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Poster display session

2707 - First prospective multicenter real-world RAS mutation comparison between OncoBEAM-based liquid biopsy and tissue analysis.

Date

11 Sep 2017

Session

Poster display session

Presenters

Jesus Garcia Foncillas

Citation

Annals of Oncology (2017) 28 (suppl_5): v22-v42. 10.1093/annonc/mdx363

Authors

J. Garcia Foncillas1, J. Tabernero2, E. Aranda Aguilar3, M. Benavides4, C.J. Camps5, R. López6, C. Montagut7, A. Anton Torres8, G. Lopez Vivanco9, E. Diaz Rubio10, F. Rojo1, A. Vivancos11

Author affiliations

  • 1 Cancer Institute, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 2 Medical Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 3 Oncology, University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 4 Oncology, Hospital Regional Universitario Carlos Haya, 29010 - Malaga/ES
  • 5 Oncology, Hospital General Universitario Valencia, 46018 - Valencia/ES
  • 6 Medical Oncology Department, HOSPITAL CLINICO DE SANTIAGO, Santiago de Compostela/ES
  • 7 Oncology, University Hospital del Mar, 8003 - Barcelona/ES
  • 8 Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 9 Oncology, Hospital de Cruces, 48903 - Barakaldo/ES
  • 10 Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 11 Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
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Resources

Abstract 2707

Background

Liquid biopsy is a powerful tool to refine the management of cancer patients by offering a minimally-invasive alternative to tumor tissue testing and rapid evaluation of overall tumor burden mutational status. To support its clinical adoption, a rigorous real-world evaluation of this method in routine clinical practice is required. OncoBEAM RAS is the only liquid biopsy assay to attain CE-IVD status for plasma RAS mutation analysis in routine colorectal cancer (CRC) patient care. The goal of the present study was to evaluate the aggregate performance of OncoBEAM RAS in10 hospital labs where the technology is installed in Spain.

Methods

Blood samples were collected in Streck cell-free DNA BCT® or EDTA tubes from metastatic CRC patients and circulating cell-free DNA from plasma was examined for RAS mutations using the OncoBEAM platform at each hospital laboratory. Results were then compared to those obtained from DNA extracted from tissue from the same patient.

Results

The overall percentage agreement (concordance) of results from plasma and tissue RAS mutation testing of 230 patients was 90.4% (208/230); 95% CI = 0.86-0.94, with positive percent agreement of 86.9% (113/130) and negative percent agreement of 95.0% (95/100). Re-analysis of tissue from all discordant cases by BEAMing revealed 2 false negative local tumor tissue RAS results. Plasma false negative results were observed more frequently in patients presenting with peritoneal and/or lung metastases only. The prevalence of RAS mutations in plasma (51.3%) and tissue (56.5%) were in accord with the expected occurrence of RAS mutations in mCRC patients.

Conclusions

In this first prospective real-world RAS mutation performance comparison study across a network of hospital laboratories certified to perform OncoBEAM testing in routine clinical practice, a high overall agreement was observed between results obtained from plasma and tissue samples. These results are comparable to those obtained in retrospective studies. Overall, these findings indicate that plasma OncoBEAM RAS testing is a viable solution for rapid delivery of RAS mutation status to determine mCRC patient eligibility for anti-EGFR therapy.

Clinical trial identification

Legal entity responsible for the study

University Hospital “Fundacion Jimenez Diaz”, Autonomous University of Madrid

Funding

Sysmex, Merck

Disclosure

All authors have declared no conflicts of interest.

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