title: A case for the use of receiver operating characteristic analysis of potential clinical efficacy biomarkers in advanced renal cell carcinoma.
abstract: OBJECTIVE
  Assess patient-level utility of suggested pretreatment biomarkers of sunitinib in advanced renal cell carcinoma.
  
  
  METHODS
  Kaplan-Meier analysis of data from a randomized, Phase II study (n = 292) suggested baseline predictive value for circulating soluble Ang-2 and MMP-2 and HIF-1α percentage of tumor expression. Using this dataset, the sensitivity, specificity and area under the curve (AUC) were calculated, using receiver operating characteristic (ROC) curves.
  
  
  RESULTS
  Based on a ROC (sensitivity vs 1 - specificity) threshold AUC value of >0.8, neither Ang-2 (0.67) nor MMP-2 (0.65), nor HIF-1α percentage of tumor expression (0.65), performed appropriately from a patient-selection standpoint.
  
  
  CONCLUSIONS
  To properly assess potential biomarkers, sensitivity and specificity characteristics should be obtained by ROC analysis.
authors.affiliation: Pfizer Oncology, 10646 Science Center Drive, San Diego, CA 92121, USA.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: English
authors.affiliation: Pfizer Oncology, 10646 Science Center Drive, San Diego, CA 92121, USA.
authors.forename: J Andrew
authors.initials: JA
authors.lastname: Williams
authors.affiliation: Pfizer Oncology, 10646 Science Center Drive, San Diego, CA 92121, USA.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Martini
authors.affiliation: Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Motzer
authors.affiliation: Pfizer Oncology, via AM Mozzoni 12, Milan, 20152, Italy.
authors.forename: Olga
authors.initials: O
authors.lastname: Valota
authors.affiliation: Pfizer Oncology, 10646 Science Center Drive, San Diego, CA 92121, USA.
authors.forename: Richard E
authors.initials: RE
authors.lastname: Buller
mesh_terms: D042702:Angiopoietin-2 / Q000097:blood / Q000378:metabolism; D014408:Biomarkers, Tumor; D002292:Carcinoma, Renal Cell / Q000378:metabolism* / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D051795:Hypoxia-Inducible Factor 1, alpha Subunit / Q000097:blood / Q000378:metabolism; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000378:metabolism* / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D020778:Matrix Metalloproteinase 2 / Q000097:blood / Q000378:metabolism; D015337:Multicenter Studies as Topic; D009367:Neoplasm Staging; D011379:Prognosis; D012372:ROC Curve; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D042702:Angiopoietin-2; D014408:Biomarkers, Tumor; D051795:Hypoxia-Inducible Factor 1, alpha Subunit; D020778:Matrix Metalloproteinase 2
keywords: ROC curves; biomarkers; renal cell carcinoma; serum soluble protein; sunitinib