Search

International audience; 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.

The impact of locoregional treatment (LRT) on overall survival (OS) in de novo metastatic breast cancer (dnMBC) is still under debate, with very few data available regarding exclusive radiotherapy (ERT) as a therapeutic modality.We evaluated the impact of ERT, exclusive surgery, or a combination of surgery plus radiotherapy (bimodality therapy, BMT) on survival outcomes in a national real-life dnMBC cohort. The primary and secondary end points were OS and progression free survival (PFS) according to LRT (ERT, exclusive surgery, BMT) and no LRT. Sensitivity analyses were performed using propensity score matched analyses.From 2008 to 2014, 4507 dnMBC patients were identified. Only patients alive and free from progression under systemic therapy at least 1 year after diagnosis were included (n = 1965). Forty-five percent of patients (891/1965) underwent LRT: 41.1% (n = 366) ERT, 13.7% (n = 122) exclusive surgery, and 45.2% (n = 403) BMT. OS adjusted for major prognostic factors was significantly longer in the ERT and BMT group compared with no-LRT group, but not exclusive surgery (hazard ratio (HR) = 0.63, 95% confidence interval (CI) [0.49, 0.80], p 0.001, HR = 0.61, 95%CI [0.47, 0.78], p 0.001 and HR = 0.87, 95%CI [0.61, 1.26], p = 0.466 respectively). Results were similar after matching on a propensity score. ERT, surgery and BMT were all associated with a significantly better PFS in multivariable analysis.ERT was significantly associated with better OS in dnMBC, in the same magnitude as BMT, compared with no-LRT. However, even with statistical models adjusted for known prognostic factors and propensity score analysis, selection biases cannot be eliminated from observational studies.

1594 Background: Risk-reducing salpingo-oophorectomy (RRSO) is the gold standard in surgical prophylaxis of pelvic high-grade serous carcinoma (HGSC) for women at risk of breast/ovarian cancer. Due to significant adverse effects of early oophorectomy, 20-30% of women delay or deny performing this operation. Recent data highlight the fallopian origin of most pelvic HGSC, especially its fimbrial part. Thus, we suggested a new two-step risk-reducing procedure: the radical fimbriectomy (RF) with delayed oophorectomy (DO) (Leblanc et al Gyn Oncol 2011), leading to the current RF/DO Phase 2 study. We present the definitive results on primary and secondary objectives of this trial. Methods: BRCA1/2 carriers or any women with a documented familial risk of breast/ovarian cancer were first counseled to perform a classical laparoscopic RRSO. If they denied, they were offered to enter the RF/DO study. All specimens were submitted to the SEE-FIM pathological protocol. Pathological data along with all intra- and 30-day and beyond post-operative adverse events were prospectively recorded. Follow-up consisted in an annual clinical breast and gynecological examination, with tumor markers and hormonal status assessment. Primary endpoint was the rate of pelvic serous carcinoma. Secondary endpoints were procedure morbidity, rates of tubal abnormalities, breast cancer, secondary oophorectomy. Results: From January 2012 to October 2014, 121 RF were performed: 120 by laparoscopy, 1 laparotomy (concurrent myomectomy). An occult neoplasia was found in 3 cases with 1 invasive HGSC. Intraoperative complications were two grade1 bleedings without transfusion with no grade ≥3 early post-operative or delayed complication. With a median follow-up of 5.3 years (0.2 -7.6), no patient developed any pelvic HGSC, 21 patients developed a breast cancer (3 de novo, 18 recurrences/contralateral.). 1 cancer-free BRCA1-mutated lady delivered safe twins, after an uneventful post-RF pregnancy obtained with assisted reproductive technology (ART). Overall, 29 women underwent DO (by choice: 12 or menopause: 17) resulting in grade 3b complication in 1 case, but no pathological abnormality. Conclusions: RF/DO appears as a safe, well tolerated and effective procedure in terms of occult neoplasia detection. A successful pregnancy with ART was possible after radical fimbriectomy. Longer follow-up and larger cohort are necessary to confirm its efficacy in terms of ovarian cancer prophylaxis. Clinical trial information: NCT01608074.