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1.
Eur J Cancer ; 50(10): 1799-1807, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24746887

ABSTRACT

PURPOSE: We compared detection measures for breast screening strategies comprising single-reading or double-reading using standard 2D-mammography or 2D/3D-mammography, based on the 'screening with tomosynthesis or standard mammography' (STORM) trial. METHODS: STORM prospectively examined screen-reading in two sequential phases, 2D-mammography alone and integrated 2D/3D-mammography, in asymptomatic women participating in Trento and Verona (Northern Italy) population-based screening services. Outcomes were ascertained from assessment and/or excision histology or follow-up. For each screen-reading strategy we calculated the number of detected and non-detected (including interval) cancers, cancer detection rates (CDRs), false positive recall (FPR) measures and incremental CDR relative to a comparator strategy. We estimated the false:true positive (FP:TP) ratio and sensitivity of each mammography screening strategy. Paired binary data were compared using McNemar's test. RESULTS: Amongst 7292 screening participants, there were 65 (including six interval) breast cancers; estimated first-year interval cancer rate was 0.82/1000 screens (95% confidence interval (CI): 0.30-1.79/1000). For single-reading, 35 cancers were detected at both 2D and 2D/3D-mammography, 20 cancers were detected only with 2D/3D-mammography compared with none at 2D-mammography alone (p<0.001) and 10 cancers were not detected. For double-reading, 39 cancers were detected at 2D-mammography and 2D/3D-mammography, 20 were detected only with 2D/3D-mammography compared with none detected at 2D-mammography alone (p<0.001) and six cancers were not detected. The incremental CDR attributable to 2D/3D-mammography (versus 2D-mammography) of 2.7/1000 screens (95% CI: 1.6-4.2) was evident for single and for double-reading. Incremental CDR attributable to double-reading (versus single-reading) of 0.55/1000 screens (95% CI: -0.02-1.4) was evident for 2D-mammography and for 2D/3D-mammography. Estimated FP:TP ratios showed that 2D/3D-mammography screening strategies had more favourable FP to TP trade-off and higher sensitivity, applying single-reading or double-reading, relative to 2D-mammography screening. CONCLUSION: The evidence we report warrants rethinking of breast screening strategies and should be used to inform future evaluations of 2D/3D-mammography that assess whether or not the estimated incremental detection translates into improved screening outcomes such as a reduction in interval cancer rates.


Subject(s)
Breast Neoplasms/diagnostic imaging , Imaging, Three-Dimensional , Mammography/methods , Mass Screening/methods , Radiographic Image Interpretation, Computer-Assisted , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Evidence-Based Medicine , False Negative Reactions , False Positive Reactions , Female , Humans , Italy/epidemiology , Middle Aged , Predictive Value of Tests , Prognosis , Prospective Studies , Reproducibility of Results , Time Factors
2.
Eur J Cancer ; 50(7): 1232-8, 2014 May.
Article in English | MEDLINE | ID: mdl-24582915

ABSTRACT

OBJECTIVE: We investigated the effect of integrating three-dimensional (3D)-mammography with 2D-mammography on radiologists' detection measures in the 'screening with tomosynthesis or standard mammography' (STORM) trial. METHODS: STORM, a prospective population-based trial (Trento and Verona breast screening services) compared sequential screen-reading: 2D-mammography alone and integrated 2D/3D-mammography. Radiologist-specific detection measures were calculated for each screen-reading phase for eight radiologists: number of detected cancers, proportion of true-positive (TP) detection, and number and rate of false-positive (FP) recalls (FPR). We estimated the incremental cancer detection rate (CDR). RESULTS: There were 59 cancers and 395 false recalls amongst 7292 screening participants. At 2D-mammography screening, radiologist-specific TP detection ranged between 38% and 83% (median 63%; mean 60% and sd 15.4%); at integrated 2D/3D-mammography, TP detection ranged between 78% and 93% (median 87%; mean 87% and sd 5.2%). For all but one radiologist, 2D/3D-mammography improved breast cancer detection (relative to 2D-mammography) ranging between 0% and 54% (median 29%; mean 27% and sd 16.2%) increase in the proportion of detected cancers. Incremental CDR attributable to integrating 3D-mammography in screening varied between 0/1000 and 5.3/1000 screens (median 1.8/1000; mean 2.3/1000 and sd 1.6/1000). Radiologist-specific FPR for 2D-mammography ranged between 1.5% and 4.2% (median 3.1%; mean 2.9% and sd 0.87%), and FPR based on the integrated 2D/3D-mammography read ranged between 1.0% and 3.3% (median 2.4%; mean 2.2% and sd 0.72%). Integrated 2D/3D-mammography screening, relative to 2D-mammography, had the effect of reducing FP and increasing TP detection for most radiologists. CONCLUSION: There was broad variability in radiologist-specific TP detection at 2D-mammography and hence in the additional TP detection and incremental CDR attributable to integrated 2D/3D-mammography; more consistent (less variable) TP-detection estimates were observed for the integrated screen-read. Integrating 3D-mammography with 2D-mammography improves radiologists' screen-reading through improved cancer detection and/or reduced FPR, with most readers achieving both using integrated 2D/3D mammography.


