Optimizing Genotype Matched Clinical Trial (GMCT) accrual in a community oncology program (COP) - solid tumors Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Thursday, July 28, 2016

Optimizing Genotype Matched Clinical Trial (GMCT) accrual in a community oncology program (COP) - solid tumors

Abstracts | link ASCO

Optimizing Genotype Matched Clinical Trial (GMCT) accrual in a community oncology program (COP).

Health Services Research and Quality of Care
Session Type and Session Title: 
This abstract will not be presented at the 2016 ASCO Annual Meeting but has been published in conjunction with the meeting.
Abstract Number: 
J Clin Oncol 34, 2016 (suppl; abstr e18036)
Steven Francis Powell, Elie G. Dib, Jonathan Scott Bleeker, Michael D. Keppen, Miroslaw Mazurczak, Keely Marie Hack, Mark Mutuota Gitau, Preston D. Steen, Shelby A. Terstriep, John Reynolds, Jayan Nair, Megan L Landsverk, Chun-Hung Chan, Paul A. Thompson, Christie Ellison, Lora Jane Black, James M. Ford, Anu G. Gaba; Sanford Health, Sioux Falls, SD; Sanford Health, Roger Maris Cancer Center, Fargo, ND; Roger Maris Cancer Center, Fargo, ND; Sanford Roger Maris Cancer Center, Fargo, ND; Sanford Health, Bismarck, ND; Sanford Health, Bemidji, MN; Stanford University School of Medicine, Stanford, CA; Sanford Health, Fargo, ND

Abstract Disclosures

Background: While molecular profiling (MP) is becoming widely accessible, clinician understanding may be a barrier to GMCT enrollment. MP programs at academic medical centers report GMCT enrollment rates at 5-17% of eligible patients. To advance precision medicine, this process must be adapted to serve COPs.  
Methods: We performed a prospective MP study (NCT02416518) at Sanford Health, a predominantly rural health care system with 4 participating COP sites. The primary outcome of the study was feasibility of testing in this setting. Secondary outcomes included correlating GMCT enrollment, impact on treatment decisions, and patient outcomes. Eligible patients included those with incurable solid tumor malignancies that had progressed on ≥ 1 prior line of therapy or had no standard first-line treatment options available, an ECOG PS of ≤ 1, adequate organ function, and recent tissue biopsy ( ≤ 14 weeks) available for MP. MP was performed using FoundationOne. A weekly, video conferenced genomic tumor board (GTB), composed of COP providers, reviewed each case for actionable alterations (AAs) and provided recommendations to the treating physician. Results: From June 2014-Dec 2015, 145 patients signed consent to participate in the prospective MP study. 120 patients were eligible for testing and 109 had reviewable MP results. Reasons for failure to complete MP included: insufficient tissue (n = 8), decline in clinical status (n = 2), and withdrawal of consent (n = 1). 99 (90.8%) of those with reviewable results had at least one AA that was felt to have a rational therapeutic option based on GTB review. Of those with an AA, 39 (39.4%) were treated based on their MP findings. 16 (16.2%) of those with an AA enrolled in GMCTs. 7 (7.1%) were treated with FDA approved on-label drug and 16 (16.2%) were treated with FDA approved off-label drug. Patient outcomes are being tracked in accordance with the corresponding GMCTs and for those treated with off-label drug.  
Conclusions: Development of a system-wide MP program in the community is feasible and can optimize accrual to GMCTs. This program will be adapted to enrich patient enrollment into rapidly emerging GMCTs available through the National Cancer Institute (NCI) and industry. Clinical trial information: NCT02416518


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