Cancer biomarkers: selecting the right drug for the right patient.
This Perspective highlights biomarkers that are expressed as a consequence of cancer development and progression. We focus on those biomarkers that are most relevant for identifying patients who are likely to respond to a given therapy, as well as those biomarkers that are most effective for measuring patient response to therapy. These two measures are necessary for selecting the right drug for the right patient, regardless of whether the setting is in drug development or in the post-approval use of the drug for patients with cancer. We also discuss the innovative designs of clinical trials and methodologies that are used to validate and qualify biomarkers for use in specific contexts. Furthermore, we look ahead to the promises and challenges in the field of cancer biomarkers.
National Cancer Institute, Cancer Imaging Program, EPN Rm 6058, 6130 Executive Blvd, Bethesda, Maryland 20852, USA. kelloffg@mail.nih.gov
Gary J
GJ
Kelloff
Caroline C
CC
Sigman
D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000235:genetics / Q000378:metabolism; D018450:Disease Progression; D055808:Drug Discovery / Q000379:methods / Q000639:trends; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D057285:Precision Medicine / Q000379:methods / Q000639:trends*
D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor