Zhen Zhang1, Rowan G Bullock2, Herbert Fritsche3. 1. School of Medicine, Johns Hopkins University, Baltimore, MD 21218, USA. 2. Vermillion, Inc., Research and Development Department, Austin, TX 78738, USA. 3. ASPiRA Labs, Austin, TX 78738, USA.
Abstract
Aims: Adnexal mass risk assessment (AMRA) stratifies patients with adnexal masses, identifying the relatively small number of malignancies from benigns which might take a 'watchful waiting' approach. Methods: AMRA uses seven biomarkers and derived from women with adnexal masses scheduled for surgery. Estimated clinical performance was calculated using fixed prevalence. Results: At 5% prevalence, the high-risk group, 7.9% total, captured 75.9% of invasive malignancies at a positive predictive value of 35.8%. High risk/intermediate risk combined had a sensitivity of 89.7 and 95.6% for pre- and post-menopausal cancers, respectively. The low-risk group, 67.8% total, had an negative predictive value of 99.0%. Conclusion: With highly differentiating risk stratification capability across histological subtypes and stages, AMRA is potentially applicable to patients with adnexal masses to assist deciding whether immediate surgery is recommended.
Aims: Adnexal mass risk assessment (AMRA) stratifies patients with adnexal masses, identifying the relatively small number of malignancies from benigns which might take a 'watchful waiting' approach. Methods:AMRA uses seven biomarkers and derived from women with adnexal masses scheduled for surgery. Estimated clinical performance was calculated using fixed prevalence. Results: At 5% prevalence, the high-risk group, 7.9% total, captured 75.9% of invasive malignancies at a positive predictive value of 35.8%. High risk/intermediate risk combined had a sensitivity of 89.7 and 95.6% for pre- and post-menopausal cancers, respectively. The low-risk group, 67.8% total, had an negative predictive value of 99.0%. Conclusion: With highly differentiating risk stratification capability across histological subtypes and stages, AMRA is potentially applicable to patients with adnexal masses to assist deciding whether immediate surgery is recommended.
Entities:
Keywords:
adnexal mass; multivariate index assay; ovarian cancer; watch and wait
Authors: Gerard Reilly; Rowan G Bullock; Jessica Greenwood; Daniel R Ure; Erin Stewart; Pierre Davidoff; Justin DeGrazia; Herbert Fritsche; Charles J Dunton; Nitin Bhardwaj; Lesley E Northrop Journal: JCO Clin Cancer Inform Date: 2022-06