Impact of Prosigna test on adjuvant treatment decision in lymph node-negative early breast cancer—a prospective national multicentre study (EMIT-1)
Ohnstad, Hege Oma; Blix, Egil Støre; Akslen, Lars Andreas; Gilje, Bjørnar; Raj, Sunil Xavier; Skjerven, Helle; Borgen, Elin; Janssen, Emiel; Mortensen, Elin Synnøve; Brekke, Marianne B.; Falk, Ragnhild Sørum; Schlichting, Ellen; Boge, Beate; Songe-Møller, Silje; Olsson, Pernilla Marie A.; Heie, Anette; Mannsåker, Bård; Vestlid, Magdalena Aas; Kursetgjerde, Torgunn; Gravdehaug, Berit; Suhrke, Pål; Sánchez, E.; Bublevic, J.; Røe, Oluf Dimitri; Geitvik, Gry; Halset, Eline Holli; Rypdal, Maria Christine; Langerød, Anita; Lømo, Jon; Garred, Øystein; Porojnicu, Alina Carmen; Engebraaten, O.; Geisler, Jürgen; Lyngra, Marianne; Hansen, M. H.; Søiland, Håvard; Nakken, T.; Asphaug, Lars; Kristensen, Vessela N.; Sørlie, Therese; Sørlie, T.; Nygård, Jan Franz; Kiserud, Cecilie E.; Reinertsen, Kristin Valborg; Russnes, Hege Elisabeth Giercksky; Naume, Bjørn
Peer reviewed, Journal article
Published version
Date
2024Metadata
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Original version
Ohnstad, H. O., Blix, E. S., Akslen, L. A., Gilje, B., Raj, S. X., Skjerven, H., ... & Naume, B. (2024). Impact of Prosigna test on adjuvant treatment decision in lymph node-negative early breast cancer—a prospective national multicentre study (EMIT-1). ESMO open, 9(6), 103475. 10.1016/j.esmoop.2024.103475Abstract
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.