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1. nab-Paclitaxel/carboplatin in elderly patients with advanced squamous non-small cell lung cancer: a retrospective analysis of a Phase III trial

Author

Gridelli C, Chen T, Ko A, O'Brien ME, Ong TJ, Socinski MA, and Postmus PE

Subjects
Taxanes, Comorbidities, Age, Chemotherapy, Histology, Therapeutics. Pharmacology, RM1-950
Abstract

Cesare Gridelli,1 Tianlei Chen,2 Amy Ko,2 Mary E O’Brien,3 Teng Jin Ong,4 Mark A Socinski,5 Pieter E Postmus6 1Division of Medical Oncology, S. G. Moscati Hospital, Avellino, Italy; 2Biostatistics, Celgene Corporation, Summit, NJ, USA; 3Medical Oncology, Royal Marsden Hospital, London, UK; 4Medical Affairs, Celgene Corporation, Summit, NJ, USA; 5Lung Cancer & Esophageal Cancer, Florida Hospital Cancer Institute, Orlando, FL, USA; 6Pulmonary Diseases, Clatterbridge Cancer Center, Liverpool, UK Background: Limited data on elderly patients with squamous advanced non-small cell lung cancer (NSCLC) preclude optimal treatment. Here, we report the outcomes of a retrospective analysis of a subset of patients ≥70 years with squamous histology from the Phase III trial that evaluated nab-paclitaxel/carboplatin vs paclitaxel/carboplatin. Patients and methods: Patients with stage IIIB/IV NSCLC received (1:1) nab-paclitaxel 100 mg/m2 on days 1, 8, and 15 or paclitaxel 200 mg/m2 on day 1, both with carboplatin area under the curve 6 mg×min/mL on day 1 every 3 weeks. The primary endpoint was independently assessed overall response rate as per the Response Evaluation Criteria in Solid Tumors v1.0. Secondary endpoints included progression-free survival, overall survival, and safety. Results: Sixty-five patients ≥70 years with squamous histology were included (nab-paclitaxel/carboplatin, n=35; paclitaxel/carboplatin, n=30). nab-Paclitaxel/carboplatin vs paclitaxel/carboplatin, respectively, resulted in an overall response rate of 46% vs 20% (response rate ratio, 2.29, P=0.029) and a median overall survival of 16.9 vs 8.6 months (hazard ratio, 0.50, P=0.018). No difference was observed in median progression-free survival (5.7 months for both). Incidences of grade 3/4 neutropenia (50% vs 63%), leukopenia (29% vs 37%), fatigue (3% vs 13%), and peripheral neuropathy (3% vs 13%) were lower, but those of thrombocytopenia (21% vs 10%) and anemia (21% vs 7%) were higher with nab-paclitaxel/carboplatin vs paclitaxel/carboplatin. Conclusion: nab-Paclitaxel/carboplatin was efficacious and tolerable in patients ≥70 years with squamous NSCLC. These results build upon prior analyses, indicating that nab-paclitaxel/carboplatin is effective for this difficult-to-treat patient subgroup. Keywords: taxanes, comorbidities, age, chemotherapy, histology

Published
2018

2. nab-paclitaxel/carboplatin induction in squamous NSCLC: longitudinal quality of life while on chemotherapy

Author

Thomas M, Spigel DR, Jotte RM, McCleod M, Socinski MA, Page RD, Gressot L, Knoble J, Juan O, Morgensztern D, Isla D, Kim ES, West H, Ko A, Ong TJ, Trunova N, and Gridelli C

Subjects
nab-paclitaxel, non-small cell lung cancer, quality of life, response, squamous, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Michael Thomas,1,2 David R Spigel,3 Robert M Jotte,4 Michael McCleod,5 Mark A Socinski,6 Ray D Page,7 Laurent Gressot,8 Jeanna Knoble,9 Oscar Juan,10 Daniel Morgensztern,11 Dolores Isla,12 Edward S Kim,13 Howard West,14 Amy Ko,15 Teng Jin Ong,15 Nataliya Trunova,15 Cesare Gridelli16 On behalf of ABOUND.sqm investigators 1Department of Thoracic Oncology/Internal Medicine, Thoraxklinik im Universitätsklinikum Heidelberg, 2Translational Lung Research Center Heidelberg, Heidelberg, Germany; 3Sarah Cannon Research Institute, Nashville, TN, 4Department of Medical Oncology/Hematology, Rocky Mountain Cancer Centers, Denver, CO, 5Florida Cancer Specialists, Fort Myers, 6Florida Hospital Cancer Institute, Orlando, FL, 7The Center for Cancer and Blood Disorders, Fort Worth, 8North Cypress Cancer Center, Cypress, TX, 9The Mark H. Zangmeister Center, Columbus, OH, USA; 10Department of Medical Oncology, Hospital Universitari i Politécnic La Fe, Valencia, Spain; 11Department of Medical Oncology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA; 12Department of Medical Oncology, University Hospital Lozano Blesa, Zaragoza, Spain; 13Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC, 14Thoracic Oncology Program, Swedish Cancer Institute, Seattle, WA, 15Celgene Corporation, Summit, NJ, USA; 16Department of Oncology/Hematology, S.G. Moscati Hospital, Avellino, Italy Background: Longitudinal data on the impact of treatment on quality of life (QoL) in advanced non-small cell lung cancer (NSCLC) are limited. In this palliative setting, treatment that does not deteriorate QoL is key. Here we report longitudinal QoL in patients with squamous NSCLC, receiving ≤4 cycles of nab-paclitaxel/carboplatin combination chemotherapy. Methods: Patients received nab-paclitaxel 100 mg/m2 days 1, 8, 15 + carboplatin area under the curve 6 mg•min/mL day 1 (q3w) for four cycles. QoL was assessed by the Lung Cancer Symptom Scale (LCSS) and Euro-QoL-5 Dimensions-5 Levels (EQ-5D-5L) at baseline and each cycle (day 1). Results: Two-hundred and six lesion-response-evaluable patients completed baseline + ≥1 postbaseline QoL assessment and were QoL evaluable. LCSS average total score and symptom burden index improved from baseline throughout four cycles. In the LCSS pulmonary symptoms score, 46% of patients reported clinically meaningful improvement (≥10 mm visual analog scale) from baseline. Individual EQ-5D-5L dimensions remained stable/improved in ≥83% of patients; ≈33% reported complete resolution of baseline problems at least once during four cycles. Generally, responders (unconfirmed complete/partial response) had higher scores vs nonresponders. Conclusion: In patients with squamous NSCLC, four cycles of nab-paclitaxel/carboplatin demonstrated clinically meaningful QoL improvements, with greater benefits in responders vs nonresponders. Keywords: nab-paclitaxel, non-small cell lung cancer, quality of life, response, squamous