Subject(s)
Breast Neoplasms/diagnostic imaging , Imaging, Three-Dimensional/methods , Mammography/methods , Aged , False Positive Reactions , Female , Humans , Mass Screening/methods , Middle Aged , Prospective Studies , Radiology , Sensitivity and Specificity
3.
Eur J Radiol ; 83(2): e84-91, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24369953

ABSTRACT

PURPOSE: To evaluate the performance of the first years since the beginning of a mammographic population-based screening program. MATERIALS AND METHODS: Women aged 49-69 were invited biennially for two-view film-screen mammography and double reading without arbitration was performed. Interval cancers (ICs) from 2001 to 2006 were identified using screening archives, local pathology archives, and hospital discharge records. The proportional incidence of IC was determined considering breast cancers expected without screening. Three offsite radiologists experienced in breast cancer screening blindly evaluated mammograms prior to diagnosis, randomly mixed with negative mammograms (1:2 ratio). Cases unrecalled at review were considered as true ICs, those recalled by only one reviewer as minimal signs, and those recalled by two or three reviewers as missed cancers. T and N stage of the reviewed ICs were evaluated and compared. RESULTS: A total of 86,276 first level mammograms were performed. Mean recall rate was 6.8% at first and 4.6% at repeat screening. We had 476 screen-detected cancers and 145 ICs (10 of them ductal carcinomas in situ). Absolute incidence was 17 per 10,000 screening examinations. Invasive proportional incidence was 19% (44/234) in the first year, 39% (91/234) in the second year, and 29% (135/468) in the two-year interval. Of 145 ICs, 130 (90%) were reviewed mixed with 287 negative controls: 55% (71/130) resulted to be true ICs, 24% (31/130) minimal signs, and 22% (28/130) missed cancers. The rate of ICs diagnosed in the first year interval was 21% (15/71) for true ICs, 46% (13/28) for missed cancers, and 39% (12/31) for minimal signs, with a significant difference of true ICs rate compared to missed cancers rate (p=0.012). A higher rate of T3 and T4 stages was found for missed cancers (18%, 5/28) compared to minimal signs (6%, 2/31) or true ICs (8%, 6/71), while the rate of N2 and N3 stage for both minimal signs (19%, 6/31) or missed cancers (25%, 7/28) was higher than that for true ICs (10%, 7/71), although all these differences were not significant (p ≥ 0.480). CONCLUSION: These results showed the possibility to comply with European Community standards in the first years of a screening program implementation.


Subject(s)
Breast Neoplasms/diagnostic imaging , Breast Neoplasms/epidemiology , Delayed Diagnosis/statistics & numerical data , Early Detection of Cancer/statistics & numerical data , Mammography/statistics & numerical data , Aged , Community Networks/statistics & numerical data , False Negative Reactions , Female , Humans , Incidence , Italy/epidemiology , Middle Aged , Reproducibility of Results , Risk Factors , Sensitivity and Specificity , Single-Blind Method
4.
Breast ; 23(1): 76-80, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24316152

ABSTRACT

BACKGROUND & OBJECTIVES: Three-dimensional (3D)-mammography (tomosynthesis) may improve breast cancer detection. We examined centre-specific effect of integrated 2D/3D mammography based on the STORM (screening with tomosynthesis or standard mammography) trial. METHODS: Asymptomatic women who attended population-based screening through Trento and Verona screening centres were recruited into STORM, a prospective comparison of screen-reading in two sequential phases: 2D-mammography only and integrated 2D/3D mammography. Outcomes were the number and rates of detected cancers and of false positive recalls (FPR), and incremental cancer detection rate (CDR). Paired binary data were compared using Mc Nemar's test. RESULTS: Of 33 cancers detected in Trento, 21 were detected at both 2D and 2D/3D screening, 12 cancers were detected only with integrated 2D/3D screening compared with none detected at 2D-only screening (P < 0.001). Of the 26 cancers detected in Verona, 18 were detected at both 2D and 2D/3D screening, 8 cancers were detected only with integrated 2D/3D screening compared with none detected at 2D-only screening (P = 0.008). There were no differences between centres in baseline CDR, and incremental CDR attributable to 3D-mammography was similar for Trento (2.8/1000 screens) and for Verona (2.6/1000 screens). Trento had 239 FPR (5.7% of screens): 103 FPR at both screen-readings, 93 FPR only at 2D-mammography compared with 43 FPR only at 2D/3D-mammography (p < 0.001). Verona had 156 FPR (5.2% of screens): 78 FPR at both screen-readings, 48 FPR only at 2D-mammography compared with 30 FPR only at 2D/3D-mammography (p = 0.054). Estimated reduction in FPR proportion had recall been conditional to 2D/3D-mammography-positivity differed between centres (21.0% versus 11.5%; P = 0.02). CONCLUSION: Integrated 2D/3D-mammography significantly increased cancer detection for both screening services; potential reduction in FPR is likely to differ between centres with those experiencing relatively higher FPR most likely to benefit from 2D/3D-mammography screening.


