On March 17, 2023, the French National Authority for Health (HAS) published an update on its recommendations for techniques to be used within the organized breast cancer screening. HAS recommends introducing mammography by tomosynthesis in association with the reconstruction of a synthetic 2D image.
The National Cancer Institute (INCa) contacted HAS to assess the opportunity to introduce mammography by tomosynthesis (3D) into the organized screening strategy for breast cancer, which currently includes only authorized 2D digital mammography. In 2019 HAS carried out an initial analysis of the literature on the performance of mammography by tomosynthesis. This time, the HAS published an evaluation report on the performance and place of tomosynthesis mammography in the nationally organized breast cancer screening program – Part 2.
The HAS recommends integrating mammography by tomosynthesis associated with the reconstruction of a synthetic 2D image (3D + 2D) in organized screening for breast cancer, provided that it is systematically associated with the reconstruction of a synthetic 2D image. In parallel with the progressive deployment of 3D+2D in the organized screening throughout the national territory, the HAS recommends maintaining the current procedure based on digital mammography (2D). The HAS does not recommend the use of 3D alone. In addition, the HAS does not recommend the concomitant use of 3D and 2D, which increases exposure to X-rays.
Evaluation of the performance and place of tomosynthesis mammography in the national organized breast cancer screening program – Part 2
Who is this recommendation for?
It is aimed at public decision-makers.
What are the objectives of this recommendation?
The National Cancer Institute (INCa) asked HAS to assess the opportunity to introduce mammography by tomosynthesis (3D) into the organized screening strategy for breast cancer.
The first part of this public health recommendation, published in December 2019, presented an inventory of data from the international literature on the performance of tomosynthesis mammography in breast cancer screening, in particular in women at average risk of breast cancer. develop breast cancer.
The objectives of this second part are to assess the relevance of introducing mammography by tomosynthesis in the organized screening strategy for breast cancer, with regard to its performance (cancer detection rate, sensitivity and specificity of screening, recall, false positive rate, interval cancer rate), its safety and its efficiency (cost-effectiveness/cost-utility analysis), as well as the conditions for possible implementation on an organizational and ethical level.
The recommendation is based on a meta-analysis carried out by the HAS, a critical review of the literature, the reasoned opinion of experts brought together within a working group, as well as on the comments made in the final proofreading by the members of this group.
HAS compared the conventional mammography technique (2D) to the tomosynthesis technique (3D) alone, then to the 3D technique associated with 2D, and finally to this 3D technique associated with synthetic image reconstruction (2Ds).
Breast cancer in France in women is the 2nd most common cancer and the 1st cause of cancer death with more than 12,000 deaths in 2018.
The DO in France is aimed at women between 50 and 74 years old with an average risk of developing breast cancer (2.5 million screenings each year) and consists of carrying out, every two years, an examination breast clinic as well as a 2D mammogram. The double reading process, specific to France, is carried out for each mammogram deemed normal or presenting a benign image by the 1st reader radiologist. Only 2D digital mammography facilities (the acquired image is two-dimensional) have been authorized in the DO since February 2019, with either of the two technologies (2D-DR (full field) or 2D-CR (with screen luminescent radio)).
Mammography by tomosynthesis comprises a series of projections acquired at different angles (the source-detector pair describing an incomplete arc of a circle around the breast), which makes it possible to reconstruct the breast image in three dimensions using mathematical reconstruction software. of picture.
Main elements considered
HAS took into consideration:
- the burden of breast cancer in France,
- the performance of the current DO with 2D digital mammography,
- the performance of 3D digital mammography alone or in combination with 2D or 2Ds,
- the expected benefit in terms of cancer detection rate, recall rate, false positives and interval cancers,
- the main data from the review of the medico-economic literature,
- international recommendations,
- the position of the members of the working group and of the CEESP.
At the end of its assessment, the HAS recommends the integration of mammography by tomosynthesis in organized screening (OD) for breast cancer, provided that it is systematically associated with the reconstruction of a synthetic 2D image (3D/2Ds ). This procedure makes it possible to improve the performance of the DO, without increasing the exposure dose. In parallel with the progressive deployment of 3D+2Ds in DO throughout the national territory, HAS recommends maintaining the current procedure in 2022 based on digital mammography (2D-DR).
The HAS does not recommend the use of 3D alone in DO since it does not show improved performance with regard to the available data. In addition, the HAS does not recommend the concomitant use of 3D and 2D which, despite an increase in performance compared to 2D alone, increases exposure to X-rays (DO involving repeated procedures).
In addition, HAS deplores the strong heterogeneity of professional practices and mammographs used in the context of French DO (whether 2D or 3D mammographs). It also recalls the importance of respecting the specifications in terms of technical, clinical and safety performance defined by the competent authorities. As part of its missions, HAS is ready to contribute to the development of additional clinical performance specifications in OD and protocols in order to standardize professional practices.
- Mammography evaluation by tomosynthesis Organized breast cancer screening – Part 2 – Report
- Mammography evaluation by tomosynthesis Organized breast cancer screening – Part 2 – Appendices