Published
2017

6. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Bachelot, T., Bouzid, K., Campone, M., Desmoulins, I., Coudert, B., Bondarenko, I., Nowecki, Z., Glogowska, I., Ciruelos Gil, E., Errihani, H., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Paluch-Shimon, S., Wardley, A., Schneeweiss, A., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Puglisi, F., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Miles, D., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhász, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vásques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M.J., Illarramendi Mañas, J., Martinez De Dueñas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcón Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., McCarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Böess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferraù, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., López, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Müller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H.M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeño, M., Ruohola, J., Berdah, J.-F., Goncalves, A., Orfeuvre, H., Grischke, E.-M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D’Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., García Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M.H., Martínez Jañez, N., Mele Olive, M., McAdam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Grève, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kütner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Lück, H.-J., Zahm, D.-M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C.H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Viñas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kühn, T., Ober, A., Repp, R., Schröder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Pérez Martínez, M., van de Wouw, A.J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Antón Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florián Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Björneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodríguez, R., Ciruelos, E., Peretz-Yablonski, T., Merot, J.-L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., and Klingbiel, D.

Published
2021
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9. RNA-based next-generation sequencing in non-small-cell lung cancer in a routine setting: an experience from an Italian referral center

Author

Luca, C, Pepe, F, Pisapia, P, Iaccarino, A, Righi, L, Listi, A, Russo, G, Campione, S, Pagni, F, Nacchio, M, Conticelli, F, Russo, M, Fabozzi, T, Vigliar, E, Bellevicine, C, Rocco, D, Laudati, S, Iannaci, G, Daniele, B, Gridelli, C, Cortinovis, D, Novello, S, Molina-Vila, M, Rosell, R, Troncone, G, Malapelle, U, Luca C., Pepe F., Pisapia P., Iaccarino A., Righi L., Listi A., Russo G., Campione S., Pagni F., Nacchio M., Conticelli F., Russo M., Fabozzi T., Vigliar E., Bellevicine C., Rocco D., Laudati S., Iannaci G., Daniele B., Gridelli C., Cortinovis D. L., Novello S., Molina-Vila M. A., Rosell R., Troncone G., Malapelle U., Luca, C, Pepe, F, Pisapia, P, Iaccarino, A, Righi, L, Listi, A, Russo, G, Campione, S, Pagni, F, Nacchio, M, Conticelli, F, Russo, M, Fabozzi, T, Vigliar, E, Bellevicine, C, Rocco, D, Laudati, S, Iannaci, G, Daniele, B, Gridelli, C, Cortinovis, D, Novello, S, Molina-Vila, M, Rosell, R, Troncone, G, Malapelle, U, Luca C., Pepe F., Pisapia P., Iaccarino A., Righi L., Listi A., Russo G., Campione S., Pagni F., Nacchio M., Conticelli F., Russo M., Fabozzi T., Vigliar E., Bellevicine C., Rocco D., Laudati S., Iannaci G., Daniele B., Gridelli C., Cortinovis D. L., Novello S., Molina-Vila M. A., Rosell R., Troncone G., and Malapelle U.

Abstract

Aim: ALK, ROS1, NTRK and RET gene fusions and MET exon 14 skipping alterations represent novel predictive biomarkers for advanced non-small-cell lung cancer (NSCLC). Therefore, testing patients for these genetic variants is crucial for choosing the best selective treatment. Over the last couple of decades, next-generation sequencing (NGS) platforms have emerged as an extremely useful tool for detecting these variants. Materials & methods: In the present study, we report our NGS molecular records produced during a year of diagnostic activity. Results: Overall, our in-house developed NGS workflow successfully analyzed n = 116/131 (88.5%) NSCLC samples. Of these, eight (6.8%) and five (4.3%) out of 116 patients harbored ALK and RET gene rearrangements, respectively: one case harbored ROS1 gene fusion (0.7%). Conclusion: Our results highlight that an RNA-based NGS analysis can reliably detect gene fusion alterations, thereby playing a pivotal role in the management of NSCLC patients.

Published
2022

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

Author

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

Abstract

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

Published
2023

11. Cilengitide combined with cetuximab and platinum-based chemotherapy as first-line treatment in advanced non-small-cell lung cancer (NSCLC) patients: results of an open-label, randomized, controlled phase II study (CERTO)

Author

Vansteenkiste, J., Barlesi, F., Waller, C.F., Bennouna, J., Gridelli, C., Goekkurt, E., Verhoeven, D., Szczesna, A., Feurer, M., Milanowski, J., Germonpre, P., Lena, H., Atanackovic, D., Krzakowski, M., Hicking, C., Straub, J., Picard, M., Schuette, W., and O'Byrne, K.

