Trials Test New Approach to Hereditary Ovarian Ca Risk Reduction



HONOLULU -- Women with genetic susceptibility to ovarian cancer had fewer menopausal symptoms with an investigational surgical approach and were less likely to regret their decision than those selecting standard risk-reducing salpingo-oophorectomy, according to research presented here.

In the U.S.-based WISP trial, those who selected salpingectomy with delayed oophorectomy were significantly less likely to report hot flashes, vaginal dryness, and weight gain at 6 months post-surgery compared to women who picked the standard treatment, reported Karen Lu, MD, of MD Anderson Cancer Center in Houston.

Significantly more patients who chose salpingo-oophorectomy had decision regret compared to those who opted for the novel approach, though scores were low for both (14.1 vs 8.7 on a 100-point scale, P=0.02).

"We have not seen interval cancers after salpingectomy thus far, and safety continues to be closely monitored," Lu said during her presentation at the Society of Gynecologic Oncology (SGO) meeting. "At this time, we do not recommend salpingectomy and delayed oophorectomy outside a clinical trial."

SGO discussant Thomas Herzog, MD, of the University of Cincinnati Cancer Institute in Ohio, agreed. "Please don't do this at home yet. I think that's the bottom line," he said. "Do it in the context of a clinical trial."

In the salpingo-oophorectomy group, decision regret scores were higher among women on hormone replacement therapy (HRT) compared with those who were not (14.3 vs 12.5), but the researchers hypothesized that these differences were driven by history of breast cancer.

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Karen Lu, MD, discussing findings from the WISP trial

"Women with a prior history of breast cancer have less angst about undergoing risk-reducing salpingo-oophorectomy," said Lu, adding that healthy women may struggle more with the decision.

Premenopausal women ages 30 to 50 were eligible for the trial. Patients received scripted counseling regarding the recommended age for oophorectomy. When looking at what other factors could have attributed to decision regret, only baseline depression predicted patients' regret at 6 months (P<0.01).

Both groups had significant decreases from baseline to 6 months post-surgery in distress over cancer risk, as measured on the 8- to 32-point Impact of Events Scale:

  • Salpingo-oophorectomy: 19.6 to 10.9
  • Delayed oophorectomy group: 20.8 to 14.0

And there were no significant between-group differences.

For QOL outcomes there was a significant difference in physical scores that favored the delayed oophorectomy group, but no difference was observed for mental health scores.

WISP (Women Choosing Surgical Prevention) is a prospective, non-randomized multicenter trial examining outcomes in 183 women with inherited mutations in ovarian cancer predisposition genes who opted for interval salpingectomy with delayed oophorectomy (n=92) or risk-reducing salpingo-oophorectomy (n=91). The study included BRCA1/2 mutation carriers (87%), those with Lynch syndrome, and those with mutations in mismatch repair genes RAD51C, BRIP1, and PALB2.

During the initial surgery in the delayed oophorectomy group, no cancers were found. One high-grade cancer was discovered in a PALB2 mutation carrier in the salpingo-oophorectomy group.

Patients in the delayed group were significantly younger than those in the salpingo-oophorectomy group (37.5 vs 40.9 years) and had significantly higher rates of prophylactic mastectomy (51% vs 35%).

Lu said the delayed option potentially encouraged women to undergo the more limited but potentially life-saving surgical prophylaxis at an earlier age rather than wait to undergo full surgical prophylaxis at the upper accepted age limit due to fear of early menopause.

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Miranda Steenbeek, MD, presenting results of the TUBA study

A second study testing this intervention, TUBA, was presented at the meeting by Miranda Steenbeek, MD, of Radboud University Medical Center in the Netherlands. This trial included 510 Dutch women with BRCA1/2 mutations, and again both groups saw decreases in cancer risk distress from baseline to 3 months and to 1 year post-surgery:

  • Salpingo-oophorectomy: 14.4 to 12.5 to 12.4
  • Delayed oophorectomy group: 14.0 to 12.6 to 12.9

Decision regret at 1 year post-surgery was also low in this study, at 13.4 with salpingo-oophorectomy and 13.0 in the delayed group. In contrast to WISP, women without HRT had the highest decision regret scores in TUBA, at 18.8. Patients in the delayed oophorectomy group were again significantly younger (36.7 vs 38.7).

The researchers are planning to collaborate on larger studies -- WISP II and TUBA II -- to determine the efficacy of the delayed approach for cancer prevention.

Herzog explained that the staged approach is predicated on the fact that the fallopian tube is the genesis for most ovarian serous cancers and that endogenous estrogens improve women's quality of life (QOL), and perhaps even survival.

"These trials are incredibly interesting and they almost give us as many questions as they do answers at this preliminary stage," said Herzog, emphasizing that the data would become more robust as both studies finish enrollment.

"I think we need a more rich understanding of what's going through these people's minds in terms of causing the regret and worry and distress," he said. "The counseling part is really important. What is being told to these women? How is it being told? What kind of compliance are we going to see with the interval surgery and what's that safety going to look like?"

Lu and Steenbeek reported no disclosures.

Herzog has industry relationships with AstraZeneca, Caris, Clovis Oncology, Genentech/Roche, and Tesaro.

Source: https://www.medpagetoday.com/meetingcoverage/sgo/78703

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