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Speak to a specialist nurse on Freephone 0800 0087 054 WHAT UKCTOCS MEANS Professor Ian Jacobs, chief investigator of the UKCTOCS research: “These are exciting and important results. For the first time we have persuasive evidence that it is possible to save lives by intervening in the course of ovarian cancer by screening and early detection. “In a disease in which there has been little progress in treatment for three decades this is a major step forward. There is still a bit further to go in assembling the complex jigsaw puzzle of ovarian cancer screening, but 85% of the pieces are now in place. One last big push is needed over the next few years for follow-up to confirm the mortality reduction and assess the cost-effectiveness of screening. “The results provide initial estimates that screening reduces mortality by 15% to 28%. We now have an approach to screening using CA125 in the Risk of Ovarian Cancer Algorithm (ROCA) which can detect over 80% of cancers, achieves a shift to earlier stage, has a low false positive rate and seems to save lives. This is a fundamental contribution to addressing the challenge of ovarian cancer. “For individual women considering whether or not to undergo screening, the trial provides additional information to enable them to make an informed decision. In making that decision women will be influenced by a range of factors including: their risk of ovarian cancer; their attitude to risk, health and screening; and by the data about the sensitivity, false positive rate and mortality benefit of screening. “I think we will look back in 10 years and see that these results provided the basis for national screening programmes which play an important role in reducing the toll from ovarian cancer. There will now be a steady stream of refinements in risk assessment to plan which groups of women to invite for screening, in determining screening interval and in developing additional screening tests to add to the ROCA.” Professor Usha Menon, who co-led the trial: “The results have shown for the first time that screening may reduce deaths due to ovarian cancer. It may be possible to prevent one in five (20%) ovarian cancer deaths if women attended yearly screening. In the trial, approximately 15 ovarian cancer deaths were prevented for every 10,000 women who attended screening with a blood test, followed up with a scan when appropriate for at least seven to 11 years. Women who underwent screening were detected at an earlier stage than those who were in the no screening arm of the trial. “However, follow-up of UKCTOCS participants for two to three years is needed before we can be sure that the reduction in deaths is definite. We also need to determine exactly how many lives could be saved – it could be less or more than one in five. This will help us assess the balance between benefits and harms of screening as well as cost effectiveness of a programme. Our data at this point is not sufficient to recommend a National Screening Programme like for breast and cervical cancer. However we remain hopeful that in three years we will be able to approach the National Screening Committee with all the information they need to make a decision as to whether the NHS should have an ovarian cancer screening programme. “We are greatly indebted to our trial participants, the funding agencies and the many NHS staff who have brought us so far.” Study author Professor Ian Jacobs, president and vicechancellor of UNSW Australia and honorary professor at UCL, co-invented the ROCA in 1996 and is also a non-executive director of Abcodia Ltd, a UCL spin out company which owns the ROCA licence. Professor Usha Menon, UCL Women’s Health, co-led the trial and receives research funding from Abcodia. 4 Follow Ovacome on Twitter and Facebook or visit www.ovacome.org.uk
ovarian cancer charity WEIGHING UP THE RISK Consultant gynaecologist Adam Rosenthal (left) interprets the UKCTOCS results for BRCA-carriers at high risk of ovarian cancer. Women who are BRCAcarriers are still advised that risk-reducing surgery to remove the fallopian tubes and ovaries is the only way to prevent ovarian cancer and is the first option to consider. It is difficult to extrapolate the results of UKCTOCS directly to high-risk women, as the trial deliberately excluded this group. This was because it was designed to answer the question of whether screening the general population aged over 50 could save lives. However, the majority of the ovarian cancers occurring on UKCTOCS were ‘high grade serous’, which is by far the commonest type seen in BRCA-carriers, so it is reasonable to anticipate that the encouraging results seen in UKCTOCS apply in the high-risk population. Impetus for screening I think the UKCTOCS data strengthens the argument for screening with the Risk of Ovarian Cancer Algorithm (ROCA) test used in the trial. This is the most accurate way of detecting ovarian cancer in apparently healthy women, and it seems likely to have saved the lives of some women who develop the disease (at least in the general population). Therefore if a high-risk woman wants to undergo screening until she has surgery, as long as she is fully informed about its limitations (such as the possibility of having a false positive result), she should consider screening with the ROCA test. Some women delay surgery until completing their families or until they have gone through the menopause, in the latter case to avoid the need to take hormone replacement therapy (HRT) until the age of natural menopause (around 51 years). HRT is necessary to alleviate menopausal symptoms and reduce the increased risks of osteoporosis and heart disease seen in women who have a premature menopause. However, there is a real risk that delaying the surgery until the menopause may be too late, particularly in BRCA1 carriers who tend to get ovarian cancer younger. On balance we wouldn’t advise women to delay surgery until the menopause. For now, women wanting screening can pay for it in the private sector. The National Screening Committee has advised that NHS commissioners and providers would be unwise to actively pursue or allow screening of high-risk women before the results of phase two of the UK Familial Ovarian Cancer Screening Study (UK FOCSS) of over 4,500 high risk women are available later this year. However, there is evidence from the first phase of UK FOCSS that screening reduces the proportion of women diagnosed at stage 3b and above. Whilst this does not prove that screening high-risk women saves lives, it might have other benefits, such as reducing the complexity and morbidity of treatment. This first phase of UK FOCSS used annual screening with ultrasound scans and CA125 blood tests, but these were not interpreted using the ROCA test. In phase two of UK FOCSS, women had an annual scan and three CA125 tests per year, analysed using the ROCA test - which we now know detects twice as many ovarian cancers as CA125 used with a simple cut-off value - in the hope of detecting cancers earlier. Women also had an annual scan (sooner if their ROCA test was not normal). Phase two of UK FOCSS will therefore provide some evidence as to whether frequent screening using these techniques has advantages over annual screening with scans and CA125 used with a cut-off. High-risk women wanting screening should follow the UK FOCSS phase two protocol if the study shows it has advantages over annual screening. The introduction of a screening programme for women at increased risk of ovarian cancer would probably depend on whether NICE feels it is costeffective and would probably also take into account the further mortality analysis from UKCTOCS. • Disclosure: Adam Rosenthal is clinical lead of UK FOCSS and has a consultancy agreement with Abcodia. Ovarian cancer news 5
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