314 results on '"Passiglia, F"'
Search Results
2. Diagnosis and treatment of early and locally advanced non-small-cell lung cancer: The 2019 AIOM (Italian Association of Medical Oncology) clinical practice guidelines
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Passiglia, F., Bertolaccini, L., Del Re, M., Facchinetti, F., Ferrara, R., Franchina, T., Malapelle, U., Menis, J., Passaro, A., Pilotto, S., Ramella, S., Rossi, G., Trisolini, R., and Novello, S.
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- 2020
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3. Immune-Checkpoint Inhibitors Combinations in Metastatic NSCLC: New Options on the Horizon?
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Passiglia F, Reale ML, Cetoretta V, and Novello S
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immune-checkpoint ,pd-1/pd-l1 ,resistance ,combinations ,non-small cell lung cancer. ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Francesco Passiglia, Maria Lucia Reale, Valeria Cetoretta, Silvia Novello Department of Oncology, University of Turin, S. Luigi Gonzaga Hospital, Orbassano (TO), ItalyCorrespondence: Silvia NovelloDepartment of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, ItalyEmail silvia.novello@unito.itAbstract: The therapeutic targeting of the programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) axis marked a milestone in the treatment of non-small cell lung cancer (NSCLC), leading to unprecedented response duration and long-term survival for a relevant subgroup of patients affected by non-oncogene-addicted, metastatic disease. However, the biological heterogeneity as well as the occurrence of innate/acquired resistance are well-known phenomena which significantly affect the therapeutic response to immunotherapy. To date, we are moving towards the second phase of the “immune-revolution”, characterized by the advent of new immune-checkpoint inhibitors combinations, aiming to target the main resistance pathways and ultimately increase the number of NSCLC patients who may derive long-term clinical benefit from immunotherapy. In this review, we provide an updated and comprehensive overview of the main PD-1/PD-L1 inhibitors’ combination approaches under clinical investigation in non-oncogene addicted, metastatic NSCLC patients, including checkpoints (other than CTLA-4) as well as “immune-metabolism” modulators, DNA repair pathway inhibitors, antiangiogenic agents, cytokines, and a new generation of vaccines, with the final aim of identifying the most promising options on the horizon.Keywords: immune-checkpoint, PD-1/PD-L1, resistance, combinations, non-small cell lung cancer
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- 2021
4. Treatment of advanced non-small-cell lung cancer: The 2019 AIOM (Italian Association of Medical Oncology) clinical practice guidelines
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Passiglia, F., Pilotto, S., Facchinetti, F., Bertolaccini, L., Del Re, M., Ferrara, R., Franchina, T., Malapelle, U., Menis, J., Passaro, A., Ramella, S., Rossi, G., Trisolini, R., and Novello, S.
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- 2020
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- View/download PDF
5. Sotorasib in KRASp.G12C mutated advanced NSCLC: Real-world data from the Italian expanded access program
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Passiglia, F, Lucia Reale, M, Lo Russo, G, Pasello, G, Minuti, G, Bulotta, A, Galetta, D, Pelizzari, G, Sini, C, Bria, E, Roca, E, Pilotto, S, Genova, C, Metro, G, Citarella, F, Chiari, R, Cortinovis, D, Delmonte, A, Russo, A, Tiseo, M, Cerea, G, Carta, A, Scotti, V, Vavalà, T, Brambilla, M, Buffoni, L, Buosi, R, Catania, C, Gori, S, Grisanti, S, Agustoni, F, Garbo, E, Malapelle, U, Novello, S, Passiglia, Francesco, Lucia Reale, Maria, Lo Russo, Giuseppe, Pasello, Giulia, Minuti, Gabriele, Bulotta, Alessandra, Galetta, Domenico, Pelizzari, Giacomo, Sini, Claudio, Bria, Emilio, Roca, Elisa, Pilotto, Sara, Genova, Carlo, Metro, Giulio, Citarella, Fabrizio, Chiari, Rita, Cortinovis, Diego, Delmonte, Angelo, Russo, Alessandro, Tiseo, Marcello, Cerea, Giulio, Carta, Annamaria, Scotti, Vieri, Vavalà, Tiziana, Brambilla, Marta, Buffoni, Lucio, Buosi, Roberta, Catania, Chiara, Gori, Stefania, Grisanti, Salvatore, Agustoni, Francesco, Garbo, Edoardo, Malapelle, Umberto, Novello, Silvia, Passiglia, F, Lucia Reale, M, Lo Russo, G, Pasello, G, Minuti, G, Bulotta, A, Galetta, D, Pelizzari, G, Sini, C, Bria, E, Roca, E, Pilotto, S, Genova, C, Metro, G, Citarella, F, Chiari, R, Cortinovis, D, Delmonte, A, Russo, A, Tiseo, M, Cerea, G, Carta, A, Scotti, V, Vavalà, T, Brambilla, M, Buffoni, L, Buosi, R, Catania, C, Gori, S, Grisanti, S, Agustoni, F, Garbo, E, Malapelle, U, Novello, S, Passiglia, Francesco, Lucia Reale, Maria, Lo Russo, Giuseppe, Pasello, Giulia, Minuti, Gabriele, Bulotta, Alessandra, Galetta, Domenico, Pelizzari, Giacomo, Sini, Claudio, Bria, Emilio, Roca, Elisa, Pilotto, Sara, Genova, Carlo, Metro, Giulio, Citarella, Fabrizio, Chiari, Rita, Cortinovis, Diego, Delmonte, Angelo, Russo, Alessandro, Tiseo, Marcello, Cerea, Giulio, Carta, Annamaria, Scotti, Vieri, Vavalà, Tiziana, Brambilla, Marta, Buffoni, Lucio, Buosi, Roberta, Catania, Chiara, Gori, Stefania, Grisanti, Salvatore, Agustoni, Francesco, Garbo, Edoardo, Malapelle, Umberto, and Novello, Silvia
- Abstract
Background: Sotorasib showed a significant improvement of progression free survival (PFS), safety and quality of life over docetaxel in patients with KRASp.G12C-mutated advanced non-small-cell lung cancer (NSCLC) within the CodeBreak-200 study. Here we report real-world efficacy and tolerability data from NSCLC patients who received sotorasib within the Italian expanded access program (EAP). Methods: Sotorasib (960 mg, orally, once daily) was available on physician request for KRASp.G12C mutant advanced NSCLC patients. Clinical-pathological and molecular data were collected from the Italian ATLAS real-world registry. Patients underwent CT-scan and responses were evaluated by RECIST criteria. Efficacy and tolerability outcomes have been assessed. Results: A total of 196 advanced NSCLC patients were treated across 30 Italian centers. Median age was 69 years old (range 33-86). Most patients were male (61 %), former (49 %) or current smokers (43 %), with ECOG-PS 0/1 (84 %) and adenocarcinoma subtype (90 %). 45 % and 32 % of patients received sotorasib in 2nd and 3rd line, respectively. Overall, response rate was 26 % and the median duration of response was 5.7 months (95 % CI: 4.4-7.0). Median PFS and OS were 5.8 months (95 % CI: 5 - 6.5) and 8.2 months (95 % CI: 6.3 - 9.9). Grade 3-4 TRAEs occurred in 16.5 % of patients, with Grade >= 3 liver enzyme increase and TRAEs-related discontinuation reported in 12 % and 4.6 % of cases. Conclusion: Real-world data from the Italian EAP confirm the tolerability and effectiveness of sotorasib in patients with KRASp.G12C-mutated advanced NSCLC and highlight the value of the national ATLAS network as source of real-world evidence driving the clinical management of NSCLC patients.
