Cancer therapy trials employing level-of-evidence-1 disease forecast cancer biomarkers uPA and its inhibitor PAI-1

References

• Cliffton EE, Grossi CE. Fibrinolytic activity of human tumors as measured by the fibrin-plate method. Cancer8, 1146–1154 (1955).
   PubMed Web of Science ®Google Scholar
• Schmitt M, Mengele K, Gkazepis A et al. Assessment of urokinase-type plasminogen activator and its inhibitor PAI-1 in breast cancer tissue: historical aspects and future prospects. Breast Care3(s2), 3–10 (2008).
   PubMed Web of Science ®Google Scholar
• Schmitt M, Mengele K, Napieralski R et al. Clinical utility of level-of-evidence-1 disease forecast cancer biomarkers uPA and its inhibitor PAI-1. Expert Rev. Mol. Diagn.10(8), 1051–1067 (2010).
   PubMed Web of Science ®Google Scholar
• López-Otín C, Overall CM. Protease degradomics: a new challenge for proteomics. Nat. Rev. Mol. Cell. Biol.3, 509–519 (2002).
   PubMed Web of Science ®Google Scholar
• Mengele K, Napieralski R, Magdolen V et al. Characteristics of the level-of-evidence-1 disease forecast cancer biomarkers uPA and its inhibitor PAI-1. Expert Rev. Mol. Diagn.10(7), 947–962 (2010).
   PubMed Web of Science ®Google Scholar
• Ulisse S, Baldini E, Sorrenti S, D’Armiento M. The urokinase plasminogen activator system: a target for anti-cancer therapy. Curr. Cancer Drug Targets9, 32–71 (2009).
   PubMed Web of Science ®Google Scholar
• Annecke K, Schmitt M, Euler U et al. uPA and PAI-1 in breast cancer: review of their clinical utility and current validation in the prospective NNBC-3 trial. Adv. Clin. Chem.45, 31–45 (2008).
   PubMed Web of Science ®Google Scholar
• O’Grady P, Lijnen HR, Duffy MJ. Multiple forms of plasminogen activator in human breast tumors. Cancer Res.45(12 Pt 1), 6216–6218 (1985).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Schmitt M, Vetter M et al. Prospective biomarker trials Chemo-N0 and NNBC-3 Europe validate the clinical utility of invasion markers uPA and PAI-1 in node-negative breast cancer. Breast Care3(s2), 11–15 (2008).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Schmitt M, Paepke S, Allgayer H, Kates RE. Tumor-associated proteolytic factors uPA and PAI-1: critical appraisal of their clinical relevance in breast cancer and their integration into decision-support algorithms. Crit. Rev. Clin. Lab. Sci.44, 179–201 (2007).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Kates RE, Schmitt M et al. Urokinase-type plasminogen activator and its inhibitor type 1 predict disease outcome and therapy response in primary breast cancer. Clin. Breast Cancer5, 348–352 (2004).
   PubMedGoogle Scholar
• Harbeck N, Kates RE, Gauger K et al. Urokinase-type plasminogen activator (uPA) and its inhibitor PAI-I: novel tumor-derived factors with a high prognostic and predictive impact in breast cancer. Thromb. Haemost.91, 450–456 (2004).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Salem M, Nitz U, Gluz O, Liedtke C. Personalized treatment of early-stage breast cancer: present concepts and future directions. Cancer Treat. Rev.36, 584–594 (2010).
   PubMed Web of Science ®Google Scholar
• van’t Veer LJ, Paik S, Hayes DF. Gene expression profiling of breast cancer: a new tumor marker. J. Clin. Oncol.23, 1631–1635 (2005).
   PubMed Web of Science ®Google Scholar
• Albain KS, Paik S, van’t Veer L. Prediction of adjuvant chemotherapy benefit in endocrine responsive, early breast cancer using multigene assays. Breast18(Suppl. 3), S141–S145 (2009).
   Web of Science ®Google Scholar
• Harris L, Fritsche H, Mennel R et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J. Clin. Oncol.25, 5287–5312 (2007).
   PubMed Web of Science ®Google Scholar
• Sturgeon CM, Duffy MJ, Stenman UH et al. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers. Clin. Chem.54(12), E11–E79 (2008).
   PubMed Web of Science ®Google Scholar
• Fornier M, Hudis C. Adjuvant chemotherapy for primary breast cancer. Curr. Oncol. Rep.7, 18–22 (2005).
