In recent years, targeted therapies have changed the history of metastatic breast cancer, and the data presented today at the European Congress of Medical Oncology (ESMO) leave no doubt: they show the longest survival observed so far.
The results are those of the Monaleesa-2 clinical study and concern the combination of ribociclib (an innovative targeted drug, of the class of CDK4 / 6 inhibitors) with letrozole (an aromatase inhibitor, one of the most widely used drugs) in women in postmenopausal for the treatment of the most common breast cancer, the “hormonal” type (Er-positive and Her2-negative), first line.
Over 5 years of median survival
The median overall survival achieved is almost 64 months, which equates to more than 5 years. “Median” means that half of the patients live longer. The study involved over 660 never-before-treated patients for advanced breast cancer. Half were treated with ribocilib and letrozole, the other half with letrozole and a placebo. At a follow-up of more than 6 years – the longest of the studies conducted to date on CDK4 / 6 inhibitors – the analysis shows that the estimated difference in improvement in median overall survival is over one year.
“We looked forward to these data, which are very solid and confirm the efficacy of molecularly targeted therapy with ribociclib. We are facing an experiment whose result is stable, definitive. Ribociclib showed a 24% reduction in the risk of death, consistent with what has already been seen in the other two MONALEESA studies ”, says Michelino De Laurentiis, Director of the Department of Breast and Thoraco-Pulmonary Oncology of the National Cancer Institute IRCCS Fondazione ‘G. Pascale ‘of Naples.
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Ribociclib in pre- e post-menopausa
In fact, there were already two studies with ribociclib conducted in different populations: MONALEESA-7 (in pre- and peri-menopausal women, in combination with endocrine therapy) and MONALEESA-3 (in postmenopausal women, in combination with fulvestrant , another anti-hormonal drug). The missing ‘piece’ was the MONALEESA-2. “The study is mature, with a median follow up of about 80 months”, continues De Laurentiis: “This means that half of the patients have been followed for at least 7 years. The data of the three trials on ribocliclib reinforce each other and place it as the only CDK4 / 6 inhibitor to have demonstrated an advantage in overall survival in all the populations studied, therefore in pre / peri and postmenopausal women and with different hormonal combinations. “. The Italian research centers have made an important contribution to the whole MONALEESA study program.
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Important findings for half of women with advanced breast cancer
There is still no register of women with metastatic breast cancer, but it is estimated that in Italy there are more than 37,000. The disease remains the leading cause of cancer death in the female population, but thanks to recent advances and targeted therapies, today many of them live with the disease for several years. How many of these patients are interested in the new data? “The one studied in MONALEESA-2 is the most frequent population with breast cancer in daily clinical practice”, replies Saverio Cinieri, Director of Medical Oncology and Breast Unit of the ‘Perrino’ Hospital in Brindisi and President-elect of the Italian Association of Oncology Medica (Aiom): “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”.
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One more year before chemo
The new results show a 12-month increase in chemotherapy free time in the ribociclib and letrozole arm compared to the letrozole alone arm. “The standard treatment of breast tumors positive for hormone receptors is the combination of a cyclin inhibitor with hormonal treatment”, recalls Pierfranco Conte, Director of the Division of Medical Oncology 2 of the Veneto Institute of Oncology in Padua: “Ribociclib is the 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 is that, at 6 years of follow-up, nearly half of the women, 44%, are still alive. Data is never seen with any treatment in this patient population. 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 ”.
Quality of life preserved even after 6 years
Furthermore, in this analysis with a longer follow-up, no new adverse events were observed: “Thanks to this therapy – adds Conte – 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 their own lives ”. When a treatment offers long overall survival – as in this case – for patients it means more time to be with the people they love and to do what makes them happy, points out Shirley A. Mertz, President of the Metastatic Breast Cancer Network ( MBCN): “These data represent new hope for women around the world”.
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