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Screening for Ovarian Cancer
Evidence Synthesis, No. 157
Investigators: Jillian T Henderson, PhD, Elizabeth M Webber, MS, and George F Sawaya, MD.
Author Information and AffiliationsStructured Abstract
Importance:
Ovarian cancer, while not common, is the fifth-leading cause of cancer death among United States women. In 2012 the U.S. Preventive Services Task Force (USPSTF) determined that harms of ovarian cancer screening outweighed benefits based on trial evidence, and recommended against screening average-risk women.
Objective:
To update the previous systematic review and inform USPSTF ovarian cancer screening guidance.
Data Sources:
MEDLINE, PubMed, and the Cochrane Collaboration Registry of Controlled Trials from January 1, 2003, through January 31, 2017, and prior literature identified in the previous review conducted for the USPSTF.
Study Selection:
English-language trials of benefits and harms of screening for ovarian cancer in average-risk women reporting health outcomes (e.g., mortality and quality of life). Interventions compared with the control condition were transvaginal ultrasound screening alone, ultrasound screening with cancer antigen 125 (CA-125) testing, and CA-125 screening alone—either with a single measurement threshold value or measures of change over time.
Data Extraction and Synthesis:
Two investigators independently reviewed abstracts and full-text articles, and then extracted data from fair- and good-quality trials.
Main Outcomes and Measures:
Ovarian cancer mortality and incidence (defined as ovarian, fallopian tube, and peritoneal cancer), ovarian cancer survival, harms associated with false positive test results, false positive surgery, screening and surgical complications.
Results:
Four RCTs (n = 293,587) were included; three reported ovarian cancer mortality (KQ1) and all reported potential harms of screening (KQ2). Three trials were rated good-quality and the small trial (n= 549) reporting only on psychological harms of screening was rated fair-quality. Two trials were conducted in the United States and two in the United Kingdom, primarily with postmenopausal, average-risk women. The Prostate, Lung, Colorectal and Ovarian (PLCO) (n = 68,557) included 4-6 rounds of annual CA-125 (≥35 U/mL threshold) and transvaginal ultrasound screening, with up to 13 years of trial data. The U.K. Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) (n = 202,546) included 7–11 rounds of either annual transvaginal ultrasound screening or CA-125 screening using the Risk of Ovarian Cancer Algorithm with up to 14 years of trial data. A smaller U.K. Pilot trial (n = 21,935) included three rounds of annual screening with CA-125 (≥30 U/mL threshold) and up to 8 years of trial data. In all three screening trials, there was not a statistically significant difference in ovarian cancer mortality associated with screening. Mortality estimates from the PLCO (RR =1.18 [95% CI, 0.82 to 1.71]) or in either arm of the UKCTOCS: ultrasound (HR = 0.91 [95% CI, 0.76 to 1.09]) and CA-125 (HR = 0.89 [95% CI, 0.74 to 1.08]) were based on more rounds of screening and larger study populations. Harms of screening in these two large screening trials included surgical investigations among screen-positive women without cancer, which ranged from 1 percent of trial participants without cancer screened with CA-125 testing in the UKCTOCS, and 3.2 percent for the ultrasound arm of the UKCTOCS and in the PLCO screening intervention. Serious surgical complications of occurred for just over 3 percent of women without cancer in the UKCTOCS intervention arms, and in 15 percent of women in the PLCO intervention arm. In the two largest trials, cumulative false-positive rates ranged from 9.8% to 44%. Evidence on psychological harms was limited but nonsignificant, except in the case of repeat followup scans and tests, which increased the risk of psychological morbidity in a subsample of the UKCTOCS participants based on the General Health Questionnaire 12 (score ≥4) (OR 1.28 [95% CI, 1.18 to 1.39]).
Conclusions and Relevance:
Since the previous review for the USPSTF, results from a large trial conducted in the United Kingdom were published. Ovarian cancer mortality did not differ between control and intervention screening conditions in any of the included trials, including two good-quality studies with adequate power to detect differences. Harms of screening include surgery following a false-positive test, often resulting in removal of one or both ovaries and/or fallopian tubes, and the potential for major surgical complications. Reports from the UKCTOCS of a potential delayed effect of screening on ovarian cancer mortality require further followup data to evaluate, but the causal mechanism for a delayed screening effect is unclear. Major trials of promising ovarian cancer screening tools have null findings to date among healthy average-risk women, and there are considerable harms associated with screening.
Contents
- Acknowledgments
- Chapter 1. Introduction
- Chapter 2. Methods
- Chapter 3. Results
- Chapter 4. Discussion
- References
- Appendix A. Detailed Methods
- Appendix B. Included Studies
- Appendix C. Excluded Studies
- Appendix D. Benefits Reported in Ovarian Cancer Screening Trials: Ovarian Cancer Mortality in Analyses Excluding Peritoneal Cancer*
Suggested citation:
Henderson JT, Webber EM, Sawaya GF. Screening for Ovarian Cancer: An Updated Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 157. AHRQ Publication No. 17-05231-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2018.
This report is based on research conducted by the Kaiser Permanente Research Affiliates Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-00007-I-EPC5, Task Order No. 2). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients).
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
5600 Fishers Lane, Rockville, MD 20857; www
.ahrq.gov - 2
Kaiser Permanente Center for Health Research, Portland, OR
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