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1. Detection of ALK fusion variants by RNA-based NGS and clinical outcome correlation in NSCLC patients treated with ALK-TKI sequences

Author: Tabbò, F, Muscarella, L, Gobbini, E, Trombetta, D, Castellana, S, Rigutto, A, Galetta, D, Maiello, E, Martelli, O, Tiseo, M, Scotti, V, Ghilardi, L, Gregorc, V, Sergi, C, Pilotto, S, Del Conte, A, Cappuzzo, F, Cortinovis, D, Osman, G, Bareggi, C, Di Maio, M, Rossi, A, Rossi, G, Bria, E, Volante, M, Scagliotti, G, Graziano, P, Novello, S, Righi, L, Tabbò F, Muscarella LA, Gobbini E, Trombetta D, Castellana S, Rigutto A, Galetta D, Maiello E, Martelli O, Tiseo M, Scotti V, Ghilardi L, Gregorc V, Sergi C, Pilotto S, Del Conte A, Cappuzzo F, Cortinovis D, Osman G, Bareggi C, Di Maio M, Rossi A, Rossi G, Bria E, Volante M, Scagliotti GV, Graziano P, Novello S, Righi L, Tabbò, F, Muscarella, L, Gobbini, E, Trombetta, D, Castellana, S, Rigutto, A, Galetta, D, Maiello, E, Martelli, O, Tiseo, M, Scotti, V, Ghilardi, L, Gregorc, V, Sergi, C, Pilotto, S, Del Conte, A, Cappuzzo, F, Cortinovis, D, Osman, G, Bareggi, C, Di Maio, M, Rossi, A, Rossi, G, Bria, E, Volante, M, Scagliotti, G, Graziano, P, Novello, S, Righi, L, Tabbò F, Muscarella LA, Gobbini E, Trombetta D, Castellana S, Rigutto A, Galetta D, Maiello E, Martelli O, Tiseo M, Scotti V, Ghilardi L, Gregorc V, Sergi C, Pilotto S, Del Conte A, Cappuzzo F, Cortinovis D, Osman G, Bareggi C, Di Maio M, Rossi A, Rossi G, Bria E, Volante M, Scagliotti GV, Graziano P, Novello S, and Righi L
Abstract: Introduction: Anaplastic lymphoma kinase (ALK) fusions identify a limited subset of non–small cell lung cancer (NSCLC) patients, whose therapeutic approach have been radically changed in recent years. However, diagnostic procedures and clinical-radiological responses to specific targeted therapies remain heterogeneous and intrinsically resistant or poor responder patients exist. Methods: A total of 290 patients with advanced NSCLC defined as ALK+ by immunohistochemistry (IHC) and/or fluorescent in situ hybridisation (FISH) test and treated with single or sequential multiple ALK inhibitors (ALKi) from 2011 to 2017 have been retrospectively retrieved from a multicentre Italian cancer network database. In 55 patients with enough leftover tumour tissue, specimens were analysed with both targeted and customised next generation sequencing panels. Identified fusion variants have been correlated with clinical outcomes. Results: Of the 55 patients, 24 received crizotinib as first-line therapy, 1 received ceritinib, while 30 received chemotherapy. Most of the patients (64%) received ALKi in sequence. An ALK fusion variant was identified in 73% of the cases, being V3 variant (E6A20) the most frequent, followed by V1 (E13A20) and more rare ones (e.g. E6A19). In three specimens, four new EML4-ALK fusion breakpoints have been reported. Neither fusion variants nor brain metastases were significantly associated with overall survival (OS), while it was predictably longer in patients receiving a sequence of ALKi. The presence of V1 variant was associated with progression-free survival (PFS) improvement when crizotinib was used (p = 0.0073), while it did not affect cumulative PFS to multiple ALKi. Conclusion: Outcomes to sequential ALKi administration were not influenced by fusion variants. Nevertheless, in V1+ patients a prolonged clinical benefit was observed. Fusion variant identification by NGS technology may add relevant information about rare chromosomal events that could be pot
Published: 2022

2. International Association for the Study of Lung Cancer (IASLC) Study of the Impact of COVID-19 on International Lung Cancer Clinical Trials

Author: Smeltzer, Mp, Scagliotti, Gv, Wakalee, Ha, Mitsudomi, T, Roy, Ub, Clark, Rc, Arndt, R, Pruett, Cd, Kelly, Kl, Ujhazy, P, Johnson, Ml, Eralp, Y, Barrios, Ch, Barlesi, F, Hirsch, Fr, Bunn, Pa, and IASLC COVID 19 and Clincal Trials Steering Committee
Published: 2022

3. Enzalutamide-resistant castration-resistant prostate cancer: challenges and solutions

Author: Tucci M, Zichi C, Buttigliero C, Vignani F, Scagliotti GV, and Di Maio M
Subjects: castration resistant prostate cancer, androgen receptor, resistance, antiandrogen, new generation hormonal therapy, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282
Abstract: Marcello Tucci,1,* Clizia Zichi,1,* Consuelo Buttigliero,1 Francesca Vignani,2 Giorgio V Scagliotti,1 Massimo Di Maio2 1Division of Medical Oncology, Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, 10043 Orbassano, Turin, Italy; 2Division of Medical Oncology, Ordine Mauriziano Hospital, Torino, Italy *These authors contributed equally to this work Abstract: The new-generation hormonal agent enzalutamide has been approved for the treatment of metastatic castration-resistant prostate cancer (CRPC), in both post- and predocetaxel setting, due to the significant improvement in overall survival. More recently, enzalutamide also showed impressive results in the treatment of men with nonmetastatic CRPC. Unfortunately, not all patients with CRPC are responsive to enzalutamide, and even in responders, benefits are limited by the development of drug resistance. Adaptive resistance of metastatic prostate cancer to enzalutamide treatment can be due to the activation of both androgen receptor (AR)-dependent pathways (expression of constitutively active AR splice variants, AR point mutations, gene amplification and overexpression) and mechanisms independent of AR signaling pathway (altered steroidogenesis, upregulation of the glucocorticoid receptor, epithelial–mesenchymal transition, neuroendocrine transformation, autophagy and activation of the immune system). In this review, we focus on resistance mechanisms to enzalutamide, exploring how we could overcome them through novel therapeutic options. Keywords: prostate cancer, enzalutamide, hormonal treatment, mechanisms of resistance, castration-resistant prostate cancer, androgen receptor
Published: 2018

4. Treatment Guidance for Patients With Lung Cancer During the Coronavirus 2019 Pandemic

Author: Dingemans, AMA, Soo, RA, Jazieh, AR, Rice, SJ, Kim, YT, Teo, LLS, Warren, GW, Xiao, SY, Smit, EF, Aerts, Joachim, Yoon, SH, Veronesi, G, De Cobelli, F, Ramalingam, SS, Garassino, MC, Wynes, MW, Behera, M, Haanen, J, Lu, S, Peters, S, Ahn, MJ, Scagliotti, GV, Adjei, AA, Belani, CP, Dingemans, AMA, Soo, RA, Jazieh, AR, Rice, SJ, Kim, YT, Teo, LLS, Warren, GW, Xiao, SY, Smit, EF, Aerts, Joachim, Yoon, SH, Veronesi, G, De Cobelli, F, Ramalingam, SS, Garassino, MC, Wynes, MW, Behera, M, Haanen, J, Lu, S, Peters, S, Ahn, MJ, Scagliotti, GV, Adjei, AA, and Belani, CP
Published: 2020

5. Overview of potential determinants of radical prostatectomy versus radiation therapy in management of clinically localized prostate cancer: results from an Italian, prospective, observational study (the Pros-IT CNR study)

Author: Antonelli, A, Palumbo, C, Noale, M, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Bruni, A, Corvò, R, Gacci, M, Magrini, S, Montironi, R, Porreca, A, Tubaro, A, Zagonel, V, Maggi, S, Alitto, A, Ambrosi, E, Aristei, C, Barbieri, M, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Berruti, A, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruno, G, Brunocilla, E, Buffoli, A, Buglione, M, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini Francolini, D, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, De Nunzio, C, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Andrea, D, Dandrea, M, De Angelis, M, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli Esposti, C, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Fabiano, M, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari, P, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico, G, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi, A, Martillotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mazzeo, E, Mearini, L, Medoro, S, Molè, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone, D, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliotti, G, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Serni, S, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simeone, C, Simone, V, Spagnoletti, G, Spinelli, M, Squillace, L, Tombolini, V, Toninelli, M, Triggiani, L, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzì, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Zaramella, S, Zeccolini, G, Zini, G, Antonelli A, Palumbo C, Noale M, Artibani W, Bassi P, Bertoni F, Bracarda S, Bruni A, Corvò R, Gacci M, Magrini SM, Montironi R, Porreca A, Tubaro A, Zagonel V, Alitto AR, Ambrosi E, Aristei C, Barbieri M, Bardari F, Bardoscia L, Barra S, Bartoncini S, Basso U, Becherini C, Bellavita R, Bergamaschi F, Berlingheri S, Berruti A, Borghesi M, Bortolus R, Borzillo V, Bosetti D, Bove G, Bove P, Brausi M, Bruno G, Brunocilla E, Buffoli A, Buglione M, Buttigliero C, Cacciamani G, Caldiroli M, Cardo G, Carmignani G, Carrieri G, Castelli E, Castrezzati E, Catalano G, Cattarino S, Catucci F, Cavallini Francolini D, Ceccarini O, Celia A, Chiancone F, Chini T, Cianci C, Cisternino A, Collura D, Corbella F, Corinti M, Corsi P, Cortese F, Corti L, De Nunzio C, Cristiano O, D'angelillo R, Da Pozzo L, D'agostino D, D'andrea D, Dandrea M, De Angelis M, De Cobelli O, De Concilio B, De Lisa A, De Luca S, De Stefani A, Deantoni CL, Degli Esposti C, Destito A, Detti B, Di Muzio N, Di Stasio A, Di Stefano C, Di Trapani D, Difino G, Fabiano M, Falivene S, Farullo G, Fedelini P, Ferrari I, Ferrau F, Ferro M, Fodor A, Fontana F, Francesca F, Francolini G, Frata P, Frezza G, Gabriele P, Galeandro M, Garibaldi E, Gennari PG, Gentilucci A, Giacobbe A, Giussani L, Giusti G, Gontero P, Guarneri A, Guida C, Gurioli A, Huqi D, Imbimbo C, Ingrosso G, Iotti C, Italia C, La Mattina P, Lamanna E, Lastrucci L, Lazzari G, Liberale F, Liguori G, Lisi R, Lohr F, Lombardo R, Lovisolo J, Ludovico GM, Macchione N, Maggio F, Malizia M, Manasse G, Mandoliti G, Mantini G, Marafioti L, Marciello L, Marconi AM, Martillotta A, Marzano S, Masciullo S, Maso G, Massenzo A, Mazzeo E, Mearini L, Medoro S, Molè R, Monesi G, Montanari E, Montefiore F, Montesi G, Morgia G, Moro G, Muscas G, Musio D, Muto P, Muzzonigro G, Napodano G, Negro CL, Nidini M, Ntreta M, Orsatti M, Palazzolo C, Palumbo I, Parisi A, Parma P, Pavan N, Pericolini M, Pinto F, Pistone A, Pizzuti V, Platania A, Polli C, Pomara G, Ponti E, Porcaro AB, Porpiglia F, Pugliese D, Pycha A, Raguso G, Rampini A, Randone DF, Roboldi V, Roscigno M, Ruggieri MP, Ruoppo G, Sanseverino R, Santacaterina A, Santarsieri M, Santoni R, Scagliotti GV, Scanzi M, Scarcia M, Schiavina R, Sciarra A, Sciorio C, Scolaro T, Scuzzarella S, Selvaggio O, Serao A, Serni S, Signor MA, Silvani M, Silvano G, Silvestris F, Simeone C, Simone V, Spagnoletti G, Spinelli MG, Squillace L, Tombolini V, Toninelli M, Triggiani L, Trinchieri A, Trodella LE, Trodella L, Trombetta C, Tronnolone L, Tucci M, Urzì D, Valdagni R, Valeriani M, Vanoli M, Vitali E, Zaramella S, Zeccolini G, Zini G., Antonelli, A, Palumbo, C, Noale, M, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Bruni, A, Corvò, R, Gacci, M, Magrini, S, Montironi, R, Porreca, A, Tubaro, A, Zagonel, V, Maggi, S, Alitto, A, Ambrosi, E, Aristei, C, Barbieri, M, Bardari, F, Bardoscia, L, Barra, S, Bartoncini, S, Basso, U, Becherini, C, Bellavita, R, Bergamaschi, F, Berlingheri, S, Berruti, A, Borghesi, M, Bortolus, R, Borzillo, V, Bosetti, D, Bove, G, Bove, P, Brausi, M, Bruno, G, Brunocilla, E, Buffoli, A, Buglione, M, Buttigliero, C, Cacciamani, G, Caldiroli, M, Cardo, G, Carmignani, G, Carrieri, G, Castelli, E, Castrezzati, E, Catalano, G, Cattarino, S, Catucci, F, Cavallini Francolini, D, Ceccarini, O, Celia, A, Chiancone, F, Chini, T, Cianci, C, Cisternino, A, Collura, D, Corbella, F, Corinti, M, Corsi, P, Cortese, F, Corti, L, De Nunzio, C, Cristiano, O, D'Angelillo, R, Da Pozzo, L, D'Agostino, D, D'Andrea, D, Dandrea, M, De Angelis, M, De Cobelli, O, De Concilio, B, De Lisa, A, De Luca, S, De Stefani, A, Deantoni, C, Degli Esposti, C, Destito, A, Detti, B, Di Muzio, N, Di Stasio, A, Di Stefano, C, Di Trapani, D, Difino, G, Fabiano, M, Falivene, S, Farullo, G, Fedelini, P, Ferrari, I, Ferrau, F, Ferro, M, Fodor, A, Fontana, F, Francesca, F, Francolini, G, Frata, P, Frezza, G, Gabriele, P, Galeandro, M, Garibaldi, E, Gennari, P, Gentilucci, A, Giacobbe, A, Giussani, L, Giusti, G, Gontero, P, Guarneri, A, Guida, C, Gurioli, A, Huqi, D, Imbimbo, C, Ingrosso, G, Iotti, C, Italia, C, La Mattina, P, Lamanna, E, Lastrucci, L, Lazzari, G, Liberale, F, Liguori, G, Lisi, R, Lohr, F, Lombardo, R, Lovisolo, J, Ludovico, G, Macchione, N, Maggio, F, Malizia, M, Manasse, G, Mandoliti, G, Mantini, G, Marafioti, L, Marciello, L, Marconi, A, Martillotta, A, Marzano, S, Masciullo, S, Maso, G, Massenzo, A, Mazzeo, E, Mearini, L, Medoro, S, Molè, R, Monesi, G, Montanari, E, Montefiore, F, Montesi, G, Morgia, G, Moro, G, Muscas, G, Musio, D, Muto, P, Muzzonigro, G, Napodano, G, Negro, C, Nidini, M, Ntreta, M, Orsatti, M, Palazzolo, C, Palumbo, I, Parisi, A, Parma, P, Pavan, N, Pericolini, M, Pinto, F, Pistone, A, Pizzuti, V, Platania, A, Polli, C, Pomara, G, Ponti, E, Porcaro, A, Porpiglia, F, Pugliese, D, Pycha, A, Raguso, G, Rampini, A, Randone, D, Roboldi, V, Roscigno, M, Ruggieri, M, Ruoppo, G, Sanseverino, R, Santacaterina, A, Santarsieri, M, Santoni, R, Scagliotti, G, Scanzi, M, Scarcia, M, Schiavina, R, Sciarra, A, Sciorio, C, Scolaro, T, Scuzzarella, S, Selvaggio, O, Serao, A, Serni, S, Signor, M, Silvani, M, Silvano, G, Silvestris, F, Simeone, C, Simone, V, Spagnoletti, G, Spinelli, M, Squillace, L, Tombolini, V, Toninelli, M, Triggiani, L, Trinchieri, A, Trodella, L, Trombetta, C, Tronnolone, L, Tucci, M, Urzì, D, Valdagni, R, Valeriani, M, Vanoli, M, Vitali, E, Zaramella, S, Zeccolini, G, Zini, G, Antonelli A, Palumbo C, Noale M, Artibani W, Bassi P, Bertoni F, Bracarda S, Bruni A, Corvò R, Gacci M, Magrini SM, Montironi R, Porreca A, Tubaro A, Zagonel V, Alitto AR, Ambrosi E, Aristei C, Barbieri M, Bardari F, Bardoscia L, Barra S, Bartoncini S, Basso U, Becherini C, Bellavita R, Bergamaschi F, Berlingheri S, Berruti A, Borghesi M, Bortolus R, Borzillo V, Bosetti D, Bove G, Bove P, Brausi M, Bruno G, Brunocilla E, Buffoli A, Buglione M, Buttigliero C, Cacciamani G, Caldiroli M, Cardo G, Carmignani G, Carrieri G, Castelli E, Castrezzati E, Catalano G, Cattarino S, Catucci F, Cavallini Francolini D, Ceccarini O, Celia A, Chiancone F, Chini T, Cianci C, Cisternino A, Collura D, Corbella F, Corinti M, Corsi P, Cortese F, Corti L, De Nunzio C, Cristiano O, D'angelillo R, Da Pozzo L, D'agostino D, D'andrea D, Dandrea M, De Angelis M, De Cobelli O, De Concilio B, De Lisa A, De Luca S, De Stefani A, Deantoni CL, Degli Esposti C, Destito A, Detti B, Di Muzio N, Di Stasio A, Di Stefano C, Di Trapani D, Difino G, Fabiano M, Falivene S, Farullo G, Fedelini P, Ferrari I, Ferrau F, Ferro M, Fodor A, Fontana F, Francesca F, Francolini G, Frata P, Frezza G, Gabriele P, Galeandro M, Garibaldi E, Gennari PG, Gentilucci A, Giacobbe A, Giussani L, Giusti G, Gontero P, Guarneri A, Guida C, Gurioli A, Huqi D, Imbimbo C, Ingrosso G, Iotti C, Italia C, La Mattina P, Lamanna E, Lastrucci L, Lazzari G, Liberale F, Liguori G, Lisi R, Lohr F, Lombardo R, Lovisolo J, Ludovico GM, Macchione N, Maggio F, Malizia M, Manasse G, Mandoliti G, Mantini G, Marafioti L, Marciello L, Marconi AM, Martillotta A, Marzano S, Masciullo S, Maso G, Massenzo A, Mazzeo E, Mearini L, Medoro S, Molè R, Monesi G, Montanari E, Montefiore F, Montesi G, Morgia G, Moro G, Muscas G, Musio D, Muto P, Muzzonigro G, Napodano G, Negro CL, Nidini M, Ntreta M, Orsatti M, Palazzolo C, Palumbo I, Parisi A, Parma P, Pavan N, Pericolini M, Pinto F, Pistone A, Pizzuti V, Platania A, Polli C, Pomara G, Ponti E, Porcaro AB, Porpiglia F, Pugliese D, Pycha A, Raguso G, Rampini A, Randone DF, Roboldi V, Roscigno M, Ruggieri MP, Ruoppo G, Sanseverino R, Santacaterina A, Santarsieri M, Santoni R, Scagliotti GV, Scanzi M, Scarcia M, Schiavina R, Sciarra A, Sciorio C, Scolaro T, Scuzzarella S, Selvaggio O, Serao A, Serni S, Signor MA, Silvani M, Silvano G, Silvestris F, Simeone C, Simone V, Spagnoletti G, Spinelli MG, Squillace L, Tombolini V, Toninelli M, Triggiani L, Trinchieri A, Trodella LE, Trodella L, Trombetta C, Tronnolone L, Tucci M, Urzì D, Valdagni R, Valeriani M, Vanoli M, Vitali E, Zaramella S, Zeccolini G, and Zini G.
Abstract: BACKGROUND: We assessed patients and tumor characteristics, as well as health-related quality of life (HRQoL) items, associated with curative intent treatment decision-making in clinically localized prostate cancer (PCa) patients. METHODS: Clinically localized PCa treated with either radical prostatectomy (RP) or radiation therapy (RT) within 12 months from diagnosis were abstracted from The PROState cancer monitoring in ITaly, from the National Research Council (Pros-IT CNR) database. Multivariable logistic regression (MLR) models predicting RT vs. RP were fitted, after adjustment for HRQoL items, patients and tumor characteristics. RESULTS: Of 1041 patients, 631 (60.2%) were treated with RP and 410 (39.8%) with RT. Relative to RT, RP patients were younger age (mean age 64.5±6.6 vs. 71.4±4.9, P<0.001) and had higher rates of D’Amico low-intermediate risk groups (31.8 vs. 21.9% low, 46.3% vs. 43.5% intermediate and 21.9% vs. 34.6% high risk, P<0.001). Overall, 93.2% of RP patients were enrolled by urologists and 82.7% of RT patients by radiation oncologists. RP patients had generally higher means values of HRQoL items. In MLR models, higher RT rates were independently associated with more advanced age (odds ratio [OR] 6.14, P<0.001) and BMI≥30 kg/m2 (OR 1.78, P<0.001). Conversely, lower rates of RT were independently associated with married (OR 0.55, P=0.01) and worker status (OR 0.52, P=0.004), enrollment in academic centers (OR 0.59, P=0.005) and higher physical composite score (OR 0.88, P=0.03) and baseline sexual function items (OR 0.92, P<0.001). CONCLUSIONS: Most patients with clinically localized prostate cancer undergoing definitive treatment at Italian institutions receive RP instead of RT. Moreover, those who are younger, married, working, as well as those with better physical and sexual function are more likely to undergo surgery.
Published: 2020

