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1. Systematic vitamin D supplementation is associated with improved outcomes and reduced thyroid adverse events in patients with cancer treated with immune checkpoint inhibitors: results from the prospective PROVIDENCE study

Author

Bersanelli, Melissa, Cortellini, Alessio, Leonetti, Alessandro, Parisi, Alessandro, Tiseo, Marcello, Bordi, Paola, Michiara, Maria, Bui, Simona, Cosenza, Agnese, Ferri, Leonarda, Giudice, Giulia Claire, Testi, Irene, Rapacchi, Elena, Camisa, Roberta, Vincenzi, Bruno, Caruso, Giuseppe, Rauti, Antonio Natale, Arturi, Federica, Tucci, Marco, Santo, Valentina, Ricozzi, Valentina, Burtet, Vanessa, Sgargi, Paolo, Todeschini, Renata, Zustovich, Fable, Stucci, Luigia Stefania, Santini, Daniele, and Buti, Sebastiano

Published
2023
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2. NGS detection of gene rearrangements and METexon14 mutations in liquid biopsy of advanced NSCLC patients: A study of two Italian centers

Author

Verzè, Michela, Boscolo Bragadin, Andrea, Minari, Roberta, Pasello, Giulia, Perrone, Fabiana, Scattolin, Daniela, Bordi, Paola, Pluchino, Monica, Leonetti, Alessandro, Mazzaschi, Giulia, Bonatti, Francesco, Gnetti, Letizia, Bottarelli, Lorena, Zulato, Elisabetta, Nardo, Giorgia, Dalle Fratte, Chiara, Padovan, Alessia, Bonanno, Laura, Tiseo, Marcello, and Indraccolo, Stefano

Published
2024
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3. Real-world outcomes of Italian patients with advanced non-squamous lung cancer treated with first-line pembrolizumab plus platinum-pemetrexed

Author

Leonetti, A, Perrone, F, Puntoni, M, Maglietta, G, Bordi, P, Bria, E, Vita, E, Gelsomino, F, De Giglio, A, Gelibter, A, Siringo, M, Mazzoni, F, Caliman, E, Genova, C, Bertolini, F, Guaitoli, G, Passiglia, F, Delcuratolo, M, Montrone, M, Cerea, G, Pasello, G, Roca, E, Belluomini, L, Cecere, F, Guida, A, Manzo, A, Adamo, V, Rastelli, F, Bulotta, A, Citarella, F, Toschi, L, Zoratto, F, Cortinovis, D, Berardi, R, Follador, A, Carta, A, Camerini, A, Salerno, F, Silva, R, Baldini, E, Cortellini, A, Brighenti, M, Santoni, M, Malorgio, F, Caminiti, C, Tiseo, M, Leonetti, Alessandro, Perrone, Fabiana, Puntoni, Matteo, Maglietta, Giuseppe, Bordi, Paola, Bria, Emilio, Vita, Emanuele, Gelsomino, Francesco, De Giglio, Andrea, Gelibter, Alain, Siringo, Marco, Mazzoni, Francesca, Caliman, Enrico, Genova, Carlo, Bertolini, Federica, Guaitoli, Giorgia, Passiglia, Francesco, Delcuratolo, Marco Donatello, Montrone, Michele, Cerea, Giulio, Pasello, Giulia, Roca, Elisa, Belluomini, Lorenzo, Cecere, Fabiana Letizia, Guida, Annalisa, Manzo, Anna, Adamo, Vincenzo, Rastelli, Francesca, Bulotta, Alessandra, Citarella, Fabrizio, Toschi, Luca, Zoratto, Federica, Cortinovis, Diego Luigi, Berardi, Rossana, Follador, Alessandro, Carta, Annamaria, Camerini, Andrea, Salerno, Flavio, Silva, Rosa Rita, Baldini, Editta, Cortellini, Alessio, Brighenti, Matteo, Santoni, Matteo, Malorgio, Francesco, Caminiti, Caterina, Tiseo, Marcello, Leonetti, A, Perrone, F, Puntoni, M, Maglietta, G, Bordi, P, Bria, E, Vita, E, Gelsomino, F, De Giglio, A, Gelibter, A, Siringo, M, Mazzoni, F, Caliman, E, Genova, C, Bertolini, F, Guaitoli, G, Passiglia, F, Delcuratolo, M, Montrone, M, Cerea, G, Pasello, G, Roca, E, Belluomini, L, Cecere, F, Guida, A, Manzo, A, Adamo, V, Rastelli, F, Bulotta, A, Citarella, F, Toschi, L, Zoratto, F, Cortinovis, D, Berardi, R, Follador, A, Carta, A, Camerini, A, Salerno, F, Silva, R, Baldini, E, Cortellini, A, Brighenti, M, Santoni, M, Malorgio, F, Caminiti, C, Tiseo, M, Leonetti, Alessandro, Perrone, Fabiana, Puntoni, Matteo, Maglietta, Giuseppe, Bordi, Paola, Bria, Emilio, Vita, Emanuele, Gelsomino, Francesco, De Giglio, Andrea, Gelibter, Alain, Siringo, Marco, Mazzoni, Francesca, Caliman, Enrico, Genova, Carlo, Bertolini, Federica, Guaitoli, Giorgia, Passiglia, Francesco, Delcuratolo, Marco Donatello, Montrone, Michele, Cerea, Giulio, Pasello, Giulia, Roca, Elisa, Belluomini, Lorenzo, Cecere, Fabiana Letizia, Guida, Annalisa, Manzo, Anna, Adamo, Vincenzo, Rastelli, Francesca, Bulotta, Alessandra, Citarella, Fabrizio, Toschi, Luca, Zoratto, Federica, Cortinovis, Diego Luigi, Berardi, Rossana, Follador, Alessandro, Carta, Annamaria, Camerini, Andrea, Salerno, Flavio, Silva, Rosa Rita, Baldini, Editta, Cortellini, Alessio, Brighenti, Matteo, Santoni, Matteo, Malorgio, Francesco, Caminiti, Caterina, and Tiseo, Marcello

Abstract

Purpose: The aim of this multi-center, retrospective/prospective cohort observational study was to evaluate outcomes in routine clinical practice of first-line chemo-immunotherapy with cis/carboplatin, pemetrexed and pembrolizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC) in 33 Italian centers. Methods: The outcome measure was to evaluate overall survival (OS) in a real-world patient population. Secondary endpoints were: progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and incidence of treatment-related adverse events (AEs). Results: 1068 patients were enrolled at the time of data cut-off (January 31st, 2023), and 812 (76.0%) belonged to the retrospective cohort. Median age was 66 years (27−85), ECOG PS was ≥ 2 in 91 (8.6%) patients; 254 (23.8%) patients had brain metastases at baseline; 38 (3.6%) patients had tumor with PD-L1 expression ≥ 50%. After a median follow-up of 17.0 months (95% CI, 16.1–17.9), median OS was 16.1 months (95% CI, 14.4–18.8) and PFS was 9.9 months (95% CI, 8.8–11.2). Median DoR (n = 493) was 14.7 months (95% CI, 13.6–17.1). ORR was 43.4% (95% CI, 40.4–46.4). Any-grade AEs occurred in 636 (59.6%) patients and grade ≥ 3 in 253 (23.7%) patients. Most common grade ≥ 3 AEs were neutropenia (6.3%) and anemia (6.3%). Conclusions: First-line chemo-immunotherapy was effective and tolerable in this large, real-world Italian study of patients with advanced non-squamous NSCLC. Our results were in line with the KEYNOTE-189 registration study, also considering the low number of PD-L1 ≥ 50% patients included in our study.

