Marlborough (Mass.)/Kerpen – May 23, 2023 – Hologic Inc., a global leader in women’s health, attended the BMC Annual Convention on April 18-19 in Berlin. 120 interested listeners followed the expert panel on the topic “Innovation and standard care – a contradiction? Developments and tangible horizons in modern breast cancer care” on which Dr. Alexander Hoffmann, Director Market Access EU North at Hologic, was present.
Access to better diagnostics, therapy and patient support for those affected was the focus of the discussion. Breast cancer is with about 71,000 new cases per year and about 18,000 deaths[1] remains the most common type of cancer in women. Today, women between the ages of 50 and 69 have the opportunity to take advantage of the Germany-wide breast cancer screening program (mammography screening). the European Commission has recently recommended it for women aged 45-74. The good news here is that the German IQWIG (Institute for Quality and Efficiency in Health Care) is now also recommending this extension of the age limits by a total of 10 years and the group of around 12 million eligible women will increase to 17 million, according to Dr. Alexander Hoffman. The way to get there is quite complex, from the adjustment of the guidelines to the remuneration regulations for the service providers. dr Hoffmann expects the complete age extension to be implemented in practice by 2027. “If this could be accelerated, that would be desirable for everyone involved,” says the Hologic expert.
ToSyMa-Studie Phase 1
Hoffmann sees the probably greater benefit for women in the conversion of the current 2D mammography standard to 3D tomographic images of tomosynthesis and refers to the ToSyMa study, phase 1 of which[2] Results were published in April 2022. This is the world‘s largest randomized, controlled, multi-centre study[3], led by the University of Münster and funded by the German Research Foundation (DFG), compares the current screening standard mammography with tomosynthesis. A 48% increase in the detection rate of invasive breast cancer was measured in the intervention group (tomosynthesis + s2D) [4]. The number of “positive” biopsies that confirm the initial suspicion (measured by the positive predictive value) could also be increased. Thus, the results suggest that one of the criticisms of screening, the concern of false positive findings, can be addressed with this method.
Results on interval carcinoma rates are expected in ToSyMa phase 2 by the beginning of 2025 at the latest and the data from the cancer registries are currently being evaluated. Interval carcinomas are a recognized surrogate for morbidity and mortality. A reduction in this would also be an indicator that the improved detection rate is not due to overdiagnosis, but rather finding the right, clinically relevant tumors. At the latest, these results should pave the way for tomosynthesis to become part of standard care.
developments in Europe
As early as 2021, the European Commission recommended tomosynthesis or mammography for all women in screening, especially as the method of choice for women with dense breasts[5].
Austria has already taken the current ECIBC guideline adjustments as an opportunity to regularly allow tomosynthesis in screening from January 2023. If you look at this “emancipated handling of the EU guidelines” – Dr. Hoffmann also sees this as a good incentive to make tomosynthesis available in screening in Germany as soon as possible.
Given the 48% increase in detection rate and rate of positive biopsies, 6,000 women with early stage breast cancer could be detected per year who go undetected today. After the implementation of the extension of the age limit, there should even be around 8,000 women, and this is only calculated on the basis of the participating women. If tumors are detected at an earlier stage, smaller tumors can be treated more gently or no longer have to be treated aggressively in advanced age, then this could also change the therapeutic methods.
About Hologic
Hologic is a leading innovative medical technology company
in the development, manufacture and sale of high-quality diagnostic and surgical products as well as medical imaging systems with a focus on gynecology. The three core business areas focus on diagnostics, imaging and gynecological surgery.
With a comprehensive collection of technology and a powerful research and development program, Hologic has been committed to improving the quality of life since its founding in 1985. To do this, Hologic uses the latest science as a basis, so that medical professionals can find the right diagnosis and therapy for patients with increasing certainty. The company’s headquarters are in Marlborough, Massachusetts.
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