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- 2024
6. Real-world outcomes of Italian patients with advanced non-squamous lung cancer treated with first-line pembrolizumab plus platinum-pemetrexed
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Leonetti, A, Perrone, F, Puntoni, M, Maglietta, G, Bordi, P, Bria, E, Vita, E, Gelsomino, F, De Giglio, A, Gelibter, A, Siringo, M, Mazzoni, F, Caliman, E, Genova, C, Bertolini, F, Guaitoli, G, Passiglia, F, Delcuratolo, M, Montrone, M, Cerea, G, Pasello, G, Roca, E, Belluomini, L, Cecere, F, Guida, A, Manzo, A, Adamo, V, Rastelli, F, Bulotta, A, Citarella, F, Toschi, L, Zoratto, F, Cortinovis, D, Berardi, R, Follador, A, Carta, A, Camerini, A, Salerno, F, Silva, R, Baldini, E, Cortellini, A, Brighenti, M, Santoni, M, Malorgio, F, Caminiti, C, Tiseo, M, Leonetti, Alessandro, Perrone, Fabiana, Puntoni, Matteo, Maglietta, Giuseppe, Bordi, Paola, Bria, Emilio, Vita, Emanuele, Gelsomino, Francesco, De Giglio, Andrea, Gelibter, Alain, Siringo, Marco, Mazzoni, Francesca, Caliman, Enrico, Genova, Carlo, Bertolini, Federica, Guaitoli, Giorgia, Passiglia, Francesco, Delcuratolo, Marco Donatello, Montrone, Michele, Cerea, Giulio, Pasello, Giulia, Roca, Elisa, Belluomini, Lorenzo, Cecere, Fabiana Letizia, Guida, Annalisa, Manzo, Anna, Adamo, Vincenzo, Rastelli, Francesca, Bulotta, Alessandra, Citarella, Fabrizio, Toschi, Luca, Zoratto, Federica, Cortinovis, Diego Luigi, Berardi, Rossana, Follador, Alessandro, Carta, Annamaria, Camerini, Andrea, Salerno, Flavio, Silva, Rosa Rita, Baldini, Editta, Cortellini, Alessio, Brighenti, Matteo, Santoni, Matteo, Malorgio, Francesco, Caminiti, Caterina, Tiseo, Marcello, Leonetti, A, Perrone, F, Puntoni, M, Maglietta, G, Bordi, P, Bria, E, Vita, E, Gelsomino, F, De Giglio, A, Gelibter, A, Siringo, M, Mazzoni, F, Caliman, E, Genova, C, Bertolini, F, Guaitoli, G, Passiglia, F, Delcuratolo, M, Montrone, M, Cerea, G, Pasello, G, Roca, E, Belluomini, L, Cecere, F, Guida, A, Manzo, A, Adamo, V, Rastelli, F, Bulotta, A, Citarella, F, Toschi, L, Zoratto, F, Cortinovis, D, Berardi, R, Follador, A, Carta, A, Camerini, A, Salerno, F, Silva, R, Baldini, E, Cortellini, A, Brighenti, M, Santoni, M, Malorgio, F, Caminiti, C, Tiseo, M, Leonetti, Alessandro, Perrone, Fabiana, Puntoni, Matteo, Maglietta, Giuseppe, Bordi, Paola, Bria, Emilio, Vita, Emanuele, Gelsomino, Francesco, De Giglio, Andrea, Gelibter, Alain, Siringo, Marco, Mazzoni, Francesca, Caliman, Enrico, Genova, Carlo, Bertolini, Federica, Guaitoli, Giorgia, Passiglia, Francesco, Delcuratolo, Marco Donatello, Montrone, Michele, Cerea, Giulio, Pasello, Giulia, Roca, Elisa, Belluomini, Lorenzo, Cecere, Fabiana Letizia, Guida, Annalisa, Manzo, Anna, Adamo, Vincenzo, Rastelli, Francesca, Bulotta, Alessandra, Citarella, Fabrizio, Toschi, Luca, Zoratto, Federica, Cortinovis, Diego Luigi, Berardi, Rossana, Follador, Alessandro, Carta, Annamaria, Camerini, Andrea, Salerno, Flavio, Silva, Rosa Rita, Baldini, Editta, Cortellini, Alessio, Brighenti, Matteo, Santoni, Matteo, Malorgio, Francesco, Caminiti, Caterina, and Tiseo, Marcello
- Abstract
Purpose: The aim of this multi-center, retrospective/prospective cohort observational study was to evaluate outcomes in routine clinical practice of first-line chemo-immunotherapy with cis/carboplatin, pemetrexed and pembrolizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC) in 33 Italian centers. Methods: The outcome measure was to evaluate overall survival (OS) in a real-world patient population. Secondary endpoints were: progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and incidence of treatment-related adverse events (AEs). Results: 1068 patients were enrolled at the time of data cut-off (January 31st, 2023), and 812 (76.0%) belonged to the retrospective cohort. Median age was 66 years (27−85), ECOG PS was ≥ 2 in 91 (8.6%) patients; 254 (23.8%) patients had brain metastases at baseline; 38 (3.6%) patients had tumor with PD-L1 expression ≥ 50%. After a median follow-up of 17.0 months (95% CI, 16.1–17.9), median OS was 16.1 months (95% CI, 14.4–18.8) and PFS was 9.9 months (95% CI, 8.8–11.2). Median DoR (n = 493) was 14.7 months (95% CI, 13.6–17.1). ORR was 43.4% (95% CI, 40.4–46.4). Any-grade AEs occurred in 636 (59.6%) patients and grade ≥ 3 in 253 (23.7%) patients. Most common grade ≥ 3 AEs were neutropenia (6.3%) and anemia (6.3%). Conclusions: First-line chemo-immunotherapy was effective and tolerable in this large, real-world Italian study of patients with advanced non-squamous NSCLC. Our results were in line with the KEYNOTE-189 registration study, also considering the low number of PD-L1 ≥ 50% patients included in our study.
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- 2024
7. The biomarkers ATLAS: An audit on 1100 non-small cell lung cancer from an Italian knowledge-based database
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Malapelle, U, Passiglia, F, Pepe, F, Pisapia, P, Lucia Reale, M, Cortinovis, D, Fraggetta, F, Galetta, D, Garbo, E, Graziano, P, Pagni, F, Pasello, G, Piovano, P, Pilotto, S, Tiseo, M, Genova, C, Righi, L, Troncone, G, Novello, S, Malapelle, Umberto, Passiglia, Francesco, Pepe, Francesco, Pisapia, Pasquale, Lucia Reale, Maria, Cortinovis, Diego, Fraggetta, Filippo, Galetta, Domenico, Garbo, Edoardo, Graziano, Paolo, Pagni, Fabio, Pasello, Giulia, Piovano, Pierluigi, Pilotto, Sara, Tiseo, Marcello, Genova, Carlo, Righi, Luisella, Troncone, Giancarlo, Novello, Silvia, Malapelle, U, Passiglia, F, Pepe, F, Pisapia, P, Lucia Reale, M, Cortinovis, D, Fraggetta, F, Galetta, D, Garbo, E, Graziano, P, Pagni, F, Pasello, G, Piovano, P, Pilotto, S, Tiseo, M, Genova, C, Righi, L, Troncone, G, Novello, S, Malapelle, Umberto, Passiglia, Francesco, Pepe, Francesco, Pisapia, Pasquale, Lucia Reale, Maria, Cortinovis, Diego, Fraggetta, Filippo, Galetta, Domenico, Garbo, Edoardo, Graziano, Paolo, Pagni, Fabio, Pasello, Giulia, Piovano, Pierluigi, Pilotto, Sara, Tiseo, Marcello, Genova, Carlo, Righi, Luisella, Troncone, Giancarlo, and Novello, Silvia
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Aims: To date, precision medicine has revolutionized the clinical management of Non-Small Cell Lung Cancer (NSCLC). International societies approved a rapidly improved mandatory testing biomarkers panel for the clinical stratification of NSCLC patients, but harmonized procedures are required to optimize the diagnostic workflow. In this context a knowledge-based database (Biomarkers ATLAS, https://biomarkersatlas.com/) was developed by a supervising group of expert pathologists and thoracic oncologists collecting updated clinical and molecular records from about 80 referral Italian institutions. Here, we audit molecular and clinical data from n = 1100 NSCLC patients collected from January 2019 to December 2020. Methods: Clinical and molecular records from NSCLC patients were retrospectively collected from the two coordinating institutions (University of Turin and University of Naples). Molecular biomarkers (KRAS, EGFR, BRAF, ROS1, ALK, RET, NTRK, MET) and clinical data (sex, age, histological type, smoker status, PD-L1 expression, therapy) were collected and harmonized. Results: Clinical and molecular data from 1100 (n = 552 mutated and n = 548 wild-type) NSCLC patients were systematized and annotated in the ATLAS knowledge-database. Molecular records from biomarkers testing were matched with main patients’ clinical variables. Conclusions: Biomarkers ATLAS (https://biomarkersatlas.com/) represents a unique, easily managing, and reliable diagnostic tool aiming to integrate clinical records with molecular alterations of NSCLC patients in the real-word Italian scenario.
