Dataset Information

ToxNav germline genetic testing and PROMinet digital mobile application toxicity monitoring: Results of a prospective single-center clinical utility study-PRECISE study.

ABSTRACT:

Introduction

In this study (PRECISE), we assess the clinical utility of a germline DNA sequencing-based test (ToxNav) for mutations in DPYD and ENOSF1 genes to alter clinician-prescribed fluoropyrimidine doses and the use of a digital application (PROMinet) to record patient-reported chemotherapy toxicity.

Materials and methods

Adult patients with a histological diagnosis of colorectal cancer (CRC) who consented to fluoropyrimidine-based chemotherapy were recruited prospectively and given a digital application to monitor and record associated toxicities. Patient samples were analyzed for 18 germline coding variants in DPYD and 1 ENOSF1 variant.

Results

Genetic testing was performed for 60 patients and identified one patient at increased risk of fluoropyrimidine-based toxicities. Uptake of genetic testing was high and results were available on average 17 days from initial clinical encounter. Patient-reported chemotherapy toxicity identified differences in 5-fluorouracil vs capecitabine regime profiles and identified profiles associated with subsequent need for chemotherapy dose reduction and hospital admission.

Discussion

The PRECISE clinical trial demonstrated that a germline DNA sequencing-based test can provide clinically relevant information to alter clinicians' fluoropyrimidine prescription. The study also obtained high volume, high granularity patient-reported toxicity data that might allow the improvement and personalization of chemotherapy management.

SUBMITTER: Lee LYW

PROVIDER: S-EPMC6797583 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

ToxNav germline genetic testing and PROMinet digital mobile application toxicity monitoring: Results of a prospective single-center clinical utility study-PRECISE study.

Lee Lennard Y W LYW Starkey Thomas T Sivakumar Shivan S Fotheringham Susan S Mozolowski Guy G Shearwood Vanessa V Palles Claire C Camilleri Philip P Church David D Kerr Rachel R Kerr David D

Cancer medicine 20190904 14

<h4>Introduction</h4>In this study (PRECISE), we assess the clinical utility of a germline DNA sequencing-based test (ToxNav) for mutations in DPYD and ENOSF1 genes to alter clinician-prescribed fluoropyrimidine doses and the use of a digital application (PROMinet) to record patient-reported chemotherapy toxicity.<h4>Materials and methods</h4>Adult patients with a histological diagnosis of colorectal cancer (CRC) who consented to fluoropyrimidine-based chemotherapy were recruited prospectively a ...[more]

PMID: 31486228

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Dataset Information

ToxNav germline genetic testing and PROMinet digital mobile application toxicity monitoring: Results of a prospective single-center clinical utility study-PRECISE study.

Introduction

Materials and methods

Results

Discussion

Publications

ToxNav germline genetic testing and PROMinet digital mobile application toxicity monitoring: Results of a prospective single-center clinical utility study-PRECISE study.

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