HONOLULU – Women with BRCA1/2 mutations who undergo risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy followed by delayed risk-reducing oophorectomy (RRS/RRO) experience reduced cancer-related worry after surgery and low levels of decision regret, according to preliminary findings from the Dutch multicenter TUBA trial.
Of 384 women included to date in the ongoing trial, 51% carried a BRCA1 mutation and 49% carried a BRCA2 mutation; 72% chose RRS/RRO. A total of 289 completed the 3-month follow-up and 197 completed 1-year follow-up. At 3 and 12 months the decline on the Cancer Worry Scale was similar in the groups after adjusting for age and other baseline characteristics, with 1.9- and 1.4-point declines from baseline scores of 14.4 and 14.0 at 3 months, and 2.2- and 1.0-point declines at 12 months in the RRSO and RRS/RRO groups, respectively, Miranda P. Steenbeek, MD, reported at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
The mean scores on the 100-point Decision Regret Scale at 1-year follow-up were low at 13.4 and 13.0 after RRSO and RRS, respectively.
“But it is interesting that there is one group of women who underwent standard salpingo-oophorectomy, but weren’t using hormone replacement therapy [HRT], as these women had a higher level of decision regret [mean score, 18.8],” said Dr. Steenbeek of Radboud University Nijmegen, the Netherlands. “It is interesting to see how these results will develop over time.”
Current recommendations for preventive surgery in woman at increased risk because of BRCA1/2 mutations call for RRSO around age 40 years. However, an innovative approach using RRS followed by RRO has emerged as recent data indicate the fallopian tube, rather than the ovary, as the origin of high-grade serous ovarian cancer, she explained.
The TUBA trial was launched at 13 Dutch oncology centers in 2015, and plans to enroll 510 BRCA1/2 mutation carriers. Participants choose either standard RRSO within current guidelines (at age 35-40 years for BRCA1 carriers, age 40-45 years for BRCA2 carriers) or the innovative RRS approach followed by RRO at up to 5 years after the current guideline age (at age 40-45 years for BRCA1 carriers, age 45-50 years for BRCA2 carriers), she said.
These early findings show that baseline levels of cancer worry are higher among women choosing RRSO, which might explain the slightly larger postsurgery decline in worry in the RRSO group, Dr. Steenbeek said, noting that the higher level of regret with RRSO without HRT might be related to more severe menopausal complaints in that subset of patients.
“Based on these results we cannot conclude whether or not salpingectomy is a safe alternative to for salpingo-oophorectomy, and therefore it is very important to not perform salpingectomy with delayed oophorectomy outside the safety of a clinical and control of a clinical trial,” she said, adding that a report on the quality of life data from the study is expected in 2020.
Dr. Steenbeek reported having no disclosures.
SOURCE: Steenbeek MP et al. SGO 2019, .