Skip to main content
Duke University Libraries
View Item 
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
    • Login
    JavaScript is disabled for your browser. Some features of this site may not work without it.

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

    Thumbnail
    View / Download
    213.3 Kb
    Date
    2016-06
    Authors
    Overman, MJ
    Morris, V
    Kee, B
    Fogelman, D
    Xiao, L
    Eng, C
    Dasari, A
    Shroff, R
    Mazard, T
    Shaw, K
    Vilar, E
    Raghav, K
    Shureiqi, I
    Liang, L
    Mills, GB
    Wolff, RA
    Hamilton, S
    Meric-Bernstam, F
    Abbruzzese, J
    Morris, J
    Maru, D
    Kopetz, S
    Show More
    (22 total)
    Repository Usage Stats
    305
    views
    783
    downloads
    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.
    Type
    Journal article
    Subject
    colorectal cancer
    molecular
    prescreening
    screening
    targeted
    Permalink
    https://hdl.handle.net/10161/11946
    Published Version (Please cite this version)
    10.1093/annonc/mdw073
    Publication Info
    Overman, MJ; Morris, V; Kee, B; Fogelman, D; Xiao, L; Eng, C; ... Kopetz, S (2016). Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials. Ann Oncol, 27(6). pp. 1068-1074. 10.1093/annonc/mdw073. Retrieved from https://hdl.handle.net/10161/11946.
    This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
    Collections
    • Scholarly Articles
    More Info
    Show full item record

    Scholars@Duke

    Abbruzzese

    James Abbruzzese

    D. C. I. Professor of Medical Oncology
    My research interests include the clinical study and treatment of pancreatic cancer.
    Shroff

    Rushad Darius Shroff

    Consulting Associate in the Department of Medicine
    Alphabetical list of authors with Scholars@Duke profiles.
    Open Access

    Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy

    Rights for Collection: Scholarly Articles

     

     

    Search Scope

    Browse

    All of DukeSpaceCommunities & CollectionsAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit DateThis CollectionAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit Date

    My Account

    LoginRegister

    Statistics

    View Usage Statistics