6. Recommendations for Implementing Lung Cancer Screening with Low-Dose Computed Tomography in Europe

Author: Veronesi, G, Baldwin, DR, Henschke, CI, Ghislandi, S, Iavicoli, S, Oudkerk, M, de Koning, Harry, Shemesh, J, Field, JK, Zulueta, JJ, Horgan, D, Navarrete, LF, Infante, MV, Novellis, P, Murray, RL, Peled, N, Rampinelli, C, Rocco, G, Rzyman, W, Scagliotti, GV, Tammemagi, MC, Bertolaccini, L, Triphuridet, N, Yip, R, de Rossi, A, Senan, S, Ferrante, G, Brain, K, van der Aalst, Carlijn, Bonomo, L, Consonni, D, van Meerbeeck, JP, Maisonneuve, P, Novello, S, Devaraj, A, Saghir, Z, Pelosi, G, Veronesi, G, Baldwin, DR, Henschke, CI, Ghislandi, S, Iavicoli, S, Oudkerk, M, de Koning, Harry, Shemesh, J, Field, JK, Zulueta, JJ, Horgan, D, Navarrete, LF, Infante, MV, Novellis, P, Murray, RL, Peled, N, Rampinelli, C, Rocco, G, Rzyman, W, Scagliotti, GV, Tammemagi, MC, Bertolaccini, L, Triphuridet, N, Yip, R, de Rossi, A, Senan, S, Ferrante, G, Brain, K, van der Aalst, Carlijn, Bonomo, L, Consonni, D, van Meerbeeck, JP, Maisonneuve, P, Novello, S, Devaraj, A, Saghir, Z, and Pelosi, G
Published: 2020

7. First-line immune-chemotherapy combination: the right strategy to fight squamous non-small-cell lung cancer?

Author: Passiglia, F, Bironzo, P, and Scagliotti, Gv
Published: 2019

8. Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer

Author: Blumenthal, GM, Bunn, PA, Chaft, JE, McCoach, CE, Perez, EA, Scagliotti, GV, Carbone, DP, Aerts, HJWL, Aisner, DL, Bergh, J, Berry, DA, Jarkowski, A, Botwood, N, Cross, DAE, Diehn, M, Drezner, NL, Doebele, RC, Blakely, CM, Eberhardt, WEE, Felip, E, Gianni, L, Keller, SP, Leavey, PJ, Malik, S, Pignatti, F, Prowell, TM, Redman, MW, Rizvi, NA, Rosell, R, Rusch, V, de Ruysscher, D, Schwartz, LH, Sridhara, R, Stahel, RA, Swisher, S, Taube, JM, Travis, WD, Keegan, P, Wiens, JR, Wistuba, II, Wynes, MW, Hirsch, FR, and Kris, MG
Subjects: Pathologic response, Neoadjuvant therapy, Induction chemotherapy, Resectable lung cancer, Preoperative therapy
Abstract: This Review Article provides a multi-stakeholder view on the current status of neoadjuvant therapy in lung cancer. Given the success of oncogene-targeted therapy and immunotherapy for patients with advanced lung cancer, there is a renewed interest in studying these agents in earlier disease settings with the opportunity to have an even greater impact on patient outcomes. There are unique opportunities and challenges with the neoadjuvant approach to drug development. To achieve more rapid knowledge turns, study designs, endpoints, and definitions of pathologic response should be standardized and harmonized. Continued dialogue with all stakeholders will be critical to design and test novel induction strategies, which could expedite drug development for patients with early lung cancer who are at high risk for metastatic recurrence.
Published: 2018

9. PALLIATIVE CARE PATIENTS HAD A CIRCADIAN RHYTHMICITY IN THEIR BREAKTHROUGH PAIN (BTP) EPISODES

Author: Campagna, S, Sperlinga, R, Milo, A, Saini, A, Berruti, A, Scagliotti, Gv, and Tampellini, M.
Published: 2018

10. Randomized phase III PITCAP trial and meta-analysis of induction chemotherapy followed by thoracic irradiation with or without concurrent taxane-based chemotherapy in locally advanced NSCLC

Author: Ardizzoni, A, Tiseo, M, Boni, L, Di Maio, M, Buffoni, L, Belvedere, O, Grossi, F, D'Alessandro, V, de Marinis, F, Barbera, S, Caroti, C, Favaretto, A, Cortinovis, D, Morrica, B, Tixi, L, Ceschia, T, Parisi, S, Ricardi, U, Grimaldi, A, Loreggian, L, Navarria, P, Huber, R, Belani, C, Bruswig, P, Scagliotti, G, Scolaro, T, Ardizzoni A, Tiseo M, Boni L, Di Maio M, Buffoni L, Belvedere O, Grossi F, D'Alessandro V, de Marinis F, Barbera S, Caroti C, Favaretto A, Cortinovis D, Morrica B, Tixi L, Ceschia T, Parisi S, Ricardi U, Grimaldi A, Loreggian L, Navarria P, Huber RM, Belani C, Bruswig PF, Scagliotti GV, Scolaro T., Ardizzoni, A, Tiseo, M, Boni, L, Di Maio, M, Buffoni, L, Belvedere, O, Grossi, F, D'Alessandro, V, de Marinis, F, Barbera, S, Caroti, C, Favaretto, A, Cortinovis, D, Morrica, B, Tixi, L, Ceschia, T, Parisi, S, Ricardi, U, Grimaldi, A, Loreggian, L, Navarria, P, Huber, R, Belani, C, Bruswig, P, Scagliotti, G, Scolaro, T, Ardizzoni A, Tiseo M, Boni L, Di Maio M, Buffoni L, Belvedere O, Grossi F, D'Alessandro V, de Marinis F, Barbera S, Caroti C, Favaretto A, Cortinovis D, Morrica B, Tixi L, Ceschia T, Parisi S, Ricardi U, Grimaldi A, Loreggian L, Navarria P, Huber RM, Belani C, Bruswig PF, Scagliotti GV, and Scolaro T.
Abstract: Background Chemo-radiotherapy is standard of care in the treatment of unresectable stage III NSCLC. We aimed at assessing whether the addition of concurrent taxane-chemotherapy to thoracic irradiation following chemotherapy was able to improve treatment outcome. Material and methods In PITCAP trial, patients with unresectable stage III NSCLC were randomized to receive 2 cycles of platinum-paclitaxel followed by 60–61.2 Gy thoracic irradiation (control arm) or by same radiotherapy with concomitant weekly paclitaxel (experimental arm). A literature-based meta-analysis including all studies with same design was also performed. Results At the time of the second interim analysis, when 151 patients were randomized, accrual was terminated. With a median follow-up of 6.1 years, median survival was 13.2 vs 15.1 months, with a 3-year survival rate of 19.5 vs 21.2% in the control and experimental arm, respectively (HR: 0.97; 95% CI 0.69–1.36; p = 0.845). Treatment toxicity was manageable in both arms. The meta-analysis of 5 trials (n = 866) confirmed the lack of a meaningful effect on 1-year overall survival of a taxane added concurrently to radiotherapy. Conclusions These results do not support a meaningful survival benefit with the addition of single agent taxane given concurrently to radiotherapy after platinum-based induction in locally advanced NSCLC.
Published: 2016

11. Screening for lung cancer

Author: Jett, JR, Horeweg, Nanda, de Koning, Harry, Pass, HI, Ball, D, Scagliotti, GV, Erasmus MC other, and Public Health
Subjects: SDG 3 - Good Health and Well-being
Published: 2014

12. Studio multicentrico di III fase in pazienti affetti da carcinoma polmonare non a piccole cellule in stadio IV non precedentemente chemiotrattati

Author: NOVELLO S, BARONE C, CASOTTI A, BUOSI R, MICHETTI G, FIORETTI M, BARBERA S, GARETTO L, MAESTRI A, SELVAGGI G, LONGO M, GIAJ LEVRA M, SCAGLIOTTI GV, SPATAFORA, Mario, NOVELLO S, BARONE C, CASOTTI A, BUOSI R, MICHETTI G, FIORETTI M, BARBERA S, GARETTO L, MAESTRI A, SPATAFORA M, SELVAGGI G, LONGO M, GIAJ LEVRA M, and SCAGLIOTTI GV
Published: 2006

13. Terapia del carcinoma polmonare non a piccole cellule in stadio IIIA e IIIB a buona prognosi

Author: ANTONELLI P, DONGHI M, GOZZELINO F, MIRABELLA S, MONACO L, SCAGLIOTTI GV, TASSI GF, SPATAFORA, Mario, DE MARINIS F, SCAGLIOTTI GV, ANTONELLI P, DONGHI M, GOZZELINO F, MIRABELLA S, MONACO L, SPATAFORA M, and TASSI GF
Published: 2004

14. Mesotelioma pleurico maligno

Author: MIRABELLA S, ANTONELLI P, DONGHI M, MONACO L, SCAGLIOTTI GV, TASSI GF, SPATAFORA, Mario, DE MARINIS F, SCAGLIOTTI GV, MIRABELLA S, ANTONELLI P, DONGHI M, MONACO L, SPATAFORA M, and TASSI GF
Published: 2004

15. EGFR pathway in advanced non-small cell lung cancer

Author: Scagliotti Gv, Merlo, Novello S, and Longo M
Subjects: Lung Neoplasms, Cetuximab, Antineoplastic Agents, Antibodies, Monoclonal, Humanized, General Biochemistry, Genetics and Molecular Biology, Erlotinib Hydrochloride, Gefitinib, Carcinoma, Non-Small-Cell Lung, Medicine, Humans, Epidermal growth factor receptor, Lung cancer, Protein Kinase Inhibitors, EGFR inhibitors, General Immunology and Microbiology, biology, business.industry, Antibodies, Monoclonal, medicine.disease, respiratory tract diseases, ErbB Receptors, Cancer research, biology.protein, Quinazolines, Erlotinib, business, Tyrosine kinase, medicine.drug
Abstract: Chemotherapy is the standard of care for patients with advanced stage non-small cell lung cancer (NSCLC) because of the a modest improvement in survival and quality of life but its efficacy has already reached a plateau. Several molecular targets involved in the uncontrolled growth of lung cancer cells has been recently discovered and Epidermal Growth Factor Receptor (EGFR) pathway is as a key therapeutic target. Strategies to block such pathway include tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. Erlotinib and gefitinib are two EGFR-TKI active against NSCLC. Their efficacy has been proven to be definitively superior in presence of activating EGFR mutation in the tumor. This evidence does not apply to the monoclonal antibody cetuximab, which efficacy in NSCLC was recently demonstrated in a single phase III study. The good tolerability profile of EGFR inhibitors make these agents suitable for maintenance and adjuvant setting, while sequencing of EGFR-TKIs and chemotherapy seems to be preferred. This article reviews the role of EGFR inhibitors focusing mainly on compounds in phase III clinical development.
Published: 2011

