Clinical utility of level-of-evidence-1 disease forecast cancer biomarkers uPA and its inhibitor PAI-1

Expert Rev Mol Diagn. 2010 Nov;10(8):1051-67. doi: 10.1586/erm.10.71.


The prognostic and/or predictive value of the cancer biomarkers, urokinase-type plasminogen activator (uPA) and its inhibitor (plasminogen activator inhibitor [PAI]-1), determined by ELISA in tumor-tissue extracts, was demonstrated for several cancer types in numerous clinically relevant retrospective or prospective studies, including a multicenter breast cancer therapy trial (Chemo-N0). Consequently, for the first time ever for any cancer biomarker for breast cancer, uPA and PAI-1 have reached the highest level of evidence, level-of-evidence-1. At present, two other breast cancer therapy trials, NNBC-3 and Plan B, also incorporating uPA and PAI-1 as treatment-assignment tools are in effect. Furthermore, small synthetic molecules targeting uPA are currently in Phase II clinical trials in patients afflicted with advanced cancer of the ovary, breast or pancreas.

Publication types

  • Review

MeSH terms

  • Biomarkers, Tumor / analysis*
  • Breast Neoplasms / chemistry
  • Breast Neoplasms / diagnosis
  • Breast Neoplasms / drug therapy
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Neoplasms / chemistry
  • Neoplasms / diagnosis*
  • Neoplasms / drug therapy*
  • Oligonucleotides, Antisense / therapeutic use
  • Plasminogen Activator Inhibitor 1 / analysis*
  • Plasminogen Activator Inhibitor 1 / genetics
  • Prognosis
  • RNA, Small Interfering / therapeutic use
  • Retrospective Studies
  • Serine Proteinase Inhibitors / therapeutic use
  • Urokinase-Type Plasminogen Activator / analysis*
  • Urokinase-Type Plasminogen Activator / genetics


  • Biomarkers, Tumor
  • Oligonucleotides, Antisense
  • Plasminogen Activator Inhibitor 1
  • RNA, Small Interfering
  • Serine Proteinase Inhibitors
  • Urokinase-Type Plasminogen Activator