Cyclin-dependent Kinase 4 and 6 (CDK4/6) inhibitors have shown clinical activity in patients with endocrine-resistant metastatic breast cancer. During the European Society for Medical Oncology (ESMO) Annual Meeting 2016, significant updates on studies with CDK4/6 inhibitors ribociclib, palbociclib and abemaciclib were presented.
At the American Association for Cancer Research, 2014 annual meeting (AACR) Richard Finn presented the results of the PALOMA-1 study with Ibrance® (palbociclib), an oral inhibitor of cyclin-dependent kinase 4/6 (CDK4/6). Based on the results of this Phase 2 study, palbociclib was recently approved by the United States Drug and Food Administration (U.S. FDA). What is the current level of evidence on palbociclib in approved indications?
Recent studies have shown new possible applications for Ki67. Huh et al. showed that low Ki67 levels in healthy breast tissue correlated with a lesser lifetime chance of breast cancer. Another study by Arnedos and colleagues concluded that palbociclib was able to invoke a significant Ki67-level drop. After a decade of Ki67-controversies, these results put the marker back in the spotlight.
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