THE AVOIDING LATE DIAGNOSIS OF OVARIAN CANCER (ALDO) PROJECT; A PILOT NATIONAL SURVEILLANCE PROGRAM FOR WOMEN WITH PATHOGENIC GERMLINE VARIANTS IN BRCA1 AND BRCA2.

Backgrounds To establish ‘real-world’ performance and cost-effectiveness of Ovarian Cancer (OC) surveillance in women with pathogenic germline BRCA1/2 variants deferring risk-reducing salpingo-oophorectomy (RRSO). Methods
875 female BRCA1/2-heterozygotes were recruited at 13 UK centres and via an online media campaign, with 767 undergoing at least one 4-monthly surveillance test with the Risk of Ovarian Cancer Algorithm (ROCA® Test). Surveillance performance was calculated with modelling of occult cancers detected at RRSO. Incremental cost-effectiveness ratio (ICER) was calculated using Markov population cohort simulation. Results 8 OCs occurred during 1277 women screen years: 2 occult OCs at RRSO (both stage 1a), and 6 screen-detected; 3 of 6 (50%) were ≤stage 3a and 5 of 6 (83%) were completely surgically cytoreduced. Modelled sensitivity, specificity, PPV and NPV for OC were 87.5% (95%CI, 47.3-99.7), 99.9% (99.9-100), 75% (34.9-96.8) and 99.9% (99.9-100) respectively. The predicted number of quality-adjusted life-years gained by surveillance was 0.179 with an ICER cost-saving of -£102,496/QALY. Conclusion
OC surveillance for women deferring RRSO in a ‘real-world’ setting is feasible and demonstrates similar performance to research trials; it down-stages OC, leading to a high complete cytoreduction rate and is cost-saving in the UK setting. Whilst RRSO remains recommended management, ROCA-based surveillance may be considered for BRCA-heterozygotes deferring such surgery.