As a faculty member I am invited to give a presentation in new treatment options, targeted treatment options, on the horizon. This is a whole session and one of those treatments is the CDK4/6 inhibitors. These treatments have become very well-known in the last years, mainly in the metastatic setting. So far we have the PALOMA trials with palbociclib but we also have seen the data from the MONALEESA2 study which investigated the use of ribociclib in this setting, in the same setting. These CDK4/6 inhibitors are very interesting for the metastatic setting because they about halve the risk of progressing in those patients with first or second line metastatic breast cancer. But there are a couple of interesting studies going on in the early breast cancer setting: there is the PENELOPE study which will finish recruitment this year and the PALLAS study which also is conducted under the umbrella of BIG, actually both studies which recruit about 4,600 patients with early breast cancer investigate if the addition of palbociclib will reduce the risk of distant relapse.
Is this existing data influencing clinical practice?
Yes and no. In the metastatic setting the drug palbociclib at least is licensed to be used in addition to endocrine treatment with an aromatase inhibitor as well as with fulvestrant, which is an oestrogen receptor down-regulator, in premenopausal as well as postmenopausal women. This freedom of using any backbone endocrine therapy which is supported by the data and to use those drugs in the pre- as well as the postmenopausal setting is very important, it gives the clinician freedom to operate and also all patients have the chance to get treated in the metastatic setting. But for the early breast cancer patients there is only access to these drugs within the clinical trials and you know not all patients will have the chance to get treated, 50% have the chance. But we don’t know if the drugs which worked in the metastatic setting will have a similar equal effect in the early breast cancer setting, that’s why a clinical trial is still very important to be conducted to get these drugs in this early breast cancer setting.