Breast cancer is the most frequent tumor in women in Spain and this year it is estimated that 35,001 new cases will be diagnosed, according to the Spanish Society of Medical Oncology (SEOM), which indicates that this disease affects one in eight women in our country. Although there have been great improvements in treatments, patients continue to be at risk of relapse for years, and in many of these cases effective therapeutic alternatives are not available.
A new therapeutic combination has managed to significantly reduce the risk of relapse in patients with localized breast cancer. This is the drug Kisqali® (ribociclib) in combination with endocrine therapy (ET), which has decreased the risk of cancer recurrence by 25.2% in patients with hormone receptor-positive and factor receptor 2 localized breast cancer. negative human epidermal growth (HR+/HER2-) stage II and III.
Kisqali® is a CDK4/6 inhibitor that blocks the activity of an abnormal protein that signals cancer cells to multiply. The drug has been developed by Novartis, which has presented the positive results of the NATALEE phase III clinical trial at the American Society of Clinical Oncology (ASCO) Congress. This new treatment approach also improved distant disease-free survival (SLED) (26% risk reduction) and relapse-free survival (RFS) (28% risk reduction), with a tendency to improve survival. global.
Data show the potential of Kisqali® to reduce the risk of recurrence of localized HR+/HER2- breast cancer, including node-negative patients
“The Phase III NATALEE clinical trial, coordinated in Spain by the GEICAM Breast Cancer Research Group, has had outstanding Spanish participation, with the involvement of 47 hospitals and the inclusion of 761 patients, representing 15% of total, placing Spain in second place, after the United States, in terms of contribution of patients”, explained Miguel Martín, president of GEICAM. “This study highlights the importance of international collaboration for the advancement of breast cancer research, by accelerating access to innovative, more effective and less toxic therapies, which translates into increased survival and improved of the quality of life of patients.
Prevent relapses in localized breast cancer
“Patients diagnosed with HR+/HER2- localized breast cancer remain at risk of cancer recurrence, as one-third of patients diagnosed with stage II and more than half of those diagnosed with stage III will unfortunately experience a recurrence of their cancer. ”, commented Dr. Shreeram Aradhye, President of Global Drug Development and Chief Medical Officer of Novartis. “The compelling data from the NATALEE study highlight the potential of Kisqali® to reduce the risk of cancer recurrence in this at-risk population, including node-negative patients, while maintaining a favorable safety profile. These results, which may transform clinical practice, reinforce the unique and well-established profile of Kisqali® as a proven treatment in HR+/HER2- metastatic breast cancer.”
The median duration of study follow-up was 34 months with clinical benefits observed after approximately two years. The NATALEE study evaluated a lower starting dose (400 mg) of Kisqali® than the dose approved for the treatment of metastatic breast cancer (MBC) (600 mg) to minimize interruptions in patient quality of life without compromising efficacy. .
Regarding the safety of the drug, the researchers have stated that it was favorable with a dose of 400 mg and that it caused few adverse effects; the most frequent were neutropenia (decreased number of blood cells) (43.8%) and those related to the liver –such as elevated transaminases– (8.3%).
“These landmark results will substantially change the way we treat patients with stage II and III HR+/HER2- localized breast cancer who need new, well-tolerated options that prevent cancer recurrence,” said Dennis J, MD. Slamon, director of Clinical/Translational Research at the Jonsson Comprehensive Cancer Center, president and CEO of Translational Research in Oncology (TRIO), and principal investigator of the NATALEE study. “Addressing this unmet need in such a large patient population could help streamline treatment decisions for the healthcare system and keep many more at-risk patients cancer-free without affecting their daily lives.” Novartis plans to submit this Phase III data to regulatory authorities in the US and Europe before the end of the year.
Source: Novartis
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