By Kim Irish, BCA Program Manager
Days 1 & 2: Wednesday, Dec 8 and Thursday, Dec 9
On Wednesday afternoon, I attended a panel called “Design & Implementation of Biomarker Studies.” Dr. Lajos Pusztai, of UT MD Anderson Cancer Center, noted that correct interpretation of data is extremely important because published results are not necessarily correct (e.g. correct interpretation of results is not absolutely necessary for publication – shocking!), and asked the probing question that begs to be answered, “Do you think there are consequences associated with how you phrase the research problem?” Asking open-ended questions that aren’t influenced by a hypothesis may mean less biased interpretations of results.
Also related to interpretation of biomarker studies, Dr. Lisa M. McShane of the National Cancer Institute noted in her talk entitled “Statistical challenges in predictive and prognostic biomarker studies: How to avoid wasting your time and specimens,” that there are a number of deficiencies in biomarker studies. These include unclear objectives or the absence of a scientific hypothesis, poor or non-existent statistical design, over-analysis, and poor reporting, among others. Dr. McShane recommended improving biomarker study design and analysis; collecting sufficient specimens of the right type, from the right patients, with data annotation; that assays be sufficiently robust and reproducible; and that researchers should report completely on what they did and what they found in order to promote reproducibility of results and comparison or pooling across studies.
There were some brief presentations related to aromatase inhibitors on Thursday morning. Here’s a short summary of what was discussed:
- Neoadjuvant aromatase inhibitor therapy promotes breast conservation and provides a rich context for biomarker research.
- Fulvestrant 500 mg appears to offer an advantage over anastrozole by delaying the onset of acquired resistance, which may be related to the different mechanism of action of fulvestrant. Data collection for a post hoc overall survival analysis related to the ‘FIRST’ study has been started, but no results were presented. Finally, several of the faculty associated with this presentation received funding from AstraZeneca, which manufactures fulvestrant.