Abstract P4-07-10: Patient profiles, management and treatment patterns in HR+, HER2- early breast cancer in a real-world setting in Spain
Authors: Martín Miguel , Sáenz Jose Ángel García , Blancas Isabel , Molero Alberto , Atienza Manuel , Cervera Jose Manuel , Brown Jacqueline , Rider Alex , Williams Rhys , Alba Emilio 
Published: March 2022

Background: Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) is the most prevalent breast cancer (BC) subtype(≈60% of all BC in Spain), 95% of which are diagnosed in early stage. Despite several treatment options, approximately 20%-25% of them will experience metastatic relapse. Early and accurate identification of patients at high risk of recurrence is critical to improve patient outcomes. It would be relevant to know how high risk patients are identified and managed in Spain. The primary objective was to describe the current approaches to patient management and standards of care for patients with early stage (I-IIIc) HR+/HER2- BC in a real world setting in Spain.Methods: Real-world data were drawn from the Adelphi Early BC I Disease Specific Program. Data included physicians´ (medical oncologists) subjective perceptions such as factors used to determine patient´s risks of recurrence, and objective variables relating to the next 8 consecutive patients with HR+ HER2- BC they consulted and completed patient record forms for, such as demographic, clinical and gene expression profiles. Data were collected between June and October 2019. The sample was analyzed to identify patients similar to those meeting the high risk of recurrence criteria used in the monarchE (mE) trial: ≥4 positive nodes, OR 1-3 positive nodes AND [grade 3 or tumor ≥5 cm or Ki-67 ≥20%]. Those not meeting the criteria were categorised as Low/moderate (L/M) risk. Results: 50 oncologists provided data on 400 consecutive patients, of which 81 (20%) were categorized as high risk. Patients´ mean age was 58 years old at diagnosis and initiated first adjuvant treatment (AT) within four months of diagnosis. 19% had family history of BC, their disease stage was predominantly II (50%), 57% had grade 2 tumors and 74% had a tumor size of 1-3cm. 50 patients (13%) met high risk clinical pathologic criteria (≥4 positive nodes, OR 1-3 positive nodes AND [grade 3 or tumor ≥5 cm]) and an additional 31 patients (8%) met high risk mE criteria based on having a Ki-67 expression of ≥20%.At diagnosis, high risk patients compared to L/M tended to be younger (mean 54,3 vs 58,5 years), with higher likelihood of BC family history (32% vs 16%), more advanced disease at diagnosis (99% vs 59% stage II or III), more likely to have grade 3 tumors (41% vs 14%) and tumors &gt;3cm (32% vs 14%). The most common biomarker/genetic tests at diagnosis were ER, PgR and Ki67, used in over 95% of patients.Genomic assays of the tumors were performed in 35% of patients, of which the most common were Oncotype Dx (58%) and MammaPrint (22%). High risk patients were less likely to have genomic assays (15% vs 40% received any). Genomic assays were more often conducted prior to starting AT therapy (66%) than at initial diagnosis (38%).Neoadjuvant and first adjuvant treatments are described in table 1. Factors frequently considered by oncologists (&gt;45% of respondents) to evaluate risk of recurrence were tumor stage, size and grade, nodal, HER2 and HR status, genomic assays and Ki-67 expression level. Conclusion: One in five patients were classified as high risk according to mE criteria, although oncologists considered additional factors to categorize patients as high risk level in their daily practice. Consequently, many patients of L/M risk according to mE criteria could still be considered as high risk by their physicians, as suggested by nearly half of patients receiving ChT treatment as adjuvant therapy.

Proportion of patients that were prescribed each class in each setting (not mutually exclusive)ChemotherapyAnthracyclineTaxaneEndocrine therapyAromatase inhibitorTamoxifenTargeted therapyTotal sampleNeoadjuvant therapy n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)Overall (n=400)75 (19)69 (92)60 (80)64 (85)28 (37)22 (29)6 (8)-High risk (n=81)17 (21)16 (94)15 (88)16 (94)8 (47)7 (41)1 (6)-L/M risk (n=319)58 (18)53 (91)45 (78)48 (83)20 (34)15 (26)5 (9)-Total sampleFirst adjuvant n (%)n (%)n (%)n (%)n (%)n (%)n (%)n (%)Overall (n=400)400 (100)217 (54)129 (32)132 (33)256 (64)177 (44)79 (20)1 (0)High risk (n=81)81 (100)66 (81)56 (69)50 (62)27 (33)18 (22)9 (11)1 (1)L/M risk (n=319)319 (100)151 (47)73 (23)82 (26)229 (72)159 (50)70 (22)-

Citation Format: Miguel Martín, Jose Ángel García Sáenz, Isabel Blancas, Alberto Molero, Manuel Atienza, Jose Manuel Cervera, Jacqueline Brown, Alex Rider, Rhys Williams, Emilio Alba. Patient profiles, management and treatment patterns in HR+, HER2- early breast cancer in a real-world setting in Spain [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-07-10.