Published
2015
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17. P1.11-01 Cobolimab with Dostarlimab and Docetaxel in Patients with Advanced Non-small Cell Lung Cancer (NSCLC): COSTAR Lung

Author

Kim, H.R., primary, Gridelli, C., additional, Kapur, D., additional, Tufman, A., additional, Felip, E., additional, Velcheti, V., additional, Kim, Y.J., additional, Goetze, T.O., additional, Lopez, P. Garrido, additional, Corre, R., additional, Penkov, K., additional, Anjum, R., additional, Di Pace, B., additional, Liu, W., additional, Borgovan, T., additional, Ledger, D., additional, Carver, J., additional, Waszak, A., additional, Dhar, A., additional, and Novello, S., additional

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

Author

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

Published
2022
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19. EP06.01-006 Multidisciplinary Team during the COVID-19 Pandemic: The BE-PACIFIC Italian Observational Study Analysis

Author

Ramella, S., primary, Morabito, A., additional, Silipigni, S., additional, Russo, A., additional, Capelletto, E., additional, Rossi, S., additional, Leonetti, A., additional, Montrone, M., additional, Facilissimo, I., additional, Romano, G., additional, Stasi, I., additional, Ceresoli, G., additional, Gridelli, C., additional, Lugini, A., additional, Pilotto, S., additional, Tagliaferri, P., additional, Bria, E., additional, Canova, S., additional, Rijavec, E., additional, Borghetti, P., additional, Brighenti, M., additional, Carta, A.M., additional, Ciuffreda, L., additional, Giusti, R., additional, Macerelli, M., additional, Verderame, F., additional, Zanelli, F., additional, Berardi, R., additional, Gregorc, V., additional, Sergi, C., additional, Vattemi, E., additional, Manglaviti, S., additional, Piovano, P.L., additional, Olmetto, E., additional, Borra, G., additional, Gori, S., additional, Aieta, M., additional, Bertolini, A., additional, Cecere, F., additional, Pasello, G., additional, Rocco, D., additional, Zulian, M., additional, Roncari, B., additional, and Novello, S., additional

Published
2022
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20. EP05.01-024 Real-life Management of Stage III NSCLC Patients in Italy: The BE-PACIFIC Observational Study

Author

Novello, S., primary, Morabito, A., additional, Silipigni, S., additional, Adamo, V., additional, Bironzo, P., additional, Rossi, S., additional, Tiseo, M., additional, Montrone, M., additional, Facilissimo, I., additional, Romano, G., additional, Stasi, I., additional, Ceresoli, G., additional, Gridelli, C., additional, Lugini, A., additional, Pilotto, S., additional, Tagliaferri, P., additional, Bria, E., additional, Cortinovis, D., additional, Grossi, F., additional, Borghetti, P., additional, Brighenti, M., additional, Carta, A.M., additional, Ciuffreda, L., additional, Giusti, R., additional, Macerelli, M., additional, Verderame, F., additional, Zanelli, F., additional, Berardi, R., additional, Gregorc, V., additional, Sergi, C., additional, Vattemi, E., additional, Ferrara, R., additional, Piovano, P.L., additional, Scotti, V., additional, Borra, G., additional, Gori, S., additional, Aieta, M., additional, Bertolini, A., additional, Cecere, F., additional, Pasello, G., additional, Rocco, D., additional, Lo Certo, G., additional, Simoni, L., additional, and Ramella, S., additional

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

Author

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

Published
2022
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22. Expert consensus on perioperative treatment for non-small cell lung cancer

Author

Duan, J, Tan, F, Bi, N, Chen, C, Chen, K-N, Cheng, Y, Chu, Q, Ge, D, Hu, J, Huang, Y, Jiang, T, Long, H, Lu, Y, Shi, M, Wang, J, Wang, Q, Yang, F, Yang, N, Yao, Y, Ying, J, Zhou, C, Zhou, Q, Bongiolatti, S, Brunelli, A, Fiorelli, A, Gobbini, E, Gridelli, C, John, T, Kim, JJ, Lin, SH, Metro, G, Minervini, F, Novoa, NM, Owen, DH, Rodriguez, M, Sakanoue, I, Scarci, M, Suda, K, Tabbo, F, Tam, TCC, Tsuchida, M, Uchino, J, Voltolini, L, Gao, S, Duan, J, Tan, F, Bi, N, Chen, C, Chen, K-N, Cheng, Y, Chu, Q, Ge, D, Hu, J, Huang, Y, Jiang, T, Long, H, Lu, Y, Shi, M, Wang, J, Wang, Q, Yang, F, Yang, N, Yao, Y, Ying, J, Zhou, C, Zhou, Q, Bongiolatti, S, Brunelli, A, Fiorelli, A, Gobbini, E, Gridelli, C, John, T, Kim, JJ, Lin, SH, Metro, G, Minervini, F, Novoa, NM, Owen, DH, Rodriguez, M, Sakanoue, I, Scarci, M, Suda, K, Tabbo, F, Tam, TCC, Tsuchida, M, Uchino, J, Voltolini, L, and Gao, S

