Background: Next-generation sequencing reports provide matched therapies and clinical trials based on genomic alterations to drive therapeutic decisions in clinical practice. Biomarker-matched oncology drug approvals and trials have grown tremendously over the past decade. From January 2000 to October 2022 alone, a total of 573 agents were approved for various oncology indications, with nearly half being targeted therapies. While matched therapies and clinical trials are current at time of issue, updated variant classification, changes in FDA approvals, and trials available are not reflected in static reports. It is not always practical nor feasible to provide a new biopsy specimen. To address this gap in clinical care, we piloted Tempus Refresh, an on-demand informatics service that provides clinicians with refreshed therapy and trial matches from prior molecular reports directly through the EHR. Here we quantify the clinical actionability of Refresh reports.
Methods: TriHealth piloted the Tempus Refresh orderable through the Epic EHR at the treating physician’s discretion. The clinical team specified prior DNA molecular reports (tissue or blood) to update. Orders were transmitted to Tempus through an HL7 interface. All alterations provided on the prior report were updated for therapeutic and trial matches through existing workflows. An updated structured report was then delivered to the TriHealth Epic EHR linked in the lab tab.
Results: From 2/2023 to 11/2023, 10 TriHealth providers participated. A total of 35 unique Refresh orders were placed via custom HL7 Epic order, of which 3 were canceled due to orders outside of pilot parameters. Of the 32 Refresh reports, 34% (11/32) contained new FDA-approved therapies (OncoKB Level 1 or 2), and 78% (25/32) were annotated with new clinical trials. The average elapsed time from original date of report issuance to Refresh order delivery was 14.5 months (range 1 month to 45 months). The mean turnaround time for issuance of a Refresh report was 29 hours (range 5 hours to 53 hours).
Conclusions: These results demonstrate that on-demand report updates increase the availability of tumor biomarker-matched therapies and trials. Furthermore, the study exhibits the feasibility of integrating updates directly into the standard EHR clinical workflow. This service provides visibility across teams and can support specialty pharmacists in therapy authorization. Considering the success of this pilot, future studies will assess the expansion of Tempus Refresh to additional sites.
VIEW THE PUBLICATION