Breast cancer in the early stages, so the risk of recurrence can be reduced by 25% – breaking latest news

Add the drug target ribociclib to standard hormone therapy significantly improves disease-free survival and markedly reduces the risk of relapse in women and men with early-stage, hormone receptor-positive, HER2-negative breast cancer. They are patients at risk of recurrence for whom more effective options are needed prevent the tumor from recurring and, very importantly, the addition of this new drug causes few side effects therefore the quality of life of the patients remains very good. Thus, the chances of recovery increase. so, Saverio Cinieripresident of the Italian Medical Oncology Association (Aiom) comments on data from the NATALEE study just presented at the American Society of Clinical Oncology annual meeting, which opens today, June 2, in Chicago.

The most frequent type of breast cancer

Hormone receptor-positive and HER2-negative breast cancer is the most frequent subtype of breast cancer and accounts for about 70% of the 55,000 new cases registered each year in Italy. It is now known that there are many different types of breast cancer and it is essential to know which histological and molecular subtype we are dealing with in order to be able to choose, among the many available therapies, the most effective one based on the individual case. Even if breast cancer is among those with the best survival rates, so much so that nine out of ten women are alive five years after diagnosis, new effective treatment strategies are needed – she explains
Fabio Puglisi, director of the Department of Medical Oncology at the IRCCS CRO in Aviano and lead author of the NATALEE study for Italy -. In fact, this neoplasm remains not only the most widespread in females, but also the leading cause of death from cancer in females. A primacy due tofrequency of breast cancerto the particular aggressiveness of some subtypes and to the possibility of having relapses even many years after diagnosis. The most impacting event from a clinical point of view, in radically operated breast cancer, is precisely the appearance of distant recurrences which is associated with a significant prognostic worsening. Thanks to scientific research, however, the opportunities for treatment and healing are expanding more and more. The results of this trial are important because they fill a fundamental need for new options, overall well tolerated (the side effects of ribociclib, with the exception of neutropenia, do not differ much from those associated with hormone therapy alone) adds Puglisi -. And why the cure does not interrupt the daily life of the patients. An important aspect, given that we are talking about people with early stage cancer who must follow treatment for several years. The NATALEE trial was designed with this goal in mind and has achieved it.

Lo studio NATALEE

Between January 2019 and April 2021, the NATALEE trial (phase three, the last before definitive approval of a new treatment) involved over 5,000 females and males with invasive, endocrine-responsive breast adenocarcinoma (hormone receptor positive and HER2- negative, i.e. HR+/HER2-) in the early stage (stage II and III), at risk of recurrence. To reduce the risk of recurrence, these patients take standard hormone treatment with a duration of 5 to 10 years, in addition or not to chemotherapy – he says Michelino De Laurentiis, director of the Department of Breast and Thoraco-Pulmonary Oncology at the National Cancer Institute IRCCS Fondazione Pascale in Naples, other lead recruiter of the NATALEE study -. The 5,101 participants were randomly divided into two groups, and 2,549 received hormone therapy plus the target drug ribociclib for three years, while the remaining 2,552 received standard hormone therapy alone. The results show a significant improvement in invasive disease-free survival, i.e. more than 90% of patients who took ribociclib were still relapse-free after three years. Plus theirs risk of recurrence is reduced by 25%. These results are so significant as to suggest that they will become the new standard strategy for this category of patients. Ribociclib (a drug that belongs to the category of cycline inhibitors) is already approved and available in Italy in postmenopausal women with advanced or metastatic breast cancer (always type HR+/HER2-) after demonstrating an important increase in survival: thanks to its addition to hormonal therapy, in fact, half of patients with metastatic or advanced breast cancer live more than 5 years. We hope that this new therapeutic solution will be approved in our country as soon as possible in order to be able to offer an effective therapeutic opportunity to a large number of patients concludes Cinieri.