Messaggi chiave
- EMIT-1 è uno studio osservazionale, a singolo braccio, disegnato per indagare l’utilità del test in vitro Prosigna come strumento diagnostico di routine. Lo studio ha incluso 2178 pazienti con carcinoma mammario precoce a(eBC) HR+/HER2- in stadio pT1-pT2 N0 che disponevano di risultati conclusivi del test. In questa sede, si presentano i dati relativi all’impatto del test sulle decisioni di trattamento.
- Le decisioni di trattamento prevedevano nessun trattamento sistemico (NT), solo terapia endocrina (ET) e chemioterapia (CT) + ET nel 27, 38 e 35% dei pazienti, rispettivamente, prima dell’esecuzione del test, vs 25, 51 e 24% dopo il test. Il 45% dei pazienti assegnati a CT + ET prima del test sono risultati candidati a sola ET dopo il test, mentre nel 12 e 18% dei pazienti inizialmente assegnati a ET e a NT, la terapia è stata modificata a CT + ET e a ET/CT + ET, rispettivamente. Nel sottogruppo con malattia pT1c-pT2 G2 e Ki67 intermedio, il test ha ridotto significativamente la variabilità tra centri osservata prima della sua esecuzione in termini di ricorso alla CT.
- In questo studio real-world, il risultato di Prosigna ha modificato le decisioni di trattamento in tutti i gruppi di rischio clinico, riducendo significativamente l’uso della CT nei pazienti classificati come a più alto rischio prima del test e minimizzando le discrepanze tra centri. I dati di follow-up, una volta disponibili, consentiranno di valutare il beneficio dell’incorporazione del test negli algoritmi decisionali anche in termini di esiti clinici e di costo-efficacia.
Abstract
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.
Findings
- 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).
Interpretation
- 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.