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

Heindel, Walter; Weigel, Stefanie; Gerß, Joachim; Hense, Hans‐Werner; Sommer, A.; Krischke, Miriam; Kerschke, Laura

doi:10.1016/s1470-2045(22)00194-2

Cited by 55 publications

(67 citation statements)

References 29 publications

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“…TS is an evolution of the digital mammography. Numerous studies confirm the effectiveness of this technology in breast cancer screening, which increases the detection rate by up to 50%, 16 17 18 19 20 and reduces the recall rate for additional images by 9% to 29%. 19 20 The detected tumors have histological and immunohistochemical characteristics similar to those detected by mammography, 21 22 23 and results are maintained in subsequent rounds.…”

Section: Considerations About Breast Tomosynthesismentioning

confidence: 88%

Recommendations for the Screening of Breast Cancer of the Brazilian College of Radiology and Diagnostic Imaging, Brazilian Society of Mastology and Brazilian Federation of Gynecology and Obstetrics Association

Urban,

Chala,

Paula

et al. 2023

Rev Bras Ginecol Obstet

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Objective To present the update of the recommendations of the Brazilian College of Radiology and Diagnostic Imaging, the Brazilian Society of Mastology and the Brazilian Federation of Associations of Gynecology and Obstetrics for breast cancer screening in Brazil. Methods Scientific evidence published in Medline, EMBASE, Cochrane Library, EBSCO, CINAHL and Lilacs databases between January 2012 and July 2022 was searched. Recommendations were based on this evidence by consensus of the expert committee of the three entities. Recommendations Annual mammography screening is recommended for women at usual risk aged 40–74 years. Above 75 years, it should be reserved for those with a life expectancy greater than seven years. Women at higher than usual risk, including those with dense breasts, with a personal history of atypical lobular hyperplasia, classic lobular carcinoma in situ, atypical ductal hyperplasia, treatment for breast cancer or chest irradiation before age 30, or even, carriers of a genetic mutation or with a strong family history, benefit from complementary screening, and should be considered individually. Tomosynthesis is a form of mammography and should be considered in screening whenever accessible and available.

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Section: Considerations About Breast Tomosynthesismentioning

confidence: 88%

Recommendations for the Screening of Breast Cancer of the Brazilian College of Radiology and Diagnostic Imaging, Brazilian Society of Mastology and Brazilian Federation of Gynecology and Obstetrics Association

Urban,

Chala,

Paula

et al. 2023

Rev Bras Ginecol Obstet

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“…The To-Be trial may be too small to provide any definite answers regarding all aspects of costs and effects for DBT screening. To shed further light on these issues, several large randomized controlled trials are currently underway in Europe such as the PROSPECTS trial in the UK, 4 the TOSYMA trial in Germany [36] and the TMIST trial in Alabama, USA [37].…”

Section: Discussionmentioning

confidence: 99%

Costs and Effects of Implementing Digital Tomosynthesis in a Population-Based Breast Cancer Screening Program: Predictions Using Results from the To-Be Trial in Norway

Moger

Holen

Hanestad

et al. 2022

PharmacoEconomics Open

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Background Although several studies from Europe and the US have shown promising screening results favoring digital breast tomosynthesis compared with standard digital mammography (DM), both costs and effects of implementing tomosynthesis in routine screening programs remain uncertain. The cost effectiveness of using tomosynthesis in routine screening is debated in the literature, and model inputs from randomized trials are lacking. Using parameters mainly from a randomized controlled trial (the To-Be trial), we simulated costs and effects of implementing tomosynthesis in the national screening program BreastScreen Norway. Methods The To-Be trial was performed in Bergen from 2016 to 2017 within BreastScreen Norway, where females were randomized to either digital breast tomosynthesis including synthetic mammograms (DBT) or DM. The trial was followed by a cohort study offering all females DBT in 2018-2019. The trial included over 37,000 females, and allowed for estimation of short-term costs and effects related to screening, recall examinations and cancer detection. Using these and recent Norwegian estimates for 10-year stage-specific survival and treatment costs, the cost effectiveness of replacing DM with DBT in BreastScreen Norway was simulated in a decision tree model with probabilistic sensitivity analyses. Outcomes included false-positive screening results, screen-detected and interval cancers, stage at diagnosis, all-cause deaths, life-years gained, costs at recall and treatment and incremental cost-effectiveness ratio. ResultsThe estimated additional cost of DBT was €8.10. Simulating ten rounds of screening from 2018 and 10-year survival and costs, 500 deaths were averted and 2300 life-years gained at an additional screening cost of €29 million for females screened with DBT versus DM. Taking over-diagnosis, recall and treatment costs into account, DBT was dominant in the deterministic analysis. The incremental cost-effectiveness ratio indicated cost savings of €1400 per life-year gained. Probabilistic sensitivity analyses showed that DBT was cost effective in over 50% of the simulations at all willingness-to-pay levels per life-year gained, and in 80% of the simulations at levels above €22,000. If willingness-to-pay levels up to €35,000 were assumed, DBT would be cost effective in over 50% of the simulations for additional costs of DBT of up to €32, almost four times the estimated additional cost of €8.10. Conclusion DBT may be cost effective if implemented in BreastScreen Norway. However, generalizability of results could depend on factors varying between countries, such as recall rates, program sensitivity and specificity, treatment cost and willingness-to-pay levels.

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“…Nevertheless, neither use of handheld US nor automated whole-breast US can be recommended as a sole modality for screening (LoE 3a/C/AGO-) [14]. Using digital breast tomosynthesis, the recall and biopsy rates were low (LoE 1a/A/AGO+) [15][16][17][18]. Synthetic 2D image reconstruction of the 3D dataset can significantly reduce radiation dose and is highly recommended (LoE 1a/A/AGO++) [16,19].…”

Section: Bc Diagnosticsmentioning

confidence: 99%

Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2023

Park‐Simon¹,

Müller²,

Jackisch³

et al. 2023

Breast Care

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Background: Each year the interdisciplinary AGO (Arbeitsgemeinschaft Gynäkologische Onkologie, German Gynecological Oncology Group) Breast Committee on Diagnosis and Treatment of Breast Cancer provides updated state-of-the-art recommendations for early and metastatic breast cancer. Summary: The updated evidence-based treatment recommendation for early and metastatic breast cancer have been released in March 2023. Key messages: This paper concisely captures the updated recommendations for early breast cancer chapter by chapter.

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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

Cited by 55 publications

References 29 publications

Recommendations for the Screening of Breast Cancer of the Brazilian College of Radiology and Diagnostic Imaging, Brazilian Society of Mastology and Brazilian Federation of Gynecology and Obstetrics Association

Recommendations for the Screening of Breast Cancer of the Brazilian College of Radiology and Diagnostic Imaging, Brazilian Society of Mastology and Brazilian Federation of Gynecology and Obstetrics Association

Costs and Effects of Implementing Digital Tomosynthesis in a Population-Based Breast Cancer Screening Program: Predictions Using Results from the To-Be Trial in Norway

Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2023

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