Conclusions for mammography screening after 25-year follow-up of the Canadian National Breast Cancer Screening Study (CNBSS).

UNLABELLED: Twenty-five-year follow-up data of the Canadian National Breast Cancer Screening Study (CNBSS) indicated no mortality reduction. What conclusions should be drawn? After conducting a systematic literature search and narrative analysis, we wish to recapitulate important details of this study, which may have been neglected: Sixty-eight percent of all included cancers were palpable, a situation that does not allow testing the value of early detection. Randomisation was performed at the sites after palpation, while blinding was not guaranteed. In the first round, this "randomisation" assigned 19/24 late stage cancers to the mammography group and only five to the control group, supporting the suspicion of severe errors in the randomisation process. The responsible physicist rated mammography quality as "far below state of the art of that time". Radiological advisors resigned during the study due to unacceptable image quality, training, and medical quality assurance. Each described problem may strongly influence the results between study and control groups. Twenty-five years of follow-up cannot heal these fundamental problems. This study is inappropriate for evidence-based conclusions. The technology and quality assurance of the diagnostic chain is shown to be contrary to today's screening programmes, and the results of the CNBSS are not applicable to them. KEY POINTS: • The evidence base of the Canadian study (CNBSS) has to be questioned.• Severe flaws in the randomization process and test methods occurred. • Problems were criticized during and after conclusion of the trial by experts.• The results are not applicable to quality-assured screening programs. • The evidence base of this study must be re-analyzed.

Influence of additional breast ultrasound on cancer detection in a cohort study for quality assurance in breast diagnosis--analysis of 102,577 diagnostic procedures.

PURPOSE: To determine the value of a breast ultrasound (US) examination in addition to mammography in cases of American College of Radiology (ACR) tissue pattern III and IV in symptomatic women and women at risk. MATERIALS AND METHODS: A prospective cohort was initiated between 2001 and 2005 with a total of 59,514 patients and 102,744 mammograms. Documentation was available for 102,557 diagnostic procedures. Breast US was indicated in all women with ACR III and IV in addition to a suspicious clinical examination and in cases of masses and focal asymmetries in mammography. RESULTS: In total, 62,006 additional USs were performed, in which 116 mammographically and clinically occult breast cancers were diagnosed (detection rate: 1.9/1,000 examinations), while mammography alone (40,551 examinations) revealed 903 cancers (22.3/1,000). Of all 1,019 breast cancer findings, 12.8% were detected because of the combination of mammography and US. In the group with ACR III/IV, 15.9% of cancers were found by supplemental US compared with mammography alone. CONCLUSION: The addition of US to mammography vs. mammography alone resulted in a significant (P < 0.01) increase in breast cancer detection rate.

[Guideline for the Early Detection of Breast Cancer in Germany 2008. Recommendations from the short version]. / Stufe-3-Leitlinie Brustkrebs-Früherkennung in Deutschland 2008 : Auszug aus der Kurzfassung: Handlungsempfehlungen.

The updated 2008 German Guideline for Early Detection of Breast Cancer provides evidence-based and consensus-based recommendations of the knowledge gained by the German Society for Surgery and the German Society of Plastic, Aesthetic, and Reconstructive Surgeons together with 29 professional societies, associations, and nonmedical organizations. The guideline is meant to assist physicians, healthy women, and patients in medical decisions with recommendations regarding the diagnostic chain in early detection of breast cancer. In addition to these recommendations, the guideline also includes descriptions of quality assurance for resources, procedures, outcomes, and evaluation using a set of quality indicators. It updates the previous version from 2003. The guideline's recommendations are presented. They are described in detail in the full publication (in German) Geburtsh Frauenh 2008; 68:251-261. The long version of the Guideline, methods report, and evidence report are available on the internet at www.awmf-leitlinien.de (reg. no. 077/001) with free access.

Factors associated with one step surgery in case of non-palpable breast cancer.

