Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Screening - changes Oct 21st

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 National Cancer Institute
 

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• Overview
• Description of the Evidence
• Changes to This Summary (10/​21/​2016)
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Overview

• Evidence of Lack of Mortality Benefit Associated with Screening
  • Single-threshold cancer antigen 125 (CA-125) levels and transvaginal ultrasound (TVU)
  • Screening with TVU alone or with multimodal screening with CA-125 levels, assessed using the Risk of Ovarian Cancer Algorithm (ROCA), with TVU
  • Statement of Harms

Note: Separate PDQ summaries on Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Prevention; Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment; Ovarian Germ Cell Tumor Treatment; and Ovarian Low Malignant Potential Tumor Treatment are also available.

Evidence of Lack of Mortality Benefit Associated with Screening

Single-threshold cancer antigen 125 (CA-125) levels and transvaginal ultrasound (TVU)

There is solid evidence to indicate that screening women aged 55 to 74 years at average risk of developing ovarian cancer with the serum marker CA-125 (at a fixed threshold for a positive result of 35 U/mL) annually for 6 years and TVU for 4 years does not result in a decrease in ovarian cancer mortality, after a median follow-up of 14.7 years.

Magnitude of Effect: The ovarian cancer mortality rate was 3.8 deaths per 10,000 women in the screened group and 3.6 deaths per 10,000 person-years in the usual-care group, yielding a mortality rate ratio of 1.06 (95% confidence interval [CI], 0.87–1.30).[1]

• Study Design: Evidence obtained from one randomized controlled trial.
• Internal Validity: Good.
• Consistency: One trial has evaluated the impact on mortality from ovarian cancer.
• External Validity: Good.

Screening with TVU alone or with multimodal screening with CA-125 levels, assessed using the Risk of Ovarian Cancer Algorithm (ROCA), with TVU

Screening with TVU alone or with multimodal screening with CA-125 levels, assessed using the ROCA, combined with TVU in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) did not show a mortality benefit of screening with either approach based on a predetermined primary endpoint among women undergoing 7 to 11 screens and a median of 11.1 years of follow-up.[2]

Magnitude of Effect: Multimodal screening was associated with a nonsignificantly lower mortality than with no screening (15% lower mortality; 95% CI, -3% to 30%; P = .10). Ultrasound only screening also resulted in nonsignificantly lower mortality (11% lower mortality; 95% CI, -7% to 27%; P = .21).[2]

• Screening complications were less than 1% for both TVU only and multimodality screening strategies.
• Study Design: Evidence obtained from one randomized controlled trial.
• Internal Validity: Good.
• Consistency: One trial has evaluated the impact on mortality from ovarian cancer using this specific approach.
• External Validity: Good—based on data from other studies assessing complementary endpoints.

Statement of Harms

Based on solid evidence, screening for ovarian cancer results in false-positive test results. Screened women had higher rates of oophorectomy and other minor complications such as fainting and bruising.

Magnitude of Effect:

• Of screened women, 9.6% had false-positive results, resulting in 6.2% undergoing surgery. The surgical complication rate was 1.2% for all screened women.
• Oophorectomy rates were 85.7 per 10,000 person-years among screened women and 64.2 per 10,000 person-years among usual-care women.
• Minor complications with screening: 58.3 cases per 10,000 women screened with CA-125 and 3.3 cases per 10,000 women screened with transvaginal sonogram (TVS).
• Study Design: Evidence obtained from one randomized controlled trial.
• Internal Validity: Good.
• Consistency: Not applicable (N/A).
• External Validity: Good.

In the TVU-only arm of the UKCTOCS trial, there were 50 false-positive surgical procedures, and in the multimodality arm, there were 14 false-positive operations per 10,000 screens.[2]

In the general population, screening is targeted to postmenopausal women, and the major complications are related to surgery. Among younger women, the potential target group among BRCA1/2 mutation carriers, oophorectomy at younger than 45 years may increase mortality secondary to cardiovascular disease. Oophorectomy, if performed among younger women, may also reduce risk of estrogen receptor–positive breast cancers, which occur with elevated frequency among carriers of BRCA2 mutations.

References

1. Buys SS, Partridge E, Black A, et al.: Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial. JAMA 305 (22): 2295-303, 2011. [PUBMED Abstract]
2. Jacobs IJ, Menon U, Ryan A, et al.: Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet 387 (10022): 945-56, 2016. [PUBMED Abstract]

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Description of the Evidence

• Updated: October 21, 2016