Published
2024

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

Author

Cortellini, Alessio, Tiseo, Marcello, Banna, Giuseppe L., Cappuzzo, Federico, Aerts, Joachim G. J. V., Barbieri, Fausto, Giusti, Raffaele, Bria, Emilio, Cortinovis, Diego, Grossi, Francesco, Migliorino, Maria R., Galetta, Domenico, Passiglia, Francesco, Santini, Daniele, Berardi, Rossana, Morabito, Alessandro, Genova, Carlo, Mazzoni, Francesca, Di Noia, Vincenzo, Signorelli, Diego, Tuzi, Alessandro, Gelibter, Alain, Marchetti, Paolo, Macerelli, Marianna, Rastelli, Francesca, Chiari, Rita, Rocco, Danilo, Gori, Stefania, De Tursi, Michele, Mansueto, Giovanni, Zoratto, Federica, Santoni, Matteo, Tudini, Marianna, Rijavec, Erika, Filetti, Marco, Catino, Annamaria, Pizzutilo, Pamela, Sala, Luca, Citarella, Fabrizio, Marco, Russano, Torniai, Mariangela, Cantini, Luca, Targato, Giada, Sforza, Vincenzo, Nigro, Olga, Ferrara, Miriam G., D’Argento, Ettore, Buti, Sebastiano, Bordi, Paola, Antonuzzo, Lorenzo, Scodes, Simona, Landi, Lorenza, Guaitoli, Giorgia, Baldessari, Cinzia, Della Gravara, Luigi, Dal Bello, Maria Giovanna, Belderbos, Robert A., Bironzo, Paolo, Carnio, Simona, Ricciardi, Serena, Grieco, Alessio, De Toma, Alessandro, Proto, Claudia, Friedlaender, Alex, Cantale, Ornella, Ricciuti, Biagio, Addeo, Alfredo, Metro, Giulio, Ficorella, Corrado, and Porzio, Giampiero

Published
2020
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6. Type 2 diabetes mellitus and efficacy outcomes from imune checkpoint blockade in patients with cancer

Author

Cortellini, Alessio, primary, D'Alessio, Antonio, additional, Cleary, Siobhan, additional, Buti, Sebastiano, additional, Bersanelli, Melissa, additional, Bordi, Paola, additional, Tonini, Giuseppe, additional, Vincenzi, Bruno, additional, Tucci, Marco, additional, Russo, Alessandro, additional, Pantano, Francesco, additional, Russano, Marco, additional, Stucci, Luigia Stefania, additional, Sergi, Maria Chiara, additional, Falconi, Martina, additional, Zarzana, Maria Antonietta., additional, Santini, Daniele, additional, Spagnolo, Francesco, additional, Tanda, Enrica T., additional, Rastelli, Francesca, additional, Giorgi, Francesca Chiara., additional, Pergolesi, Federica, additional, Giusti, Raffaele, additional, Filetti, Marco, additional, Lo Bianco, Francesca, additional, Marchetti, Paolo, additional, Botticelli, Andrea, additional, Gelibter, Alain, additional, Siringo, Marco, additional, Ferrari, Marco, additional, Marconcini, Riccardo, additional, Vitale, Maria Giuseppa., additional, Nicolardi, Linda, additional, Chiari, Rita, additional, Ghidini, Michele, additional, Nigro, Olga, additional, Grossi, Francesco, additional, De Tursi, Michele, additional, Di Marino, Pietro, additional, Queirolo, Paola, additional, Bracarda, Sergio, additional, Macrini, Serena, additional, Inno, Alessandro, additional, Zoratto, Federica, additional, Veltri, Enzo, additional, Spoto, Chiara, additional, Vitale, Maria Grazia., additional, Cannita, Katia, additional, Gennari, Alessandra, additional, Morganstein, Daniel L., additional, Mallardo, Domenico, additional, Nibid, Lorenzo, additional, Sabarese, Giovanna, additional, Brunetti, Leonardo, additional, Perrone, Giuseppe, additional, Ascierto, Paolo A., additional, Ficorella, Corrado, additional, and Pinato, David J., additional

Published
2023
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7. EPMA-World Congress 2015: Bonn, Germany. 3-5 September 2015