PURPOSE: To examine factors associated with one step surgery in case of non-palpable breast cancer. MATERIALS AND METHODS: Clinical data of 152 consecutively diagnosed patients with breast cancer were analyzed retrospectively. Preoperative diagnostic findings were divided in subgroups: mammographically visible mass/microcalcifications/sonographically visible mass/sonographically visible architectural distortion. Correlation between tumor-size, radiologic tumor morphology, quality of localization and number of operation was evulated. For localization exact wire position was defined less than 3mm apart from the lesion. RESULTS: One hundred and thirty-six patients attempted breast conservation and underwent preoperative tumor localization. Fourteen of 16 patients had mastectomy without preoperative localization. Average tumor size was 12mm for one-operation, and 17mm for re-operation. Significant correlation (p<0.001) was found between one operation and masses visible in mammograms (55/62 (89%) patients) or sonography (53/64 (83%) patients). Significant correlation was found (p<0.001) between more re-operation and microcalcifications in mammograms (33/89 (37% patients). In 123/138 (89%) cases wire position was central, in 15/138 (11%) cases distance was maximally 10mm. No significant correlation was found between number of operation and wire position. Re-operation was required in 38 cases. CONCLUSION: Mammographically or sonographically visible mass, small size of tumors, preoperative percutaneous biopsy and exact preoperative localization are important for a single step procedure for definite surgical treatment, that we found in 74% of the patients.

Mammography of ductal carcinoma in situ of the breast: review of 909 cases with radiographic-pathologic correlations.

We retrospectively analysed mammographies of 909 ductal carcinoma in situ (DCIS) (1980-1999) and compared our results to those of literature. Microcalcifications were present in 75% of the cases, and soft-tissue abnormalities in 27% cases with association with calcifications in 14% of cases. Palpable masses were found in 12% of the cases and nipple discharge was present in 12% of the cases. The radiographic-pathologic correlation allowed to suspect the DCIS "aggressiveness" on radiologic signs. Granular, linear, branching and/or galactophoric topography of the microcalcifications were correlated with necrosis, grade 3, comedocarcinoma type. A number of microcalcifications higher than 20 was correlated with necrosis and grade 3. Mammographic size was correlated to histologic size. Masses were correlated with grade 1. A diagnosis strategy can be proposed with a multidisciplinar approach.

Results of breast conserving therapy for early breast cancer and the role of mammographic follow-up.

PURPOSE: The following article is a review of 23 years of breast-conserving therapy in our hospital. This study was performed to assess and improve the follow-up care of women with early breast cancer and to evaluate whether or not biannual mammogram is useful. METHODS AND MATERIALS: Between 1972 and December 1995, 3072 women with pathological size pT1 and pT2 breast cancer were treated with conservative surgery and radiation therapy. Eighty-five patients developed a recurrence in the treated breast as the first site of failure, 12 of which had positive axillary nodes. In the following patient study, those with an noninvasive recurrence were excluded. A retrospective assessment of the entire mammographic course was made, starting with the mammogram at the time of original diagnosis to the mammogram of the recurrence. RESULTS: In our study group the probability for local failure ranged from 1 to 2% per year. At 5 and 10 years the actuarial rates were 5 and 10%. The median time to recurrence was 41 months (range 8-161). Twenty-six (31%) recurrences were detected by mammography alone, 10 (12%) by clinical examination only, and 35 (41%) by both methods. For the patients with an ipsilateral recurrence, the overall actuarial 5- and 10-year survival after treatment was 87 and 70%, respectively. The 5-year actuarial rate of survival from salvage mastectomy was 61%. CONCLUSION: Considering the high percentage of recurrences detectable by mammography and the possibility of detection within a short-term interval, we think biannual mammographic follow-up is appropriate for the first years following breast-conserving therapy.

Interdisciplinary consensus on the use and technique of vacuum-assisted stereotactic breast biopsy.

