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Participants will develop a biomarker-based testing algorithm to individualize the selection of mAb therapy, given in combination with standard 5-FU-based chemotherapy, to maximize clinical benefit for patients receiving first-line treatment for metastatic colorectal cancer.
In a recent study, polymorphisms in enzymes critical for androgen synthesis were identified that were associated with progression free survival in men receiving first line hormonal therapy for prostate cancer. Participants in Challenge 2 will plan the development and evaluation of a genetic clinical test to identify subgroups of patients with metastatic prostate cancer who may benefit from early incorporation of androgen targeted therapy. We will focus on germline polymorphisms that may modify therapeutic benefit. The development plan will include an outline of biologic studies and clinical trials to demonstrate the utility of the molecular test(s). Topics covered in the discussion will include specimen requirements, choice of genetic markers, assay analytical performance, choice of targeted therapy, design of a definitive clinical trial, and regulatory issues.
Participants will be challenged to develop a clinical test based on a molecular profile that will identify which patients with resectable non-small cell lung cancer are most likely to benefit from currently available adjuvant chemotherapy regimens. The discussion will cover topics such as specimen requirements, assay analytical performance, choice of assay platform, considerations in use of retrospective specimen collections, design of a definitive clinical trial, and regulatory issues. Special considerations in the development and validation of clinical tests based on high-throughput marker assays such as gene expression microarray profiling or other high-dimensional multiplex tests will be emphasized.
Challenge 4 will evaluate the prognostic and predictive characteristics of FLT3 internal tandem duplication (ITD) in acute myeloid leukemia (AML). Strategies to determine how to use FLT3-ITD as a prognostic marker in AML will help participants understand the pathophysiology of wild type and mutated FLT3 in AML. Evaluation of FLT3 as a potential prognostic marker will reinforce the need to consider allelic ratios of wild type and mutated FLT3 and whether this is an important feature in AML prognosis. Evaluation of FLT3 as a therapeutic target will foster an understanding of how to approach clinical trials design including laboratory assessments and strategies required for patient eligibility assessment.
EORTC is partially supported by the Belgian National Lottery and by the Belgian Federal Science Policy Office