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Observational Study
. 2025 Aug;111(4):293-301.
doi: 10.1177/03008916251341996. Epub 2025 Jul 10.

Biomarker testing implementation for molecularly targeted therapy in non-small cell lung cancer patients

Daniele Lorenzini  1   2 , Gabriella Gaudioso  3 , Alessandro Scardoni  4 , Lorenzo Blandi  5 , Alessandro Del Gobbo  6 , Paola Rafaniello Raviele  6 , Stefano Ferrero  6   7 , Silvio M Veronese  8 , Calogero Lauricella  8 , Fabio Pagni  9 , Davide Seminati  9 , Monica Miozzo  10 , Chiara Pesenti  10 , Umberto Gianelli  11 , Simona Buiatiotis  11 , Caterina Fumagalli  11 , Elena Guerini Rocco  2   12 , Alessandra Rappa  12 , Massimo Barberis  12 , Nicola Fusco  2   12 , Alberto Ranghiero  12 , Stefano La Rosa  13 , Fausto Sessa  13 , Daniela Furlan  13 , Nora Sahnane  13 , Carlo Patriarca  14 , Maria Giulia Cangi  15 , Alessandra Lume  15 , Claudio Doglioni  15 , Maurilio Ponzoni  15 , William Vermi  16 , Mauro Novali  17 , Marco Paulli  18   19 , Emanuela Boveri  18 , Luigi Terracciano  20   21 , Silvia Uccella  20   21 , Annarita Destro  20 , Elena Tamborini  1 , Federica Perrone  1 , Fabio Pasotti  22 , Francesco Agustoni  23 , Filippo De Braud  2   24 , Francesco Grossi  25 , Salvatore Siena  2   26 , Giuseppe Curigliano  2   27 , Sabrina Buoro  22 , Giancarlo Pruneri  1   2
Affiliations
Observational Study

Biomarker testing implementation for molecularly targeted therapy in non-small cell lung cancer patients

Daniele Lorenzini et al. Tumori. 2025 Aug.

Abstract

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.

Keywords: Lung adenocarcinoma; NGS; precision oncology; target therapy.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Estimated total cases of lung cancer per year in Lombardy Region (blue bar) and LUAD (orange bar), compared to NGS test performed in 2023 (green bar). LUAD: Lung adenocarcinoma. NGS: Next-generation Sequencing.
Figure 2.
Figure 2.
Actionable molecular alterations.
See this image and copyright information in PMC

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