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Human Kallikrein 13 Protein in Ovarian Cancer Cytosols: A New Favorable Prognostic Marker

From the Department of Biochemistry and Molecular Biology, Faculty of Biology, University of Athens, Athens, Greece; Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Clinical Research Unit, Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany

Address reprint requests to Eleftherios P. Diamandis, MD, PhD, Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, 600 University Avenue, Toronto, Ontario, Canada M5G 1X5; e-mail: ediamandis{at}mtsinai.on.ca.

PURPOSE: Human kallikrein 13 (hK13; encoded by the KLK13 gene) is a secreted serine protease expressed in endocrine tissues, including the prostate, testis, breast, and ovary. We have previously reported steroid hormone regulation of the KLK13 gene and its clinical value as a marker of favorable prognosis in breast cancer at the mRNA level. We hypothesized that hK13 may represent a potential biomarker for ovarian carcinomas.

PATIENTS AND METHODS: Using a newly developed enzyme-linked immunosorbent assay (ELISA), hK13 levels were quantified in 131 ovarian tumor extracts and correlated with various clinicopathological variables and outcome (progression-free survival [PFS], overall survival [OS]), over a median follow-up period of 42 months.

RESULTS: hK13 concentration in ovarian tumor cytosols ranged from 0 to 18.4 ng/mg of total protein. An optimal cutoff value of 0.13 ng/mg (67^th percentile) was selected, based on the ability of hK13 values to predict the PFS of the study population, to categorize tumors as hK13-positive or negative. Women with hK13-positive tumors most often had early stage (stage I/II) disease, no residual tumor after surgery and optimal debulking success (P < .05). Univariate and multivariate Cox regression analyses revealed that patients with hK13-positive tumors had a significantly longer PFS and OS than hK13-negative patients (P < .05). Kaplan-Meier survival curves further confirmed a reduced risk of relapse and death in women with hK13-positive tumors (P = .007 and P = .002, respectively).

CONCLUSION: These results indicate that hK13 is an independent marker of favorable prognosis in ovarian cancer.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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