PURPOSE: Quality assurance of stereotactic vacuum-assisted breast biopsy (VB). METHOD: A consensus was achieved based on the existing literature and the experience of VB users (Ethicon Endosurgery, Norderstedt). RESULTS: The imaging work-up must be completed according to existing standards before an indication for stereotactic VB is established. Indications include microcalcifications and small non-palpable masses; for the time being lesions very close to the skin and architectural distortions (radial scar) are considered less suitable. Acquisition of >20 cores (11 Gauge) should be routinely attempted (goals: as complete a removal of small lesions as possible, thereby increasing diagnostic confidence and reducing so-called 'underestimates'). The pre/post-fire and post-biopsy stereotactic images and a post-biopsy orthogonal mammogram must be documented. All cases with no or uncertain histopathological correlation require discussion in a regular interdisciplinary conference and a documented consensus concerning further work-up or therapy. Standardised documentation of the primary findings and follow-up mammography after approximately 6 months is requested. CONCLUSION: This consensus includes protocols for the establishment of an indication, performance indicators, interdisciplinary interpretation and therapeutic recommendation, documentation and follow-up. It does not replace official recommendations for percutaneous biopsy.

Electropotential evaluation as a new technique for diagnosing breast lesions.

A new approach, termed the Biofield test, may have the potential to augment the process of diagnosing breast cancer. This technique is based on the analysis of skin surface electrical potentials measured by an array of specially designed sensors which are placed on the breasts. Measurements are recorded noninvasively and then analyzed using pattern recognition algorithms to produce an immediate and objective assessment of breast tissue in vivo. Initial clinical trials suggests that the test can achieve a sensitivity of approximately 90% and a specificity of 40-50%, which indicates that the test might be useful for excluding cancer when it is, in fact, absent. Although research to date has focused on the differential diagnosis of suspicious breast lesions, future applications could include breast cancer screening, close surveillance and diagnosis of recurrent cancers in breasts previously treated with conservative therapy, and monitoring the effectiveness of breast cancer therapies. Improvements and new applications are expected to occur as additional research and validation in actual clinical settings is performed.

[Phantom experiments and early clinical experience with a mammogram apparatus using a grid (author's transl)]. / Phantomuntersuchungen und erste klinische Erfahrungen an einem Raster-Mammographiegerät.

The effect of a grid on film quality and dose was investigated in a newly developed mammographic apparatus (Mammo Diagnost U--C. H. F. Müller). It was shown that available film-screen combinations used with a grid produced practically the same picture quality as Definix Medical used without screen or grid. Although the dose required is almost doubled by the use of the grid, the latter, nevertheless, produces a reduction of surface dose to about a quarter (4 cm. plexiglass phantom). Using a film-screen combination not at present commercially available, there was some improvement in the demonstration of microcalcification, but the improvement resulted in an increase in the required radiation dose.

[Determinants of observer variability in early diagnostic mammography--a ROC analysis]. / Determinanten der Beobachter-Variabilität bei der Früherkennungsmammographie--eine ROC-Analyse.

As part of the German mammographic study, the participating doctors were given test films of 30 histologically confirmed cases. Regarding the indications for biopsy there was good sensitivity (the median amongst 25 doctors was 0.87). Specificity (median 0.86) could be improved. Comparison of individual results with the majority showed considerable variability within the group of doctors performing mammography. ROC analysis indicated that there was considerable observer variability which was independent from the specialty or praxis characteristics of the participants. The inclusion of mammography in an early diagnostic programme requires continuing education of the participants in this technique. This should be supported by further methods of quality assurance.

Breast ultrasound elastography--results of 193 breast lesions in a prospective study with histopathologic correlation.

PURPOSE: To evaluate the diagnostic performance of ultrasound elastography in breast masses. MATERIAL AND METHODS: 193 lesions (129 benign, 64 malignant) were analyzed with the EUB 8500 Logos-ultrasonic-unit (Hitachi Medical, Japan) and a linear-array-transducer of 7.5-13-MHz. Standard of reference was cytology (FNAfine needle aspiration) or histology (core biopsy). The elastic-score was classified according to a 6-point colour-scale (Ueno classification; 1-3 = benign, 4-5 = malignant). Conventional B-mode ultrasound (US) findings were classified according to the BI-RADS classification. Statistical analysis included sensitivity, specificity, ROC-analysis and kappa-values for intra-/interobserver reliability. RESULTS: The mean score for elasticity was 4.1 ± 0.9 for malignant lesions, and 2.1 ± 1.0 for benign lesions (p < 0.001). With a best cut-off point between elasticity scores 3 and 4, sensitivity was 96.9%, and specificity 76%. Setting a best cut-off point for conventional US between BI-RADS 4 and 5, sensitivity was 57.8%, and specificity 96.1%. Elastography provided higher sensitivity and lower specificity than conventional US, but two lesions with elasticity score 1 were false negative, whereas no lesion scored BI-RADS 1-3 were false negative. ROC-curve was 0.884 for elastography, and 0.820 for conventional US (p < 0.001). Weighted kappa-values for intra-/interobserver reliability were 0.784/0.634 for BI-RADS classification, and 0.720/0.561 for elasticity scores. CONCLUSION: In our study setting, elastography does not have the potential to replace conventional B-mode US for the detection of breast cancer, but may complement conventional US to improve the diagnostic performance.

