A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women.
Ontology highlight
ABSTRACT: Background
Chinese women tend to have small and dense breasts and ultrasound is a common method for breast cancer screening in China. However, its efficacy and cost comparing with mammography has not been evaluated in randomised trials.Methods
At 14 breast centres across China during 2008-2010, 13 339 high-risk women aged 30-65 years were randomised to be screened by mammography alone, ultrasound alone, or by both methods at enrollment and 1-year follow-up.Results
A total of 12 519 and 8692 women underwent the initial and second screenings, respectively. Among the 30 cancers (of which 15 were stage 0/I) detected, 5 (0.72/1000) were in the mammography group, 11 (1.51/1000) in the ultrasound group, and 14 (2.02/1000) in the combined group (P=0.12). In the combined group, ultrasound detected all the 14 cancers, whereas mammography detected 8, making ultrasound more sensitive (100 vs 57.1%, P=0.04) with a better diagnostic accuracy (0.999 vs 0.766, P=0.01). There was no difference between mammography and ultrasound in specificity (100 vs 99.9%, P=0.51) and positive predictive value (72.7 vs 70.0%; P=0.87). To detect one cancer, the costs of ultrasound, mammography, and combined modality were $7876, $45 253, and $21 599, respectively.Conclusions
Ultrasound is superior to mammography for breast cancer screening in high-risk Chinese women.
SUBMITTER: Shen S
PROVIDER: S-EPMC4366890 | biostudies-literature | 2015 Mar
REPOSITORIES: biostudies-literature
Publications
A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women.
Shen S S Zhou Y Y Xu Y Y Zhang B B Duan X X Huang R R Li B B Shi Y Y Shao Z Z Liao H H Jiang J J Shen N N Zhang J J Yu C C Jiang H H Li S S Han S S Ma J J Sun Q Q
British journal of cancer 20150317 6
<h4>Background</h4>Chinese women tend to have small and dense breasts and ultrasound is a common method for breast cancer screening in China. However, its efficacy and cost comparing with mammography has not been evaluated in randomised trials.<h4>Methods</h4>At 14 breast centres across China during 2008-2010, 13 339 high-risk women aged 30-65 years were randomised to be screened by mammography alone, ultrasound alone, or by both methods at enrollment and 1-year follow-up.<h4>Results</h4>A total ...[more]
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Project description:ContextScreening ultrasound may depict small, node-negative breast cancers not seen on mammography.ObjectiveTo compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with ultrasound plus mammography vs mammography alone in women at elevated risk of breast cancer.Design, setting, and participantsFrom April 2004 to February 2006, 2809 women, with at least heterogeneously dense breast tissue in at least 1 quadrant, were recruited from 21 sites to undergo mammographic and physician-performed ultrasonographic examinations in randomized order by a radiologist masked to the other examination results. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2637 (96.8%) of the 2725 eligible participants.Main outcome measuresDiagnostic yield, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) of combined mammography plus ultrasound vs mammography alone and the positive predictive value of biopsy recommendations for mammography plus ultrasound vs mammography alone.ResultsForty participants (41 breasts) were diagnosed with cancer: 8 suspicious on both ultrasound and mammography, 12 on ultrasound alone, 12 on mammography alone, and 8 participants (9 breasts) on neither. The diagnostic yield for mammography was 7.6 per 1000 women screened (20 of 2637) and increased to 11.8 per 1000 (31 of 2637) for combined mammography plus ultrasound; the supplemental yield was 4.2 per 1000 women screened (95% confidence interval [CI], 1.1-7.2 per 1000; P = .003 that supplemental yield is 0). The diagnostic accuracy for mammography was 0.78 (95% CI, 0.67-0.87) and increased to 0.91 (95% CI, 0.84-0.96) for mammography plus ultrasound (P = .003 that difference is 0). Of 12 supplemental cancers detected by ultrasound alone, 11 (92%) were invasive with a median size of 10 mm (range, 5-40 mm; mean [SE], 12.6 [3.0] mm) and 8 of the 9 lesions (89%) reported had negative nodes. The positive predictive value of biopsy recommendation after full diagnostic workup was 19 of 84 for mammography (22.6%; 95% CI, 14.2%-33%), 21 of 235 for ultrasound (8.9%, 95% CI, 5.6%-13.3%), and 31 of 276 for combined mammography plus ultrasound (11.2%; 95% CI. 7.8%-15.6%).ConclusionsAdding a single screening ultrasound to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but it will also substantially increase the number of false positives.Trial registrationclinicaltrials.gov Identifier: NCT00072501.
