, Dingemans, A.M., additional, Dziadziuszko, R., additional, Faivre-Finn, C., additional, Feldman, J., additional, Felip, E., additional, Curigliano, G., additional, Herbst, R., additional, Jänne, P.A., additional, John, T., additional, Mitsudomi, T., additional, Mok, T., additional, Normanno, N., additional, Paz-Ares, L., additional, Ramalingam, S., additional, Sequist, L., additional, Vansteenkiste, J., additional, Wistuba, I.I., additional, Wolf, J., additional, Wu, Y.L., additional, Yang, S.R., additional, Yang, J.C.H., additional, Yatabe, Y., additional, Pentheroudakis, G., additional, and Peters, S., additional

Published
2022
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37. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC.

Author

Wu, Y-L, John, T, Grohe, C, Majem, M, Goldman, JW, Kim, S-W, Kato, T, Laktionov, K, Vu, HV, Wang, Z, Lu, S, Lee, KY, Akewanlop, C, Yu, C-J, de Marinis, F, Bonanno, L, Domine, M, Shepherd, FA, Zeng, L, Atasoy, A, Herbst, RS, Tsuboi, M, Wu, Y-L, John, T, Grohe, C, Majem, M, Goldman, JW, Kim, S-W, Kato, T, Laktionov, K, Vu, HV, Wang, Z, Lu, S, Lee, KY, Akewanlop, C, Yu, C-J, de Marinis, F, Bonanno, L, Domine, M, Shepherd, FA, Zeng, L, Atasoy, A, Herbst, RS, and Tsuboi, M

Abstract

INTRODUCTION: Adjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a clinically meaningful improvement in disease-free survival (DFS) in patients with resected stages IB to IIIA EGFR-mutated (EGFRm) NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA. METHODS: Patients with resected stages IB to IIIA EGFRm NSCLC were randomized 1:1 to receive osimertinib or placebo for 3 years. Adjuvant chemotherapy before randomization was not mandatory, per physician and patient choice. DFS in the overall population (IB-IIIA), with and without adjuvant chemotherapy, was a prespecified analysis. Exploratory analyses included the following: adjuvant chemotherapy use by patient age, disease stage, and geographic location; DFS by adjuvant chemotherapy use and disease stage. RESULTS: Overall, 410 of 682 patients (60%) received adjuvant chemotherapy (osimertinib, n = 203; placebo, n = 207) for a median duration of 4.0 cycles. Adjuvant chemotherapy use was more frequent in patients: aged less than 70 years (338 of 509; 66%) versus more than or equal to 70 years (72 of 173; 42%); with stages II to IIIA (352 of 466; 76%) versus stage IB (57 of 216; 26%); and enrolled in Asia (268 of 414; 65%) versus outside of Asia (142 of 268; 53%). A DFS benefit favoring osimertinib versus placebo was observed in patients with (DFS hazard ratio = 0.16, 95% confidence interval: 0.10-0.26) and without adjuvant chemotherapy (hazard ratio = 0.23, 95% confidence interval: 0.13-0.40), regardless of disease stage. CONCLUSIONS: These findings support adjuvant osimertinib as an effective treatment for patients with stages IB to IIIA EGFRm NSCLC after resection, with or without previous adjuvant chemotherapy.

Published
2022

38. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial

Author

Majem, M, Goldman, JW, John, T, Grohe, C, Laktionov, K, Kim, S-W, Kato, T, Vu, HV, Lu, S, Li, S, Lee, KY, Akewanlop, C, Yu, C-J, de Marinis, F, Bonanno, L, Domine, M, Shepherd, FA, Atagi, S, Zeng, L, Kulkarni, D, Medic, N, Tsuboi, M, Herbst, RS, Wu, Y-L, Majem, M, Goldman, JW, John, T, Grohe, C, Laktionov, K, Kim, S-W, Kato, T, Vu, HV, Lu, S, Li, S, Lee, KY, Akewanlop, C, Yu, C-J, de Marinis, F, Bonanno, L, Domine, M, Shepherd, FA, Atagi, S, Zeng, L, Kulkarni, D, Medic, N, Tsuboi, M, Herbst, RS, and Wu, Y-L

