Abstract
BackgroundThe objective of this study was to compare the efficacy of biomarkers in assessing the risk of breast cancer recurrence in patients with node-negative or micrometastatic grade II breast cancer. Specifically, we compared risk assessments based on the St. Gallen clinicopathological criteria, Ki67 expression and urokinase plasminogen activator (uPA)/plasminogen activator inhibitor-1 (PAI-1) expression.MethodsThis retrospective study included 347 patients with breast cancer followed at Limoges University Hospital. The optimal cut-off for high Ki67 expression (Ki67hi) was established as 20%. The threshold for uPA and PAI-1 positivity was 3 ng/mg and 14 ng/mg, respectively.ResultsKi67 expression was lower in uPA/PAI-1-negative than in uPA/PAI-1-positive tumours (227 tumours; P = 0.04). The addition of Ki67 status to the St. Gallen criteria resulted in a 28% increase in the rate of identification of high-risk tumours with a potential indication for chemotherapy (P < 0.001). When considering uPA/PAI-1 levels together with the St Gallen criteria (including Ki67 expression), the number of cases identified as having a high recurrence risk with a potential indication for adjuvant chemotherapy increased by 20% (P < 0.001). Adjuvant chemotherapy was 9% less likely to be recommended by a multidisciplinary board when using the current criteria compared with using a combination of the St. Gallen criteria and Ki67 and uPA/PAI-1 status (P = 0.03).ConclusionsTaken together, our data show discordance among markers in identifying the risk of recurrence, even though each marker may prove to be independently valid.
Highlights
The objective of this study was to compare the efficacy of biomarkers in assessing the risk of breast cancer recurrence in patients with node-negative or micrometastatic grade II breast cancer
Application of our study inclusion criteria resulted in a final cohort of 347 patients, selected primarily because they had available urokinase plasminogen activator (uPA)/plasminogen activator inhibitor-1 (PAI-1) data
All tumours were evaluated (Tables 1–3), and the results from grade II tumours were used because the use of uPA/PAI-1 expression as a recurrence marker has been validated in these tumours only
Summary
The objective of this study was to compare the efficacy of biomarkers in assessing the risk of breast cancer recurrence in patients with node-negative or micrometastatic grade II breast cancer. We compared risk assessments based on the St. Gallen clinicopathological criteria, Ki67 expression and urokinase plasminogen activator (uPA)/plasminogen activator inhibitor-1 (PAI-1) expression. Promising biomarkers used to stratify patients into different risk groups include Ki67 and urokinase plasminogen activator (uPA)/plasminogen activator inhibitor-1 (PAI-1) [4,5,6,7]. Reproducible data at a I-B level of evidence (LoE) suggest that Ki67 is a prognostic marker in early stage breast cancer [8], as well as a positive predictive factor for adjuvant chemotherapy [9], especially in patients with luminal B tumours [10]. In addition to the traditional parameters, guidelines recommend using proliferation markers, such as Ki67, to define patient subgroups [2]
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