Patient selection for a developmental therapeutics program using whole genome and Transcriptome analysis.
Summary: Introduction Given the high level of uncertainty surrounding the outcomes of early phase clinical trials, whole genome and transcriptome analysis (WGTA) can be used to optimize patient selection and study assignment. In this retrospective analysis, we reviewed the impact of this approach on...
| Published in: | Investigational New Drugs Vol. 38; no. 5; pp. 1601 - 1605 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Springer Nature
Oct2020
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=145889445&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 145889445 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01676997 OH2 jtl: Investigational New Drugs issn: 01676997 maglogo: N pubinfo: dt: Oct2020 vid: 38 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 145889445 145889445 145889445 10.1007/s10637-020-00892-8 145889445 ppf: 1601 ppct: 4 formats: tig: atl: Patient selection for a developmental therapeutics program using whole genome and Transcriptome analysis. aug: au: Lavoie, Jean-Michel Mitchell, Teresa Lee, Sung-Eun Deol, Balvir Chia, Stephen K. Gelmon, Karen A. Kollmannsberger, Christian K. Tinker, Anna V. Jones, Steven J. M. Marra, Marco Laskin, Janessa Renouf, Daniel J. affil: Department of Medical Oncology, BC Cancer, 600 West 10th Avenue, V5Z 4E6, Vancouver, BC, Canada sug: subj: Patient Selection Therapeutics Program Development Gene Expression Profiling Genome Individualized Medicine Human Retrospective Design Biopsy Molecular Biology Gene Expression RNA Analysis ab: Summary: Introduction Given the high level of uncertainty surrounding the outcomes of early phase clinical trials, whole genome and transcriptome analysis (WGTA) can be used to optimize patient selection and study assignment. In this retrospective analysis, we reviewed the impact of this approach on one such program. Methods Patients with advanced malignancies underwent fresh tumor biopsies as part of our personalized medicine program (NCT02155621). Tumour molecular data were reviewed for potentially clinically actionable findings and patients were referred to the developmental therapeutics program. Outcomes were reviewed in all patients, including those where trial selection was driven by molecular data (matched) and those where there was no clear molecular rationale (unmatched). Results From January 2014 to January 2018, 28 patients underwent WGTA and enrolled in clinical trials, including 2 patients enrolled in two trials. Fifteen patients were matched to a treatment based on a molecular target. Five patients were matched to a trial based upon single-gene DNA changes, all supported by RNA data. Ten cases were matched on the basis of genome-wide data (n = 4) or RNA gene expression only (n = 6). With a median follow-up of 6.7 months, the median time on treatment was 8.2 weeks. Discussion When compared to single-gene DNA-based data alone, WGTA led to a 3-fold increase in treatment matching. In a setting where there is a high level of uncertainty around both the investigational agents and the biomarkers, more data are needed to fully evaluate the impact of routine use of WGTA. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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