Mark E Sherman1, Marion Piedmonte1, Phuong L Mai1, Olga B Ioffe1, Brigitte M Ronnett1, Linda Van Le1, Iouri Ivanov1, Maria C Bell1, Stephanie V Blank1, Paul DiSilvestro1, Chad A Hamilton1, Krishnansu S Tewari1, Katie Wakeley1, Noah D Kauff1, S Diane Yamada1, Gustavo Rodriguez1, Steven J Skates1, David S Alberts1, Joan L Walker1, Lori Minasian1, Karen Lu1, Mark H Greene2. 1. Mark E. Sherman, Phuong L. Mai, Lori Minasian, and Mark H. Greene, National Cancer Institute, Rockville; Olga B. Ioffe, University of Maryland Medical Center; Brigitte M. Ronnett, Johns Hopkins Medical Institutions, Baltimore; Chad A. Hamilton, Walter Reed National Military Medical Center, Bethesda, MD; Marion Piedmonte, Roswell Park Cancer Institute, Buffalo; Stephanie V. Blank, New York University School of Medicine; Noah D. Kauff, Memorial Sloan Kettering Cancer Center; New York, NY; Linda Van Le, University of North Carolina at Chapel Hill, Chapel Hill, NC; Iouri Ivanov, Columbus Cancer Council, Columbus, OH; Maria C. Bell, Sanford University of South Dakota Medical Center, Sioux Falls, SD; Paul DiSilvestro, Women and Infants Hospital, Providence, RI; Krishnansu S. Tewari, University of California Medical Center Irvine, Orange, CA; Katie Wakeley, Tufts University; Steven J. Skates, Massachusetts General Hospital, Boston, MA; S. Diane Yamada, University of Chicago, Chicago; Gustavo Rodriguez, North Shore University Health System, Evanston, IL; David S. Alberts, University of Arizona Cancer Center, Tucson, AZ; Joan L. Walker, University of Oklahoma, Oklahoma City, OK; and Karen Lu, MD Anderson Cancer Center, Houston, TX. 2. Mark E. Sherman, Phuong L. Mai, Lori Minasian, and Mark H. Greene, National Cancer Institute, Rockville; Olga B. Ioffe, University of Maryland Medical Center; Brigitte M. Ronnett, Johns Hopkins Medical Institutions, Baltimore; Chad A. Hamilton, Walter Reed National Military Medical Center, Bethesda, MD; Marion Piedmonte, Roswell Park Cancer Institute, Buffalo; Stephanie V. Blank, New York University School of Medicine; Noah D. Kauff, Memorial Sloan Kettering Cancer Center; New York, NY; Linda Van Le, University of North Carolina at Chapel Hill, Chapel Hill, NC; Iouri Ivanov, Columbus Cancer Council, Columbus, OH; Maria C. Bell, Sanford University of South Dakota Medical Center, Sioux Falls, SD; Paul DiSilvestro, Women and Infants Hospital, Providence, RI; Krishnansu S. Tewari, University of California Medical Center Irvine, Orange, CA; Katie Wakeley, Tufts University; Steven J. Skates, Massachusetts General Hospital, Boston, MA; S. Diane Yamada, University of Chicago, Chicago; Gustavo Rodriguez, North Shore University Health System, Evanston, IL; David S. Alberts, University of Arizona Cancer Center, Tucson, AZ; Joan L. Walker, University of Oklahoma, Oklahoma City, OK; and Karen Lu, MD Anderson Cancer Center, Houston, TX. greenem@mail.nih.gov.
Abstract
PURPOSE: Risk-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 METHODS: This 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. RESULTS: Invasive 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. CONCLUSION: Clinically 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.
PURPOSE: Risk-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 METHODS: This 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. RESULTS: Invasive 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. CONCLUSION: Clinically 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.
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