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- 2024
8. Primary and metastatic brain cancer genomics and emerging biomarkers for immunomodulatory cancer treatment
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Passiglia, F., Caglevic, C., Giovannetti, E., Pinto, JA., Manca, P., Taverna, S., Listì, A., Gil-Bazo, I., Raez, LE., Russo, A., and Rolfo, C.
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- 2018
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9. EP11.01-01 Final Analysis of First-Line Chemo-Immunotherapy in Patients with Advanced Lung Adenocarcinoma: An Italian Real-World Study
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Leonetti, A., primary, Perrone, F., additional, Puntoni, M., additional, Bordi, P., additional, Maglietta, G., additional, Bria, E., additional, Gelsomino, F., additional, Gelibter, A., additional, Caliman, E., additional, Genova, C., additional, Guaitoli, G., additional, Passiglia, F., additional, Montrone, M., additional, Oresti, S., additional, Pasello, G., additional, Roca, E., additional, Pilotto, S., additional, Cecere, F.L., additional, Guida, A., additional, Manzo, A., additional, Russo, A., additional, Rastelli, F., additional, Bulotta, A., additional, Citarella, F., additional, Toschi, L., additional, Zoratto, F., additional, Cortinovis, D.L., additional, Paoloni, F., additional, Follador, A., additional, Carta, A., additional, Camerini, A., additional, Di Maio, M., additional, and Tiseo, M., additional
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- 2023
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10. Epidermal growth factor receptor exon 20 insertion variants in non-small cell lung cancer patients
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Malapelle, U, Pilotto, S, Reale, M, Passiglia, F, Pisapia, P, Pepe, F, Belluomini, L, Galetta, D, Cortinovis, D, Tiseo, M, Passaro, A, Seminati, D, Pagni, F, Parra, H, Migliorino, M, Rocco, D, Troncone, G, Novello, S, Malapelle U., Pilotto S., Reale M. L., Passiglia F., Pisapia P., Pepe F., Belluomini L., Galetta D., Cortinovis D., Tiseo M., Passaro A., Seminati D., Pagni F., Parra H. S., Migliorino M. R., Rocco D., Troncone G., Novello S., Malapelle, U, Pilotto, S, Reale, M, Passiglia, F, Pisapia, P, Pepe, F, Belluomini, L, Galetta, D, Cortinovis, D, Tiseo, M, Passaro, A, Seminati, D, Pagni, F, Parra, H, Migliorino, M, Rocco, D, Troncone, G, Novello, S, Malapelle U., Pilotto S., Reale M. L., Passiglia F., Pisapia P., Pepe F., Belluomini L., Galetta D., Cortinovis D., Tiseo M., Passaro A., Seminati D., Pagni F., Parra H. S., Migliorino M. R., Rocco D., Troncone G., and Novello S.
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Epidermal growth factor receptor (EGFR) exon 20 insertions occur rarely among different cancer types, with the highest frequency reported among non-small-cell lung cancer (NSCLC) patients, particularly adenocarcinomas (ADCs). Exon 20 insertions fall back in the tyrosine kinase domain, and can be clustered into two principal groups represented by in frame insertions and three to 21 bp (corresponding to 1–7 amino acids) duplications within amino acids 762 and 774. The identification of these alterations is key for an adequate management of NSCLC patients due to the possibility to treat these patients with specific targeted therapies. Next generation sequencing (NGS) technology, able to detect several hotspot gene mutations for different patients simultaneously, is the best detection approach due to its higher sensitivity and specificity compared to other techniques. Here we reviewed the principal biological characteristics, the main detection technologies and treatment options for NSCLC patients harbouring EGFR exon 20 insertions.
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- 2022
11. A Narrow NGS Panel in the Analysis of KRAS p.G12C Mutation in Longitudinal Series of NSCLC Patients: A Pilot Study
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Pepe, F., Russo, G., Scimone, C., Listì, A., Righi, L., Troncone, G., Passiglia, F., Novello, S., and Malapelle, U.
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- 2023
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12. Liquid Biopsy Monitoring in BRAF-V600E Mutated NSCLC Patients Treated With Dabrafenib Plus Trametinib: A Prospective, Explorative, Multicentric Study. LiBRA_study (GOIRC-03-2020)
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Pluchino, M., Minari, R., Leonetti, A., Bonatti, F., Passiglia, F., Sartore-Bianchi, A., Cortinovis, D., Toschi, L., Gelsomino, F., Frega, S., and Tiseo, M.
