Abstract 3574: Detection of serum CYFRA 21-1 as a biomarker for stratification of ovarian cancer risk in women with a pelvic mass

Abstract CYFRA 21-1 is a known lung cancer biomarker. In subjects with ovarian cancer (N = 159) and those with benign gynecological diseases (N = 53), serum CYFRA 21-1 reported a sensitivity (SN) of 44% and a specificity (SP) of 95% for ovarian cancer detection at a cut-off value of 2.4 ng/mL using an ELISA assay (Hasholzner U, et al, 1994). Another report showed a SN of 41% and a SP of 95% for ovarian cancer (N = 37) versus benign ovarian cysts, endometriosis, pelvic inflammatory disease, bowel disease and liver cirrhosis (N = 168) using an ELISA assay (Tempfer C, et al, 1998). We carried out a pilot study to evaluate the serum CYFRA 21-1 as a biomarker for stratification of ovarian cancer risk in women with a pelvic mass. Methods: ARCHITECT CYFRA 21-1 was used to measure the levels of serum CYFRA 21-1. Single point frozen serum samples from 171 female subjects with a pelvic mass were randomly selected from the archive clinical trial described by Moore R et al (2009). Of the 171 subjects, 42 had epithelial ovarian cancer (EOC), 5 with low malignant potential tumor (LMP) and 124 with benign pelvic masses. Results: To stratify EOC from benign pelvic masses and LMP, the following performance was obtained for serum CYFRA 21-1: Notes: The cutpoints were set at 1.2 and 1.8 ng/mL to reach a 75% and 95% SP, respectively. Conclusion: Serum CYFRA 21-1 appears to be a useful biomarker for stratification of EOC from benign pelvic mass and LMP. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 3574. doi:1538-7445.AM2012-3574