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ASCO Guidelines on Pharmacogenomic Testing for Breast and Colorectal Cancer

HER2 test­ing is an impor­tant pre­dic­tor of response to ther­apy in 20%–25% of patients with breast can­cer; how­ever, approx­i­mately 20% of test­ing has been reported to be inac­cu­rate. In response, the Amer­i­can Soci­ety of Clin­i­cal Oncol­ogy (ASCO), in con­junc­tion with the Col­lege of Amer­i­can Pathol­o­gists (CAP), pub­lished guide­lines for HER2 test­ing in patients with breast can­cer. The expert panel con­cluded that immuno­his­to­chem­istry and flu­o­res­cence in situ hybridiza­tion test­ing assays are accept­able. They also defined pos­i­tive HER2 results for either test­ing meth­ods as well as addi­tional test­ing meth­ods for final deter­mi­na­tion of equiv­o­cal results. To ensure accu­rate results, the panel rec­om­mended that results be obtained from a CAP-​​accredited laboratory.

ASCO has also been work­ing on a pro­vi­sional clin­i­cal opin­ion, an early ver­sion of a for­mal guide­line, to assist clin­i­cal deci­sion mak­ing in col­orec­tal can­cer. Approx­i­mately 30%–40% of col­orec­tal can­cers express a mutated KRAS gene. Although approved for col­orec­tal can­cer, cetux­imab (Erbitux®) and pan­i­tu­mumab (Vectibix®) are inef­fec­tive in block­ing EGFR in patients with the mutated KRAS gene. As a result, ASCO rec­om­mends that patients with col­orec­tal can­cer be tested for KRAS muta­tions prior to the start of treat­ment with either of these drugs.

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