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- 2023
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13. 4P FDG PET derived metabolic tumor volume (MTV) and its transcriptomic correlates as biomarker to predict efficacy of immune checkpoint inhibitors (ICB) alone or in combination with chemotherapy in advanced NSCLC: A multicentric study
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Dall'Olio, F.G., primary, Garcia, C.A., additional, Zrafi, W.S., additional, Fortunati, E., additional, Bettayeb, A., additional, Zalcman, G., additional, Remon Masip, J., additional, Hendriks, L., additional, Tagliamento, M., additional, Bonardel, G., additional, Helissey, C., additional, Roelants, V., additional, Fourquet, A., additional, Aboubakar, F., additional, Chaput-Gras, N., additional, Passiglia, F., additional, Monnet, I., additional, Planchard, D., additional, Barlesi, F., additional, and Besse, B., additional
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- 2022
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14. Differential influence of antibiotic therapy and other medications on oncological outcomes of patients with non-small cell lung cancer treated with first-line pembrolizumab versus cytotoxic chemotherapy
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Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, Pinato DJ, Cortellini, A, Di Maio, M, Nigro, O, Leonetti, A, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Giusti, R, Ferrara, M, Bria, E, D'Argento, E, Grossi, F, Rijavec, E, Guida, A, Berardi, R, Torniai, M, Sforza, V, Genova, C, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Della Gravara, L, Inno, A, Michele, T, Grassadonia, A, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Santini, D, Citarella, F, Russano, M, Cantini, L, Tuzi, A, Bordi, P, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Passiglia, F, Bironzo, P, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Friedlaender, A, Addeo, A, Cannita, K, Ficorella, C, Porzio, G, Pinato, D, Cortellini A, Di Maio M, Nigro O, Leonetti A, Cortinovis D, Aerts JG, Guaitoli G, Barbieri F, Giusti R, Ferrara MG, Bria E, D'Argento E, Grossi F, Rijavec E, Guida A, Berardi R, Torniai M, Sforza V, Genova C, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Della Gravara L, Inno A, Michele T, Grassadonia A, Di Marino P, Mansueto G, Zoratto F, Filetti M, Santini D, Citarella F, Russano M, Cantini L, Tuzi A, Bordi P, Minuti G, Landi L, Ricciardi S, Migliorino MR, Passiglia F, Bironzo P, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Friedlaender A, Addeo A, Cannita K, Ficorella C, Porzio G, and Pinato DJ
- Abstract
Background Some concomitant medications including antibiotics (ATB) have been reproducibly associated with worse survival following immune checkpoint inhibitors (ICIs) in unselected patients with non-small cell lung cancer (NSCLC) (according to programmed death-ligand 1 (PD-L1) expression and treatment line). Whether such relationship is causative or associative is matter of debate. Methods We present the outcomes analysis according to concomitant baseline medications (prior to ICI initiation) with putative immune-modulatory effects in a large cohort of patients with metastatic NSCLC with a PD-L1 expression >= 50%, receiving first-line pembrolizumab monotherapy. We also evaluated a control cohort of patients with metastatic NSCLC treated with first-line chemotherapy. The interaction between key medications and therapeutic modality (pembrolizumab vs chemotherapy) was validated in pooled multivariable analyses. Results 950 and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Corticosteroid and proton pump inhibitor (PPI) therapy but not ATB therapy was associated with poorer performance status at baseline in both the cohorts. No association with clinical outcomes was found according to baseline statin, aspirin, beta-blocker and metformin within the pembrolizumab cohort. On the multivariable analysis, ATB emerged as a strong predictor of worse overall survival (OS) (HR=1.42 (95% CI 1.13 to 1.79); p=0.0024), and progression free survival (PFS) (HR=1.29 (95% CI 1.04 to 1.59); p=0.0192) in the pembrolizumab but not in the chemotherapy cohort. Corticosteroids were associated with shorter PFS (HR=1.69 (95% CI 1.42 to 2.03); p<0.0001), and OS (HR=1.93 (95% CI 1.59 to 2.35); p<0.0001) following pembrolizumab, and shorter PFS (HR=1.30 (95% CI 1.08 to 1.56), p=0.0046) and OS (HR=1.58 (95% CI 1.29 to 1.94), p<0.0001), following chemotherapy. PPIs were associated with worse OS (HR=1.49 (95% CI 1.26 to 1.77); p<0.0001) with pem
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- 2021
15. EP08.01-007 Real-World Outcomes of Patients with Advanced Lung Adenocarcinoma Treated with First-Line Chemo-Immunotherapy in Italy
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F. Perrone, A. Leonetti, primary, Puntoni, M., additional, Bordi, P., additional, Maglietta, G., additional, Carpana, C., additional, Gelsomino, F., additional, Passiglia, F., additional, Genova, C., additional, Montrone, M., additional, Caliman, E., additional, Cerea, G., additional, Pasello, G., additional, Cecere, F., additional, Manzo, A., additional, Adamo, V., additional, Citarella, F., additional, Toschi, L., additional, Gelibter, A., additional, Rastelli, F., additional, Carta, A., additional, Guida, A., additional, Camerini, A., additional, Paoloni, F., additional, Bertolini, F., additional, and Tiseo, M., additional
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- 2022
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16. EP16.03-011 The European Program for ROutine Testing of Patients with Advanced Lung Cancer (EPROPA) 1 Year Activity
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Passiglia, F., primary, Righi, L., additional, Listì, A., additional, Tabbò, F., additional, Bironzo, P., additional, Reale, M.L., additional, Sini, C., additional, Vallone, S., additional, Arizio, F., additional, Parravicini, M.V. Pacchiana, additional, Mazilu, L., additional, Linardou, H., additional, Roca, E., additional, Buffoni, L., additional, Mohorcic, K., additional, Barbieri, V., additional, Pignataro, D., additional, Araujo, A., additional, Ares, L. Paz, additional, Felip, E., additional, Secen, N., additional, Comanescu, A., additional, Szmytke, E., additional, Scagliotti, G., additional, and Novello, S., additional
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- 2022
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17. EP16.03-040 Biomarkersatlas.com: the Italian NSCLC Precision Medicine Knowledge Data Base
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Malapelle, U., primary, Pepe, F., additional, Pisapia, P., additional, Righi, L., additional, Listì, A., additional, Reale, M.L., additional, Passiglia, F., additional, Tiseo, M., additional, Genova, C., additional, Galetta, D., additional, Cortinovis, D., additional, Pilotto, S., additional, Migliorino, M.R., additional, Parra, H. Soto, additional, Cappuzzo, F., additional, Novello, S., additional, and Troncone, G., additional
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- 2022
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18. 1124P Pralsetinib in RET fusion-positive non-small cell lung cancer: A real-world data (RWD) analysis from the Italian expanded access program (EAP)
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Passaro, A., primary, Lo Russo, G., additional, Passiglia, F., additional, D'Arcangelo, M., additional, Sbrana, A., additional, Russano, M., additional, Bonanno, L., additional, Giusti, R., additional, Metro, G., additional, Bertolini, F., additional, Grisanti, S., additional, Carta, A., additional, Cecere, F.L., additional, Montrone, M., additional, Massa, G., additional, Attili, I., additional, and de Marinis, F., additional
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- 2022
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19. EP08.02-101 Real-world Data from KRAS-mutant Advanced NSCLC: the ATLAS Multicenter Cohort Study
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Bungaro, M., primary, Garbo, E., additional, Jacobs, F., additional, Reale, M.L., additional, Passiglia, F., additional, Tiseo, M., additional, Genova, C., additional, Galetta, D., additional, Malapelle, U., additional, Troncone, G., additional, and Novello, S., additional
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- 2022
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20. 1355P Clinical trial enrollment among lung cancer patients: A real-world multicenter analysis
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Reale, M.L., primary, Capelletto, E., additional, Buttigliero, C., additional, Bordi, P., additional, Ricciardi, S., additional, Belluomini, L., additional, Garbo, E., additional, Leonetti, A., additional, Lombardi, A., additional, Dodi, A., additional, Napoli, V., additional, Casali, M., additional, Soregaroli, D., additional, Insolda, J., additional, Bironzo, P., additional, Tiseo, M., additional, Migliorino, M.R., additional, Pilotto, S., additional, Passiglia, F., additional, and Novello, S., additional
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- 2022
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21. EP02.04-001 Alectinib as Neoadjuvant Treatment in Surgically Resectable Stage III ALK-Positive NSCLC: ALNEO Phase II Trial (GOIRC-01-2020)
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Leonetti, A., primary, Minari, R., additional, Boni, L., additional, Gnetti, L., additional, Bordi, P., additional, Verzè, M., additional, Ampollini, L., additional, Gelsomino, F., additional, Toschi, L., additional, Cecere, F., additional, Pilotto, S., additional, Metro, G., additional, Passiglia, F., additional, Cortinovis, D., additional, Guaitoli, G., additional, Pasello, G., additional, Delmonte, A., additional, Mazzoni, F., additional, Bria, E., additional, Galetta, D., additional, Genova, C., additional, Rocco, D., additional, Soto Parra, H., additional, Bearz, A., additional, Migliorino, M.R., additional, Camerini, A., additional, Tognetto, M., additional, and Tiseo, M., additional
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- 2022
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22. P2.16A.01 Actionable Alterations Identification in NSCLC by Comprehensive Genomic Profiling for Clinical Trial Enrollment: EPROPA
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Vallone, S., Passiglia, F., Listi, A., Bironzo, P., Merlini, A., Benso, F., Napoli, F., Barbu, F.A., Zambelli, V., Tabbò, F., Reale, M.L., Sini, C., Roca, E., Taveggia, P.A., Simionato, F., Buffoni, L., Mazilu, L., Barbieri, V., Pignataro, D., Araujo, A., Paz-Ares, L., Félip, E., Secen, N., Comanescu, A., Mati Ramizi, K., Bettini, A.C., Scotti, V., Linardou, H., Mohorcic, K., Meoni, G., Volante, M., Scagliotti, G., Malapelle, U., Righi, L., and Novello, S.