Author

Abraham, Jella-Andrea, Golubnitschaja, Olga, Akhmetov, Ildar, Andrews, Russell J., Quintana, Leonidas, Andrews, Russell J., Baban, Babak, Liu, Jun Yao, Qin, Xu, Wang, Tailing, Mozaffari, Mahmood S., Bati, Viktoriia V., Meleshko, Tamara V., Levchuk, Olga B., Boyko, Nadiya V., Bauer, Joanna, Boerner, Ewa, Podbielska, Halina, Bomba, Alojz, Petrov, Viktor O., Drobnych, Volodymyr G., Bubnov, Rostyslav V., Bykova, Oksana M., Boyko, Nadiya V., Brunner-La Rocca, Hans-Peter, Fleischhacker, Lutz, Golubnitschaja, Olga, Heemskerk, Frank, Helms, Thomas, Jaarsma, Tiny, Kinkorová, Judita, Ramaekers, Jan, Ruff, Peter, Schnur, Ivana, Vanoli, Emilio, Verdu, Jose, Brunner-La Rocca, Hans-Peter, Bubnov, Rostyslav V., Grabovetskyi, Sergiy A., Mykhalchenko, Olena M., Tymoshok, Natalia O., Shcherbakov, Oleksandr B., Semeniv, Igor P., Spivak, Mykola Y., Bubnov, Rostyslav V., Ostapenko, Tetyana V., Bubnov, Rostyslav V., Kobyliak, Nazarii M., Zholobak, Nadiya M., Spivak, Mykola Ya., Cauchi, John Paul, Cherepakhin, Dmitrii, Bakay, Marina, Borovikov, Artem, Suchkov, Sergey, Cieślik, Barbara, Migasiewicz, Agnieszka, Podbielska, Maria-Luiza, Pelleter, Markus, Giemza, Agnieszka, Podbielska, Halina, Cirak, Sebahattin, Del Re, Marzia, Bordi, Paola, Citi, Valentina, Palombi, Marta, Pinto, Carmine, Tiseo, Marcello, Danesi, Romano, Einhorn, Lukas, Fazekas, Judit, Muhr, Martina, Schoos, Alexandra, Panakova, Lucia, Herrmann, Ina, Manzano-Szalai, Krisztina, Oida, Kumiko, Fiebiger, Edda, Singer, Josef, Jensen-Jarolim, Erika, Elnar, Arpiné A., Ouamara, Nadia, Boyko, Nadiya, Coumoul, Xavier, Antignac, Jean-Philippe, Le Bizec, Bruno, Eppe, Gauthier, Renaut, Jenny, Bonn, Torsten, Guignard, Cédric, Ferrante, Margherita, Chiusano, Maria Liusa, Cuzzocrea, Salvatore, O’Keeffe, Gerard, Cryan, John, Bisson, Michelle, Barakat, Amina, Hmamouchi, Ihsane, Zawia, Nasser, Kanthasamy, Anumantha, Kisby, Glen E., Alves, Rui, Pérez, Oscar Villacañas, Burgard, Kim, Spencer, Peter, Bomba, Norbert, Haranta, Martin, Zaitseva, Nina, May, Irina, Grojean, Stéphanie, Body-Malapel, Mathilde, Harari, Florencia, Harari, Raul, Yeghiazaryan, Kristina, Golubnitschaja, Olga, Calabrese, Vittorio, Nemos, Christophe, Soulimani, Rachid, Evsevyeva, Maria E., Mishenko, Elena A., Kumukova, Zurida V., Chudnovsky, Evgeniy V., Smirnova, Tatyana A., Evsevyeva, Maria E., Ivanova, Ludmila V., Eremin, Michail V., Rostovtseva, Maria V., Evsevyeva, Maria E., Eremin, Michail V., Koshel, Vladimir I., Sergeeva, Oksana V., Konovalova, Nadesgda M., Girotra, Shantanu, Golubnitschaja, Olga, Golubnitschaja, Olga, Debald, Manuel, Kuhn, Walther, Yeghiazaryan, Kristina, Bubnov, Rostyslav V., Goncharenko, Vadym M., Lushchyk, Ulyana, Grech, Godfrey, Konieczka, Katarzyna, Golubnitschaja, Olga, Erwich, Jan Jaap, Costigliola, Vincenzo, Yeghiazaryan, Kristina, Gembruch, Ulrich, Goncharenko, Vadym M., Beniuk, Vasyl O., Kalenska, Olga V., Bubnov, Rostyslav V., Goncharenko, Vadym M., Beniuk, Vasyl O., Bubnov, Rostyslav V., Melnychuk, Olga, Gorbacheva, Irina A., Orekhova, Lyudmila Y., Tachalov, Vadim V., Grechanyk, Olena I., Abdullaiev, Rizvan Ya., Bubnov, Rostyslav V., Hagan, Suzanne, Martin, Eilidh, Pearce, Ian, Oliver, Katherine, Haytac, Cenk, Salimov, Fariz, Yoksul, Servin, Kunin, Anatoly A., Moiseeva, Natalia S., Herrera-Imbroda, Bernardo, del Río-González, Sergio, Lara, Maria Fernanda, Angulo, Antonia, Machuca Santa-Cruz, Francisco Javier, Herrera-Imbroda, Bernardo, del Río-González, Sergio, Lara, Maria Fernanda, Ionescu, John, Isamulaeva, Alfiya Z., Kunin, Anatoly A., Magomedov, Shamil Sh., Isamulaeva, Aida I., Josifova, Tatjana, Kapalla, Marko, Kubáň, Juraj, Golubnitschaja, Olga, Costigliola, Vincenzo, Costigliola, Vincenzo, Kapalla, Marko, Kubáň, Juraj, Golubnitschaja, Olga, Kent, Anthony, Fisher, Tom, Dias, Tilak, Kinkorová, Judita, Topolčan, Ondřej, Kohl, Matthias, Kunin, Anatoly A., Moiseeva, Natalia S., Kurchenko, Andrii I., Beniuk, Vasyl A., Goncharenko, Vadym M., Bubnov, Rostyslav V., Boyko, Nadiya V., Strokan, Andriy M., Kzhyshkowska, Julia, Gudima, Alexandru, Stankevich, Ksenia S., Filimonov, Victor D., Klüter, Harald, Mamontova, Evgeniya M., Tverdokhlebov, Sergei I., Lushchyk, Ulyana B., Novytskyy, Viktor V., Babii, Igor P., Lushchyk, Nadiya G., Riabets, Lyudmyla S., Legka, Ivanna I., Marcus-Kalish, Mira, Mitelpunkt, Alexis, Galili, Tal, Shachar, Neta, Benjamini, Yoav, Migasiewicz, Agnieszka, Pelleter, Markus, Bauer, Joanna, Dereń, Ewelina, Podbielska, Halina, Moiseeva, Natalia S., Kunin, Anatoly A., Kunin, Dmitry A., Moiseeva, Natalia S., Ippolitov, Yury A., Kunin, Dmitry A., Morozov, Alexei N., Chirkova, Natalia V., Aliev, Nakhid T., Mozaffari, Mahmood S., Liu, Jun Yao, Baban, Babak, Mozaffari, Mahmood S., Liu, Jun Yao, Abdelsayed, Rafik, Shi, Xing-Ming, Baban, Babak, Novák, Jaroslav, Štork, Milan, Zeman, Václav, Oosterhuis, Wytze P., Theodorsson, Elvar, Orekhova, Lyudmila Y., Kudryavtseva, Tatyana V., Isaeva, Elena R., Tachalov, Vadim V., Loboda, Ekaterina S., Pazzagli, Mario, Malentacchi, Francesca, Mancini, Irene, Brandslund, Ivan, Vermeersch, Pieter, Schwab, Matthias, Marc, Janja, van Schaik, Ron H. N., Siest, Gerard, Theodorsson, Elvar, Di Resta, Chiara, Pleva, Matus, Juhar, Jozef, Pleva, Matus, Juhar, Jozef, Polívka jr., Jiří, Janků, Filip, Pešta, Martin, Doležal, Jan, Králíčková, Milena, Polívka, Jiří, Polívka, Jiří, Lukešová, Alena, Müllerová, Nina, Ševčík, Petr, Rohan, Vladimír, Richter, Kneginja, Miloseva, Lence, Niklewski, Günter, Richter, Kneginja, Acker, Jens, Niklewski, Guenter, Safonicheva, Olga, Costigliola, Vincenzo, Safonicheva, Olga, Sautin, Maxim, Sinelnikova, Janna, Suchkov, Sergey, Secer, Songül, von Bandemer, Stephan, Shapira, Niva, Shcherbakov, Aleksandr, Kunin, Anatoly A., Moiseeva, Natalia S., Shumilovich, Bogdan R., Lipkind, Zhanna, Vorobieva, Yulia, Kunin, Dmitry A., Sudareva, Anastasiia V., Smokovski, Ivica, Milenkovic, Tatjana, Solís-Herrera, Arturo, Arias-Esparza, María del Carmen, Suchkov, Sergey, Sridhar, Krishna Chander, Golubnitschaja, Olga, Studneva, Maria, Song, Sihong, Creeden, James, Мandrik, Мark, Suchkov, Sergey, Theodorsson, Elvar, Tofail, Syed A. M., Topolčan, Ondřej, Kinkorová, Judita, Fiala, Ondřej, Karlíková, Marie, Svobodová, Šárka, Kučera, Radek, Fuchsová, Radka, Třeška, Vladislav, Šimánek, Václav, Pecen, Ladislav, Šoupal, Jan, Svačina, Štěpán, Tretyak, Evgeniya, Studneva, Maria, Suchkov, Sergey, Trovato, Francesca M., Martines, Giuseppe Fabio, Brischetto, Daniela, Catalano, Daniela, Musumeci, Giuseppe, Trovato, Guglielmo M., Tsangaris, George Th., Anagnostopoulos, Athanasios K., Tsangaris, George Th., Anagnostopoulos, Athanasios K., Verdú, José, Gutiérrez, German, Rovira, Jordi, Martinez, Marta, Fleischhacker, Lutz, Green, Donna, Garson, Arthur, Tamburini, Elena, Cuomo, Stefano, Martinez-Leon, Juan, Abrisqueta, Teresa, Brunner-La Rocca, Hans-Peter, Jaarsma, Tiny, Arredondo, Teresa, Vera, Cecilia, Fico, Giuseppe, Golubnitschaja, Olga, Arribas, Fernando, Onderco, Martina, Vara, Isabel, Verdú, José, Sambo, Francesco, Di Camillo, Barbara, Cobelli, Claudio, Facchinetti, Andrea, Fico, Giuseppe, Bellazzi, Riccardo, Sacchi, Lucia, Dagliati, Arianna, Segnani, Daniele, Tibollo, Valentina, Ottaviano, Manuel, Gabriel, Rafael, Groop, Leif, Postma, Jacqueline, Martinez, Antonio, Hakaste, Liisa, Tuomi, Tiinamaija, Zarkogianni, Konstantia, Volchek, Igor, Pototskaya, Nina, Petrov, Andrey, Volchek, Igor, Pototskaya, Nadezhda, Petrov, Andrey, Voog-Oras, Ülle, Jagur, Oksana, Leibur, Edvitar, Niibo, Priit, Jagomägi, Triin, Nguyen, Minh Son, Pruunsild, Chris, Piikov, Dagmar, Saag, Mare, Wang, Wei, Wang, Wei, Weinhäusel, Andreas, Pulverer, Walter, Wielscher, Matthias, Hofner, Manuela, Noehammer, Christa, Soldo, Regina, Hettegger, Peter, Gyurjan, Istvan, Kulovics, Ronald, Schönthaler, Silvia, Beikircher, Gabriel, Kriegner, Albert, Pabinger, Stephan, Vierlinger, Klemens, Yüzbaşıoğlu, Ayşe, Özgüç, Meral, EFLM, on behalf of ZENITH consortium, and on behalf of MOSAIC consortium

Published
2016
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8. Monitoring cfDNA in Plasma and in Other Liquid Biopsies of Advanced EGFR Mutated NSCLC Patients: A Pilot Study and a Review of the Literature

Author

Verzè, Michela, primary, Minari, Roberta, additional, Gnetti, Letizia, additional, Bordi, Paola, additional, Leonetti, Alessandro, additional, Cosenza, Agnese, additional, Ferri, Leonarda, additional, Majori, Maria, additional, De Filippo, Massimo, additional, Buti, Sebastiano, additional, Gasparro, Donatello, additional, Nizzoli, Rita, additional, Azzoni, Cinzia, additional, Bottarelli, Lorena, additional, Squadrilli, Anna, additional, Mozzoni, Paola, additional, and Tiseo, Marcello, additional

Published
2021
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9. Dynamic Evaluation of Circulating miRNA Profile in EGFR-Mutated NSCLC Patients Treated with EGFR-TKIs

Author

Leonetti, Alessandro, primary, Capula, Mjriam, additional, Minari, Roberta, additional, Mazzaschi, Giulia, additional, Gregori, Alessandro, additional, El Hassouni, Btissame, additional, Papini, Filippo, additional, Bordi, Paola, additional, Verzè, Michela, additional, Avan, Amir, additional, Tiseo, Marcello, additional, and Giovannetti, Elisa, additional

Published
2021
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10. Differential influence of antibiotic therapy and other medications on oncological outcomes of patients with non-small cell lung cancer treated with first-line pembrolizumab versus cytotoxic chemotherapy

