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IRIS
Background The prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use. Patients and methods According to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study. Primary objective was to compare percentage of patients alive and without recurrence at 2 years in patients with high versus low LI (#NCT02364024). Associations of LI with patient recurrence and survival were analysed, and multivariable models were adjusted for treatment and relevant factors. Automated testing of LI was performed on virtual slides without access to clinical data. Results Among the 1220 CC patients enrolled, LI was high, low and not evaluable in 241 (19.8%), 790 (64.8%) and 189 (15.5%), respectively. Primary objective was met with a 2-year recurrence rate of 14.4% versus 21.1% in patients with high and low LI, respectively (p = 0.02). Patients with high LI also had better disease free survival (DFS) and overall survival (OS). Tumour stage, grade, RAS status and BRAF status were with LI the only prognostic markers in multivariable analysis for OS. Subgroup analyses revealed that high LI had better DFS and OS in mismatch repair (MMR) proficient patients, and in patients without RAS mutation, but not in MMR deficient and RAS mutated patients. Conclusion Although this is the first validation with high level of evidence (IIB) of the prognostic value of a LI test in colon cancers, it still needs to be confirmed in independent series of colon cancer patients.
Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX
Emile J. -F.;Julie C.;Le Malicot K.;Lepage C.;Tabernero J.;Mini E.;Folprecht G.;Van Laethem J. -L.;Dimet S.;Boulagnon-Rombi C.;Allard M. -A.;Penault-Llorca F.;Bennouna J.;Laurent-Puig P.;Taieb J.;Thaler J.;Greil R.;Gaenzer J.;Eisterer W.;Tschmelitsch J.;Keil F.;Samonigg H.;Zabernigg A.;Schmid F.;Steger G.;Steinacher R.;Andel J.;Jagdt B.;Lang A.;Fridrik M.;Fugger R.;Hofbauer F.;Woell E.;Geissler D.;Lenauer A.;Prager M.;D'Haens G.;Demolin G.;Kerger J.;Deboever G.;Ghillebert G.;Polus M.;Van Cutsem E.;Kalantari H. R.;Delaunoit T.;Goeminne J. C.;Peeters M.;Vergauwe P.;Houbiers G.;Humblet Y.;Janssens J.;Schrijvers D.;Vanderstraeten E.;Van Laethem J. -L.;Vermorken J.;Van Daele D.;Ferrante M.;Forget F.;Hendlisz A.;Yilmaz M.;Nielsen S. E.;Vestermark L.;Larsen J.;Zawadi M. -A.;Bouche O.;Mineur L.;Bennouna-Louridi J.;Dourthe L. M.;Ychou M.;Boucher E.;Taieb J.;Pezet D.;Desseigne F.;Ducreux M.;Texereau P.;Miglianico L.;Rougier P.;Fratte S.;Levache C. -B.;Merrouche Y.;Ellis S.;Locher C.;Ramee J. -F.;Garnier C.;Viret F.;Chauffert B.;Cojean-Zelek I.;Michel P.;Lecaille C.;Borel C.;Seitz J. -F.;Smith D.;Lombard-Bohas C.;Andre T.;Gornet J. -M.;Fein F.;Coulon-Sfairi M. -A.;Kaminsky M. -C.;Lagasse J. -P.;Luet D.;Etienne P. -L.;Gasmi M.;Vanoli A.;Nguyen S.;Aparicio T.;Perrier H.;Stremsdoerfer N.;Laplaige P.;Arsene D.;Auby D.;Bedenne L.;Coriat R.;Denis B.;Geoffroy P.;Piot G.;Becouarn Y.;Bordes G.;Deplanque G.;Dupuis O.;Fruge F.;Guimbaud R.;Lecomte T.;Lledo G.;Sobhani I.;Asnacios A.;Azzedine A.;Desauw C.;Galais M. -P.;Gargot D.;Lam Y. -H.;Abakar-Mahamat A.;Berdah J. -F.;Catteau S.;Clavero-Fabri M. -C.;Codoul J. -F.;Legoux J. -L.;Goldfain D.;Guichard P.;Verge D. P.;Provencal J.;Vedrenne B.;Brezault-Bonnet C.;Cleau D.;Desir J. -P.;Fallik D.;Garcia B.;Gaspard M. -H.;Genet D.;Hartwig J.;Krummel Y.;Budnik T. M.;Palascak-Juif V.;Randrianarivelo H.;Rinaldi Y.;Aleba A.;Darut-Jouve A.;de Gramont A.;Hamon H.;Wendehenne F.;Matzdorff A.;Stahl M. K.;Schepp W.;Burk M.;Mueller L.;Folprecht G.;Geissler M.;Mantovani-Loeffler L.;Hoehler T.;Asperger W.;Kroening H.;von Weikersthal L. F.;Fuxius S.;Groschek M.;Meiler J.;Trarbach T.;Rauh J.;Ziegenhagen N.;Kretzschmar A.;Graeven U.;Nusch A.;von Wichert G.;Hofheinz R. -D.;Kleber G.;Schmidt K. -H.;Vehling-Kaiser