Non-Small Cell Lung Cancer Testing on Reference Specimens: An Italian Multicenter Experience
Por:
F. PEPE, G. RUSSO, A. VENUTA, C. SCIMONE, M. NACCHIO, P. PISAPIA, G. GOTERI, F. BARBISAN, C. CHIAPPETTA, A. PERNAZZA, D. CAMPAGNA, M. GIORDANO, G. PERRONE, G. SABARESE, A. ALTIMARI, D. DE BIASE, G. TALLINI, D. CALISTRI, E. CHIADINI, L. CAPELLI, A. SANTINELLI, A. GULINI, E. PIERPAOLI, M. BADIALI, S. MURRU, R. MURGIA, E. ROCCO, K. VENETIS, N. FUSCO, D. MOROTTI, A. GIANATTI, D. FURLAN, G. ROSSI, L. MELOCCHI, M. RUSSO, C. DE LUCA, L. PALUMBO, S. SIMONELLI, A. MAFFÈ, P. DI CELLE, T. VENESIO, M. SCATOLINI, E. GROSSO, S. ORECCHIA, M. FASSAN, M. BALISTRERI, E. ZULATO, D. REGHELLIN, E. LAZZARI, M. SANTACATTERINA, M. PIREDDA, M. RICCARDI, L. LAURINO, E. ROZ, D. LONGO, D. ROMEO, C. FAZZARI, A. MORENO-MANUEL, G. PUGLIA, A. PRJIBELSKI, D. SHAFRANSKAYA, L. RIGHI, A. LISTÌ, D. VITALE, A. IACCARINO, U. MALAPELLE and G. TRONCONE
Publicada:
11 ene 2024
Ahead of Print:
1 ene 2024
Resumen:
IntroductionBiomarker 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.MethodsSample 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) Delta 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.ResultsOverall, a median DNA concentration of 3.3 ng/mu L (range 0.1-10.0 ng/mu L) and 13.4 ng/mu L (range 2.0-45.8 ng/mu L) were obtained with automated and manual technical procedures, respectively. RNA concentrations of 5.7 ng/mu L (range 0.2-11.9 ng/mu L) and 9.3 ng/mu L (range 0.5-18.0 ng/mu L) 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.ConclusionsOptimized 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.
Filiaciones:
F. PEPE:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
G. RUSSO:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
A. VENUTA:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
C. SCIMONE:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
M. NACCHIO:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
P. PISAPIA:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
G. GOTERI:
Polytech Univ Marche Reg, Pathol Anat Inst, Ancona, Italy
F. BARBISAN:
Polytech Univ Marche Reg, Pathol Anat Inst, Ancona, Italy
C. CHIAPPETTA:
AOU Policlin Umberto 1, AOU Policlin Umberto1, Rome, Italy
A. PERNAZZA:
Polo Pontino Sapienza Univ Rome, Dept Med Surg Sci & Biotechnol, Latina, Italy
D. CAMPAGNA:
San Giovanni Addolorata Hosp, Dept Pathol, I-00184 Rome, Italy
M. GIORDANO:
San Giovanni Addolorata Hosp, Dept Pathol, I-00184 Rome, Italy
G. PERRONE:
Univ Campus Biomed Roma, Dept Med & Surg, Res Unit Anat Pathol, Via Alvaro Portillo 21, I-00128 Rome, Italy
Fdn Policlin Univ Campus Biomed, Anat Pathol Operat Res Unit, Via Alvaro Portillo 200, I-00128 Rome, Italy
G. SABARESE:
Fdn Policlin Univ Campus Biomed, Anat Pathol Operat Res Unit, Via Alvaro Portillo 200, I-00128 Rome, Italy
A. ALTIMARI:
Univ Bologna, Hosp Bologna Sant Orsola Malpighi Polyclin, Mol Pathol, Bologna, Italy
D. DE BIASE:
Univ Bologna, Pharm & Biotechnol FaBiT, Mol Pathol Lab, Bologna, Italy
G. TALLINI:
Univ Bologna, Hosp Bologna Sant Orsola Malpighi Polyclin, Mol Pathol, Bologna, Italy
Univ Bologna, Pharm & Biotechnol FaBiT, Mol Pathol Lab, Bologna, Italy
Univ Bologna, Dept Med & Surg Sci, Bologna, Italy
D. CALISTRI:
IRCCS, Ist Romagnolo Studio Tumori IRST Dino Amadori, Biosci Lab, I-47014 Meldola, Italy
E. CHIADINI:
IRCCS, Ist Romagnolo Studio Tumori IRST Dino Amadori, Biosci Lab, I-47014 Meldola, Italy
L. CAPELLI:
IRCCS, Ist Romagnolo Studio Tumori IRST Dino Amadori, Biosci Lab, I-47014 Meldola, Italy
A. SANTINELLI:
Anat Pathol Azienda Sanit Territoriale Pesaro Urbi, Pesaro, Italy
A. GULINI:
Anat Pathol Azienda Sanit Territoriale Pesaro Urbi, Pesaro, Italy
E. PIERPAOLI:
Anat Pathol Azienda Sanit Territoriale Pesaro Urbi, Pesaro, Italy
M. BADIALI:
Pediat Hosp A Cao ASL8, Lab Genet & Genom, Cagliari, Italy