16. Low-dose computed tomography screening: experiences from the randomized population-based Nelson screening trial

Author: Klaveren, RJ, de Koning, Harry, Pass, HICD, Minna, JD, Johnson, DH, Scagliotti, GV, Turrisi, AT, Pulmonary Medicine, and Public Health
Published: 2010

17. Gemcitabine/cisplatin as induction therapy for stage IIIA N2 non-small-cell lung cancer

Author: Scagliotti, Gv
Subjects: Male, Lung Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Chemotherapy, Adjuvant, Cisplatin, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Deoxycytidine, Disease-Free Survival, Female, Humans, Neoplasm Staging, Preoperative Care, Randomized Controlled Trials as Topic, Remission Induction, Tomography, Emission-Computed, Chemotherapy, Clinical Trials, Non-Small-Cell Lung, Tomography, Adjuvant, Carcinoma, Phase II as Topic, Gemcitabine, Phase III as Topic, Squamous Cell, Emission-Computed
Abstract: Because the majority of patients with stage IIIA N2 non-small-cell lung cancer (NSCLC) ultimately die of distant metastases, recent efforts to improve their intermediate- and long-term survival have focused on neoadjuvant chemotherapy (with or without radiotherapy) as an induction regimen followed by surgical resection. Over the last 15 years, more than 25 phase II trials and two small randomized phase III trials were terminated early because interim analyses confirmed the feasibility of the neoadjuvant approach and suggested a twofold increase in overall survival time compared to surgery alone. The gemcitabine (Gemzar)/cisplatin (Platinol) regimen proved effective in unresectable locally advanced and metastatic NSCLC. Consequently, it is logical to investigate the activity of this combination in locally advanced NSCLC. Preliminary results of five phase II trials have reported an average response rate60% in a mixed study population (IIIA and IIIB). Treatment is well tolerated. In studies using the 4-week schedule, the gemcitabine dose was frequently omitted on day 15, mainly due to thrombocytopenia. In January 2000, a randomized clinical trial (Chemotherapy for Early Stages Trial [ChEST]) was initiated in Italy to compare the efficacy of surgery alone vs surgery plus preoperative gemcitabine/cisplatin in early-stage disease (T2-3 N0, T1-2 N1, T3 N1) with the primary end point being progression-free survival.
Published: 2000

18. Preliminary results of a dose-finding study of paclitaxel and carboplatin in patients with advanced non-small cell lung cancer

Author: Scagliotti, Gv, Crinó, L, Pozzi, E, Corgna, E, Palladino, M, Masiero, P, Salsano, V, Gentile, A, and Tonato, M
Subjects: Adult, Male, Infusions, Lung Neoplasms, Neutropenia, Adolescent, Paclitaxel, Antineoplastic Agents, Drug Administration Schedule, Carboplatin, Parenteral, Phytogenic, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Humans, Infusions, Parenteral, Non-Small-Cell Lung, Aged, Carcinoma, Drug Tolerance, Middle Aged, Antineoplastic Agents, Phytogenic, Thrombocytopenia, Treatment Outcome, Female
Abstract: This ongoing phase I study sought to establish the maximum tolerated dose of the combination of carboplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given without routine growth factor support to previously untreated patients with stage IIIB and IV non-small cell lung cancer. Paclitaxel was administered as a 3-hour intravenous infusion. The carboplatin infusion was administered over 30 minutes immediately afterward. Patients were assigned sequentially to one of eight treatment groups in which paclitaxel and carboplatin were administered in doses ranging from 130 to 185 mg/m2 and from 230 to 350 mg/m2, respectively. Twenty-four patients have been treated to date, and the maximum tolerated dose has been reached at paclitaxel 185 mg/m2 and carboplatin 350 mg/m2. The combination has an excellent safety profile, with only a few, short-lasting episodes of neutropenia observed and no evidence of infection. At the doses tested, thrombocytopenia has not occurred.
Published: 1996

19. Blood cell redistribution in the lung after administration of recombinant human granulocyte-macrophage colony-stimulating factor

Author: Gatti, E, primary, Scagliotti, GV, additional, Ferrari, G, additional, Mutti, L, additional, Pozzi, E, additional, Stacchini, A, additional, Fubini, L, additional, and Aglietta, M, additional
Published: 1995
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20. TNP-ALPHA DETERMINATION IN SERUM AND PLEURAL EFFUSION IN PATIENTS WITH LUNG-CANCER

Author: SCAGLIOTTI, GV, primary, GATTI, E, additional, FERRARI, G, additional, MUTTI, L, additional, and POZZI, E, additional
Published: 1995
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21. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study.

Author: Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, Solal-Celigny P, Rodriguez G, Krzakowski M, Mehta ND, Lipton L, García-Sáenz JA, Pereira JR, Prabhash K, Ciuleanu TE, Kanarev V, Wang H, Balakumaran A, Jacobs I, and Scagliotti, Giorgio Vittorio
Published: 2012
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22. Primary pleuropulmonary sarcoma: a rare disease entity.

Author: Giaj Levra M, Novello S, Scagliotti GV, Papotti M, and Le Cesne A
Published: 2012
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23. Role of hormone receptor expression in patients with advanced-stage lung cancer treated with chemotherapy.

Author: Monica V, Longo M, Felice B, Scagliotti GV, Papotti M, and Novello S
Published: 2012
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24. Rationale and Design of MARQUEE: A Phase III, Randomized, Double-Blind Study of Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Patients With Locally Advanced or Metastatic, Nonsquamous, Non-Small-Cell Lung Cancer.

Author: Scagliotti GV, Novello S, Schiller JH, Hirsh V, Sequist LV, Soria JC, von Pawel J, Schwartz B, Von Roemeling R, and Sandler AB
Published: 2012
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25. The role of the insulin-like growth factor signaling pathway in non-small cell lung cancer and other solid tumors.

Author: Scagliotti GV and Novello S
Abstract: The type 1 insulin-like growth factor receptor (IGF-1R) and its downstream signaling components have become increasingly recognized as having a driving role in the development of malignancy, and consequently IGF-1R has become a potential target for cancer therapy. Several inhibitors of IGF-1R are in clinical development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). These IGF-1R-targeted agents include monoclonal antibodies such as cixutumumab (IMC-A12), AMG-479, AVE1642, BIIB022, dalotuzumab (MK-0646), and robatumumab (Sch717454), the ligand neutralizing antibody Medi-573, and the small molecule inhibitors BMS-754807, linsitinib (OSI-906), XL228, and AXL1717. Two phase III trials of the anti-IGF-1R monoclonal antibody, figitumumab (CP-751,871), were discontinued in 2010 as it was considered unlikely either trial would meet their primary endpoints. In light of disappointing clinical data with figitumumab and other targeted agents, it is likely that the use of molecular markers will become important in predicting response to treatment. This review outlines the role of IGF-1R signaling in solid tumors with a particular focus on NSCLC, and provides an overview of clinical data. [ABSTRACT FROM AUTHOR]
Published: 2012

26. Tasisulam sodium (LY573636 sodium) as third-line treatment in patients with unresectable, metastatic non-small-cell lung cancer: a phase-II study.

Author: Scagliotti GV, Ilaria R Jr, Novello S, von Pawel J, Fischer JR, Ermisch S, de Alwis DP, Andrews J, Reck M, Crino L, Eschbach C, and Manegold C
Published: 2012
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27. Immunohistochemical subtyping of nonsmall cell lung cancer not otherwise specified in fine-needle aspiration cytology: A retrospective study of 103 cases with surgical correlation.

Author: Righi L, Graziano P, Fornari A, Rossi G, Barbareschi M, Cavazza A, Pelosi G, Scagliotti GV, and Papotti M
Published: 2011
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28. Pulmonary toxicity related to systemic treatment of nonsmall cell lung cancer.

Author: De Sanctis A, Taillade L, Vignot S, Novello S, Conforti R, Spano JP, Scagliotti GV, and Khayat D
Published: 2011
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29. p63 and p73 isoform expression in non-small cell lung cancer and corresponding morphological normal lung tissue.

Author: Iacono ML, Monica V, Saviozzi S, Ceppi P, Bracco E, Papotti M, Scagliotti GV, Lo Iacono, Marco, Monica, Valentina, Saviozzi, Silvia, Ceppi, Paolo, Bracco, Enrico, Papotti, Mauro, and Scagliotti, Giorgio V
Published: 2011
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30. Thymidylate synthase but not excision repair cross-complementation group 1 tumor expression predicts outcome in patients with malignant pleural mesothelioma treated with pemetrexed-based chemotherapy.

Author: Righi L, Papotti MG, Ceppi P, Billè A, Bacillo E, Molinaro L, Ruffini E, Scagliotti GV, and Selvaggi G
Published: 2010
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31. Histologic subtype in NSCLC: does it matter?

Author: Scagliotti GV and Selvaggi G
Abstract: Platinum-based doublet chemotherapy remains the cornerstone of therapy in the first-line setting in advanced non--small-cell lung cancer (NSCLC) for patients with good performance status. However, this paradigm has recently been challenged by the results of a study that showed a survival benefit with the addition of bevacizumab to carboplatin and paclitaxel in bevacizumab-eligible patients and by the superior efficacy of gefitinib and erlotinib compared to chemotherapy in epidermal growth factor receptor (EGFR) gene mutation--positive tumors (mainly adenocarcinomas). In addition, histology has been recently recognized as a potential predictive factor in advanced NSCLC patients treated with chemotherapy. Prospective data from a preplanned subgroup analysis of a phase III study and retrospective reviews consistently reported a significant interaction between treatment by histology and response/survival in nonsquamous NSCLCs treated with pemetrexed, compared to squamous cell carcinoma (SCC). Thymidylate synthase, the main target of pemetrexed, was found to be differentially expressed among the histotypes of lung cancer, being lower in adenocarcinoma and higher in SCC and small-cell lung cancer. Thus, the availability of adequate amounts of tissue from biopsies to allow accurate pathologic subclassifications at diagnosis will be critical to help the oncologist select the most appropriate chemotherapy regimen as we move toward an individualized molecularly based approach. [ABSTRACT FROM AUTHOR]
Published: 2009

32. Survival without toxicity for cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemonaïve patients with advanced non-small cell lung cancer: a risk-benefit analysis of a large phase III study.

Author: Scagliotti GV, Park K, Patil S, Rolski J, Goksel T, Martins R, Gans SJ, Visseren-Grul C, and Peterson P
Abstract: BACKGROUND: In a large phase III study, cisplatin and pemetrexed had non-inferior efficacy and better tolerability compared with cisplatin and gemcitabine in chemonaïve patients with non-small cell lung cancer (NSCLC). The current analysis characterised the clinical benefit (i.e. survival) relative to clinical risk (i.e. drug-related toxicity) of the doublets. PATIENTS AND METHODS: A total of 1669 patients (of 1725 randomised) received 500 mg/m(2) pemetrexed IV followed by 75 mg/m(2) cisplatin IV on day 1 or gemcitabine 1250 mg/m(2) on days 1 and 8 and 75 mg/m(2) cisplatin on day 1, administered every 3 weeks for up to 6 cycles. Survival without toxicity (i.e. clinical benefit to risk) was defined as the time from randomisation to the first occurrence of any grade 3 or 4 drug-related toxicity or death, and was analysed using Kaplan-Meier and Cox methods. RESULTS: In the overall patient population, survival without grade 3 or 4 drug-related toxicity was significantly longer for patients treated with cisplatin and pemetrexed versus cisplatin and gemcitabine (HR=0.70; P<0.001), as was survival without grade 4 drug-related toxicity (HR=0.83; P<0.001). For patients with non-squamous NSCLC, survival without toxicity with cisplatin and pemetrexed was superior to cisplatin and gemcitabine for grade 3 or 4 drug-related toxicity (HR=0.64; P<0.001) and for grade 4 drug-related toxicity (HR=0.77; P<0.001), whereas no treatment-arm difference was observed in the squamous subgroup. CONCLUSIONS: Patients with non-squamous NSCLC treated with front-line cisplatin and pemetrexed have superior survival without toxicity (i.e. clinical benefit-to-risk profile) compared with patients treated with cisplatin and gemcitabine. [ABSTRACT FROM AUTHOR]
Published: 2009
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33. Nonsmall cell lung cancer in never smokers.

Author: Scagliotti GV, Longo M, and Novello S
Published: 2009
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34. Pooled analysis of the effect of age on adjuvant cisplatin-based chemotherapy for completely resected non--small-cell lung cancer.

Author: Früh M, Rolland E, Pignon J, Seymour L, Ding K, Tribodet H, Winton T, Le Chevalier T, Scagliotti GV, Douillard JY, Spiro S, and Shepherd FA
Published: 2008

35. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non--small-cell lung cancer.

Author: Scagliotti GV, Parikh P, von Pawel J, Biesma B, Vansteenkiste J, Manegold C, Serwatowski P, Gatzemeier U, Digumarti R, Zukin M, Lee JS, Mellemgaard A, Park K, Patil S, Rolski J, Goksel T, de Marinis F, Simms L, Sugarman KP, and Gandara D
Published: 2008

36. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group.

Author: Pignon J, Tribodet H, Scagliotti GV, Douillard J, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D, Le Chevalier T, and LACE Collaborative Group
Published: 2008

37. Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer.

Author: Socinski MA, Novello S, Brahmer JR, Rosell R, Sanchez JM, Belani CP, Govindan R, Atkins JN, Gillenwater HH, Pallares C, Tye L, Selaru P, Chao RC, Scagliotti GV, Socinski, Mark A, Novello, Silvia, Brahmer, Julie R, Rosell, Rafael, Sanchez, Jose M, and Belani, Chandra P
Published: 2008
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38. Combined measurements of neuron specific enolase and bombesin/gastrin releasing peptide in lung cancer

Author: Scagliotti, GV, primary, Piani, M, additional, Gatti, E, additional, Gozzelino, F, additional, Albera, C, additional, and Pozzi, E, additional
Published: 1989
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39. In reply:.

