Providing a risk consultation with MammoRisk®?
MammoRisk®, a scoring tool.
The risk model used by MammoRisk® is based on assessment of an individual’s risk using a database of individuals monitored over time, through comparison with the outcomes of their “closest” neighbours.
This “Nearest Neighbours” method uses machine learning algorithms to assess an individual’s risk of developing a serious pathology. Out of a number of so-called “neighbour” individuals (the same characteristics: age, family history, etc.), it aims to assess how many are likely to develop a disease. This makes it possible to assess an individual’s risk in comparison with their “closest” neighbours. This flexible method can be adapted to all databases and replaces the complex and abstruse mathematical models that have been used so far. This innovative approach to risk calculation has been patented. Applied to breast cancer, it has been validated on data from organised screening programme in France and the United States, in collaboration with several screening organisations.
Which patients are eligible?
MammoRisk® has been designed for all women (≥ 40 years of age) with no specific known risk of breast cancer. It is intended not only for women with a family history of breast cancer, but also for women with no predisposition, from 40 years of age, who would like to find out their risk of developing the disease through a test that is simple and quick to use.
However, MammoRisk® is not intended for women with a high risk of breast cancer, i.e. women who have received thoracic radiation (Hodgkin’s disease), who have a multiple family history of breast and/or ovarian cancer (Eisinger score ≥ 3), with a personal history of breast cancer or a history of atypical hyperplasia or LCIS, and for whom specific screening is already recommended.
The MammoRisk® assessment
At the end of the test, MammoRisk® provides a clear and accurate report giving an estimate of the absolute 5-year breast cancer risk, i.e. the probability of developing invasive breast cancer within 5 years: Moderate Risk / Intermediate Risk / High Risk. On the basis of this estimate, the doctor will be able to establish a personalised follow-up programme in a decision shared with the patient.
The 5 risk factors taken into account by MammoRisk®
Breast cancer is the most common form of cancer in women in France, the European Union and the United States. The number of cases observed each year has been decreasing since 2005, but the disease was still the main cause of cancer-related deaths in women in 2012. If detected at an early stage, breast cancer can be cured in 9 in 10 cases.
Source : www.e-cancer.fr (Institut National Du Cancer) ; IARC (International Agency Research on Cancer) ; Globocan 2018
The presence of a family history of breast cancer is one of the main risk factors for breast cancer, especially if it was diagnosed at an early age in family members. Almost 20 to 30% of breast cancers occur in women with a family history of breast cancer, i.e. several cases of breast cancer in the same family.
Campagnoli C et al. Breast cancer and hormone replacement therapy: putting the risk into perspective. Gynecol Endocrinol. 2001
Women with significant breast density are at a higher risk for breast cancer: women with the highest density have 4 to 6 times more risk of breast cancer than women whose breasts are made up almost entirely of adipose tissue. Breast density decreases with age, but certain breast cancer risk factors are also associated with breast density: breast density is higher in women who do not have children, whose first pregnancy was later in life, who have higher alcohol consumption, or who have a high body mass index (after menopause).
DenSeeMammo® is a software developed by Predilife. It allows breast density to be automatically assessed from a mammogram.
Boyd NF et al. Mammographic Density and the Risk and Detection of Breast Cancer.N Engl J Med 2007
The PRS is the result of a genetic test. The PRS is obtained by combining several SNPs (Single Nucleotide Polymorphisms) into a polygenic risk score. While the risk associated with an individual SNP is low, combining several SNPs into a polygenic risk score increases the power of the association. The PRS is statistically independent from established clinical risk factors.
It has been demonstrated that SNPs play a complementary role in relation to other breast cancer risk factors, such as breast density and family history, for predicting breast cancer risk. Combinations of risk models that include traditional variables + breast density + PRS can be used to more accurately estimate population risk. This makes it possible to refine and better identify high risk and low risk groups.
Vachon CM, et al. The contributions of breast density and common genetic variation to breast cancer risk. J Natl Cancer Inst. 2015;107(5). Shieh et Al. Breast Cancer Screening in the Precision Medicine Era: Risk-Based Screening in a Population-Based Trial. JNCI J Natl Cancer Inst (2017) 109(5) Yanes et Al. Clinical applications of polygenic breast cancer risk: a critical review and perspectives of an emerging field Breast Cancer Research (2020) 22:21
A personal history of breast biopsy is associated with an increased risk of breast cancer. However, biopsy is not a risk factor in itself, but rather a risk marker. A biopsy can be performed when an abnormality or lesion in the breast is suspected.
Cuzick J et al.Epidemiology of breast cancer–selected highlights.Breast. 2003
Predilife is a partner of the European MyPEBS study, in charge of the breast cancer risk assessment platform.
The main objective of the randomised MyPeBS (My Personal Breast Screening) study is to compare the current organised screening measures – based on the single criterion of age (except where women are identified as very high risk) – with a new screening strategy offering a type and frequency of tests based on each woman’s risk level.
The study, funded by the European Union and sponsored by Unicancer, plans to recruit 85,000 women aged 40 to 70 years in 6 countries (France, United Kingdom, Italy, Belgium, Israel, Spain), with a follow-up period of 4 years. Half of the women will undergo standard screening, and half will undergo screening based on an assessment of their risk.
Predilife is a partner of the MyPEBS study, in charge of the individual breast cancer risk assessment platform. To find out more: www.mypebs.eu
This project received funding from the European Union as part of the Horizon 2020 research and innovation programme – grant agreement no. 755394
For more information: www.mypebs.eu
Would you like more information?
Personalised screening: A strong expectation among women
Conducted in 2017, the Riviera study showed that the majority of women :
- Expect more information about screening exams
- Have a poor estimate of their risk of breast cancer
- Are in favour of an assessment of their risk of breast cancer
- 97% of women accept a breast cancer risk prevention consultation with a city doctor.
- 36% of the women included were identified with a high risk of breast cancer, potentially justifying more intensive screening or oncogenetic consultation (aimed at detecting a possible genetic predisposition to breast cancer).
- 27% of the participants were at low risk.
Results of the Riviera clinical study (NCT02997384) promoted by the Gustave Roussy centre and financed by the ARC foundation: 452 women, in 26 city practices (general practitioners, gynaecologists and radiologists). Measurement of the acceptance rate, the need for information, understanding and impact on the state of anxiety at 48 hours and at 1 year.
Source: Veron L. et al, Feasibility of breast cancer risk assessment and personalized breast screening recommendations delivery in community practice: a national prospective study (poster), EBCC 2018.
(1) *99% relative 5-year survival rate for localised cancer. Source: www.cancer.org
(2) (3)(4) Source: Les cancers en France, 2016 and 2018 edition – INCa
MammoRisk® and DenSeeMammo® are Class I medical devices manufactured by Predilife. They are regulated health products which carry the CE mark under these regulations. Read their user manuals carefully before use.
MammoRisk® and DenSeeMammo® are not diagnostic tests. MammoRisk® is a breast cancer risk assessment test. DenSeeMammo® is an automatic breast density evaluation software.