Subject(s)
Breast Neoplasms/diagnostic imaging , Carcinoma/diagnostic imaging , Mammography/methods , Aged , Carcinoma, Intraductal, Noninfiltrating/diagnostic imaging , Early Detection of Cancer , Female , Humans , Imaging, Three-Dimensional , Middle Aged , Prospective Studies , Radiographic Image Interpretation, Computer-Assisted , Sensitivity and Specificity
5.
Radiol Med ; 118(7): 1119-36, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23801389

ABSTRACT

PURPOSE: Accurate measurement of breast tumour size is fundamental for treatment planning. We compared the accuracy of digital mammography (DM), digital breast tomosynthesis (DBT), ultrasound (US) and magnetic resonance imaging (MRI) for the preoperative evaluation of breast cancer size. MATERIALS AND METHODS: We retrospectively reviewed 149 breast cancers in 110 patients who underwent DM, DBT, US and MRI between January 2010 and December 2011, before definitive surgery. The lesions were measured by two radiologists, without knowledge of the final histological examination, considered the gold standard. For each imaging modality, the maximum tumour size was measured to the nearest millimetre; the measurements were considered concordant if they were within ± 5 mm. Pearson's correlation coefficient was calculated for each imaging modality. RESULTS: The median pathological tumour size was 22.3 mm. MRI and DBT had a level of concordance with pathology of 70% and 66%, respectively, which was higher than that of DM (54%). DBT and MRI measurements had a better correlation with pathological tumour size (R:0.89 and R:0.92, respectively) compared to DM (R:0.83) and US (R:0.77). CONCLUSIONS: DBT and MRI are superior to DM and US in the preoperative assessment of breast tumour size. DBT seems to improve the accuracy of DM, although MRI remains the most accurate imaging modality for breast cancer extension.


Subject(s)
Breast Neoplasms/pathology , Adult , Aged , Breast Neoplasms/surgery , Female , Humans , Magnetic Resonance Imaging , Mammography , Middle Aged , Neoplasm Staging , Retrospective Studies , Tomography, X-Ray Computed , Ultrasonography, Mammary
6.
Breast ; 22(5): 806-9, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23558244

ABSTRACT

PURPOSE: To evaluate increment cancer detection rate generated by ultrasound (US). MATERIALS AND METHODS: US only detected cancers were assessed for 22,131 self-referring asymptomatic women with negative mammography and subgroups by age, previous cancer, breast density. Invasive assessment and surgical biopsy rate were evaluated. RESULTS: The overall US detection was 1.85 per thousand (41/22,131). In the subgroups it was: 1.95 per thousand (22/11,274) in women <50 years vs 1.75 per thousand (19/10,857) in women ≥ 50 years (p = 0.42), 5.49 per thousand (12/2183) in women with previous cancer vs 1.45 per thousand (29/19,948) in women without cancer history (p = 0.0004), 2.21 per thousand (22/9960) in dense breasts (p = 0.17) vs 1.56 per thousand (19/12,171) in fatty breasts. The US generated invasive assessment was 1.9% (422/22,131). The benign to malignant open surgical biopsy ratio was 0.17 (7/41). CONCLUSION: Adding US to negative mammography allowed for substantial incremental cancer detection rate (1.85 per thousand), particularly at age <50 years, in women with previous breast cancer and in dense breasts.


Subject(s)
Breast Neoplasms/diagnostic imaging , Breast Neoplasms/pathology , Breast/pathology , Carcinoma/diagnostic imaging , Carcinoma/pathology , Neoplasm Recurrence, Local/diagnostic imaging , Ultrasonography, Mammary/statistics & numerical data , Adult , Age Factors , Aged , Aged, 80 and over , Asymptomatic Diseases , Biopsy , Breast Density , Female , Humans , Mammary Glands, Human/abnormalities , Mammography , Middle Aged , Neoplasm Invasiveness
7.
Lancet Oncol ; 14(7): 583-9, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23623721

ABSTRACT

BACKGROUND: Digital breast tomosynthesis with 3D images might overcome some of the limitations of conventional 2D mammography for detection of breast cancer. We investigated the effect of integrated 2D and 3D mammography in population breast-cancer screening. METHODS: Screening with Tomosynthesis OR standard Mammography (STORM) was a prospective comparative study. We recruited asymptomatic women aged 48 years or older who attended population-based breast-cancer screening through the Trento and Verona screening services (Italy) from August, 2011, to June, 2012. We did screen-reading in two sequential phases-2D only and integrated 2D and 3D mammography-yielding paired data for each screen. Standard double-reading by breast radiologists determined whether to recall the participant based on positive mammography at either screen read. Outcomes were measured from final assessment or excision histology. Primary outcome measures were the number of detected cancers, the number of detected cancers per 1000 screens, the number and proportion of false positive recalls, and incremental cancer detection attributable to integrated 2D and 3D mammography. We compared paired binary data with McNemar's test. FINDINGS: 7292 women were screened (median age 58 years [IQR 54-63]). We detected 59 breast cancers (including 52 invasive cancers) in 57 women. Both 2D and integrated 2D and 3D screening detected 39 cancers. We detected 20 cancers with integrated 2D and 3D only versus none with 2D screening only (p<0.0001). Cancer detection rates were 5.3 cancers per 1000 screens (95% CI 3.8-7.3) for 2D only, and 8.1 cancers per 1000 screens (6.2-10.4) for integrated 2D and 3D screening. The incremental cancer detection rate attributable to integrated 2D and 3D mammography was 2.7 cancers per 1000 screens (1.7-4.2). 395 screens (5.5%; 95% CI 5.0-6.0) resulted in false positive recalls: 181 at both screen reads, and 141 with 2D only versus 73 with integrated 2D and 3D screening (p<0.0001). We estimated that conditional recall (positive integrated 2D and 3D mammography as a condition to recall) could have reduced false positive recalls by 17.2% (95% CI 13.6-21.3) without missing any of the cancers detected in the study population. INTERPRETATION: Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls. Randomised controlled trials are needed to compare integrated 2D and 3D mammography with 2D mammography for breast cancer screening. FUNDING: National Breast Cancer Foundation, Australia; National Health and Medical Research Council, Australia; Hologic, USA; Technologic, Italy.


