Defining Clinical Effectiveness of Risk-Reducing Early Salpingectomy in High-Risk BRCA Carriers: Insights from the PROTECTOR Cohort

Highlight

– Risk-reducing early salpingectomy (RRES) with delayed oophorectomy (DO) is a novel two-stage prevention strategy that potentially avoids premature menopause compared to risk-reducing salpingo-oophorectomy (RRSO).
– Using the estimand framework, the UK PROTECTOR study proposes evaluating clinical effectiveness primarily through the proportion of ovarian cancers prevented after RRES.
– Sample size estimations indicate that enrolling approximately 1150 women undergoing RRES with 8 to 10 years follow-up provides adequate power to demonstrate clinical benefit versus no surgery and noninferiority to RRSO.
– The study emphasizes the practicality of using expected risk at baseline and superiority/noninferiority testing to interpret findings across cohorts more cohesively.

Study Background and Disease Burden