Introduction/Background*Risk-reducing salpingectomy (RRS) with delayed oophorectomy (DO) has gained interest for women at high risk for ovarian cancer in the last years. In the first place because of the increasing number of studies pointing towards the fallopian tube as tissue of origin. In the second place because two studies demonstrated the positive effect on menopause-related quality of life and sexual functioning compared to standard risk reducing salpingo-oophorectomy (RRSO). However, the strategy is not yet proven to be safe. In the current TUBA-WISP II study, we aim to investigate whether RRS with DO is non-inferior to the current standard RRSO regarding ovarian cancer risk.
Methodology In this international prospective multicenter preference trial, women choose between the novel RRS with DO and the current standard RRSO. RRS can be performed after the completion of child bearing and until the age of 40 (BRCA1), 45 (BRCA2) or 50 (BRIP1, RAD51C and RAD51D pathogenic variant (PV) carriers). Subsequent DO is recommended at a maximum delay of five years beyond the upper limit of the current guideline age for RRSO. The current guideline age, which is also recommended for RRSO within the study, is 35-40 for BRCA1, 40-45 for BRCA2 and 45-50 for BRIP1, RAD51C, and RAD51D PV-carriers. The primary outcome measure is the cumulative ovarian cancer incidence at target age: 46 for BRCA1 and 51 for BRCA2-PV carriers. A total 1500 BRCA1 and 1500 BRCA2-PV carriers are needed to prove non-inferiority of RRS with DO compared to RRSO. Kaplan-Meier analysis with Inverse probability weighting will be used to estimate the cumulative incidence at the appropriate target age (46 or 51) per BRCA-type.
Conclusion*As RRS with DO is proven to be beneficial in regard to menopause-related quality of life and sexual functioning, the current international study is investigating the non-inferiority to RRSO regarding ovarian cancer incidence.
Trial registration NCT04294927
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.