Author: Scagliotti GV and Sugarman KP
Published: 2008

40. Disease-specific and general health-related quality of life in newly diagnosed prostate cancer patients: The Pros-IT CNR study

Author: Angelo, Porreca, Marianna, Noale, Walter, Artibani, Pier Francesco Bassi, Filippo, Bertoni, Sergio, Bracarda, Giario Natale Conti, Renzo, Corvò, Mauro, Gacci, Pierpaolo, Graziotti, Magrini, STEFANO MARIA, Vincenzo, Mirone, Rodolfo, Montironi, Giovanni, Muto, Stefano, Pecoraro, Umberto, Ricardi, Elvio, Russi, Andrea, Tubaro, Vittorina, Zagonel, Gaetano, Crepaldi, Stefania, Maggi, Pierfrancesco, Bassi, Stefano Maria Magrini, Anna Rita Alitto, Enrica, Ambrosi, Alessandro, Antonelli, Cynthia, Aristei, Michele, Barbieri, Franco, Bardari, Lilia, Bardoscia, Salvina, Barra, Sara, Bartoncini, Umberto, Basso, Carlotta, Becherini, Rita, Bellavita, Franco, Bergamaschi, Stefania, Berlingheri, Berruti, Alfredo, Marco, Borghesi, Roberto, Bortolus, Valentina, Borzillo, Davide, Bosetti, Giuseppe, Bove, Pierluigi, Bove, Maurizio, Brausi, Alessio, Bruni, Giorgio, Bruno, Eugenio, Brunocilla, Alberto, Buffoli, BUGLIONE DI MONALE E BASTIA, Michela, Consuelo, Buttigliero, Giovanni, Cacciamani, Michela, Caldiroli, Giuseppe, Cardo, Giorgio, Carmignani, Giuseppe, Carrieri, Emanuele, Castelli, Elisabetta, Castrezzati, Gianpiero, Catalano, Susanna, Cattarino, Francesco, Catucci, Francolini Dario Cavallini, Ofelia, Ceccarini, Antonio, Celia, Francesco, Chiancone, Tommaso, Chini, Claudia, Cianci, Antonio, Cisternino, Devis, Collura, Franco, Corbella, Matteo, Corinti, Paolo, Corsi, Fiorenza, Cortese, Luigi, Corti, Cosimo de Nunzio, Olga, Cristiano, Rolando, M D'Angelillo, Luigi Da Pozzo, Daniele, D'Agostino, Carolina, D'Elia, Matteo, Dandrea, Michele De Angelis, Paolo De Angelis, Ottavio De Cobelli, Bernardino De Concilio, Antonello De Lisa, Stefano De Luca, Agostina De Stefani, Chiara Lucrezia Deantoni, Esposti Claudio Degli, Anna, Destito, Beatrice, Detti, Nadia Di Muzio, Andrea Di Stasio, Calogero Di Stefano, Danilo Di Trapani, Giuseppe, Difino, Sara, Falivene, Giuseppe, Farullo, Paolo, Fedelini, Ilaria, Ferrari, Francesco, Ferrau, Matteo, Ferro, Andrei, Fodor, Francesco, Fontanta, Francesco, Francesca, Giulio, Francolini, Paolo, Frata, Giovanni, Frezza, Pietro, Gabriele, Maria, Galeandro, Elisabetta, Garibaldi, Pietro Giovanni Gennari, Alessandro, Gentilucci, Alessandro, Giacobbe, Laura, Giussani, Giuseppe, Giusti, Paolo, Gontero, Alessia, Guarneri, Cesare, Guida, Alberto, Gurioli, Dorijan, Huqi, Ciro, Imbimbo, Gianluca, Ingrosso, Cinzia, Iotti, Corrado, Italia, Pierdaniele La Mattina, Enza, Lamanna, Luciana, Lastrucci, Grazia, Lazzari, Fabiola, Liberale, Giovanni, Liguori, Roberto, Lisi, Frank, Lohr, Riccardo, Lombardo, Jon A, J Lovisolo, Giuseppe Mario Ludovico, Nicola, Macchione, Francesca, Maggio, Michele, Malizia, Gianluca, Manasse, Giovanni, Mandoliti, Giovanna, Mantini, Luigi, Marafioti, Luisa, Marciello, Alberto Mario Marconi, Antonietta, Martilotta, Salvino, Marzano, Stefano, Masciullo, Gloria, Maso, Adele, Massenzo, Ercole, Mazzeo, Luigi, Mearini, Serena, Medoro, Rosa, Molè, Giorgio, Monesi, Emanuele, Montanari, Franco, Montefiore, Giampaolo, Montesi, Giuseppe, Morgia, Gregorio, Moro, Giorgio, Muscas, Daniela, Musio, Paolo, Muto, Giovanni, Muzzonigro, Giorgio, Napodano, Carlo Luigi Augusto Negro, Mattia, Nidini, Maria, Ntreta, Marco, Orsatti, Carmela, Palazzolo, Isabella, Palumbo, Alessandro, Parisi, Paolo, Parma, Nicola, Pavan, Martina, Pericolini, Francesco, Pinto, Antonio, Pistone, Valerio, Pizzuti, Angelo, Platania, Caterina, Polli, Giorgio, Pomara, Elisabetta, Ponti, Antonio Benito Porcaro, Francesco, Porpiglia, Dario, Pugliese, Armin, Pycha, Giuseppe, Raguso, Andrea, Rampini, Donato Franco Randone, Valentina, Roboldi, Marco, Roscigno, Maria Paola Ruggieri, Giuseppe, Ruoppo, Roberto, Sanseverino, Anna, Santacaterina, Michele, Santarsieri, Riccardo, Santoni, Sarah, Scagliarini, Giorgio Vittorio Scagliotti, Mauro, Scanzi, Marcello, Scarcia, Riccardo, Schiavina, Alessandro, Sciarra, Carmine, Sciorio, Tindaro, Scolaro, Salvatore, Scuzzarella, Oscar, Selvaggio, Armando, Serao, Sergio, Serni, Marco Andrea Signor, Mauro, Silvani, Giovanni, Silvano, Franco, Silvestris, Simeone, Claudio, Valeria, Simone, Girolamo, Spagnoletti, Matteo Giulio Spinelli, Luigi, Squillace, Vincenzo, Tombolini, Mariastella, Toninelli, Triggiani, Luca, Alberto, Trinchieri, Luca Eolo Trodella, Lucio, Trodella, Carlo, Trombetta, Lidia, Tronnolone, Marcello, Tucci, Daniele, Urzì, Riccardo, Valdagni, Maurizio, Valeriani, Maurizio, Vanoli, Elisabetta, Vitali, Alessandro, Volpe, Stefano, Zaramella, Guglielmo, Zeccolini, Giampaolo, Zini, Porreca, Angelo, Noale, Marianna, Artibani, Walter, Bassi, Pier Francesco, Bertoni, Filippo, Bracarda, Sergio, Conti, Giario Natale, Corvò, Renzo, Gacci, Mauro, Graziotti, Pierpaolo, Magrini, Stefano Maria, Mirone, Vincenzo, Montironi, Rodolfo, Muto, Giovanni, Pecoraro, Stefano, Ricardi, Umberto, Russi, Elvio, Tubaro, Andrea, Zagonel, Vittorina, Crepaldi, Gaetano, Maggi, Stefania, Gaetano, Crepaldi, Umberto, Basso, Luigi, Corti, D'Agostino, Daniele, Matteo, Dandrea, Davide, Bosetti, Gianpiero, Catalano, Ottavio, De Cobelli, Lucrezia, Deantoni Chiara, Nadia, Di Muzio, Ferro, Matteo, Andrei, Fodor, Pierdaniele, La Mattina, Emanuele, Montanari, Barbieri, Michele, Valentina, Borzillo, Chiancone, Francesco, Sara, Falivene, Paolo, Fedelini, Imbimbo, Ciro, Paolo, Muto, Sarah, Scagliarini, Giovanni, Muzzonigro, Enrica, Ambrosi, Alessandro, Antonelli, Lilia, Bardoscia, Stefania, Berlingheri, Alfredo, Berruti, Alberto, Buffoli, Michela, Buglione, Mauro, Scanzi, Elisabetta, Castrezzati, Paolo, Frata, Giulio, Francolini, Beatrice, Detti, Tommaso, Chini, Carlotta, Becherini, Olga, Cristiano, Cesare, Guida, Sara, Bartoncini, Consuelo, Buttigliero, Emanuele, Castelli, Devis, Collura, Stefano, De Luca, Pietro, Gabriele, Elisabetta, Garibaldi, Alessandro, Giacobbe, Paolo, Gontero, Alessia, Guarneri, Alberto, Gurioli, Francesco, Porpiglia, Franco, Randone Donato, Vittorio, Scagliotti Giorgio, Cynthia, Aristei, Rita, Bellavita, Isabella, Palumbo, Franco, Bardari, Augusto, Negro Carlo Luigi, Franco, Bergamaschi, Maria, Galeandro, Cinzia, Iotti, Giuseppe, Raguso, Paola, Ruggieri Maria, Giuseppe, Ruoppo, Marco, Borghesi, Eugenio, Brunocilla, Claudio, Degli Esposti, Giovanni, Frezza, Michele, Malizia, Maria, Ntreta, Alessandro, Parisi, Riccardo, Schiavina, Roberto, Bortolu, Giuseppe, Bove, Antonio, Cisternino, Carrieri, Giuseppe, Giuseppe, Difino, Oscar, Selvaggio, Maurizio, Brausi, Alessio, Bruni, Frank, Lohr, Ercole, Mazzeo, Enza, Lamanna, Calogero, Di Stefano, Giorgio, Bruno, Michela, Caldiroli, Ilaria, Ferrari, Laura, Giussani, Lovisolo Jon, A. J., Mario, Marconi Alberto, Giuseppe, Cardo, Mario, Ludovico Giuseppe, Marcello, Scarcia, Giorgio, Carmignani, Salvina, Barra, Dario, Cavallini Francolini, Franco, Corbella, Ofelia, Ceccarini, Luigi, Da Pozzo, Agostina, De Stefani, Corrado, Italia, Stefano, Masciullo, Valentina, Roboldi, Marco, Roscigno, Antonio, Celia, Bernardino, De Concilio, Claudia, Cianci, Francesco, Francesca, Giorgio, Pomara, Michele, Santarsieri, Fiorenza, Cortese, Andrea, Di Stasio, Franco, Montefiore, Armando, Serao, D'Elia, Carolina, Armin, Pycha, Dorijan, Huqi, Paolo, De Angeli, Nicola, Macchione, Francesco, Fontanta, Giorgio, Monesi, Antonello, De Lisa, Giuseppe, Giusti, Giorgio, Musca, Anna, Destito, Rosa, Molè, Danilo, Di Trapani, Francesco, Ferrau, Carmela, Palazzolo, Angelo, Platania, Anna, Santacaterina, Grazia, Lazzari, Fabiola, Liberale, Gregorio, Moro, Giovanni, Liguori, Nicola, Pavan, Francesca, Maggio, Marco, Orsatti, Giovanni, Mandoliti, Giampaolo, Montesi, Luigi, Marafioti, Antonietta, Martilotta, Adele, Massenzo, Luisa, Marciello, Salvino, Marzano, Caterina, Polli, Gloria, Maso, Serena, Medoro, Giuseppe, Morgia, Napodano, Giorgio, Pistone, Antonio, Roberto, Sanseverino, Mattia, Nidini, Paolo, Parma, Valerio, Pizzuti, Sciorio, Carmine, Scuzzarella, Salvatore, Tindaro, Scolaro, Porreca A, Noale M, Artibani W, Bassi PF, Bertoni F, Bracarda S, Conti GN, Corvò R, Gacci M, Graziotti P, Magrini SM, Mirone V, Montironi R, Muto G, Pecoraro S, Ricardi U, Russi E, Tubaro A, Zagonel V, Crepaldi G, Maggi S, Crepaldi G, Maggi S, Noale M, Porreca A, Artibani W, Bassi P, Bracarda S, Conti GN, Corvò R, Graziotti P, Russi E, Mirone V, Montironi R, Bertoni F, Gacci M, Magrini SM, Muto G, Pecoraro S, Ricardi U, Tubaro A, Zagonel V, Alitto AR, Ambrosi E, Antonelli A, Aristei C, Barbieri M, Bardari F, Bardoscia L, Barra S, Bartoncini S, Basso U, Becherini C, Bellavita R, Bergamaschi F, Berlingheri S, Berruti A, Borghesi M, Bortolus R, Borzillo V, Bosetti D, Bove G, Bove P, Brausi M, Bruni A, Bruno G, Brunocilla E, Buffoli A, Buglione M, Buttigliero C, Cacciamani G, Caldiroli M, Cardo G, Carmignani G, Carrieri G, Castelli E, Castrezzati E, Catalano G, Cattarino S, Catucci F, Cavallini FD, Ceccarini O, Celia A, Chiancone F, Chini T, Cianci C, Cisternino A, Collura D, Corbella F, Corinti M, Corsi P, Cortese F, Corti L, de Nunzio C, Cristiano O, D'Angelillo RM, Da Pozzo L, D'agostino D, D'Elia C, Dandrea M, De Angelis M, De Angelis P, De Cobelli O, De Concilio B, De Lisa A, De Luca S, De Stefani A, Deantoni CL, Degli EC, Destito A, Detti B, Di Muzio N, Di Stasio A, Di Stefano C, Di Trapani D, Difino G, Falivene S, Farullo G, Fedelini P, Ferrari I, Ferrau F, Ferro M, Fodor A, Fontanta F, Francesca F, Francolini G, Frata P, Frezza G, Gabriele P, Galeandro M, Garibaldi E, Gennari PG, Gentilucci A, Giacobbe A, Giussani L, Giusti G, Gontero P, Guarneri A, Guida C, Gurioli A, Huqi D, Imbimbo C, Ingrosso G, Iotti C, Italia C, La Mattina P, Lamanna E, Lastrucci L, Lazzari G, Liberale F, Liguori G, Lisi R, Lohr F, Lombardo R, Lovisolo JAJ, Ludovico GM, Macchione N, Maggio F, Malizia M, Manasse G, Mandoliti G, Mantini G, Marafioti L, Marciello L, Marconi AM, Martilotta A, Marzano S, Masciullo S, Maso G, Massenzo A, Mazzeo E, Mearini L, Medoro S, Molè R, Monesi G, Montanari E, Montefiore F, Montesi G, Morgia G, Moro G, Muscas G, Musio D, Muto P, Muzzonigro G, Napodano G, Negro CLA, Nidini M, Ntreta M, Orsatti M, Palazzolo C, Palumbo I, Parisi A, Parma P, Pavan N, Pericolini M, Pinto F, Pistone A, Pizzuti V, Platania A, Polli C, Pomara G, Ponti E, Porcaro AB, Porpiglia F, Pugliese D, Pycha A, Raguso G, Rampini A, Randone DF, Roboldi V, Roscigno M, Ruggieri MP, Ruoppo G, Sanseverino R, Santacaterina A, Santarsieri M, Santoni R, Scagliarini S, Scagliotti GV, Scanzi M, Scarcia M, Schiavina R, Sciarra A, Sciorio C, Scolaro T, Scuzzarella S, Selvaggio O, Serao A, Serni S, Signor MA, Silvani M, Silvano G, Silvestris F, Simeone C, Simone V, Spagnoletti G, Spinelli MG, Squillace L, Tombolini V, Toninelli M, Triggiani L, Trinchieri A, Trodella LE, Trodella L, Trombetta C, Tronnolone L, Tucci M, Urzì D, Valdagni R, Valeriani M, Vanoli M, Vitali E, Volpe A, Zaramella S, Zeccolini G, Zini G, Porreca, A., Noale, M., Artibani, W., Bassi, P. F., Bertoni, F., Bracarda, S., Conti, G. N., Corvo, R., Gacci, M., Graziotti, P., Magrini, S. M., Mirone, V., Montironi, R., Muto, G., Pecoraro, S., Ricardi, U., Russi, E., Tubaro, A., Zagonel, V., Crepaldi, G., Maggi, S., Alitto, A. R., Ambrosi, E., Antonelli, A., Aristei, C., Barbieri, M., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Maurizio, B., Alessio, B., Giorgio, B., Eugenio, B., Alberto, B., Michela, B., Consuelo, B., Giovanni, C., Michela, C., Giuseppe, C., Giorgio, C., Emanuele, C., Elisabetta, C., Gianpiero, C., Susanna, C., Catucci, F., Dario, C. F., Ofelia, C., Antonio, C., Francesco, C., Tommaso, C., Claudia, C., Devis, C., Franco, C., Matteo, C., Paolo, C., Fiorenza, C., Luigi, C., Cosimo, N., Cristiano, O., D'Angelillo, R. M., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli, E. C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontanta, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A. J., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Morgia, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Serni, S., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simeone, C., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Triggiani, L., Trinchieri, A., Trodella, L. E., Trodella, L., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Porreca, A, Noale, M, Artibani, W, Bassi, P, Bertoni, F, Bracarda, S, Conti, G, Corvò, R, Gacci, M, Graziotti, P, Magrini, S, Mirone, V, Montironi, R, Muto, G, Pecoraro, S, Ricardi, U, Russi, E, Tubaro, A, Zagonel, V, Crepaldi, G, Maggi, S, and Da Pozzo, L
Subjects: Male, 030232 urology & nephrology, Severity of Illness Index, Prostate cancer, 0302 clinical medicine, Quality of life, Activities of Daily Living, Diagnosis, Medicine, Age Factor, Prospective Studies, Prospective cohort study, Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA, Age Factors, Pros-IT CNR study, General Medicine, Health Survey, Middle Aged, Neoadjuvant Therapy, 3. Good health, Italy, 030220 oncology & carcinogenesis, lcsh:R858-859.7, Regression Analysis, Public Health, Human, Diagnosi, prostate cancer, survival, quality of life, medicine.medical_specialty, lcsh:Computer applications to medicine. Medical informatics, Regression Analysi, 03 medical and health sciences, Percutaneous Coronary Intervention, Internal medicine, Severity of illness, Humans, Aged, Cancer staging, business.industry, Research, Environmental and Occupational Health, Public Health, Environmental and Occupational Health, Prostatic Neoplasms, Cancer, medicine.disease, Health Surveys, Comorbidity, Quality of Life, Prospective Studie, Settore MED/24, Prostatic Neoplasm, business, Sexual function
Abstract: Background The National Research Council (CNR) prostate cancer monitoring project in Italy (Pros-IT CNR) is an observational, prospective, ongoing, multicentre study aiming to monitor a sample of Italian males diagnosed as new cases of prostate cancer. The present study aims to present data on the quality of life at time prostate cancer is diagnosed. Methods One thousand seven hundred five patients were enrolled. Quality of life is evaluated at the time cancer was diagnosed and at subsequent assessments via the Italian version of the University of California Los Angeles-Prostate Cancer Index (UCLA-PCI) and the Short Form Health Survey (SF-12). Results At diagnosis, lower scores on the physical component of the SF-12 were associated to older ages, obesity and the presence of 3+ moderate/severe comorbidities. Lower scores on the mental component were associated to younger ages, the presence of 3+ moderate/severe comorbidities and a T-score higher than one. Urinary and bowel functions according to UCLA-PCI were generally good. Almost 5% of the sample reported using at least one safety pad daily to control urinary loss; less than 3% reported moderate/severe problems attributable to bowel functions, and sexual function was a moderate/severe problem for 26.7%. Diabetes, 3+ moderate/severe comorbidities, T2 or T3-T4 categories and a Gleason score of eight or more were significantly associated with lower sexual function scores at diagnosis. Conclusions Data collected by the Pros-IT CNR study have clarified the baseline status of newly diagnosed prostate cancer patients. A comprehensive assessment of quality of life will allow to objectively evaluate outcomes of different profile of care.
Published: 2018

