For those with early-stage “hormonal-type” breast cancer, the targeted drug ribociclib after surgery is confirmed to reduce the risk of recurrence 4 years after diagnosis. The latest data from the Natalee study, presented today at the annual Esmo congress in Barcelona, confirm a 28.5% reduction in the risk of recurrence compared to hormone therapy alone.
When the risk of relapse lasts a long time
Table of Contents
- 1 When the risk of relapse lasts a long time
- 2 The benefit also for patients with negative lymph nodes
- 3 How ribociclib works
- 4 – What is the role of ribociclib in reducing the risk of recurrence in hormonal breast cancer?
- 5 – What impact does ribociclib have on the risk of breast cancer recurrence?
Table of Contents
Every year in Italy there are over 55 thousand new diagnoses of breast cancer and in about 70% the tumor is hormone-responsive (HR+/HER2-), that is, it grows in response to female hormones. “This type of tumor usually has a good prognosis in the short term, but it can recur over time, even after 20-30 years,” explains Michelino De LaurentiisDirector of the Department of Breast and Thoracic-Pulmonary Oncology at the National Cancer Institute IRCCS Fondazione ‘G. Pascale’ in Naples. It is estimated, says the oncologist, that one in three women with stage II carcinoma and half with stage III will have a recurrence: “Ribociclib, added to standard hormone therapy, is one of the most promising new treatments.” To date, in fact, adjuvant therapy, which is prescribed after surgery to reduce the risk of relapse, is based on hormone therapy and, in the most high-risk cases, chemotherapy.
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The benefit also for patients with negative lymph nodes
In the Natalee study, conducted on over 5,000 patients (women and men), the drug was taken for three consecutive years and at the extended follow-up of 4 years, the relevant clinical benefit of adding ribociclib to endocrine therapy continues to increase, both in patients with positive lymph nodes and in those with negative lymph nodes: the benefit of survival free from invasive disease observed in this new analysis is in fact similar in all subgroups of patients, including those with negative lymph nodes. “This is a very important aspect, because the Natalee study includes a large population of patients at risk of recurrence that also includes those with negative lymph nodes, who need new therapeutic options”. The data on the safety profile are also in line with the results reported previously and no new signals have been identified.
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How ribociclib works
The drug belongs to the class of cyclin-dependent kinase inhibitors, a class of drugs that help slow the progression of cancer by inhibiting two proteins: cyclin-dependent kinases 4 and 6 (CDK4/6). These drugs have substantially improved survival in women with metastatic hormone-responsive breast cancer, and only one of these, abemaciclib, is currently approved for early-stage cancer for those at higher risk of recurrence.
The Natalee study will continue to follow up to obtain more mature data on overall survival. “While waiting for regulatory approval from health authorities, we are very encouraged by these long-term results from the Natalee study,” said Paola Coco, CSO & Medical Affairs Head, Novartis Italia. “A large number of patients diagnosed with early-stage HR+/HER2- breast cancer remain at risk of recurrence; with the results achieved and the growing evidence, Novartis’ research and scientific innovation are contributing to the reduction of this risk consistently in a large population, offering a new therapeutic option also to patients with negative lymph nodes.”
– What is the role of ribociclib in reducing the risk of recurrence in hormonal breast cancer?
Reducing the Risk of Recurrence in Hormonal Breast Cancer: The Promising Role of Ribociclib
Breast cancer is one of the leading causes of cancer-related deaths in women worldwide. According to the World Health Organization (WHO), there were over 2.3 million new cases of breast cancer diagnosed globally in 2020. In Italy alone, there are over 55,000 new diagnoses every year, with approximately 70% of these being hormone-responsive (HR+/HER2-), meaning that they grow in response to female hormones. While this type of cancer usually has a good prognosis in the short term, it can recur over time, even after 20-30 years.
