In the middle of September, the Food and Drug Administration (FDA) approved treatment with Ribociclib (Kisqali), combined with hormonal therapy, also for early stage breast cancer patients with hormone receptor-positive HER2-negative tumors who have undergone surgery and are at high risk of recurrence (i.e. either with lymph node involvement, or if there is no nodal involvement, either with a tumor size ˃ 5 cm or a tumor size of 2 to 5 with high-grade features).
Ribociclib is a type of targeted therapy. It is called “a cancer growth inhibitor”, since by its unique mechanism it interferes with the growth of cancer cells which are eventually destroyed.
The approval was based on results from a clinical trial in which 5,101 breast cancer patients who met the abovementioned criteria were enrolled.
Patients were randomly assigned to receive either Ribociclib plus standard endocrine therapy (study group), or endocrine therapy alone (control group).
At about 3 years follow-up, the probability of disease recurrence was significantly lower for the study group patients receiving Ribociclib combined with endocrine therapy, compared to those in the control group receiving endocrine therapy alone.
Side effects observed among the study group patients were consistent with the current safety profile for Ribociclib in combination with hormonal therapy.
Based on the promising study results, the researchers believe that the addition of Ribociclib to adjuvant endocrine therapy can improve outcomes in patients with high-risk early stage breast cancer.
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