| S-EPMC2718688 | biostudies-literature
Project description:The cost-effectiveness of mammography screening among Chinese women remains contentious. Here, we characterized breast cancer (BC) epidemiology in Hong Kong and evaluated the cost-effectiveness of personalized risk-based screening. We used the Hong Kong Breast Cancer Study (a case-control study with 3501 cases and 3610 controls) and Hong Kong Cancer Registry to develop a risk stratification model based on well-documented risk factors. We used the Shanghai Breast Cancer Study to validate the model. We considered risk-based programs with different screening age ranges and risk thresholds under which women were eligible to join if their remaining BC risk at the starting age exceeded the threshold. The lifetime risk (15-99 years) of BC ranged from 1.8% to 26.6% with a mean of 6.8%. Biennial screening was most cost-effective when the starting age was 44 years, and screening from age 44 to 69 years would reduce breast cancer mortality by 25.4% (95% credible interval [CrI] = 20.5%-29.4%) for all risk strata. If the risk threshold for this screening program was 8.4% (the average remaining BC risk among US women at their recommended starting age of 50 years), the coverage was 25.8%, and the incremental cost-effectiveness ratio (ICER) was US$18 151 (95% CrI = $10 408-$27 663) per quality-of-life-year (QALY) compared with no screening. The ICER of universal screening was $34 953 (95% CrI = $22 820-$50 268) and $48 303 (95% CrI = $32 210-$68 000) per QALY compared with no screening and risk-based screening with 8.4% threshold, respectively. Organized BC screening in Chinese women should commence as risk-based programs. Outcome data (e.g., QALY loss because of false-positive mammograms) should be systemically collected for optimizing the risk threshold.
| S-EPMC8346705 | biostudies-literature
Project description:ObjectiveTo compare the outcomes of digital breast tomosynthesis (DBT) screening combined with ultrasound (US) with those of digital mammography (DM) combined with US in women with dense breasts.Materials and methodsA retrospective database search identified consecutive asymptomatic women with dense breasts who underwent breast cancer screening with DBT or DM and whole-breast US simultaneously between June 2016 and July 2019. Women who underwent DBT + US (DBT cohort) and DM + US (DM cohort) were matched using 1:2 ratio according to mammographic density, age, menopausal status, hormone replacement therapy, and a family history of breast cancer. The cancer detection rate (CDR) per 1000 screening examinations, abnormal interpretation rate (AIR), sensitivity, and specificity were compared.ResultsA total of 863 women in the DBT cohort were matched with 1726 women in the DM cohort (median age, 53 years; interquartile range, 40-78 years) and 26 breast cancers (9 in the DBT cohort and 17 in the DM cohort) were identified. The DBT and DM cohorts showed comparable CDR (10.4 [9 of 863; 95% confidence interval {CI}: 4.8-19.7] vs. 9.8 [17 of 1726; 95% CI: 5.7-15.7] per 1000 examinations, respectively; P = 0.889). DBT cohort showed a higher AIR than the DM cohort (31.6% [273 of 863; 95% CI: 28.5%-34.9%] vs. 22.4% [387 of 1726; 95% CI: 20.5%-24.5%]; P < 0.001). The sensitivity for both cohorts was 100%. In women with negative findings on DBT or DM, supplemental US yielded similar CDRs in both DBT and DM cohorts (4.0 vs. 3.3 per 1000 examinations, respectively; P = 0.803) and higher AIR in the DBT cohort (24.8% [188 of 758; 95% CI: 21.8%-28.0%] vs. 16.9% [257 of 1516; 95% CI: 15.1%-18.9%; P < 0.001).ConclusionDBT screening combined with US showed comparable CDR but lower specificity than DM screening combined with US in women with dense breasts.
