Affiliations: Medical Oncology Clinical Research Unit, Center for
Cancer Research, NCI, NIH, DHHS, Bethesda, MD, USA | Cancer Diagnosis Program, Division of Cancer Treatment
and Diagnosis, NCI, NIH, DHHS, Bethesda, MD, USA
Note: [] Corresponding author: Barbara A. Conley, M.D., Head,
Aerodigestive Cancer Clinical Research Section, Medical Oncology Clinical
Research Unit, National Cancer Institute, Center for Cancer Research, 10 Center
Drive, Room 12C103A, Bethesda, MD 20892, USA. Tel.: +1 301 435 4004; Fax: +1
301 402 0172; E-mail: conleyb@mail.nih.gov
Abstract: The elucidation of the human genome and advances in knowledge about
molecular abnormalities, signaling pathways, influence of the local tissue
milieu and the relevance of genetic polymorphisms offer hope of designing more
effective, individualized cancer treatment plans. Although the scientific and
medical literature is replete with reports of putative prognostic or predictive
markers for cancer, few new diagnostics have been incorporated into routine
clinical practice. Criteria are needed to a) identify markers that have the
promise to be clinically useful; b) assess the best methodology for clinical
evaluation of the markers in question and c) confirm or validate that using the
marker adds useful information compared to using standard prognostic factors
alone. This review presents a methodology for the clinical evaluation of
putative prognostic and predictive markers in cancer, with considerations of
pitfalls in the early evaluation, rationale for development and optimization of
assay methodology, and examples of possible clinical trials for assessing the
clinical utility of putative markers.
