المؤلفون: 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

المساهمون: 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

مصطلحات موضوعية: KRASp.G12C, Non-small cell lung cancer, Sotorasib, Targeted therapy

الوصف: 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.

العلاقة: info:eu-repo/semantics/altIdentifier/pmid/38157806; volume:187; firstpage:107444; journal:LUNG CANCER; https://hdl.handle.net/11577/3503269Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85181527265

الإتاحة: https://doi.org/10.1016/j.lungcan.2023.107444Test
https://hdl.handle.net/11577/3503269Test

المؤلفون: 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

المصدر: Lung Cancer ; volume 191, page 107787 ; ISSN 0169-5002

مصطلحات موضوعية: Cancer Research, Pulmonary and Respiratory Medicine, Oncology

الإتاحة: https://doi.org/10.1016/j.lungcan.2024.107787Test
https://api.elsevier.com/content/article/PII:S0169500224000953?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0169500224000953?httpAccept=text/plainTest

المؤلفون: 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

المساهمون: 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

مصطلحات موضوعية: KRASp.G12C, Non-small cell lung cancer, Sotorasib, Targeted therapy

الوصف: 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.

العلاقة: info:eu-repo/semantics/altIdentifier/wos/WOS:001157132500001; volume:187; firstpage:107444; journal:LUNG CANCER; https://hdl.handle.net/11588/949265Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85181527265

الإتاحة: https://doi.org/10.1016/j.lungcan.2023.107444Test
https://hdl.handle.net/11588/949265Test

المؤلفون: Umberto Malapelle, Francesco Passiglia, Francesco Pepe, Pasquale Pisapia, Maria Lucia Reale, Diego Cortinovis, Filippo Fragetta, Domenico Galetta, Edoardo Garbo, Paolo Graziano, Fabio Pagni, Giulia Pasello, Pierluigi Piovano, Sara Pilotto, Marcello Tiseo, Carlo Genova, Luisella Righi, Giancarlo Troncone, Silvia Novello

المساهمون: Malapelle, Umberto, Passiglia, Francesco, Pepe, Francesco, Pisapia, Pasquale, Lucia Reale, Maria, Cortinovis, Diego, Fragetta, 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

مصطلحات موضوعية: database, molecular record, clinical record, NSCLC

الوصف: 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.comTest/) 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.comTest/) 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.

العلاقة: journal:LUNG CANCER; https://hdl.handle.net/11573/1708187Test

الإتاحة: https://doi.org/10.1016/j.lungcan.2024.107787Test
https://hdl.handle.net/11573/1708187Test