   PubMedGoogle Scholar
• Bernard-Marty C, Cardoso F, Piccart MJ. Facts and controversies in systemic treatment of metastatic breast cancer. Oncologist9, 617–632 (2004).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Kates RE, Schmitt M. Clinical relevance of invasion factors urokinase-type plasminogen activator and plasminogen activator inhibitor type 1 for individualized therapy decisions in primary breast cancer is greatest when used in combination. J. Clin. Oncol.20, 1000–1007 (2002).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Kates RE, Look MP et al. Enhanced benefit from adjuvant chemotherapy in breast cancer patients classified high-risk according to urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (n = 3424). Cancer Res.62, 4617–4622 (2002).
   PubMed Web of Science ®Google Scholar
• Jänicke F, Prechtl A, Thomssen C et al. Randomized adjuvant chemotherapy trial in high-risk, lymph node-negative breast cancer patients identified by urokinase-type plasminogen activator and plasminogen activator inhibitor type 1. J. Natl Cancer Inst.93, 913–920 (2001).
   PubMed Web of Science ®Google Scholar
• Look MP, van Putten WL, Duffy MJ et al. Pooled analysis of prognostic impact of urokinase-type plasminogen activator and its inhibitor PAI-1 in 8377 breast cancer patients. J. Natl Cancer Inst.94, 116–128 (2002).
   PubMed Web of Science ®Google Scholar
• Hayes DF, Bast RC, Desch CE et al. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. J. Natl Cancer Inst.88, 1456–1466 (1996).
   PubMed Web of Science ®Google Scholar
• Jänicke F, Pache L, Schmitt M et al. Both the cytosols and detergent extracts of breast cancer tissues are suited to evaluate the prognostic impact of the urokinase-type plasminogen activator and its inhibitor, plasminogen activator inhibitor type 1. Cancer Res.54, 2527–2530 (1994).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Schmitt M, Meisner C et al. Final 10-year analysis of prospective multicenter Chemo-N0 trial for validation of ASCO-recommended biomarkers uPA/PAI-1 for therapy decision making in node-negative breast cancer. J. Clin. Oncol.27, 15s(suppl.) (2009) (abstract 511).
   Google Scholar
• Goldhirsch A, Glick JH, Gelber RD, Senn HJ. Meeting highlights: international consensus panel on the treatment of primary breast cancer. J. Natl Cancer Inst.90, 1601–1608 (1998).
   PubMed Web of Science ®Google Scholar
• Harbeck N, Meisner C, Prechtl A et al. Level-I evidence for prognostic and predictive impact of uPA and PAI-1 in node-negative breast cancer provided by second scheduled analysis of multicenter Chemo-N0 therapy trial. Breast Cancer Res. Treat.69, 213 (2001).
   Web of Science ®Google Scholar
• Thomssen C, Harbeck N, Dittmer J et al. Feasibility of measuring the prognostic factors uPA and PAI-1 in core needle biopsy breast cancer specimens. J. Natl Cancer Inst.101, 1028–1029 (2009).
   PubMedGoogle Scholar
• Malinowsky K, Böllner C, Hipp S, Berg D, Schmitt M, Becker KF. uPA and PAI-1 analysis from fixed tissues – new perspectives for a known set of predictive markers. Curr. Med. Chem.17, 4370–4377 (2010).
   PubMed Web of Science ®Google Scholar
• Grebenchtchikov N, Maguire TM, Riisbro R et al. Measurement of plasminogen activator system components in plasma and tumor tissue extracts obtained from patients with breast cancer: an EORTC Receptor and Biomarker Group collaboration. Oncol. Rep.14, 235–239 (2005).
   PubMed Web of Science ®Google Scholar
• Aapro MS. Adjuvant therapy of primary breast cancer: a review of key findings from the 7th international conference, St. Gallen, February 2001. Oncologist6, 376–385 (2001).
   PubMedGoogle Scholar
• Martín M, Rodríguez-Lescure A, Ruiz A et al. Randomized Phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by paclitaxel for early breast cancer. J. Natl Cancer Inst.100, 805–814 (2008).
   PubMedGoogle Scholar
• Martín M, Seguí MA, Antón A et al. Adjuvant docetaxel for high-risk, node-negative breast cancer. N. Engl. J. Med.363, 2200–2210 (2010).
   PubMed Web of Science ®Google Scholar
• Goldhirsch A, Glick JH, Gelber RD, Coates AS, Senn HJ. Meeting highlights: International Consensus Panel on the Treatment of Primary Breast Cancer Seventh International Conference on Adjuvant Therapy of Primary Breast Cancer. J. Clin. Oncol.19, 3817–3827 (2001).
