Researchers in Europe examined the utility of a biomarker to determine treatment for women with node-negative breast cancer. These biomarkers are urokinase-type plasminogen activator (uPA) and its type 1 inhibitor (PAI-1). Using an ELISA assay, 12 sites in Germany and the Netherlands divided patients into low risk (uPA of 3 ng/mg or less) and higher risk. The first group (arm A) included 283 low-risk patients assigned no systemic therapy after surgery. The high-risk patients were randomized into arm B1 (CMF chemotherapy; 242 patients) or arm B2 (observation/no chemotherapy; 125 patients)). A third grow (B3) included those who declined randomization (122).
1o year results: Low-risk patients had a 10-year disease recurrence rate of 12.9%(95% Confidence Interval, 9.1-18.1%), whereas the rate for high-risk patients was 23% (95% CI 16.9-30.8). Patients with high uPA/PAI-1 had a 1.84x higher risk of recurrence, as compared to the low-risk group. And the 10-year survival was different too: low-risk 89.8%; high-risk 79.1%. The authors concluded that nearly half of node-negative patients could be managed without chemotherapy, but that those with higher levels of uPA/PAI-1 would benefit from chemotehrapy after surgery.
My take: Although clinically interesting, this is not yet actionable for me: 1) The study used “older” chemotherapy; 2) No patients received anti-estrogen (endocrine) therapy; and 3) Information is limited when compared to microarray profiling and proteomoics (tests such as OncoType DX and MammoPrint). For the latter tests, we gain more clinical information regarding prognosis and potential response to treatment. In the USA, OncoType DX is widely used, and national guidelines (ASCO) include recommendations for its use. I’m Dr. Michael Hunter.
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Reference: European Journal of Cancer (2013;491825-1835, PMD 23490655)