41. Should adjuvant chemotherapy become standard treatment in all patients with resected non-small-cell lung cancer?

Author: Le Chevalier T, Arriagada R, Pignon J, Scagliotti GV, Le Chevalier, Thierry, Arriagada, Rodrigo, Pignon, Jean-Pierre, and Scagliotti, Giorgio V
Abstract: Surgery remains the main curative treatment for patients with early-stage non-small-cell lung cancer (NSCLC); however, because many patients probably have undetectable micrometastasis even at diagnosis, adjuvant treatment is usually needed. The results for radiotherapy have mostly been disappointing, and a strong emphasis has, therefore, been placed on chemotherapy as the preferred modality. Adjuvant chemotherapy, and in particular, platinum-based regimens, have been assessed in several studies, but the results have been conflicting. Most trials have included patients with a wide range of disease stages and have shown, at most, only moderate improvements in survival. Thus, although clearly indicated in some patients, whether adjuvant chemotherapy should be used in all patients with resected disease is highly controversial. In this debate, Thierry Le Chevalier and colleagues and Giorgio Scagliotti present opposing arguments for whether this approach should be considered standard. [ABSTRACT FROM AUTHOR]
Published: 2005
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42. A phase II study of paclitaxel in advanced bronchioloalveolar carcinoma (EORTC trial 08956)

Author: Scagliotti, Giorgio Vittorio, Smit, E, Bosquee, L, O'Brien, M, Ardizzoni, A, Zatloukal, P, Eberhardt, W, Smid Geirnaerdt, M, de Bruin HG, Dussenne, S, Legrand, C, Giaccone, G, European Organisation for Research, Treatment of Cancer Lung Cancer Group, VU University medical center, Radiology & Nuclear Medicine, Scagliotti GV, Smit E, Bosquee L, O'Brien M, Ardizzoni A, Zatloukal P, Eberhardt W, Smid-Geirnaerdt M, de Bruin HG, Dussenne S, Legrand C, and Giaccone G
Subjects: Adult, Male, Pulmonary and Respiratory Medicine, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Paclitaxel, medicine.medical_treatment, Phases of clinical research, Gastroenterology, paclitaxel, bronchoalveolar carcinoma, phase II study, 03 medical and health sciences, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Carcinoma, Humans, Progression-free survival, Infusions, Intravenous, Lung cancer, Survival analysis, Aged, Chemotherapy, business.industry, Incidence (epidemiology), Adenocarcinoma, Bronchiolo-Alveolar, Middle Aged, medicine.disease, Antineoplastic Agents, Phytogenic, Survival Analysis, 3. Good health, Surgery, Treatment Outcome, 030228 respiratory system, Oncology, 030220 oncology & carcinogenesis, Disease Progression, Female, business, Progressive disease
Abstract: Purpose: The incidence of bronchioloalveolar carcinoma (BAC) has risen steadily over the last decades along with the increasing frequency of adenocarcinomas. BAC is relatively resistant to commonly used chemotherapy regimens. A phase 11 study with single agent pactitaxel in patients with stages IIIB, IV or recurrent BAC was performed. Experimental design: Patients with BAC with at least one target bidimensionally measurable lesion staged as unresectable stages IIIB, IV or recurrent disease, not previously irradiated; ECOG performance status 0-2; life expectancy greater than 3 months; age range between 18 and 75, received pactitaxel at a dose of 200 mg/m(2) i.v. as 3 h continuous infusion on day 1 every 21 days. Treatment was continued until progression or up to a maximum of six cycles. Results: Nineteen patients were eligible. Median number of cycles was 3 (range 0-6); 35% of patients received the planned six cycles of chemotherapy. One patient died of unrelated cause before the start of treatment. Both hematological and non-hematological toxicities were generally mild. Only one partial response (PR) was observed among the 18 eligible patients who started protocol treatment, with a response rate of 5.6% (95% Cl: 0.1-27.3%). After an independent review, two PR were confirmed, for a response rate of 11.1% (95% CI: 1.4-34.7%); nine patients had stable disease (50.0%), three patients had progressive disease (11.1%) and four patients were not assessable (22.2%). Median survival was 8.6 months (95% CI: 5.8-14.5) and 1-year survival was 35.0% (95% CI: 14.1-55.8). Median progression free survival for all patients was 2.2 months (95% CI: 1.5-6.0). The study was terminated due to the low response rate. Conclusions: Pactitaxel as single agent in stages IIIB-IV BAC was well tolerated and manageable but of limited efficacy. BAC should not be excluded from trials of new forms of chemotherapy. (c) 2005 Elsevier Ireland Ltd. All rights reserved.
Published: 2005

43. Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone

Author: A. Masotti, Silvia Novello, Giovanni Selvaggi, M. Fioretti, Mario Spatafora, C. Barone, Roberta Buosi, Paolo Bruzzi, Santi Barbera, P Mazzanti, G.V. Scagliotti, L. Crinò, L. Garetto, V Dongiovanni, G. Michetti, NOVELLO S, BRUZZI P, BARONE C, BUOSI R, MASOTTI A, MICHETTI G, FIORETTI M, BARBERA S, SPATAFORA M, GARETTO L, MAZZANTI P, DONGIOVANNI V, SELVAGGI G, CRINO L, and SCAGLIOTTI GV
Subjects: Oncology, Male, medicine.medical_specialty, Randomization, Lung Neoplasms, Time Factors, medicine.drug_class, medicine.medical_treatment, Antimetabolite, Deoxycytidine, Drug Administration Schedule, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Lung cancer, Neoplasm Staging, Cisplatin, Chemotherapy, business.industry, Hematology, Middle Aged, medicine.disease, Survival Analysis, Gemcitabine, Confidence interval, Surgery, Treatment Outcome, Female, business, medicine.drug, Follow-Up Studies
Abstract: BACKGROUND: This randomised phase III study investigated if in responsive and stable disease (SD) stage IV patients after two courses of cisplatin and gemcitabine, single-agent gemcitabine (experimental arm) was not inferior in terms of overall survival (OS) to cisplatin-gemcitabine (standard arm). PATIENTS AND METHODS: Noninferiority was defined as an increase in the hazard of death (HR) < or = 1.33 in the experimental arm. From January 2001 to February 2004, 340 patients were registered and 250 were randomised. Cisplatin was administered on day 1 at 75 mg/m2 and Gemcitabine on days 1 and 8 at 1250 mg/m2 every 3 weeks. RESULTS: Response rate after two courses was 29%. The 1-year progression-free survival was 13% in both arms. One-year survival was 52% in the standard and 42% in the experimental arm for an HR of 1.21 [90% confidence interval (CI) 0.97-1.51]. Postprogression survival was in favour of the standard arm (HR 1.30, 95% CI 0.99-1.70, P = 0.051). Grades 3-4 toxicity favoured in the experimental arm. CONCLUSION: In responsive and SD patients with stage IV non-small-cell lung cancer it was not possible to demonstrate that three courses of gemcitabine alone are not inferior, in terms of OS, to the standard approach of three courses of cisplatin-gemcitabine.
Published: 2007

44. Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: A randomized phase III study of the Italian Lung Cancer Project

Author: Maurizio Tonato, F. Gozzelino, F. De Marinis, Sergio Ricci, Sandro Barni, A. Masotti, Anna Ceribelli, F. Di Costanzo, Roberto Bianco, L. Crinò, C. Gridelli, Giorgio V. Scagliotti, Giorgio Cruciani, V. Adamo, Giuseppe Ferrara, L. Portalone, M. Rinaldi, M. Marangolo, M. Sassi, Alberto Ravaioli, Crinò, L., Scagliotti, Gv, Ricci, S, De Marinis, F, Rinaldi, M, Gridelli, C, Ceribelli, A, Bianco, Roberto, Marangolo, M, Di Costanzo, F, Sassi, M, Barni, S, Ravaioli, A, Adamo, V, Portalone, L, Cruciani, G, Masotti, A, Ferrara, G, Gozzelino, F, and Tonato, M.
Subjects: Male, Cancer Research, Lung Neoplasms, Antimetabolites, medicine.medical_treatment, chemotherapy, Gastroenterology, Deoxycytidine, chemistry.chemical_compound, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Non-Small-Cell Lung, Mesna, Ifosfamide, Middle Aged, Antineoplastic, Nitrogen mustard, Survival Rate, medicine.anatomical_structure, Oncology, Italy, Female, Drug, Adult, Aged, Antimetabolites, Antineoplastic, Cisplatin, Dose-Response Relationship, Drug, Humans, Mitomycin, Quality of Life, Sample Size, medicine.drug, medicine.medical_specialty, Dose-Response Relationship, Internal medicine, medicine, Lung cancer, Chemotherapy, business.industry, Carcinoma, medicine.disease, Gemcitabine, Supraclavicular lymph nodes, Surgery, lung cancer, chemistry, business
Abstract: PURPOSE: To compare gemcitabine and cisplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) chemotherapy in patients with stage IIIB (limited to T4 for pleural effusion and N3 for supraclavicular lymph nodes) or stage IV non–small-cell lung cancer (NSCLC). The end points were the evaluation of quality of life (QoL), response rates, survival, and toxicity. PATIENTS AND METHODS: Three hundred seven patients were randomized to receive either gemcitabine 1,000 mg/m2 on days 1, 8, and 15 plus cisplatin 100 mg/m2 on day 2, every 28 days, or mitomycin 6 mg/m2, ifosfamide 3,000 mg/m2, and mesna on day 1 plus cisplatin 100 mg/m2 on day 2, every 28 days. The whole-blood cell count was repeated on day 1 in both arms and weekly in the GC arm before each gemcitabine administration. RESULTS: No major differences in changes in QoL were observed between the two treatment arms. The objective response rate was 38% in the GC arm compared with 26% in the MIC arm (P = .029). The median survival time was 8.6 months in the GC arm and 9.6 months in the MIC arm (P = .877, log-rank test). Grade 3 and 4 thrombocytopenia was significantly worse in the GC arm (64% v 28%, P < .001), whereas grade 3 and 4 alopecia was reported more commonly in the MIC arm (39% v 12%, P < .001). CONCLUSION: We report an increased response rate without changes in QoL and a similar overall survival, time to progression, and time to treatment failure for the GC when compared with the MIC regimen in the treatment of advanced NSCLC.
Published: 1999

45. CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors.

Author: Skoulidis F, Araujo HA, Do MT, Qian Y, Sun X, Cobo AG, Le JT, Montesion M, Palmer R, Jahchan N, Juan JM, Min C, Yu Y, Pan X, Arbour KC, Vokes N, Schmidt ST, Molkentine D, Owen DH, Memmott R, Patil PD, Marmarelis ME, Awad MM, Murray JC, Hellyer JA, Gainor JF, Dimou A, Bestvina CM, Shu CA, Riess JW, Blakely CM, Pecot CV, Mezquita L, Tabbó F, Scheffler M, Digumarthy S, Mooradian MJ, Sacher AG, Lau SCM, Saltos AN, Rotow J, Johnson RP, Liu C, Stewart T, Goldberg SB, Killam J, Walther Z, Schalper K, Davies KD, Woodcock MG, Anagnostou V, Marrone KA, Forde PM, Ricciuti B, Venkatraman D, Van Allen EM, Cummings AL, Goldman JW, Shaish H, Kier M, Katz S, Aggarwal C, Ni Y, Azok JT, Segal J, Ritterhouse L, Neal JW, Lacroix L, Elamin YY, Negrao MV, Le X, Lam VK, Lewis WE, Kemp HN, Carter B, Roth JA, Swisher S, Lee R, Zhou T, Poteete A, Kong Y, Takehara T, Paula AG, Parra Cuentas ER, Behrens C, Wistuba II, Zhang J, Blumenschein GR, Gay C, Byers LA, Gibbons DL, Tsao A, Lee JJ, Bivona TG, Camidge DR, Gray JE, Lieghl N, Levy B, Brahmer JR, Garassino MC, Gandara DR, Garon EB, Rizvi NA, Scagliotti GV, Wolf J, Planchard D, Besse B, Herbst RS, Wakelee HA, Pennell NA, Shaw AT, Jänne PA, Carbone DP, Hellmann MD, Rudin CM, Albacker L, Mann H, Zhu Z, Lai Z, Stewart R, Peters S, Johnson ML, Wong KK, Huang A, Winslow MM, Rosen MJ, Winters IP, Papadimitrakopoulou VA, Cascone T, Jewsbury P, and Heymach JV
Subjects: Animals, Female, Humans, Male, Mice, Antibodies, Monoclonal pharmacology, Antibodies, Monoclonal therapeutic use, B7-H1 Antigen metabolism, B7-H1 Antigen antagonists & inhibitors, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Non-Small-Cell Lung immunology, Clinical Trials, Phase III as Topic, Mutation, Nitric Oxide Synthase Type II metabolism, T-Lymphocytes drug effects, T-Lymphocytes immunology, Tumor Microenvironment drug effects, Tumor Microenvironment immunology, Tumor Suppressor Proteins genetics, Tumor Suppressor Proteins metabolism, Genes, Tumor Suppressor, AMP-Activated Protein Kinase Kinases genetics, AMP-Activated Protein Kinase Kinases metabolism, CTLA-4 Antigen antagonists & inhibitors, CTLA-4 Antigen metabolism, Drug Resistance, Neoplasm drug effects, Drug Resistance, Neoplasm genetics, Immune Checkpoint Inhibitors pharmacology, Immune Checkpoint Inhibitors therapeutic use, Kelch-Like ECH-Associated Protein 1 genetics, Kelch-Like ECH-Associated Protein 1 metabolism, Lung Neoplasms drug therapy, Lung Neoplasms genetics, Lung Neoplasms immunology, Lung Neoplasms pathology
Abstract: For patients with advanced non-small-cell lung cancer (NSCLC), dual immune checkpoint blockade (ICB) with CTLA4 inhibitors and PD-1 or PD-L1 inhibitors (hereafter, PD-(L)1 inhibitors) is associated with higher rates of anti-tumour activity and immune-related toxicities, when compared with treatment with PD-(L)1 inhibitors alone. However, there are currently no validated biomarkers to identify which patients will benefit from dual ICB 1,2 . Here we show that patients with NSCLC who have mutations in the STK11 and/or KEAP1 tumour suppressor genes derived clinical benefit from dual ICB with the PD-L1 inhibitor durvalumab and the CTLA4 inhibitor tremelimumab, but not from durvalumab alone, when added to chemotherapy in the randomized phase III POSEIDON trial 3 . Unbiased genetic screens identified loss of both of these tumour suppressor genes as independent drivers of resistance to PD-(L)1 inhibition, and showed that loss of Keap1 was the strongest genomic predictor of dual ICB efficacy-a finding that was confirmed in several mouse models of Kras-driven NSCLC. In both mouse models and patients, KEAP1 and STK11 alterations were associated with an adverse tumour microenvironment, which was characterized by a preponderance of suppressive myeloid cells and the depletion of CD8 + cytotoxic T cells, but relative sparing of CD4 + effector subsets. Dual ICB potently engaged CD4 + effector cells and reprogrammed the tumour myeloid cell compartment towards inducible nitric oxide synthase (iNOS)-expressing tumoricidal phenotypes that-together with CD4 + and CD8 + T cells-contributed to anti-tumour efficacy. These data support the use of chemo-immunotherapy with dual ICB to mitigate resistance to PD-(L)1 inhibition in patients with NSCLC who have STK11 and/or KEAP1 alterations., Competing Interests: Competing interests F.S. reports consulting for AstraZeneca, Amgen, Revolution Medicines, Novartis, BridgeBio, Beigene, BergenBio, Guardant Health, Calithera Biosciences, Tango Therapeutics, Hookipa Pharma, Novocure, Merck Sharp & Dohme, Roche; grant or research support from Amgen, Mirati Therapeutics, Revolution Medicines, Pfizer, Novartis, Merck & Co; stockholder in BioNTech, Moderna; and honoraria from ESMO, Japanese Lung Cancer Society, Medscape, Intellisphere, VSPO McGill Universite de Montreal, RV Mais Promocao Eventos, MJH Life Sciences, IDEOlogy Health, MI&T, PER, CURIO, DAVA Oncology, the American Association for Cancer Research and the International Association for the Study of Lung Cancer. M.M. reports stockholder in Roche Holdings. N.J. reports shareholder and former employee of Pionyr Immunotherapeutics. J.M.J. reports stock of D2G Oncology. C.M., Y.Y., X.P. and A.H. report employee of Tango Therapeutics. K.C.A. reports personal fees from Sanofi Genzyme and other support from Revolution Medicines, Genentech, and Mirati outside the submitted work. N.V. receives consulting fees from Sanofi Genzyme, Oncocyte, Eli Lilly, Regeneron, and research funding to the institution from Mirati, Oncocyte, and Circulogene, outside the submitted work. P.D.P. reports advisory fees from AstraZeneca and Jazz Pharmaceuticals. M.E.M. reports research funding from Eli Lilly (Inst), AstraZeneca (Inst), Merck (Inst), Genentech (Inst); consulting role with AstraZeneca, Novocure, Boehringer Ingelheim, Janssen, Takeda, Blueprint Pharmaceuticals, Bayer, Bristol Myers Squibb, Ikena; honorarium from Thermo Fisher Scientific; and stock in Merck, Johnson & Johnson. M.M.A. reports grants and personal fees from Genentech, Bristol Myers Squibb and AstraZeneca; grants from Lilly; and personal fees from Maverick, Blueprint Medicine, Syndax, Nektar, Gritstone, ArcherDX, Mirati, NextCure, Novartis, EMD Serono and Panvaxal/NovaRX, outside of the submitted work. J.C.M. reports consulting or honoraria: MJH Life Sciences, Johnson & Johnson and Doximity; and research funding (to institution): Merck via the Conquer Cancer Foundation. J.F.G. reports served as a compensated consultant or received honoraria from Bristol Myers Squibb, Genentech (Roche), Takeda, Loxo (Lilly), Blueprint Medicine, Gilead, Moderna, AstraZeneca, Mariana Therapeutics, Mirati, Jounce, Merus Pharmacueticals, Nuvalent, Pfizer, Novocure, AI Proteins, Novartis, Merck, iTeos, Karyopharm and Silverback Therapeutics; research support from Novartis, Genentech (Roche) and Takeda; institutional research support from Bristol Myers Squibb, Palleon, Tesaro, Moderna, Blueprint, Jounce, Array Biopharma, Merck, Adaptimmune, Novartis and Alexo; has equity in AI Proteins; and has an immediate family member who is an employee with equity at Ironwood Pharmaceuticals. A.D. reports honoraria: Intellisphere, Roche (Genentech); ad board: TP Therapeutics, Guardant Health, AnHeart Therapeutics, ChromaCode; clinical trial support: Syntrix Pharmaceuticals, Novartis, Merck, AnHeart Therapeutics, Sorrento Therapeutics, Guardant Health and Philogen. C. M. Bestvina reports consulting or advisory role: AstraZeneca, Genentech, AbbVie, Curio Science, OncLive Clinical Congress Consultants, Seagen, Creative Educational Concepts, Takeda, Janssen, CVS, Bristol Myers Squibb (Celgene), Jazz Pharmaceuticals, Novartis, Sanofi–Regeneron and Novocure; speakers’ bureau: Merck; research funding: Bristol Myers Squibb and AstraZeneca. C.A.S. reports advisory boards to AstraZeneca, Gilead, Janssen, Genentech, Mirati, Takeda and Arcus Biosciences. J.W.R. reports honoraria or consulting (self): Boehringer Ingelheim, BMS, Turning Point Roche (Genentech), Biodesix, EMD Serono, Daiichi Sankyo, Blueprint, Novartis, Regeneron, Sanofi, Janssen, Jazz Pharmaceuticals, Bayer, Beigene, Merus and Seagen; research support (to institution): ArriVent, Merck, Novartis, AstraZeneca, Spectrum, Revolution Medicines, IO Biotech and Kinnate. C. M. Blakely reports research funding: AstraZeneca, Novartis, Mirati, Spectrum, Takeda, Puma and Pfizer; and consulting: Janssen and Bayer. C.V.P. reports a founder and equity and intellectual property in EnFuego Therapeutics. F.T. reports speaker bureau or honoraria: Roche, AstraZeneca, Novartis and Takeda. M.S. reports institutional support: Dracen Pharmaceuticals; advisory board: Amgen, AstraZeneca, Boehringer Ingelheim, Janssen Pharmaceuticals, Novartis, Pfizer, Roche, Sanofi-Aventis, Siemens Healthineers, Takeda Pharmaceuticals and Bristol Myers Squibb; leadership or fiduciary role: ESMO and EORTC. S.D. reports independent image analysis for hospital-contracted clinical research trials programs for Merck, Pfizer, Bristol Myers Squibb, Novartis, Roche, Polaris, Cascadian, Abbvie, Gradalis, Bayer, Zai laboratories, Biengen, Resonance and Analise; research grants from Lunit, GE, Qure AI; and an honorarium from Siemens. M.J.M. reports AstraZeneca, Bristol Myers Squibb and Istari Oncology & Regeneron. A.G.S. reports AstraZeneca, Genentech (Roche) and Bristol Myers Squibb. A.N.S. reports serving as a consultant and/or advisory board member for Eli Lilly, Daiichi Sankyo and Zymeworks; and research funding from Eli Lilly, Novartis, Daiichi Sankyo, Genentech, AstraZeneca, Memgen, Mersana, Turning Point Therapeutics, BioAtla and Genmab to his institution. J.R. reports consulting fees or honoraria from AstraZeneca, Takeda, Sanofi Genzyme, Genentech, Guardant Health, Summit, G1 Therapeutics, BioAtla, Jazz, Amgen, and Janssen; contracted for research (institutional) with AstraZeneca, BioAtla, Blueprint Medicines, EpimAb Biotherapeutics, LOXO Oncology, Enliven, Redcloud and ORIC. T.S. reports advisory board or consulting fees for Seagen, Astellas and AstraZeneca; and research grant GRAIL. S.B.G. reports research funding from AstraZeneca, Boehringer Ingelheim and Mirati; and consulting or advisory board member for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Amgen, Blueprint Medicine, Sanofi Genzyme, Daiichi Sankyo, Takeda, Janssen, Summit Therapeutics, Merck and Regeneron. J.K. reports for Arterys. K.S. reports consultant, advisor or speaker for Clinica Alemana Santiago, Shattuck Labs, AstraZeneca, EMD Serono, Takeda, Torque/Repertoire Therapeutics, CSRlife, Agenus, Genmab, OnCusp, Parthenon Therapeutics, Bristol Myers Squibb, Roche, Molecular Templates, Abbvie, Sanofi, Merck, PeerView, PER and Forefront Collaborative; research funding from Navigate BP, Tesaro/GSK, Moderna, Takeda, Surface Oncology, Pierre-Fabre, Merck, Bristol Myers Squibb, AstraZeneca, Ribon Therapeutics, Eli Lilly, Boehringer Ingelheim, Genentech (Roche) and Akoya Biosciences. K.D.D. reports consulting fees or other remuneration from Rain Therapeutics. V.A. reports research funding to Johns Hopkins University from AstraZeneca and Personal Genome Diagnostics, has received research funding to Johns Hopkins University from Bristol Myers Squibb and Delfi Diagnostics in the past five years and is an advisory board member for Neogenomics and AstraZeneca. V.A. is an inventor on patent applications (63/276,525, 17/779,936, 16/312,152, 16/341,862, 17/047,006 and 17/598,690) submitted by Johns Hopkins University related to cancer genomic analyses, ctDNA therapeutic response monitoring and immunogenomic features of response to immunotherapy that have been licensed to one or more entities. Under the terms of these license agreements, the University and inventors are entitled to fees and royalty distributions. K.A.M. reports consulting or advisory fees from AstraZeneca, Amgen, Janssen, Mirati Therapeutics, Daiichi Sankyo (Lilly) and Puma Biotechnology, as well as honoraria from AstraZeneca. K.A.M. receives research funding to Johns Hopkins University from Bristol Myers Squibb and Mirati Therapeutics. P.M.F. reports consulting fee (for example, advisory board): Ascendis, AstraZeneca, BMS, Curevac, Novartis, Regeneron, G1, Genelux, Genentech, Gritstone, Merck, Janssen, F-Star, Sanofi, Amgen, Fosun, Teva, Synthekine, Flame, Iteos, Tavotek and Teva; contracted research: AstraZeneca, BMS, Novartis, Regeneron and BioNTech. B.R. reports advisory board or consultant: Regeneron, AstraZeneca, Amgen; honoraria: Targeted Oncology. E.M.V.A reports advisory or consulting: Tango Therapeutics, Genome Medical, Genomic Life, Enara Bio, Manifold Bio, Monte Rosa, Novartis Institute for Biomedical Research, Riva Therapeutics and Serinus Bio; research support: Novartis, BMS and Sanofi; equity: Tango Therapeutics, Genome Medical, Genomic Life, Syapse, Enara Bio, Manifold Bio, Microsoft, Monte Rosa, Riva Therapeutics and Serinus Bio; patents: institutional patents filed on chromatin mutations and immunotherapy response, and methods for clinical interpretation; intermittent legal consulting on patents for Foaley & Hoag; editorial boards: JCO Precision Oncology and Science Advances. A.L.C. reports consulting for AstraZeneca, Merus and Tempus; research funds from AstraZeneca, Genentech (Roche), Merck and Novartis. J.W.G. reports research grants: AstraZeneca, BMS, Eli Lilly, Genentech, Merck and Pfizer; consulting fees: AstraZeneca, BMS, Genentech, Gilead, Gritstone, Eli Lilly, Pfizer and Regeneron. C.A. reports consulting or advisory role: Genentech, Lilly, Celgene, Merck, AstraZeneca, Blueprint Genetics, Shionogi, Daiichi Sankyo–AstraZeneca, Sanofi/Regeneron, Eisai, BeiGene, Turning Point Therapeutics, Pfizer, Janssen, Boehringer Ingelheim; research funding: Genentech/Roche (Inst), Incyte (Inst), Macrogenics (Inst), Merck Sharp & Dohme (Inst) and AstraZeneca–MedImmune (Inst). L.R. reports honoraria: Merck, AstraZeneca, Genzyme, EMD Serono and Astellas Pharmas; consulting or advisory role: Amgen. J.W.N. reports honoraria: CME Matters, Clinical Care Options CME, Research to Practice CME, Medscape CME, Biomedical Learning Institute CME, MLI Peerview CME, Prime Oncology CME, Projects in Knowledge CME, Rockpointe CME, MJH Life Sciences CME, Medical Educator Consortium, HMP education consulting or advisory role: AstraZeneca, Genentech (Roche), Exelixis, Takeda Pharmaceuticals, Eli Lilly, Amgen, Iovance Biotherapeutics, Blueprint Pharmaceuticals, Regeneron Pharmaceuticals, Natera, Sanofi, D2G Oncology, Surface Oncology, Turning Point Therapeutics, Mirati Therapeutics, Gilead Sciences, Abbive, Summit Therapeutics, Novartis, Novocure, Janssen Oncology, Anheart Therapeutics Research Funding: Genentech (Roche), Merck, Novartis, Boehringer Ingelheim, Exelixis, Nektart Therapeutics, Takeda Pharmaceuticals, Adaptimmune, GlaxoSmithKline, Janssen Pharmaceuticals, Abbvie Pharmaceuticals and Novocure. Y.Y.E. reports honoraria: CME Matters, Clinical Care Options CME, Research to Practice CME, Medscape CME, Biomedical Learning Institute CME, MLI Peerview CME, Prime Oncology CME, Projects in Knowledge CME, Rockpointe CME, MJH Life Sciences CME, Medical Educator Consortium, HMP education consulting or advisory role: AstraZeneca, Genentech (Roche), Exelixis, Takeda Pharmaceuticals, Eli Lilly, Amgen, Iovance Biotherapeutics, Blueprint Pharmaceuticals, Regeneron Pharmaceuticals, Natera, Sanofi, D2G Oncology, Surface Oncology, Turning Point Therapeutics, Mirati Therapeutics, Gilead Sciences, Abbive, Summit Therapeutics, Novartis, Novocure, Janssen Oncology, Anheart Therapeutics Reserach Funding: Genentech/Roche, Merck, Novartis, Boehringer Ingelheim, Exelixis, Nektart Therapeutics, Takeda Pharmaceuticals, Adaptimmune, GlaxoSmithKline, Janssen Pharmaceuticals, Abbvie Pharmaceuticals and Novocure. M.V.N. reports research funding to institution: Mirati, Novartis, Checkmate (ended), Alaunos, AstraZeneca, Pfizer, Genentech, Navire; consultant or advisory board: Mirati, Merck/MSD, Novartis and Genentech. X.L. reports receiving consulting or advisory fees from EMD Serono (Merck KGaA), AstraZeneca, Spectrum Pharmaceutics, Novartis, Eli Lilly, Boehringer Ingelheim, Hengrui Therapeutics, Janssen, Blueprint Medicines, Regeneron, Sensei Biotherapeutics, Abion and Abbvie, and research funding from Eli Lilly, EMD Serono, Janssen, ArriVent, Teligene, BlackDiamond, Regeneron and Boehringer Ingelheim. V.K.L. reports consultant or advisory role for Takeda, Seattle Genetics, BMS, AstraZeneca, Guardant Health and AnHeart Therapeutics and has received research funding from GSK, BMS, AstraZeneca, Merck and Seattle Genetics. W.E.L. reports advisory boards: Eisai and Takeda, Grand Rounds and BMS for repotrectinib. J.A.R. reports consultancy, stock, Genprex; patents issued and pending. T.C. reports speaker fees or honoraria from the Society for Immunotherapy of Cancer (SITC), Mark Foundation for Cancer Research, Bristol Myers Squibb, Roche, Medscape, IDEOlogy Health, Physicians’ Education Resource (PER), OncLive and PeerView; travel and/or food/beverage expenses from SITC, International Association for the Study of Lung Cancer, Parker Institute for Cancer Immunotherapy, PER, Dava Oncology, IDEOlogy Health, AstraZeneca and Bristol Myers Squibb; advisory role or consulting fees from MedImmune–AstraZeneca, Bristol Myers Squibb, Merck, Genentech, Arrowhead Pharmaceuticals, Pfizer and Regeneron; and institutional research funding from MedImmune–AstraZeneca, Bristol Myers Squibb and EMD Serono. J.Z. reports grants from Merck, grants and personal fees from Johnson & Johnson and Novartis, personal fees from Bristol Myers Squibb, AstraZeneca, GenePlus, Innovent and Hengrui outside the submitted work. G.R.B. reports grant or contract for clinical trial from MacroGenics; grants from Amgen, Bayer, Adaptimmune, Exelixis, Daiichi Sankyo, GlaxoSmithKline, Immatics, Immunocore, Incyte, Kite Pharma, MacroGenics, Torque, AstraZeneca, Bristol Myers Squibb, Celgene, Genentech, MedImmune, Merck, Novartis, Roche, Sanofi, Xcovery, Tmunity Therapeutics, Regeneron, BeiGene, Repertoire Immune Medicines, Verastem, CytomX Therapeutics and Duality Biologics; consulting fees from AbbVie, Adicet, Amgen, Ariad, Bayer, Clovis Oncology, AstraZeneca, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Instil Bio, Genentech, Genzyme, Gilead, Eli Lilly, Janssen, MedImmune, Merck, Novartis, Roche, Sanofi, Tyme Oncology, Xcovery, Virogin Biotech, Maverick Therapeutics, BeiGene, Regeneron, Cytomx Therapeutics, Intervenn Biosciences and Onconova Therapeutics; participation in advisory boards at Virogin Biotech and Maverick Therapeutics; stock in Virogin Biotech; and employment of family member at Johnson & Johnson/Janssen. C.G. reports member of the advisory board at Jazz Pharmaceuticals, AstraZeneca and Bristol Myers Squibb and served as speaker for AstraZeneca and BeiGene. L.A.B. reports consulting fees and research funding from AstraZeneca, GenMab and Sierra Oncology and research funding from Tolero Pharmaceuticals and served as advisor or consultant for PharmaMar, AbbVie, Bristol Myers Squibb, Alethia, Merck, Pfizer, Jazz Pharmaceuticals, Genentech and Debiopharm Group. D.L.G. reports AstraZeneca, Eli Lilly, Menarini Richerche, 4D Pharma, Onconova Therapeutics and Sanofi. A.T. reports Ariad, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche, Seattle Genetics, Gilead Sciences and Summit Therapeutics. T.G.B. reports Chan-Zuckerberg Biohub. D.R.C. reports CoI Company sponsored trials at institution (PI roles): AZ, Roche (Genentech) advisory role: ad hoc advisory boards or consultations 2023: Abbvie (steering committee), Anheart, Beigene (IDMC), Eli Lilly (IDMC), Imagene, Immunocore, Janssen, Mirati (IDMC), Prelude, Seattle Genetics, Valencee; 2022: Abbvie, Anheart, Appolomics (SRC), AstraZeneca–Daiichi (ILD adjudication committee), Beigene (DSMB) Dizal, EMD Serono, Elevation, Hengrui, (DSMB), Hummingbird, Janssen, Medtronic, Mersana (ILD adjudication committee), Mirati, Nalo Therapeutics, Onkure, Regeneron, Roche, Sanofi, Takeda, Theseus, Xcovery; 2021: Abbvie, Amgen, Anheart, Apollomics (SRC), AstraZeneca (SRC/SC), Beigene (DSMC), Bio-Thera (DSMB), Blueprint, Daiichi Sankyo (ILD adjudication committee), Elevation (SRC), Eli Lilly (DSMB and NCCN), EMD Serono, Helsinn (DSMB), Hengrui (DSMC), Janssen, Kestrel (SAB, Shares), Mersana, Nuvalent (SAB), Puma (NCCN), Ribon, Roche (Genentech), Sanofi, Seattle Genetics, Takeda and Turning Point. J.E.G. reports honoraria: Jazz Pharmaceuticals, Merck and OncoCyte; consulting or advisory role: AstraZeneca, Blueprint Medicines, Bristol Myers Squibb, EMD Serono, Lilly, Sanofi, Merck Sharp & Dohme, Loxo, Jazz Pharmaceuticals, Novartis, AstraZeneca–MedImmune, Janssen Scientific Affairs, National Comprehensive Cancer Network, AbbVie and Regeneron; research funding: Merck (Inst), AstraZeneca (Inst), Bristol Myers Squibb (Inst), Boehringer Ingelheim (Inst), Genentech (Roche) (Inst), G1 Therapeutics (Inst), Novartis (Inst), Pfizer (Inst), Ludwig Institute for Cancer Research (Inst), SWOG (Inst), Array BioPharma (Inst) and ECOG-ACRIN (Inst). N.L. reports CME and research funding: AstraZeneca. B.L. reports Genentech (Roche), Eli Lilly, Merck, Pfizer, Janssen, Daiichi Sankyo, Takeda, Mirati, Novartis and Guardant 360. J.R.B. reports grant funding: AstraZeneca; advisory board: AstraZeneca, Amgen, Novartis, Incyte, Bristol Myers Squibb, Genentech, Janssen, Sanofi, Regeneron, Merck, GlaxoSmithKline; DSMB: Sanofi, Janssen and GlaxoSmithKline. M.C.G. reports AstraZeneca, Abion, MSD International, Bayer, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Incyte, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron, Merck, Blueprint, Janssen, Sanofi, AbbVie, BeiGenius, Oncohost and Medscape. D.R.G. reports institutional research grants from Amgen, AstraZeneca, Genentech and Merck; consultant or advisory board for Adagene, AstraZeneca, Roche (Genentech), Guardant, IO Biotech, Oncocyte, OncoHost, Lilly, Merck and Novartis. E.B.G. reports consulting or advisory role: Novartis, GlaxoSmithKline, Merck, Boehringer Ingelheim, Shionogi, Eisai, Bristol Myers Squibb, ABL Bio, Xilio Therapeutics, Natera, Sanofi–Regeneron, Lilly, Personalis, Gilead Sciences, AstraZeneca, AbbVie–Abbott, Arcus Biosciences, Seagan and Summit Therapeutics; research funding: Merck (Inst), Genentech (Inst), AstraZeneca (Inst), Novartis (Inst), Lilly (Inst), Bristol Myers Squibb (Inst), Mirati Therapeutics (Inst), Dynavax Technologies (Inst), Iovance Biotherapeutics (Inst), Neon Therapeutics (Inst), EMD Serono (Inst), ABL Bio (Inst) and Daiichi Sankyo–UCB Japan (Inst); patents, royalties, other intellectual property: diagnosistic and therapeutic use of ‘Motif Neoepitopes’ as defined by Cummings et al.76. N.A.R. reports an employee at Synthekine and holds equity at Synthekine and Gritstone. G.V.S. reports honoraria, research funding and personal fees from AstraZeneca, Bayer, BeiGene Switzerland, F. Hoffman–La Roche, Merck Sharpe & Dohme, Eli Lilly, Johnson & Johnson, Pfizer, Takeda Oncology, Tesaro and Verastem outside the submitted work. J.W. reports advisory boards and lecture fees: Amgen, AstraZeneca, Bayer, Blueprint, BMS, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Ignyta, Janssen, Lilly, Loxo, Merck, Mirati, MSD (Merck Sharp & Dohme), Novartis, Nuvalent, Pfizer, Roche, Seattle Genetics, Takeda and Turning Point; research support (to institution): BMS, Janssen, Novartis, Pfizer and AstraZeneca. B.B. reports receiving grants from AbbVie, Amgen, AstraZeneca, Chugai, Daiichi Sankyo, Ellipse, EISAI, Genmab, Genzyme Corporation, Hedera Dx, Inivata, IPSEN, Janssen, MSD, PharmaMar, Roche (Genentech), Sanofi, Socar Research, Tahio Oncology and Turning Point Therapeutics. R.S.H. reports consulting roles with AbbVie Pharmaceuticals, ARMO Biosciences, AstraZeneca, Biodesix, Bolt Biotherapeutics, Bristol Myers Squibb, Cybrexa Therapeutics, eFFECTOR Therapeutics, Eli Lilly, EMD Serono, Genentech (Roche), Genmab, Halozyme Therapeutics, Heat Biologics, I-Mab Biopharma, Immunocore, Infinity Pharmaceuticals, Loxo Oncology, Merck, Mirati Therapeutics, Nektar, Neon Therapeutics, NextCure, Novartis, Oncternal Therapeutics, Pfizer, Sanofi, Seattle Genetics, Shire, Spectrum Pharmaceuticals, STCube Pharmaceuticals, Symphogen, Takeda, Tesaro, Tocagen and WindMIL Therapeutics; advisory board roles with AstraZeneca, Bolt Biotherapeutics, Cybrexa Therapeutics, EMD Serono, I-Mab Biopharma, Immunocore, Infinity Pharmaceuticals, Neon Therapeutics, Novartis and STCube Pharmaceuticals; research support from AstraZeneca, Eli Lilly, Genentech (Roche) and Merck; and non-executive board membership for Junshi Pharmaceuticals and Immunocore. H.A.W. reports grants or contracts from any entity: Bayer, Arrys Therapeutics, AstraZeneca–Medimmune, BMS, Clovis Oncology, Genentech (Roche), Merck, Novartis, Seagen, Xcovery and Helsinn; advisory board: Mirati, Merck and Genentech (Roche); leadership: International Association for the Study of Lung Cancer (IASLC), President; ECOG-ACRIN, executive committee. N.A.P. reports an employee at Synthekine and holds equity at Synthekine and Gritstone. A.T.S. is currently an employee of Novartis. P.A.J. reports stock and other ownership interests: Gatekeeper Pharmaceuticals and Loxo; consulting or advisory role: Pfizer, Boehringer Ingelheim, AstraZeneca, Merrimack, Chugai, Roche (Genentech), Loxo, Mirati Therapeutics, Araxes Pharma, Ignyta, Lilly, Takeda, Novartis, Biocartis, Voronoi Health Analytics, SFJ Pharmaceuticals Group, Sanofi, Daiichi Sankyo, Silicon Therapeutics, Nuvalent, Eisai, Bayer, Syndax, AbbVie, Allorion Therapeutics, Accutar Biotech, Transcenta, Monte Rosa Therapeutics, Scorpion Therapeutics, Merus, Frontier Medicines, Hongyun Biotech and Duality Biologics; research funding: AstraZeneca (Inst), Astellas Pharma (Inst), Daiichi Sankyo (Inst), Lilly (Inst), Boehringer Ingelheim (Inst), Puma Biotechnology (Inst), Takeda (Inst) and Revolution Medicines (Inst); patents, royalties, other intellectual property: I am a co-inventor on a DFCI owned patent on EGFR mutations licensed to Lab Corp. I receive post-marketing royalties from this invention. D.P.C. reports advisory boards or consulting: Abbvie, Arcus Biosciences, AstraZeneca, BMS Israel, G1 Therapeutics, Genentech, GlaxoSmithKline, InThought, Iovance Biotherapeutics, Janssen, Jazz, JNJ, Merck–EMD Serono, Merck KGaA, Mirati, MSD, Novartis, Novocure, OncoHost, Pfizer Egypt, Regeneron, Roche and Sanofi; KOL/presentation/education/forum: AstraZeneca, Curio Science, Intellisphere, Merck US, OncLive, Pfizer, PPD Development and Roche Taiwan. M.D.H. is an employee of and stockholder in AstraZeneca. C.M.R. reports consulted regarding oncology drug development with AbbVie, Amgen, AstraZeneca, D2G, Daiichi Sankyo, Epizyme, Genentech (Roche), Ipsen, Jazz, Kowa, Lilly, Merck and Syros. He serves on the scientific advisory boards of Auron, Bridge Medicines, DISCO, Earli and Harpoon Therapeutics. L.A. is an employee of Foundation Medicine and a stockholder of Roche Holding AG. H.M. reports full-time employee of AstraZeneca and stock/shares. Z.Z. reports employee of AstraZeneca as well as stockholder of AstraZeneca and Pfizer. Z.L. reports full-time employee and stock owner of AstraZeneca. R.S. reports other support from AstraZeneca during the conduct of the study, as well as other support from Pfizer outside the submitted work. S.P. reports consultation or advisory role: AbbVie, Amgen, Arcus, AstraZeneca, Bayer, Beigene, BerGenBio, Biocartis, BioInvent, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F-Star, Fishawack, Foundation Medicine, Genzyme, Gilead, GSK, Hutchmed, Illumina, Incyte, Ipsen, iTeos, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Mirati, Nykode Therapeutics, Novartis, Novocure, PharmaMar, Promontory Therapeutics, Pfizer, Regeneron, Roche (Genentech), Sanofi, Seattle Genetics and Takeda; Board of Directors position: Galenica; talk in a company’s organized public event: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Foundation Medicine, GSK, Illumina, Ipsen, Merck Sharp and Dohme, Mirati, Novartis, Pfizer, Roche (Genentech), Sanofi and Takeda; receipt of grants or research support: principal investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, Arcus, AstraZeneca, Beigene, Bristol Myers Squibb, GSK, iTeos, Merck Sharp and Dohme, Mirati, PharmaMar, Promontory Therapeutics, Roche (Genentech) and Seattle Genetics. J.M.J. and M.J.R. are employees and shareholders of D2G Oncology. I.P.W. is a co-founder, employee and shareholder of D2G Oncology. M.M.W. is a co-founder, shareholder, member of the board of directors and compensated scientific advisor of D2G Oncology. I.P.W. and M.M.W. are co-inventors of patents relating to technologies for an autochthonous mouse model of human cancer, which D2G Oncology has exclusively licensed from Stanford University. V.A.P. reports Pfizer employee and stockholder. K.K.W. is a founder and equity holder of G1 Therapeutics and has sponsored research agreements with Takeda, TargImmune, Bristol Myers Squibb, Mirati, Merus and Alkermes, and consulting and sponsored research agreements with AstraZeneca, Janssen, Pfizer, Novartis, Merck, Zentalis, BridgeBio and Blueprint. P.J. reports employee and stock or stock options of AstraZeneca. I.I.W. reports honoraria from Genentech (Roche), Bayer, Bristol Myers Squibb, AstraZeneca, Pfizer, Merck, Guardant Health, Flame, Novartis, Sanofi, Daiichi Sankyo, Amgen, Janssen, Merus, G1 Therapeutics, Abbvie, Catalyst Therapeutics, Regeneron, Oncocyte, Medscape, Platform Health and Physicians’ Education Resources; research support from Genentech, Merck, Bristol Myers Squibb, Medimmune, Adaptive, Adaptimmune, EMD Serono, Pfizer, Takeda, Amgen, Karus, Johnson & Johnson, Bayer, Iovance, 4D, Novartis and Akoya. A.G.P. reports Pfizer. J.V.H. reports Advisory Committees: Genentech, Mirati Therapeutics, Eli Lilly, Janssen, Boehringer Ingelheim, Regeneron, Takeda, BerGenBio, Jazz, Curio Science, Novartis, AstraZeneca, BioAlta, Sanofi, Spectrum, GlaxoSmithKline, EMD Serono, BluePrint Medicine and Chugai; research support: AstraZeneca, Boehringer Ingelheim, Spectrum, Mirati, Bristol Myers Squibb and Takeda; licensing or royalties: Spectrum. H.A.A., M.T.D., A.G.C., Y.Q., R.P., D.M., D.H.O., R.M., J.A.H., L.M., S.C.M.L., R.P.J., C.L., Z.W., M.G.W., D.V., H.S., M.K., S.K., Y.N., J.T.A., J.S., L.L., H.N.K., B.C., S.S., R.L., T.Z., J.J.L., D.P., M.L.J. T.T., A.P., Y.K. and J.L.: no disclosures were reported by these authors., (© 2024. The Author(s).)
Published: 2024
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46. Hormonal Agents in Localized and Advanced Prostate Cancer: Current Use and Future Perspectives.