Published
2022

23. Evaluation of the Molecular Landscape in PD-L1 Positive Metastatic NSCLC: Data from Campania, Italy

Author

Pisapia, P, Iaccarino, A, De Luca, C, Acanfora, G, Bellevicine, C, Bianco, R, Daniele, B, Ciampi, L, De Felice, M, Fabozzi, T, Formisano, L, Giordano, P, Gridelli, C, Ianniello, G, Libroia, A, Maione, P, Nacchio, M, Pagni, F, Palmieri, G, Pepe, F, Russo, G, Salatiello, M, Santaniello, A, Scamarcio, R, Seminati, D, Troia, M, Troncone, G, Vigliar, E, Malapelle, U, Pisapia, Pasquale, Iaccarino, Antonino, De Luca, Caterina, Acanfora, Gennaro, Bellevicine, Claudio, Bianco, Roberto, Daniele, Bruno, Ciampi, Luisa, De Felice, Marco, Fabozzi, Teresa, Formisano, Luigi, Giordano, Pasqualina, Gridelli, Cesare, Ianniello, Giovanni Pietro, Libroia, Annamaria, Maione, Paolo, Nacchio, Mariantonia, Pagni, Fabio, Palmieri, Giovanna, Pepe, Francesco, Russo, Gianluca, Salatiello, Maria, Santaniello, Antonio, Scamarcio, Rachele, Seminati, Davide, Troia, Michele, Troncone, Giancarlo, Vigliar, Elena, Malapelle, Umberto, Pisapia, P, Iaccarino, A, De Luca, C, Acanfora, G, Bellevicine, C, Bianco, R, Daniele, B, Ciampi, L, De Felice, M, Fabozzi, T, Formisano, L, Giordano, P, Gridelli, C, Ianniello, G, Libroia, A, Maione, P, Nacchio, M, Pagni, F, Palmieri, G, Pepe, F, Russo, G, Salatiello, M, Santaniello, A, Scamarcio, R, Seminati, D, Troia, M, Troncone, G, Vigliar, E, Malapelle, U, Pisapia, Pasquale, Iaccarino, Antonino, De Luca, Caterina, Acanfora, Gennaro, Bellevicine, Claudio, Bianco, Roberto, Daniele, Bruno, Ciampi, Luisa, De Felice, Marco, Fabozzi, Teresa, Formisano, Luigi, Giordano, Pasqualina, Gridelli, Cesare, Ianniello, Giovanni Pietro, Libroia, Annamaria, Maione, Paolo, Nacchio, Mariantonia, Pagni, Fabio, Palmieri, Giovanna, Pepe, Francesco, Russo, Gianluca, Salatiello, Maria, Santaniello, Antonio, Scamarcio, Rachele, Seminati, Davide, Troia, Michele, Troncone, Giancarlo, Vigliar, Elena, and Malapelle, Umberto

Abstract

Background: Immune-checkpoint inhibitors (ICIs) have increased and improved the treatment options for patients with non-oncogene-addicted advanced stage non-small cell lung cancer (NSCLC). However, the role of ICIs in oncogene-addicted advanced stage NSCLC patients is still debated. In this study, in an attempt to fill in the informational gap on the effect of ICIs on other driver mutations, we set out to provide a molecular landscape of clinically relevant oncogenic drivers in programmed death-ligand 1 (PD-L1) positive NSCLC patients. Methods: We retrospectively reviewed data on 167 advanced stage NSCLC PD-L1 positive patients (≥1%) who were referred to our clinic for molecular evaluation of five driver oncogenes, namely, EGFR, KRAS, BRAF, ALK and ROS1. Results: Interestingly, n = 93 (55.7%) patients showed at least one genomic alteration within the tested genes. Furthermore, analyzing a subset of patients with PD-L1 tumor proportion score (TPS) ≥ 50% and concomitant gene alterations (n = 8), we found that n = 3 (37.5%) of these patients feature clinical benefit with ICIs administration, despite the presence of a concomitant KRAS gene alteration. Conclusions: In this study, we provide a molecular landscape of clinically relevant biomarkers in NSCLC PD-L1 positive patients, along with data evidencing the clinical benefit of ICIs in patient NSCLC PD-L1 positive alterations.