Subject(s)
Breast Neoplasms/diagnostic imaging , Carcinoma, Ductal, Breast/diagnostic imaging , Carcinoma, Intraductal, Noninfiltrating/diagnostic imaging , Carcinoma, Lobular/diagnostic imaging , Early Detection of Cancer/standards , Mammography/methods , Tomography, X-Ray Computed , Aged , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/epidemiology , Carcinoma, Ductal, Breast/pathology , Carcinoma, Intraductal, Noninfiltrating/epidemiology , Carcinoma, Intraductal, Noninfiltrating/pathology , Carcinoma, Lobular/epidemiology , Carcinoma, Lobular/pathology , Female , Follow-Up Studies , Humans , Italy/epidemiology , Middle Aged , Neoplasm Invasiveness , Prognosis , Prospective Studies , Radiographic Image Interpretation, Computer-Assisted
8.
J Med Screen ; 20(1): 39-45, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23390204

ABSTRACT

OBJECTIVE: In addition to disease-specific mortality, a randomized controlled cancer screening trial may be evaluated in terms of excess mortality, in which case no patient-specific information on causes of death is needed. We studied the effect of not accounting for attendance on the calculated excess mortality in a prostate cancer screening trial. METHODS: The numerator of the excess mortality rate related to prostate cancer diagnoses in each study arm equals the excess number of deaths observed in the cancer patients. The estimation of the expected number of deaths in the absence of the prostate cancer diagnoses has to account for the self-selection of those participating in the trial, particularly if the proportion of non-participants is substantial. SETTING: The European prostate cancer screening trial (ERSPC). RESULTS: In the screening arm, non-attendees had roughly twice the mortality rate of attendees. Approximately twice as many cancers were detected in the screening arm compared with the control arm, primarily in attendees. Unless attendance is properly accounted for, the expected mortality of prostate cancer patients in the screening arm is overestimated by 0.9-3.6 deaths per 1000 person-years. CONCLUSIONS: Attendees have a lower all-cause mortality rate (are healthier) and a higher probability of a prostate cancer diagnosis than non-attendees and the men randomized to the control arm. If attendance is not accounted for, the excess mortality and the between-arm excess mortality rate ratio are underestimated and screening is considered more effective than it actually is. These effects may be sizeable, notably if non-attendance is common. Correcting for attendance status is important in the calculation of the excess mortality rate in prostate cancer patients that can be used in conjunction with a disease-specific mortality analysis in a randomized controlled cancer screening trial.


Subject(s)
Early Detection of Cancer/methods , Prostatic Neoplasms/diagnosis , Humans , Male , Mass Screening , Prostate-Specific Antigen/analysis , Prostatic Neoplasms/mortality , Survival Rate
9.
J Natl Cancer Inst ; 105(5): 321-33, 2013 Mar 06.
Article in English | MEDLINE | ID: mdl-23297042

ABSTRACT

BACKGROUND: It has been proposed that magnetic resonance imaging (MRI) be used to guide breast cancer surgery by differentiating residual tumor from pathologic complete response (pCR) after neoadjuvant chemotherapy. This meta-analysis examines MRI accuracy in detecting residual tumor, investigates variables potentially affecting MRI performance, and compares MRI with other tests. METHODS: A systematic literature search was undertaken. Hierarchical summary receiver operating characteristic (HSROC) models were used to estimate (relative) diagnostic odds ratios ([R]DORs). Summary sensitivity (correct identification of residual tumor), specificity (correct identification of pCR), and areas under the SROC curves (AUCs) were derived. All statistical tests were two-sided. RESULTS: Forty-four studies (2050 patients) were included. The overall AUC of MRI was 0.88. Accuracy was lower for "standard" pCR definitions (referent category) than "less clearly described" (RDOR = 2.41, 95% confidence interval [CI] = 1.11 to 5.23) or "near-pCR" definitions (RDOR = 2.60, 95% CI = 0.73 to 9.24; P = .03.) Corresponding AUCs were 0.83, 0.90, and 0.91. Specificity was higher when negative MRI was defined as contrast enhancement less than or equal to normal tissue (0.83, 95% CI = 0.64 to 0.93) vs no enhancement (0.54, 95% CI = 0.39 to 0.69; P = .02), with comparable sensitivity (0.83, 95% CI = 0.69 to 0.91; vs 0.87, 95% CI = 0.80 to 0.92; P = .45). MRI had higher accuracy than mammography (P = .02); there was only weak evidence that MRI had higher accuracy than clinical examination (P = .10). No difference in MRI and ultrasound accuracy was found (P = .15). CONCLUSIONS: MRI accurately detects residual tumor after neoadjuvant chemotherapy. Accuracy was lower when pCR was more rigorously defined, and specificity was lower when test negativity thresholds were more stringent; these definitions require standardization. MRI is more accurate than mammography; however, studies comparing MRI and ultrasound are required.


