title: Biomarker: Predictive or Prognostic?
abstract: To demonstrate that a biomarker is predictive of treatment benefit, the study requires biomarker status on all patients as well as patients who were treated with the agent of interest and patients not so treated, preferably in the context of a randomized study. A formal statistical test of the treatment-by-biomarker interaction should be significant. To establish whether a marker is purely prognostic, it needs to be demonstrated that there is a significant association between the biomarker and outcome, regardless of treatment, and that treatment effects do not depend on the biomarker. Finally, a biomarker may have both predictive and prognostic implications. These concepts are summarized in Figure 2.
authors.affiliation: From Weill Cornell Medical College, New York, NY. kab2053@med.cornell.edu.
authors.forename: Karla V
authors.initials: KV
authors.lastname: Ballman
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood*; D001943:Breast Neoplasms / Q000097:blood* / Q000401:mortality* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000097:blood* / Q000401:mortality* / Q000503:physiopathology; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D016019:Survival Analysis
chemical_list: D014408:Biomarkers, Tumor