   PubMed Web of Science ®Google Scholar
• Svetlovska D, Mardiak J, Kristova V. Trastuzumab in the adjuvant treatment of breast cancer. Bratisl. Lek. Listy108, 100–103 (2007).
   PubMed Web of Science ®Google Scholar
• Degenhardt T, Gluz O, Thomssen C et al. Risk group selection in primary breast cancer according to ASCO recommended biomarkers Oncotype DX and uPA/PAI-1. First experience from prospective multicenter WSG Plan B trial. Cancer Res.70, 209s (2010) (Abstract P2-09-05).
   Google Scholar
• Paik S, Shak S, Tang G et al. Multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N. Engl. J. Med.351, 2817–2826 (2004).
   PubMed Web of Science ®Google Scholar
• Zujewski JA, Kamin L. Trial assessing individualized options for treatment for breast cancer, the TAILORx trial. Future Oncol.4, 603–610 (2008).
   PubMed Web of Science ®Google Scholar
• Dowsett M, Cuzick J, Wale C et al. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen, a transATAC study. J. Clin. Oncol.28, 1829–1834 (2010).
   PubMed Web of Science ®Google Scholar
• Muehlenweg B, Sperl S, Magdolen V, Schmitt M, Harbeck N. Interference with the urokinase plasminogen activator system: a promising therapy concept for solid tumours. Expert Opin. Biol. Ther.1, 683–961 (2001).
   PubMed Web of Science ®Google Scholar
• Setyono-Han B, Stürzebecher J, Schmalix WA et al. Suppression of rat breast cancer metastasis and reduction of primary tumour growth by the small synthetic urokinase inhibitor WX-UK1. Thromb. Haemost.93, 779–786 (2005).
   PubMed Web of Science ®Google Scholar
• Nienaber V, Wang J, Davidson D, Henkin J. Re-engineering of human urokinase provides a system for structure-based drug design at high resolution and reveals a novel structural subsite. J. Biol. Chem.275, 7239–7248 (2000).
   PubMed Web of Science ®Google Scholar
• Bruncko M, McClellan WJ, Wendt MD et al. Naphthamidine urokinase plasminogen activator inhibitors with improved pharmacokinetic properties. Bioorg. Med. Chem. Lett.15, 93–98 (2005).
   PubMed Web of Science ®Google Scholar
• Henneke I, Greschus S, Savai R et al. Inhibition of urokinase activity reduces primary tumor growth and metastasis formation in a murine lung carcinoma model. Am. J. Respir. Crit. Care Med.181, 611–619 (2010).
   PubMed Web of Science ®Google Scholar
• Joossens J, Ali OM, El-Sayed I et al. Small, potent, and selective diaryl phosphonate inhibitors for urokinase-type plasminogen activator with in vivo antimetastatic properties. J. Med. Chem.50, 6638–6646 (2007).
   PubMed Web of Science ®Google Scholar
• Goldstein LJ. Experience in Phase I trials and an upcoming Phase II study with uPA inhibitors in metastatic breast cancer. Breast Care3(s2), 25–28 (2008).
   PubMed Web of Science ®Google Scholar
• Heinemann V, Ebert MP, Pinter T, Bevan P, Neville NG, Mala C. Randomized phase II trial with an uPA inhibitor (WX-671) in patients with locally advanced nonmetastatic pancreatic cancer. J. Clin. Oncol.28, 15s(suppl.) (2010) (Abstract 4060).
   PubMed Web of Science ®Google Scholar
• Goldstein LJ, Stemmer SM, Schmalfeldt B et al. Phase II, two-arm, double-blind, multicenter, randomized study of the combination of oral WX-671 plus capecitabine versus capecitabine in first-line HER2-negative metastatic breast cancer (MBC). J. Clin. Oncol.28, 15s(suppl.) (2010) (abstract TPS131).
   PubMed Web of Science ®Google Scholar
• Schmitt M, Harbeck N, Thomssen C et al. Clinical impact of the plasminogen activation system in tumor invasion and metastasis: prognostic relevance and target for therapy. Thromb. Haemost.78, 285–296 (1997).
   PubMed Web of Science ®Google Scholar
• Schmitt M, Jänicke F, Graeff H. Tumor-associated proteases. Fibrinolysis6(suppl. 4), 3–26 (1992).
   Google Scholar
• Guo Y, Higazi AA, Arakelian A et al. A peptide derived from the nonreceptor binding region of urokinase plasminogen activator (uPA) inhibits tumor progression and angiogenesis and induces tumor cell death in vivo. FASEB J.14, 1400–1410 (2000).
