RESUMO
PURPOSE: The aim of this study was to determine variability in visually assessed mammographic breast density categorization among radiologists practicing in Indonesia, the Netherlands, South Africa, and the United States. METHODS: Two hundred consecutive 2-D full-field digital screening mammograms obtained from September to December 2017 were selected and retrospectively reviewed from four global locations, for a total of 800 mammograms. Three breast radiologists in each location (team) provided consensus density assessments of all 800 mammograms using BI-RADS® density categorization. Interreader agreement was compared using Gwet's AC2 with quadratic weighting across all four density categories and Gwet's AC1 for binary comparison of combined not dense versus dense categories. Variability of distribution among teams was calculated using the Stuart-Maxwell test of marginal homogeneity across all four categories and using the McNemar test for not dense versus dense categories. To compare readers from a particular country on their own 200 mammograms versus the other three teams, density distribution was calculated using conditional logistic regression. RESULTS: For all 800 mammograms, interreader weighted agreement for distribution among four density categories was 0.86 (Gwet's AC2 with quadratic weighting; 95% confidence interval, 0.85-0.88), and for not dense versus dense categories, it was 0.66 (Gwet's AC1; 95% confidence interval, 0.63-0.70). Density distribution across four density categories was significantly different when teams were compared with one another and one team versus the other three teams combined (P < .001). Overall, all readers placed the largest number of mammograms in the scattered and heterogeneous categories. CONCLUSIONS: Although reader teams from four different global locations had almost perfect interreader agreement in BI-RADS density categorization, variability in density distribution across four categories remained statistically significant.
Assuntos
Densidade da Mama , Neoplasias da Mama , Humanos , Feminino , Variações Dependentes do Observador , Estudos Retrospectivos , Mamografia , Mama/diagnóstico por imagem , Neoplasias da Mama/diagnóstico por imagemRESUMO
BACKGROUND: Extremely dense breast tissue is associated with increased breast cancer risk and limited sensitivity of mammography. The DENSE trial showed that additional magnetic resonance imaging (MRI) screening in women with extremely dense breasts resulted in a substantial reduction in interval cancers. The cost-effectiveness of MRI screening for these women is unknown. METHODS: We used the MISCAN-breast microsimulation model to simulate several screening protocols containing mammography and/or MRI to estimate long-term effects and costs. The model was calibrated using results of the DENSE trial and adjusted to incorporate decreases in breast density with increasing age. Screening strategies varied in the number of MRIs and mammograms offered to women ages 50-75 years. Outcomes were numbers of breast cancers, life-years, quality-adjusted life-years (QALYs), breast cancer deaths, and overdiagnosis. Incremental cost-effectiveness ratios (ICERs) were calculated (3% discounting), with a willingness-to-pay threshold of 22 000. RESULTS: Calibration resulted in a conservative fit of the model regarding MRI detection. Both strategies of the DENSE trial were dominated (biennial mammography; biennial mammography plus MRI). MRI alone every 4 years was cost-effective with 15 620 per QALY. Screening every 3 years with MRI alone resulted in an incremental cost-effectiveness ratio of 37 181 per QALY. All strategies with mammography and/or a 2-year interval were dominated because other strategies resulted in more additional QALYs per additional euro. Alternating mammography and MRI every 2 years was close to the efficiency frontier. CONCLUSIONS: MRI screening is cost-effective for women with extremely dense breasts, when applied at a 4-year interval. For a willingness to pay more than 22 000 per QALY gained, MRI at a 3-year interval is cost-effective as well.
