New results from the world's biggest ovarian cancer screening trial led by UCL suggest that screening based on an annual blood test may help reduce the number of women dying from the disease by around 20%.
The research, published today (Thursday) in the Lancet*, also cautions that longer follow up is needed to establish more certain estimates of how many deaths from ovarian cancer could be prevented by screening. Estimates from the results so far are promising, but the exact figures remain uncertain.
The UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)** is an international ovarian cancer screening trial, led by UCL and funded by the Medical Research Council, Cancer Research UK, Department of Health and The Eve Appeal.
Ovarian cancer was diagnosed in 1,282 women during the 14-year study of more than 200,000 post-menopausal women aged 50 to 74, of whom 649 had died of the disease by the trial end in December 2014.
The study showed a delayed effect on mortality between the screening and control arms, which became significant after the first seven years of the trial. The research team are now following up the study for three more years to establish the full impact of ovarian cancer screening.
The early results suggested that approximately 15 ovarian cancer deaths could be prevented for every 10,000 women who attend a screening programme that involves annual blood tests for between seven to 11 years.
The trial also confirmed previous findings that on average, for every three women who had surgery as a result of an abnormal screen, one woman had ovarian cancer while two women did not. For those who had surgery, around three per cent had major complications, which is the standard complication rate for this type of surgery in the NHS.
The screening blood test, called ROCA*** uses a statistical calculation to interpret changing levels over time of a blood protein called CA125, which is linked to ovarian cancer. This gives a more accurate calculation of a woman's individual risk of having ovarian cancer, compared with an alternative method which uses a one-off blood test measuring a fixed 'cut-off' point for CA125. The ROCA is licensed to Abcodia Ltd., a UCL spin out company.
Study author Professor Ian Jacobs, President and Vice-Chancellor of UNSW Australia and Honorary Professor at UCL, who co-invented the ROCA in 1996 and is also a non-executive director of Abcodia Ltd. said: "I am delighted that the UKCTOCS results suggest that early detection by screening can save lives. Longer follow up is needed but this brings hope in the fight against a disease for which the outlook for women is poor and has not improved much during the last three decades."
Professor Usha Menon, UCL Women's Health, who co-led the trial and receives research funding from Abcodia Ltd., said: "UKCTOCS has been an immense research effort spanning 14 years, over 200,000 women and 700,000 annual screens. Finally we have data which suggests that screening may prevent ovarian cancer deaths. This is welcome news and provides fresh impetus for renewed efforts in this area."
Dr Fiona Reddington, Cancer Research UK's head of population research, said: "This trial has been incredibly useful in improving our understanding of ovarian cancer. Detecting it early is vital to make sure that patients have the best treatment options and that more women can survive the disease. It's uncertain whether or not screening can reduce ovarian cancer deaths overall. While this is an important step in ovarian cancer research, we would not recommend a national screening programme at this point."
Athena Lamnisos, CEO of The Eve Appeal said: "These results don't necessarily signal the introduction of a national screening programme, but they are an exciting step forward for early detection of ovarian cancer. Medical research takes time to shift from the lab bench to the hospital bedside; today, the UKCTOCS results move early detection one step closer."
