101. Pathologic Findings at Risk-Reducing Salpingo-Oophorectomy: Primary Results From Gynecologic Oncology Group Trial GOG-0199
- Author
-
Sherman, Mark E, Piedmonte, Marion, Mai, Phuong L, Ioffe, Olga B, Ronnett, Brigitte M, Van Le, Linda, Ivanov, Iouri, Bell, Maria C, Blank, Stephanie V, DiSilvestro, Paul, Hamilton, Chad A, Tewari, Krishnansu S, Wakeley, Katie, Kauff, Noah D, Yamada, S Diane, Rodriguez, Gustavo, Skates, Steven J, Alberts, David S, Walker, Joan L, Minasian, Lori, Lu, Karen, and Greene, Mark H
- Subjects
Aging ,Ovarian Cancer ,Cancer ,Prevention ,Rare Diseases ,Clinical Research ,Breast Cancer ,Patient Safety ,Adult ,Biomarkers ,Tumor ,Breast Neoplasms ,CA-125 Antigen ,Fallopian Tube Neoplasms ,Female ,Genes ,BRCA1 ,Genes ,BRCA2 ,Genetic Predisposition to Disease ,Humans ,Middle Aged ,Mutation ,Neoplasm Invasiveness ,Neoplasms ,Unknown Primary ,Ovarian Neoplasms ,Ovariectomy ,Risk Factors ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
PurposeRisk-reducing salpingo-oophorectomy (RRSO) lowers mortality from ovarian/tubal and breast cancers among BRCA1/2 mutation carriers. Uncertainties persist regarding potential benefits of RRSO among high-risk noncarriers, optimal surgical age, and anatomic origin of clinically occult cancers detected at surgery. To address these topics, we analyzed surgical treatment arm results from Gynecologic Oncology Group Protocol-0199 (GOG-0199), the National Ovarian Cancer Prevention and Early Detection Study.Participants and methodsThis analysis included asymptomatic high-risk women age ≥ 30 years who elected RRSO at enrollment. Women provided risk factor data and underwent preoperative cancer antigen 125 (CA-125) serum testing and transvaginal ultrasound (TVU). RRSO specimens were processed according to a standardized tissue processing protocol and underwent central pathology panel review. Research-based BRCA1/2 mutation testing was performed when a participant's mutation status was unknown at enrollment. Relationships between participant characteristics and diagnostic findings were assessed using univariable statistics and multivariable logistic regression.ResultsInvasive or intraepithelial ovarian/tubal/peritoneal neoplasms were detected in 25 (2.6%) of 966 RRSOs (BRCA1 mutation carriers, 4.6%; BRCA2 carriers, 3.5%; and noncarriers, 0.5%; P < .001). In multivariable models, positive BRCA1/2 mutation status (P = .0056), postmenopausal status (P = .0023), and abnormal CA-125 levels and/or TVU examinations (P < .001) were associated with detection of clinically occult neoplasms at RRSO. For 387 women with negative BRCA1/2 mutation testing and normal CA-125 levels, findings at RRSO were benign.ConclusionClinically occult cancer was detected among 2.6% of high-risk women undergoing RRSO. BRCA1/2 mutation, postmenopausal status, and abnormal preoperative CA-125 and/or TVU were associated with cancer detection at RRSO. These data can inform management decisions among women at high risk of ovarian/tubal cancer.
- Published
- 2014