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

Skates, Steven J; Greene, Mark H.; Buys, Saundra S; Mai, Phuong L; Brown, Powel; Piedmonte, Marion; Rodriguez, Gustavo; Schorge, John O; Sherman, Mark; Daly, Mary B; Rutherford, Thomas; Brewster, Wendy R; O'Malley, David M; Partridge, Edward; Boggess, John; Drescher, Charles W; Isaacs, Claudine; Berchuck, Andrew; Domchek, Susan; Davidson, Susan A; Edwards, Robert; Elg, Steven A; Wakeley, Katie; Phillips, Kelly-Anne; Armstrong, Debroah; Horowitz, Ira; Fabian Carol J; Walker, Joan; Sluss, Patrick M; Welch, William; Minasian, Lori; Horick, Nora K; Kasten, Carol H; Nayfield, Susan; Alberts, David; Finkelstein, Dianne M; Lu, Karen H

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Affiliation

Massachusetts General Hospital, Boston, MA
National Cancer Institute, Rockville, MD
Huntsman Cancer Institute, University of Utah, School of Medicine, Salt Lake City, UT
MD Anderson Cancer Center, Houston, TX
Roswell Park Cancer Institute, Buffalo, NY
NorthShore University Health System, Evanston, IL
Fox Chase Cancer Center, Philadelphia, PA
University of South Florida, Tampa, FL
University of North Carolinia, Chapel Hill, NC
Ohio State University and the James Cancer Center, Columbus, OH
University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, AL
Rex Cancer Center, Raleigh, NC
Fred Hutchinson Cancer Research Center, Seattle, WA
Georgetown University Medical Center, Lombardi Cancer Center, Washington, DC
Duke University Medical Center, Division of Gynecologic Oncology, Durham, NC
University of Pennsylvania, Abramson Cancer Center, Philadelphia, PA
Denver Health Medical Center, Denver, CO
Magee-Womens Hospital, Pittsburgh, PA
The Iowa Clinic, Gynecologic Oncology, Des Moines, IA
Dana-Farber Cancer Center in Clinical Affiliation with South Shore Hospital, South Weymouth, MA
Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia
Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia
Johns Hopkins Kimmel Cancer Center, Baltimore, MD
Emory University School of Medicine, Atlanta, GA
The University of Kansas Cancer Center, Westwood, KS
Stephenson Cancer Center, University of Oklahoma HSC, Oklahoma City, OK
Brigham and Women's Hospital, Boston, MA
Food and Drug Administration, Silver Spring, MD
University of Florida, Gainseville, FL
University of Arizona Cancer Center, Tucson, AZ

Issue Date

2017-01-31

Citation

Skates, S. J., Greene, M. H., Buys, S. S., Mai, P. L., Brown, P., Piedmonte, M., . . . Lu, K. H. (2017). 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. Clinical Cancer Research, 23(14), 3628-3637.

Journal

Clinical Cancer Research

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This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.

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 6-12 monthly CA125>35U/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 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.

Note

12 month embargo; Published OnlineFirst January 31, 2017

DOI

10.1158/1078-0432.CCR-15-2750

Version

Final accepted manuscript

Sponsors

The ROCA study was supported mainly by research grants/contracts from NCI to sites in the Cancer Genetics Network, the Ovarian SPORE program, and the Early Detection Research Network (CA078284 D. Finkelstein, CA078134 H. Anton-Culver, CA078164 D. Bowen, CA078156 S. Domchek, CA078148 C. Griffin, CA078146 C. Isaacs, CA078174 G. Mineau, CA078157 J. Schildkraut, CA078142 L. Strong, HHSN2612007440000C D. Finkelstein, CA083638 R. Ozols, CA083591 E. Partridge, CA086389 H. Lynch); Fujirebio Diagnostics Inc supported the CGN study for one year after NCI funding ended. Drs. P. Mai and M. Greene were supported by the Intramural Research Program, NCI/NIH. The Gynecologic Oncology Group’s study (GOG-0199) was supported by intramural research funds from the Clinical Genetics Branch, and National Cancer Institute grants to the Gynecologic Oncology Group (GOG) Administrative Office and Tissue Bank (CA027469 P. Di Saia), the GOG Statistical and Data Center (CA037517 J. Blessing), and by NCI’s Community Clinical Oncology Program (CCOP) grant (CA101165 P. Di Saia). Participation by the investigators of the Australia and New Zealand Gynaecological Oncology Group (ANZGOG) is gratefully acknowledged. K-A. Phillips is an Australian National Breast Cancer Foundation Fellow.

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