Author

Cortellini, Alessio, primary, Di Maio, Massimo, additional, Nigro, Olga, additional, Leonetti, Alessandro, additional, Cortinovis, Diego L, additional, Aerts, Joachim GJV, additional, Guaitoli, Giorgia, additional, Barbieri, Fausto, additional, Giusti, Raffaele, additional, Ferrara, Miriam G, additional, Bria, Emilio, additional, D'Argento, Ettore, additional, Grossi, Francesco, additional, Rijavec, Erika, additional, Guida, Annalisa, additional, Berardi, Rossana, additional, Torniai, Mariangela, additional, Sforza, Vincenzo, additional, Genova, Carlo, additional, Mazzoni, Francesca, additional, Garassino, Marina Chiara, additional, De Toma, Alessandro, additional, Signorelli, Diego, additional, Gelibter, Alain, additional, Siringo, Marco, additional, Marchetti, Paolo, additional, Macerelli, Marianna, additional, Rastelli, Francesca, additional, Chiari, Rita, additional, Rocco, Danilo, additional, Della Gravara, Luigi, additional, Inno, Alessandro, additional, Michele, De Tursi, additional, Grassadonia, Antonino, additional, Di Marino, Pietro, additional, Mansueto, Giovanni, additional, Zoratto, Federica, additional, Filetti, Marco, additional, Santini, Daniele, additional, Citarella, Fabrizio, additional, Russano, Marco, additional, Cantini, Luca, additional, Tuzi, Alessandro, additional, Bordi, Paola, additional, Minuti, Gabriele, additional, Landi, Lorenza, additional, Ricciardi, Serena, additional, Migliorino, Maria R, additional, Passiglia, Francesco, additional, Bironzo, Paolo, additional, Metro, Giulio, additional, Adamo, Vincenzo, additional, Russo, Alessandro, additional, Spinelli, Gian Paolo, additional, Banna, Giuseppe L, additional, Friedlaender, Alex, additional, Addeo, Alfredo, additional, Cannita, Katia, additional, Ficorella, Corrado, additional, Porzio, Giampiero, additional, and Pinato, David J, additional

Published
2021
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11. Smoking status during first‐line immunotherapy and chemotherapy in NSCLC patients: A case–control matched analysis from a large multicenter study

Author

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

Published
2021
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12. Clinical Impact of COVID-19 in a Single-Center Cohort of a Prospective Study in Cancer Patients Receiving Immunotherapy

Author

Bersanelli, Melissa, primary, Zielli, Teresa, additional, Perrone, Fabiana, additional, Casartelli, Chiara, additional, Pratticò, Fabiana, additional, Rapacchi, Elena, additional, Camisa, Roberta, additional, Tognetto, Michele, additional, Clemente, Alberto, additional, Giannarelli, Diana, additional, Rebuzzi, Sara Elena, additional, Leonetti, Alessandro, additional, Bordi, Paola, additional, Tiseo, Marcello, additional, and Buti, Sebastiano, additional

Published
2020
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13. Emergence of a HER2-amplified clone during disease progression in an ALK-rearranged NSCLC patient treated with ALK-inhibitors: a case report

Author

Minari, Roberta, primary, Gnetti, Letizia, additional, Lagrasta, Costanza Annamaria, additional, Squadrilli, Anna, additional, Bordi, Paola, additional, Azzoni, Cinzia, additional, Bottarelli, Lorena, additional, Cosenza, Agnese, additional, Ferri, Leonarda, additional, Caruso, Giuseppe, additional, Silini, Enrico Maria, additional, and Tiseo, Marcello, additional

Published
2020
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14. Palliative radiotherapy in advanced cancer patients treated with immune‑checkpoint inhibitors: The PRACTICE study

Author

Bersanelli, Melissa, primary, Lattanzi, Elisabetta, additional, D'Abbiero, Nunziata, additional, Buti, Sebastiano, additional, Leonetti, Alessandro, additional, Can�, Maria, additional, Trapani, Salvatore, additional, Gravina, Gianluca, additional, Porzio, Giampiero, additional, Cannita, Katia, additional, Di Marino, Pietro, additional, Grassadonia, Antonino, additional, Tinari, Nicola, additional, De Tursi, Michele, additional, Giaiacopi, Elisa, additional, Michiara, Maria, additional, Bordi, Paola, additional, Perrone, Fabiana, additional, Caravatta, Luciana, additional, Trignani, Marianna, additional, Genovesi, Domenico, additional, Natoli, Clara, additional, Ficorella, Corrado, additional, Tiseo, Marcello, additional, and Cortellini, Alessio, additional

Published
2019
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15. Profile of atezolizumab in the treatment of metastatic non-small-cell lung cancer: patient selection and perspectives

Author

Facchinetti,Francesco, Bordi,Paola, Leonetti,Alessandro, Buti,Sebastiano, and Tiseo,Marcello

Subjects
Drug Design, Development and Therapy
Abstract

Francesco Facchinetti, Paola Bordi, Alessandro Leonetti, Sebastiano Buti, Marcello Tiseo Medical Oncology Unit, University Hospital of Parma, Parma, Italy Abstract: Programed cell death-1/programed death ligand-1 (PD-1/PD-L1) blockade represents an affirmed reality in the treatment of advanced non-small-cell lung cancer (NSCLC) patients. Atezolizumab, an anti-PD-L1 agent, figures among the drugs that provide previously unenvisaged outcomes in the pretreated setting of metastatic NSCLC. Increasing evidence vouches for the early administration of PD-1/PD-L1 blockers in untreated patients, encompassing atezolizumab combinations with chemotherapy and the anti-angiogenic agent bevacizumab. Moreover, the development of atezolizumab allowed to derive several hints regarding clinical and immunological factors predictive of its activity and efficacy, some of them exclusive among this class of drugs. This review provides an overview of atezolizumab development throughout clinical trials toward its applicability in the routine practice, with a particular focus on patient selection based on clinical and immune-related factors. Keywords: non-small cell lung cancer, NSCLC, immune checkpoint blockers, ICB, PD-1, PD-L1, atezolizumab development, biomarkers

Published
2018

16. Mutational analysis of plasma circulating tumor DNA in EGFR mutated lung cancer. Results of a prospective study

Author

Bordi, Paola

Subjects
EGFR, MED/06, circulating DNA, Non compilare, NSCLC, plasmatic monitoring
Abstract

Gli inibitori tirosin chinasici TKI (Tyrosine Kinase Inhibitor) di prima e seconda generazione (erlotinib, gefitinib, afatinib) rappresentano lo standard di trattamento nei pazienti affetti da NSCLC avanzato EGFR-mutato. Nei pazienti che sviluppano resistenza acquisita mediata dalla presenza della mutazione T790M osimertinib invece rappresenta il trattamento di prima scelta. In entrambe queste tipologie di pazienti, l’analisi del DNA tumorale circolante (ctDNA) estratto da campioni di sangue rappresenta un’alternativa alla re-biopsia tissutale per il monitoraggio evolutivo molecolare. Lo studio ha analizzato l’assetto mutazionale plasmatico di pazienti trattati con EGFR-TKI al fine di valutarne il ruolo prognostico e predittivo di risposta al trattamento.Sono stati arruolati 77 pazienti affetti da NSCLC di cui 37 trattati in prima linea e 40 con tumore T790M-positivo dopo progressione a TKI e avviati a osimertinib. Mediante ddPCR, i livelli di mutazione attivante e mutazione di resistenza sono stati quantificati nel ctDNA estratto da campioni di sangue prelevati prima della terapia e dopo 12 settimane di trattamento e correlati con i principali indicatori di outcome. Nel sottogruppo di pazienti trattati in prima linea, il disease control rate (DCR) è risultato del 84%, con PFS globale pari a 13 mesi (IC 95% 4.8 – 21.1). La mediana per la sopravvivenza globale non è stata raggiunta essendo la sopravvivenza a 12 e 24 mesi rispettivamente del 79% e 58%. I pazienti con plasma negativo per mutazioni al basale sembrerebbero presentare miglior PFS, seppur la differenza non sia statisticamente significativa. La frequenza allelica della mutazione attivante al basale è risultata positivamente associata a miglior risposta al trattamento con valori al limite della significatività statistica (p = 0.05). Inoltre, tutti i pazienti che hanno mostrato progressione di malattia come miglior risposta al trattamento hanno registrato valori ≤ 1.1%, mentre pazienti con frequenza allelica maggiore hanno avuto controllo sulla malattia. Un valore al di sotto di 1.1%, identificato come cut-off, ha quindi una sensibilità del 100% e una specificità del 73% nell’identificare pazienti che andranno in progressione al trattamento di prima linea. Lo shrinkage tumorale in corso di terapia ha mostrato di essere positivamente correlato con la negatività alla ddPCR dopo 2 mesi di terapia (p = 0.029) e con la clearance plasmatica (p = 0.043). Nei pazienti trattati con osimertinib, il DCR è risultato pari al 70%, con 11 mesi di PFS mediana (95% CI: 5.2 – 16.8) e 15.4 mesi di OS mediana di (95% CI: 11.4 – 19.4). Una frequenza allelica (FA) mediana di mutazione attivante