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- 2024
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23. MA01.03 Neoadjuvant Alectinib in Potentially Resectable Stage III ALK-Positive NSCLC: Interim Analysis of ALNEO-GOIRC-01-2020 Phase II Trial
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Leonetti, A., Boni, L., Gnetti, L., Cortinovis, D.L., Mazzoni, F., Pasello, G., Passiglia, F., Bearz, A., Pilotto, S., Gelsomino, F., Metro, G., Bertolini, F., Toschi, L., Soto Parra, H., Delmonte, A., Cecere, F.L., Ricciardi, S., Bria, E., Tognetto, M., and Tiseo, M.
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- 2024
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24. 1828P A cross-sectional study investigating the current diagnostic & therapeutical approaches to bone metastases (BoM) in patients (pts) with non-small cell lung cancer (NSCLC)
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Pilotto, S., Avancini, A., Giaj-Levra, N., Minuti, G., Pasqualini, G., Colonese, F., Di Federico, A., Fozza, A., Montrone, M., Olmetto, E., Pastorello, E., Reale, M.L., Riva, S.T., Roca, E., Sini, C., Viscardi, G., and Passiglia, F.
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- 2024
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25. 1349P A prospective study on clinicians’ attitudes and survival outcomes for patients with NSCLC and poor performance status in the immunotherapy era: PICASO study (GOIRC-04-2020)
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Facchinetti, F., Camerini, A., Bennati, C., Bordi, P., De Carlo, E., Mazzoni, F., Metro, G., Bertolini, F., Longo, L., Ricciardi, S., Pilotto, S., Bria, E., Giardina, D., Passiglia, F., Cortinovis, D.L., Scotti, V., Novello, S., Tognetto, M., Di Maio, M., and Tiseo, M.
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- 2024
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26. 1301P BRAF-mutant metastatic non-small cell lung cancer: Real-world data from the Italian biomarker ATLAS database
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Russo, A., Sini, C., Cortinovis, D.L., Muscarella, L.A., Perrone, F., Bria, E., Grisanti, S., Piovano, P.L., Veccia, A., Antonuzzo, L., Citarella, F., Belluomini, L., Reale, M.L., Pignataro, D., Roca, E., Calvetti, L., Passiglia, F., Novello, S., and Baldini, E.
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- 2024
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27. 1283P Advanced ALK-positive non-small cell lung cancer (NSCLC) patients: Real-world treatment patterns and outcomes from the Italian biomarker ATLAS database
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Reale, M.L., Scattolin, D., Bria, E., Vitale, A., Grisanti, S., Costa, J., Galetta, D., Sini, C., Minuti, G., Citarella, F., Roca, E., Agustoni, F., Tiseo, M., Cortinovis, D.L., Pilotto, S., Ricciardi, S., Passiglia, F., Malapelle, U., Novello, S., and Pasello, G.
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- 2024
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28. Rate and risk factors of recurrent immune checkpoint inhibitor-related pneumonitis in patients with lung cancer.
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Tao, H, Li, F, Wu, D, Ji, S, Liu, Q, Wang, L, Liu, B, Facchinetti, F, Leong, TL, Passiglia, F, Hu, Y, Tao, H, Li, F, Wu, D, Ji, S, Liu, Q, Wang, L, Liu, B, Facchinetti, F, Leong, TL, Passiglia, F, and Hu, Y
- Abstract
BACKGROUND: Immune checkpoint inhibitors (ICIs) have become standard treatments for lung cancer patients. Immune checkpoint inhibitor-related pneumonitis (CIP) was the leading cause of death among ICIs-related adverse events (irAEs). Recurrent episodes of CIP without rechallenge of ICIs were reported in several cases and maybe a unique feature of CIP. Knowledge gaps remain regarding the rate and risk factors associated to CIP's recurrence. METHODS: Data from 1,102 lung cancer patients receiving ICIs treatment between January 2016 and January 2021 were retrospectively collected and analyzed. CIP was diagnosed according to typical clinical features and/or new typical imaging changes. Recurrence of CIP (CIP-R) was defined as recurrent CIP after initial CIP improved after proper treatment. Logistic regression was used to assess risk factors associated with CIP recurrence. RESULTS: Eighty out of 1,102 (7.26%) patients were diagnosed with CIP. Twenty of those 78 (25.64%) patients suffered CIP-R, 2 patients died and were therefore excluded from the denominator. The median onset of initial pneumonitis for patients without and with recurrence was 3.49 months [interquartile range (IQR), 0.26-31.93 months] and 2.78 months (IQR, 1.22-20.93 months), respectively (P=0.48). The median interval duration between initial CIP and CIP-R was 1.54 months (IQR, 0.98-16.70 months). Recurrence of CIP was more common in males (P=0.03), squamous histology (P=0.016), and in patients who received chest radiotherapy (P=0.049). The duration of prednisolone equivalent dose ≥15 mg/day in CIP-R was significantly shorter, at 3.71 weeks (2.86-6.57 weeks) compared with 6.36 weeks in those without recurrence (IQR, 3.12-9.86 weeks) (P=0.001). Non-squamous histology [odds ratio (OR), 0.182; 95% confidence interval (CI): 0.038-0.860; P=0.031] and prolonged administration of prednisolone equivalent dose ≥15 mg/day for more than 4 weeks (OR, 0.082; 95% CI: 0.02-0.342; P=0.001) were independently associated w
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- 2022
29. Immune-related Adverse Events of Pembrolizumab in a Large Real-world Cohort of Patients With NSCLC With a PD-L1 Expression ≥ 50% and Their Relationship With Clinical Outcomes
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Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, Cannita K., Cortellini, A, Friedlaender, A, Banna, G, Porzio, G, Bersanelli, M, Cappuzzo, F, Aerts, J, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Berardi, R, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, Di Marino, P, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Ghidini, M, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Occhipinti, M, Citarella, F, Marco, R, Torniai, M, Cantini, L, Follador, A, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Leonetti, A, Pettoruti, L, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Bertolini, F, Della Gravara, L, Dal Bello, M, Belderbos, R, De Filippis, M, Cecchi, C, Ricciardi, S, Donisi, C, De Toma, A, Proto, C, Addeo, A, Cantale, O, Ricciuti, B, Genova, C, Morabito, A, Santini, D, Ficorella, C, Cannita, K, Cortellini A, Friedlaender A, Banna GL, Porzio G, Bersanelli M, Cappuzzo F, Aerts JGJV, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Berardi R, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Inno A, Di Marino P, Mansueto G, Zoratto F, Santoni M, Tudini M, Ghidini M, Filetti M, Catino A, Pizzutilo P, Sala L, Occhipinti MA, Citarella F, Marco R, Torniai M, Cantini L, Follador A, Sforza V, Nigro O, Ferrara MG, D'Argento E, Leonetti A, Pettoruti L, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Bertolini F, Della Gravara L, Dal Bello MG, Belderbos RA, De Filippis M, Cecchi C, Ricciardi S, Donisi C, De Toma A, Proto C, Addeo A, Cantale O, Ricciuti B, Genova C, Morabito A, Santini D, Ficorella C, and Cannita K.