###
Notes to Editors
For a copy of the paper, or to speak to one of the authors, contact Harry Dayantis in the UCL press office, T: +44(0)20 3108 3844, M: +44(0)7747 565056, E: h.dayantis@ucl.ac.uk
*Jacobs, Menon et al., 'Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial' will be published in The Lancet at 12 noon UK time on Thursday 17 December at the following URL: http://dx.doi.org/10.1016/S0140-6736(15)01224-6
The authors will be holding a public meeting about the trial results to coincide with the publication. Event details, including a link to live stream the event, are available at the following URL: http://www.ucl.ac.uk/live/ukctocs
A patient-focused event led by women's cancer charities will also be taking place after the main event at 2-4pm, where case studies will be available. If you would like to attend the charity event please register at the following URL: https://www.eventbrite.co.uk/e/uk-collaborative-trial-of-ovarian-cancer-screening-ukctocs-research-event-tickets-19704990156
A patient-focused event led by women's cancer charities will also be taking place after the main event at 2-4pm, where case studies will be available. If you would like to attend the charity event please register at the following URL: https://www.eventbrite.co.uk/e/uk-collaborative-trial-of-ovarian-cancer-screening-ukctocs-research-event-tickets-19704990156
**The trial involved 202,638 post-menopausal women aged 50 to 74 who were randomly assigned to annual multimodal screening using the Risk of Ovarian Cancer Algorithm (ROCA), annual transvaginal ultrasound, or no test.
Initial analysis of the results across the 14 years of the trial found a reduction in ovarian cancer mortality due to screening that did not reach statistical significance. However, after further analysis that allowed for the delay between entry into the trial and developing the disease, and excluding women with evidence of already having ovarian cancer at entry, the statistically significant results suggest that screening reduces the number of women dying of ovarian cancer by around 20% over the 14 years of the study. The study allows us to be almost certain that screening reduces the number of women dying from ovarian cancer by somewhere between 0% and 40%, so further follow up is required to narrow this estimate.
***Based on the ROCA test score, a woman's risk is categorised as either normal - where she should continue with annual screening; intermediate - requiring a repeat blood test in 3 months or elevated - where a repeat blood test is required along with a transvaginal ultrasound in 6 weeks.
The ROCA has been licensed to Abcodia Ltd., a UCL spin out company. UCL is a major shareholder and CRUK have a small shareholding. Professor Jacobs is an Abcodia shareholder and Non-Executive Director and Professor Usha Menon is an Abcodia shareholder. As co-inventors, Dr Steven Skates and Professor Ian Jacobs will receive a share of the ROCA royalties from MGH (Massachusetts General Hospital) and QMUL (Queen Mary University of London) respectively, where they were based when they invented the test. Following an agreement with UCL, Abcodia has provided research funding to the Gynaecology Cancer Research Centre at UCL directed by Professor Menon since 2011 for the purpose of maintaining and accessing the UKCTOCS biobank. Abcodia acquired the ROCA license in 2014 from MGH and QMUL and has in late 2015 started offering the test in the UK and USA. In order to obtain expert advice on the use of the ROCA, Abcodia has agreed to pay for consultancy roles with members of the UKCTOCS team: Professor Ian Jacobs (University of New South Wales, UCL, University Of Manchester); Dr Steven Skates (MGH); Dr Anne Dawnay (UCLH); Dr Mourad Seif (University of Manchester and St Mary's Hospital).
National survival statistics for ovarian cancer are summarised on the Cancer Research UK website: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer/survival#heading-Zero
UKCTOCS is the world's largest ovarian cancer screening trial. 1.2 million women across England, Wales and Northern Ireland were invited to participate. 202,638 postmenopausal women aged between 50 and 74 years who did not have a strong family history of ovarian cancer were recruited through 13 participating NHS Trust from 2001-2005. They were randomly allocated to three groups: multimodal screening (50,640) or transvaginal ultrasound (50,639) who underwent annual screening until December 2011; or to a control group (101,359) who were not screened. Annual screening continued until December 2011. The control group is in accordance with current NHS guidelines as there is no evidence at present to support an ovarian cancer screening programme. All women are being followed up. http://www.instituteforwomenshealth.ucl.ac.uk/womens-cancer/gcrc/ukctocs
The trial is being run from the Gynaecological Cancer Research Centre, Women's Cancer, UCL EGA Institute for Women's Health. It was funded by the Medical Research Council, Cancer Research UK and Department of Health and is supported by gynaecological cancer research charity The Eve Appeal and the National Institute for Health Research University College London Hospitals Biomedical Research Centre.
Journal
The Lancet