Edward Partridge1, Aimee R Kreimer, Robert T Greenlee, Craig Williams, Jian-Lun Xu, Timothy R Church, Bruce Kessel, Christine C Johnson, Joel L Weissfeld, Claudine Isaacs, Gerald L Andriole, Sheryl Ogden, Lawrence R Ragard, Saundra S Buys. 1. From the University of Alabama at Birmingham School of Medicine, Birmingham, Alabama; Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland; Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin; Information Management Services, Rockville, Maryland; University of Minnesota, Minneapolis, Minnesota; Pacific Health Research Institute, Honolulu, Hawaii; Henry Ford Health System, Detroit, Michigan; University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania; Lombardi Cancer Center, Georgetown University, Washington, DC; Washington University School of Medicine, St. Louis, Missouri; University of Colorado Cancer Center, University of Colorado Denver, Denver, Colorado; Westat, Inc., Rockville, Maryland; and Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah.
Abstract
OBJECTIVE: To test whether annual screening with transvaginal ultrasonography and CA 125 reduces ovarian cancer mortality. METHODS: Data from the first four annual screens, denoted T0-T3, are reported. A CA 125 value at or above 35 units/mL or an abnormality on transvaginal ultrasonography was considered a positive screen. Diagnostic follow-up of positive screens was performed at the discretion of participants' physicians. Diagnostic procedures and cancers were tracked and verified through medical records. RESULTS: Among 34,261 screening arm women without prior oophorectomy, compliance with screening ranged from 83.1% (T0) to 77.6% (T3). Screen positivity rates declined slightly with transvaginal ultrasonography, from 4.6 at T0 to 2.9-3.4 at T1-T3; CA 125 positivity rates (range 1.4-1.8%) showed no time trend. Eighty-nine invasive ovarian or peritoneal cancers were diagnosed; 60 were screen detected. The positive predictive value (PPV) and cancer yield per 10,000 women screened on the combination of tests were similar across screening rounds (range 1.0-1.3% for PPV and 4.7-6.2 for yield); however, the biopsy (surgery) rate among screen positives decreased from 34% at T0 to 15-20% at T1-T3. The overall ratio of surgeries to screen-detected cancers was 19.5:1. Seventy-two percent of screen-detected cases were late stage (III/IV). CONCLUSION: Through four screening rounds, the ratio of surgeries to screen-detected cancers was high, and most cases were late stage. However, the effect of screening on mortality is as yet unknown. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00002540 LEVEL OF EVIDENCE: II.
OBJECTIVE: To test whether annual screening with transvaginal ultrasonography and CA 125 reduces ovarian cancer mortality. METHODS: Data from the first four annual screens, denoted T0-T3, are reported. A CA 125 value at or above 35 units/mL or an abnormality on transvaginal ultrasonography was considered a positive screen. Diagnostic follow-up of positive screens was performed at the discretion of participants' physicians. Diagnostic procedures and cancers were tracked and verified through medical records. RESULTS: Among 34,261 screening arm women without prior oophorectomy, compliance with screening ranged from 83.1% (T0) to 77.6% (T3). Screen positivity rates declined slightly with transvaginal ultrasonography, from 4.6 at T0 to 2.9-3.4 at T1-T3; CA 125 positivity rates (range 1.4-1.8%) showed no time trend. Eighty-nine invasive ovarian or peritoneal cancers were diagnosed; 60 were screen detected. The positive predictive value (PPV) and cancer yield per 10,000 women screened on the combination of tests were similar across screening rounds (range 1.0-1.3% for PPV and 4.7-6.2 for yield); however, the biopsy (surgery) rate among screen positives decreased from 34% at T0 to 15-20% at T1-T3. The overall ratio of surgeries to screen-detected cancers was 19.5:1. Seventy-two percent of screen-detected cases were late stage (III/IV). CONCLUSION: Through four screening rounds, the ratio of surgeries to screen-detected cancers was high, and most cases were late stage. However, the effect of screening on mortality is as yet unknown. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00002540 LEVEL OF EVIDENCE: II.