Assuntos
Densidade da Mama , Neoplasias da Mama , Idoso , Neoplasias da Mama/diagnóstico por imagem , Ensaios Clínicos como Assunto , Análise Custo-Benefício , Detecção Precoce de Câncer/métodos , Feminino , Humanos , Imageamento por Ressonância Magnética , Mamografia/métodos , Programas de Rastreamento , Pessoa de Meia-IdadeRESUMO
BackgroundDigital breast tomosynthesis (DBT) is a promising screening test, but its outcomes and cost-effectiveness remain uncertain.PurposeTo determine if biennial DBT is cost-effective in a screening setting, when compared with digital mammography (DM) in the Netherlands, and to quantify the uncertainty.Materials and MethodsIn this study, performed from March 2018 to February 2019, the MIcrosimulation SCreening ANalysis model was used to conduct a probabilistic sensitivity analysis (PSA), consisting of 10 000 model runs with 1 000 000 women simulated per run. The Bayesian Cost-Effectiveness Analysis package and the Sheffield Accelerated Value of Information tool were used to process PSA outcomes. Two simulated cohorts born in 1970 were invited to undergo biennial screening between ages 50 and 74 years-one cohort was assigned to DM screening, and one was assigned to DBT screening. DM input parameters were based on data from the Dutch breast cancer screening program. DBT parameters were based on literature and expert opinion. Willingness-to-pay thresholds of 20 000 ($22 000) and 35 000 ($38 500) per life-year gained (LYG) were considered. Effects and costs were discounted at 3.5% per year.ResultsDBT resulted in a gain of 13 additional life-years per 1000 women invited to screening (7% increase, 13 of 193), followed over lifetime, compared with DM and led to 2% (four of 159) fewer false-positive results. DBT screening led to incremental discounted lifetime effects of 5.09 LYGs (95% confidence interval: -0.80, 9.70) and an increase in lifetime costs of 137 555 ($151 311) per 1000 women (95% confidence interval: 31 093 [$34 202], 263 537 [$289 891]) compared with DM, resulting in a mean incremental cost-effectiveness ratio of 27 023 ($29 725) per LYG. The probability of DBT being more cost-effective was 0.36 at 20 000 and 0.66 at 35 000 per LYG.ConclusionSwitching from digital mammography to biennial digital breast tomosynthesis is not cost-effective at a willingness-to-pay threshold of 20 000 per life-year gained, but digital breast tomosynthesis has a higher probability of being more cost-effective than digital mammography at a threshold of 35 000 per life-year gained.© RSNA, 2020Online supplemental material is available for this article.See also the editorial by Slanetz in this issue.
Assuntos
Neoplasias da Mama/diagnóstico por imagem , Mamografia/economia , Idoso , Teorema de Bayes , Análise Custo-Benefício , Detecção Precoce de Câncer , Feminino , Humanos , Expectativa de Vida , Programas de Rastreamento , Pessoa de Meia-Idade , Sensibilidade e EspecificidadeRESUMO
OBJECTIVES: To evaluate at which sensitivity digital breast tomosynthesis (DBT) would become cost-effective compared to digital mammography (DM) in a population breast cancer screening program, given a constant estimate of specificity. METHODS: In a microsimulation model, the cost-effectiveness of biennial screening for women aged 50-75 was simulated for three scenarios: DBT for women with dense breasts and DM for women with fatty breasts (scenario 1), DBT for the whole population (scenario 2) or maintaining DM screening (reference). For DM, sensitivity was varied depending on breast density from 65 to 87%, and for DBT from 65 to 100%. The specificity was set at 96.5% for both DM and DBT. Direct medical costs were considered, including screening, biopsy and treatment costs. Scenarios were considered to be cost-effective if the incremental cost-effectiveness ratio (ICER) was below 20,000 per life year gain (LYG). RESULTS: For both scenarios, the ICER was more favourable at increasing DBT sensitivity. Compared with DM screening, 0.8-10.2% more LYGs were found when DBT sensitivity was at least 75% for scenario 1, and 4.7-18.7% when DBT sensitivity was at least 80% for scenario 2. At 96 per DBT, scenario 1 was cost-effective at a DBT sensitivity of at least 90%, and at least 95% for scenario 2. At 80 per DBT, these values decreased to 80% and 90%, respectively. CONCLUSION: DBT is more likely to be a cost-effective alternative to mammography in women with dense breasts. Whether DBT could be cost-effective in a general population highly depends on DBT costs. KEY POINTS: ⢠DBT could be a cost-effective screening modality for women with dense breasts when its sensitivity is at least 90% at a maximum cost per screen of 96. ⢠DBT has the potential to be cost-effective for screening all women when sensitivity is at least 90% at a maximum cost per screen of 80. ⢠Whether DBT could be used as an alternative to mammography for screening all women is highly dependent on the cost of DBT per screen.
Assuntos
Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/economia , Análise Custo-Benefício , Detecção Precoce de Câncer/economia , Mamografia/economia , Programas de Rastreamento/economia , Idoso , Biópsia , Mama/diagnóstico por imagem , Mama/patologia , Densidade da Mama , Simulação por Computador , Europa (Continente) , Feminino , Custos de Cuidados de Saúde , Humanos , Cadeias de Markov , Pessoa de Meia-Idade , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Because the incidence of breast cancer increases between 45 and 50years of age, a reconsideration is required of the current starting age (typically 50years) for routine mammography. Our aim was to evaluate the quantitative benefits, harms, and cost-effectiveness of lowering the starting age of breast cancer screening in the Dutch general population. METHODS: Economic modelling with a lifelong perspective compared biennial screening for women aged 48-74years and for women aged 46-74years with the current Dutch screening programme, which screen women between the ages of 50 and 74years. Tumour deaths prevented, years of life saved (YOLS), false-positive rates, radiation-induced tumours, costs and incremental cost-effectiveness ratios (ICERs) were evaluated. RESULTS: Starting the screening at 48 instead of 50 years of age led to increases in: the number of small tumours detected (4.0%), tumour deaths prevented (5.6%), false positives (9.2%), YOLS (5.6%), radiation-induced tumours (14.7%), and costs (4.1%). Starting the screening at 46 instead of 48 years of age increased the number of small tumours detected (3.3%), tumour deaths prevented (4.2%), false positives (8.8%), YOLS (3.7%), radiation-induced tumours (15.2%), and costs (4.0%). The ICER was 5600/YOLS for the 48-74 scenario and 5600/YOLS for the 46-74 scenario. CONCLUSIONS: Women could benefit from lowering the starting age of screening as more breast cancer deaths would be averted. Starting regular breast cancer screening earlier is also cost-effective. As the number of additional expected harms is relatively small in both the scenarios examined, and the difference in ICERs is not large, introducing two additional screening rounds is justifiable.
