Know in just 15 days if the chosen therapy will work, thanks to the liquid biopsy. An important possibility for those with metastatic breast cancer, because saving precious time can make a difference to survival. And this is exactly what an entirely Italian research is aiming for, which will be presented on June 6 at the annual meeting of the American Society of Clinical Oncology – ASCO, underway in Chicago.
The studio BioItaLEE
The study is called BioItaLEE and concerns patients with the most common type of breast cancer (the ‘hormone-sensitive’ and HER2 negative), treated with a standard first-line therapy, namely the combination of ribociclib (a CDK4 inhibitor / 6) and letrozole (an aromatase inhibitor). The researchers used two markers to track disease response to treatment over time: thymidine kinase 1 and circulating tumor DNA, measured by liquid biopsy. “BioItaLEE for the first time in the world has considered the combination of two biomarkers, measured with blood samples”, explains Michelino De Laurentiis, Coordinator of the BioItaLEE study and Director of the Department of Breast and Thoraco-Pulmonary Oncology, National Cancer Institute IRCCS Foundation ‘ G. Pascale ‘of Naples: “This method seems to give earlier information than the traditional CT scan to monitor the progress of the treatment. If the data of the study are confirmed, with the liquid biopsy we could know in advance which tumors are resistant to treatment, to the exclusive advantage of the patients “.
The promises of liquid biopsy
The trial involved 287 patients from 47 Italian centers. The variation of the two biomarkers was measured with a blood sample before the start of therapy and after 15 days. “The initial values of thymidine kinase 1 activity and circulating tumor DNA are important, but are informative, because therapy with ribociclib in some cases is able to reduce them, thus resolving any initial resistance”, underlines Grazia Arpino , Professor of Medical Oncology at the Federico II University of Naples, who presents the BioItaLEE study at the ASCO Congress: “Therefore, the dynamic analysis of the variation of biomarkers during the first two weeks of treatment is necessary to get a better idea clear about the possible outcome of the therapy. We are faced with preliminary data that we can define as ‘hypothesis generators’, because they trace a path that will have to be confirmed with further clinical studies. Their usefulness, however, could be important because, after only 15 days from the start of therapy, we may already be able to understand how the patient is responding and cope with any resistance “.
“This all-Italian work is enjoying great international interest”, says Saverio Cinieri, President of the Italian Association of Medical Oncology (AIOM): “It defines a research model, which is part of precision oncology and opens up important prospects for chronicizing metastatic disease. It also represents a sign of the vitality of our country’s research, which demonstrates that it knows how to involve many centers in complex experiments. The evidences obtained need further confirmation in order to be applied in daily clinical practice, but they mark an important starting point for further research “.
Advances in breast cancer metastatic breast
In 2020, about 55 thousand new cases of breast cancer were estimated in Italy. More than 37,000 women live with the diagnosis of metastatic disease, which in about 70% of cases expresses hormone receptors. “Ribociclib – continues De Laurentiis – is the only drug of the class of CDK4 / 6 inhibitors capable of boasting total consistency and solidity of results. In fact, it has shown an overall survival advantage in pre / peri and postmenopausal women and with different hormonal combinations. The BioItaLEE data are not yet definitive, but go in the direction of confirming the efficacy already demonstrated in the MONALEESA-2 study, with half of the patients living over 5 years “. “We are proud to have supported this study of high scientific value – concludes Gianluca Fincato, Medical Director of Novartis Oncology-. We have always been at the forefront of researching therapies that improve the survival of patients with breast cancer. The BioItaLEE study is an example of the results produced by the fruitful collaboration between the scientific community and industry “.