Published
2022

34. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Miles, D., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Campone, M., additional, Bondarenko, I., additional, Nowecki, Z., additional, Errihani, H., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, Trask, P., additional, du Toit, Y., additional, Pena-Murillo, C., additional, Revelant, V., additional, Klingbiel, D., additional, Bachelot, T., additional, Bouzid, K., additional, Desmoulins, I., additional, Coudert, B., additional, Glogowska, I., additional, Ciruelos Gil, E., additional, Dalenc, F., additional, Ricci, F., additional, Dieras, V., additional, Kaufman, B., additional, Ferreira, A., additional, Mano, M., additional, Kalofonos, H., additional, Andreetta, C., additional, Montemurro, F., additional, Barrett, S., additional, Zhang, Q., additional, Mavroudis, D., additional, Matus, J., additional, Villarreal Garza, C., additional, Beato, C., additional, Ismael, G., additional, Hu, X., additional, Abdel Azeem, H., additional, Gaafar, R., additional, Perrin, C., additional, Kerbrat, P., additional, Ettl, J., additional, Paepke, S., additional, Hitre, E., additional, Lang, I., additional, Trudeau, M., additional, Verma, S., additional, Li, H., additional, Hoffmann, O., additional, Aktas, B., additional, Cariello, A., additional, Cruciani, G., additional, Tienghi, A., additional, Tondini, C., additional, Al-Twegieri, T., additional, Loman, N., additional, Laing, R., additional, Miles, D., additional, Brain, E., additional, Fasching, P., additional, Lux, M., additional, Frassoldati, A., additional, Aziz, Z., additional, Salas, J., additional, Streb, J., additional, Krzemieniecki, K., additional, Wronski, A., additional, Garcia Garcia, J., additional, Menjon Beltran, S., additional, Cicin, I., additional, Schmid, P., additional, Gallagher, C., additional, Turner, N., additional, Tong, Z., additional, Boer, K., additional, Juhász, B., additional, Horvath, Z., additional, Bianchini, G., additional, Gianni, L., additional, Curigliano, G., additional, Juarez Ramiro, A., additional, Susnjar, S., additional, Matos, E., additional, Sevillano, E., additional, Garcia Estevez, L., additional, Gokmen, E., additional, Uslu, R., additional, Wildiers, H., additional, Schutz, F., additional, Cruz, M., additional, Bourgeois, H., additional, von Schumann, R., additional, Stemmer, S., additional, Dominguez, A., additional, Morales-Vásques, F., additional, Wojtukiewicz, M., additional, Trifunovic, J., additional, Echarri Gonzalez, M.J., additional, Illarramendi Mañas, J., additional, Martinez De Dueñas, E., additional, Voitko, N., additional, Hicks, J., additional, Waters, S., additional, Barrett-Lee, P., additional, Wheatley, D., additional, De Boer, R., additional, Cocquyt, V., additional, Jerusalem, G., additional, Barrios, C., additional, Panasci, L., additional, Mattson, J., additional, Tanner, M., additional, Gozy, M., additional, Vasilopoulos, G., additional, Papandreou, C., additional, Revesz, J., additional, Battelli, N., additional, Benedetti, G., additional, Latini, L., additional, Gridelli, C., additional, Lazaro Leon, J., additional, Alarcón Company, J., additional, Arance Fernandez, A., additional, Barnadas Molins, A., additional, Calvo Plaza, I., additional, Bratos, R., additional, Gonzalez Martin, A., additional, Izarzugaza Peron, Y., additional, Klint, L., additional, Kovalev, A., additional, McCarthy, N., additional, Yeo, B., additional, Kee, D., additional, Thomson, J., additional, White, S., additional, Greil, R., additional, Wang, S., additional, Artignan, X., additional, Juhasz-Böess, I., additional, Rody, A., additional, Ngan, R., additional, Dourleshter, F., additional, Goldberg, H., additional, Doni, L., additional, Di Costanzo, F., additional, Ferraù, F., additional, Drobniene, M., additional, Aleknavicius, E., additional, Rashid, K., additional, Costa, L., additional, de la Cruz Merino, L., additional, Garcia Saenz, J., additional, López, R., additional, Del Val Munoz, O., additional, Ozyilkan, O., additional, Azribi, F., additional, Jaafar, H., additional, Baird, R., additional, Verrill, M., additional, Beith, J., additional, Petzer, A., additional, Moreira de Andrade, J., additional, Bernstein, V., additional, Macpherson, N., additional, Rayson, D., additional, Saad Eldin, I., additional, Achille, M., additional, Augereau, P., additional, Müller, V., additional, Rasco, A., additional, Evron, E., additional, Katz, D., additional, Berardi, R., additional, Cascinu, S., additional, De Censi, A., additional, Gennari, A., additional, El-Saghir, N., additional, Ghosn, M., additional, Oosterkamp, H.M., additional, Van den Bosch, J., additional, Kukulska, M., additional, Kalinka, E., additional, Alonso, J., additional, Dalmau Portulas, E., additional, Del Mar Gordon Santiago, M., additional, Pelaez Fernandez, I., additional, Aksoy, S., additional, Altundag, K., additional, Senol Coskun, H., additional, Bozcuk, H., additional, Shparyk, Y., additional, Barraclough, L., additional, Levitt, N., additional, Panwar, U., additional, Kelly, S., additional, Rigg, A., additional, Varughese, M., additional, Castillo, C., additional, Fein, L., additional, Malik, L., additional, Stuart-Harris, R., additional, Singer, C., additional, Stoeger, H., additional, Samonigg, H., additional, Feng, J., additional, Cedeño, M., additional, Ruohola, J., additional, Berdah, J.-F., additional, Goncalves, A., additional, Orfeuvre, H., additional, Grischke, E.-M., additional, Simon, E., additional, Wagner, S., additional, Koumakis, G., additional, Papazisis, K., additional, Ben Baruch, N., additional, Fried, G., additional, Geffen, D., additional, Karminsky, N., additional, Peretz, T., additional, Cavanna, L., additional, Pedrazzioli, P., additional, Grasso, D., additional, Ruggeri, E., additional, D’Auria, G., additional, Moscetti, L., additional, Juozaityte, E., additional, Rodriguez Cid, J., additional, Roerdink, H., additional, Siddiqi, N., additional, Passos Coelho, J., additional, Arcediano Del Amo, A., additional, Garcia Garre, E., additional, García Gonzalez, M., additional, Garcia-Palomo Perez, A., additional, Herenandez Perez, C., additional, Lopez Alvarez, P., additional, Lopez De Ceballos, M.H., additional, Martínez Jañez, N., additional, Mele Olive, M., additional, McAdam, K., additional, Perren, T., additional, Dunn, G., additional, Humphreys, A., additional, Taylor, W., additional, Vera, R., additional, Kaen, L., additional, Andel, J., additional, Steger, G., additional, De Grève, J., additional, Huizing, M., additional, Hegg, R., additional, Joy, A., additional, Kuruvilla, P., additional, Sehdev, S., additional, Smiljanic, S., additional, Kütner, R., additional, Alexandre, J., additional, Grosjean, J., additional, Laplaige, P., additional, Largillier, R., additional, Maes, P., additional, Martin, P., additional, Pottier, V., additional, Christensen, B., additional, Khandan, F., additional, Lück, H.-J., additional, Zahm, D.-M., additional, Fountzilas, G., additional, Karavasilis, V., additional, Safra, T., additional, Inbar, M., additional, Ryvo, L., additional, Bonetti, A., additional, Seles, E., additional, Giacobino, A., additional, Chavarri Guerra, Y., additional, de Jongh, F., additional, van der Velden, A., additional, van Warmerdam, L., additional, Vrijaldenhoven, S., additional, Smorenburg, C.H., additional, Cavero, M., additional, Andres Conejero, R., additional, Oltra Ferrando, A., additional, Redondo Sanchez, A., additional, Ribelles Entrena, N., additional, Saura Grau, S., additional, Viñas Vilaro, G., additional, Bachmeier, K., additional, Beresford, M., additional, Butt, M., additional, Joffe, J., additional, Poole, C., additional, Woodings, P., additional, Chakraborti, P., additional, Yordi, G., additional, Woodward, N., additional, Nobre, A., additional, Luiz Amorim, G., additional, Califaretti, N., additional, Fox, S., additional, Robidoux, A., additional, Li, E., additional, Li, N., additional, Jiang, J., additional, Soria, T., additional, Padrik, P., additional, Lahdenpera, O., additional, Barletta, H., additional, Dohollou, N., additional, Genet, D., additional, Prulhiere, K., additional, Coeffic, D., additional, Facchini, T., additional, Vieillot, S., additional, Catala, S., additional, Teixeira, L., additional, Hesse, T., additional, Kühn, T., additional, Ober, A., additional, Repp, R., additional, Schröder, W., additional, Pectasides, D., additional, Bodoky, G., additional, Kahan, Z., additional, Jiveliouk, I., additional, Rosengarten, O., additional, Rossi, V., additional, Alabiso, O., additional, Pérez Martínez, M., additional, van de Wouw, A.J., additional, Smok-Kalwat, J., additional, Damasecno, M., additional, Augusto, I., additional, Sousa, G., additional, Saadein, A., additional, Abdelhafiez, N., additional, Abulkhair, O., additional, Antón Torres, A., additional, Corbellas Aparicio, M., additional, Llorente Domenech, R., additional, Florián Jerico, J., additional, Garcia Mata, J., additional, Gil Raga, M., additional, Galan Brotons, A., additional, Llombart Cussac, A., additional, Llorca Ferrandiz, C., additional, Martinez Del Prado, P., additional, Olier Garate, C., additional, Rodriguez Sanchez, C., additional, Sanchez Gomez, R., additional, Santisteban Eslava, M., additional, Soberino, J., additional, Vidal Losada Garcia, M., additional, Soto de Prado, D., additional, Torrego Garcia, J., additional, Vicente Rubio, E., additional, Garcia, M., additional, Murias Rosales, A., additional, Granstam Björneklett, H., additional, Narbe, U., additional, Jafri, M., additional, Rea, D., additional, Newby, J., additional, Jones, A., additional, Westwell, S., additional, Ring, A., additional, Alonso, I., additional, and Rodríguez, R., additional