Subject(s)
Antineoplastic Agents/therapeutic use , Breast Neoplasms/diagnosis , Breast Neoplasms/drug therapy , Magnetic Resonance Imaging , Neoadjuvant Therapy , Neoplasm, Residual/diagnosis , Anthracyclines/administration & dosage , Antibodies, Monoclonal, Humanized/therapeutic use , Area Under Curve , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/diagnosis , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Lobular/diagnosis , Carcinoma, Lobular/drug therapy , Chemotherapy, Adjuvant , Female , Humans , Mammography , Neoadjuvant Therapy/methods , Neoplasm Staging , Odds Ratio , ROC Curve , Sensitivity and Specificity , Taxoids/administration & dosage , Trastuzumab
10.
J Med Screen ; 20(1): 33-38, 2013 Mar.
Article in English | MEDLINE | ID: mdl-28075228

ABSTRACT

Objectives To assess the effect of screening in terms of excess mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC). Methods A total of 141,578 men aged 55-69 were randomized to systematic screening or usual care in ERSPC sections in Finland, Italy, the Netherlands and Sweden. The excess number of deaths was defined as the difference between the observed number of deaths in the prostate cancer (PC) patients and the expected number of deaths up to 31 December 2006. The expected number was derived from mortality of all study participants before a diagnosis with PC adjusted for study centre, study arm and study attendance. The excess mortality rates were compared between the two study arms. Results The PC incidence was 9.25 per 1000 person-years in the intervention arm and 5.49 per 1000 person-years in the control arm, relative risk (RR) 1.69 (95% confidence interval [CI] 1.62-1.76). The excess mortality among men with PC was 0.29 per 1000 person-years in the intervention arm and 0.37 per 1000 person-years in the control arm; the RR for excess mortality was 0.77 (95% CI 0.55-1.08). The absolute risk reduction in the excess mortality was 0.08 per 1000 person-years. The overall mortality was not significantly different between the intervention and the control arms of the study: RR 0.99 (95% CI 0.96-1.01). Conclusions Although the reduction in excess mortality was not statistically significant, the between-arm reduction in excess mortality rate was in line with the previously reported 20% reduction in the disease-specific mortality. This finding indicates that the reduction in PC mortality in the ERSPC trial cannot be due to a bias in cause of death adjudication.


Subject(s)
Early Detection of Cancer , Prostate-Specific Antigen/blood , Prostatic Neoplasms/diagnosis , Aged , Finland/epidemiology , Humans , Italy/epidemiology , Male , Mass Screening , Middle Aged , Netherlands/epidemiology , Prostatic Neoplasms/mortality , Sweden/epidemiology
11.
N Engl J Med ; 367(7): 595-605, 2012 Aug 16.
Article in English | MEDLINE | ID: mdl-22894572

ABSTRACT

BACKGROUND: After 11 years of follow-up, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported a 29% reduction in prostate-cancer mortality among men who underwent screening for prostate-specific antigen (PSA) levels. However, the extent to which harms to quality of life resulting from overdiagnosis and treatment counterbalance this benefit is uncertain. METHODS: On the basis of ERSPC follow-up data, we used Microsimulation Screening Analysis (MISCAN) to predict the number of prostate cancers, treatments, deaths, and quality-adjusted life-years (QALYs) gained after the introduction of PSA screening. Various screening strategies, efficacies, and quality-of-life assumptions were modeled. RESULTS: Per 1000 men of all ages who were followed for their entire life span, we predicted that annual screening of men between the ages of 55 and 69 years would result in nine fewer deaths from prostate cancer (28% reduction), 14 fewer men receiving palliative therapy (35% reduction), and a total of 73 life-years gained (average, 8.4 years per prostate-cancer death avoided). The number of QALYs that were gained was 56 (range, -21 to 97), a reduction of 23% from unadjusted life-years gained. To prevent one prostate-cancer death, 98 men would need to be screened and 5 cancers would need to be detected. Screening of all men between the ages of 55 and 74 would result in more life-years gained (82) but the same number of QALYs (56). CONCLUSIONS: The benefit of PSA screening was diminished by loss of QALYs owing to postdiagnosis long-term effects. Longer follow-up data from both the ERSPC and quality-of-life analyses are essential before universal recommendations regarding screening can be made. (Funded by the Netherlands Organization for Health Research and Development and others.).


Subject(s)
Early Detection of Cancer , Prostate-Specific Antigen/blood , Prostatic Neoplasms/diagnosis , Quality of Life , Quality-Adjusted Life Years , Aged , Diagnostic Errors/adverse effects , Early Detection of Cancer/adverse effects , Early Detection of Cancer/psychology , Europe , Follow-Up Studies , Humans , Male , Mass Screening , Middle Aged , Prostatic Neoplasms/blood , Prostatic Neoplasms/mortality , Randomized Controlled Trials as Topic
12.
Breast ; 21(3): 406-8, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22709871

