Dr. Hudis on BOLERO-3 Trial Biomarker Observations

Clifford A. Hudis, MD, ASCO president, chief, Breast Cancer Medicine Service, attending physician, Memorial Sloan-Kettering Cancer Center, comments on exploratory biomarker observations from the BOLERO-3 trial.

This analysis, presented at the 2013 European Cancer Congress, looked at correlations between key members of the PI3K/mTOR pathway and the efficacy of everolimus in a group of patients for the identification of potential predictive biomarkers. This analysis showed an association between PTEN status and S6 status and potential benefits of everolimus.

While there are hypotheses worth exploring, Hudis remains cautious, as nothing is applicable to clinical benefit yet. Because of this, the oncology community is left with the bottom-line results of BOLERO-3: 5-week difference in progression-free survival at a financial and toxicity cost that may not justify benefit. Investigators need to look further in this space and validate biomarkers, Hudis says.

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