Feasibility of Adjuvant Treatment with Abemaciclib—Real-World Data from a Large German Breast Center

Abstract

Abemaciclib significantly improves invasive disease-free survival when combined with endocrine therapy in clinical high-risk patients with HR+/Her2− early breast cancer (eBC). The objective of the following study was to model how many patients with eBC would be available for adjuvant treatment with abemaciclib in a real-world setting. Patients that underwent complete surgical treatment for eBC between January 2018 and December 2020 in a large single-center university hospital in Germany were eligible. Descriptive statistics were used to describe the patient population that could benefit from abemaciclib according to the inclusion criteria of monarchE. Of 1474 patients with eBC, 1121 (76.1%) had a HR+/Her2− subtype. Of these, 217 (19.4%) fulfilled the monarchE inclusion criteria. Within patients that fulfilled the monarchE inclusion criteria, 48.9% received no adjuvant or neoadjuvant chemotherapy. Thus, in a real-world situation, fewer patients will be pretreated with chemotherapy than was the case in monarchE. Breast care units are facing a significant patient burden, since the 2-year abemaciclib therapy requires regular monitoring of toxicities. Specific care concepts to strengthen therapy adherence as well as further studies to deescalate adjuvant systemic treatment and individualize CDK 4/6 inhibitor therapy are therefore needed.

Which Patients Do We Need to Test for BRCA1/2 Mutation? Feasibility of Adjuvant Olaparib Treatment in Early Breast Cancer–Real-World Data from Two Large German Breast Centers

“…In HR+/HER2− eBC, nearly all patients who are eligible for adjuvant olaparib treatment also fulfill the inclusion criteria of the monarchE trial and are therefore candidates for a CDK4/6 inhibitor therapy with abemaciclib [2,28]. Moreover, ribociclib might be approved for use in high-risk HR+/HER2− eBC patients based on the findings of the phase III NATALEE trial, the first results of which were recently presented at the ASCO meeting [29,30].…”

The efficacy of sacituzumab govitecan and trastuzumab deruxtecan on stable and active brain metastases in metastatic breast cancer patients—a multicenter real-world analysis

“…HR and HER2 receptor expression was assessed by board-certified pathologists according to local standards as previously described. 27 , 28 , 29 …”

“…Data processing and statistical analyses were carried out using Jupyter Notebook on Anaconda, with the Python extension packages pandas, numeric Python, and lifelines as previously described. 27 , 28 , 29 Comparative statistics of survival analyses were carried out using the log-rank test with a significance level of α = 0.05. Affinity Publisher 2 (Serif Europe Ltd., Nottingham, UK) was used for data visualization.…”

Recurrence Score® Result Impacts Treatment Decisions in Hormone Receptor-Positive, HER2-Negative Patients with Early Breast Cancer in a Real-World Setting—Results of the IRMA Trial

“…The most frequent tumor subtype is hormone receptor-positive (HR+), HER2-negative (HER2−) early breast cancer (eBC). Patients with no or 1–3 involved pathologic lymph nodes account for approximately 70% of all breast cancer cases [ 3 , 4 ]. Patients with high clinicopathologic risk factors, such as large tumor size, high tumor grade, lymph node involvement, or a high proliferative index (Ki67) often undergo chemotherapy to reduce the risk of recurrence [ 5 , 6 ].…”