- Abstract
Background: The role of immune-related adverse events (irAEs), as a surrogate predictor of the efficacy of checkpoint inhibitors, has not yet been described in the setting of first-line, single-agent pembrolizumab for patients with metastatic non-small-cell lung-cancer (NSCLC) with a programmed death-ligand 1 (PD-L1) expression of ≥ 50%. Patients and methods: We previously conducted a multicenter retrospective analysis in patients with treatment-naive metastatic NSCLC and a PD-L1 expression of ≥ 50% receiving first-line pembrolizumab. Here, we report the results of the irAE analysis and the potential correlation between irAEs and clinical outcomes. Results: A total of 1010 patients were included in this analysis; after a 6-week landmark selection, 877 (86.8%) patients were included in the efficacy analysis. Any grade irAEs (P < .0001), grade 3/4 irAEs (P = .0025), leading to discontinuation irAEs (P = .0144), multiple-site and single-site irAEs (P < .0001), cutaneous irAEs (P = .0001), endocrine irAEs (P = .0227), pulmonary irAEs (P = .0479), and rheumatologic irAEs (P = .0018) were significantly related to a higher objective response rate. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0005), cutaneous irAEs (P = .0042), endocrine irAEs (P < .0001), gastrointestinal irAEs (P = .0391), and rheumatologic irAEs (P = .0086) were significantly related to progression-free survival. Any grade irAEs (P < .0001), single-site irAEs (P < .0001), multiple-site irAEs (P = .0003), cutaneous irAEs (P = .0002), endocrine irAEs (P = .0001), and rheumatologic irAEs (P = .0214) were significantly related to overall survival. Conclusions: This study confirms the feasibility and the safety of first-line, single-agent pembrolizumab, in a large, real-world cohort of patients with NSCLC with PD-L1 expression ≥ 50%. The occurrence of irAEs may be a surrogate of clinical activity and improved outcomes in this setting.
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- 2020
30. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation
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Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, Ficorella C., Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, and Ficorella C.
- Abstract
Background The association between obesity and outcomes in patients receiving programmed death-1/programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04-2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37-0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45-0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01-1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49-0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.
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- 2020
31. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50
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Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, Porzio G., Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, and Porzio G.
- Abstract
Background: Single-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%. Methods: We conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%. Results: One thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2–49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9–9.5; 599 events) and 17.2 months (95% CI 15.3–22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis. Conclusion: Pembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effe
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- 2020
32. POSC248 Real-World Patient Characteristics and Treatment Patterns in Non-Small Cell Lung Cancer (NSCLC) Patients with KRAS P.G12C Mutant Tumors in Italy
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Malapelle, U, primary, Giannopoulou, M, additional, Moscetti, A, additional, Laino, V, additional, and Passiglia, F, additional
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- 2022
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33. P59.20 Natural History of KRAS Mutant Non-Small-Cell Lung Cancer in the Immunotherapy Era: A Single-Centre Retrospective Study
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Bironzo, P., primary, Jacobs, F., additional, Cani, M., additional, Reale, M.L., additional, Tabbò, F., additional, Olmetto, E., additional, Capelletto, E., additional, Napoli, V., additional, Passiglia, F., additional, Listì, A., additional, Righi, L., additional, Di Maio, M., additional, Novello, S., additional, and Scagliotti, G., additional
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- 2021
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34. 1783P Multi-parametric T cells profiling in broncho-alveolar lavage fluid (BAL) and blood from advanced lung cancer patients
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Mariniello, A., primary, Tabbò, F., additional, Indellicati, D., additional, Geuna, M., additional, Tesauro, M., additional, Rezmives, N.A., additional, Di Maio, M., additional, Bironzo, P., additional, Reale, M.L., additional, Passiglia, F., additional, Listi, A., additional, Capelletto, E., additional, Carnio, S., additional, Bertaglia, V., additional, Mecca, C., additional, Consito, L.T., additional, De Filippis, M., additional, Bungaro, M., additional, Paratore, C., additional, and Novello, S., additional
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- 2021
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35. 1368TiP EPROPA: The European program for routine testing of patients with advanced lung cancer
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Passiglia, F., primary, Tabbò, F., additional, Righi, L., additional, Bironzo, P., additional, Reale, M.L., additional, Listi, A., additional, Sini, C., additional, Vallone, S., additional, Arizio, F., additional, Secen, N.M., additional, Paz-Ares, L., additional, Felip, E., additional, Araújo, A., additional, Linardou, H., additional, Mohorcic, K., additional, Mazilu, L., additional, Szmytke, E., additional, Comanescu, A., additional, Scagliotti, G., additional, and Novello, S., additional
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- 2021
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36. EP.06B.12 A Knowledge-Based Database on 1100 Non-Small Cell Lung Cancer from Italian Clinical Experience: The Biomarkers ATLAS
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Malapelle, U., Passiglia, F., Pepe, F., Pisapia, P., Reale, M.L., Cortinovis, D.L., Fragetta, F., Galetta, D., Garbo, E., Graziano, P., Pagni, F., Pasello, G., Piovano, P., Pilotto, S., Tiseo, M., Genova, C., Righi, L., Troncone, G., and Novello, S.
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- 2024
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37. Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations
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Passiglia, F, Cappuzzo, F, Alabiso, O, Bettini, A, Bidoli, P, Chiari, R, Defferrari, C, Delmonte, A, Finocchiaro, G, Francini, G, Gelsomino, F, Giannarelli, D, Giordano, M, Illiano, A, Livi, L, Martelli, O, Natoli, C, Puppo, G, Ricevuto, E, Roca, E, Turci, D, Galetta, D, Passiglia F, Cappuzzo F, Alabiso O, Bettini AC, Bidoli P, Chiari R, Defferrari C, Delmonte A, Finocchiaro G, Francini G, Gelsomino F, Giannarelli D, Giordano M, Illiano A, Livi L, Martelli O, Natoli C, Puppo G, Ricevuto E, Roca E, Turci D, Galetta D., Passiglia, F, Cappuzzo, F, Alabiso, O, Bettini, A, Bidoli, P, Chiari, R, Defferrari, C, Delmonte, A, Finocchiaro, G, Francini, G, Gelsomino, F, Giannarelli, D, Giordano, M, Illiano, A, Livi, L, Martelli, O, Natoli, C, Puppo, G, Ricevuto, E, Roca, E, Turci, D, Galetta, D, Passiglia F, Cappuzzo F, Alabiso O, Bettini AC, Bidoli P, Chiari R, Defferrari C, Delmonte A, Finocchiaro G, Francini G, Gelsomino F, Giannarelli D, Giordano M, Illiano A, Livi L, Martelli O, Natoli C, Puppo G, Ricevuto E, Roca E, Turci D, and Galetta D.
- Abstract
Background: The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouring KRAS mutations. Methods: Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events. Results: Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) were KRAS wild-type mutations. KRAS status did not influence nivolumab efficacy in terms of ORR (20% vs 17%, P = 0.39) and DCR (47% vs 41%, P = 0.23). The median PFS and OS were 4 vs 3 months (P = 0.5) and 11.2 vs 10 months (P = 0.8) in the KRAS-positive vs the KRAS-negative group. The 3-months PFS rate was significantly higher in the KRAS-positive group as compared to the KRAS-negative group (53% vs 42%, P = 0.01). The percentage of any grade and grade 3–4 AEs were 45% vs 33% (P = 0.003) and 11% vs 6% (P = 0.03) in KRAS-positive and KRAS-negative groups, respectively. Conclusions: Nivolumab is an effective and safe treatment option for patients with previously treated, advanced non-squamous NSCLC regardless of KRAS mutations.
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- 2019
38. EP06.03-18 Atlas: Italian Knowledge Based Database for Biomarkers Analysis In NSCLC Patients
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Malapelle, U., Pepe, F., Passiglia, F., Pisapia, P., Reale, M.L., Cortinovis, D., Fragetta, F., Galetta, D., Garbo, E., Graziano, P., Pagni, F., Pilotto, S., Tiseo, M., Troncone, G., and Novello, S.
