Over 7,000 women in Italy are participating in a study that aims to understand if and how to change breast cancer screening to personalize it. No longer a “one size fits all” but a “tailor-made” screening, with different tests at different time intervals, decided case by case. The study – which we tell you about in the new Health Breast newsletter – is called My PeBS (acronym for My Personal Breast Screening), involves 7 countries and is funded with 12.5 million euros from the Horizon 2020 program: until 2025 it will recruit in all 85 thousand women between 40 and 70 years, of which 30 thousand in our country, at 6 centers (in Emilia Romagna, Piedmont and Tuscany) coordinated by the Local Health Authority of Reggio Emilia.
The goal of screening is to detect breast cancer as early as possible, to reduce above all the number of deaths, but also the severity of the disease and, consequently, the necessary treatments. All programs have traditionally used the same “universal” age-based strategy, in which women between the ages of 50 and 69 are invited for a mammogram every 2 or 3 years. “It has been observed that screening leads to a reduction in breast cancer mortality ranging between 20% and 40%, depending on the studies considered,” he explains. Silvia Deandrea, President of the National Mammographic Screening Group (Gisma): “For some time, however, experiments have been carried out to understand how to increase its sensitivity and effectiveness”.
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The My PeBS study – also presented at the Gisma congress that was held last December – is one of these, and is among the largest. Participants are randomly divided into two groups: half of them will continue to be called for a normal mammogram at the end of the two canonical years, as foreseen by the current screening program; for the other half, on the other hand, risk factors will be analyzed first.
Alongside the classic variables – such as age, reproductive and hormonal history (menopause, age at menarche, age at first child), family history, previous breast biopsies and breast density (i.e. the percentage of glandular mass compared to fat mass) – will be also performed a genomic analysis of over 300 genetic mutations (called SNPs, variants of the DNA of a single letter) associated with the risk of breast cancer, thanks to simple saliva samples.
As explained on the website of the National Screening Observatory Paolo Giorgi Rossi, director of the Inter-Company Epidemiology Service of the Reggio Emilia Local Health Authority, “each variant is associated with a minimal change in the probability of having breast cancer and therefore carries insignificant information in itself. But, combining more than 300 SNPs together, we obtains a score that allows to discriminate fairly accurately women who have a very low risk from women who have a higher risk “.
Based on the overall score, 4 risk levels are then established, which correspond to different screening protocols:
– women in the low-risk group (less than 1% risk of developing cancer at 5 years) are asked to repeat mammography after 4 years;
– women at medium risk are invited to participate in a mammogram every 2 years, as in the standard programs, but with the addition of an ultrasound in the case of very dense breasts;
– women with an above average risk (but less than 6%) are invited every year and they too receive an ultrasound in case of very dense breasts;
– women with a risk of more than 6% have an MRI and a mammogram every year up to the age of 60, and then only the annual mammogram (a program similar to that foreseen for women with mutations in the BRCA genes).
The data will tell us if this type of personalized approach is better than the standard one in reducing the incidence of cancers discovered already in stage II or more advanced, and if it is also cost-effective, and therefore sustainable for the national health system.
3D mammography and age extension: still little applied
Some progress has been made in recent years. In Emilia Romagna, for example, those who participate in mammography screening are also investigated to identify the possible presence of BRCA mutations and, in this case, access the active surveillance service. In Veneto, an Italian study – the Verona Pilot Study – is demonstrating that tomosynthesis (the so-called 3D mammography) is an effective screening test, capable of identifying the smallest lesions better than digital mammography.
There is also the indication – European and Italian – to extend the invitation to other population groups, starting from 45 and up to 74. In 2019, however, only three Regions did so, with a huge effort. “A recommendation of the Italian guidelines is forthcoming that will cover women between 45 and 49 to indicate the best interval between tests in this age group (annual or biennial), and a group of experts has been set up that will decide whether to introduce the tomosynthesis as a first level exam “, continues Deandrea:” At the moment, however, neither the extension of the age groups nor the tomosynthesis are in the LEA (the essential levels of assistance, guaranteed by the health system, ed), so it is up to the Regions or individual centers to find resources to support them “.
New ways are also being sought to involve people who do not adhere to the invitation today and to improve services so that they reach the still uncovered population. Suffice it to say that, again in 2019 (in the pre-Covid era), 8,300 cancers discovered thanks to screening were 8,300, i.e. only about 16% of all cancers diagnosed in each age group (53,000).
Also in Veneto, for example, a system of “open invitations” is being tested, managed in a very efficient way and through an online platform, where women can change appointments independently: an approach that is also reducing downtime for technicians, where the mammography unit is not used. “We must be able to intercept that 30-50%, depending on the Regions, who do not respond to invitations: who just do not do mammography or who do it outside the programs, working on general practitioners and on women – says Deandrea. – making people understand the value of screening, which is not offered as a series B, but as a series A, in which every aspect is monitored and transparency is guaranteed. Screening experiences the crisis of not being the novelty: it must be revisited and rediscovered. , of course, we need to try to improve the accuracy of the test, also thanks to artificial intelligence, on which we are focusing a lot in Europe “.
Why and what to change
Of course, before changing there must be proven proof that every change brings a real advantage, even more so since we are talking about services provided with public funds. But there are those who think that a step forward can no longer be postponed. “There is still a large number of women who do not accept the invitation, simply because they do not believe in screening: it is not sufficiently explained to them what the advantage of participating is, they find in many ASL equipment with over 10 years of life, as has shown the recent census of the Regional Agency for health services, according to which 20% is to be scrapped “, underlines Adriana Bonifacino, oncologist and president of the IncontraDonna Onlus association: “Moreover, since the programs started, the world has changed a lot. For example: today women move much more than once for work or other needs: ASL and Region change, sometimes nation. Those who join the screening do not receive documentation to take with them “. It could be argued that this is not going in the same direction as a digitalization of health, with the health record that should always be accessible online. “But this is not the case everywhere, unfortunately”, Bonifacino says: “Documentation does not travel on the network, because this network is not everywhere. If a person changes residence he does not have comparable documentation, or he obtains it by overcoming many difficulties of order bureaucratic”.
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IncontraDonna has developed a proposal, currently being examined by the Ministry of Health: “Screening is a pro-active health program, but we think it should be even more so and meet the different needs of women. It would be useful, for example. , have mobile units to reach small towns. The lady who lives in a small town or hamlet has the right to be reached by the first ring of prevention, that is, screening. I am talking about proximity medicine: the investments of the next PNRR are aimed mainly to the prevention and support of the territory and to the link between health houses and hospitals “.
Still, the risk factors and incidence have changed. Suffice it to say that many more women have dense breasts than in the past, that the diet has changed and that the use of Pma has increased: “Not everyone is lucky enough to live in Veneto or Emilia Romagna, where there are experimental programs – concludes l ‘oncologist – The same can be said for women at high risk due to familiarity. The Sant’Andrea Hospital in Rome, where I work, provides a path only because there are people who keep it alive: it is not systematic and it is not structural. For this reason I believe that the centrality of the state is needed “.