Published
2018

17. Syndrome of inappropriate anti-diuretic hormone secretion in cancer patients: results of the first multicenter Italian study

Author

Berardi, Rossana, primary, Mastroianni, Candida, additional, Lo Russo, Giuseppe, additional, Buosi, Roberta, additional, Santini, Daniele, additional, Montanino, Agnese, additional, Carnaghi, Carlo, additional, Tiseo, Marcello, additional, Chiari, Rita, additional, Camerini, Andrea, additional, Barni, Sandro, additional, De Marino, Valeria, additional, Ferrari, Daris, additional, Cristofano, Antonella, additional, Doni, Laura, additional, Freddari, Federica, additional, Fumagalli, Daniele, additional, Portalone, Luigi, additional, Sarmiento, Roberta, additional, Schinzari, Giovanni, additional, Sperandi, Francesca, additional, Tucci, Marcello, additional, Inno, Alessandro, additional, Ciuffreda, Libero, additional, Mariotti, Marita, additional, Mariani, Cinzia, additional, Caramanti, Miriam, additional, Torniai, Mariangela, additional, Gallucci, Rosaria, additional, Bennati, Chiara, additional, Bordi, Paola, additional, Buffoni, Lucio, additional, Galeassi, Achille, additional, Ghidini, Michele, additional, Grossi, Emidio, additional, Morabito, Alessandro, additional, Vincenzi, Bruno, additional, and Arvat, Emanuela, additional

Published
2019
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18. Palliative radiotherapy in advanced cancer patients treated with immune-checkpoint inhibitors: The PRACTICE study.

Author

Bersanelli, Melissa, Lattanzi, Elisabetta, D'Abbiero, Nunziata, Buti, Sebastiano, Leonetti, Alessandro, Canè, Maria Giulia, Trapani, Salvatore, Gravina, Gianluca, Porzio, Giampiero, Cannita, Katia, Marino, Pietro Di, Grassadonia, Antonino, Tinari, Nicola, Tursi, Michele De, Giaiacopi, Elisa, Michiara, Maria, Bordi, Paola, Perrone, Fabiana, Caravatta, Luciana, and Trignani, Marianna

Subjects
CANCER patients, IPILIMUMAB, PROGRESSION-free survival, CANCER radiotherapy, PALLIATIVE treatment of cancer, IMMUNOTHERAPY
Abstract

In the present study, the influence of purely palliative radiotherapy (pRT) on the outcomes of patients with advanced cancer undergoing immune checkpoint blockade was evaluated. Patients were stratified into three groups: Patients who had received pRT within 6 months prior to the initiation of immunotherapy (previous pRT); patients who received pRT during immunotherapy (concurrent pRT); and patients who did not receive RT prior to or during immunotherapy (no RT group), and these groups were compared. The median overall survival (mOS), median progression free survival (mPFS) and median time-to-treatment failure (mTTF) for the previous pRT group were significantly shorter compared with the no RT group (mOS, 3.6 vs. 12.1 months, respectively, P=0.0095; mPFS 1.8 vs. 5.4 months, respectively, P=0.0016; mTTF 1.8 vs. 5.7 months, respectively, P=0.0035). The concurrent pRT group had a longer mTTF compared with the previous pRT group and similar outcomes to the no RT group. In the previous pRT group, 26.9% of the patients experienced immune-related adverse events compared with 40.1% of patients in the no RT group. Despite the use of pRT during immunotherapy being considered safe, the results of the present study suggest that pRT has a negative effect on immune balance. [ABSTRACT FROM AUTHOR]

Published
2020
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19. Nivolumab in never-smokers with advanced squamous non-small cell lung cancer: Results from the Italian cohort of an expanded access program

Author

Garassino, Marina Chiara, primary, Crinò, Lucio, additional, Catino, Annamaria, additional, Ardizzoni, Andrea, additional, Cortesi, Enrico, additional, Cappuzzo, Federico, additional, Bordi, Paola, additional, Calabrò, Luana, additional, Barbieri, Fausto, additional, Santo, Antonio, additional, Altavilla, Giuseppe, additional, Ambrosio, Francesca, additional, Mini, Enrico, additional, Vasile, Enrico, additional, Morgillo, Floriana, additional, Scoppola, Alessandro, additional, Bengala, Carmelo, additional, Follador, Alessandro, additional, Tedde, Natale, additional, Giannarelli, Diana, additional, Lo Russo, Giuseppe, additional, and Vitiello, Fabiana, additional

Published
2018
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20. Concurrent Acquired BRAF V600E Mutation and MET Amplification as Resistance Mechanism of First-Line Osimertinib Treatment in a Patient with EGFR-Mutated NSCLC

Author

Minari, Roberta, primary, Bordi, Paola, additional, La Monica, Silvia, additional, Squadrilli, Anna, additional, Leonetti, Alessandro, additional, Bottarelli, Lorena, additional, Azzoni, Cinzia, additional, Lagrasta, Costanza Anna Maria, additional, Gnetti, Letizia, additional, Campanini, Nicoletta, additional, Petronini, Pier Giorgio, additional, Alfieri, Roberta, additional, and Tiseo, Marcello, additional

Published
2018
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21. Clinical and hematologic parameters address the outcomes of non-small-cell lung cancer patients treated with nivolumab

Author

Facchinetti, Francesco, primary, Veneziani, Michele, additional, Buti, Sebastiano, additional, Gelsomino, Francesco, additional, Squadrilli, Anna, additional, Bordi, Paola, additional, Bersanelli, Melissa, additional, Cosenza, Agnese, additional, Ferri, Leonarda, additional, Rapacchi, Elena, additional, Mazzaschi, Giulia, additional, Leonardi, Francesco, additional, Quaini, Federico, additional, Ardizzoni, Andrea, additional, Missale, Gabriele, additional, and Tiseo, Marcello, additional

Published
2018
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22. Global methodology for developmental neurotoxicity testing inhumans and animals early and chronically exposed to chemicalcontaminants

