PATIENT STRATIFICATION FOR CANCER THERAPY BASED ON GENOMIC DNA MICROARRAY ANALYSIS

摘要

The method of the invention comprises the stratification of a cancer patientpopulation into various cancer therapy groups based on analysis by genomic DNAmicroarray of multiple gene amplifications or deletions present or absent inthe diseased tissue of each patient. In particular, the invention involvespatient stratification into one of at least four cancer therapy groups basedon the microarray analysis of gene amplification or gene deletion at multiplechromosome locations. The invention has the significant clinical advantage ofguiding selection of expensive cancer adjuvant drugs for use with patientsmost likely to respond positively to the individual drug. For example, agenomic DNA microarray simultaneously measuring 59 separate geneamplifications or gene deletions in diseased tissue can be used to stratifysolid tumor cancer patients, such as breast cancer patients, into at leastnine groups: those most likely to respond to (i) anti-HER-2/neu therapy(Herceptin®), (ii) anti-EGFR therapy (C225 antibody), (iii) anti-AKT1therapy (cis-platin), (iv) anti-PIK3CA therapy, (v) anti-thymidylates synthasetherapy (5-fluorouracil), (iv) anti-Topoisomerase II therapy (doxorubicin),(vii) anti-cmyc therapy, (viii) combination of anti-HER-2 therapy and anti-AKT1 therapy, and (ix) combination of anti-EGFR and anti-AKT1 therapy. Theinvention has the further advantage of identifying patients most likely torespond synergistically to a particular combination of adjuvant therapies.