Author: Turco F, Buttigliero C, Delcuratolo MD, Gillessen S, Vogl UM, Zilli T, Fossati N, Gallina A, Farinea G, Di Stefano RF, Calabrese M, Saporita I, Crespi V, Poletto S, Palesandro E, Di Maio M, Scagliotti GV, and Tucci M
Subjects: Humans, Male, Antineoplastic Agents, Hormonal therapeutic use, Receptors, Androgen metabolism, Treatment Outcome, Prostatic Neoplasms drug therapy, Prostatic Neoplasms pathology, Prostatic Neoplasms metabolism, Androgen Receptor Antagonists therapeutic use, Androgen Antagonists therapeutic use
Abstract: Prostate cancer (PC) is generally a hormone-dependent tumor. Androgen deprivation therapy ( has been the standard of care in metastatic disease for more than 80 years. Subsequent studies have highlighted the efficacy of ADT even in earlier disease settings such as in localized disease or in the case of biochemical recurrence (BCR). Improved knowledge of PC biology and ADT resistance mechanisms have led to the development of novel generation androgen receptor pathway inhibitors (ARPI). Initially used only in patients who became resistant to ADT, ARPI have subsequently shown to be effective when used in patients with metastatic hormone-naive disease and in recent years their effectiveness has also been evaluated in localized disease and in case of BCR. The objective of this review is to describe the current role of agents interfering with the androgen receptor in different stages of PC and to point out future perspectives., Competing Interests: Disclosure Fabio Turco: Travel support: Bayer. Silke Gillessen: (last 3 years) personal honoraria for participation in advisory boards from Amgen, MSD; other honoraria from Radio-televisione Svizzera Italiana (RSI), German-speaking European School of Oncology (DESO); invited speaker for ESMO, Swiss group for Clinical Cancer Research (SAKK), Swiss Academy of Multidisciplinary oncology (SAMO), Orikata academy research group, China Anticancer Association Genitourinary Oncology Committee (CACA-GU); Speaker's bureau for Janssen Cilag; travel grant from ProteoMEdiX and AstraZeneca. Institutional honoraria for participation in advisory boards or in Independent Data Monitoring Committees and Steering Committees from AAA International, Amgen, AstraZeneca, Astellas Pharma, Bayer, Bristol-Myers Squibb, DAIICHI Sankyo, Janssen, Modra Pharmaceuticals, MSD, Myriad Genetic, Novartis, Orion, Pfizer, Roche, Telixpharma, Tolermo Pharmaceutcials; invited speaker for Swiss group for Clinical Cancer Research (SAKK), Cold Spring Harbor Laboratory, ASCO GU; other honoraria from PeerVoice, Silvio Grasso Consulting, WebMD-Medscape. Patent royalties and other intellectual property for a research method for biomarker WO2009138392 Ursula Vogl: Advisory role (institutional): Janssen, Astellas, Merck, MSD, Pfizer, Roche, Bayer, BMS, Novartis AAA. Travel support: Janssen, Merck, Ipsen; Speakers Bureau (compensated, institutional): Janssen, Astellas, Pfizer, Roche, SAMO, BMS, Ipsen. Grant: Fond'Action The remaining authors declare no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
Published: 2024
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47. TFEB controls sensitivity to chemotherapy and immuno-killing in non-small cell lung cancer.