| S-EPMC10067692 | biostudies-literature
Project description:IntroductionThe US plays a crucial role in screening Asian women for breast disease. ABUS offers several advantages over traditional HHUS, including quicker examination, objectivity, and the ability to store and reconstruct images. This study marks the first large-scale opportunistic screening of ABUS in the population.MethodsBetween January 1, 2016, and December 31, 2019, 10,537 women aged 35-75 years from nine districts were randomly assigned to either HHUS or ABUS groups. Diagnostic methods were quantified, and comparisons were made using the Chi-square test.ResultsThe screening groups consisted of 5,445 participants for HHUS and 4,936 for ABUS. The HHUS and ABUS groups identified 90 carcinomas and 292 benign lesions or 71 carcinomas and 178 benign lesions, respectively. SE), SP, AC, PPV, and NPV for HHUS were 51.11%, 93.84%, 93.13%, 12.23%, and 99.13%, respectively, while for ABUS, they were 66.20%, 93.77%, 93.38%, 13.43%, and 98.98%. The area under the curve (AUC) values for HHUS and ABUS were 0.72 (95% CI: 0.67-0.78) and 0.86 (95% CI: 0.82-0.91), respectively, indicating superior diagnostic performance of ABUS over HHUS (Delong test p < 0.05).DiscussionABUS is user-friendly, requires minimal training, reduces reliance on examiner experience, and demonstrates potential for superior sensitivity compared to HHUS in breast cancer screening.
| S-EPMC11790623 | biostudies-literature
Project description:ImportanceGuidelines recommend individualizing screening mammography decisions for women aged 75 years and older. However, little pragmatic guidance is available to help counsel patients.ObjectiveTo provide an evidence-based approach for individualizing decision-making about screening mammography in older women.Evidence acquisitionWe searched PubMed for English-language studies in peer-reviewed journals published from January 1, 1990, to February 1, 2014, to identify risk factors for late-life breast cancer in women aged 65 years and older and to quantify the benefits and harms of screening mammography for women aged 75 years and older.FindingsAge is the major risk factor for developing and dying from breast cancer. Breast cancer risk factors that reflect hormonal exposures in the distant past, such as age at first birth or age at menarche, are less predictive of late-life breast cancer than factors indicating recent hormonal exposures such as high bone mass or obesity. Randomized trials of the benefits of screening mammography did not include women older than 74 years. Thus it is not known if screening mammography benefits older women. Observational studies favor extending screening mammography to older women who have a life expectancy of more than 10 years. Modeling studies estimate 2 fewer breast cancer deaths/1000 women who in their 70s continue biennial screening for 10 years instead of stopping screening at age 69. Potential harms of continued screening over 10 years include false-positive mammograms in approximately 200/1000 women screened and overdiagnosis (ie, finding breast cancer that would not have clinically surfaced otherwise) in approximately 13/1000 women screened. Providing information about life expectancy along with potential benefits and harms of screening may help older women's decision-making about screening mammography.Conclusions and relevanceFor women with less than a 10-year life expectancy, recommendations to stop screening mammography should emphasize increased potential harms from screening and highlight health promotion measures likely to be beneficial over the short term. For women with a life expectancy of more than 10 years, deciding whether potential benefits of screening outweigh harms becomes a value judgment for patients, requiring a realistic understanding of screening outcomes.
