A 2-Stage Ovarian Cancer Screening Strategy Using the Risk of Ovarian Cancer Algorithm (ROCA) Identifies Early-Stage Incident Cancers and Demonstrates High Positive Predictive Value

Abstract

BACKGROUND A 2‐stage ovarian cancer screening strategy was evaluated that incorporates change of carbohydrate antigen 125 (CA125) levels over time and age to estimate risk of ovarian cancer. Women with high‐risk scores were referred for transvaginal ultrasound (TVS). METHODS A single‐arm, prospective study of postmenopausal women was conducted. Participants underwent an annual CA125 blood test. Based on the Risk of Ovarian Cancer Algorithm (ROCA) result, women were triaged to next annual CA125 test (low risk), repeat CA125 test in 3 months (intermediate risk), or TVS and referral to a gynecologic oncologist (high risk). RESULTS A total of 4051 women participated over 11 years. The average annual rate of referral to a CA125 test in 3 months was 5.8%, and the average annual referral rate to TVS and review by a gynecologic oncologist was 0.9%. Ten women underwent surgery on the basis of TVS, with 4 invasive ovarian cancers (1 with stage IA disease, 2 with stage IC disease, and 1 with stage IIB disease), 2 ovarian tumors of low malignant potential (both stage IA), 1 endometrial cancer (stage I), and 3 benign ovarian tumors, providing a positive predictive value of 40% (95% confidence interval = 12.2%, 73.8%) for detecting invasive ovarian cancer. The specificity was 99.9% (95% confidence interval = 99.7%, 100%). All 4 women with invasive ovarian cancer were enrolled in the study for at least 3 years with low‐risk annual CA125 test values prior to rising CA125 levels. CONCLUSIONS ROCA followed by TVS demonstrated excellent specificity and positive predictive value in a population of US women at average risk for ovarian cancer. Cancer 2013;119:3454–3461.. © 2013 American Cancer Society.

Validation of a Biomarker Panel and Longitudinal Biomarker Performance for Early Detection of Ovarian Cancer

“…6 The ROCA is now being evaluated as a first-line screen prompting TVS as a second-line screen, as a part of a multimodal screening (MMS) strategy in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) 7 and in the Normal Risk Ovarian Cancer Screening Study (NROSS) in the United States. 8 With each new CA125 test, a ROCA score is calculated, and women are triaged into a lowrisk group (annual CA125 screening referral), intermediaterisk group (3-month repeat CA125 referral), and a high-risk group (referral to TVS and a gynecological oncologist and, if necessary, surgery). 7 Triaging is revised based on the new ROCA score for every new CA125 result.…”

Endometriosis and Cancer: Is There an Association?

“…A recent prospective study validated the high PPV (40 %) and specifi city (99.9 %) using ROCA. Additionally, early stage cancers were detected (stage I or II) [ 146 ].…”

Epidemiological overview, advances in diagnosis, prevention, treatment and management of epithelial ovarian cancer in Mexico

“…However, ROC and ROCA are very promising. [29][30][31] Keeping a record with a symptom index (non-specific abdominal pain, sensation of abdominal distention, constipation alternating with diarrhea, rectal tenesmus, pelvic sore, and feeling of early satiety) did not reach a predictive value of 10. Even so, it is suggested that the patient should have a TVUS every 6 months and the measuring of CA 125 in case of having these symptoms more than 12 times a month.…”