Abstract

PURPOSE: In the phase III ADAURA trial, adjuvant treatment with osimertinib versus placebo, with/without prior adjuvant chemotherapy, resulted in a statistically significant and clinically meaningful disease-free survival benefit in completely resected stage IB-IIIA EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQoL) outcomes from ADAURA. PATIENTS AND METHODS: Patients randomized 1:1 received oral osimertinib 80 mg or placebo for 3 years or until recurrence/discontinuation. HRQoL (secondary endpoint) was measured using the Short Form-36 (SF-36) health survey at baseline, 12, and 24 weeks, then every 24 weeks until recurrence or treatment completion/discontinuation. Exploratory analyses of SF-36 score changes from baseline until week 96 and time to deterioration (TTD) were performed in the overall population (stage IB-IIIA; N = 682). Clinically meaningful changes were defined using the SF-36 manual. RESULTS: Baseline physical/mental component summary (PCS/MCS) scores were comparable between osimertinib and placebo (range, 46-47) and maintained to Week 96, with no clinically meaningful differences between arms; difference in adjusted least squares (LS) mean [95% confidence intervals (CI), -1.18 (-2.02 to -0.34) and -1.34 (-2.40 to -0.28), for PCS and MCS, respectively. There were no differences between arms for TTD of PCS and MCS; HR, 1.17 (95% CI, 0.82-1.67) and HR, 0.98 (95% CI, 0.70-1.39), respectively. CONCLUSIONS: HRQoL was maintained with adjuvant osimertinib in patients with stage IB-IIIA EGFRm NSCLC, who were disease-free after complete resection, with no clinically meaningful differences versus placebo, further supporting adjuvant osimertinib as a new treatment in this setting. See related commentary by Patil and Bunn, p. 2204.

Published
2022

39. Hypofractionated proton therapy for non-small cell lung cancer: Ready for prime time? A systematic review and meta-analysis

Author

Volpe, S, Piperno, G, Colombo, F, Biffi, A, Comi, S, Mastroleo, F, Maria Camarda, A, Casbarra, A, Cattani, F, Corrao, G, de Marinis, F, Spaggiari, L, Guckenberger, M, Orecchia, R, Alterio, D, Jereczek-Fossa, B, Volpe, Stefania, Piperno, Gaia, Colombo, Francesca, Biffi, Annalisa, Comi, Stefania, Mastroleo, Federico, Maria Camarda, Anna, Casbarra, Alessia, Cattani, Federica, Corrao, Giulia, de Marinis, Filippo, Spaggiari, Lorenzo, Guckenberger, Matthias, Orecchia, Roberto, Alterio, Daniela, Jereczek-Fossa, Barbara Alicja, Volpe, S, Piperno, G, Colombo, F, Biffi, A, Comi, S, Mastroleo, F, Maria Camarda, A, Casbarra, A, Cattani, F, Corrao, G, de Marinis, F, Spaggiari, L, Guckenberger, M, Orecchia, R, Alterio, D, Jereczek-Fossa, B, Volpe, Stefania, Piperno, Gaia, Colombo, Francesca, Biffi, Annalisa, Comi, Stefania, Mastroleo, Federico, Maria Camarda, Anna, Casbarra, Alessia, Cattani, Federica, Corrao, Giulia, de Marinis, Filippo, Spaggiari, Lorenzo, Guckenberger, Matthias, Orecchia, Roberto, Alterio, Daniela, and Jereczek-Fossa, Barbara Alicja

Abstract

Background: Hypofractionated proton beam radiotherapy (PBT) is gaining attention in early-stage non-small cell lung cancer (ES-NSCLC). However, there is a large unmet need to define indications, prescription doses and potential adverse events of protons in this clinical scenario. Hence, the present work aims to provide a critical literature revision, and to investigate associations between fractionation schedules/ biological effective doses (BEDs), oncological outcomes and toxicities.Materials and methods: This systematic review and meta-analysis complied with the PRISMA recommendations. Inclusion criteria were: 1) curative-intent hypofractionated PBT for ES-NSCLC (>= 3 Gy(RBE)/fraction), 2) report of the clinical outcomes of interest, 3) availability of full-text written in English. The bibliographic search was performed on the NCBI Pubmed, Embase and Scopus in September 2021; no other limitations were applied. The BED was calculated for each included study (alpha/beta = 10 Gy); the median BED for all studies was used as a threshold for stratifying selected evidence into "high" and "low"-dose subgroups. Heterogeneity was tested using chi-square statistics; inconsistency was measured with the I2 index. Pooled estimate was obtained by fitting both the fixed-effect and the DerSimonian and Laird random-effect model.Results: Eight studies and 401 patients were available for the meta-analysis; median follow-up was 32.8 months. The median delivered BED was 105.6 Gy(RBE). A BED >= 105.6 Gy(RBE) consistently provided superior OS, CSS, DFS and LC rates (i.e.: 4-year OS: 0.56 [0.34-0.76] for BED < 105.6 Gy(RBE) and 0.78 [0.64-0.88] for BED >= 105.6 Gy(RBE)). The meta-analysis of proportions showed a comparable probability of developing acute grade >= 2 toxicity between the two groups, while the probability of any late grade >= 2 event was almost three-times greater for BED >= 105.6 Gy(RBE), with rib fractures being more common in the high dose group.Concl

