WISP: A prospective, multi-center trial of salpingectomy with delayed oophorectomy versus risk reducing salpingo-oophorectomy in women at increased risk for hereditary ovarian cancer

Lu, Karen H.; Nebgen, Denise R.; Bowen, Deborah J.; Bakkum-Gamez, Jamie N.; Romero, Iris L.; Roche, Kara Long; Levine, Douglas A.; Soletsky, Beth; Carter, J.; Hickey, Martha; Crase, Jamie; Gavin, Kathleen; Polinsky, Deborah; Swisher, Elizabeth M.

doi:10.1016/j.ygyno.2019.04.055

Cited by 7 publications

(6 citation statements)

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“…In addition, 2 phase II studies in BRCA carriers, the Tubectomy in BRCA mutation carriers (TUBA) and Women Choosing Surgical Prevention (WISP) trials, are investigating the impact of stepwise early risk-reducing salpingectomy followed by delayed oophorectomy between the ages of 35e40 years for BRCA1 and 40e45 years for BRCA2, which has great implication for the treatment of high-risk women with regard to premature menopause and cancer risk reduction. 50,51…”

Section: Research Implicationsmentioning

confidence: 99%

The rapid adoption of opportunistic salpingectomy at the time of hysterectomy for benign gynecologic disease in the United States

Mandelbaum

Adams

Yoshihara

et al. 2020

American Journal of Obstetrics and Gynecology

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BACKGROUND: Mounting evidence for the role of distal fallopian tubes in the pathogenesis of epithelial ovarian cancer has led to opportunistic salpingectomy being increasingly performed at the time of benign gynecologic surgery. Opportunistic salpingectomy has now been recommended as best practice in the United States to reduce future risk of ovarian cancer even in low-risk women. Preliminary analyses have suggested that performance of opportunistic salpingectomy is increasing. OBJECTIVE: To examine trends in opportunistic salpingectomy in women undergoing benign hysterectomy and to determine how the publication of the tubal hypothesis in 2010 may have contributed to these trends. STUDY DESIGN: This is a population-based, retrospective, observational study examining the National Inpatient Sample between January 2001 and September 2015. Women younger than 50 years who underwent inpatient hysterectomy for benign gynecologic disease were grouped as hysterectomy alone vs hysterectomy with opportunistic salpingectomy. All women had ovarian conservation, and those with adnexal pathology were excluded. Linear segmented regression with log transformation was used to assess temporal trends. An interrupted time-series analysis was then used to assess the impact of the 2010 publication of the tubal hypothesis on opportunistic salpingectomy trends. A regression-tree model was constructed to examine patterns in the use of opportunistic salpingectomy. A binary logistic regression model was then fitted to identify independent characteristics associated with opportunistic salpingectomy. Sensitivity analysis was performed in women aged 50e65 years to further assess surgical trends in a wider age group.RESULTS: There were 98,061 (9.0%) women who underwent hysterectomy with opportunistic salpingectomy and 997,237 (91.0%) women who underwent hysterectomy alone without opportunistic salpingectomy. The rate at which opportunistic salpingectomy was being performed gradually increased from 2.4% to 5.7% between 2001 and 2010 (2.4-fold increase; P<.001), predicting a 7.0% rate of opportunistic salpingectomy in 2015. However, in 2010, the rate of opportunistic salpingectomy began to increase substantially and reached 58.4% by 2015 (10.2-fold increase; P<.001). In multivariable analysis, the largest change in the performance of opportunistic salpingectomy occurred after 2010 (adjusted odds ratio, 5.42; 95% confidence interval, 5.34e5.51; P<.001). In a regression-tree model, women who had a hysterectomy at urban teaching hospitals in the Midwest after 2013 had the highest chance of undergoing opportunistic salpingectomy during benign hysterectomy (76.4%). In the sensitivity analysis of women aged 50e65 years, a similar exponential increase in opportunistic salpingectomy was observed from 5.8% in 2010 to 55.8% in 2015 (9.8-fold increase; P<.001). CONCLUSION: Our study suggests that clinicians in the United States rapidly adopted opportunistic salpingectomy at the time of benign hysterectomy following the publication of data implicating the di...

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Section: Research Implicationsmentioning

confidence: 99%

The rapid adoption of opportunistic salpingectomy at the time of hysterectomy for benign gynecologic disease in the United States

Mandelbaum

Adams

Yoshihara

et al. 2020

American Journal of Obstetrics and Gynecology

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“…Isolated STIC was found in one PALB2 mutation carrier and none were found in the high-risk family history group or among 41 patients with defects in other homologous recombination genes or mismatch repair genes [54]. One other study has identified intraepithelial neoplasia without invasive carcinoma in a PALB2 mutation carrier, although only preliminary results are available [68]. A small retrospective study of 18 patients showed no serous intraepithelial precursor lesions among patients with RAD51C, BARD1, BRIP1, PALB2 or CHEK2 mutations who underwent RRBSO [11].…”

