Risk-reducing
salpingo-oophorectomy is the gold standard for the prophylaxis of
ovarian cancer in high-risk women. Due to significant adverse effects, 20-30% of women delay or refuse early
oophorectomy. This prospective pilot study (NCT01608074) aimed to assess the efficacy of radical
fimbriectomy followed by a delayed
oophorectomy in preventing ovarian and pelvic invasive
cancer (the primary endpoint) and to evaluate the safety of both procedures. The key eligibility criteria were pre-menopausal women ≥35 years with a high risk of
ovarian cancer who refused a risk-reducing
salpingo-oophorectomy. All the surgical specimens were subjected to the SEE-
FIM protocol. From January 2012 to October 2014, 121 patients underwent RF, with 51 in an ambulatory setting. Occult
neoplasia was found in two cases, with one tubal high-grade serous ovarian
carcinoma. Two patients experienced grade 1
intraoperative complications. No early or delayed grade ≥3 post-operative complications occurred. After 7.3 years of median follow-up, no cases of pelvic invasive
cancer have been noted. Three of the fifty-two patients developed de novo
breast cancer. One BRCA1-mutated woman delivered twins safely. Twenty-five patients underwent menopause, including fifteen who had received
chemotherapy for
breast cancer, and twenty-three underwent menopause before the delayed
oophorectomy, while two did not undergo a delayed
oophorectomy at all. Overall, 46 women underwent a delayed
oophorectomy. No abnormalities were found in any delayed
oophorectomy specimens. Radical
fimbriectomy followed by delayed
oophorectomy appears to be a safe and well-tolerated risk-reducing approach, which avoids early menopause for patients with a high risk of breast and
ovarian cancer.