title: Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial.
abstract: BACKGROUND
  Screening for ovarian cancer with cancer antigen 125 (CA-125) and transvaginal ultrasound has an unknown effect on mortality.
  
  
  OBJECTIVE
  To evaluate the effect of screening for ovarian cancer on mortality in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.
  
  
  METHODS
  Randomized controlled trial of 78,216 women aged 55 to 74 years assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. Intervention The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years (median [range], 12.4 years [10.9-13.0 years]) for cancer diagnoses and death until February 28, 2010.
  
  
  METHODS
  Mortality from ovarian cancer, including primary peritoneal and fallopian tube cancers. Secondary outcomes included ovarian cancer incidence and complications associated with screening examinations and diagnostic procedures.
  
  
  RESULTS
  Ovarian cancer was diagnosed in 212 women (5.7 per 10,000 person-years) in the intervention group and 176 (4.7 per 10,000 person-years) in the usual care group (rate ratio [RR], 1.21; 95% confidence interval [CI], 0.99-1.48). There were 118 deaths caused by ovarian cancer (3.1 per 10,000 person-years) in the intervention group and 100 deaths (2.6 per 10,000 person-years) in the usual care group (mortality RR, 1.18; 95% CI, 0.82-1.71). Of 3285 women with false-positive results, 1080 underwent surgical follow-up; of whom, 163 women experienced at least 1 serious complication (15%). There were 2924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10,000 person-years) in the intervention group and 2914 deaths (76.2 per 10,000 person-years) in the usual care group (RR, 1.01; 95% CI, 0.96-1.06).
  
  
  CONCLUSIONS
  Among women in the general US population, simultaneous screening with CA-125 and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality. Diagnostic evaluation following a false-positive screening test result was associated with complications. Trial Registration clinicaltrials.gov Identifier: NCT00002540.
authors.affiliation: Huntsman Cancer Institute, University of Utah Health Sciences Center, Salt Lake City, USA.
authors.forename: Saundra S
authors.initials: SS
authors.lastname: Buys
authors.forename: Edward
authors.initials: E
authors.lastname: Partridge
authors.forename: Amanda
authors.initials: A
authors.lastname: Black
authors.forename: Christine C
authors.initials: CC
authors.lastname: Johnson
authors.forename: Lois
authors.initials: L
authors.lastname: Lamerato
authors.forename: Claudine
authors.initials: C
authors.lastname: Isaacs
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Reding
authors.forename: Robert T
authors.initials: RT
authors.lastname: Greenlee
authors.forename: Lance A
authors.initials: LA
authors.lastname: Yokochi
authors.forename: Bruce
authors.initials: B
authors.lastname: Kessel
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Church
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.forename: Joel L
authors.initials: JL
authors.lastname: Weissfeld
authors.forename: Mona N
authors.initials: MN
authors.lastname: Fouad
authors.forename: David
authors.initials: D
authors.lastname: Chia
authors.forename: Barbara
authors.initials: B
authors.lastname: O'Brien
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Ragard
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Clapp
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Rathmell
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Riley
authors.forename: Patricia
authors.initials: P
authors.lastname: Hartge
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pinsky
authors.forename: Claire S
authors.initials: CS
authors.lastname: Zhu
authors.forename: Grant
authors.initials: G
authors.lastname: Izmirlian
authors.forename: Barnett S
authors.initials: BS
authors.lastname: Kramer
authors.forename: Anthony B
authors.initials: AB
authors.lastname: Miller
authors.forename: Jian-Lun
authors.initials: JL
authors.lastname: Xu
authors.forename: Philip C
authors.initials: PC
authors.lastname: Prorok
authors.forename: John K
authors.initials: JK
authors.lastname: Gohagan
authors.forename: Christine D
authors.initials: CD
authors.lastname: Berg
mesh_terms: D000368:Aged; D018394:CA-125 Antigen / Q000097:blood*; D002423:Cause of Death; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000097:blood / Q000000981:diagnostic imaging* / Q000401:mortality* / Q000601:surgery; D010052:Ovariectomy / Q000009:adverse effects; D014463:Ultrasonography / Q000009:adverse effects; D014481:United States / Q000453:epidemiology; D014621:Vagina / Q000000981:diagnostic imaging
chemical_list: D018394:CA-125 Antigen