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dc.contributor.authorOhnstad, Hege Oma
dc.contributor.authorBlix, Egil Støre
dc.contributor.authorAkslen, Lars Andreas
dc.contributor.authorGilje, Bjørnar
dc.contributor.authorRaj, Sunil Xavier
dc.contributor.authorSkjerven, Helle
dc.contributor.authorBorgen, Elin
dc.contributor.authorJanssen, Emiel
dc.contributor.authorMortensen, Elin Synnøve
dc.contributor.authorBrekke, Marianne B.
dc.contributor.authorFalk, Ragnhild Sørum
dc.contributor.authorSchlichting, Ellen
dc.contributor.authorBoge, Beate
dc.contributor.authorSonge-Møller, Silje
dc.contributor.authorOlsson, Pernilla Marie A.
dc.contributor.authorHeie, Anette
dc.contributor.authorMannsåker, Bård
dc.contributor.authorVestlid, Magdalena Aas
dc.contributor.authorKursetgjerde, Torgunn
dc.contributor.authorGravdehaug, Berit
dc.contributor.authorSuhrke, Pål
dc.contributor.authorSánchez, E.
dc.contributor.authorBublevic, J.
dc.contributor.authorRøe, Oluf Dimitri
dc.contributor.authorGeitvik, Gry
dc.contributor.authorHalset, Eline Holli
dc.contributor.authorRypdal, Maria Christine
dc.contributor.authorLangerød, Anita
dc.contributor.authorLømo, Jon
dc.contributor.authorGarred, Øystein
dc.contributor.authorPorojnicu, Alina Carmen
dc.contributor.authorEngebraaten, O.
dc.contributor.authorGeisler, Jürgen
dc.contributor.authorLyngra, Marianne
dc.contributor.authorHansen, M. H.
dc.contributor.authorSøiland, Håvard
dc.contributor.authorNakken, T.
dc.contributor.authorAsphaug, Lars
dc.contributor.authorKristensen, Vessela N.
dc.contributor.authorSørlie, Therese
dc.contributor.authorNygård, Jan Franz
dc.contributor.authorKiserud, Cecilie E.
dc.contributor.authorReinertsen, Kristin Valborg
dc.contributor.authorRussnes, Hege Elisabeth Giercksky
dc.contributor.authorNaume, Bjørn
dc.date.accessioned2024-09-25T07:20:07Z
dc.date.available2024-09-25T07:20:07Z
dc.date.issued2024-06-04
dc.description.abstractBackground: EMIT-1 is a national, observational, single-arm trial designed to assess the value of the Prosigna, Prediction Analysis of Microarray using the 50 gene classifier (PAM50)/Risk of Recurrence (ROR), test as a routine diagnostic tool, examining its impact on adjuvant treatment decisions, clinical outcomes, side-effects and cost-effectiveness. Here we present the impact on treatment decisions.<p> <p>Patients and methods: Patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative pT1-pT2 lymph node-negative early breast cancer (EBC) were included. The Prosigna test and standard histopathology assessments were carried out. Clinicians’ treatment decisions were recorded before (pre-Prosigna) and after (postProsigna) the Prosigna test results were disclosed. <p>Results: Of 2217 patients included, 2178 had conclusive Prosigna results. The pre-Prosigna treatment decisions were: no systemic treatment (NT) in 27% of patients, endocrine treatment alone (ET) in 38% and chemotherapy (CT) followed by ET (CT þ ET) in 35%. Post-Prosigna treatment decisions were 25% NT, 51% ET and 24% CT þ ET, respectively. Adjuvant treatment changed in 28% of patients, including 21% change in CT use. Among patients assigned to CT þ ET preProsigna, 45% were de-escalated to ET post-Prosigna. Of patients assigned to ET, 12% were escalated to CT þ ET and 8% were de-escalated to NT; of those assigned to NT, 18% were escalated to ET/CT þ ET. CT was more frequently recommended for patients aged 50 years. In the subgroup with pT1c-pT2 G2 and intermediate Ki67 (0.5- 1.5 local laboratory median Ki67 score), the pre-Prosigna CT treatment decision varied widely across hospitals (3%- 51%). Post-Prosigna, the variability of CT use was markedly reduced (8%-24%). The correlation between Ki67 and ROR score within this subgroup was poor (r ¼ 0.25-0.39). The median ROR score increased by increasing histological grade, but the ROR score ranges were wide (for G1 0-79, G2 0-90, G3 16-94). <p>Conclusion: The Prosigna test result changed adjuvant treatment decisions in all EBC clinical risk groups, markedly decreased the CT use for patients categorized as higher clinical risk pre-Prosigna and reduced treatment decision discrepancies between hospitals.en_US
dc.identifier.citationOhnstad HO, Blix ES, Akslen LA, Gilje B, Raj S, Skjerven H, Borgen E, Janssen EA, Mortensen E, Brekke MB, Falk R, Schlichting E, Boge B, Songe-Møller S, Olsson PMA, Heie A, Mannsåker B, Vestlid, Kursetgjerde T, Gravdehaug B, Suhrke P, Sánchez E, Bublevic, Røe OD, Geitvik G, Halset EH, Rypdal MC, Langerød A, Lømo J, Garred Ø, Porojnicu AC, Engebraaten O, Geisler J, Lyngra M, Hansen, Søiland H, Nakken, Asphaug L, Kristensen VN, Sørlie T, Sørlie T, Nygård JF, Kiserud CE, Reinertsen KV, Russnes HE, Naume B. Impact of Prosigna test on adjuvant treatment decision in lymph node-negative early breast cancer—a prospective national multicentre study (EMIT-1). ESMO Open. 2024;9(6)en_US
dc.identifier.cristinIDFRIDAID 2275032
dc.identifier.doi10.1016/j.esmoop.2024.103475
dc.identifier.issn2059-7029
dc.identifier.urihttps://hdl.handle.net/10037/34850
dc.language.isoengen_US
dc.publisherElsevieren_US
dc.relation.journalESMO Open
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2024 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleImpact of Prosigna test on adjuvant treatment decision in lymph node-negative early breast cancer—a prospective national multicentre study (EMIT-1)en_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution 4.0 International (CC BY 4.0)
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