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Purpose In the ACOSOG Z0011 trial, completing axillary lymph node dissection (cALND) did not benefit patients with T1–T2 cN0 early breast cancer and 1–2 positive sentinel lymph nodes (SLN) undergoing breast-conserving surgery (BCT). This paper reports cALND rates in the clinical routine for patients who had higher (T3–T4) tumor stages and/or underwent mastectomy but otherwise met the ACOSOG Z0011 eligibility criteria. Aim of this study is to determine cALND time trends and non-sentinel axillary metastases (NSAM) rates to estimate occult axillary tumor burden. Methods Data were included from patients treated in 179 German breast cancer centers between 2008 and 2015. Time-trend rates were analyzed for cALND of patients with T3–T4 tumors separated for BCT and mastectomy and regarding presence of axillary macrometastases or micrometastases. Results Data were available for 188,909 patients, of whom 19,009 were identified with 1–2 positive SLN. Those 19,009 patients were separated into 4 cohorts: (1) Patients with T1–T2 tumors receiving BCT (ACOSOG Z0011 eligible; n = 13,741), (2) T1–T2 with mastectomy (n = 4093), (3) T3–T4 with BCT (n = 269), (4) T3–T4 with mastectomy (n = 906). Among patients with T3–T4 tumors, cALND rates declined from 2008 to 2015: from 88.2 to 62.6% for patients receiving mastectomy and from 96.6 to 58.1% in patients receiving BCT. Overall rates for any NSAM after cALND for cohorts 1–4 were 33.4%, 42.3%, 46.9%, 58.8%, respectively. Conclusions The cALND rates have decreased substantially in routine care in patients with ‘extended’ ACOSOG Z0011 eligibility criteria. Axillary tumor burden is higher in these patients than in the ACOSOG Z0011 trial.

To explore the ability of intraoperative specimen radiography (SR) to correctly identify positive margins in patients receiving breast conserving surgery (BCS). To assess whether the reoperation rate can be reduced by using this method. This retrospective study included 470 consecutive cases receiving BCS due to a primarily diagnosed breast cancer. SR was carried out in two planes, assessing the specimen regarding the presence of the lesion and its relation to all margins. If indicated, re-excision of selective orientations was advised. Under consideration of gross inspection and the SR-findings, it was up to the surgeon whether to perform re-resections. The recommendations for re-excision were, separately for each orientation, compared to the histopathological results, serving as gold standard. Intraoperative SR was performed in 470 cases, thus 2820 margins were assessed. Of those, 2510 (89.0%) were negative and 310 (11.0%) positive. SR identified 2179 (77.3%) margins correctly as negative, whereas 331 (11.7%) clear margins were misjudged as positive. Of 310 infiltrated margins, SR identified 114 (4.0%) correctly, whereas 196 (7.0%) infiltrated margins were missed. This resulted in a sensitivity/specificity of 36.8%/86.8% and PPV/NPV of 25.6%/91.8%. Through targeted re-resections positive margins could be reduced by 31.0% [310 to 214 (7.6%)]. On case level, the rate of secondary procedures could be reduced by 37.0% [from 162 to 102 (21.7%)]. SR is a helpful tool to identify infiltrated margins and to reduce the rate of secondary surgeries by recommending targeted re-excisions of according orientations in order to obtain a final negative margin status.

Locoregional control is a prerequisite to cure primary breast cancer but the prediction of locoregional recurrence to guide further local therapy following neoadjuvant chemotherapy remains a challenge. The CPS + EG score was designed to predict distant recurrences. Here we examine its ability to predict both not only distant but also locoregional recurrences with respect to accuracy and clinical applicability. Clinical data from 432 patients with primary breast cancer treated with neoadjuvant chemotherapy between 2003 and 2011 were prospectively collected. Using the Kaplan–Meier method we analyzed the risk of local and distant recurrences according to individual CPS + EG scores, stratified by type of surgery. Possible confounding of the relationship between recurrence risk and CPS + EG score by established risk factors was accounted for in multiple survival regression models. Additionally, we analyzed the performance of the CPS + EG score to predict isolated locoregional recurrence by censoring patients with prior or simultaneous distant metastases. 5-year locoregional recurrence-free survival was 90%, and 5-year distant metastases-free survival was 82%. The CPS + EG score stratified patients into six prognostic groups with distinct 5-year locoregional recurrence-free survival, ranging from 100 to 41% (p = 0.02) and 5-year distant metastases-free survival, ranging from 96 to 35% (p

