Addition of abemaciclib (Verzenio) to hormonal therapy shows significant long-term clinical benefits compared with endocrine therapy alone in patients with high-risk, hormone receptor-positive, HER2-negative (HR+) early breast cancer /HER2-). These are the results of the 5-year effectiveness analysis carried out within the framework study monarchE, presented at ESMO Congresswhich took place last month in Madrid.
The main conclusions:
the therapeutic combination of abemaciclib plus endocrine therapy improved invasive disease-free survival (IDFS) by almost 8%; the addition of abemaciclib increased distant relapse-free survival (DRFS) by almost 7% the number of deaths was lower in the abemaciclib group, but the difference was not statistically significant
HR+/HER2– breast tumors are the most common subtype of breast cancer. Although, in general, it is associated with favorable response rates to therapy, the presence of nodal dissemination determines a high risk of early relapse, requiring an intensive therapeutic regimen. Abemaciclib is a CDK 4/6 inhibitor approved for use in women with metastatic or locally advanced HR+/HER2- breast cancer in combination with an aromatase inhibitor or fulvestrant.
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The monarchE study included two cohorts, totaling more than 5600 people. In the first cohort, high-risk breast cancer patients were enrolled, established on the basis of the clinical pathological characteristics, the number of involved axillary nodes, the stage of the disease (grade 3), tumor dimensions (minimum 5 cm).
The second cohort included patients with lower disease grade and tumor size, but who showed high levels of the proliferation marker Ki-67. Participants were randomized to either 2 years of abemaciclib plus endocrine therapy or hormone therapy alone, followed by continued endocrine therapy for an additional 3–8 years. To date, over 80% of the participants in the study have finished taking abemaciclib for at least 2 years.
The benefits on IDFS were similar in the various patient subgroups analyzed, including the elderly, postmenopausal or perimenopausal, those who had previously received adjuvant or neoadjuvant chemotherapy, regardless of tumor size, number of affected lymph nodes, prognosis according to stage or tumor grade or the order in which hormone therapies were administered (tamoxifen initiation versus aromatase inhibitors). The number of adverse events, including severe ones, was higher in people who received the therapeutic combination, with the categories of adverse events reported being similar between the two groups.
The study participants should be monitored further, because in this subtype of breast cancer half of the recurrences occur after 5 years. The optimal duration of abemaciclib should be investigated, whether adjuvant treatment should be re-administered when there are signs of re-proliferation of malignant cells, and whether re-initiation of CDK 4/6 inhibitor therapy after detection of metastases is beneficial.
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2023-11-28 09:41:44
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