Published
2021
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36. Crizotinib in MET-Deregulated or ROS1-Rearranged Pretreated Non-Small Cell Lung Cancer (METROS): A Phase II, Prospective, Multicenter, Two-Arms Trial

Author

Landi, L, Chiari, R, Tiseo, M, D'Incà, F, Dazzi, C, Chella, A, Delmonte, A, Bonanno, L, Giannarelli, D, Cortinovis, D, de Marinis, F, Borra, G, Morabito, A, Gridelli, C, Galetta, D, Barbieri, F, Grossi, F, Capelletto, E, Minuti, G, Mazzoni, F, Verusio, C, Bria, E, Alì, G, Bruno, R, Proietti, A, Fontanini, G, Crinò, L, Cappuzzo, F, Landi L, Chiari R, Tiseo M, D'Incà F, Dazzi C, Chella A, Delmonte A, Bonanno L, Giannarelli D, Cortinovis D, de Marinis F, Borra G, Morabito A, Gridelli C, Galetta D, Barbieri F, Grossi F, Capelletto E, Minuti G, Mazzoni F, Verusio C, Bria E, Alì G, Bruno R, Proietti A, Fontanini G, Crinò L, Cappuzzo F, Landi, L, Chiari, R, Tiseo, M, D'Incà, F, Dazzi, C, Chella, A, Delmonte, A, Bonanno, L, Giannarelli, D, Cortinovis, D, de Marinis, F, Borra, G, Morabito, A, Gridelli, C, Galetta, D, Barbieri, F, Grossi, F, Capelletto, E, Minuti, G, Mazzoni, F, Verusio, C, Bria, E, Alì, G, Bruno, R, Proietti, A, Fontanini, G, Crinò, L, Cappuzzo, F, Landi L, Chiari R, Tiseo M, D'Incà F, Dazzi C, Chella A, Delmonte A, Bonanno L, Giannarelli D, Cortinovis D, de Marinis F, Borra G, Morabito A, Gridelli C, Galetta D, Barbieri F, Grossi F, Capelletto E, Minuti G, Mazzoni F, Verusio C, Bria E, Alì G, Bruno R, Proietti A, Fontanini G, Crinò L, and Cappuzzo F

Abstract

Purpose: MET-deregulated NSCLC represents an urgent clinical need because of unfavorable prognosis and lack of specific therapies. Although recent studies have suggested a potential role for crizotinib in patients harboring MET amplification or exon 14 mutations, no conclusive data are currently available. This study aimed at investigating activity of crizotinib in patients harboring MET or ROS1 alterations. Patients and Methods: Patients with pretreated advanced NSCLC and evidence of ROS1 rearrangements (cohort A) or MET deregulation (amplification, ratio MET/CEP7 >2.2 or MET exon 14 mutations, cohort B) were treated with crizotinib 250 mg twice daily orally. The coprimary endpoint was objective response rate in the two cohorts. Results: From December 2014 to March 2017, 505 patients were screened and a total of 52 patients (26 patients per cohort) were enrolled onto the study. At data cutoff of September 2017, in cohort A, objective response rate was 65%, and median progression-free survival and overall survival were 22.8 months [95% confidence interval (CI) 15.2–30.3] and not reached, respectively. In cohort B, objective response rate was 27%, median progression-free survival was 4.4 months (95% CI 3.0–5.8), and overall survival was 5.4 months (95% CI, 4.2–6.5). No difference in any clinical endpoint was observed between MET-amplified and exon 14–mutated patients. No response was observed among the 5 patients with cooccurrence of a second gene alteration. No unexpected toxicity was observed in both cohorts. Conclusions: Crizotinib induces response in a fraction of MET-deregulated NSCLC. Additional studies and innovative therapies are urgently needed.