Author: Akman M, Monteleone C, Doronzo G, Godel M, Napoli F, Merlini A, Campani V, Nele V, Balmas E, Chontorotzea T, Fontana S, Digiovanni S, Barbu FA, Astanina E, Jafari N, Salaroglio IC, Kopecka J, De Rosa G, Mohr T, Bertero A, Righi L, Novello S, Scagliotti GV, Bussolino F, and Riganti C
Subjects: Humans, Mice, Animals, Female, Immunotherapy methods, Cell Line, Tumor, Male, Retrospective Studies, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Non-Small-Cell Lung immunology, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung metabolism, Basic Helix-Loop-Helix Leucine Zipper Transcription Factors metabolism, Basic Helix-Loop-Helix Leucine Zipper Transcription Factors genetics, Lung Neoplasms drug therapy, Lung Neoplasms immunology, Lung Neoplasms pathology, Lung Neoplasms genetics, Lung Neoplasms metabolism
Abstract: Background: In non-small cell lung cancer (NSCLC) the efficacy of chemo-immunotherapy is affected by the high expression of drug efflux transporters as ABCC1 and by the low expression of ABCA1, mediating the isopentenyl pyrophosphate (IPP)-dependent anti-tumor activation of Vγ9Vδ2 T-lymphocytes. In endothelial cells ABCA1 is a predicted target of the transcription factor EB (TFEB), but no data exists on the correlation between TFEB and ABC transporters involved in the chemo-immuno-resistance in NSCLC., Methods: The impact of TFEB/ABCC1/ABCA1 expression on NSCLC patients' survival was analyzed in the TCGA-LUAD cohort and in a retrospective cohort of our institution. Human NSCLC cells silenced for TFEB (shTFEB) were analyzed for ABC transporter expression, chemosensitivity and immuno-killing. The chemo-immuno-sensitizing effects of nanoparticles encapsulating zoledronic acid (NZ) on shTFEB tumors and on tumor immune-microenvironment were evaluated in Hu-CD34 + mice by single-cell RNA-sequencing., Results: TFEB low ABCA1 low ABCC1 high and TFEB high ABCA1 high ABCC1 low NSCLC patients had the worst and the best prognosis, respectively, in the TCGA-LUAD cohort and in a retrospective cohort of patients receiving platinum-based chemotherapy or immunotherapy as first-line treatment. By silencing shTFEB in NSCLC cells, we demonstrated that TFEB was a transcriptional inducer of ABCA1 and a repressor of ABCC1. shTFEB cells had also a decreased activity of ERK1/2/SREBP2 axis, implying reduced synthesis and efflux via ABCA1 of cholesterol and its intermediate IPP. Moreover, TFEB silencing reduced cholesterol incorporation in mitochondria: this event increased the efficiency of OXPHOS and the fueling of ABCC1 by mitochondrial ATP. Accordingly, shTFEB cells were less immuno-killed by the Vγ9Vδ2 T-lymphocytes activated by IPP and more resistant to cisplatin. NZ, which increased IPP efflux but not OXPHOS and ATP production, sensitized shTFEB immuno-xenografts, by reducing intratumor proliferation and increasing apoptosis in response to cisplatin, and by increasing the variety of anti-tumor infiltrating cells (Vγ9Vδ2 T-lymphocytes, CD8 + T-lymphocytes, NK cells)., Conclusions: This work suggests that TFEB is a gatekeeper of the sensitivity to chemotherapy and immuno-killing in NSCLC, and that the TFEB low ABCA1 low ABCC1 high phenotype can be predictive of poor response to chemotherapy and immunotherapy. By reshaping both cancer metabolism and tumor immune-microenvironment, zoledronic acid can re-sensitize TFEB low NSCLCs, highly resistant to chemo- and immunotherapy., (© 2024. The Author(s).)
Published: 2024
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48. Platinum-Based Chemotherapy Attenuates the Effector Response of CD8 T Cells to Concomitant PD-1 Blockade.

Author: Mariniello A, Nasti TH, Chang DY, Hashimoto M, Malik S, McManus DT, Lee J, McGuire DJ, Cardenas MA, Umana P, Nicolini V, Antia R, Saha A, Buchwald Z, Kissick H, Ghorani E, Novello S, Sangiolo D, Scagliotti GV, Ramalingam SS, and Ahmed R
Subjects: Animals, Mice, Immune Checkpoint Inhibitors pharmacology, Immune Checkpoint Inhibitors therapeutic use, Lymphocytic choriomeningitis virus immunology, Disease Models, Animal, Cisplatin pharmacology, Cisplatin administration & dosage, Lymphocytic Choriomeningitis immunology, Lymphocytic Choriomeningitis drug therapy, Lymphocytic Choriomeningitis virology, Humans, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacology, Mice, Inbred C57BL, Lung Neoplasms drug therapy, Lung Neoplasms immunology, Lung Neoplasms pathology, CD8-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes drug effects, Programmed Cell Death 1 Receptor antagonists & inhibitors
Abstract: Purpose: Combination of chemotherapy with programmed cell death 1 (PD-1) blockade is a front-line treatment for lung cancer. However, it remains unknown whether and how chemotherapy affects the response of exhausted CD8 T cells to PD-1 blockade., Experimental Design: We used the well-established mouse model of T-cell exhaustion with chronic lymphocytic choriomeningitis virus (LCMV) infection to assess the effect of chemotherapy (cisplatin+pemetrexed) on T-cell response to PD-1 blockade, in the absence of the impact of chemotherapy on antigen release and presentation observed in tumor models., Results: When concomitantly administered with PD-1 blockade, chemotherapy affected the differentiation path of LCMV-specific CD8 T cells from stem-like to transitory effector cells, thereby reducing their expansion and production of IFNγ. After combination treatment, these restrained effector responses resulted in impaired viral control, compared with PD-1 blockade alone. The sequential combination strategy, where PD-1 blockade followed chemotherapy, proved to be superior to the concomitant combination, preserving the proliferative response of exhausted CD8 T cells to PD-1 blockade. Our findings suggest that the stem-like CD8 T cells themselves are relatively unaffected by chemotherapy partly because they are quiescent and maintained by slow self-renewal at the steady state. However, upon the proliferative burst mediated by PD-1 blockade, the accelerated differentiation and self-renewal of stem-like cells may be curbed by concomitant chemotherapy, ultimately resulting in impaired overall CD8 T-cell effector functions., Conclusions: In a translational context, we provide a proof-of-concept to consider optimizing the timing of chemo-immunotherapy strategies for improved CD8 T-cell functions. See related commentary by Vignali and Luke, p. 1705., (©2023 The Authors; Published by the American Association for Cancer Research.)
Published: 2024
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49. Niraparib plus Dostarlimab in Pleural Mesothelioma or Non-Small Cell Lung Cancer Harboring HRR Mutations: Interim Results of the UNITO-001 Phase II Prospective Trial.

Author: Passiglia F, Righi L, Bironzo P, Listì A, Farinea G, Capelletto E, Novello S, Merlini A, and Scagliotti GV
Subjects: Humans, Recombinational DNA Repair, Prospective Studies, Mutation, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Lung Neoplasms drug therapy, Lung Neoplasms genetics, Mesothelioma, Malignant, Mesothelioma, Pleural Neoplasms, Indazoles, Piperidines, Antibodies, Monoclonal, Humanized
Abstract: Purpose: Treatment of homologous recombination repair-deficient (HRD)-tumors with PARP inhibitors has the potential to further increase tumor immunogenicity, suggesting a synergistic effect with immunotherapy. Here we present the preliminary results of niraparib in combination with dostarlimab for pleural mesothelioma (PM) or non-small cell lung cancer (NSCLC) harboring HRR mutations., Patients and Methods: UNITO-001 is a phase II, prospective, study aiming to investigate the combination of niraparib plus dostarlimab in pretreated patients with HRD and programmed death ligand-1 (PD-L1) ≥1% NSCLC and/or PM. The primary endpoint is progression-free survival (PFS)., Results: Seventeen of 183 (10%) screened patients (12 PM and 5 NSCLC) were included. The objective response rate (ORR) was 6% [95% confidence interval (CI): 0.1-28.7] and the disease control rate (DCR) was 53% (95% CI: 27.8-77). Median PFS was 3.1 (95% CI: 2.7-N.A) and median overall survival (OS) was 4.2 (95% CI: 1.58-NA) months. The PFS was 14.1 months in one PM patient harboring a germline BAP1 mutation. The treatment duration was 9.8 months in one PM patient harboring a somatic BRCA2 mutation. The most common adverse events (AE) were grade 1-2 lymphopenia (59%), anemia (35%), hyponatremia (29%), and hypokalemia (29%). Grade ≥3 AEs were reported in 23% of the patients., Conclusions: This preliminary analysis highlighted the lack of antitumor activity for the combination of niraparib and dostarlimab in patients with PM and/or advanced NSCLC harboring BAP1 somatic mutations. A potential antitumor activity emerged for PM with germline BAP1 and/or BRCA2 somatic mutations along with a good tolerability profile., (©2023 American Association for Cancer Research.)
Published: 2024
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50. Tislelizumab versus chemotherapy as second-line treatment for European and North American patients with advanced or metastatic esophageal squamous cell carcinoma: a subgroup analysis of the randomized phase III RATIONALE-302 study.

Author: Ajani J, El Hajbi F, Cunningham D, Alsina M, Thuss-Patience P, Scagliotti GV, Van den Eynde M, Kim SB, Kato K, Shen L, Li L, Ding N, Shi J, Barnes G, and Van Cutsem E
Subjects: Humans, Quality of Life, Antibodies, Monoclonal, Humanized pharmacology, Antibodies, Monoclonal, Humanized therapeutic use, Esophageal Squamous Cell Carcinoma drug therapy, Esophageal Neoplasms drug therapy, Esophageal Neoplasms pathology
Abstract: Background: The phase III RATIONALE-302 study evaluated tislelizumab, an anti-programmed cell death protein 1 antibody, as second-line (2L) treatment for advanced/metastatic esophageal squamous cell carcinoma (ESCC). This prespecified exploratory analysis investigated outcomes in patients from Europe and North America (Europe/North America subgroup)., Patients and Methods: Patients with tumor progression during/after first-line systemic treatment were randomized 1 : 1 to open-label tislelizumab or investigator's choice of chemotherapy (paclitaxel, docetaxel, or irinotecan)., Results: The Europe/North America subgroup comprised 108 patients (tislelizumab: n = 55; chemotherapy: n = 53). Overall survival (OS) was prolonged with tislelizumab versus chemotherapy (median: 11.2 versus 6.3 months), with a hazard ratio (HR) of 0.55 [95% confidence interval (CI) 0.35-0.87]; HR was similar irrespective of programmed death-ligand 1 score [≥10%: 0.47 (95% CI 0.18-1.21); <10%: 0.55 (95% CI 0.30-1.01)]. Median progression-free survival was 2.3 versus 2.7 months with tislelizumab versus chemotherapy [HR: 0.97 (95% CI 0.64-1.47)]. Overall response rate was greater with tislelizumab (20.0%) versus chemotherapy (11.3%), with more durable response (median duration of response: 5.1 versus 2.1 months). Tislelizumab had a favorable safety profile versus chemotherapy, with fewer patients experiencing ≥grade 3 treatment-related adverse events (13.0% versus 51.0%). Those on tislelizumab experienced less deterioration in health-related quality of life, physical functioning, and/or disease- and treatment-related symptoms (i.e. fatigue, pain, and eating problems) as compared to those on chemotherapy, per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and QLQ-OES18 scores., Conclusions: As a 2L therapy for advanced/metastatic ESCC, tislelizumab improved OS and had a favorable safety profile as compared to chemotherapy in European/North American ESCC patients in the randomized phase III RATIONALE-302 study., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Published: 2024
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