title: Personalized oncology: genomic screening in phase 1.
abstract: Improvements in cancer genomics and tumor biology have reinforced the evidence of cancer development driven by numerous genomic alterations. Advanced genomics technology can be used to characterize genomic alterations that potentially drive tumor growth. With the possibility of screening thousands of genes simultaneously, personalized molecular medicine has become an option. New treatments are being investigated in phase 1 trials around the world. Traditionally, the goal of phase 1 studies was to determine the optimal dose and assess dose-limiting toxicity of a potential new experimental drug. Only a limited number of patients will benefit from the treatment. However, introducing genomic mapping to select patients for early clinical trials with targeted molecular therapy according to the genomic findings, may lead to a better outcome for the patient, an enrichment of phase 1 trials, and thereby accelerated drug development. The overall advantage is to determine which mutation profiles correlate with sensitivity or lack of resistance to specific targeted therapies. The utility and current limitations of genomic screening to guide selection to Phase 1 clinical trial will be discussed.
authors.affiliation: Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Ida Viller
authors.initials: IV
authors.lastname: Tuxen
authors.forename: Lars
authors.initials: L
authors.lastname: Jønson
authors.forename: Eric
authors.initials: E
authors.lastname: Santoni-Rugiu
authors.forename: Jane Preuss
authors.initials: JP
authors.lastname: Hasselby
authors.forename: Finn Cilius
authors.initials: FC
authors.lastname: Nielsen
authors.forename: Ulrik
authors.initials: U
authors.lastname: Lassen
mesh_terms: D014408:Biomarkers, Tumor / Q000235:genetics; D002874:Chromosome Mapping; D017321:Clinical Trials, Phase I as Topic; D004252:DNA Mutational Analysis; D005820:Genetic Testing; D014644:Genetic Variation; D023281:Genomics; D006801:Humans; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology*; D018579:Patient Selection; D057285:Precision Medicine
chemical_list: D014408:Biomarkers, Tumor
keywords: Personalized medicine; cancer; next generation sequencing; phase 1; targeted treatment