OBJECTIVES : To describe patient characteristics, diagnostic testing and treatment patterns among patients with HR+, HER2- EBC in routine clinical practice in Italy, focusing on those at high risk of recurrence, defined according to monarchE inclusion criteria (≥4 positive nodes, OR 1–3 positive nodes AND [grade 3 or tumour ≥5cm or Ki-67 ≥20%]).

METHODS : Italian real-world data were obtained from the Adelphi EBC I Disease Specific Programme, a point-in-time observational study. Medical oncologists (n=51), meeting study criteria and selected at random from publicly available lists, completed patient record forms (Jun–Aug 2019) for up to their next eight patients with HR+, HER2- EBC who were receiving/had completed adjuvant therapy within the 12 months prior to data collection. Data were analysed descriptively

RESULTS : Of 401 patients (mean age at diagnosis 57.3 years; 96.8% female; 77.2%/19.5%/3.3% with ECOG performance status 0/1/2), 67 (17%) met monarchE high-risk criteria. Overall, in patients with high-risk disease, 24 had ≥4 positive nodes, 43 had 1–3 positive nodes, 39 had a grade 3 tumour (at data collection), 5 had a tumour >5cm, 38 had Ki-67 ≥20% (at diagnosis); 52 (13%) patients met clinicopathologic high-risk criteria when Ki-67 expression levels are excluded. Tumour Ki-67 expression testing was conducted in 72.5% (242/334) of low/moderate-risk EBC patients and 91.0% (61/67) of high-risk EBC patients; 26.6% (89/334) and 16.4% (11/67) of patients, respectively, underwent tumour genomic testing. Chemotherapy was the most common first adjuvant regimen (received by 59.6% [199/334] and 94.0% [63/67] of patients with low/moderate-risk and high-risk EBC, respectively).

CONCLUSIONS

: In this real-world study of patients with HR+, HER2- EBC in Italy, 17% had high risk of recurrence as defined in monarchE. Among patients with high-risk EBC, Ki-67 testing was conducted more frequently than among those with low/moderate-risk disease, and chemotherapy was the most frequently used first adjuvant regimen.