Combo of DBT and synthesized mammography has higher detection rate of breast cancer, says study
Germany: Digital breast tomosynthesis (DBT) plus synthesized 2D (s2D) mammography can detect more invasive breast cancer than digital mammography alone, a recent study has stated. The study appears in the journal The Lancet Oncology on April 12, 2022.
The current standard of breast cancer screening is two-dimensional (2D) full-field digital mammography. DBT generates pseudo-three dimensional datasets of the breast from which s2D mammograms can be reconstructed. This innovative approach lowers the likelihood of overlapping breast tissues that can conceal features of malignancy.
Prof Walter Heindel, University of Münster and University Hospital Münster, Münster, Germany, and colleagues aimed to compare digital breast tomosynthesis combined with s2D mammography and digital screening mammography for the detection of invasive breast cancer in TOSYMA -- a randomized, open-label, superiority trial was done at 17 screening units in two federal states of Germany.
Eligible participants were women aged 50–69 years who had been invited to participate in a population-wide, quality-controlled mammography screening program. 689 women were randomly assigned in the ratio of 1:1 to receive digital breast tomosynthesis plus s2D mammography (n=49 804) or digital mammography alone (n=49 830).
The detection rate of invasive breast cancer and invasive interval cancer rate at 24 months was the primary endpoints, analyzed in the modified full analysis set, which included all randomly assigned participants who underwent either type of screening examination. Ten examinations, corresponding to second study participants were excluded. According to the intention-to-treat principle, analyses were done. In the follow-up study, interval cancer rates will be reported. Safety was assessed in the as-treated population, which included all participants who were randomly assigned.
The findings of the study were as follows:
- Invasive breast cancers were detected in 354 of 49 715 women with evaluable primary endpoint data in the digital breast tomosynthesis plus s2D group (detection rate 7·1 case per 1000 women screened) and in 240 of 49 762 women in the digital mammography group (4·8 cases per 1000 women screened; odds ratio 1·48).
- Adverse events and device deficiencies were rare (six adverse events in each group; 23 device deficiencies in the digital breast tomosynthesis plus s2D group vs five device deficiencies in the digital mammography group) and no serious adverse events were reported.
The researchers concluded, "evaluation of interval cancer rates in the follow-up study will further help to investigate incremental long-term benefits of digital breast tomosynthesis screening."
Reference:
Heindel W, Weigel S, Gerß J, Hense HW, Sommer A, Krischke M, Kerschke L; TOSYMA Screening Trial Study Group. Digital breast tomosynthesis plus synthesised mammography versus digital screening mammography for the detection of invasive breast cancer (TOSYMA): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Oncol. 2022 Apr 12:S1470-2045(22)00194-2. doi: 10.1016/S1470-2045(22)00194-2. Epub ahead of print. PMID: 35427470.
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