Author

Abraham, Jella-Andrea, Golubnitschaja, Olga, Akhmetov, Ildar, Andrews, Russell J., Quintana, Leonidas, Baban, Babak, Liu, Jun Yao, Qin, Xu, Wang, Tailing, Mozaffari, Mahmood S., Bati, Viktoriia V., Meleshko, Tamara V., Levchuk, Olga B., Boyko, Nadiya V., Bauer, Joanna, Boerner, Ewa, Podbielska, Halina, Bomba, Alojz, Petrov, Viktor O., Drobnych, Volodymyr G., Bubnov, Rostyslav V., Bykova, Oksana M., Brunner-La Rocca, Hans-Peter, Fleischhacker, Lutz, Heemskerk, Frank, Helms, Thomas, Jaarsma, Tiny, Kinkorová, Judita, Ramaekers, Jan, Ruff, Peter, Schnur, Ivana, Vanoli, Emilio, Verdu, Jose, Grabovetskyi, Sergiy A., Mykhalchenko, Olena M., Tymoshok, Natalia O., Shcherbakov, Oleksandr B., Semeniv, Igor P., Spivak, Mykola Y., Ostapenko, Tetyana V., Kobyliak, Nazarii M., Zholobak, Nadiya M., Spivak, Mykola Ya., Cauchi, John Paul, Cherepakhin, Dmitrii, Bakay, Marina, Borovikov, Artem, Suchkov, Sergey, Cieślik, Barbara, Migasiewicz, Agnieszka, Podbielska, Maria-Luiza, Pelleter, Markus, Giemza, Agnieszka, Cirak, Sebahattin, Del Re, Marzia, Bordi, Paola, Citi, Valentina, Palombi, Marta, Pinto, Carmine, Tiseo, Marcello, Danesi, Romano, Einhorn, Lukas, Fazekas, Judit, Muhr, Martina, Schoos, Alexandra, Panakova, Lucia, Herrmann, Ina, Manzano-Szalai, Krisztina, Oida, Kumiko, Fiebiger, Edda, Singer, Josef, Jensen-Jarolim, Erika, Elnar, Arpiné A., Ouamara, Nadia, Boyko, Nadiya, Coumoul, Xavier, Antignac, Jean-Philippe, Le Bizec, Bruno, Eppe, Gauthier, Renaut, Jenny, Bonn, Torsten, Guignard, Cédric, Ferrante, Margherita, Chiusano, Maria Liusa, Cuzzocrea, Salvatore, O’Keeffe, Gerard, Cryan, John, Bisson, Michelle, Barakat, Amina, Hmamouchi, Ihsane, Zawia, Nasser, Kanthasamy, Anumantha, Kisby, Glen E., Alves, Rui, Pérez, Oscar Villacañas, Burgard, Kim, Spencer, Peter, Bomba, Norbert, Haranta, Martin, Zaitseva, Nina, May, Irina, Grojean, Stéphanie, Body-Malapel, Mathilde, Harari, Florencia, Harari, Raul, Yeghiazaryan, Kristina, Calabrese, Vittorio, Nemos, Christophe, Soulimani, Rachid, Evsevyeva, Maria E., Mishenko, Elena A., Kumukova, Zurida V., Chudnovsky, Evgeniy V., Smirnova, Tatyana A., Ivanova, Ludmila V., Eremin, Michail V., Rostovtseva, Maria V., Koshel, Vladimir I., Sergeeva, Oksana V., Konovalova, Nadesgda M., Girotra, Shantanu, Debald, Manuel, Kuhn, Walther, Goncharenko, Vadym M., Lushchyk, Ulyana, Grech, Godfrey, Konieczka, Katarzyna, Erwich, Jan Jaap, Costigliola, Vincenzo, Gembruch, Ulrich, Beniuk, Vasyl O., Kalenska, Olga V., Melnychuk, Olga, Gorbacheva, Irina A., Orekhova, Lyudmila Y., Tachalov, Vadim V., Grechanyk, Olena I., Abdullaiev, Rizvan Ya., Hagan, Suzanne, Martin, Eilidh, Pearce, Ian, Oliver, Katherine, Haytac, Cenk, Salimov, Fariz, Yoksul, Servin, Kunin, Anatoly A., Moiseeva, Natalia S., Herrera-Imbroda, Bernardo, del Río-González, Sergio, Lara, Maria Fernanda, Angulo, Antonia, Machuca Santa-Cruz, Francisco Javier, Ionescu, John, Isamulaeva, Alfiya Z., Magomedov, Shamil Sh., Isamulaeva, Aida I., Josifova, Tatjana, Kapalla, Marko, Kubáň, Juraj, Kent, Anthony, Fisher, Tom, Dias, Tilak, Topolčan, Ondřej, Kohl, Matthias, Kurchenko, Andrii I., Beniuk, Vasyl A., Strokan, Andriy M., Kzhyshkowska, Julia, Gudima, Alexandru, Stankevich, Ksenia S., Filimonov, Victor D., Klüter, Harald, Mamontova, Evgeniya M., Tverdokhlebov, Sergei I., Lushchyk, Ulyana B., Novytskyy, Viktor V., Babii, Igor P., Lushchyk, Nadiya G., Riabets, Lyudmyla S., Legka, Ivanna I., Marcus-Kalish, Mira, Mitelpunkt, Alexis, Galili, Tal, Shachar, Neta, Benjamini, Yoav, Dereń, Ewelina, Kunin, Dmitry A., Ippolitov, Yury A., Morozov, Alexei N., Chirkova, Natalia V., Aliev, Nakhid T., Abdelsayed, Rafik, Shi, Xing-Ming, Novák, Jaroslav, Štork, Milan, Zeman, Václav, Oosterhuis, Wytze P., Theodorsson, Elvar, Kudryavtseva, Tatyana V., Isaeva, Elena R., Loboda, Ekaterina S., Pazzagli, Mario, Malentacchi, Francesca, Mancini, Irene, Brandslund, Ivan, Vermeersch, Pieter, Schwab, Matthias, Marc, Janja, van Schaik, Ron H. N., Siest, Gerard, Di Resta, Chiara, Pleva, Matus, Juhar, Jozef, Polívka, Jiří, Janků, Filip, Pešta, Martin, Doležal, Jan, Králíčková, Milena, Lukešová, Alena, Müllerová, Nina, Ševčík, Petr, Rohan, Vladimír, Richter, Kneginja, Miloseva, Lence, Niklewski, Günter, Acker, Jens, Niklewski, Guenter, Safonicheva, Olga, Sautin, Maxim, Sinelnikova, Janna, Secer, Songül, von Bandemer, Stephan, Shapira, Niva, Shcherbakov, Aleksandr, Shumilovich, Bogdan R., Lipkind, Zhanna, Vorobieva, Yulia, Sudareva, Anastasiia V., Smokovski, Ivica, Milenkovic, Tatjana, Solís-Herrera, Arturo, Arias-Esparza, María del Carmen, Sridhar, Krishna Chander, Studneva, Maria, Song, Sihong, Creeden, James, Мandrik, Мark, Tofail, Syed A. M., Fiala, Ondřej, Karlíková, Marie, Svobodová, Šárka, Kučera, Radek, Fuchsová, Radka, Třeška, Vladislav, Šimánek, Václav, Pecen, Ladislav, Šoupal, Jan, Svačina, Štěpán, Tretyak, Evgeniya, Trovato, Francesca M., Martines, Giuseppe Fabio, Brischetto, Daniela, Catalano, Daniela, Musumeci, Giuseppe, Trovato, Guglielmo M., Tsangaris, George Th., Anagnostopoulos, Athanasios K., Verdú, José, Gutiérrez, German, Rovira, Jordi, Martinez, Marta, Green, Donna, Garson, Arthur, Tamburini, Elena, Cuomo, Stefano, Martinez-Leon, Juan, Abrisqueta, Teresa, Arredondo, Teresa, Vera, Cecilia, Fico, Giuseppe, Arribas, Fernando, Onderco, Martina, Vara, Isabel, Sambo, Francesco, Di Camillo, Barbara, Cobelli, Claudio, Facchinetti, Andrea, Bellazzi, Riccardo, Sacchi, Lucia, Dagliati, Arianna, Segnani, Daniele, Tibollo, Valentina, Ottaviano, Manuel, Gabriel, Rafael, Groop, Leif, Postma, Jacqueline, Martinez, Antonio, Hakaste, Liisa, Tuomi, Tiinamaija, Zarkogianni, Konstantia, Volchek, Igor, Pototskaya, Nina, Petrov, Andrey, Pototskaya, Nadezhda, Voog-Oras, Ülle, Jagur, Oksana, Leibur, Edvitar, Niibo, Priit, Jagomägi, Triin, Nguyen, Minh Son, Pruunsild, Chris, Piikov, Dagmar, Saag, Mare, Wang, Wei, Weinhäusel, Andreas, Pulverer, Walter, Wielscher, Matthias, Hofner, Manuela, Noehammer, Christa, Soldo, Regina, Hettegger, Peter, Gyurjan, Istvan, Kulovics, Ronald, Schönthaler, Silvia, Beikircher, Gabriel, Kriegner, Albert, Pabinger, Stephan, Vierlinger, Klemens, Yüzbaşıoğlu, Ayşe, and Özgüç, Meral

Published
2016

23. Patients with NSCLC may display a low ratio of p.T790M vs. activating EGFR mutations in plasma at disease progression: implications for personalised treatment

Author

Del Re, Marzia, primary, Bordi, Paola, additional, Petrini, Iacopo, additional, Rofi, Eleonora, additional, Mazzoni, Francesca, additional, Belluomini, Lorenzo, additional, Vasile, Enrico, additional, Restante, Giuliana, additional, Di Costanzo, Francesco, additional, Falcone, Alfredo, additional, Frassoldati, Antonio, additional, van Schaik, Ron H.N., additional, Steendam, Christi M.J., additional, Chella, Antonio, additional, Tiseo, Marcello, additional, Morganti, Riccardo, additional, and Danesi, Romano, additional

Published
2017
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24. MA14.06 Nivolumab in Never Smoker Patients with Advanced Squamous NSCLC: Results from the Italian Expanded Access Programme (EAP)

Author

Lo Russo, Giuseppe, primary, Crinò, Lucio, additional, Galetta, Domenico, additional, Ardizzoni, Andrea, additional, Cortesi, Enrico, additional, Cappuzzo, Frederico, additional, Bordi, Paola, additional, Calabrò, Luana, additional, Barbieri, Fausto, additional, Santo, Antonio, additional, Altavilla, Giuseppe, additional, Cartenì, Giacomo, additional, Mini, Enrico, additional, Vasile, Enrico, additional, Morgillo, Floriana, additional, Scoppola, Alessandro, additional, Bengala, Carmelo, additional, Fasola, Gianpiero, additional, Tedde, Natale, additional, and Piantedosi, Francovito, additional

