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Poster display session

4069 - Biomarker testing practices in the SECURE (proSpective obsErvational clinical practiCe stUdy in the first-line management of metastatic colorectal cancer [mCRC] with eRbitux in combination with chemothErapy) study

Date

09 Sep 2017

Session

Poster display session

Presenters

Gerasimos Aravantinos

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

G. Aravantinos1, A. Shahrasbi2, M. Oukkal3, B. Larbaoui4, P. Ronga5, D. Messinger6, J. Hamad7, W. Benbrahim8

Author affiliations

  • 1 2nd Oncology Clinic, Hospital of Agioi Anargyroi; General Oncology Hospital of Kifissia, 145 64 - Athens/GR
  • 2 Medical Oncology, Dr. Abdolali Shahrasbi's Private Clinic, Tehran/IR
  • 3 Medical Oncology, Clinique de chimiothérapie de Beau Fraisier; hospitalier (CHU) de Beni Messous, Algiers/DZ
  • 4 Medical Oncology, Centre Anti Cancer "Emir Abdel Kader" d'Oran, Oran/DZ
  • 5 Global Medical Affairs Oncology, Merck KGaA, 64293 - Darmstadt/DE
  • 6 Biostatistics, Prometris GmbH, Mannheim/DE
  • 7 Global Medical Affairs And Global Drug Safety, Merck Serono Middle East FZE-LLC, 22730 - Dubai/AE
  • 8 Medical Oncology, Anti Cancer Center, Batna/DZ
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Resources

Abstract 4069

Background

First-line treatment decisions in patients with mCRC are influenced by biomarker testing. The purpose of the SECURE study is to obtain real-world evidence regarding the decision pathway in first-line treatment selection. Here, we report information concerning biomarker testing practices in the SECURE study.

Methods

SECURE is a 2-part, noninterventional, multicenter, multinational, open-label, prospective phase 4 study being conducted in Algeria, Egypt, Greece, Iran, and Oman. In the first part of the study, patients with previously untreated mCRC were followed to record biomarker testing practices and first-line treatment decisions; treatment decisions were entirely at the discretion of the investigators. The second phase of the study – which is ongoing – involves monitoring clinical outcomes in patients with RAS wild-type mCRC treated with cetuximab-based regimens.

Results

Biomarker testing was performed in 169 of the 182 (92.9%) evaluable patients in the first phase of the SECURE study. KRAS (91.8%), NRAS (74.2%), BRAF (25.8%), and EGFR (20.9%) were the most commonly assayed biomarkers; also, microsatellite instability, PI3KCA, p53, PTEN, and MSH6 were measured in 

Conclusions

SECURE provides clarity regarding the decision pathway for patients presenting with mCRC. Our findings suggest that biomarker testing occurs in the overwhelming majority of cases, although opportunities may exist to further optimize biomarker testing practices and better guide treatment decisions.

Clinical trial identification

EMR062202-567

Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany

Funding

Merck KGaA, Darmstadt, Germany

Disclosure

G. Aravantinos: Advisory/Board Member: Amgen, Astra-Zeneca, BMS, GSKM Roche, Sanofi. Honoraria: Genesis Pharma SA. A. Shahrasbi: Advisory/Board Member/Honoraria: Merck. P. Ronga: Employment: Merck KGaA, Darmstadt, Germany. D. Messinger: Employment/Consultancy: Full-time employee of PROMETRIS GmbH, which has a contract with Merck KGaA, Darmstadt, Germany regarding statistical consultancy. J. Hamad: Employment: Merck Serono Middle East FZE-LLC. All other authors have declared no conflicts of interest.

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