title: Impact of guideline-based use of uPA/PAI-1 on patient outcome in intermediate-risk early breast cancer.
abstract: The purpose of this study was to evaluate the influence of guideline-based prospective use of uPA/PAI-1 on clinical outcome in an intermediate-risk cohort of breast cancer patients. We analyzed 381 consecutive primary breast cancer patients (2003-2011) at the breast center Ostbayern meeting the following criteria: M0/N0/estrogen receptor (ER)+/G2. Clinical-pathological data, uPA/PAI-1, and follow-up data were collected. Decisions for adjuvant chemotherapy were made upon consideration of prospectively measured uPA/PAI-1. Observed disease-free survival (DFS) and overall survival (OS) were calculated by Kaplan-Meier estimates. Using guideline-based analysis of uPA/PAI-1, treatment with adjuvant chemotherapy was avoided in 86.5 % of patients with low uPA/PAI-1, i.e., 38.8 % of the total patient collective. Median follow-up was 52.5 months. Five-year relapse-free survival in intermediate-risk patients (N0, G2) without chemotherapy was 99 %. Five-year overall survival including all causes of death was 95 %. By using uPA/PAI-1, adjuvant chemotherapy can be avoided in a major part of patients with intermediate-risk breast cancer. Nevertheless, DFS and OS of these patients at 5 years remain excellent. The potential, but hardly measurable, benefit of adjuvant chemotherapy has to be set in contrast with its associated side effects and increased morbidity. Patients with high uPA/PAI-1 show benefit from chemotherapy. In this subgroup, a very good OS was observed as well. These findings strongly support the use of uPA/PAI-1 together with clinic-pathological parameters as an evidence-based, clinically relevant and inexpensive decision tool in the routine of a breast center.
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany. thomas.kolben@med.uni-muenchen.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kolben
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics, Hospital Deggendorf, Deggendorf, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Augustin
authors.affiliation: Department for Gynecology and Obstetrics, Charité University Hospital Berlin, Berlin, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Armbrust
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany.
authors.forename: T M
authors.initials: TM
authors.lastname: Kolben
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Degenhardt
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Burgmann
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Goess
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Ditsch
authors.affiliation: REK Consulting, Otterfing, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Kates
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Harbeck
authors.affiliation: Breast Center, Department for Gynecology and Obstetrics and Comprehensive Cancer Center of LMU, University Hospital Munich - Grosshadern, Ludwig-Maximilians-University, Marchioninistr. 15, 81377, Munich, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Wuerstlein
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D014408:Biomarkers, Tumor; D001943:Breast Neoplasms / Q000188:drug therapy / Q000378:metabolism* / Q000401:mortality* / Q000473:pathology; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009367:Neoplasm Staging; D017395:Plasminogen Activator Inhibitor 1 / Q000378:metabolism*; D011379:Prognosis; D016896:Treatment Outcome; D014568:Urokinase-Type Plasminogen Activator / Q000378:metabolism*
chemical_list: D014408:Biomarkers, Tumor; D017395:Plasminogen Activator Inhibitor 1; D014568:Urokinase-Type Plasminogen Activator
keywords: Intermediate-risk breast cancer; Outcome; uPA/PAI-1