ABSTRACT

Ongoing debate regarding the value of pre-operative MRI in staging patients with newly diagnosed breast cancer has resulted from the lack of evidence on its clinical efficacy, which contrasts MRIs capability for detecting additional disease (occult on conventional imaging) in the cancerous breast. We undertook a validation study of EUSOMA criteria that recommend selection of breast conserving surgery (BCS) candidates to pre-operative MRI. We examined whether these criteria were associated with a differential likelihood of a recommendation for mastectomy. In a cohort of 200 subjects, recommended for BCS following mammography (M) and ultrasound (US), and who also subsequently had pre-operative MRI, the proportions recommended for mastectomy based on MRI, where the criterion was present versus absent were: invasive lobular cancer (17.9% versus 17.4%; p=0.87); high familial risk (14.7% versus 18.1%; p=0.82); M/US tumour size discrepancy >1cm (32.1% versus 15.1%; p=0.05); and for any of these criteria versus none (21.6% versus 14.3%; p=0.24). These findings suggest that EUSOMA criteria for selection to pre-operative MRI may be inefficient as they do not appear to differentiate those at risk of having more extensive disease and likely to receive a mastectomy recommendation, with the exception of M/US tumour size discrepancy.


Subject(s)
Breast Neoplasms/diagnosis , Breast Neoplasms/surgery , Carcinoma/diagnosis , Carcinoma/surgery , Magnetic Resonance Imaging/methods , Preoperative Period , Adult , Aged , Breast Neoplasms/pathology , Carcinoma/pathology , Female , Humans , Mastectomy , Medical Oncology/methods , Middle Aged , Patient Selection , Ultrasonography, Mammary/methods
13.
Lancet Oncol ; 13(4): e148-60, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22469125

ABSTRACT

As the mean age of the global population increases, breast cancer in older individuals will be increasingly encountered in clinical practice. Management decisions should not be based on age alone. Establishing recommendations for management of older individuals with breast cancer is challenging because of very limited level 1 evidence in this heterogeneous population. In 2007, the International Society of Geriatric Oncology (SIOG) created a task force to provide evidence-based recommendations for the management of breast cancer in elderly individuals. In 2010, a multidisciplinary SIOG and European Society of Breast Cancer Specialists (EUSOMA) task force gathered to expand and update the 2007 recommendations. The recommendations were expanded to include geriatric assessment, competing causes of mortality, ductal carcinoma in situ, drug safety and compliance, patient preferences, barriers to treatment, and male breast cancer. Recommendations were updated for screening, primary endocrine therapy, surgery, radiotherapy, neoadjuvant and adjuvant systemic therapy, and metastatic breast cancer.


Subject(s)
Aged , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Carcinoma, Intraductal, Noninfiltrating/epidemiology , Carcinoma, Intraductal, Noninfiltrating/therapy , Breast Neoplasms/pathology , Breast Neoplasms, Male/epidemiology , Breast Neoplasms, Male/pathology , Breast Neoplasms, Male/therapy , Carcinoma, Intraductal, Noninfiltrating/pathology , Combined Modality Therapy , Decision Making , Europe/epidemiology , Female , Geriatric Assessment , Humans , Male , Middle Aged , Neoplasm Metastasis , Neoplasm Staging , Practice Guidelines as Topic , Societies, Medical
14.
Tumori ; 98(1): 113-8, 2012.
Article in English | MEDLINE | ID: mdl-22495711

ABSTRACT

AIMS AND BACKGROUND: To assess the diagnostic accuracy of stereotactic vacuum-assisted biopsy of nonpalpable breast lesions. METHODS AND STUDY DESIGN: 769 consecutive vacuum-assisted biopsy procedures were retrospectively reviewed. Positive predictive value for carcinoma (B5) at vacuum-assisted biopsy was assessed on the overall series and by age, lesion morphology and size, degree of suspicion and calendar period. The accuracy of vacuum-assisted biopsy was based on surgical histology or follow-up (no change at 12 months was assumed as negative). RESULTS: Lesions were depicted as isolated microcalcifications, opacity + microcalcifications, or opacity in 716 (93.1%), 28 (3.6%), or 25 (3.2%) cases, respectively. Vacuum-assisted biopsy was negative (B1 = 63; B2 = 319) in 382 (49.7%), borderline (B3) in 142 (18.5%), suspicious (B4) in 2 (0.3%), and positive (B5) in 243 (31.6%) cases (in situ = 185, 24.1%), invasive = 58 (7.5%)), respectively. Age (χ²df3 = 19.50; P <0.002), size (χ²df4 = 51.02; P = 10⁻6) and degree of suspicion (χ²df2 = 146.68; P = 10⁻6) were associated with a B5 outcome, no significant association was evident for morphology (χ²df2 = 0,47; P <0.78), whereas calendar period had a moderate but significant inverse association (χ²df2 = 6.12; P <0.04). The positive predictive value for surgically confirmed carcinoma (in situ or invasive) was 0% for B1, 0.7% for B2, 12.3% for B3, 100% for B4, 92.7% for in situ B5, and 94.6% for invasive B5. Conversion from in situ B5 to invasive was 12.3% and was insignificantly associated with size (χ²df2 = 0.95; P = 0.62) and histology grade (χ²df2 = 3.64; P = 0.16). Down-grading of vacuum-assisted biopsy lesions to a less severe histology occurred in 13 (7.2%) in situ and in 16 (28.6%) invasive carcinomas. B3 cases upgrading to more severe lesions was 0%, 4.5% or 16.0% in the presence of no, mild, or severe atypia. CONCLUSIONS: The study confirmed a good performance of vacuum-assisted biopsy, possibly influenced by the local scenario (e.g., radiologist's and pathologist's interobserver variability and sampling modality). Conflicting results with the literature may have local explanations rather than being due to inadequate performance.


