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Plasma S100P and hyaluronic acid (HA): markers for metastatic breast cancer (P-1157)

Prof. Barbara Burwinkel, DKFZ / University Clinic Heidelberg

DKFZ

Challenge

Conventional tumor markers have limited value for prognostication and treatment monitoring in metastatic breast cancer (MBC) patients and novel circulating tumor markers therefore need to be explored. Hyaluronic acid (HA) is a major macropolysaccharide in the extracellular matrix and is reported to be associated with tumor progression. In our study, we investigated plasma HA level with respect to progression free survival (PFS) and overall survival (OS), as well as the treatment monitoring value in MBC patients. The prognostic value of plasma HA level was investigated in a discovery cohort of 212 MBC patients with 2.5-year follow-up and validated in an independent validation cohort of 334 patients with 5-year follow-up. The treatment monitoring value of plasma HA level was investigated in 61 MBC patients from discovery cohort who had been radiographically examined after first complete cycle of chemo therapy. We found a robust association between high plasma HA level and poor prognosis of MBC patients in both discovery (pPFS = 7.92 × 10(-6) and pOS = 5.27 × 10(-5)) and validation studies (pPFS = 3.66 × 10(-4) and pOS = 1.43 × 10(-4)). In the discovery cohort, the plasma HA level displayed independent prognostic value after adjusted for age and clinicopathological factors, with respect to PFS and OS. Further, the decrease of plasma HA level displayed good concordance with treatment response evaluated by radiographic examination (AUC = 0.79). Plasma HA level displays prognostic value, as well as treatment monitoring value for MBC patients.

Technology

The technology describe two serum/plasma markers, in combination or alone, for stage discrimination and prediction of survival as well as treatment response in breast cancer patients. Test statistics show that these markers perform better than established ones like the number of circulating tumor cells (CTCs).

Commercial Opportunity

DKFZ is looking for a commercial partner to establish the test (Plasma S100P and hyaluronic acid) for metastatic breast cancer in a routine clinical setting.

Development Status

Marker approved and verified in studies of 320 (S100P in combination with HA) and 334 (HA only) patients with different disease stages.

Patent Situation

Priority patent application filed April 16th in 2014 “New Biomarkers for metastatic breast cancer” as EP 1416486 5.9. PCT filed as WO2015/158652, which was nationalized in Europe (EP3132266, pending), China (CN106489074, pending) and USA (US2017030912, pending).