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

被引：103

作者：

Skates, Steven J. ^{[1
]}

Greene, Mark H. ^{[2
]}

Buys, Saundra S. ^{[3
]}

Mai, Phuong L. ^{[2
]}

Brown, Powel ^{[4
]}

Piedmonte, Marion ^{[5
]}

Rodriguez, Gustavo ^{[6
]}

Schorge, John O. ^{[1
]}

Sherman, Mark ^{[2
]}

Daly, Mary B. ^{[7
]}

Rutherford, Thomas ^{[8
]}

Brewster, Wendy R. ^{[9
]}

O'Malley, David M. ^{[10
,11
]}

Partridge, Edward ^{[12
]}

Boggess, John ^{[13
]}

Drescher, Charles W. ^{[14
]}

Isaacs, Claudine ^{[15
]}

Berchuck, Andrew ^{[16
]}

Domchek, Susan ^{[17
]}

Davidson, Susan A. ^{[18
]}

Edwards, Robert ^{[19
]}

Elg, Steven A. ^{[20
]}

Wakeley, Katie ^{[21
]}

Phillips, Kelly-Anne ^{[22
,23
,24
]}

Armstrong, Deborah ^{[25
]}

Horowitz, Ira ^{[26
]}

Fabian, Carol J. ^{[27
]}

Walker, Joan ^{[28
]}

Sluss, Patrick M. ^{[1
]}

Welch, William ^{[29
]}

Minasian, Lori ^{[2
]}

Horick, Nora K. ^{[1
]}

Kasten, Carol H. ^{[30
]}

Nayfield, Susan ^{[31
]}

Alberts, David ^{[32
]}

Finkelstein, Dianne M. ^{[1
]}

Lu, Karen H. ^{[4
]}

机构：

[1] Massachusetts Gen Hosp, 50 Staniford St,Suite 560, Boston, MA 02114 USA

[2] NCI, Rockville, MD USA

[3] Univ Utah, Sch Med, Huntsman Canc Inst, Salt Lake City, UT USA

[4] MD Anderson Canc Ctr, Houston, TX USA

[5] Roswell Pk Canc Inst, Buffalo, NY 14263 USA

[6] NorthShore Univ Hlth Syst, Evanston, IL USA

[7] Fox Chase Canc Ctr, 7701 Burholme Ave, Philadelphia, PA 19111 USA

[8] Univ S Florida, Tampa, FL USA

[9] Univ N Carolina, Chapel Hill, NC USA

[10] Ohio State Univ, Columbus, OH 43210 USA

[11] James Canc Ctr, Columbus, OH USA

[12] Univ Alabama Birmingham, Comprehens Canc Ctr, Birmingham, AL USA

[13] Rex Canc Ctr, Raleigh, NC USA

[14] Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA

[15] Georgetown Univ, Med Ctr, Lombardi Canc Ctr, Washington, DC 20007 USA

[16] Duke Univ, Med Ctr, Div Gynecol Oncol, Durham, NC USA

[17] Univ Penn, Abramson Canc Ctr, Philadelphia, PA USA

[18] Denver Hlth Med Ctr, Denver, CO USA

[19] Magee Womens Hosp, Pittsburgh, PA USA

[20] Iowa Clin, Gynecol Oncol, Des Moines, IA USA

[21] South Shore Hosp, Dana Farber Canc Ctr Clin Affiliat, South Weymouth, MA USA

[22] Peter MacCallum Canc Ctr, Div Canc Med, Melbourne, Vic, Australia

[23] Univ Melbourne, Sir Peter MacCallum Dept Oncol, Melbourne, Vic, Australia

[24] Univ Melbourne, Melbourne Sch Populat & Global Hlth, Ctr Biostat & Epidemiol, Melbourne, Vic, Australia

[25] Johns Hopkins Kimmel Canc Ctr, Baltimore, MD USA

[26] Emory Univ, Sch Med, Atlanta, GA USA

[27] Univ Kansas, Ctr Canc, Westwood, KS USA

[28] Univ Oklahoma HSC, Stephenson Canc Ctr, Oklahoma City, OK USA

[29] Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA

[30] US FDA, Silver Spring, MD USA

[31] Univ Florida, Gainesville, FL USA

[32] Univ Arizona, Ctr Canc, Tucson, AZ USA

来源：

CLINICAL CANCER RESEARCH | 2017年 / 23卷 / 14期

关键词：

REDUCING SALPINGO-OOPHORECTOMY; SERUM CA 125; TRANSVAGINAL ULTRASOUND; COLLABORATIVE TRIAL; FOLLOW-UP; BRCA1; MUTATION; PERFORMANCE; MORTALITY; CARCINOMA;

D O I：

10.1158/1078-0432.CCR-15-2750

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 levelmayidentify 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. (C) 2017 AACR.

引用

页码：3628 / 3637

页数：10

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