A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women.
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ABSTRACT:
SUBMITTER: Shen S
PROVIDER: S-EPMC4366890 | biostudies-literature | 2015 Mar
REPOSITORIES: biostudies-literature
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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:Guidelines recommend individualizing screening mammography decisions for women aged 75 years and older. However, little pragmatic guidance is available to help counsel patients.To provide an evidence-based approach for individualizing decision-making about screening mammography in older women.We 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.Age 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.For 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:Annual 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.To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer.From 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.Cancer detection rate (yield), sensitivity, specificity, positive predictive value (PPV3) of biopsies performed and interval cancer rate.A 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.The 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.clinicaltrials.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
Project description:We compared the long-term impact of 1- and 2-year screening mammography intervals using prognostic, screening, and outcome information for women aged 50-74 years obtained from the Screening Mammography Program of British Columbia in two time periods, prior to 1997 (policy of annual mammography) and after 1997 (biennial mammography). Survival was estimated for both periods using a prognostic model and the expected rate of interval and screen-detected cancers. The likelihood of a screen-detected cancer with annual screening was 2.32 per thousand screens and with biennial screening was 3.32 per thousand screens. The prognostic profile of screen-detected cancers was better than that of interval cancers. Among both screen-detected and interval cancers, the prognostic profiles with annual and biennial screening were similar. The estimated breast cancer-specific survival rates for women undergoing annual and biennial screening mammography were 95.2 and 94.6% at 5 years, and 90.4 and 89.2% at 10 years, respectively. Annual compared to biennial mammography was associated with a 1.2% increase in the estimated 10-year breast cancer-specific survival for women aged 50-74 years, diagnosed with invasive breast cancer after screening programme attendance.
| S-EPMC2361910 | biostudies-other
Project description:The incidence rate of breast cancer is increasing and has become the most common cancer in Vietnamese women while the survival rate is lower than that of developed countries. Early detection to improve breast cancer survival as well as reducing risk factors remains the cornerstone of breast cancer control according to the World Health Organization (WHO). This study aims to evaluate the costs and outcomes of introducing a mammography screening program for Vietnamese women aged 45-64 years, compared to the current situation of no screening.Decision analytical modeling using Markov chain analysis was used to estimate costs and health outcomes over a lifetime horizon. Model inputs were derived from published literature and the results were reported as incremental cost-effectiveness ratios (ICERs) and/or incremental net monetary benefits (INMBs). One-way sensitivity analyses and probabilistic sensitivity analyses were performed to assess parameter uncertainty.The ICER per life year gained of the first round of mammography screening was US$3647.06 and US$4405.44 for women aged 50-54 years and 55-59 years, respectively. In probabilistic sensitivity analyses, mammography screening in the 50-54 age group and the 55-59 age group were cost-effective in 100% of cases at a threshold of three times the Vietnamese Gross Domestic Product (GDP) i.e., US$6332.70. However, less than 50% of the cases in the 60-64 age group and 0% of the cases in the 45-49 age group were cost effective at the WHO threshold. The ICERs were sensitive to the discount rate, mammography sensitivity, and transition probability from remission to distant recurrence in stage II for all age groups.From the healthcare payer viewpoint, offering the first round of mammography screening to Vietnamese women aged 50-59 years should be considered, with the given threshold of three times the Vietnamese GDP per capita.
| S-EPMC5868837 | biostudies-literature
Project description:BACKGROUND: Breast cancer is the most commonly diagnosed cancer among women and a leading cause of death from cancer in women in Europe. Although breast cancer incidence is on the rise worldwide, breast cancer mortality over the past 25 years has been stable or decreasing in some countries and a fall in breast cancer mortality rates in most European countries in the 1990s was reported by several studies, in contrast, in Greece have not reported these favourable trends. In Greece, the age-standardised incidence and mortality rate for breast cancer per 100.000 in 2006 was 81,8 and 21,7 and although it is lower than most other countries in Europe, the fall in breast cancer mortality that observed has not been as great as in other European countries. There is no national strategy for screening in this country. This study reports on the use of mammography among middle-aged women in rural Crete and investigates barriers to mammography screening encountered by women and their primary care physicians. METHODS: DESIGN: Semi-structured individual interviews. SETTING AND PARTICIPANTS: Thirty women between 45-65 years of age, with a mean age of 54,6 years, and standard deviation 6,8 from rural areas of Crete and 28 qualified primary care physicians, with a mean age of 44,7 years and standard deviation 7,0 serving this rural population. MAIN OUTCOME MEASURE: Qualitative thematic analysis. RESULTS: Most women identified several reasons for not using mammography. These included poor knowledge of the benefits and indications for mammography screening, fear of pain during the procedure, fear of a serious diagnosis, embarrassment, stress while anticipating the results, cost and lack of physician recommendation. Physicians identified difficulties in scheduling an appointment as one reason women did not use mammography and both women and physicians identified distance from the screening site, transportation problems and the absence of symptoms as reasons for non-use. CONCLUSION: Women are inhibited from participating in mammography screening in rural Crete. The provision of more accessible screening services may improve this. However physician recommendation is important in overcoming women's inhibitions. Primary care physicians serving rural areas need to be aware of barriers preventing women from attending mammography screening and provide women with information and advice in a sensitive way so women can make informed decisions regarding breast cancer screening.
| S-EPMC2588567 | biostudies-literature
Project description:BackgroundDecades of persuasive messages have reinforced the importance of traditional screening mammography at regular intervals. A potential new paradigm, risk-based screening, adjusts mammography frequency based on a woman's estimated breast cancer risk in order to maximize mortality reduction while minimizing false positives and overdiagnosis. Women's views of risk-based screening are unknown.ObjectiveTo explore women's views and personal acceptability of a potential risk-based mammography screening paradigm.DesignFour semi-structured focus group discussions about screening mammography and surveys before provision of information about risk-based screening. We analyzed coded focus group transcripts using a mixed deductive (content analysis) and inductive (grounded theory) approach.ParticipantsConvenience sample of 29 women (40-74 years old) with no personal history of breast cancer recruited by print and online media in New Hampshire and Vermont.ResultsTwenty-seven out of 29 women reported having undergone mammography screening. All participants were white and most were highly educated. Some women accepted the idea that early cancer detection with traditional screening was beneficial-although many also reported hearing inconsistent recommendations from clinicians and mixed messages from media reports about mammography. Some women were familiar with a risk-based screening paradigm (primarily related to cervical cancer, n?=?8) and thought matching screening mammography frequency to personal risk made sense (n?=?8). Personal acceptability of risk-based screening was mixed. Some believed risk-based screening could reduce the harms of false positives and overdiagnosis (n?=?7). Others thought screening less often might result in missing a dangerous diagnosis (n?=?14). Many (n?=?18) expressed concerns about the feasibility of risk-based screening and questioned whether breast cancer risk estimates could be accurate. Some suspected that risk-based mammography was motivated by a desire to save money (n?=?6).ConclusionSome women thought risk-based screening made sense. Willingness to abandon traditional screening for the new paradigm was mixed. Broad acceptability of risk-based screening will require clearer communication about its rationale and feasibility and consistent messages from the health care team.
| S-EPMC6206346 | biostudies-literature