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- 2023
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39. 1403P Sotorasib in KRAS p.G12C mutated advanced NSCLC: Real-word data from the Italian Expanded Access Program
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Reale, M.L., Passiglia, F., Brambilla, M., Pasello, G., Minuti, G., Bulotta, A., Pizzutilo, P., Sini, C., Costa, J., Roca, E., Bria, E., Pilotto, S., Genova, C., Metro, G., Citarella, F., Bordi, P., Russo, A., Chiari, R., Andrikou, K., and Novello, S.
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- 2023
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40. RAS as a positive predictive biomarker: focus on lung and colorectal cancer patients
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Malapelle, U, Passiglia, F, Cremolini, C, Reale, M, Pepe, F, Pisapia, P, Avallone, A, Cortinovis, D, De Stefano, A, Fassan, M, Fontanini, G, Galetta, D, Lauricella, C, Listì, A, Loupakis, F, Pagni, F, Pietrantonio, F, Pilotto, S, Righi, L, Bianchi, A, Parra, H, Tiseo, M, Verzè, M, Troncone, G, Novello, S, Malapelle, Umberto, Passiglia, Francesco, Cremolini, Chiara, Reale, Maria Lucia, Pepe, Francesco, Pisapia, Pasquale, Avallone, Antonio, Cortinovis, Diego, De Stefano, Alfonso, Fassan, Matteo, Fontanini, Gabriella, Galetta, Domenico, Lauricella, Calogero, Listì, Angela, Loupakis, Fotios, Pagni, Fabio, Pietrantonio, Filippo, Pilotto, Sara, Righi, Luisella, Bianchi, Andrea Sartore, Parra, Hector Soto, Tiseo, Marcello, Verzè, Michela, Troncone, Giancarlo, Novello, Silvia, Malapelle, U, Passiglia, F, Cremolini, C, Reale, M, Pepe, F, Pisapia, P, Avallone, A, Cortinovis, D, De Stefano, A, Fassan, M, Fontanini, G, Galetta, D, Lauricella, C, Listì, A, Loupakis, F, Pagni, F, Pietrantonio, F, Pilotto, S, Righi, L, Bianchi, A, Parra, H, Tiseo, M, Verzè, M, Troncone, G, Novello, S, Malapelle, Umberto, Passiglia, Francesco, Cremolini, Chiara, Reale, Maria Lucia, Pepe, Francesco, Pisapia, Pasquale, Avallone, Antonio, Cortinovis, Diego, De Stefano, Alfonso, Fassan, Matteo, Fontanini, Gabriella, Galetta, Domenico, Lauricella, Calogero, Listì, Angela, Loupakis, Fotios, Pagni, Fabio, Pietrantonio, Filippo, Pilotto, Sara, Righi, Luisella, Bianchi, Andrea Sartore, Parra, Hector Soto, Tiseo, Marcello, Verzè, Michela, Troncone, Giancarlo, and Novello, Silvia
- Abstract
Rat sarcoma (RAS) oncogenes have intensively been investigated during the last decades. Taking into account all human tumours, Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) gene is the most frequently mutated (about 22%) among the three isoforms, followed by Neuroblastoma RAS Viral Oncogene Homolog (NRAS) (8%) and Harvey Rat Sarcoma Viral Oncogene Homolog (HRAS) (3%). In the last years, careful attention has been paid on KRAS and NRAS gene mutations in non-small-cell lung cancer (NSCLC) and colorectal cancer (CRC) patients because of their prognostic and predictive roles. In particular, a large body of literature data has been generated investigating clinical outcomes of targeted treatments in NSCLC and CRC KRAS- and NRAS-mutated patients. The latest evidences are here reviewed, providing also an overview of the real-world RAS mutation testing practice across different Italian laboratories. On this basis, we propose a knowledge-based system, www.rasatlas.com, to support the healthcare personnel in the management of patients featuring RAS gene mutations in the landscape of precision oncology.
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- 2021
41. Immune-checkpoint inhibitors in non-small cell lung cancer: A tool to improve patients' selection
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Banna, G, Passiglia, F, Colonese, F, Canova, S, Menis, J, Addeo, A, Russo, A, Cortinovis, D, Banna GL, Passiglia F, Colonese F, Canova S, Menis J, Addeo A, Russo A, Cortinovis D, Banna, G, Passiglia, F, Colonese, F, Canova, S, Menis, J, Addeo, A, Russo, A, Cortinovis, D, Banna GL, Passiglia F, Colonese F, Canova S, Menis J, Addeo A, Russo A, and Cortinovis D
- Abstract
The identification of reliable predictive biomarkers of efficacy or resistance to immune-oncology (I–O) agents is a major issue for translational research and clinical practice. However, along with PDL1 and molecular features other clinical, radiological and laboratory factors can be considered for the selection of those patients who would not be the best candidate for immune-checkpoint inhibitors (ICPIs). We examined these factors, emerging from the results of currently available studies in non-small cell lung cancer (NSCLC), aiming to provide a useful and manageable tool which can help Oncologists in their everyday clinical practice. A thorough patient evaluation and close clinical monitoring, due to limited, early or inconclusive currently available data, should be deserved for patients with a pre-existing symptomatic chronic obstructive pulmonary disease, age >75 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 1, a time to progression (TTP) < three months and progressive disease (PD) as the best response to the previous treatment, hepatitis or HIV-infections, high neutrophil to lymphocyte ratio (NLR), or on treatment with high-dose steroids, when the use of ICPIs is considered. Limited data are available to consider that ICPIs are safe in patients with interstitial lung disease, bronchiolitis obliterans organizing pneumonia and autommune diseases. Early evidence on steroids, vaccinations and antibiotics suggest their possible interaction with ICPIs and need to be more investigated in clinical trials. Oncogene-addicted NSCLC harboring EGFR-mutations and low tumor-infiltrating T-lymphocytes (TILs) seems not to gain benefit from I–O.
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- 2018
42. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression >= 50%: a multicenter study with external validation
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Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., Ficorella, C., Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., and Ficorella, C.
- Abstract
Background The association between obesity and outcomes in patients receiving programmed death-1/ programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04– 2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37–0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45–0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01–1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49–0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.