   PubMed Web of Science ®Google Scholar
• Guo Y, Mazar AP, Lebrun JJ, Rabbani SA. An antiangiogenic urokinase-derived peptide combined with tamoxifen decreases tumor growth and metastasis in a syngeneic model of breast cancer. Cancer Res.62, 4678–4684 (2002).
   PubMed Web of Science ®Google Scholar
• Boyd DD, Kim SJ, Wang H, Jones TR, Gallick GE. A urokinase-derived peptide (A6) increases survival of mice bearing orthotopically grown prostate cancer and reduces lymph node metastasis. Am. J. Pathol.162, 619–626 (2003).
   PubMed Web of Science ®Google Scholar
• Damaj BB, Incardonna F, Piotrowicz R, Howell SB, Finlayson M. A6 peptide binds to CD44 and inhibits migration and metastasis of CD44+ cell lines in in vitro and in vivo studies. Presented at: American Association for Cancer Research 101st Annual Meeting. Washington, DC, USA, 17–21 April 2010 (abstract 5120).
   Google Scholar
• Damaj BB, Wen Y, Schneider L, Howell S, Finlayson F. A6 peptide exhibits potent anti chemotactic activity against human breast and ovarian cancer cell lines. Presented at: American Association for Cancer Research Annual Meeting. San Diego, CA, USA, 12–16 April 2008 (abstract 1170).
   Google Scholar
• Franco P, Vocca I, Carriero MV et al. Activation of urokinase receptor by a novel interaction between the connecting peptide region of urokinase and αvβ5 integrin. J. Cell Sci.119(Pt 16), 3424–3434 (2006).
   PubMed Web of Science ®Google Scholar
• Mishima K, Mazar AP, Gown A et al. A peptide derived from the non-receptor-binding region of urokinase plasminogen activator inhibits glioblastoma growth and angiogenesis in vivo in combination with cisplatin. Proc. Natl Acad. Sci. USA97, 8484–8489 (2000).
   PubMed Web of Science ®Google Scholar
• van Troostenburg AR, Lee D, Jones TR et al. Safety, tolerability and pharmacokinetics of subcutaneous A6, an 8-amino acid peptide with anti-angiogenic properties, in healthy men. Int. J. Clin. Pharmacol. Ther.42, 253–259 (2004).
   PubMed Web of Science ®Google Scholar
• Berkenblit A, Matulonis UA, Kroener JF et al. A6, a urokinase plasminogen activator (uPA)-derived peptide in patients with advanced gynecologic cancer: a phase I trial. Gynecol. Oncol.99, 50–57 (2005).
   PubMed Web of Science ®Google Scholar
• Ghamande SA, Silverman MH, Huh W et al. A phase 2, randomized, double-blind, placebo-controlled trial of clinical activity and safety of subcutaneous A6 in women with asymptomatic CA125 progression after first-line chemotherapy of epithelial ovarian cancer. Gynecol. Oncol.111, 89–94 (2008).
   PubMed Web of Science ®Google Scholar
• Navaratna D, Menicucci G, Maestas J, Srinivasan R, McGuire P, Das A. A peptide inhibitor of the urokinase/urokinase receptor system inhibits alteration of the blood–retinal barrier in diabetes. FASEB J.22, 3310–3317 (2008).
   PubMed Web of Science ®Google Scholar
• Koh HJ, Bessho K, Cheng L et al. Inhibition of choroidal neovascularization in rats by the urokinase-derived peptide A6. Invest. Ophthalmol. Vis. Sci.45, 635–640 (2004).
   PubMed Web of Science ®Google Scholar
• Koh HJ, Freeman WR, Azen SP et al. Effect of a novel octapeptide urokinase fragment, A6, on experimental choroidal neovascularization in the monkey. Retina26, 202–209 (2006).
   PubMed Web of Science ®Google Scholar
• Duffy MJ, O’Grady P, Devaney D, O’Siorain L, Fennelly JJ, Lijnen HJ. Urokinase-plasminogen activator, a marker for aggressive breast carcinomas. Preliminary report. Cancer62, 531–533 (1988).
   PubMed Web of Science ®Google Scholar
• Jänicke F, Schmitt M, Ulm K, Gössner W, Graeff H. Urokinase-type plasminogen activator antigen and early relapse in breast cancer. Lancet2(8670), 1049 (1989).
