At the Colorado Center for Gynecological Oncology, we are always interested in new research studies and their findings. The article below reports on the Women Choosing Surgical Prevention (WISP) trial that began in 2016. Read below for more information on the trial and patient feedback.
SGO 2019: Less Worry, More Symptoms and Regret With Risk-Reducing Salpingo-Oophorectomy
Women at increased risked for hereditary ovarian cancer who underwent risk-reducing salpingo-oophorectomy experienced less worry but worse menopausal symptoms and more regret compared with those who underwent salpingectomy with delayed oophorectomy, the Women Choosing Surgical Prevention (WISP) trial reported (ClinicalTrials.gov Identifier: NCT02760849). Trial findings were presented at the 2019 Society of Gynecologic Oncology (SGO) 50th Annual Meeting on Women’s Cancer (LBA3), held March 16–19 in Honolulu, Hawaii.
Jan Sunde, MD, associate professor and director of the division of gynecologic oncology at Baylor College of Medicine, told Cancer Network that, overall, these findings make sense. “Women who have their ovaries out are the most reassured that they’re not going to get cancer, but they also on the other hand have more menopausal symptoms and regret being in menopause.”
The WISP trial is a prospective, nonrandomized, multicenter study among women at increased risk for hereditary ovarian cancer. The trial is designed to evaluate changes in women’s sexual function for risk-reducing salpingo-oophorectomy, which is the standard of care, vs salpingectomy with delayed oophorectomy.
The trial began enrolling patients in 2016 and has a target enrollment of 270 women. Eligible women include those who are premenopausal, between the ages of 30 and 50 years, and have a pathogenic germline mutation that puts her at a higher risk for ovarian cancer. Women were permitted to choose preventative treatment with risk-reducing salpingo-oophorectomy or salpingectomy with delayed oophorectomy. Questionnaires were completed at baseline and 6 months after surgery.
To date, 190 patients have enrolled on trial, with 99 selecting risk-reducing salpingo-oophorectomy and 91 selecting salpingectomy with delayed oophorectomy. For the risk-reducing salpingo-oophorectomy group, the median age is 40.0 (range, 38.0–45.0 years), while the median age is 37.0 (range, 34.0–41.0 years) for the salpingectomy with delayed oophorectomy group. Both groups of patients had similar characteristics across race, mutation, marital status, education, and income. Among all patients, 51% were BRCA1 carriers and 39% were BRCA2 carriers.
“It’s a very preliminary result,” cautioned Sunde. The primary completion date for the trial is estimated to be May 2041, and he said that while it’s reassuring that nobody has had any cancers yet, at this point the numbers are “way too small” to see a difference between the treatment groups.
In terms of changes of sexual function between the treatment groups, women who chose risk-reducing salpingo-oophorectomy had significantly worse menopausal systems compared with women who chose salpingectomy with delayed oophorectomy at 6 months after surgery. Menopausal symptoms that were worse included hot flashes (P < .0001), night sweats (P = .008), vaginal dryness (P = .004), and weight gain (P = .02).
Women who chose risk-reducing salpingo-oophorectomy also reported higher levels of regret than women who chose salpingectomy with delayed oophorectomy (P < .009), regardless of whether she was receiving hormone replacement therapy to manage menopausal symptoms. Both groups of women had significantly lower distress after surgery, and women who chose risk-reducing salpingo-oophorectomy experienced an even greater lowering of distress (P < .0006).
“Obviously, if it can be shown that it’s safe for these women to have their ovaries in place, until menopause, clearly that’s a better option,” Sunde said. However, he said, “We’re not going to have an answer for a very long time.”