Performance Characteristics of the Ultrasound Strategy during Incidence Screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)

Abstract

Randomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultrasound arm of UKCTOCS. 44,799 of the 50,639 women who were randomised to annual screening with transvaginal ultrasound attended annual incidence screening between 28 April 2002 and 31 December 2011. Transvaginal ultrasound was used both as the first and the second line test. Participants were followed up through electronic health record linkage and postal questionnaires. Out of 280,534 annual incidence screens, 960 women underwent screen-positive surgery. 113 had ovarian/tubal cancer (80 invasive epithelial). Of the screen-detected invasive epithelial cancers, 37.5% (95%CI: 26.9–49.0) were Stage I/II. An additional 52 (50 invasive epithelial) were diagnosed within one year of their last screen. Of the 50 interval epithelial cancers, 6.0% (95%CI: 1.3–16.5) were Stage I/II. For detection of all ovarian/tubal cancers diagnosed within one year of screen, the sensitivity, specificity, and positive predictive values were 68.5% (95%CI: 60.8–75.5), 99.7% (95%CI: 99.7–99.7), and 11.8% (95%CI: 9.8–14) respectively. When the analysis was restricted to invasive epithelial cancers, sensitivity, specificity and positive predictive values were 61.5% (95%CI: 52.6–69.9); 99.7% (95%CI: 99.7–99.7) and 8.3% (95%CI: 6.7–10.3), with 12 surgeries per screen positive. The low sensitivity coupled with the advanced stage of interval cancers suggests that ultrasound scanning as the first line test might not be suitable for population screening for ovarian cancer. Trial registration: ISRCTN22488978. Registered on 6 April 2000.

Plasma cfDNA methylation markers for the detection and prognosis of ovarian cancer

“…Screening strategies have been widely studied for OC, such as transvaginal sonography (TVS) and cancer antigen 125 (CA125). 4 However, these methods had poor sensitivities (69.0%‒93.8%) and specificities (58.0%‒94.6%) 5 , 6 and failed to improve survival in the randomized controlled trial for OC screening. 4 , 7 Therefore, no recommended screening approach is available for OC nowadays.…”

Special Issue “Gynaecological Cancers Risk: Breast Cancer, Ovarian Cancer and Endometrial Cancer”

“…While this is potentially cost-saving for high income countries, genetic testing costs need to fall further for this to be cost-effective for low income countries. Kalsi et al [ 5 ] show that an annual ultrasound-based screening strategy for ovarian cancer is not suitable as it misses 37.5% of cancers and does not downstage disease. Ovarian cancer screening using the Ca125 biomarker alone also has not demonstrated a mortality benefit [ 6 ].…”