The Risk of Relapse: A Long-Term Concern
The risk of recurrence is a significant concern for women with hormone-sensitive breast cancer. According to Dr. Michelino De Laurentiis, Director of the Department of Breast and Thoracic-Pulmonary Oncology at the National Cancer Institute IRCCS Fondazione ‘G. Pascale’ in Naples, “one in three women with stage II carcinoma and half with stage III will have a recurrence.” This highlights the need for effective adjuvant therapies that can reduce the risk of relapse.
Ribociclib: A New Therapy to Reduce the Risk of Recurrence
A recent study presented at the annual ESMO congress in Barcelona has confirmed that the targeted drug ribociclib, taken after surgery, reduces the risk of recurrence in women with early-stage hormone-sensitive breast cancer. The Natalee study, which involved over 5,000 patients (women and men), showed a 28.5% reduction in the risk of recurrence compared to hormone therapy alone. This benefit was observed not only in patients with positive lymph nodes but also in those with negative lymph nodes, making it a promising new treatment option for a larger population of patients at risk of recurrence.
How Ribociclib Works
Ribociclib belongs to the class of cyclin-dependent kinase inhibitors, which help slow the progression of cancer by inhibiting two proteins: cyclin-dependent kinases 4 and 6 (CDK4/6). This class of drugs has substantially improved survival in women with metastatic hormone-responsive breast cancer, and only one of these, abemaciclib, is currently approved for early-stage cancer for those at higher risk of recurrence.
Benefits for Patients with Negative Lymph Nodes
The Natalee study has shown that the benefit of adding ribociclib to endocrine therapy is not limited to patients with positive lymph nodes. In fact, the study found that the benefit of survival free from invasive disease was similar in all subgroups of patients, including those with negative lymph nodes. This is a significant finding, as patients with negative lymph nodes are often considered to be at lower risk of recurrence and may not have been considered for adjuvant therapy in the past.
Safety Profile
The data on the safety profile of ribociclib are in line with previous reports, and no new signals have been identified. This suggests that the drug is well-tolerated and can be safely added to standard hormone therapy.
The Future of Breast Cancer Treatment
The Natalee study confirms the promising role of ribociclib in reducing the risk of recurrence in women with early-stage hormone-sensitive breast cancer. As the study continues, it is likely that we will learn more about the long-term benefits and risks of this therapy. In the meantime, the data suggest that ribociclib may become a new standard of care for women with hormone-sensitive breast cancer, providing them with a greater chance of survival free from invasive disease.
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– What impact does ribociclib have on the risk of breast cancer recurrence?
Breast Cancer Breakthrough: Targeted Drug Ribociclib Reduces Recurrence Risk by 28.5%
Breast cancer is one of the most common cancers affecting women worldwide, with over 55,000 new diagnoses in Italy alone every year. While hormone-responsive breast cancer (HR+/HER2-) has a good prognosis in the short term, it can recur over time, even after 20-30 years. However, a recent study has confirmed that the targeted drug ribociclib, taken after surgery, can reduce the risk of recurrence by 28.5% compared to hormone therapy alone.
When the Risk of Relapse Lasts a Long Time
According to Michelino De Laurentiis, Director of the Department of Breast and Thoracic-Pulmonary Oncology at the National Cancer Institute IRCCS Fondazione ‘G. Pascale’ in Naples, one in three women with stage II carcinoma and half with stage III will have a recurrence. The risk of relapse lasts a long time, making it essential to find effective treatments to reduce this risk.
The Benefit Also for Patients with Negative Lymph Nodes
The Natalee study, conducted on over 5,000 patients, has shown that ribociclib can benefit patients with negative lymph nodes, in addition to those with positive lymph nodes. The study found that the benefit of survival free from invasive disease observed in this new analysis is similar in all subgroups of patients, including those with negative lymph nodes.
How Ribociclib Works
Ribociclib is a cyclin-dependent kinase inhibitor, which slows the progression of cancer by inhibiting two proteins: cyclin-dependent kinases 4 and 6 (CDK4/6). This inhibition prevents the growth of cancer cells