| S-EPMC4391705 | biostudies-literature
Project description:The role of further hormone therapy in castration-resistant prostate cancer (CRPC) remains unclear. We performed a multi-centre randomised phase III study comparing the use of Dexamethasone, Aspirin, and immediate addition of Diethylstilbestrol (DAiS) vs Dexamethasone, Aspirin, and deferred (until disease progression) addition of Diethylstilbestrol (DAdS).From 2001 to 2008, 270 men with chemotherapy-naive CRPC were randomly assigned, in a 1 : 1 ratio, to receive either DAiS or DAdS. They were stratified for performance status, presence of bone metastases, and previous normalisation of prostate-specific antigen (PSA) to androgen deprivation. The study end points were the proportion of patients achieving a 50% PSA response, progression-free survival (PFS), overall survival, and quality of life. Intention-to-treat analysis was carried out. The effect of treatment was studied first by Kaplan-Meier curves and log-rank test, and finally through multivariable stratified Cox's proportional hazards model adjusting for the effects of possible baseline prognostic factors. Quality of life was analysed using multivariate analysis of variance.At study entry, the median age was 76 years (inter-quartile range: 70-80 years), the median PSA was 79 ng ml(-1), and 76% of the cohort had metastatic disease. The response rates for DAiS (68%) and DAdS (64%) were not significantly different (P=0.49). Similar to the response rate, neither the PFS (median=8.1 months for both arms) nor the overall survival (19.4 vs 18.8 months) differed significantly between the DAiS and DAdS groups (P>0.20). However, the response rate for the DAiS (68%) was significantly higher than the response rate of DA (before adding Diethylstilbestrol) (50%) (P=0.002). Similarly, the median time to progression for DAiS (8.6 months) was significantly longer than that of DA (4.5 months) (P<0.001). Multivariable analysis showed that patients with previous haemoglobin ≥11 g dl(-1) decreased the risk of death significantly (hazard ratio: 0.44, 95% CI: 0.25-0.77). Patients treated with previous anti-androgens alone had more than 5 times more risk of death compared with patients treated with gonadorelin analogues throughout their castration-sensitive phase. Treatment sequencing did not affect the quality of life but pre-treatment performance status did. The incidence of veno-thromboembolic events was 22% (n=28) in DAiS and 11% (n=14) in the DA arm (P=0.02). Painful gynaecomastia occurred in only 1% on DA, whereas in 40% on DAiS (P=0.001).Dexamethasone and immediate Diethylstilbestrol resulted in neither higher PSA response rate nor higher PFS compared with Dexamethasone with deferred Diethylstilbestrol. There was no suggestion of significantly improved overall survival or quality of life. Given the significantly higher toxicity of Diethylstilbestrol, deferring Diethylstilbestrol until failure of Dexamethasone is the preferred strategy when using these agents in CRPC.
| S-EPMC3049603 | biostudies-other
Project description:ObjectivesTo evaluate the potential of contrast-enhanced mammography (CEM) for reducing the biopsy rate of screening recalls.MethodsRecalled women were prospectively enrolled to undergo CEM alongside standard assessment (SA) through additional views, tomosynthesis, and/or ultrasound. Exclusion criteria were symptoms, implants, allergy to contrast agents, renal failure, and pregnancy. SA and CEM were independently evaluated by one of six radiologists, who recommended biopsy or 2-year follow-up. Biopsy rates according to SA or recombined CEM (rCEM) were compared with the McNemar's test. Diagnostic performance was calculated considering lesions with available final histopathology.ResultsBetween January 2019 and July 2021, 220 women were enrolled, 207 of them (median age 56.6 years) with 225 suspicious findings analysed. Three of 207 patients (1.4%) developed mild self-limiting adverse reactions to iodinated contrast agent. Overall, 135/225 findings were referred for biopsy, 90/225 by both SA and rCEM, 41/225 by SA alone and 4/225 by rCEM alone (2/4 being one DCIS and one invasive carcinoma). The rCEM biopsy rate (94/225, 41.8%, 95% CI 35.5-48.3%) was 16.4% lower (p < 0.001) than the SA biopsy rate (131/225, 58.2%, 95% CI 51.7-64.5%). Considering the 124/135 biopsies with final histopathology (44 benign, 80 malignant), rCEM showed a 93.8% sensitivity (95% CI 86.2-97.3%) and a 65.9% specificity (95% CI 51.1-78.1%), all 5 false negatives being ductal carcinoma in situ detectable as suspicious calcifications on low-energy images.ConclusionsCompared to SA, the rCEM-based work-up would have avoided biopsy for 37/225 (16.4%) suspicious findings. Including low-energy images in interpretation provided optimal overall CEM sensitivity.Key points• The work-up of suspicious findings detected at mammographic breast cancer screening still leads to a high rate of unnecessary biopsies, involving between 2 and 6% of screened women. • In 207 recalled women with 225 suspicious findings, recombined images of contrast-enhanced mammography (CEM) showed a 93.8% sensitivity and a 65.9% specificity, all 5 false negatives being ductal carcinoma in situ detectable on low-energy images as suspicious calcifications. • CEM could represent an easily available one-stop shop option for the morphofunctional assessment of screening recalls, potentially reducing the biopsy rate by 16.4%.
