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Patient selection for a developmental therapeutics program using whole genome and Transcriptome analysis.

Jean-Michel Lavoie1, Teresa Mitchell2, Sung-Eun Lee2

  • 1Department of Medical Oncology, BC Cancer, 600 West 10th Avenue, Vancouver, BC, V5Z 4E6, Canada. jeanmichel.lavoie@bccancer.bc.ca.

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Summary

Whole genome and transcriptome analysis (WGTA) significantly increases treatment matching for advanced cancer patients in early phase trials. This comprehensive molecular profiling optimizes patient selection and study assignment, improving personalized medicine approaches.

Keywords:
Personalized medicinePhase 1 clinical trialsTreatment allocationWhole genome and Transcriptome analysis

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Area of Science:

  • Oncology
  • Genomics
  • Clinical Trials

Background:

  • Early phase clinical trials face high uncertainty in outcomes.
  • Personalized medicine programs aim to optimize patient selection and treatment assignment.
  • Whole genome and transcriptome analysis (WGTA) offers comprehensive molecular data.

Purpose of the Study:

  • To evaluate the impact of WGTA on patient selection and treatment matching in a personalized medicine program.
  • To compare the effectiveness of WGTA-driven matching versus traditional methods.
  • To assess outcomes for patients undergoing WGTA in early phase clinical trials.

Main Methods:

  • Retrospective analysis of patients with advanced malignancies undergoing fresh tumor biopsies.
  • WGTA performed on tumor samples to identify clinically actionable findings.
  • Patients referred to a developmental therapeutics program based on molecular data (matched) or not (unmatched).
  • Outcomes reviewed for all enrolled patients.

Main Results:

  • 28 patients underwent WGTA and enrolled in clinical trials between January 2014 and January 2018.
  • 15 patients were matched to treatments based on molecular targets.
  • WGTA led to a 3-fold increase in treatment matching compared to single-gene DNA data alone.
  • Median follow-up was 6.7 months, with a median time on treatment of 8.2 weeks.

Conclusions:

  • WGTA enhances treatment matching for advanced cancer patients in early phase trials.
  • Comprehensive genomic data improves the identification of potential therapeutic targets.
  • Further research is needed to fully assess the routine use of WGTA in clinical practice.