A new therapeutic option for patients with early breast cancer

The European Commission has approved the use of abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with early-stage breast cancer HR + and HER2-, node-positive and at high risk of relapse. The monarchE phase 3 randomized trial showed a statistically significant improvement in invasive disease-free survival in patients receiving abemaciclib plus hormone therapy compared with patients receiving only hormone therapy.

- A positive decision on the use of abemaciclib and tamoxifen or an aromatase inhibitor during the adjuvant postoperative treatment of patients with hormone-dependent and HER2-negative breast cancer is very important as it concerns patients at high risk of disease recurrence. The decision is based on the results of a correctly planned and conducted phase III study, which showed a reduction in the risk of relapse while satisfactorily tolerating the treatment. The median invasive disease-free survival in patients receiving abamaciclib in combination with hormone therapy was significantly improved with a reduction in the risk of relapse of around 30%, and the benefits persist with longer follow-up. Abemaciclib is the first CDK4/6 inhibitor that has proven effective in adjuvant postoperative treatment in patients with hormone-dependent breast cancer - says Prof. Maciej Krzakowski, national consultant in the field of clinical oncology.

The monarchE study randomized 5,637 male and female patients with HR +, HER2- early breast cancer at high risk of recurrence from more than 600 centers in 38 countries.

Patients were treated with abemaciclib in combination with hormone therapy for two years or until treatment discontinuation criteria were met. After the end of study treatment, they will continue to receive adjuvant hormone therapy for a total of at least 5 years and up to a maximum of 10 years.

The safety profile of abemaciclib in HR +, HER2- in early breast cancer was consistent with the known safety profile of this drug in advanced breast cancer. No new, previously unheard of adverse events were observed.