Subject(s)
Biopsy, Needle/methods , Breast Neoplasms/diagnosis , Breast Neoplasms/surgery , Stereotaxic Techniques , Adult , Aged , Breast Diseases/diagnosis , Breast Diseases/surgery , Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/diagnosis , Carcinoma, Intraductal, Noninfiltrating/diagnosis , Female , Humans , Italy , Middle Aged , Neoplasm Grading , Palpation , Predictive Value of Tests , Retrospective Studies , Vacuum
16.
N Engl J Med ; 366(11): 981-90, 2012 Mar 15.
Article in English | MEDLINE | ID: mdl-22417251

ABSTRACT

BACKGROUND: Several trials evaluating the effect of prostate-specific antigen (PSA) testing on prostate-cancer mortality have shown conflicting results. We updated prostate-cancer mortality in the European Randomized Study of Screening for Prostate Cancer with 2 additional years of follow-up. METHODS: The study involved 182,160 men between the ages of 50 and 74 years at entry, with a predefined core age group of 162,388 men 55 to 69 years of age. The trial was conducted in eight European countries. Men who were randomly assigned to the screening group were offered PSA-based screening, whereas those in the control group were not offered such screening. The primary outcome was mortality from prostate cancer. RESULTS: After a median follow-up of 11 years in the core age group, the relative reduction in the risk of death from prostate cancer in the screening group was 21% (rate ratio, 0.79; 95% confidence interval [CI], 0.68 to 0.91; P=0.001), and 29% after adjustment for noncompliance. The absolute reduction in mortality in the screening group was 0.10 deaths per 1000 person-years or 1.07 deaths per 1000 men who underwent randomization. The rate ratio for death from prostate cancer during follow-up years 10 and 11 was 0.62 (95% CI, 0.45 to 0.85; P=0.003). To prevent one death from prostate cancer at 11 years of follow-up, 1055 men would need to be invited for screening and 37 cancers would need to be detected. There was no significant between-group difference in all-cause mortality. CONCLUSIONS: Analyses after 2 additional years of follow-up consolidated our previous finding that PSA-based screening significantly reduced mortality from prostate cancer but did not affect all-cause mortality. (Current Controlled Trials number, ISRCTN49127736.).


Subject(s)
Early Detection of Cancer , Prostate-Specific Antigen/blood , Prostatic Neoplasms/mortality , Age Factors , Aged , Cause of Death , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/prevention & control , Risk
17.
Breast ; 21(4): 503-6, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22285387

ABSTRACT

Breast radiological density is a determinant of breast cancer risk and of mammography sensitivity and may be used to personalize screening approach. We first analyzed the reproducibility of visual density assessment by eleven experienced radiologists classifying a set of 418 digital mammograms: reproducibility was satisfactory on a four (BI-RADS D1-2-3-4: weighted kappa = 0.694-0.844) and on a two grade (D1-2 vs D3-4: kappa = 0.620-0.851), but subjects classified as with dense breast would range between 25.1 and 50.5% depending on the classifying reader. Breast density was then assessed by computer using the QUANTRA software which provided systematically lower density percentage values as compared to visual classification. In order to predict visual classification results in discriminating dense and non-dense breast subjects on a two grade scale (D3-4 vs, D1-2) the best fitting cut off value observed for QUANTRA was ≤22.0%, which correctly predicted 88.6% of D1-2, 89.8% of D3-4, and 89.0% of total cases. Computer assessed breast density is absolutely reproducible, and thus to be preferred to visual classification. Thus far few studies have addressed the issue of adjusting computer assessed density to reproduce visual classification, and more similar comparative studies are needed.


Subject(s)
Breast Neoplasms/diagnostic imaging , Mammography/methods , Radiographic Image Interpretation, Computer-Assisted/methods , Adult , Aged , Aged, 80 and over , Female , Humans , Middle Aged , Observer Variation , Reproducibility of Results , Software
18.
Breast Cancer Res Treat ; 133(1): 267-71, 2012 May.
Article in English | MEDLINE | ID: mdl-22270938

ABSTRACT

There is limited evidence on the role of 3D mammography with tomosynthesis in breast screening, although early studies suggest that it may improve specificity. We prospectively evaluated the effect of integrating 3D mammography as a triage to assessment in 158 consecutive recalls to assessment (recalled in standard 2D-mammographic screening) in asymptomatic subjects. Radiologists provided 3D mammography-based opinion as to whether recall/assessment was warranted or unnecessary, and all subjects proceeded to assessment. 3D triage was positive (confirmed the need for assessment) in all 21 subjects with breast cancer (there were no false negatives), and would have avoided recall in 102 of 137 (74.4%) subjects with a negative/benign final outcome in whom 3D triage did not recommend recall. Proportion of true negative 3D triage (as a proxy for potential reduction in recalls) was slightly higher in dense than non-dense breasts, did not differ across age-groups, but was significantly associated with the type of lesion seen on imaging (being highest for distortions, asymmetric densities, and lesions with ill-defined margins). While the simulation design may have over-estimated the potential for 3D mammography triage to reduce recalls, this study clearly demonstrates its capability to improve breast screening specificity and to reduce recall rates. Future studies of 3D mammography should further assess its role as a recall-reducing strategy in screening practice and should include formal cost-analysis.