   PubMed Web of Science ®Google Scholar
• Jänicke F, Schmitt M, Graeff H. Clinical relevance of the urokinase-type and tissue-type plasminogen activators and of their type 1 inhibitor in breast cancer. Semin. Thromb. Hemost.17, 303–312 (1991).
   PubMed Web of Science ®Google Scholar
• Igbokwe A, Lopez-Terrada DH. Molecular testing of solid tumors. Arch. Pathol. Lab. Med.135, 67–82 (2011).
   PubMed Web of Science ®Google Scholar
• Dotan E, Goldstein LJ. Optimizing chemotherapy regimens for patients with early-stage breast Cancer Clin. Breast Cancer10(Suppl. 1), E8–E15 (2010).
   Google Scholar
• Sweep CG, Geurts-Moespot J, Grebenschikov N et al. External quality assessment of trans-European multicentre antigen determinations (enzyme-linked immunosorbent assay) of urokinase-type plasminogen activator (uPA) and its type 1 inhibitor (PAI-1) in human breast cancer tissue extracts. Br. J. Cancer78, 1434–1441 (1998).
   PubMed Web of Science ®Google Scholar
• Jankun J, Skotnicka M, Lysiak-Szydłowska W, Al-Senaidy A, Skrzypczak-Jankun E. Diverse inhibition of plasminogen activator inhibitor type 1 by theaflavins of black tea. Int. J. Mol. Med.27, 525–529 (2011).
   PubMed Web of Science ®Google Scholar
• Madsen JB, Dupont DM, Andersen TB et al. RNA aptamers as conformational probes and regulatory agents for plasminogen activator inhibitor-1. Biochemistry49, 4103–4115 (2010).
   PubMed Web of Science ®Google Scholar
• Andreasen PA. PAI-1 – a potential therapeutic target in cancer. Curr. Drug Targets8, 1030–1041 (2007).
   PubMed Web of Science ®Google Scholar
• Henri NL, Hayes DF. Uses and abuses of tumor markers in the diagnosis, monitoring, and treatment of primary and metastatic breast Cancer Oncol.11, 541–552 (2006).
   PubMed Web of Science ®Google Scholar
• Harris TJ, McCormick F. The molecular pathology of cancer. Nat. Rev. Clin. Oncol.7, 251–265 (2010).
   PubMed Web of Science ®Google Scholar
• Sotiriou C, Pusztai L. Gene-expression signatures in breast cancer. N. Engl. J. Med.360, 790–800 (2009).
   PubMed Web of Science ®Google Scholar
• Gilligan TD, Hayes DF, Seidenfeld J, Temin S. ASCO Clinical Practice Guideline on uses of serum tumor markers in adult males with germ cell tumors. J. Oncol. Pract.6, 199–202 (2010).
   PubMedGoogle Scholar
• Locker GY, Hamilton S, Harris J et al. ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J. Clin. Oncol.24, 5313–5327 (2006).
   PubMed Web of Science ®Google Scholar
• Sturgeon CM, Duffy MJ, Hofmann BR et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in liver, bladder, cervical, and gastric cancers. Clin. Chem.56(6), E1–E48 (2010).
   Google Scholar
• McShane LM, Altman DG, Sauerbrei W et al. Reporting recommendations for tumor MARKer prognostic studies (REMARK). Nat. Clin. Pract. Oncol.2, 416–422 (2005).
   PubMedGoogle Scholar
• Harbeck N, Thomssen C. A new look at node-negative breast cancer. Oncologist16(Suppl. 1), 51–60 (2011).
   PubMed Web of Science ®Google Scholar
• Hofmeister V, Schrama D, Becker JC. Anti-cancer therapies targeting the tumor stroma. Cancer Immunol. Immunother.57, 1–17 (2008).
   PubMed Web of Science ®Google Scholar
• Schaller J, Gerber SS. The plasmin-antiplasmin system: structural and functional aspects. Cell. Mol. Life Sci.68, 785–801 (2011).
   PubMed Web of Science ®Google Scholar
• Rijken DC, Lijnen HR. New insights into the molecular mechanisms of the fibrinolytic system. J. Thromb. Haemost.7, 4–13 (2009).
   PubMed Web of Science ®Google Scholar
• Kantelhardt EJ, Vetter M, Schmidt M et al. Prospective evaluation of prognostic factors uPA/PAI-1 in node-negative breast cancer: Phase III NNBC3-Europe trial (AGO, GBG, EORTC-PBG) comparing 6 × FEC versus 3 × FEC/3 × docetaxel. BMC Cancer11, 140 (2011).
   PubMed Web of Science ®Google Scholar