Daniele Lorenzini, Gabriella Gaudioso, Alessandro Scardoni, Lorenzo Blandi, Alessandro Del Gobbo, Paola Rafaniello Raviele, Stefano Ferrero, Silvio M Veronese, Calogero Lauricella, Fabio Pagni, Davide Seminati, Monica Miozzo, Chiara Pesenti, Umberto Gianelli, Simona Buiatiotis, Caterina Fumagalli, Elena Guerini Rocco, Alessandra Rappa, Massimo Barberis, Nicola Fusco, Alberto Ranghiero, Stefano La Rosa, Fausto Sessa, Daniela Furlan, Nora Sahnane, Carlo Patriarca, Maria Giulia Cangi, Alessandra Lume, Claudio Doglioni, Maurilio Ponzoni, William Vermi, Mauro Novali, Marco Paulli, Emanuela Boveri, Luigi Terracciano, Silvia Uccella, Annarita Destro, Elena Tamborini, Federica Perrone, Fabio Pasotti, Francesco Agustoni, Filippo De Braud, Francesco Grossi, Salvatore Siena, Giuseppe Curigliano, Sabrina Buoro, Giancarlo Pruneri
{"title":"非小细胞肺癌患者分子靶向治疗的生物标志物检测实施。","authors":"Daniele Lorenzini, Gabriella Gaudioso, Alessandro Scardoni, Lorenzo Blandi, Alessandro Del Gobbo, Paola Rafaniello Raviele, Stefano Ferrero, Silvio M Veronese, Calogero Lauricella, Fabio Pagni, Davide Seminati, Monica Miozzo, Chiara Pesenti, Umberto Gianelli, Simona Buiatiotis, Caterina Fumagalli, Elena Guerini Rocco, Alessandra Rappa, Massimo Barberis, Nicola Fusco, Alberto Ranghiero, Stefano La Rosa, Fausto Sessa, Daniela Furlan, Nora Sahnane, Carlo Patriarca, Maria Giulia Cangi, Alessandra Lume, Claudio Doglioni, Maurilio Ponzoni, William Vermi, Mauro Novali, Marco Paulli, Emanuela Boveri, Luigi Terracciano, Silvia Uccella, Annarita Destro, Elena Tamborini, Federica Perrone, Fabio Pasotti, Francesco Agustoni, Filippo De Braud, Francesco Grossi, Salvatore Siena, Giuseppe Curigliano, Sabrina Buoro, Giancarlo Pruneri","doi":"10.1177/03008916251341996","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Recent advancements in identifying druggable molecular drivers in lung adenocarcinoma (LUAD), have transformed treatment paradigms. In recent years, Next Generation Sequencing (NGS) has gained momentum as an essential tool for in-depth simultaneous analysis of multiple genes, thereby streamlining the diagnostic process in LUAD. Despite this, the implementation of NGS testing in both the US and Europe remains suboptimal.</p><p><strong>Aims: </strong>In compliance with a decree issued by the Italian Ministry of Health, Lombardy Region recently launched an initiative to implement NGS testing in patients with advanced LUAD. In this context, a real-world prospective observational study was planned to assess the efficacy of the regional network of molecular laboratories in testing nine biomarkers (<i>KRAS</i> p.G12C, <i>EGFR</i>, <i>BRAF, HER2, MET</i> mutations; <i>ALK</i>, <i>ROS1</i>, <i>NTRK1-3</i>, <i>RET</i> rearrangements), for on-label molecularly targeted drugs.</p><p><strong>Results: </strong>In 2023, out of the 2784 advanced/metastatic LUAD patients expected in Lombardy, 2343 (84.2%) were successfully evaluated with an NGS panel including all the nine biomarkers for on-label drugs. Actionable aberrations were identified in 45.5% of the patients (1068/2343), predominantly involving <i>EGFR</i>, <i>KRAS</i>, and <i>ALK</i> genes.</p><p><strong>Conclusion: </strong>Our data provide evidence that establishing a structured network of NGS hubs is mandatory to ensure access of advanced LUAD patients to molecularly targeted treatments.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"3008916251341996"},"PeriodicalIF":2.0000,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Biomarker testing implementation for molecularly targeted therapy in non-small cell lung cancer patients.\",\"authors\":\"Daniele Lorenzini, Gabriella Gaudioso, Alessandro Scardoni, Lorenzo Blandi, Alessandro Del Gobbo, Paola Rafaniello Raviele, Stefano Ferrero, Silvio M Veronese, Calogero Lauricella, Fabio Pagni, Davide Seminati, Monica Miozzo, Chiara Pesenti, Umberto Gianelli, Simona Buiatiotis, Caterina Fumagalli, Elena Guerini Rocco, Alessandra Rappa, Massimo Barberis, Nicola Fusco, Alberto Ranghiero, Stefano La Rosa, Fausto Sessa, Daniela Furlan, Nora Sahnane, Carlo Patriarca, Maria Giulia Cangi, Alessandra Lume, Claudio Doglioni, Maurilio Ponzoni, William Vermi, Mauro Novali, Marco Paulli, Emanuela Boveri, Luigi Terracciano, Silvia Uccella, Annarita