Sebastian Mongares Snow
In breast cancerpatients with the hormone receptor-positive and human epidermal growth factor receptor 2-negative subtype (HR+/HER 2-) have a high risk of relapse. During the annual congress of the European Society of Medical Oncology (ESMO 2024) new data have been presented from a new analysis of the Natalee phase III study, which reflects that add ribociclib (Kisqali) to the Endocrine therapy reduces the risk of relapse.
He Dr. Miguel Gil i GilUnit Coordinator in the Catalan Institute of Oncology (ICO)you need to “These data confirm those previously presented but with an update to four years.”. Specifically, Dr. Gil i Gil points out that “ribociclib 400mg/dx 21 days every 28, for three years, added to hormonal treatment, significantly reduced the risk of recurrence due to hormone receptor-positive breast cancer by 28.5% compared to patients treated with hormone therapy alone”.
Furthermore, the oncologist details that “This benefit was observed in all subgroups of patients, including those of lymph node negative diseasepatients youths as well as patients of advanced age and the study demonstrated a well-tolerated safety profile.”
Inside the Natalee study, Spain has been a key country in the research. “761 Spanish women have participated in the Natalee study – representing 15 percent of the total, being the second recruiting country – through the Spanish Breast Cancer Research Group (GEICAM) which has coordinated it in Spain and which is carried out in collaboration with Translational Research in Oncology (TRIO).“, develops Dr. Gil and Gil
Efficacy and safety
Breast cancer is the most frequently diagnosed cancer worldwide and it is estimated that in 2024 a total of 36,395 new cases will be detected in Spain, with different subtypes of the disease. In the case of patients with this HR+/ subtype, as Dr. Gil i Gil specifies, “People who have had surgery for stage II or III hormone receptor + and HER2 – breast cancer have a significant risk of recurrence, often as metastatic disease.”. Furthermore, according to the specialist, “this risk is greater the more affected axillary nodes there are. But there are also cases with free axillary nodes that relapse, with 10% of these cases occurring before three years of age.”
Considering these risks, the arrival of new effective therapies in HR+/HER2- breast cancer that improve the prognosis of these patients is essential.Until now, in addition to chemotherapy and hormonal treatment, we had the possibility of indicating abemaciclib for cases with more than three affected nodes or cases between one and three nodes and other aggressiveness factors.“explains Dr. Gil and Gil “With these data, we will soon have the possibility of indicating ribociclib in cases without axillary involvement and at high risk of relapse.”, he explains. The oncologist also highlights that with this treatment, “another drug that produces fewer gastrointestinal side effects than abemaciclib”.
The FDA has already approved the use of ribociclib in this indication, while the EMA and the AEMPS have not yet issued their opinion.
In this sense, Dr. Gil i Gil, indicates that “Ribociclib is a treatment that is approved for hormone receptor-positive HER2-negative metastatic breast cancer and is indicated as first-line treatment in this situation.”. Regarding the availability of this drug for patients with the HR+/HER2- subtype, the specialist recalls that “theThe FDA has approved its indication after surgery and radiotherapy in stages II and III to prevent relapse.”. “We are pending the opinion of the European agency (EMA) and the Spanish agency (Aemps) to be able to indicate this treatment to our fellow citizens“, he says.
As for the tolerability of ribociclib, Dr. Gil i Gil points out that “As with other drugs in its group (CDK 4-6 inhibitors) it produces a Decreased white blood cells; this usually does not cause any symptomsbut requires a monthly analytical check-up and following the weekly rest schedule after 21 days of treatment”. “He Another adverse effect to watch out for is elevated liver enzymes.which occurs in approximately 15% of cases,” he added, indicating that “the other adverse effects are very rare.”.
Breast cancer research
Dr. Gil i Gil focuses on every year the mortality rate decreases for breast cancer despite the fact that every year there is a slight increase in incidence. This reduction in deaths in recent years is due, in his words, to the fact that there is “better local treatments and advances in new medical treatments obtained through research”.
Now, the specialist considers, “Breast cancer research must increasingly be directed at attacking the specific weak points of each tumor.”. The specialist explains that, since breast cancer is “a set of different diseases with different genetic alterations, drugs must be found that attack them and at the same time are more tolerable”. “Combining risk by stage (size and nodes) with specific mutations is how we will continue to improve the cure rate.“, he adds.
Finally, regarding where research should focus on the unmet needsDr. Gil i Gil believes that “it should address aspects such as prevent or improve the after-effects of the treatmentsreintegration into working life after treatment or exercise, among others.”