[Are breast biopsies adequately funded? A process cost & revenue analysis]. / Ist die Mammabiopsie ausreichend finanziert? Eine Prozesskosten & Erlösbetrachtung.

PURPOSE: The objective of the study was to determine whether the various breast biopsy procedures specified in the S 3 guidelines are sensibly represented within the current German health system as considered from a cost evaluation perspective. MATERIALS AND METHODS: This prospectively designed multicenter study analyzed 221 breast biopsies at 7 institutions from 04/2006 to 01/2007. Core needle biopsies, vacuum-assisted biopsies and surgical open biopsies under sonographic or mammographic guidance were evaluated. During an analysis of process costs, the individual process steps were recorded in diagrammatic form and assigned to the true consumption of resources. The actual resource consumption costs were entered. A process-related breakeven analysis was conducted to check whether the reimbursement of individual biopsy types covers the costs. RESULTS: Only sonographically guided core needle biopsy and surgical open biopsy are adequately reimbursed in the current German health system. All other breast biopsies indicate a negative profit margin. The principal reasons for under-funding are found in the area of reimbursement of investment and non-personnel costs. CONCLUSION: The reimbursement of breast biopsies must be improved in order to guarantee nationwide care of the population using the breast biopsy methods recommended in the S 3 guidelines and to avoid disincentives with respect to breast biopsy indications.

False-negative results after stereotactically guided vacuum biopsy.

The purpose of this study was to determine the false negative rate of stereotactically guided vacuum biopsy (VB). Data of patients with benign lesions in VB were evaluated retrospectively during a median follow-up period of 21 months. A total of 404 VB were considered benign and representative and were recommended for follow-up. Of these 404 lesions, 195 were completely removed radiologically. Follow-up data were available for 354/404 patients (87.6%), with intervals ranging from 3 to 66 months (median 21, mean 22.4). Reintervention or surgery was necessary in 13/354 (3.7%) cases. Of these cases, 5/354 (1.4%) turned out to be false negatives. Four of these cases showed large areas of microcalcifications or several clusters, and only partial removal was possible due to the size of the lesions. Although VB is an accurate procedure for diagnosing nonpalpable breast lesions with a low cancer miss rate, we consider the exclusion of malignancy in cases of disseminated microcalcifications or several clusters as a limitation. The radiologic-pathologic correlation in these cases is a challenge, particularly in terms of the residuals. Strict follow-up of benign lesions is essential to avoid delayed cancer diagnosis.

Beyond mammography screening: quality assurance in breast cancer diagnosis (The QuaMaDi Project).

As many breast cancer cases are detected outside mammographic screening, a multidisciplinary quality management (QuaMaDi) project involving gynaecologists, double reading by radiologists. and centralised assessment, documentation, evaluation and feedback was implemented into routine breast cancer diagnosis in part of Schleswig-Holstein (Germany) with a population of 365,000 women. A cohort of 59,514 patients eligible for diagnostic mammography was examined from May 2001 to December 2005 and quality indicators, breast cancer incidence and tumour stage distribution were analysed. A total of 102,744 diagnostic processes were initiated, for 23.8% of which (24,470) a third expert reading at the reference centre was performed. Further assessment was recommended for 6.3% (6442) of all patients. In total, 1056 breast cancer cases were diagnosed (10.3 per 1000 examinations). Patients of the QuaMaDi project had a higher proportion of 'in situ' and T1 tumours (62.6% vs Schleswig-Holstein: 48.6%), showing that the implementation of high standards in routine diagnostic mammography can improve the quality of breast cancer diagnosis and care.