Subject(s)
Breast Neoplasms/diagnostic imaging , Carcinoma/diagnostic imaging , Mammography , Tomography , Adult , Aged , Early Detection of Cancer , False Positive Reactions , Female , Humans , Imaging, Three-Dimensional , Middle Aged , Prospective Studies , Sensitivity and Specificity
19.
Breast ; 21(4): 449-54, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22088803

ABSTRACT

INTRODUCTION: Core needle biopsy (CNB) has progressively replaced fine needle aspiration cytology (FNAC) in the diagnosis of breast lesions. Less information is available on how these tests perform for biopsy of ultrasound (US) visible breast lesions. This study examines the outcomes of CNB and FNAC in a large series ascertained with surgical histology or clinical-imaging follow-up. MATERIALS AND METHODS: Retrospective five-year audit of 3233 consecutive US-guided needle samplings of solid breast lesions, from self-referred symptomatic or asymptomatic subjects, performed by six radiologists in the same time-frame (2003-2006): 1950 FNAC and 1283 CNB. The probability of undergoing CNB as a first test instead of FNAC was evaluated using logistic regression. Accuracy and inadequacy were calculated for each of CNB and FNAC performed as first test. Accuracy measures included equivocal or borderline/atypical lesions as positive results. RESULTS: The probability of CNB as a first test instead of FNAC increased significantly over time, when there was a pre-test higher level of suspicion, in younger (relative to older) women, with increasing lesion size on imaging, and for palpable (relative to impalpable) lesions. Inadequacy rate was lower for CNB (B1 = 6.9%) than for FNAC (C1 = 17.7%), p < 0.001, and specifically in malignant lesions (B1 = 0.9% vs. C1 = 4.5%; p < 0.001). False negative rate was equally low for both CNB and FNAC (1.7% each test). CNB performed significantly better than FNAC for absolute sensitivity (93.1% vs. 74.4%; p < 0.001) and complete sensitivity (97.4% vs. 93.8%; p = 0.001), however specificity was lower for CNB than FNAC (88.3% vs. 96.4%; p < 0.001). Absolute diagnostic accuracy was higher for CNB than FNAC (84.5% vs. 71.9; p < 0.001) while FNAC performed better than CNB for complete diagnostic accuracy (95.4% vs. 93.2; p < 0.008). In the small subgroup assessed with CNB after an inconclusive initial FNAC (231 cases) there was improved complete sensitivity (from 93.8% to 97.0%) however this also increased costs. CONCLUSION: FNAC and CNB were generally performed in different patients, thus our study reported indirect comparisons of these tests. Although FNAC performed well (except for relatively high inadequacy), CNB had significantly better performance based on measures of sensitivity, but this was associated with lower specificity for CNB relative to FNAC. Overall, CNB is the more reliable biopsy method for sonographically-visible lesions; where FNAC is used as the first-line test, inadequate or inconclusive FNAC can be largely resolved by using repeat sampling with CNB.


Subject(s)
Biopsy, Needle/methods , Breast Neoplasms/pathology , Aged , Aged, 80 and over , Biopsy, Fine-Needle , Breast Neoplasms/diagnostic imaging , Female , Humans , Logistic Models , Medical Audit , Middle Aged , Retrospective Studies , Sensitivity and Specificity , Ultrasonography, Mammary
20.
Tumori ; 97(5): 547-50, 2011.
Article in English | MEDLINE | ID: mdl-22158481

ABSTRACT

AIMS AND BACKGROUND: The best screening strategy for colorectal cancer is still debated. We simulated two screening strategies, namely flexible sigmoidoscopy (single episode) and immunological fecal occult blood test (FOBT) (five biennial rounds) and comparing their results as regards advanced adenomas and colorectal cancer detection. METHODS: A Markov model was developed to estimate the number of advanced adenomas and colorectal cancer detected with the two compared screening strategies. Two different scenarios, namely a) where the same compliance (50%) at both flexible sigmoidoscopy and immunological FOBT invitation is applied, and b) where the actual compliance observed at a national level (immunological FOBT, 45%; flexible sigmoidoscopy, 30%) is applied. RESULTS: In scenario a), immunological FOBT would detect a total of 20,573 adenomas and 3,952 colorectal cancers, performing 74,507 total colonoscopies compared to 20,939 and 2,511, respectively, detected by flexible sigmoidoscopy, with 17,985 total colonoscopies. In scenario b), immunological FOBT would detect 17,845 advanced adenomas with 65,215 colonoscopies performed compared to 12,672 detected by flexible sigmoidoscopy with 10,796 colonoscopies. The probability of having a colonoscopy for a subject attending all the five immunological FOBT rounds was 15.9%. CONCLUSIONS: The simulation suggests that also immunological FOBT screening may achieve a substantial detection of advanced adenomas and therefore may have an impact on colorectal cancer incidence.


Subject(s)
Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/epidemiology , Early Detection of Cancer/methods , Mass Screening/methods , Occult Blood , Sigmoidoscopy , Adenoma/diagnosis , Adenoma/epidemiology , Carcinoma/diagnosis , Carcinoma/epidemiology , Colonoscopy , Colorectal Neoplasms/pathology , Female , Humans , Italy/epidemiology , Male , Patient Compliance/statistics & numerical data , Sigmoidoscopy/statistics & numerical data
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