Markers of Prognosis and Response to Treatment: Ready for Clinical Use in Oncology? A Biostatistician's Viewpoint

Hayes D.F. , Bast R.C. , Desch C.E. . Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst 1996; 88: 1456–66.

Hayes D.F. , Trock B. , Harris A.L. Assessing the clinical impact of prognostic factors: when is “statistically significant” clinically useful? Breast Cancer Res Treat 1998; 52: 305–19.

Altman D.G. Systematic reviews of evaluations of prognostic variables. BMJ 2001; 323: 224–8.

Gion M. , Boracchi P. , Biganzoli E. , Daidone M.G. A guide for reviewing submitted manuscripts (and indications for the design of translational research studies on biomarkers). Int J Biol Markers 1999; 14: 123–33.

Altman D.G. , Lausen B. , Sauerbrei W. , Schumacher M. Dangers of using “optimal” cutpoints in the evaluation of prognostic factors. J Natl Cancer Inst 1994; 86: 829–35.

Sargent D. , Allegra C. Issues in clinical trial design for tumor marker studies. Semin Oncol 2002; 29: 222–30.

Galea M.H. , Blamey R.W. , Elston C.E. , Ellis I.O. The Nottingham Prognostic Index in primary breast cancer. Breast Cancer Res Treat 1992; 22: 207–19.

Cooke T. , Reeves J. , Lannigan A. , Stanton P. The value of the human epidermal growth factor receptor-2 (HER2) as a prognostic marker. Eur J Cancer 2001; 37(Suppl 1): 3–10.

Coradini D. , Boracchi P. , Daidone M.G. . Contribution of vascular endothelial growth factor to the Nottingham prognostic index in node-negative breast cancer. Br J Cancer 2001; 85: 795–7.

Hansen S. , Grabau D.A. , Sorensen F.B. , Bak M. , Vach W. , Rose C. Vascular grading of angiogenesis: prognostic significance in breast cancer. Br J Cancer 2000; 82: 339–47.

Hayes D.F. , Thor A.D. c-erbB-2 in breast cancer: development of a clinically useful marker. Semin Oncol 2002; 29: 231–45.

Goldhirsch A. , Glick J.H. , Gelber R.D. , Coates A.S. , Senn H-J . Meeting highlights: International consensus panel on the treatment of primary breast cancer. J Clin Oncol 2001; 19: 3817–27.

Mansour E.G. , Gray R. , Shatila A.H. . Survival advantage of adjuvant chemotherapy in high-risk node-negative breast cancer: ten-year analysis - an intergroup study. J Clin Oncol 1998; 16: 3486–92.

Harbeck N. , Kates R.E. , 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 2002; 20: 1000–7.

Lockwood C.A. , Ricciardelli C. , Raymond W.A. , Seshadri R. , McCaul K. , Horsfall D.J. A simple index using video image analysis to predict disease outcome in primary breast cancer. Int J Cancer 1999; 84: 203–8.

Altman D.G. , Royston P. What do we mean by validating a prognostic model? Stat Med 2000; 19: 453–73.

Ravdin P.M. Is Her2 of value in identifying patients who particularly benefit from anthracyclines during adjuvant therapy? A qualified yes. J Natl Cancer Inst Monogr 2001; 80–4.

Sledge G.W. Jr. . Is HER-2/neu a predictor of anthracycline utility? No. J Natl Cancer Inst Monogr 2001; 85–7.

Vogel C.L. , Cobleigh M.A. , Tripathy D. . Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20: 719–26.

Eiermann W. Trastuzumab combined with chemotherapy for the treatment of HER2-positive metastatic breast cancer: pivotal trial data. Ann Oncol 2001; 12: 57–62.

Slamon D.J. , Leyland-Jones B. , Shak S. . Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344: 783–92.

Amadori D. , Nanni O. , Marangolo M. . Disease-free survival advantage of adjuvant cyclophosphamide, methotrexate, and fluorouracil in patients with node-negative, rapidly proliferating breast cancer: a randomized multicenter study. J Clin Oncol 2000; 18: 3125–34.

Paradiso A. , Schittulli F. , Cellamare G. . Randomized clinical trial of adjuvant fluorouracil, epirubicin, and cyclophosphamide chemotherapy for patients with fast-proliferating, node-negative breast cancer. J Clin Oncol 2001; 19: 3929–37.

Janicke F. , Prechtl A. , Thomssen C. . 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 2001; 93: 913–20.