Non-Small Cell Lung Cancer Testing on Reference Specimens: An Italian Multicenter Experience.

Autor: Pepe F; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Russo G; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Venuta A; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Scimone C; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Nacchio M; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Pisapia P; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Goteri G; Pathological Anatomy Institute, Polytechnic University of Marche Region, Ancona, Italy., Barbisan F; Pathological Anatomy Institute, Polytechnic University of Marche Region, Ancona, Italy., Chiappetta C; Department of Pathology, AOU Policlinico Umberto I, Rome, Italy., Pernazza A; Department of Medico-Surgical Sciences and Biotechnologies, Polo Pontino-Sapienza University, Latina, Italy., Campagna D; Department of Pathology, San Giovanni-Addolorata Hospital, 00184, Rome, Italy., Giordano M; Department of Pathology, San Giovanni-Addolorata Hospital, 00184, Rome, Italy., Perrone G; Research Unit of Anatomical Pathology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21-00128, Rome, Italy.; Anatomical Pathology Operative Research Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200-00128, Rome, Italy., Sabarese G; Anatomical Pathology Operative Research Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200-00128, Rome, Italy., Altimari A; Molecular Pathology, University of Bologna Hospital of Bologna Sant'Orsola-Malpighi Polyclinic, Bologna, Italy., de Biase D; Pharmacy and Biotechnology (FaBiT), Molecular Pathology Laboratory, University of Bologna, Bologna, Italy., Tallini G; Molecular Pathology, University of Bologna Hospital of Bologna Sant'Orsola-Malpighi Polyclinic, Bologna, Italy.; Pharmacy and Biotechnology (FaBiT), Molecular Pathology Laboratory, University of Bologna, Bologna, Italy.; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy., Calistri D; Biosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', 47014, Meldola, Italy., Chiadini E; Biosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', 47014, Meldola, Italy., Capelli L; Biosciences Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', 47014, Meldola, Italy., Santinelli A; Anatomic Pathology Azienda Sanitaria Territoriale Pesaro-Urbino, Pesaro, Italy., Gulini AE; Anatomic Pathology Azienda Sanitaria Territoriale Pesaro-Urbino, Pesaro, Italy., Pierpaoli E; Anatomic Pathology Azienda Sanitaria Territoriale Pesaro-Urbino, Pesaro, Italy., Badiali M; Laboratory of Genetics and Genomics-Pediatric Hospital A.Cao-ASL8, Cagliari, Italy., Murru S; Laboratory of Genetics and Genomics-Pediatric Hospital A.Cao-ASL8, Cagliari, Italy., Murgia R; Experimental Medicine Unit, Department of Biomedical Sciences, University of Cagliari, 09124, Cagliari, Italy., Guerini Rocco E; Division of Pathology, IEO, European Institute of Oncology IRCCS, Via Giuseppe Ripamonti 435, 20141, Milan, Italy.; Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy., Venetis K; Division of Pathology, IEO, European Institute of Oncology IRCCS, Via Giuseppe Ripamonti 435, 20141, Milan, Italy., Fusco N; Division of Pathology, IEO, European Institute of Oncology IRCCS, Via Giuseppe Ripamonti 435, 20141, Milan, Italy.; Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy., Morotti D; Pathology Unit and Medical Genetics Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy., Gianatti A; Pathology Unit and Medical Genetics Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy., Furlan D; Pathology Unit, Department of Medicine and Technological Innovation, University of Insubria, Varese, Italy., Rossi G; Department of Anatomical Pathology, Fondazione Poliambulanza, 25124, Brescia, Italy., Melocchi L; Department of Anatomical Pathology, Fondazione Poliambulanza, 25124, Brescia, Italy., Russo M; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., De Luca C; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Palumbo L; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Simonelli S; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Maffè A; Genetics and Molecular Biology Unit, Santa Croce e Carle Hospital, 12100, Cuneo, Italy., Francia di Celle P; Molecular Pathology, AOU Città della Salute e della Scienza di Torino, 10126, Turin, Italy., Venesio T; Candiolo Cancer Institute, FPO-IRCCS, 10060, Candiolo, Italy., Scatolini M; Molecular Oncology Lab, Fondazione Edo ed Elvo Tempia, Biella, Italy., Grosso E; Molecular Oncology Lab, Fondazione Edo ed Elvo Tempia, Biella, Italy., Orecchia S; Pathology Division, S. Antonio and Biagio Hospital, Alessandria, Italy., Fassan