Interval and Subsequent Round Breast Cancer in a Randomized Controlled Trial Comparing Digital Breast Tomosynthesis and Digital Mammography Screening

Hofvind, Solveig; Moshina, Nataliia; Holen, Åsne Sørlien; Danielsen, Anders Skyrud; Lee, Christoph I.; Houssami, Nehmat; Aase, Hildegunn Siv; Akslen, Lars A.; Haldorsen, Ingfrid S.

doi:10.1148/radiol.2021203936

Cited by 27 publications

(37 citation statements)

References 24 publications

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“…These results are in line with results from prospective studies, as for CD at baseline, 5,9,28 interval cancer 5,28 and subsequent screening 16,17 …”

Section: Discussionsupporting

confidence: 89%

“…These results are in line with results from prospective studies, as for CD at baseline, 5,9,28 interval cancer 5,28 and subsequent screening. 16,17 This design allows to evaluate whether a net increase in CD of DBT vs DM exists in the screened population, overcoming the potential bias of the learning curve linked to successive DBT rounds, and to estimate the lead time gain of DBT vs DM.…”

Section: Lead Time Gainmentioning

confidence: 99%

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A randomised controlled trial of digital breast tomosynthesis vs digital mammography as primary screening tests: Screening results over subsequent episodes of the Proteus Donna study

Armaroli

Frigerio

Correale

et al. 2022

Intl Journal of Cancer

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Proteus Donna is a randomised controlled trial aimed at prospectively evaluating screening with digital breast tomosynthesis (DBT), including interval cancer detection (ICD) and cancer detection (CD) in the analysis as a cumulative measure over subsequent screening episodes. Consenting women aged 46 to 68 attending the regional Breast Screening Service were randomly assigned to conventional digital mammography (DM, control arm) or DBT in addition to DM (DBT, study arm). At the subsequent round all participants underwent DM. Thirty‐six months follow‐up allowed for the identification of cancers detected in the subsequent screening and interscreening interval. Relative risk (RR) and 95% confidence interval (95% CI) were computed. Cumulative CD and Nelson‐Aalen incidence were analysed over the follow‐up period. Between 31 December 2014 and 31 December 2017, 43 022 women were randomised to DM and 30 844 to DBT. At baseline, CD was significantly higher (RR: 1.44, 95% CI: 1.21‐1.71) in the study arm. ICD did not differ significantly between the two arms (RR: 0.92, 95% CI: 0.62‐1.35). At subsequent screening with DM, the CD was lower (nearly significant) in the study arm (RR: 0.83, 95% CI: 0.65‐1.06). Over the follow‐up period, the cumulative CD (comprehensive of ICD) was slightly higher in the study arm (RR: 1.15, 95% CI: 1.01‐1.31). The Nelson‐Aalen cumulative incidence over time remained significantly higher in the study arm for approximately 24 months. Benign lesions detection was higher in the study arm at baseline and lower at subsequent tests. Outcomes are consistent with a lead time gain of DBT compared to DM, with an increase in false positives and moderate overdiagnosis.

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“…These results are in line with results from prospective studies, as for CD at baseline, 5,9,28 interval cancer 5,28 and subsequent screening 16,17 …”

Section: Discussionsupporting

confidence: 89%

Section: Lead Time Gainmentioning

confidence: 99%

A randomised controlled trial of digital breast tomosynthesis vs digital mammography as primary screening tests: Screening results over subsequent episodes of the Proteus Donna study

Armaroli

Frigerio

Correale

et al. 2022

Intl Journal of Cancer

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“…However, limitations of mammography have also been observed. The sensitivity of mammography is relatively lower for women of young age with dense breasts 40 , 49 . In addition, overdiagnosis might increase with the increasing diagnostic rate of breast cancer in younger women with the widespread use of mammography 54 , 56 .…”

Section: Imaging Techniques For Screening Breast Cancermentioning

confidence: 99%

Breast cancer screening and early diagnosis in Chinese women

Ding

Yang

et al. 2022

Cancer Biol Med

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Breast cancer is the most common malignant tumor in Chinese women, and its incidence is increasing. Regular screening is an effective method for early tumor detection and improving patient prognosis. In this review, we analyze the epidemiological changes and risk factors associated with breast cancer in China and describe the establishment of a screening strategy suitable for Chinese women. Chinese patients with breast cancer tend to be younger than Western patients and to have denser breasts. Therefore, the age of initial screening in Chinese women should be earlier, and the importance of screening with a combination of ultrasound and mammography is stressed. Moreover, Chinese patients with breast cancers have several ancestry-specific genetic features, and aiding in the determination of genetic screening strategies for identifying high-risk populations. On the basis of current studies, we summarize the development of risk-stratified breast cancer screening guidelines for Chinese women and describe the significant improvement in the prognosis of patients with breast cancer in China.

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“…It is apparent that the detection rate (number of screen-detected cancers per stage per 1000 screenings) for TNM1 cancers 1 and 2 2), while the opposite is true for TNM3 (Table 2) and interval cancers (Table 1). Interval cancer was defined as breast cancer diagnosed 24 months after negative screening or 6-24 months after false-positive screening [28]. Detailed information on the trial and clinical results are given elsewhere [10,28].…”

Section: Description Of the Model The To-be Sample And General Assump...mentioning

confidence: 99%

“…Interval cancer was defined as breast cancer diagnosed 24 months after negative screening or 6-24 months after false-positive screening [28]. Detailed information on the trial and clinical results are given elsewhere [10,28].…”

Section: Description Of the Model The To-be Sample And General Assump...mentioning

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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Interval and Subsequent Round Breast Cancer in a Randomized Controlled Trial Comparing Digital Breast Tomosynthesis and Digital Mammography Screening

Cited by 27 publications

References 24 publications

A randomised controlled trial of digital breast tomosynthesis vs digital mammography as primary screening tests: Screening results over subsequent episodes of the Proteus Donna study

A randomised controlled trial of digital breast tomosynthesis vs digital mammography as primary screening tests: Screening results over subsequent episodes of the Proteus Donna study

Breast cancer screening and early diagnosis in Chinese women

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

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