Published
2019

37. Effect on quality of life of cisplatin added to single-agent chemotherapy as first-line treatment for elderly patients with advanced non-small cell lung cancer: Joint analysis of MILES-3 and MILES-4 randomised phase 3 trials

Author

Morabito, A, Piccirillo, M, Maione, P, Luciani, A, Cavanna, L, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Morgillo, F, Burgio, M, Ferrara, D, Rosetti, F, Bianco, R, Artioli, F, Cortinovis, D, Gebbia, V, Fregoni, V, Mencoboni, M, Sandomenico, C, Rossi, A, Montanino, A, Manzo, A, Rocco, G, Arenare, L, Daniele, G, Signoriello, S, Gallo, C, Perrone, F, Gridelli, C, Morabito A, Piccirillo MC, Maione P, Luciani A, Cavanna L, Bonanno L, Filipazzi V, Leo S, Cinieri S, Morgillo F, Burgio MA, Ferrara D, Rosetti F, Bianco R, Artioli F, Cortinovis D, Gebbia V, Fregoni V, Mencoboni M, Sandomenico C, Rossi A, Montanino A, Manzo A, Rocco G, Arenare L, Daniele G, Signoriello S, Gallo C, Perrone F, Gridelli C., Morabito, A, Piccirillo, M, Maione, P, Luciani, A, Cavanna, L, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Morgillo, F, Burgio, M, Ferrara, D, Rosetti, F, Bianco, R, Artioli, F, Cortinovis, D, Gebbia, V, Fregoni, V, Mencoboni, M, Sandomenico, C, Rossi, A, Montanino, A, Manzo, A, Rocco, G, Arenare, L, Daniele, G, Signoriello, S, Gallo, C, Perrone, F, Gridelli, C, Morabito A, Piccirillo MC, Maione P, Luciani A, Cavanna L, Bonanno L, Filipazzi V, Leo S, Cinieri S, Morgillo F, Burgio MA, Ferrara D, Rosetti F, Bianco R, Artioli F, Cortinovis D, Gebbia V, Fregoni V, Mencoboni M, Sandomenico C, Rossi A, Montanino A, Manzo A, Rocco G, Arenare L, Daniele G, Signoriello S, Gallo C, Perrone F, and Gridelli C.

Abstract

Objectives: To evaluate the effect on quality of life (QOL)of the addition of cisplatin to single-agent chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer (NSCLC)enrolled in two parallel phase 3 trials, MILES-3 and MILES-4. Patients and methods: Advanced NSCLC pts, >70 years old, performance status (PS)0–1, were eligible. Patients were randomly assigned to chemotherapy without or with cisplatin. EORTC QLQ C30 and LC13 questionnaires were planned at baseline, end of cycle 1 and end of cycle 2 in both trials and were used for joint QOL analysis. Trial-specific data including questionnaires at non-shared time-points were used for additional analyses. Intention-to-treat strategy was applied. Analyses were adjusted for baseline QOL, stage, performance status, gender, age, size of centre, trial, histotype and non-platinum companion drug. Results: Overall, 458/531 pts (86%)answered baseline questionnaire and missing rates over treatment were slightly higher among patients receiving cisplatin. Mean change in sore mouth after cycle 2 was worse with cisplatin (P = 0.02). The size of differences between arms was in the small-medium range for peripheral neuropathy and alopecia (0.25 and 0.31 after one and 0.28 and 0.36 after two cycles, respectively)and for nausea/vomiting, sore mouth and dysphagia after two cycles (0.26, 0.38 and 0.25, respectively)always in the direction of worsening with cisplatin. Using a 10% change from baseline as clinically relevant threshold to categorize response, there was no significant difference between the arms. Time to deterioration of sore mouth and alopecia, with progression/death as competitive risk, was shorter with cisplatin (HR 1.72 95%CI 1.02–2.89, P = 0.04 and HR 1.84 95%CI 1.09–3.10, P = 0.02, respectively). Conclusion: The addition of cisplatin to single agent chemotherapy worsens sore mouth and alopecia and does not improve any QOL items in elderly patients with advanced NSCLC.

Published
2019

40. 94P ESCAT ranking of genomic alterations collected in the Italian Registry of Actionable Mutations

Author

Abate, R. Esposito, primary, De Luca, A., additional, Novello, S., additional, Curigliano, G., additional, Marchetti, P., additional, Fasola, G., additional, Conte, P., additional, Milella, M., additional, Pruneri, G., additional, Frassineti, L.G., additional, Cremolini, C., additional, Gridelli, C., additional, Adamo, V., additional, Berardi, R., additional, Antonuzzo, L., additional, Russo, A., additional, Tondini, C., additional, Morabito, A., additional, Pinto, C., additional, and Normanno, N., additional

Published
2021
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41. 1207O Bevacizumab + erlotinib vs erlotinib alone as first-line treatment of pts with EGFR mutated advanced non squamous NSCLC: Final analysis of the multicenter, randomized, phase III BEVERLY trial

Author

Piccirillo, M.C., primary, Bonanno, L., additional, Garassino, M.C.C., additional, Dazzi, C., additional, Cavanna, L., additional, Esposito, G., additional, Burgio, M.A., additional, Rosetti, F., additional, Rizzato, S., additional, Arenare, L., additional, Gargiulo, P., additional, Di Liello, R., additional, De Marinis, F., additional, Crinò, L., additional, Morgillo, F., additional, Ciardiello, F., additional, Normanno, N., additional, Gallo, C., additional, Gridelli, C., additional, and Morabito, A., additional

Published
2021
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43. 167P Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small cell lung cancer (aNSCLC): A pooled analysis of 6 randomized trials

Author

Gargiulo, P., primary, Di Liello, R., additional, Arenare, L., additional, Gridelli, C., additional, Morabito, A., additional, Ciardiello, F., additional, Gebbia, V., additional, Maione, P., additional, Spagnuolo, A., additional, Palumbo, G., additional, Esposito, G., additional, Della Corte, C.M., additional, Morgillo, F., additional, Mancuso, G., additional, Gravina, A., additional, Schettino, C., additional, Di Maio, M., additional, Gallo, C., additional, Perrone, F., additional, and Piccirillo, M.C., additional

Published
2021
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46. 1304P Brigatinib (BRG) vs crizotinib (CRZ) in Asian vs non-Asian patients (pts): Update from ALTA-1L

Author

Ahn, M-J., primary, Kim, H.R., additional, Yang, J.C-H., additional, Han, J-Y., additional, Li, J.Y-C., additional, Hochmair, M.J., additional, Chang, G-C., additional, Delmonte, A., additional, Lee, K.H., additional, Campelo, M.R. Garcia, additional, Gridelli, C., additional, Spira, A., additional, Califano, R., additional, Griesinger, F., additional, Ghosh, S., additional, Felip, E., additional, Kim, D-W., additional, Zhang, P., additional, Popat, S., additional, and Camidge, D.R., additional