S. MURRU:
Pediat Hosp A Cao ASL8, Lab Genet & Genom, Cagliari, Italy
R. MURGIA:
Univ Cagliari, Dept Biomed Sci, Expt Med Unit, I-09124 Cagliari, Italy
E. ROCCO:
IEO European Inst Oncol IRCCS, Div Pathol, Via Giuseppe Ripamonti 435, I-20141 Milan, Italy
Univ Milan, Dept Oncol & Hemato Oncol, Via Festa Perdono 7, I-20122 Milan, Italy
K. VENETIS:
IEO European Inst Oncol IRCCS, Div Pathol, Via Giuseppe Ripamonti 435, I-20141 Milan, Italy
N. FUSCO:
IEO European Inst Oncol IRCCS, Div Pathol, Via Giuseppe Ripamonti 435, I-20141 Milan, Italy
Univ Milan, Dept Oncol & Hemato Oncol, Via Festa Perdono 7, I-20122 Milan, Italy
D. MOROTTI:
Papa Giovanni XXIII Hosp, Pathol Unit, Bergamo, Italy
Papa Giovanni XXIII Hosp, Med Genet Lab, Bergamo, Italy
A. GIANATTI:
Papa Giovanni XXIII Hosp, Pathol Unit, Bergamo, Italy
Papa Giovanni XXIII Hosp, Med Genet Lab, Bergamo, Italy
D. FURLAN:
Univ Insubria, Dept Med & Technol Innovat, Pathol Unit, Varese, Italy
G. ROSSI:
Fdn Poliambulanza, Dept Anat Pathol, I-25124 Brescia, Italy
L. MELOCCHI:
Fdn Poliambulanza, Dept Anat Pathol, I-25124 Brescia, Italy
M. RUSSO:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
C. DE LUCA:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
L. PALUMBO:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
S. SIMONELLI:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
A. MAFFÈ:
Santa Croce & Carle Hosp, Genet & Mol Biol Unit, I-12100 Cuneo, Italy
P. DI CELLE:
Santa Croce & Carle Hosp, Genet & Mol Biol Unit, I-12100 Cuneo, Italy
T. VENESIO:
FPO IRCCS, Candiolo Canc Inst, I-10060 Candiolo, Italy
M. SCATOLINI:
Fdn Edo & Elvo Tempia, Mol Oncol Lab, Biella, Italy
E. GROSSO:
Fdn Edo & Elvo Tempia, Mol Oncol Lab, Biella, Italy
S. ORECCHIA:
S Antonio & Biagio Hosp, Pathol Div, Alessandria, Italy
M. FASSAN:
Univ Padua, Dept Med DIMED, Padua, Veneto, Italy
Veneto Inst Oncol IOV IRCCS, Padua, Italy
M. BALISTRERI:
Univ Hosp Padua, Surg Pathol Unit, Padua, Italy
E. ZULATO:
Univ Hosp Padua, Surg Pathol Unit, Padua, Italy
D. REGHELLIN:
San Bortolo Hosp, Dept Pathol, Vicenza, Italy
E. LAZZARI:
San Bortolo Hosp, Dept Pathol, Vicenza, Italy
M. SANTACATTERINA:
San Bortolo Hosp, Dept Pathol, Vicenza, Italy
M. PIREDDA:
San Bortolo Hosp, Dept Pathol, Vicenza, Italy
M. RICCARDI:
Osped Angelo, Dept Pathol, Azienda Ulss3 Serenissima, Venice, Italy
L. LAURINO:
Osped Angelo, Dept Pathol, Azienda Ulss3 Serenissima, Venice, Italy
E. ROZ:
La Maddalena Clin Canc, Pathol Unit, Palermo, Italy
D. LONGO:
UOSD Anat Patol Azienda Osped Papardo, Unita Messina, Messina, Italy
D. ROMEO:
UOSD Anat Patol Azienda Osped Papardo, Unita Messina, Messina, Italy
C. FAZZARI:
UOSD Anat Patol Azienda Osped Papardo, Unita Messina, Messina, Italy
:
Fdn Invest Hosp Gen Univ Valencia, Mol Oncol Lab, Valencia 46014, Spain
Fdn Invest Hosp Gen Univ Valencia, Ctr Invest Principe Felipe, TRIAL Mixed Unit, Valencia 46014, Spain
Ctr Invest Biomed Red Canc CIBERONC, Madrid 28029, Spain
G. PUGLIA:
Inst Agr & Forest Syst Mediterranean, Natl Res Council ISAFOM CNR, I-95128 Catania, Italy
A. PRJIBELSKI:
St Petersburg State Univ, Inst Translat Biomed, Ctr Algorithm Biotechnol, St Petersburg, Russia
D. SHAFRANSKAYA:
St Petersburg State Univ, Inst Translat Biomed, Ctr Algorithm Biotechnol, St Petersburg, Russia
L. RIGHI:
Univ Turin, San Luigi Hosp, Dept Oncol, I-10043 Orbassano, TO, Italy
A. LISTÌ:
Univ Turin, San Luigi Hosp, Dept Oncol, I-10043 Orbassano, TO, Italy
D. VITALE:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
A. IACCARINO:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
U. MALAPELLE:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
G. TRONCONE:
Federico II Univ Naples, Dept Publ Hlth, Via S Pansini 5, I-80131 Naples, Italy
AOU Citta Salute & Sci Torino, Mol Pathol, I-10126 Turin, Italy
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