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UKCTOCS

Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial

N = 202,638NCT00058032

Population
Postmenopausal women aged 50 to 74 years without increased familial ovarian cancer risk
Design
Randomised controlled trial in 13 centres in England, Wales and Northern Ireland. Postmenopausal women aged 50 to 74 years were allocated in blocks of 32 in a 1:1:2 ratio to annual multimodal screening (MMS: serum CA125 interpreted with the risk of ovarian cancer algorithm), annual transvaginal ultrasound screening (USS), or no screening. Exclusions were previous bilateral oophorectomy or ovarian malignancy, increased familial ovarian cancer risk and active non-ovarian malignancy. The primary outcome was death due to ovarian cancer (death due to ovarian or tubal cancer in the 2021 long-term report). The 2016 primary report was analysed by modified intention to screen and the 2021 report by intention to screen.
Primary endpoint
Ovarian cancer mortality
Arms
  • No screening (control, n = 101,359): No screening
  • Multimodal screening (experimental, n = 50,640): Annual serum CA125 interpreted with the risk of ovarian cancer algorithm, with repeat CA125 and transvaginal ultrasound as second-line test
  • Ultrasound screening (experimental, n = 50,639): Annual transvaginal ultrasound screening
People
Jacobs IJ
Δ Ovarian cancer mortality−0.05 pointsΔ Ovarian cancer mortality0 points
Show the numbers
Results reported for UKCTOCS
EndpointAnalysisMultimodal screening / Ultrasound screeningNo screeningEffect
Ovarian cancer mortalityModified intention to screen (202,546 women eligible for analysis)primarymedian follow-up 11.1 yearsJacobs 20160.29%0.34%P=0.10 (MMS); 0.21 (USS)Death due to ovarian cancer by 31 December 2014: 148 women in the MMS group, 154 in the USS group and 347 in the no-screening group. Primary analysis (Cox model) mortality reduction over years 0 to 14: 15% (95% CI -3 to 30) with MMS and 11% (-7 to 27) with USS. A prespecified analysis excluding prevalent cases gave an average mortality reduction of 20% (-2 to 40) with MMS.
Ovarian cancer mortalityIntention to screen (202,562 women analysed)long term-updatemedian follow-up 16.3 yearsMenon 20210.6%0.6%P=0.58 (MMS); 0.36 (USS)Death due to ovarian or tubal cancer by 30 June 2020: 296 women in the MMS group, 291 in the USS group and 619 in the no-screening group. No significant reduction was observed in either group compared with no screening.
Results reported for UKCTOCS
EndpointAnalysisMultimodal screening / Ultrasound screeningNo screeningEffect
Ovarian cancer mortalityModified intention to screen (202,546 women eligible for analysis)primarymedian follow-up 11.1 yearsJacobs 20160.29%0.34%P=0.10 (MMS); 0.21 (USS)Death due to ovarian cancer by 31 December 2014: 148 women in the MMS group, 154 in the USS group and 347 in the no-screening group. Primary analysis (Cox model) mortality reduction over years 0 to 14: 15% (95% CI -3 to 30) with MMS and 11% (-7 to 27) with USS. A prespecified analysis excluding prevalent cases gave an average mortality reduction of 20% (-2 to 40) with MMS.
Ovarian cancer mortalityIntention to screen (202,562 women analysed)long term-updatemedian follow-up 16.3 yearsMenon 20210.6%0.6%P=0.58 (MMS); 0.36 (USS)Death due to ovarian or tubal cancer by 30 June 2020: 296 women in the MMS group, 291 in the USS group and 619 in the no-screening group. No significant reduction was observed in either group compared with no screening.
Primary publication: Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2016;387(10022):945-956. PubMedDOI

Appears in

Sources

  1. Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2016;387(10022):945-956.

    PubMedDOI

  2. Menon U, Gentry-Maharaj A, Burnell M, Singh N, Ryan A, Karpinskyj C, et al. Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2021;397(10290):2182-2193.

    PubMedDOI