U.;Baum C.;Schuette J.;Haag G. M.;Holtkamp W.;Potenberg J.;Reiber T.;Schliesser G.;Schmoll H. -J.;Schneider-Kappus W.;Abenhardt W.;Denzlinger C.;Henning J.;Marxsen B.;Derigs H. G.;Lambertz H.;Becker-Boost I.;Caca K.;Constantin C.;Decker T.;Eschenburg H.;Gabius S.;Hebart H.;Hoffmeister A.;Horst H. -A.;Kremers S.;Leithaeuser M.;Mueller S.;Wagner S.;Daum S.;Schlegel F.;Stauch M.;Heinemann V.;Maiello E.;Latini L.;Zaniboni A.;Amadori D.;Aprile G.;Barni S.;Mattioli R.;Martoni A.;Passalacqua R.;Nicolini M.;Pasquini E.;Rabbi C.;Aitini E.;Ravaioli A.;Barone C.;Biasco G.;Tamberi S.;Gambi A.;Verusio C.;Marzola M.;Lelli G.;Boni C.;Cascinu S.;Bidoli P.;Vaghi M.;Cruciani G.;Di Costanzo F.;Sobrero A.;Mini E.;Petrioli R.;Aglietta M.;Alabiso O.;Capuzzo F.;Falcone A.;Corsi D. C.;Labianca R.;Salvagni S.;Chiara S.;Ciuffreda L.;Ferrau F.;Giuliani F.;Lonardi S.;Gebbia N.;Mantovani G.;Sanches E.;Mellidez J. C.;Santos P.;Freire J.;Sarmento C.;Costa L.;Pinto A. M.;Barroso S.;Santo J. E.;Guedes F.;Monteiro A.;Sa A.;Furtado I.;Salazar R.;Aguilar E. A.;Herrero F. R.;Valera J. S.;Ayerbes M. V.;Batlle J. F.;Gil S.;Esteve A. A.;Garcia-Giron C.;Vivanco G. L.;Salvia A. S.;Orduna V. A.;Garcia R. V.;Gallego J.;Sureda B. M.;Remon J.;Safont Aguilera M. J.;Nogueras L. C.;Merino B. Q.;Castro C. G.;de Prado P. M.;Pericay C. P.;Figueiras M. C.;Jordan I. G.;Gome Reina M. J.;Garcia A. L. -L.;Garcia-Ramos A. A.;Cervantes A.;Martos C. F.;Gaspar E. M.;Montero I. C.;Emperador P. E.;Carbonero A. L.;Castillo M. G.;Garcia T. G.;Lopez J. G.;Flores E. G.;Morales M. G.;Munoz M. L.;Martin A. L.;Maurel J.;Camara J. C.;Garcia R. D.;Salgado M.;Busquier I. H.;Ruiz T. C.;Munoa A. L.;Aliguer M. N.;de Taranco A. V. O.;Urena M. M.;Gaspa F. L.;Ponce J. J.;Roig C. B.;Jimenez P. V.;Brotons A. G.;Rodriguez S. A.;Martinez J. A.;Ruiz L. C.;Ruiz M. C.;Bridgewater J.;Glynne-Jones R.;Tahir S.;Hickish T.;Cassidy J.;Samuel L.
2017-01-01
Abstract
Background The prognostic value of lymphocyte infiltration (LI) of colorectal carcinoma (CC) has been demonstrated by several groups. However, no validated test is currently available for clinical practice. We previously described an automated and reproducible method for testing LI and aimed to validate it for clinical use. Patients and methods According to National Institutes of Health criteria, we designed a prospective validation of this biomarker in patients included in the PETACC8 phase III study. Primary objective was to compare percentage of patients alive and without recurrence at 2 years in patients with high versus low LI (#NCT02364024). Associations of LI with patient recurrence and survival were analysed, and multivariable models were adjusted for treatment and relevant factors. Automated testing of LI was performed on virtual slides without access to clinical data. Results Among the 1220 CC patients enrolled, LI was high, low and not evaluable in 241 (19.8%), 790 (64.8%) and 189 (15.5%), respectively. Primary objective was met with a 2-year recurrence rate of 14.4% versus 21.1% in patients with high and low LI, respectively (p = 0.02). Patients with high LI also had better disease free survival (DFS) and overall survival (OS). Tumour stage, grade, RAS status and BRAF status were with LI the only prognostic markers in multivariable analysis for OS. Subgroup analyses revealed that high LI had better DFS and OS in mismatch repair (MMR) proficient patients, and in patients without RAS mutation, but not in MMR deficient and RAS mutated patients. Conclusion Although this is the first validation with high level of evidence (IIB) of the prognostic value of a LI test in colon cancers, it still needs to be confirmed in independent series of colon cancer patients.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11768/110091
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.