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
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. Data from prospective Cance...
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| Published in: | Clinical cancer research Vol. 23; no. 14; pp. 3628 - 3637 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
15.07.2017
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| ISSN: | 1078-0432, 1557-3265 |
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| Abstract | 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.
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
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.
Specificity for ultrasound referral was 92% versus 90% (
= 0.0001), and PPV was 4.6% versus 10% (
> 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
controls;
= 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).
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.
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| AbstractList | 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. 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. 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 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. Specificity for ultrasound referral was 92% versus 90% ( = 0.0001), and PPV was 4.6% versus 10% ( > 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 controls; = 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). 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. . |
| Author | Brown, Powel Rutherford, Thomas Finkelstein, Dianne M Armstrong, Deborah Greene, Mark H Phillips, Kelly-Anne Mai, Phuong L Brewster, Wendy R Alberts, David Skates, Steven J Rodriguez, Gustavo Edwards, Robert Boggess, John Schorge, John O Nayfield, Susan Lu, Karen H Daly, Mary B Davidson, Susan A Kasten, Carol H Piedmonte, Marion Walker, Joan Domchek, Susan Sherman, Mark Isaacs, Claudine Welch, William Wakeley, Katie Horowitz, Ira O'Malley, David M Drescher, Charles W Buys, Saundra S Horick, Nora K Fabian, Carol J Berchuck, Andrew Sluss, Patrick M Minasian, Lori Partridge, Edward Elg, Steven A |
| Author_xml | – sequence: 1 givenname: Steven J surname: Skates fullname: Skates, Steven J organization: Massachusetts General Hospital, Boston, Massachusetts – sequence: 2 givenname: Mark H surname: Greene fullname: Greene, Mark H organization: National Cancer Institute, Rockville, Maryland – sequence: 3 givenname: Saundra S surname: Buys fullname: Buys, Saundra S organization: Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah – sequence: 4 givenname: Phuong L surname: Mai fullname: Mai, Phuong L organization: National Cancer Institute, Rockville, Maryland – sequence: 5 givenname: Powel surname: Brown fullname: Brown, Powel organization: MD Anderson Cancer Center, Houston, Texas – sequence: 6 givenname: Marion surname: Piedmonte fullname: Piedmonte, Marion organization: Roswell Park Cancer Institute, Buffalo, New York – sequence: 7 givenname: Gustavo surname: Rodriguez fullname: Rodriguez, Gustavo organization: NorthShore University Health System, Evanston, Illinois – sequence: 8 givenname: John O surname: Schorge fullname: Schorge, John O organization: Massachusetts General Hospital, Boston, Massachusetts – sequence: 9 givenname: Mark surname: Sherman fullname: Sherman, Mark organization: National Cancer Institute, Rockville, Maryland – sequence: 10 givenname: Mary B surname: Daly fullname: Daly, Mary B organization: Fox Chase Cancer Center, Philadelphia, Pennsylvania – sequence: 11 givenname: Thomas surname: Rutherford fullname: Rutherford, Thomas organization: University of South Florida, Tampa, Florida – sequence: 12 givenname: Wendy R surname: Brewster fullname: Brewster, Wendy R organization: University of North Carolina, Chapel Hill, North Carolina – sequence: 13 givenname: David M surname: O'Malley fullname: O'Malley, David M organization: Ohio State University and the James Cancer Center, Columbus, Ohio – sequence: 14 givenname: Edward surname: Partridge fullname: Partridge, Edward organization: University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham, Alabama – sequence: 15 givenname: John surname: Boggess fullname: Boggess, John organization: Rex Cancer Center, Raleigh, North Carolina – sequence: 16 givenname: Charles W surname: Drescher