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- 2020
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43. First-line pembrolizumab in advanced non-small cell lung cancer patients with poor performance status
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Facchinetti, F, Mazzaschi, G, Barbieri, F, Passiglia, F, Mazzoni, F, Berardi, R, Proto, C, Cecere, F, Pilotto, S, Scotti, V, Rossi, S, Del Conte, A, Vita, E, Bennati, C, Ardizzoni, A, Cerea, G, Migliorino, M, Sala, E, Camerini, A, Bearz, A, De Carlo, E, Zanelli, F, Guaitoli, G, Garassino, M, Ciccone, L, Sartori, G, Toschi, L, Dall'Olio, F, Landi, L, Pizzutilo, E, Bartoli, G, Baldessari, C, Novello, S, Bria, E, Cortinovis, D, Rossi, G, Rossi, A, Banna, G, Camisa, R, Di Maio, M, Tiseo, M, Cecere, FL, Migliorino, MR, Garassino, MC, Ciccone, LP, Dall'Olio, FG, Pizzutilo, EG, Banna, GL, Facchinetti, F, Mazzaschi, G, Barbieri, F, Passiglia, F, Mazzoni, F, Berardi, R, Proto, C, Cecere, F, Pilotto, S, Scotti, V, Rossi, S, Del Conte, A, Vita, E, Bennati, C, Ardizzoni, A, Cerea, G, Migliorino, M, Sala, E, Camerini, A, Bearz, A, De Carlo, E, Zanelli, F, Guaitoli, G, Garassino, M, Ciccone, L, Sartori, G, Toschi, L, Dall'Olio, F, Landi, L, Pizzutilo, E, Bartoli, G, Baldessari, C, Novello, S, Bria, E, Cortinovis, D, Rossi, G, Rossi, A, Banna, G, Camisa, R, Di Maio, M, Tiseo, M, Cecere, FL, Migliorino, MR, Garassino, MC, Ciccone, LP, Dall'Olio, FG, Pizzutilo, EG, and Banna, GL
- Abstract
Background: Pembrolizumab is the first-line standard of care for advanced non–small cell lung cancer (NSCLC) with a PD-L1 tumour proportion score (TPS) ≥ 50%. Eastern Cooperative Oncology Group performance status (PS) 2 patients may receive pembrolizumab, despite the absence of sustaining evidence. Patients and methods: GOIRC-2018-01 is a multicentre, retrospective, observational study. PS 2 NSCLC patients with a PD-L1 TPS ≥50% receiving first-line pembrolizumab from June 2017 to December 2018 at 21 Italian institutions were included. Clinical-pathological characteristics were correlated with disease response and survival outcomes; adverse events were recorded. The primary objective was 6-months progression-free rate (6-months PFR). Results: One hundred fifty-three patients (median age 70 years) were enrolled. At a median follow-up of 18.2 months, median progression-free survival (PFS) and overall survival (OS) were 2.4 (95% confidence interval, 95% CI, 1.6–2.5) and 3.0 months (95% CI 2.4–3.5), respectively. 6-months PFR was 27% (95% CI 21–35%). Patients with a PS 2 determined by comorbidities (n = 41) had significantly better outcomes compared with disease burden-induced PS 2 (n = 112). Indeed, 6-months PFR was 49% versus 19%, median PFS 5.6 versus 1.8 months and OS 11.8 versus 2.8 months, respectively. Additional potential prognostic factors (radiotherapy, antibiotics, steroids received before pembrolizumab) correlated with clinical outcomes. The determinant of PS 2 resulted the only factor independently impacting on both PFS and OS. No toxicity issues emerged. Conclusions: Outcomes of PS 2 NSCLC patients with PD-L1 TPS ≥50% receiving first-line pembrolizumab were globally dismal but strongly dependent on the reason conditioning the poor PS itself.
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- 2020
44. KRAS inhibition in non-small cell lung cancer: Past failures, new findings and upcoming challenges
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Passiglia, F, Malapelle, U, Del Re, M, Righi, L, Pagni, F, Furlan, D, Danesi, R, Troncone, G, Novello, S, Passiglia, Francesco, Malapelle, Umberto, Del Re, Marzia, Righi, Luisella, Pagni, Fabio, Furlan, Daniela, Danesi, Romano, Troncone, Giancarlo, Novello, Silvia, Passiglia, F, Malapelle, U, Del Re, M, Righi, L, Pagni, F, Furlan, D, Danesi, R, Troncone, G, Novello, S, Passiglia, Francesco, Malapelle, Umberto, Del Re, Marzia, Righi, Luisella, Pagni, Fabio, Furlan, Daniela, Danesi, Romano, Troncone, Giancarlo, and Novello, Silvia
- Abstract
Despite the high prevalence of Kirsten rat sarcoma (KRAS) mutations in non-small cell lung cancer (NSCLC), for a long time it has been defined as an 'undruggable target', with precision medicine not considered as an adequate approach to treat this subgroup of patients. After several years of efforts, preliminary data from early clinical trials have recently demonstrated that direct pharmacological inhibition of KRAS p.G12C mutation is possible, emerging as an effective targeted treatment for about 10-12% of patients with advanced NSCLC, with potential relevant impact on their long-term survival and quality of life. This review reports the current status of KRAS mutations detection in the Italian real-word scenario, summarises the biological basis of KRAS inhibition in NSCLC and provides an updated overview of therapeutic strategies, discussing the potential reasons for past failures and analysing the upcoming challenges related to the advent of new targeted agents in clinical practice.
- Published
- 2020
45. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression >= 50%: a multicenter study with external validation
- Author
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Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, GL, Aerts, Joachim, Barbieri, F, Giusti, R, Cortinovis, DL, Migliorino, MR, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Rastelli, F, Chiari, R, De Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, Luca, Targato, G, Nigro, O, Ferrara, MG, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbo, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, GL, Aerts, Joachim, Barbieri, F, Giusti, R, Cortinovis, DL, Migliorino, MR, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Rastelli, F, Chiari, R, De Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, Luca, Targato, G, Nigro, O, Ferrara, MG, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbo, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, and Ficorella, C
- Published
- 2020
46. Erratum to: The diagnostic accuracy of circulating tumor DNA for the detection of EGFR-T790M mutation in NSCLC: a systematic review and meta-analysis (Scientific Reports, (2018), 8, 1, (13379), 10.1038/s41598-018-30780-4)
- Author
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Passiglia F., Rizzo S., Di Maio M., Galvano A., Badalamenti G., Listi A., Gulotta L., Castiglia M., Fulfaro F., Bazan V., Russo A., Passiglia F., Rizzo S., Di Maio M., Galvano A., Badalamenti G., Listi A., Gulotta L., Castiglia M., Fulfaro F., Bazan V., and Russo A.
- Subjects
circulating tumor DNA, NSCLC ,Settore MED/06 - Oncologia Medica - Abstract
A correction to this article has been published and is linked from the HTML and PDF versions of this paper. The error has been fixed in the paper.
- Published
- 2018
47. First-line immune-chemotherapy combination: the right strategy to fight squamous non-small-cell lung cancer?
- Author
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Passiglia, F, Bironzo, P, and Scagliotti, Gv
- Published
- 2019
48. A systematic review and meta-analysis of trials assessing activity of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) for pre-treated advanced malignant mesothelioma (aMM)
- Author
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Tagliamento, M., primary, Bironzo, P., additional, De Luca, E., additional, Pignataro, D., additional, Rapetti, S.G., additional, Audisio, M., additional, Bertaglia, V., additional, Paratore, C., additional, Bungaro, M., additional, Olmetto, E., additional, Artusio, E., additional, Reale, M.L., additional, Zichi, C., additional, Capelletto, E., additional, Carnio, S., additional, Buffoni, L., additional, Passiglia, F., additional, Novello, S., additional, and Di Maio, M., additional
- Published
- 2019
- Full Text
- View/download PDF
49. The elderly patient individualized chemotherapy (EPIC) trial, a study for an aged population of non-small cell lung cancer
- Author
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Passiglia, F., primary, Capelletto, E., additional, Grossi, F., additional, Bidoli, P., additional, Galetta, D., additional, Follador, A., additional, Valmadre, G.P., additional, Defferrari, C., additional, Caffo, O., additional, Bearz, A., additional, Colantonio, I., additional, Gregorc, V., additional, Scotti, V., additional, Cognetti, F., additional, Cordero, L., additional, Arizio, F., additional, Novello, S., additional, Torri, V., additional, and Scagliotti, G., additional
- Published
- 2019
- Full Text
- View/download PDF
50. P2.14-17 Correlation Between Clinic-Pathological Data and T790M Detection in EGFR Mutated NSCLC Patients Progressing on 1st/2nd Generation TKIs
- Author
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Pignataro, D., primary, Tagliamento, M., additional, Reale, M.L., additional, Tabbò, F., additional, Bungaro, M., additional, Paratore, C., additional, Cetoretta, V., additional, De Filippis, M., additional, Bertaglia, V., additional, Passiglia, F., additional, Righi, L., additional, Bironzo, P., additional, and Novello, S., additional
- Published
- 2019
- Full Text
- View/download PDF
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