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Clin Cancer Res. 2017 Jul 15;23(14):3628-3637. doi: 10.1158/1078-0432.CCR-15-2750. Epub 2017 Jan 31.

Early Detection of Ovarian Cancer using the Risk of Ovarian Cancer Algorithm with Frequent CA125 Testing in Women at Increased Familial Risk - Combined Results from Two Screening Trials.

Author information

1
Massachusetts General Hospital, Boston, Massachusetts.
2
National Cancer Institute, Rockville, Maryland.
3
Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah.
4
MD Anderson Cancer Center, Houston, Texas.
5
Roswell Park Cancer Institute, Buffalo, New York.
6
NorthShore University Health System, Evanston, Illinois.
7
Fox Chase Cancer Center, Philadelphia, Pennsylvania.
8
University of South Florida, Tampa, Florida.
9
University of North Carolina, Chapel Hill, North Carolina.
10
Ohio State University and the James Cancer Center, Columbus, Ohio.
11
University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, Alabama.
12
Rex Cancer Center, Raleigh, North Carolina.
13
Fred Hutchinson Cancer Research Center, Seattle, Washington.
14
Georgetown University Medical Center, Lombardi Cancer Center, Washington, District of Columbia.
15
Duke University Medical Center, Division of Gynecologic Oncology, Durham, North Carolina.
16
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania.
17
Denver Health Medical Center, Denver, Colorado.
18
Magee-Womens Hospital, Pittsburgh, Pennsylvania.
19
The Iowa Clinic, Gynecologic Oncology, Des Moines, Iowa.
20
Dana-Farber Cancer Center in Clinical Affiliation with South Shore Hospital, South Weymouth, Massachusetts.
21
Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia.
22
Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia.
23
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.
24
Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland.
25
Emory University School of Medicine, Atlanta, Georgia.
26
The University of Kansas Cancer Center, Westwood, Kansas.
27
Stephenson Cancer Center, University of Oklahoma HSC, Oklahoma City, Oklahoma.
28
Brigham and Women's Hospital, Boston, Massachusetts.
29
Food and Drug Administration, Silver Spring, Maryland.
30
University of Florida, Gainesville, Florida.
31
University of Arizona Cancer Center, Tucson, Arizona.

Abstract

Purpose: Women at familial/genetic ovarian cancer risk often undergo screening despite unproven efficacy. Research suggests each woman has her own CA125 baseline; significant increases above this level may identify cancers earlier than standard 6- to 12-monthly CA125 > 35 U/mL.Experimental Design: Data from prospective Cancer Genetics Network and Gynecologic Oncology Group trials, which screened 3,692 women (13,080 woman-screening years) with a strong breast/ovarian cancer family history or BRCA1/2 mutations, were combined to assess a novel screening strategy. Specifically, serum CA125 q3 months, evaluated using a risk of ovarian cancer algorithm (ROCA), detected significant increases above each subject's baseline, which triggered transvaginal ultrasound. Specificity and positive predictive value (PPV) were compared with levels derived from general population screening (specificity 90%, PPV 10%), and stage-at-detection was compared with historical high-risk controls.Results: Specificity for ultrasound referral was 92% versus 90% (P = 0.0001), and PPV was 4.6% versus 10% (P > 0.10). Eighteen of 19 malignant ovarian neoplasms [prevalent = 4, incident = 6, risk-reducing salpingo-oophorectomy (RRSO) = 9] were detected via screening or RRSO. Among incident cases (which best reflect long-term screening performance), three of six invasive cancers were early-stage (I/II; 50% vs. 10% historical BRCA1 controls; P = 0.016). Six of nine RRSO-related cases were stage I. ROCA flagged three of six (50%) incident cases before CA125 exceeded 35 U/mL. Eight of nine patients with stages 0/I/II ovarian cancer were alive at last follow-up (median 6 years).Conclusions: For screened women at familial/genetic ovarian cancer risk, ROCA q3 months had better early-stage sensitivity at high specificity, and low yet possibly acceptable PPV compared with CA125 > 35 U/mL q6/q12 months, warranting further larger cohort evaluation. Clin Cancer Res; 23(14); 3628-37. ©2017 AACR.

PMID:
28143870
PMCID:
PMC5726402
DOI:
10.1158/1078-0432.CCR-15-2750
[Indexed for MEDLINE]
Free PMC Article

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