In the HR-positive HER2-negative advanced breast cancer setting, after first line with endocrine therapy plus CDK for 6 months, we have several potential effective options, either endocrine-based plus-minus targeted therapies. For instance, we have Elacestrant for ESR1-mutated tumors, Capivasertib plus Fulvestrant in patients with alterations in the PI3 kinase AKT pathway...
In the HR-positive HER2-negative advanced breast cancer setting, after first line with endocrine therapy plus CDK for 6 months, we have several potential effective options, either endocrine-based plus-minus targeted therapies. For instance, we have Elacestrant for ESR1-mutated tumors, Capivasertib plus Fulvestrant in patients with alterations in the PI3 kinase AKT pathway. We have Everolimus plus Exemestane. And the scenario is rapidly evolving in this setting. And also we have chemotherapy. We have several ADCs. We have Trastuzumab-Deruxtecan for patients with HER2 low and HER2 ultra low tumors. So among all these therapies, clinicians may decide for individual patients based on clinical and also biological characteristics of the tumors. But our findings in this selected population of patients are really clinically important because we found an additional benefit of 10.5 months, which is comparable or even superior to what can be achieved with several available second or third-line endocrine-based treatments. So this does not mean that these treatments are not usable and not effective in these patients, but that in selected population of patients, we may postpone the use of these therapies and to use as much as possible the first-line treatment with CDK4-6 inhibitors, which is effective and very well tolerated. And in this respect, I would like to briefly comment the last slide that I showed yesterday, because we found that patients undergoing first-line continuation beyond progressive disease do not have higher attrition rates during subsequent lines of therapy. So this means that these patients do not miss the opportunity to benefit from second and third-line endocrine-based therapies, but also disease and cytotoxic treatments. This simply means that in this very well-selected population of patients, we may postpone the use of these therapies. Of course, we must select these patients very well. And I think that the analysis that we presented, the multivariable analysis, is very informative because we found that patients with better performance status, higher ER and PGR expression, lower Ki67 expression, and those patients who receive concomitant locoregional therapies are those patients who achieve the highest benefit from first-line CDK4-6 inhibitor-based continuation beyond disease progression. And we should take into account the results of this multivariable analysis when trying to select these patients in clinical practice.
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