Results from four rounds of ovarian cancer screening in a randomized trial.
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).


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00002540


METHODS
II.
Partridge
Edward
E
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.
Kreimer
Aimee R
AR
Greenlee
Robert T
RT
Williams
Craig
C
Xu
Jian-Lun
JL
Church
Timothy R
TR
Kessel
Bruce
B
Johnson
Christine C
CC
Weissfeld
Joel L
JL
Isaacs
Claudine
C
Andriole
Gerald L
GL
Ogden
Sheryl
S
Ragard
Lawrence R
LR
Buys
Saundra S
SS
D000368:Aged; D018394:CA-125 Antigen / Q000097:blood*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000592:standards / Q000706:statistics & numerical data*; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000097:blood* / Q000000981:diagnostic imaging* / Q000401:mortality / Q000473:pathology; D010349:Patient Compliance; D011237:Predictive Value of Tests; D014463:Ultrasonography / Q000706:statistics & numerical data*
D018394:CA-125 Antigen