Published
2017
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25. P2.03b-063 Molecular Profiling in Advanced Non-Small-Cell Lung Cancer: Preliminary Data of an Italian Observational Prospective Study

Author

Gobbini, Elisa, primary, Gregorc, Vanesa, additional, Galetta, Domenico, additional, Riccardi, Ferdinando, additional, Bordi, Paola, additional, Scotti, Vieri, additional, Ceribelli, Anna, additional, Buffoni, Lucio, additional, Maiello, Evaristo, additional, Delmonte, Angelo, additional, Franchina, Tindara, additional, Migliorino, Maria Rita, additional, Cortinovis, Diego, additional, Pisconti, Salvatore, additional, Di Maio, Massimo, additional, Graziano, Paolo, additional, Bria, Emilio, additional, Rossi, Giulio, additional, Rossi, Antonio, additional, Pasello, Giulia, additional, Sergi, Concetta, additional, Martelli, Olga, additional, Cinieri, Saverio, additional, Lunghi, Alice, additional, and Novello, Silvia, additional

Published
2017
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27. L718Q Mutation as New Mechanism of Acquired Resistance to AZD9291 in EGFR -Mutated NSCLC

Author

Bersanelli, Melissa, primary, Minari, Roberta, additional, Bordi, Paola, additional, Gnetti, Letizia, additional, Bozzetti, Cecilia, additional, Squadrilli, Anna, additional, Lagrasta, Costanza Anna Maria, additional, Bottarelli, Lorena, additional, Osipova, Ganna, additional, Capelletto, Enrica, additional, Mor, Marco, additional, and Tiseo, Marcello, additional

Published
2016
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29. Contribution of KRAS mutations and c.2369C > T (p.T790M) EGFR to acquired resistance to EGFR-TKIs in EGFR mutant NSCLC: a study on circulating tumor DNA

Author

Del Re, Marzia, primary, Tiseo, Marcello, additional, Bordi, Paola, additional, D’Incecco, Armida, additional, Camerini, Andrea, additional, Petrini, Iacopo, additional, Lucchesi, Maurizio, additional, Inno, Alessandro, additional, Spada, Daniele, additional, Vasile, Enrico, additional, Citi, Valentina, additional, Malpeli, Giorgio, additional, Testa, Enrica, additional, Gori, Stefania, additional, Falcone, Alfredo, additional, Amoroso, Domenico, additional, Chella, Antonio, additional, Cappuzzo, Federico, additional, Ardizzoni, Andrea, additional, Scarpa, Aldo, additional, and Danesi, Romano, additional

Published
2016
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32. Nivolumab in never-smokers with advanced squamous non-small cell lung cancer: Results from the Italian cohort of an expanded access program

Author

Marina Chiara Garassino, Annamaria Catino, Luana Calabrò, Francesca Ambrosio, Carmelo Bengala, Alessandro Follador, Fabiana Vitiello, Floriana Morgillo, Lucio Crinò, Paola Bordi, Enrico Mini, Giuseppe Lo Russo, Enrico Vasile, Andrea Ardizzoni, Antonio Santo, Federico Cappuzzo, Alessandro Scoppola, Giuseppe Altavilla, Diana Giannarelli, Enrico Cortesi, Natale Tedde, Fausto Barbieri, Garassino, M. C., Crino, L., Catino, A., Ardizzoni, A., Cortesi, E., Cappuzzo, F., Bordi, P., Calabro, L., Barbieri, F., Santo, A., Altavilla, G., Ambrosio, F., Mini, E., Vasile, E., Morgillo, F., Scoppola, A., Bengala, C., Follador, A., Tedde, N., Giannarelli, D., Lo Russo, G., Vitiello, F., Garassino, Marina Chiara, Crinò, Lucio, Catino, Annamaria, Ardizzoni, Andrea, Cortesi, Enrico, Cappuzzo, Federico, Bordi, Paola, Calabrò, Luana, Barbieri, Fausto, Santo, Antonio, Altavilla, Giuseppe, Ambrosio, Francesca, Mini, Enrico, Vasile, Enrico, Morgillo, Floriana, Scoppola, Alessandro, Bengala, Carmelo, Follador, Alessandro, Tedde, Natale, Giannarelli, Diana, Lo Russo, Giuseppe, and Vitiello, Fabiana

Subjects
Oncology, Male, Cancer Research, Lung Neoplasms, medicine.medical_treatment, never-smokers, carcinoma, Health Services Accessibility, Cohort Studies, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, 80 and over, Medicine, 030212 general & internal medicine, squamous non-small cell lung cancer, RC254-282, Aged, 80 and over, never-smoker, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, General Medicine, Middle Aged, Prognosis, expanded access program, italian, nivolumab, Survival Rate, Nivolumab, 030220 oncology & carcinogenesis, Cohort, Carcinoma, Squamous Cell, Disease Progression, Female, Case-Control Studie, Human, Cohort study, Expanded access program, italian, never-smokers, nivolumab, squamous non-small cell lung cancer, adult, aged, aged, 80 and over, carcinoma, non-small-cell lung, squamous cell, case-control studies, cohort studies, disease progression, female, follow-up studies, humans, lung neoplasms, male, middle aged, nivolumab, non-smokers, Prognosis, survival rate, health services accessibility, Adult, medicine.medical_specialty, Italian, Prognosi, Follow-Up Studie, 03 medical and health sciences, Internal medicine, Humans, Survival rate, Aged, squamous cell, Expanded access program, business.industry, Case-control study, Immunotherapy, Non-Smokers, Lung Neoplasm, non-small-cell lung, Non-Smoker, Expanded access, Case-Control Studies, Squamous non-small cell lung cancer, Cohort Studie, business, Follow-Up Studies
Abstract

Objectives: Never-smokers may be a distinct subgroup among patients with advanced non-small cell lung cancer, appearing to benefit less from immunotherapy than smokers. We report results from never-smokers enrolled in the Italian cohort of the nivolumab expanded access program in pre-treated patients with advanced squamous non-small cell lung cancer. Materials and methods: Nivolumab (3 mg/kg every 2 weeks for ≤24 months) was available on physician request. Efficacy data included objective tumor response, date of progression, and survival information. Safety was monitored. Results: Overall, 371 patients received at least one dose of nivolumab, including 31 never-smokers (8%). Objective response rate, disease-control rate, and median overall survival were 23%, 45%, and 12.1 months (95% confidence interval: 3.7–20.4), respectively, in never-smokers, and 18%, 47%, and 7.9 months (95% confidence interval: 6.2–9.6), respectively, in the overall expanded access program population. Any-grade and grade 3–4 treatment-related adverse events were reported in 12 (39%) and 3 (10%) never-smokers, respectively, and in 109 (29%) and 21 (6%) patients, respectively, in the overall expanded access program population. Grade 3–4 treatment-related adverse events in non-smokers were increased transaminases (n = 2; 6%) and diarrhea (n = 1; 3%). Treatment-related adverse events led to treatment discontinuation in 4 non-smokers (17%) and in 26 patients (9%) overall. Conclusion: Pre-treated never-smokers with advanced squamous non-small cell lung cancer in this Italian expanded access program demonstrated efficacy and safety that were consistent with those in the overall expanded access program population and clinical trials. These results suggest that a proportion of never-smoker patients with squamous non-small cell lung cancer may be responsive to immunotherapy. Other factors, such as the tumor mutational load and the status of programmed death-ligand 1, anaplastic lymphoma kinase, and epidermal growth factor receptor, might play a potential key role.

