title: New strategies in personalized medicine for solid tumors: molecular markers and clinical trial designs.
abstract: The delineation of signaling pathways to understand tumor biology combined with the rapid development of technologies that allow broad molecular profiling and data analysis has led to a new era of personalized medicine in oncology. Many academic institutions now routinely profile patients and discuss their cases in meetings of personalized medicine tumor boards before making treatment recommendations. Clinical trials initiated by pharmaceutical companies often require specific markers for enrollment or at least explore multiple options for future markers. In addition to the still small number of targeted agents that are approved for the therapy of patients with histological and molecularly defined tumors, a broad range of novel targeted agents in development are undergoing clinical studies with companion profiling to determine the best-responding patient population. Although the present focus of profiling lies in genetic analyses, additional tests of RNA, protein, and immune parameters are being developed and incorporated in clinical research, and these methods are likely to contribute significantly to future patient selection and treatment approaches. As the advances in tumor biology and human genetics have identified promising tumor targets, the ongoing clinical evaluation of novel agents will now need to show if the promise can be translated into benefit for patients.
authors.affiliation: Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.
authors.forename: Juliane M
authors.initials: JM
authors.lastname: Jürgensmeier
authors.affiliation: Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Eder
authors.affiliation: Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut. roy.herbst@yale.edu.
authors.forename: Roy S
authors.initials: RS
authors.lastname: Herbst
mesh_terms: D014408:Biomarkers, Tumor / Q000235:genetics*; D002986:Clinical Trials as Topic; D020869:Gene Expression Profiling; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology; D018579:Patient Selection; D057285:Precision Medicine; D012107:Research Design
chemical_list: D014408:Biomarkers, Tumor