M; Department of Medicine-DIMED, University of Padua, Padua, Veneto, Italy.; Veneto Institute of Oncology-IOV-IRCCS, Padua, Italy., Balistreri M; Surgical Pathology Unit, University Hospital of Padua, Padua, Italy., Zulato E; Surgical Pathology Unit, University Hospital of Padua, Padua, Italy., Reghellin D; Department of Pathology, San Bortolo Hospital, Vicenza, Italy., Lazzari E; Department of Pathology, San Bortolo Hospital, Vicenza, Italy., Santacatterina M; Department of Pathology, San Bortolo Hospital, Vicenza, Italy., Piredda ML; Department of Pathology, San Bortolo Hospital, Vicenza, Italy., Riccardi M; Department of Pathology, Azienda Ulss3 Serenissima, Ospedale dell'Angelo, Venice, Italy., Laurino L; Department of Pathology, Azienda Ulss3 Serenissima, Ospedale dell'Angelo, Venice, Italy., Roz E; Pathology Unit, La Maddalena Clinic for Cancer, Palermo, Italy., Longo D; UOSD di Anatomia Patologica dell'Azienda Ospedaliera Papardo, Messina, Italy., Romeo DP; UOSD di Anatomia Patologica dell'Azienda Ospedaliera Papardo, Messina, Italy., Fazzari C; UOSD di Anatomia Patologica dell'Azienda Ospedaliera Papardo, Messina, Italy., Moreno-Manuel A; Molecular Oncology Laboratory, Fundación Investigación Hospital General Universitario de Valencia, 46014, Valencia, Spain.; TRIAL Mixed Unit, Centro Investigación Príncipe Felipe-Fundación Investigación Hospital General Universitario de Valencia, 46014, Valencia, Spain.; Centro de Investigación Biomédica en Red Cáncer, CIBERONC, 28029, Madrid, Spain., Puglia GD; Institute for Agricultural and Forest Systems in the Mediterranean, National Research Council (ISAFOM-CNR), 95128, Catania, Italy., Prjibelski AD; Center for Algorithmic Biotechnology, Institute of Translational Biomedicine, St. Petersburg State University, St. Petersburg, Russia., Shafranskaya D; Center for Algorithmic Biotechnology, Institute of Translational Biomedicine, St. Petersburg State University, St. Petersburg, Russia., Righi L; Department of Oncology, San Luigi Hospital, University of Turin, Orbassano, TO, Italy., Listì A; Department of Oncology, San Luigi Hospital, University of Turin, Orbassano, TO, Italy., Vitale D; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Iaccarino A; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy., Malapelle U; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy. umberto.malapelle@unina.it., Troncone G; Department of Public Health, Federico II University of Naples, Via S. Pansini, 5, 80131, Naples, Italy.
Jazyk: angličtina
Zdroj: Oncology and therapy [Oncol Ther] 2024 Mar; Vol. 12 (1), pp. 73-95. Date of Electronic Publication: 2024 Jan 11.
DOI: 10.1007/s40487-023-00252-5
Abstrakt: Introduction: Biomarker testing is mandatory for the clinical management of patients with advanced non-small cell lung cancer (NSCLC). Myriads of technical platforms are now available for biomarker analysis with differences in terms of multiplexing capability, analytical sensitivity, and turnaround time (TAT). We evaluated the technical performance of the diagnostic workflows of 24 representative Italian institutions performing molecular tests on a series of artificial reference specimens built to mimic routine diagnostic samples.
Methods: Sample sets of eight slides from cell blocks of artificial reference specimens harboring exon 19 EGFR (epidermal growth factor receptor) p.E746_AT50del, exon 2 KRAS (Kirsten rat sarcoma viral oncogene homologue) p.G12C, ROS1 (c-ros oncogene 1)-unknown gene fusion, and MET (MET proto-oncogene, receptor tyrosine kinase) Δ exon 14 skipping were distributed to each participating institution. Two independent cell block specimens were validated by the University of Naples Federico II before shipment. Methodological and molecular data from reference specimens were annotated.
Results: Overall, a median DNA concentration of 3.3 ng/µL (range 0.1-10.0 ng/µL) and 13.4 ng/µL (range 2.0-45.8 ng/µL) were obtained with automated and manual technical procedures, respectively. RNA concentrations of 5.7 ng/µL (range 0.2-11.9 ng/µL) and 9.3 ng/µL (range 0.5-18.0 ng/µL) were also detected. KRAS exon 2 p.G12C, EGFR exon 19 p.E736_A750del hotspot mutations, and ROS1 aberrant transcripts were identified in all tested cases, whereas 15 out of 16 (93.7%) centers detected MET exon 14 skipping mutation.
Conclusions: Optimized technical workflows are crucial in the decision-making strategy of patients with NSCLC. Artificial reference specimens enable optimization of diagnostic workflows for predictive molecular analysis in routine clinical practice.
(© 2024. The Author(s).)
Databáze: MEDLINE
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