Ovarian cancer surveillance using the Risk of Ovarian Cancer Algorithm (ROCA) is effective in the real world, according to results of a study published in the Journal of Medical Genetics.

ROCA had high sensitivity, specificity, and positive and negative predictive values in a real-world population of patients with germline BRCA1/2 variants who elected to defer risk-reducing bilateral salpingo-oophorectomy.

The ROCA test uses an algorithm to calculate the risk of ovarian or fallopian tube cancer based on longitudinal changes in CA125 as well as age, menopausal status, and lifetime risk category. An abnormal ROCA result indicates the need for a repeat test and potentially a transvaginal ultrasound. Concerning results signal the need for surgical intervention. 


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The aim of this study was to evaluate the real-world effectiveness of ROCA. The study included 767 women. Their median age at baseline was 40 (range, 34.5-83.3) years, and 77.2% of patients were premenopausal. BRCA1 mutations were present in 44.7% of patients, BRCA2 mutations were present in 54.1%, and both mutations were present in 0.8%.

The patients underwent surveillance with ROCA every 4 months. A total of 591 patients completed surveillance without surgery, and 157 patients withdrew during surveillance.

In the remaining 19 patients (2.5%), ROCA surveillance prompted surgery. This group included 6 patients with screen-detected ovarian or fallopian tube cancer, 2 who underwent false-positive surgery, and 11 who had surveillance-related surgery that “may have been due to transiently high non-concerning abnormal ROCA results,” according to the researchers.

Of the 2 patients who underwent false-positive surgeries, 1 had bilateral functional cysts and 1 had endometriosis.

A total of 8 patients were diagnosed with ovarian or fallopian tube cancer. Two cancers were occult, and both were stage IA. Six cases were detected by screening, and this included 3 cases that were stage IIIA or lower. In 83% of these cases (5/6), complete surgical cytoreduction was achieved. 

The modeled sensitivity for the detection of ovarian or fallopian tube cancer at 4 months after the last surveillance test was 87.5%. The specificity was 99.9%, the positive predictive value was 75%, and the negative predictive value was 99.9%. 

The number of quality-adjusted life years (QALY) gained with ROCA was estimated to be 0.179. The estimated cost savings was £102,496 (about $116,283 USD) per QALY.

ROCA surveillance for ovarian or fallopian tube cancer “can be considered for women with pathogenic germline BRCA1/BRCA2 alterations who decline risk-reducing surgery,” the researchers concluded.

Disclosures: This research was supported, in part, by Abcodia Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Philpott S, Raikou M, Manchanda R, et al. The avoiding late diagnosis of ovarian cancer (ALDO) project; a pilot national surveillance programme for women with pathogenic germline variants in BRCA1 and BRCA2. J Med Genet. Published online November 1, 2022. doi:10.1136/jmg-2022-108741