fullname: Drescher, Charles W organization: Fred Hutchinson Cancer Research Center, Seattle, Washington – sequence: 17 givenname: Claudine surname: Isaacs fullname: Isaacs, Claudine organization: Georgetown University Medical Center, Lombardi Cancer Center, Washington, District of Columbia – sequence: 18 givenname: Andrew surname: Berchuck fullname: Berchuck, Andrew organization: Duke University Medical Center, Division of Gynecologic Oncology, Durham, North Carolina – sequence: 19 givenname: Susan surname: Domchek fullname: Domchek, Susan organization: University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania – sequence: 20 givenname: Susan A surname: Davidson fullname: Davidson, Susan A organization: Denver Health Medical Center, Denver, Colorado – sequence: 21 givenname: Robert surname: Edwards fullname: Edwards, Robert organization: Magee-Womens Hospital, Pittsburgh, Pennsylvania – sequence: 22 givenname: Steven A surname: Elg fullname: Elg, Steven A organization: The Iowa Clinic, Gynecologic Oncology, Des Moines, Iowa – sequence: 23 givenname: Katie surname: Wakeley fullname: Wakeley, Katie organization: Dana-Farber Cancer Center in Clinical Affiliation with South Shore Hospital, South Weymouth, Massachusetts – sequence: 24 givenname: Kelly-Anne surname: Phillips fullname: Phillips, Kelly-Anne organization: Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia – sequence: 25 givenname: Deborah surname: Armstrong fullname: Armstrong, Deborah organization: Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland – sequence: 26 givenname: Ira surname: Horowitz fullname: Horowitz, Ira organization: Emory University School of Medicine, Atlanta, Georgia – sequence: 27 givenname: Carol J surname: Fabian fullname: Fabian, Carol J organization: The University of Kansas Cancer Center, Westwood, Kansas – sequence: 28 givenname: Joan surname: Walker fullname: Walker, Joan organization: Stephenson Cancer Center, University of Oklahoma HSC, Oklahoma City, Oklahoma – sequence: 29 givenname: Patrick M surname: Sluss fullname: Sluss, Patrick M organization: Massachusetts General Hospital, Boston, Massachusetts – sequence: 30 givenname: William surname: Welch fullname: Welch, William organization: Brigham and Women's Hospital, Boston, Massachusetts – sequence: 31 givenname: Lori surname: Minasian fullname: Minasian, Lori organization: National Cancer Institute, Rockville, Maryland – sequence: 32 givenname: Nora K surname: Horick fullname: Horick, Nora K organization: Massachusetts General Hospital, Boston, Massachusetts – sequence: 33 givenname: Carol H surname: Kasten fullname: Kasten, Carol H organization: Food and Drug Administration, Silver Spring, Maryland – sequence: 34 givenname: Susan surname: Nayfield fullname: Nayfield, Susan organization: University of Florida, Gainesville, Florida – sequence: 35 givenname: David surname: Alberts fullname: Alberts, David organization: University of Arizona Cancer Center, Tucson, Arizona – sequence: 36 givenname: Dianne M surname: Finkelstein fullname: Finkelstein, Dianne M organization: Massachusetts General Hospital, Boston, Massachusetts – sequence: 37 givenname: Karen H surname: Lu fullname: Lu, Karen H organization: MD Anderson Cancer Center, Houston, Texas |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28143870$$D View this record in MEDLINE/PubMed |
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| Snippet | Women at familial/genetic ovarian cancer risk often undergo screening despite unproven efficacy. Research suggests each woman has her own CA125 baseline;... Purpose: Women at familial/genetic ovarian cancer risk often undergo screening despite unproven efficacy. Research suggests each woman has her own CA125... |
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| SubjectTerms | Adult Aged Algorithms Breast Neoplasms - blood Breast Neoplasms - diagnosis Breast Neoplasms - epidemiology Breast Neoplasms - genetics CA-125 Antigen - blood Early Detection of Cancer Female Humans Membrane Proteins - blood Middle Aged Neoplasm Staging Ovarian Neoplasms - blood Ovarian Neoplasms - epidemiology Ovarian Neoplasms - genetics Ovarian Neoplasms - pathology Risk Factors |
| Title | 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 |
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