Impact of Prosigna test on adjuvant treatment decision in lymph node-negative early breast cancer-a prospective national multicentre study (EMIT-1).

Autor:	Ohnstad HO; Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo., Blix ES; Department of Oncology, University of North Norway, Tromsø; Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø., Akslen LA; Centre for Cancer Biomarkers CCBIO, Department of Clinical Medicine, Section for Pathology, University of Bergen, Bergen; Department of Pathology Haukeland University Hospital, Bergen., Gilje B; Department of Haematology and Oncology, Stavanger University Hospital, Stavanger., Raj SX; Department of Oncology, St Olavs Hospital, Trondheim., Skjerven H; Department of Breast Surgery, Vestre Viken Hospital Trust, Drammen., Borgen E; Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo., Janssen EAM; Department of Pathology, Stavanger University Hospital, Stavanger; Department of Chemistry, Bioscience and Environmental Engineering, Stavanger University, Stavanger, Norway; Menzies Health Institute Queensland and Griffith University, Southport, Australia., Mortensen E; Department of Pathology, University of North Norway, Tromsø., Brekke MB; Department of Pathology, St Olavs Hospital, Trondheim., Falk RS; Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo., Schlichting E; Department of Oncology, Breast and Endocrine Surgery Unit, Division of Cancer Medicine, Oslo University Hospital, Oslo., Boge B; Department of Oncology, Hospital of Southern Norway, Kristiansand., Songe-Møller S; Department of Oncology, Østfold Hospital Trust, Kalnes., Olsson P; Department of Breast Surgery, Innlandet Hospital Trust, Hamar., Heie A; Department of Breast Surgery, Haukeland University Hospital, Bergen., Mannsåker B; Department of Oncology, Nordland Hospital, Bodø., Vestlid MA; Department of Breast Surgery, Telemark Hospital Trust, Skien., Kursetgjerde T; Department of Oncology, Møre og Romsdal Hospital Trust, Ålesund., Gravdehaug B; Department of Breast Surgery, Akershus University Hospital, Lørenskog., Suhrke P; Department of Pathology, Vestfold Hospital Trust, Tønsberg., Sanchez E; Department of Oncology, Haugesund Hospital, Haugesund., Bublevic J; Department of Oncology, Førde Central Hospital, Førde., Røe OD; Department of Oncology, Levanger Hospital, Levanger., Geitvik GA; Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo., Halset EH; Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo., Rypdal MC; Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo., Langerød A; Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo., Lømo J; Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo., Garred Ø; Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo., Porojnicu A; Department of Oncology, Vestre Viken Hospital Trust, Drammen., Engebraaten O; Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo; Institute of Clinical Medicine, University of Oslo, Oslo., Geisler J; Institute of Clinical Medicine, University of Oslo, Oslo; Department of Oncology, Akershus University Hospital, Lørenskog., Lyngra M; Department of Pathology, Akershus University Hospital, Lørenskog., Hansen MH; Department of Breast Surgery, University of North Norway, Tromsø., Søiland H; Department of Research, Stavanger University Hospital, Stavanger; Department of Clinical Science, University of Bergen, Bergen., Nakken T; User representative, Oslo University Hospital, Oslo., Asphaug L; Clinical Trials Unit, Oslo University Hospital, Oslo; Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo., Kristensen V; Institute of Clinical Medicine, University of Oslo, Oslo., Sørlie T; Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo; Institute of Clinical Medicine, University of Oslo, Oslo., Nygård JF; Cancer Registry of Norway, Oslo., Kiserud CE; National Advisory Unit for Late Effects after Cancer Treatment, Oslo University Hospital, Oslo, Norway., Reinertsen KV; Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo; National Advisory Unit for Late Effects after Cancer Treatment, Oslo University Hospital, Oslo, Norway., Russnes HG; Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo; Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo; Institute of Clinical Medicine, University of Oslo, Oslo., Naume B; Department of Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo; Institute of Clinical Medicine, University of Oslo, Oslo. Electronic address: BNa@ous-hf.no.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2024 Jun; Vol. 9 (6), pp. 103475. Date of Electronic Publication: 2024 Jun 04.
DOI:	10.1016/j.esmoop.2024.103475
Abstrakt:	Background: 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. 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 (post-Prosigna) the Prosigna test results were disclosed. 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 + ET) in 35%. Post-Prosigna treatment decisions were 25% NT, 51% ET and 24% CT + ET, respectively. Adjuvant treatment changed in 28% of patients, including 21% change in CT use. Among patients assigned to CT + ET pre-Prosigna, 45% were de-escalated to ET post-Prosigna. Of patients assigned to ET, 12% were escalated to CT + ET and 8% were de-escalated to NT; of those assigned to NT, 18% were escalated to ET/CT + 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 = 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). 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. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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