Published
2018

33. Predictive role of erythrocyte macrocytosis during treatment with pemetrexed in advanced non-small cell lung cancer patients

Author

Roberta Camisa, Sebastiano Buti, S.G. Rapetti, Antonio Rossi, Giovenzio Genestreti, Isabella Sperduti, Stefano Panni, Emilio Bria, Giampaolo Tortora, Massimo Di Maio, Andrea Ardizzoni, Debora Pezzuolo, Paola Bordi, Silvia Novello, Marcello Tiseo, Sara Pilotto, Buti, Sebastiano, Bordi, Paola, Tiseo, Marcello, Bria, Emilio, Sperduti, Isabella, Di Maio, Massimo, Panni, Stefano, Novello, Silvia, Rapetti, Simonetta Grazia, Pilotto, Sara, Genestreti, Giovenzio, Rossi, Antonio, Pezzuolo, Debora, Camisa, Roberta, Tortora, Giampaolo, and Ardizzoni, Andrea

Subjects
Oncology, Erythrocyte Indices, Male, Cancer Research, Erythrocytes, Lung Neoplasms, Macrocytosis, Antineoplastic Agent, Erythrocyte Indice, Non-small cell lung cancer, Retrospective Studie, Risk Factors, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Prospective cohort study, Non-Small-Cell Lung, Mean corpuscular volume, Aged, 80 and over, medicine.diagnostic_test, Middle Aged, Prognosis, Pemetrexed, Predictive role, Prognostic, Adult, Aged, Antineoplastic Agents, Erythrocytes, Abnormal, Female, Humans, Neoplasm Staging, ROC Curve, Retrospective Studies, Survival Analysis, Treatment Outcome, Survival Analysi, Human, medicine.drug, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Prognosi, medicine.drug_class, Antimetabolite, Internal medicine, medicine, Lung cancer, Survival analysis, Antineoplastic Combined Chemotherapy Protocol, Performance status, business.industry, Risk Factor, Carcinoma, medicine.disease, Lung Neoplasm, Abnormal, Macrocytosi, business
Abstract

Objectives Pemetrexed has been approved for the treatment of advanced non-small cell lung cancer (NSCLC) non-squamous histology, both as first- and second-line therapy. Pemetrexed is an antimetabolite drug, that inhibits enzymes involved in nucleotides bio-synthesis arresting cancer cells cycle. The aim of this study was the evaluation of the impact of pemetrexed on erythrocyte mean corpuscular volume (MCV) change and its possible correlation with disease control rate (DCR), progression free (PFS) and overall survival (OS) in NSCLC patients. Materials and methods A retrospective collection of clinical and laboratory data (including basal MCV and maximum MCV occurred during therapy) in advanced NSCLC patients treated with pemetrexed at seven Italian centers was performed. Nonparametric tests, univariate and multivariate analysis were used to assess correlation between variables and to identify predictors of outcomes. Results 191 patients were enrolled: median age 62, 60% male, 61% performance status (PS) 0, 91% stage IV, 88% adenocarcinoma histotype, 25% never smoker, 62% received pemetrexed as first-line. Mean MCV significantly increased from basal (89 fL) to during treatment (94 fL), with mean ΔMCV = 4 fL. The median time from therapy start to maximum MCV was 2.2 months. Median PFS was 7 [CI95% 6–8] and 3 [CI95% 2–4] months [ P = 0.0016], and median survival was 17 [CI95% 12–23] and 10 [CI95% 8–12] months [ P = 0.02], in patients with ΔMCV > 5 fL ( n = 80) and ΔMCV ≤ 5 fL ( n = 111), respectively. Multivariate analysis identified age ≥62, PS 0, adenocarcinoma histology and ΔMCV > 5 fL as independent predictors of longer PFS. A ΔMCV > 5 fL significantly correlates with DCR. Conclusion Pemetrexed induces macrocytosis. ΔMCV > 5 fL on pemetrexed therapy correlated with better DCR, PFS and OS. These results deserve further validation in prospective studies.

Published
2014

34. Il santo, l’icona e l’anatema. A margine di alcune raffigurazioni di Santo Stefano Iuniore nella pittura monumentale bizantina

Author

DE GIORGI, Manuela, Maria Luigia Fobelli, Giulia Bordi, Paola Pogliani, Iole Carlettini, Maria Raffaella Menna, and DE GIORGI, Manuela

Subjects
Arte bizantina, Iconoclastia, Icona
Abstract

Alla luce di alcune desuete raffigurazioni di santo Stefano Iuniore nell'ecumene bizantina, lo studio indaga - con un approccio comparato immagini-fonti testuali - l'origine di un particolare attributo iconografico del santo nell'iconografia dell'Impero d'Oriente; nella fattispecie, un cartiglio che trasmette un 'anatema' tratto dalle fonti dell'iconoclastia bizantina. Considerata la limitata diffusione cronologica e geografica di queste esigue testimonianze pittoriche, emerge un quadro di diffusione dell''icona' di santo Stefano limitato alla sola area greco-balcanica e rintracciato in un momento storico - tra XIII e XIV secolo - che vede il rinnovarsi di istanze iconodule.

Published
2014

35. Contribution of KRAS mutations and c.2369C > T (p.T790M) EGFR to acquired resistance to EGFR-TKIs in EGFR mutant NSCLC: a study on circulating tumor DNA.

Author

Del Re M, Tiseo M, Bordi P, D'Incecco A, Camerini A, Petrini I, Lucchesi M, Inno A, Spada D, Vasile E, Citi V, Malpeli G, Testa E, Gori S, Falcone A, Amoroso D, Chella A, Cappuzzo F, Ardizzoni A, Scarpa A, and Danesi R

Subjects
Adult, Aged, Carcinoma, Non-Small-Cell Lung enzymology, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung pathology, Drug Resistance, Neoplasm, Female, Humans, Lung Neoplasms enzymology, Lung Neoplasms genetics, Lung Neoplasms pathology, Male, Middle Aged, Carcinoma, Non-Small-Cell Lung drug therapy, DNA, Neoplasm genetics, ErbB Receptors genetics, Genes, ras, Lung Neoplasms drug therapy, Mutation, Protein Kinase Inhibitors pharmacology
Abstract

Introduction: KRAS oncogene mutations (MUTKRAS) drive resistance to EGFR inhibition by providing alternative signaling as demonstrated in colo-rectal cancer. In non-small cell lung cancer (NSCLC), the efficacy of treatment with EGFR tyrosine kinase inhibitors (EGFR-TKIs) depends on activating EGFR mutations (MUTEGFR). However, inhibition of EGFR may select resistant cells displaying alternative signaling, i.e., KRAS, or restoration of EGFR activity due to additional MUTEGFR, i.e., the c.2369C > T (p.T790MEGFR)., Aim: The aim of this study was to investigate the appearance of MUTKRAS during EGFR-TKI treatment and their contribution to drug resistance., Methods: This study used cell-free circulating tumor DNA (cftDNA) to evaluate the appearance of codon 12 MUTKRAS and p.T790MEGFR mutations in 33 advanced NSCLC patients progressing after an EGFR-TKI., Results: p.T790MEGFR was detected in 11 (33.3%) patients, MUTKRAS at codon 12 in 3 (9.1%) while both p.T790MEGFR and MUTKRAS codon 12 were found in 13 (39.4%) patients. Six patients (18.2%) were KRAS wild-type (WTKRAS) and negative for p.T790MEGFR. In 8 subjects paired tumor re-biopsy/plasma samples were available; the percent concordance of tissue/plasma was 62.5% for p.T790MEGFR and 37.5% for MUTKRAS. The analysis of time to progression (TTP) and overall survival (OS) in WTKRAS vs. MUTKRAS were not statistically different, even if there was a better survival with WTKRAS vs. MUTKRAS, i.e., TTP 14.4 vs. 11.4 months (p = 0.97) and OS 40.2 vs. 35.0 months (p = 0.56), respectively., Conclusions: MUTKRAS could be an additional mechanism of escape from EGFR-TKI inhibition and cftDNA is a feasible approach to monitor the molecular development of drug resistance.

Published
2017
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36. Circulating DNA in diagnosis and monitoring EGFR gene mutations in advanced non-small cell lung cancer.

Author

Bordi P, Del Re M, Danesi R, and Tiseo M

Abstract

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are current treatments for advanced non-small cell lung cancer (NSCLC) harboring activating EGFR gene mutations. Histological or cytological samples are the standard tumor materials for EGFR mutation analysis. However, the accessibility of tumor samples is not always possible and satisfactory in advanced NSCLC patients. Moreover, totality of EGFR mutated NSCLC patients will develop resistance to EGFR-TKIs. Repeat biopsies to study genetic evolution as a result of therapy are difficult, invasive and may be confounded by intra-tumor heterogeneity. Thus, exploring accurate and less invasive techniques to (I) diagnosis EGFR mutation if tissue is not available or not appropriate for molecular analysis and to (II) monitor EGFR-TKI treatment are needed. Circulating DNA fragments carrying tumor specific sequence alterations [circulating cell-free tumor DNA (cftDNA)] are found in the cell-free fraction of blood, representing a variable and generally small fraction of the total circulating DNA. cftDNA has a high degree of specificity to detect EGFR gene mutations in NSCLC. Studies have shown the feasibility of using cftDNA to diagnosis of EGFR activating gene mutations and also to monitor tumor dynamics in NSCLC patients treated with EGFR-TKIs. These evidences suggested that non-invasive techniques based on blood samples had a great potential in EGFR mutated NSCLC patients. In this review, we summarized these non-invasive approaches and relative scientific data now available, considering their possible applications in clinical practice of NSCLC treatment.

Published
2015
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