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The serum concentration of human kallikrein 10 represents a novel biomarker for ovarian cancer diagnosis and prognosis

Human kallikrein 10 (hK10) is a secreted serine protease that is highly expressed in ovarian tissue. We hypothesized that hK10 might represent a novel serological marker for ovarian cancer. We quantified by immunoassay, hK10 in sera from 97 normal women (controls), 141 patients with benign gynecologic diseases, and 146 patients with ovarian cancer. We then examined the diagnostic and prognostic value of this measurement in ovarian cancer. We found that normal serum hK10 ranged from 50 to 1040 ng/liter (mean = 439 ng/liter). hK10 concentration is significantly elevated in serum of presurgical ovarian cancer patients (range: 10611,746 ng/liter; mean = 1067 ng/liter) but not in serum of patients with benign gynecologic diseases (range: 120-1200 ng/liter; mean = 447 ng/ liter). When a cutoff of 700 ng/liter was selected (diagnostic specificity = 90%), the diagnostic sensitivity for ovarian cancer is 54%. About 35% of CA125-negative ovarian cancer patients (CA125 1 cm), suboptimal debulking, and no response to chemotherapy (all Ps <0.001). In univariate Cox survival analysis, high serum hK10 is associated with increased risk for relapse and death (hazard ratio = 2.59 and 3.15, respectively, P less than or equal to 0.003). This prognostic value remains significant for overall survival in the multivariate analysis. Kaplan-Meier survival curves demonstrated similar findings. Serum hK10 represents a novel biomarker for ovarian cancer. We conclude that preoperative serum hK10 concentration is a strong and independent unfavorable prognostic marker for ovarian cancer

Human kallikrein 6 (hK6):A new potential serum biomarker for diagnosis and prognosis of ovarian carcinoma

Purpose : The discovery of new ovarian cancer biomarkers that are suitable for early disease diagnosis and prognosis may ultimately lead to improved patient management and outcomes. Patients and Methods: We measured, by immunoassay, human kallikrein 6 (hK6) concentration in serum of 97 apparently healthy women, 141 women with benign abdominal diseases, and 146 women with histologically proven primary ovarian carcinoma. We then calculated the diagnostic sensitivity and specificity of this test and examined the association of serum hK6 concentration with various clinicopathologic variables and patient survival. Results: Serum hK6 concentration between normal and benign disease patients was not different (mean, 2.9 and 3.1 mug/L, respectively). However, hK6 in presurgical serum of ovarian cancer patients was highly elevated (mean, 6.8 mug/L; P <.001). Serum hK6 decreased after surgery (to a mean of 3.9 mug/L) in 68% of patients. The diagnostic sensitivity of serum hK6 at 90% and 95% specificity is 52% and 47%, respectively, in the whole patient population. For early stage disease (stage I or II), sensitivity is approximately 21% to 26%. When combined with CA- 125, at 90% specificity, sensitivity increases to 72% (for all patients) and to 42% in stage I or II disease. Serum hK6 concentration correlates moderately with CA-125 and is higher in patients with late-stage, higher-grade disease and in patients with serous histotype. Preoperative serum hK6 concentration is a powerful predictor of disease-free and overall survival in both univariate and multivariate analyses. Conclusions: Serum hK6 concentration seems to be a new biomarker for ovarian carcinoma and may have value for disease diagnosis and prognosis. J Clin Oncol 21:1035-1043. (C) 2003 by American Society of Clinical Oncology