Section: Incidence Of Preneoplastic Lesions and Occult Carcinoma In H...mentioning

confidence: 96%

“…Lastly, the PROTECTOR (ISRCTN25173360) and WISP (NCT02760849) trials will focus on quality of life outcomes following staged RRBSO including sexual function, psychological well-being, and satisfaction/regret [102]. Preliminary data from WISP presented in 2019 showed no patients had developed carcinoma and women who underwent a staged procedure had fewer menopausal symptoms and less decision regret, even when compared to women who received hormone replacement therapy [68].…”

Section: Ongoing Clinical Trialsmentioning

confidence: 99%

Hereditary Ovarian Carcinoma: Cancer Pathogenesis Looking beyond BRCA1 and BRCA2

Samuel

Diaz-Barbe

Pinto

et al. 2022

Cells

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Besides BRCA1 and BRCA2, several other inheritable mutations have been identified that increase ovarian cancer risk. Surgical excision of the fallopian tubes and ovaries reduces ovarian cancer risk, but for some non-BRCA hereditary ovarian cancer mutations the benefit of this intervention is unclear. The fallopian tubes of women with hereditary ovarian cancer mutations provide many insights into the early events of carcinogenesis and process of malignant transformation. Here we review cancer pathogenesis in hereditary cases of ovarian cancer, the occurrence of pre-invasive lesions and occult carcinoma in mutation carriers and their clinical management.

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“…On the basis of these promising results, several prospective, observational trials are currently enrolling patients to further evaluate the impact of SDO over RRSO on efficacy in preventing the development of ovarian cancer and on quality of life. These trials include the Women Choosing Surgical Prevention (WISP) study (US: NCT02760849), the Early Salpingectomy (Tubectomy) with Delayed Oophorectomy in BRCA1/2 Mutation Carriers (TUBA) study (Netherlands: NCT02321228) [39,40], the Preventing Ovarian Cancer through Early Excision of Tubes and Late Ovarian Removal (PROTECTOR) trial (United Kingdom: ISRCTN25173360), and most recently, A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers (SOR-OCk) study (United States: NRG-CC008/NCT04251052).…”

Section: Is Sdo a Better Option?mentioning

confidence: 99%

“…The WISP trial is a nonrandomized phase 2 trial, conducted at multiple centers in the United States, which recently reported their preliminary results regarding quality of life [40], showing that women who selected RRSO (n = 99) had significantly worse menopausal symptoms after surgery than women who selected SDO (n = 91). Specifically, hot flashes, night sweats, vaginal dryness, and weight gain were significantly worse in the RRSO arm.…”

Section: Is Sdo a Better Option?mentioning

confidence: 99%

Salpingectomy for the Risk Reduction of Ovarian Cancer: Is It Time for a Salpingectomy-alone Approach?

Boerner¹,

Roche²

2021

Journal of Minimally Invasive Gynecology

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To summarize published evidence supporting current strategies for the prevention of epithelial ovarian cancer in women with a genetic, elevated risk for the development of this disease, as well as the emerging data on the novel salpingectomy with delayed oophorectomy (SDO) strategy. Furthermore, we will explore whether salpingectomy alone is a viable risk-reducing strategy for these women. We will also discuss current national guidelines for risk-reducing surgery based on patients' individual genetic predisposition. Data Sources: MEDLINE, PubMed, EMBASE, and the Cochrane Database, with a focus on randomized controlled trials and large prospective, observational studies. Methods of Study Selection:The key search terms for our review included Medical Subject Headings: "salpingectomy," "ovarian cancer," and "risk-reducing surgery." Tabulation, Integration, and Results: The fallopian tube is now well established as the site of origin for most ovarian cancers, particularly high-grade serous carcinomas. This finding has led to the development of new preventive surgical techniques, such as SDO, which may be associated with fewer side effects. However, until the results of ongoing trials are reported and the impact of SDO on ovarian cancer risk reduction is established, it should not be recommended outside of clinical trials, and bilateral salpingo-oophorectomy remains the treatment of choice for risk-reducing surgery, especially in women with a genetic, high risk for ovarian cancer. Conclusion:The decision to undergo risk-reducing surgery among women with an elevated risk for ovarian cancer should be made after comprehensive consultation and individually based on genetic predisposition, childbearing status, and personal preference.

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WISP: A prospective, multi-center trial of salpingectomy with delayed oophorectomy versus risk reducing salpingo-oophorectomy in women at increased risk for hereditary ovarian cancer

Cited by 7 publications

References 0 publications

The rapid adoption of opportunistic salpingectomy at the time of hysterectomy for benign gynecologic disease in the United States

The rapid adoption of opportunistic salpingectomy at the time of hysterectomy for benign gynecologic disease in the United States

Hereditary Ovarian Carcinoma: Cancer Pathogenesis Looking beyond BRCA1 and BRCA2

Salpingectomy for the Risk Reduction of Ovarian Cancer: Is It Time for a Salpingectomy-alone Approach?

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