115PSequencing of cancer panels through “next generation sequencing” (NGS) in the clinical practice of a phase 1 trial unit

A L Wiermann,V Boni,M J de Miguel,F Lopéz-Ríos, E Calvo

Annals of Oncology(2018)

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Abstract
Background: The fundamental principle of precision oncology is the correspondence of molecular, genomic and clinical data with the underlying mechanisms of specific therapeutic agents in order to provide more effective and rational cancer treatment strategies. Methods: Retrospective study that describes the demographic aspects in a series of 28 consecutive cases of patients of different types of neoplasia screened to Phase I trials, where used a panel of 52 genes Oncomine Focus Assay Panel (ONCOMINE), done through NGS with the simultaneous analysis of DNA and RNA, being able to assess mutations, hotspots, variations in single nucleotide (SNV), indels, variations in the number of copies (CNVs) and gene fusions with a low requirement for sample quantity, and for use in paraffined samples (FFPE). Results: The median age was 61 years, with variation from 19 to 81 years-15 men 56.57%, and 13 women 43.46%. The clinical diagnoses of the patients, being the majority of Lung Cancer, Colon Cancer, and Pancreatic Cancer, with 25%, 17.86%, and 10%,71% respectively. More than 75% of the patients were already on lines 3 and 4 of their treatments. Among the patients, 42.86% have been newly biopsied, to do this test. Adenocarcinoma has been the most frequently present histological subtype. The average time for availability of the test reports is 20 days, with variation from 9 to 39 days. One patient did not have enough material to carry out the test, and in all the others good DNA amplification was obtained. RNA amplification has not been obtained in 3 cases. In 60.71% of the cases in this sample, potential molecular targets were detected, however, of the patients screened for Phase 1 trials, only one was enrolled in a trial with a drug targeted to the alteration presented. Multiple types of mutations were assessed.10 patients didn't have any relevant alterations. Conclusions: Our analysis shows the feasibility of using genomic tests in clinical practice. In the future, most patients will harbor pharmacologically treatable genomic alterations, a result consistent with our observation. The current trials in immunotherapy may explain the low recruitment in targeted drug trials There is an urgent need for new trial designs to address this new reality. Legal entity responsible for the study: Start Madrid at HM Sanchinarro Hospital Funding: Has not received any funding Disclosure: All authors have declared no conflicts of interest.
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Key words
sequencing,cancer panels,trial unit
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