Published
2022

40. ESMO expert consensus statements on the management of EGFR mutant non-small-cell lung cancer

Author

Passaro, A., Leighl, N., Blackhall, F., Popat, S., Kerr, K., Ahn, M. J., Arcila, M. E., Arrieta, O., Planchard, D., de Marinis, F., Dingemans, A. M., Dziadziuszko, R., Faivre-Finn, C., Feldman, J., Felip, E., Curigliano, G., Herbst, R., Janne, P. A., John, T., Mitsudomi, T., Mok, T., Normanno, N., Paz-Ares, L., Ramalingam, S., Sequist, L., Vansteenkiste, J., Wistuba, I. I., Wolf, J., Wu, Y. L., Yang, S. R., Yang, J. C. H., Yatabe, Y., Pentheroudakis, G., Peters, S., Passaro, A., Leighl, N., Blackhall, F., Popat, S., Kerr, K., Ahn, M. J., Arcila, M. E., Arrieta, O., Planchard, D., de Marinis, F., Dingemans, A. M., Dziadziuszko, R., Faivre-Finn, C., Feldman, J., Felip, E., Curigliano, G., Herbst, R., Janne, P. A., John, T., Mitsudomi, T., Mok, T., Normanno, N., Paz-Ares, L., Ramalingam, S., Sequist, L., Vansteenkiste, J., Wistuba, I. I., Wolf, J., Wu, Y. L., Yang, S. R., Yang, J. C. H., Yatabe, Y., Pentheroudakis, G., and Peters, S.

Abstract

The European Society for Medical Oncology (ESMO) held a virtual consensus-building process on epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer in 2021. The consensus included a multidisciplinary panel of 34 leading experts in the management of lung cancer. The aim of the consensus was to develop recommendations on topics that are not covered in detail in the current ESMO Clinical Practice Guideline and where the available evidence is either limited or conflicting. The main topics identified for discussion were: (i) tissue and biomarkers analyses; (ii) early and locally advanced disease; (iii) metastatic disease and (iv) clinical trial design, patient's perspective and miscellaneous. The expert panel was divided into four working groups to address questions relating to one of the four topics outlined above. Relevant scientific literature was reviewed in advance. Recommendations were developed by the working groups and then presented to the entire panel for further discussion and amendment before voting. This manuscript presents the recommendations developed, including findings from the expert panel discussions, consensus recommendations and a summary of evidence supporting each recommendation.

Published
2022

41. 24P Tepotinib in patients with MET exon 14 skipping NSCLC: Efficacy and safety by line of therapy

Author

Griesinger, F., primary, Felip, E., additional, Smit, E.F., additional, Veillon, R., additional, Raskin, J., additional, Thomas, M., additional, Conte, P., additional, Kowalski, D., additional, Paz-Ares, L., additional, Garcia Ledo, G., additional, de Marinis, F., additional, Scherz, A., additional, Berghoff, K., additional, Bruns, R., additional, Otto, G., additional, and Paik, P., additional

Published
2022
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44. Efficacy of Brigatinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer Who Progressed on Alectinib or Ceritinib: ALTA-2 Study

Author

Ignatius Ou SH, Nishio, M, Ahn, Mj, Mok, T, Barlesi, F, Zhou, C, Felip, E, de Marinis, F, Kim, Sw, Pérol, M, Liu, G, Migliorino, Mr, Kim, Dw, Novello, S, Bearz, A, Garrido, P, Mazieres, J, Morabito, A, Lin, Hm, Yang, H, Niu, H, Zhang, P, and Kim, Es.

Subjects
anaplastic lymphoma kinase, circulating tumor DNA, non–small cell lung cancer, tumor biomarker
Published
2022

48. LBA63 SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC)

Author

Borghaei, H., Johnson, M.L., Garon, E.B., He, K., Planchard, D., Reck, M., Popat, S., Herbst, R.S., Leal, T.A., Dumoulin, D., de Marinis, F., Reynolds, C.H., Theelen, W.S.M.E., Percent, I., Gutierrez Calderon, V., Madroszyk Flandin, A-C., Shazer, R.L., Yan, X., Harrigan, R., and Peters, S.

Published
2023
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