2017 Annual Meeting

SC32-Predictive Biomarkers: Lessons from Clinical Trials

March 8 2017, 1:30pm to 5:30pm


SC32-Predictive Biomarkers Lessons from Clinical Trials


Session Credits: 3 CME and 3 SAMs


Faculty: Sunil Badve, MD, FRCPath, Indiana University, Indianapolis, IN; Reinhard Buettner, MD, University of Cologne, Institute of Pathology, Germany and Josef Ruschoff, MD, Targos Molecular Pathology GmbH. Germaniastrasse 7. D-34119 Kassel, Germany

Recent developments in our molecular understanding of cancer and upcoming biomarkers predicting therapy response in breast, lung and gastric cancer will be addressed.

  • Breast - Biomarker assessment plays a critical role in the diagnosis of cancers particularly breast cancers as patients are increasingly getting subtype specific therapies. The assessment of predictive biomarkers involves the use of National guidelines, which continue to evolve based on the data available from Clinical trials. Additionally, novel therapeutic directed against targets in the tumor microenvironment such as angiogenesis and immune molecules will be discussed.
  • Lung -The most recent WHO classification of lung cancer has integrated systematically molecular signatures, clinically validated biomarkers and histopathological features. We will focus on Non-Small Cell Lung Cancer (NSCLC) subtypes driven by genetically activated oncogenic signaling and review data regarding to molecular testing and delivering biomarker-directed therapies. We will further discuss strategies for comprehensive biomarker testing by multiplex/deep sequencing assays using next-generation sequencing (NGS).
  • Upper GI cancer - Comprehensive molecular evaluation in gastric adenocarcinoma (GC) have revealed four molecular subtypes (TCGA Nature 2014) providing evidence for a number of targetable genetic lesions. Experiences from HER2 testing within the Trastuzumab for Gastric Cancer (ToGA) trial will be presented as one of the first predictive biomarkers in GC. The current status of biomarkers under investigation such as PTEN for AKT/PI3K directed therapies and PD-1/ PD-L1 for immune therapies or markers without proven significance so far (EGFR, VEGF, cMET) will be summarized. Finally, recent developments using multiplex approaches will be addressed.
  • Pan-Cancer Therapeutics -Novel genomic methods are being used to classify tumors according to molecular phenotype rather than tissues of origin. The methodological approaches and types of molecular cancers will be discussed. The course will utilize a molecular, drug and trial specific approach. While there will be short lectures about the molecular basis, detailed information about optimal testing of each predictive biomarker and its implication for therapy decision making will be provided.

Upon completion of this educational activity, participants should be able to:

  1. Determine the clinical significance of predictive biomarkers
  2. Describe the benefits and limitations of each biomarker
  3. Describe the reporting issues related to testing platforms


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