Destro, Elena Tamborini, Federica Perrone, Fabio Pasotti, Francesco Agustoni, Filippo De Braud, Francesco Grossi, Salvatore Siena, Giuseppe Curigliano, Sabrina Buoro, Giancarlo Pruneri\",\"doi\":\"10.1177/03008916251341996\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Recent advancements in identifying druggable molecular drivers in lung adenocarcinoma (LUAD), have transformed treatment paradigms. In recent years, Next Generation Sequencing (NGS) has gained momentum as an essential tool for in-depth simultaneous analysis of multiple genes, thereby streamlining the diagnostic process in LUAD. Despite this, the implementation of NGS testing in both the US and Europe remains suboptimal.</p><p><strong>Aims: </strong>In compliance with a decree issued by the Italian Ministry of Health, Lombardy Region recently launched an initiative to implement NGS testing in patients with advanced LUAD. In this context, a real-world prospective observational study was planned to assess the efficacy of the regional network of molecular laboratories in testing nine biomarkers (<i>KRAS</i> p.G12C, <i>EGFR</i>, <i>BRAF, HER2, MET</i> mutations; <i>ALK</i>, <i>ROS1</i>, <i>NTRK1-3</i>, <i>RET</i> rearrangements), for on-label molecularly targeted drugs.</p><p><strong>Results: </strong>In 2023, out of the 2784 advanced/metastatic LUAD patients expected in Lombardy, 2343 (84.2%) were successfully evaluated with an NGS panel including all the nine biomarkers for on-label drugs. Actionable aberrations were identified in 45.5% of the patients (1068/2343), predominantly involving <i>EGFR</i>, <i>KRAS</i>, and <i>ALK</i> genes.</p><p><strong>Conclusion: </strong>Our data provide evidence that establishing a structured network of NGS hubs is mandatory to ensure access of advanced LUAD patients to molecularly targeted treatments.</p>\",\"PeriodicalId\":23349,\"journal\":{\"name\":\"Tumori\",\"volume\":\" \",\"pages\":\"3008916251341996\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-07-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Tumori\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/03008916251341996\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Tumori","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/03008916251341996","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Biomarker testing implementation for molecularly targeted therapy in non-small cell lung cancer patients.
Background: Recent advancements in identifying druggable molecular drivers in lung adenocarcinoma (LUAD), have transformed treatment paradigms. In recent years, Next Generation Sequencing (NGS) has gained momentum as an essential tool for in-depth simultaneous analysis of multiple genes, thereby streamlining the diagnostic process in LUAD. Despite this, the implementation of NGS testing in both the US and Europe remains suboptimal.
Aims: In compliance with a decree issued by the Italian Ministry of Health, Lombardy Region recently launched an initiative to implement NGS testing in patients with advanced LUAD. In this context, a real-world prospective observational study was planned to assess the efficacy of the regional network of molecular laboratories in testing nine biomarkers (KRAS p.G12C, EGFR, BRAF, HER2, MET mutations; ALK, ROS1, NTRK1-3, RET rearrangements), for on-label molecularly targeted drugs.
Results: In 2023, out of the 2784 advanced/metastatic LUAD patients expected in Lombardy, 2343 (84.2%) were successfully evaluated with an NGS panel including all the nine biomarkers for on-label drugs. Actionable aberrations were identified in 45.5% of the patients (1068/2343), predominantly involving EGFR, KRAS, and ALK genes.
Conclusion: Our data provide evidence that establishing a structured network of NGS hubs is mandatory to ensure access of advanced LUAD patients to molecularly targeted treatments.
期刊介绍：
Tumori Journal covers all aspects of cancer science and clinical practice with a strong focus on prevention, translational medicine and clinically relevant reports. We invite the publication of randomized trials and reports on large, consecutive patient series that investigate the real impact of new techniques, drugs and devices inday-to-day clinical practice.
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