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

• DOI: 10.1093/jnci/93.12.913
• Publication Date: 2002-07-26T22:55:00Z
• Authors: F. Janicke; A. Prechtl; C. Thomssen; N. Harbeck; C. Meisner; M. Untch; C. G. J. F. Sweep; H.-K. Selbmann; H. Graeff; M. Schmitt
• Keywords: Adjuvant Chemotherapy; Plasminogen activator inhibitor-1

Background: Most patients with lymph node-negative breast cancer are cured by locoregional treatment; however, about 30% relapse. Because traditional histomorphologic and clinical factors fail to identify the high-risk who may benefit from adjuvant chemotherapy, other prognostic needed. In a unicenter study, we have found that levels of urokinase-type plasminogen activator (uPA) inhibitor type 1 (PAI-1) in primary tumor predictive disease recurrence. Thus, designed Chemo N0 prospective randomized multicenter therapy trial investigate further whether uPA PAI-1 such identified these chemotherapy. After 4.5 years, present results first interim analysis. Methods: We studied 556 cancer. The median follow-up was 32 months. All low (≤3 ng/mg protein) (≤14 were observed. Patients high (>3 and/or (>14 randomly assigned combination chemotherapy or subjected observation only. statistical tests two-sided. Results: A total 241 had PAI-1, 315 elevated PAI-1. estimated 3-year recurrence rate for (low-risk group) 6.7% (95% confidence interval [CI] = 2.5% 10.8%). This (high-risk 14.7% CI 8.5% 20.9%) (P .006). First analysis suggests group benefit, 43.8% lower probability at 3 years than (intention-to-treat analysis: relative risk 0.56; 95% 0.25 1.28), but is needed confirmation. Conclusions: Using been able classify half as risk, whom be avoided, appear