| S-EPMC9668944 | biostudies-literature
Project description:ImportanceIncreasing use of screening breast magnetic resonance imaging (MRI), including among women at low or average risk of breast cancer, raises concerns about resulting mammary and extramammary cascades (downstream services and new diagnoses) of uncertain value.ObjectiveTo estimate rates of cascade events (ie, laboratory tests, imaging tests, procedures, visits, hospitalizations, and new diagnoses) and associated spending following screening breast MRI vs mammography among commercially insured US women.Design, setting, and participantsThis cohort study used 2016 to 2018 data from the MarketScan research database (IBM Corporation), which includes claims and administrative data from large US employers and commercial payers. Participants included commercially insured women aged 40 to 64 years without prior breast cancer who received an index bilateral screening breast MRI or mammogram between January 1, 2017, and June 30, 2018. We used propensity scores based on sociodemographic, clinical, and utilization variables to match MRI recipients to mammogram recipients in each month of index service use. Data were analyzed from October 8, 2020, to October 28, 2021.ExposuresBreast MRI vs mammography.Main outcomes and measuresMammary and extramammary cascade event rates and associated total and patient out-of-pocket spending in the 6 months following the index test.ResultsIn this study, 9208 women receiving breast MRI were matched with 9208 women receiving mammography (mean [SD] age, 51.4 [6.7] years). Compared with mammogram recipients, breast MRI recipients had 39.0 additional mammary cascade events per 100 women (95% CI, 33.7-44.2), including 5.0 additional imaging tests (95% CI, 3.8-6.2), 17.3 additional procedures (95% CI, 15.5-19.0), 13.0 additional visits (95% CI, 9.4-17.2), 0.34 additional hospitalizations (95% CI, 0.18-0.50), and 3.0 additional new diagnoses (95% CI, 2.5-3.6). For extramammary cascades, breast MRI recipients had 19.6 additional events per 100 women (95% CI, 8.6-30.7) including 15.8 additional visits (95% CI, 10.2-21.4) and no statistically significant differences in other events. Breast MRI recipients had higher total spending for mammary events ($564 more per woman; 95% CI, $532-$596), extramammary events ($42 more per woman; 95% CI, $16-$69), and overall ($1404 more per woman; 95% CI, $1172-$1636). They also had higher overall out-of-pocket spending ($31 more per woman; 95% CI, $6-$55).Conclusions and relevanceIn this cohort study of commercially insured women, breast MRI was associated with more mammary and extramammary cascade events and spending relative to mammography. These findings can inform cost-benefit assessments and coverage policies to ensure breast MRI is reserved for patients for whom benefits outweigh harms.
