Abstract：
:DNA focused panel sequencing has been rapidly adopted to assess therapeutic targets in advanced/refractory cancer. Integrated Genomic Profiling (IGP) utilising DNA/RNA with tumour/normal comparisons in a Clinical Laboratory Improvement Amendments (CLIA) compliant setting enables a single assay to provide: therapeutic target prioritisation, novel target discovery/application and comprehensive germline assessment. A prospective study in 35 advanced/refractory cancer patients was conducted using CLIA-compliant IGP. Feasibility was assessed by estimating time to results (TTR), prioritising/assigning putative therapeutic targets, assessing drug access, ascertaining germline alterations, and assessing patient preferences/perspectives on data use/reporting. Therapeutic targets were identified using biointelligence/pathway analyses and interpreted by a Genomic Tumour Board. Seventy-five percent of cases harboured 1-3 therapeutically targetable mutations/case (median 79 mutations of potential functional significance/case). Median time to CLIA-validated results was 116 days with CLIA-validation of targets achieved in 21/22 patients. IGP directed treatment was instituted in 13 patients utilising on/off label FDA approved drugs (n = 9), clinical trials (n = 3) and single patient IND (n = 1). Preliminary clinical efficacy was noted in five patients (two partial response, three stable disease). Although barriers to broader application exist, including the need for wider availability of therapies, IGP in a CLIA-framework is feasible and valuable in selection/prioritisation of anti-cancer therapeutic targets.
journal_name
Sci Repjournal_title
Scientific reportsauthors
Borad MJ,Egan JB,Condjella RM,Liang WS,Fonseca R,Ritacca NR,McCullough AE,Barrett MT,Hunt KS,Champion MD,Patel MD,Young SW,Silva AC,Ho TH,Halfdanarson TR,McWilliams RR,Lazaridis KN,Ramanathan RK,Baker A,Aldrich J,doi
10.1038/s41598-016-0021-4subject
Has Abstractpub_date
2016-12-23 00:00:00pages
25issue
1issn
2045-2322pii
10.1038/s41598-016-0021-4journal_volume
6pub_type
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