Published
2020
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48. Risk-related 18F-FDG PET/CT and new diagnostic strategies in patients with solitary pulmonary nodule: the ITALIAN multicenter trial

Author

Spadafora, M, Pace, L, Evangelista, L, Mansi, L, Del Prete, F, Saladini, G, Miletto, P, Fanti, S, Del Vecchio, S, Guerra, L, Pepe, G, Peluso, G, Nicolai, E, Storto, G, Ferdeghini, M, Giordano, A, Farsad, M, Schillaci, O, Gridelli, C, Cuocolo, A, Spadafora M., Pace L., Evangelista L., Mansi L., Del Prete F., Saladini G., Miletto P., Fanti S., Del Vecchio S., Guerra L., Pepe G., Peluso G., Nicolai E., Storto G., Ferdeghini M., Giordano A., Farsad M., Schillaci O., Gridelli C., Cuocolo A., Spadafora, M, Pace, L, Evangelista, L, Mansi, L, Del Prete, F, Saladini, G, Miletto, P, Fanti, S, Del Vecchio, S, Guerra, L, Pepe, G, Peluso, G, Nicolai, E, Storto, G, Ferdeghini, M, Giordano, A, Farsad, M, Schillaci, O, Gridelli, C, Cuocolo, A, Spadafora M., Pace L., Evangelista L., Mansi L., Del Prete F., Saladini G., Miletto P., Fanti S., Del Vecchio S., Guerra L., Pepe G., Peluso G., Nicolai E., Storto G., Ferdeghini M., Giordano A., Farsad M., Schillaci O., Gridelli C., and Cuocolo A.

Abstract

Purpose: Diagnosis of solitary pulmonary nodule (SPN) is an important public health issue and 18F-FDG PET/CT has proven to be more effective than CT alone. Pre-test risk stratification and clinical presentation of SPN could affect the diagnostic strategy. A relevant issue is whether thoracic segmental (s)-PET/CT could be implemented in patients with SPN. This retrospective multicenter study compared the results of FDG whole-body (wb)-PET/CT to those of s-PET/CT. Methods: 18F-FDG PET/CT of 502 patients, stratified for pre-test cancer risk, were retrospectively analyzed. The thoracic part of wb-PET/CT, considered s-PET/CT, was compared to wb-PET/CT. Clinical and PET/CT variables were investigated for SPN characterization as well as for identification of patients in whom s-PET/CT could be performed. Histopathology or follow-up data were used as a reference. Results: In the study population, 36% had malignant, 35% benign, and 29% indeterminate SPN. 18F-FDG uptake indicative of thoracic and extra-thoracic lesions was detectable in 13% and 3% of the patients. All patients with extra-thoracic metastases (n = 13) had thoracic lymph node involvement and highest 18F-FDG uptake at level of SPN (negative predictive value 100%). Compared to wb-PET/CT, s-PET/CT could save about 2/3 of 18F-FDG dose, radiation exposure or scan-time, without affecting the clinical impact of PET/CT. Conclusion: Pre-test probability of malignancy can guide the diagnostic strategy of 18FDG-PET/CT in patients with SPN. In subjects with low-intermediate pretest probability s-PET/CT imaging might be planned in advance, while in those at high risk and with thoracic lymph node involvement a wb-PET/CT is necessary

Published
2018

49. Cisplatin-Based First-Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: Joint Analysis of MILES-3 and MILES-4 Phase III Trials

Author

Gridelli, C, Morabito, A, Cavanna, L, Luciani, A, Maione, P, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Ciardiello, F, Burgio, M, Bilancia, D, Cortinovis, D, Rosetti, F, Bianco, R, Gebbia, V, Artioli, F, Bordonaro, R, Fregoni, V, Mencoboni, M, Nelli, F, Riccardi, F, di Isernia, G, Costanzo, R, Rocco, G, Daniele, G, Signoriello, S, Piccirillo, M, Gallo, C, Perrone, F, Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, Perrone F., Gridelli, C, Morabito, A, Cavanna, L, Luciani, A, Maione, P, Bonanno, L, Filipazzi, V, Leo, S, Cinieri, S, Ciardiello, F, Burgio, M, Bilancia, D, Cortinovis, D, Rosetti, F, Bianco, R, Gebbia, V, Artioli, F, Bordonaro, R, Fregoni, V, Mencoboni, M, Nelli, F, Riccardi, F, di Isernia, G, Costanzo, R, Rocco, G, Daniele, G, Signoriello, S, Piccirillo, M, Gallo, C, Perrone, F, Gridelli C, Morabito A, Cavanna L, Luciani A, Maione P, Bonanno L, Filipazzi V, Leo S, Cinieri S, Ciardiello F, Burgio MA, Bilancia D, Cortinovis D, Rosetti F, Bianco R, Gebbia V, Artioli F, Bordonaro R, Fregoni V, Mencoboni M, Nelli F, Riccardi F, di Isernia G, Costanzo R, Rocco G, Daniele G, Signoriello S, Piccirillo MC, Gallo C, and Perrone F.

Abstract

Purpose: To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods: Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed a of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results: From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion: The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.

Published
2018

50. Efficacy of gemcitabine plus platinum chemotherapy compared with other platinum containing regimens in advanced non-small-cell lung cancer: a meta-analysis of survival outcomes

Author

Le Chevalier, T., Scagliotti, G., Natale, R., Danson, S., Rosell, R., Stahel, R., Thomas, P., Rudd, R.M., Vansteenkiste, J., Thatcher, N., Manegold, C., Pujol, J.-L., van Zandwijk, N., Gridelli, C., van Meerbeeck, J.P., Crino, L., Brown, A., FitzGerald, P., Aristides, M., and Schiller, J.H.

Published
2005
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