Authors: J R van Nagell; P D DePriest; M B Reedy; H H Gallion; F R Ueland; E J Pavlik; R J Kryscio Journal: Gynecol Oncol Date: 2000-06 Impact factor: 5.482
Authors: Usha Menon; Steven J Skates; Sara Lewis; Adam N Rosenthal; Barnaby Rufford; Karen Sibley; Nicola Macdonald; Anne Dawnay; Arjun Jeyarajah; Robert C Bast; David Oram; Ian J Jacobs Journal: J Clin Oncol Date: 2005-11-01 Impact factor: 44.544
Authors: P C Prorok; G L Andriole; R S Bresalier; S S Buys; D Chia; E D Crawford; R Fogel; E P Gelmann; F Gilbert; M A Hasson; R B Hayes; C C Johnson; J S Mandel; A Oberman; B O'Brien; M M Oken; S Rafla; D Reding; W Rutt; J L Weissfeld; L Yokochi; J K Gohagan Journal: Control Clin Trials Date: 2000-12
Authors: Saundra S Buys; Edward Partridge; Mark H Greene; Philip C Prorok; Douglas Reding; Thomas L Riley; Patricia Hartge; Richard M Fagerstrom; Lawrence R Ragard; David Chia; Grant Izmirlian; Mona Fouad; Christine C Johnson; John K Gohagan Journal: Am J Obstet Gynecol Date: 2005-11 Impact factor: 8.661
Authors: Steven J Skates; Usha Menon; Nicola MacDonald; Adam N Rosenthal; David H Oram; Robert C Knapp; Ian J Jacobs Journal: J Clin Oncol Date: 2003-05-15 Impact factor: 44.544
Authors: H Kobayashi; Y Yamada; T Sado; M Sakata; S Yoshida; R Kawaguchi; S Kanayama; H Shigetomi; S Haruta; Y Tsuji; S Ueda; T Kitanaka Journal: Int J Gynecol Cancer Date: 2007-07-21 Impact factor: 3.437
Authors: Sarah J Nyante; Amanda Black; Aimée R Kreimer; Máire A Duggan; J Daniel Carreon; Bruce Kessel; Saundra S Buys; Lawrence R Ragard; Karen A Johnson; Barbara K Dunn; Lois Lamerato; John M Commins; Christine D Berg; Mark E Sherman Journal: Gynecol Oncol Date: 2010-12-07 Impact factor: 5.482
Authors: Aykan A Karabudak; Julie Hafner; Vivekananda Shetty; Songming Chen; Angeles Alvarez Secord; Michael A Morse; Ramila Philip Journal: J Cancer Res Clin Oncol Date: 2013-09-03 Impact factor: 4.553
Authors: Barbara A Goff; Kimberly A Lowe; Jeannette C Kane; Marissa D Robertson; Marcia A Gaul; M Robyn Andersen Journal: Gynecol Oncol Date: 2011-11-06 Impact factor: 5.482
Authors: Tom Walsh; Silvia Casadei; Ming K Lee; Christopher C Pennil; Alex S Nord; Anne M Thornton; Wendy Roeb; Kathy J Agnew; Sunday M Stray; Anneka Wickramanayake; Barbara Norquist; Kathryn P Pennington; Rochelle L Garcia; Mary-Claire King; Elizabeth M Swisher Journal: Proc Natl Acad Sci U S A Date: 2011-10-17 Impact factor: 11.205
Authors: Patricia G Moorman; Nadine J Barrett; Frances Wang; J Anthony Alberg; Elisa V Bandera; J B Barnholtz-Sloan; Melissa Bondy; Michele L Cote; Ellen Funkhouser; Linda E Kelemen; Lauren C Peres; Edwards S Peters; A G Schwartz; Paul D Terry; Sydnee Crankshaw; Sarah E Abbott; Joellen M Schildkraut Journal: J Womens Health (Larchmt) Date: 2018-11-27 Impact factor: 2.681