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Neoplasias da Mama/diagnóstico , Detecção Precoce de Câncer/economia , Programas de Rastreamento/economia , Modelos Teóricos , Idoso , Análise Custo-Benefício , Feminino , Humanos , Incidência , Mamografia , Pessoa de Meia-IdadeRESUMO
INTRODUCTION: Invasive breast cancer comprises a spectrum of histologic changes with purely lobular and purely ductal cancer on either side and mixed lesions in between. Our aim was to evaluate to what extent preoperative magnetic resonance imaging (MRI) leads to the finding of additional malignancies and the effect on surgical management in the subcategory of women with invasive ductolobular disease. PATIENTS AND METHODS: From 2007 to 2012, 109 patients diagnosed with breast cancer containing a lobular component underwent preoperative MRI. The MRI findings were compared with the findings from mammography and ultrasonography. Clinically relevant additional MRI findings were verified histologically. The histologic slides were reviewed, and the percentage of the lobular component was determined. In a multidisciplinary setting, the TNM classification and surgical policy were determined using the conventional imaging findings and as a scenario that included preoperative MRI. RESULTS: MRI revealed additional malignant foci in 28 of 109 patients (26%). More extensive disease was seen in 25 patients (23%). The preoperative MRI findings changed the TNM classification in 42% of the patients and altered the surgical policy in 37%. No correlation was found between the lobular component and the probability of detecting additional malignant foci, more extensive disease, or the frequency of a change in TNM classification or surgical policy. According to the final pathology report, the change in surgical policy was justified in 85% of the patients. CONCLUSION: In patients with breast cancer presenting with lobular differentiation at biopsy, preoperative MRI can lead to the detection of additional malignancies and clinically relevant changes in surgical policy in a high percentage of patients, irrespective of the lobular component. The use of MRI as a part of the standard workup of such patients deserves consideration.
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Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/diagnóstico por imagem , Carcinoma Ductal de Mama/patologia , Carcinoma Lobular/diagnóstico por imagem , Carcinoma Lobular/patologia , Idoso , Biópsia com Agulha de Grande Calibre , Neoplasias da Mama/cirurgia , Carcinoma Ductal de Mama/cirurgia , Carcinoma Lobular/cirurgia , Feminino , Humanos , Imageamento por Ressonância Magnética , Mamografia , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Cuidados Pré-Operatórios/métodos , Cuidados Pré-Operatórios/normas , Fatores de Risco , Ultrassonografia MamáriaRESUMO
OBJECTIVE: Increased recall rates in the Dutch breast cancer screening program call for a new assessment strategy aiming to reduce unnecessary costs and anxiety. Diagnostic work-up (usual care) includes multidisciplinary hospital assessment and is similar for all recalled women, regardless of the radiologist's suspicion of breast cancer. This is similar in many Canadian settings. We developed a novel assessment strategy that offers women with a low suspicion of breast cancer a quick and non-invasive assessment by a screening radiologist (intervention). We compared these two strategies in a cost-effectiveness analysis based on a randomized controlled trial: multicentre randomized controlled trial (MASS trial, Netherlands National Trial Register: NTR1480). METHODS: Participants were enrolled between August 2010 and December 2012 and were randomly assigned to either the intervention or control group (allocation ratio 2:1). Fourteen assessment centres participated in the study. Questionnaires were used to record quality of life (EuroQol-5D), health care use and costs after recall. RESULTS: Our study comprised 366 women, of whom 288 were randomly assigned to the intervention group and 88 to the control group. The mean difference in cost was 153/CAD $226 (95% confidence interval 107-199/CAD $158-294, p<0.001). We found no significant differences in quality of life. The bootstrapped incremental cost-effectiveness ratios in the cost-effectiveness plane showed that the intervention was the efficient, cost-saving modality. CONCLUSION: Our data show the benefits of tailoring diagnostic assessment to the screening radiologist's suspicion of breast cancer. Scenarios of implementing such a strategy in the Dutch screening or health care system are currently being discussed with various stakeholders.