Data from a new study indicate that half of postmenopausal women with HR-positive or HER2-negative cancer met their goal of chronic disease
It is one of the most important news that emerged at the annual meeting of the European Society for Medical Oncology (Esmo) in progress in these days: thanks to the addition of a new drug, half of patients with metastatic or advanced breast cancer live more than 5 years. This is the longest survival achieved so far in breast cancer at this stage and allows us to talk about the real chronicization of the disease. This is demonstrated by the results of the final overall survival analysis of the phase three MONALEESA-2 study which followed the participants for many years, the longest observation period in this area.
Achieved the goal of making the disease chronic
The phase three trial evaluated the new medicine ribociclib in combination with letrozole versus letrozole alone in postmenopausal women with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR + / HER2-) advanced or metastatic breast cancer without first-line they are used in the first instance when metastases develop). With the addition of ribociclib, the median overall survival was 63.9 months (i.e. over 5 years). with a statistically significant overall survival benefit of 12 months compared to treatment with letrozole alone. The data from MONALEESA-2 presented at Esmo 2021 concern the population with breast cancer more frequent in daily clinical practice – explains Saverio Cinieri, Director of Medical Oncology and Breast Unit of the Perrino Hospital in Brindisi and elected president of the Italian Association of Medical Oncology -. In fact, postmenopausal women represent about 70% of those with endocrine-sensitive breast cancer and half of these correspond to the profile of the patients included in the study. These important overall survival data are encouraging and allow us to state that the goal of chronicizing advanced disease has been achieved. This means that if we cannot permanently eliminate the tumor, we can to control it better and better, allowing the person to live a substantially normal life with few side effects.
A stable, definitive result: the risk of death decreases by 24%
One in eight women in Italy will get breast cancer in their lifetime. With 55 thousand new cases diagnosed in 2020 and 37 thousand Italians living with a metastatic neoplasm, this tumor is the most widespread not only among females, but in the entire population. And despite the many advances made (fortunately 87% of patients live 5 years after diagnosis) it remains the leading cause of cancer death among Italians. Metastatic breast cancer is a very often incurable disease, but today it is increasingly chronic – clarifies Michelino De Laurentiis, director of the Department of Breast and Thoraco-Pulmonary Oncology at the National Cancer Institute Pascale Foundation of Naples -. This means that it is possible, using the available therapies wisely and in the right sequence, to obtain control of the disease and make it regress, thus allowing patients to live with the tumor even for years. with this in mind we anxiously awaited the results of the MONALEESA-2 trial which are very solid and confirm the efficacy of the molecular target therapy with ribociclib. -. There were already two studies with ribociclib conducted on different populations: MONALEESA-7 and 3. The missing “piece” was precisely 2, which was mature, with a median follow-up of about 80 months: this means that half of the patients were followed for at least 7 years. We are facing an experiment whose stable, definitive result – continues De Laurentiis -. Ribociclib showed a 24% reduction in the risk of death, consistent with what has already been seen in the other two studies. Median overall survival, 63.9 months, is the longest ever recorded in all types of breast cancer. The data of the three trials on ribocliclib reinforce each other and place it as the only CDK4 / 6 inhibitor to have demonstrated an overall survival advantage in all the populations studied, therefore in pre / peri and postmenopausal women and with different hormonal combinations. .
Women live longer and better
Ribociclib, for the therapy of these patients, has already obtained reimbursement from the Italian Medicines Agency and well tolerated by the patients, as confirmed by the data of this trial in which no new adverse events were observed. hormone receptors the combination of a cyclin inhibitor with hormone treatment – points out Pierfranco Conte, director of Medical Oncology 2 at the Veneto Oncological Institute of Padua -. Ribociclib the only drug of the class of CDK4 / 6 inhibitors able to boast a total consistency and solidity of results, regardless of the menopausal condition and the line of therapy. Another “number” that measures the extent of the MONALEESA-2 study that, at 6 years of follow-up, almost half of the women, 44%, are still alive. Data is never seen with any treatment in this patient population. Italy has made an important contribution to the whole MONALEESA study program. Furthermore, CDK4 / 6 inhibitors make it possible to avoid recourse to front-line chemotherapy or to postpone it, with great advantages in terms of quality of life and less toxicity – concludes Conte -. Thanks to this therapy we are able to offer patients not only long-term survival, but also to improve their quality of life, with excellent disease control. In fact, the majority of women can continue to lead a normal life.
September 20, 2021 (change September 20, 2021 | 15:47)
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