| S-EPMC9008498 | biostudies-literature
Project description:ContextAnnual ultrasound screening may detect small, node-negative breast cancers that are not seen on mammography. Magnetic resonance imaging (MRI) may reveal additional breast cancers missed by both mammography and ultrasound screening.ObjectiveTo determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer.Design, setting, and participantsFrom April 2004-February 2006, 2809 women at 21 sites with elevated cancer risk and dense breasts consented to 3 annual independent screens with mammography and ultrasound in randomized order. After 3 rounds of both screenings, 612 of 703 women who chose to undergo an MRI had complete data. The reference standard was defined as a combination of pathology (biopsy results that showed in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes) and 12-month follow-up.Main outcome measuresCancer detection rate (yield), sensitivity, specificity, positive predictive value (PPV3) of biopsies performed and interval cancer rate.ResultsA total of 2662 women underwent 7473 mammogram and ultrasound screenings, 110 of whom had 111 breast cancer events: 33 detected by mammography only, 32 by ultrasound only, 26 by both, and 9 by MRI after mammography plus ultrasound; 11 were not detected by any imaging screen. Among 4814 incidence screens in the second and third years combined, 75 women were diagnosed with cancer. Supplemental incidence-screening ultrasound identified 3.7 cancers per 1000 screens (95% CI, 2.1-5.8; P < .001). Sensitivity for mammography plus ultrasound was 0.76 (95% CI, 0.65-0.85); specificity, 0.84 (95% CI, 0.83-0.85); and PPV3, 0.16 (95% CI, 0.12-0.21). For mammography alone, sensitivity was 0.52 (95% CI, 0.40-0.64); specificity, 0.91 (95% CI, 0.90-0.92); and PPV3, 0.38 (95% CI, 0.28-0.49; P < .001 all comparisons). Of the MRI participants, 16 women (2.6%) had breast cancer diagnosed. The supplemental yield of MRI was 14.7 per 1000 (95% CI, 3.5-25.9; P = .004). Sensitivity for MRI and mammography plus ultrasound was 1.00 (95% CI, 0.79-1.00); specificity, 0.65 (95% CI, 0.61-0.69); and PPV3, 0.19 (95% CI, 0.11-0.29). For mammography and ultrasound, sensitivity was 0.44 (95% CI, 0.20-0.70, P = .004); specificity 0.84 (95% CI, 0.81-0.87; P < .001); and PPV3, 0.18 (95% CI, 0.08 to 0.34; P = .98). The number of screens needed to detect 1 cancer was 127 (95% CI, 99-167) for mammography; 234 (95% CI, 173-345) for supplemental ultrasound; and 68 (95% CI, 39-286) for MRI after negative mammography and ultrasound results.ConclusionThe addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer resulted in not only a higher cancer detection yield but also an increase in false-positive findings.Trial registrationclinicaltrials.gov Identifier: NCT00072501.
| S-EPMC3891886 | biostudies-literature
Project description:BackgroundLower mammography screening rates among minority and low income women contribute to increased morbidity and mortality from breast cancer.ObjectiveTo evaluate the effect of a patient navigation intervention on adherence rates to biennial screening mammography among women engaged in primary care at an inner-city academic medical center.DesignQuality improvement intervention with a concurrent control group, conducted from February to November of 2008.Study subjectsAll women in a hospital-based primary care practice aged 51-70 years. Subjects were randomized at the level of their primary care provider, such that half of the patients in the practice received the intervention, while the other half received usual care.InterventionsIntervention subjects whose last mammogram was >18 months prior received a combination of telephone calls and reminder letters from patient navigators trained to identify barriers to care. Navigators were integrated into primary care teams and interacted directly with patients, providers, and radiology to coordinate care. Navigators utilized an electronic report to track subjects. Adherence rates to biennial mammography were assessed in intervention and control groups at baseline and post-intervention.Key resultsA total of 3,895 women were randomized to intervention (n = 1,817) and control (n = 2,078) groups. Mean age was 60, 71% were racial/ethnic minorities, 23% were non-English speaking, and 63% had public or no health insurance. At baseline, there was no difference in mammography adherence between the control and intervention groups (78%, respectively, p = 0.55). After the 9-month intervention, mammogram adherence was higher in the intervention group compared with the control group (87% vs. 76%, respectively, p < 0.001). Except among Hispanic women who demonstrated high rates in both the intervention and control groups (85% and 83%, respectively), all racial/ethnic and insurance groups demonstrated higher adherence in the intervention group.ConclusionsPatient navigation improves biennial mammography rates for inner city, low income, minority populations.
| S-EPMC3019333 | biostudies-literature