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Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials.

dc.contributor.author Overman, MJ
dc.contributor.author Morris, V
dc.contributor.author Kee, B
dc.contributor.author Fogelman, D
dc.contributor.author Xiao, L
dc.contributor.author Eng, C
dc.contributor.author Dasari, A
dc.contributor.author Shroff, R
dc.contributor.author Mazard, T
dc.contributor.author Shaw, K
dc.contributor.author Vilar, E
dc.contributor.author Raghav, K
dc.contributor.author Shureiqi, I
dc.contributor.author Liang, L
dc.contributor.author Mills, GB
dc.contributor.author Wolff, RA
dc.contributor.author Hamilton, S
dc.contributor.author Meric-Bernstam, F
dc.contributor.author Abbruzzese, J
dc.contributor.author Morris, J
dc.contributor.author Maru, D
dc.contributor.author Kopetz, S
dc.coverage.spatial England
dc.date.accessioned 2016-05-01T13:45:18Z
dc.date.issued 2016-06
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/27045102
dc.identifier mdw073
dc.identifier.uri https://hdl.handle.net/10161/11946
dc.description.abstract BACKGROUND: Incorporation of multiple enrichment biomarkers into prospective clinical trials is an active area of investigation, but the factors that determine clinical trial enrollment following a molecular prescreening program have not been assessed. PATIENTS AND METHODS: Patients with 5-fluorouracil-refractory metastatic colorectal cancer at the MD Anderson Cancer Center were offered screening in the Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC) program to identify eligibility for companion phase I or II clinical trials with a therapy targeted to an aberration detected in the patient, based on testing by immunohistochemistry, targeted gene sequencing panels, and CpG island methylation phenotype assays. RESULTS: Between August 2010 and December 2013, 484 patients were enrolled, 458 (95%) had a biomarker result, and 157 (32%) were enrolled on a clinical trial (92 on biomarker-selected and 65 on nonbiomarker selected). Of the 458 patients with a biomarker result, enrollment on biomarker-selected clinical trials was ninefold higher for predefined ATTACC-companion clinical trials as opposed to nonpredefined biomarker-selected clinical trials, 17.9% versus 2%, P < 0.001. Factors that correlated positively with trial enrollment in multivariate analysis were higher performance status, older age, lack of standard of care therapy, established patient at MD Anderson, and the presence of an eligible biomarker for an ATTACC-companion study. Early molecular screening did result in a higher rate of patients with remaining standard of care therapy enrolling on ATTACC-companion clinical trials, 45.1%, in contrast to nonpredefined clinical trials, 22.7%; odds ratio 3.1, P = 0.002. CONCLUSIONS: Though early molecular prescreening for predefined clinical trials resulted in an increase rate of trial enrollment of nonrefractory patients, the majority of patients enrolled on clinical trials were refractory to standard of care therapy. Within molecular prescreening programs, tailoring screening for preidentified and open clinical trials, temporally linking screening to treatment and optimizing both patient and physician engagement are efforts likely to improve enrollment on biomarker-selected clinical trials. CLINICAL TRIALS NUMBER: The study NCT number is NCT01196130.
dc.language eng
dc.relation.ispartof Ann Oncol
dc.relation.isversionof 10.1093/annonc/mdw073
dc.subject colorectal cancer
dc.subject molecular
dc.subject prescreening
dc.subject screening
dc.subject targeted
dc.title Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials.
dc.type Journal article
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/27045102
pubs.begin-page 1068
pubs.end-page 1074
pubs.issue 6
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Cancer Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group Medicine
pubs.organisational-group Medicine, Medical Oncology
pubs.organisational-group School of Medicine
pubs.publication-status Published
pubs.volume 27
dc.identifier.eissn 1569-8041


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