In breast cancer, completion axillary lymph node dissection (cALND) was previously recommended for patients with at least one tumour-affected sentinel lymph node (SLN). Several prospective trials predominantly in patients undergoing breast-conserving surgery showed no benefit and increased arm morbidity with this procedure. We report the influence of these trials on clinical practice of patients undergoing mastectomy. We analysed prospectively collected data from patients with primary invasive breast cancer treated at German breast cancer units between January 2008 and December 2015. Time trends of cALND rates were analysed in patients undergoing mastectomy for T1/2N0M0 breast cancer with one or two tumour-involved SLNs. Multivariable logistic regression was used to determine factors influencing the decision not to perform cALND. Among the entire study cohort of 166,074 patients treated at 179 breast cancer units, 4093 patients (2%) had T1/2N0M0 breast cancer with one or two tumour-involved SLNs and underwent mastectomy. cALND rates decreased from 89.9% in 2010 to 55.5% in 2015 (p

To report on 10 years of high-risk service screening with annual MRI in the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC). A cohort of 4,573 high-risk, previously unaffected women (954 BRCA1 carriers, 598 BRCA2 carriers, 3021 BRCA1/2 non-carriers) participating in the GC-HBOC surveillance program was prospectively followed. Screening outcomes for 14,142 screening rounds with MRI between 2006 and 2015 were analyzed and stratified by risk group, type of screening round, and age. A total of 221 primary breast cancers (185 invasive, 36 in situ) were diagnosed within 12 months of an annual screening round with MRI. Of all cancers, 84.5% (174/206, 15 unknown) were stage 0 or I. In BRCA1 carriers, 16.9% (10/59, 5 unknown) of all incident cancers (screen-detected and interval cancers combined) and in BRCA2 carriers 12.5% (3/24, 4 unknown) were stage IIA or higher, compared to only 4.8% (2/42, 2 unknown) in high-risk BRCA1/2 non-carriers. Program sensitivity was 89.6% (95% CI 84.9–93.0) with no significant differences in sensitivity between risk groups or by age. Specificity was significantly lower in the first screening round (84.6%, 95% CI 83.6–85.7) than in subsequent screening rounds (91.1%, 95% CI 90.6–91.7), p

In the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, patients with 1 or 2 tumour-involved sentinel lymph nodes (SLNs) gained no benefit from completion axillary lymph dissection (cALND). We examined implementation of evidence from this trial into routine clinical management. Data were included from patients diagnosed with primary breast cancer in German breast cancer units between 2008 and 2015 and analysed retrospectively from a prospective maintained database. Descriptive analyses assessed time-trend changes in axillary surgery. Factors associated with cALND in patients with 1 or 2 positive SLNs were identified using multivariable logistic regression analysis. Overall, 179 breast cancer units provided data for 188,909 patients, of whom 13,741 (7.3%) had pT1/2cN0M0 invasive breast cancer with 1 or 2 tumour-involved SLNs and underwent breast-conserving surgery and adjuvant radiotherapy. cALND use decreased from 94.6% in 2008 to 46.9% in 2015 (p

Breast cancer is the leading cause of death from cancer in women and the most common cancer in the world [1]. To date, many patients with estrogen-receptor-positive (ER+) breast cancer are overtreated with chemotherapy when the rationale for adjuvant chemotherapy is based on clinicopathologic parameters. Different studies were able to demonstrate that a 21-gene expression assay (Oncotype DX® Genomic Health, Redwood City, CA) can predict the benefit from adjuvant chemotherapy in ER+ breast cancers [2, 3] and provide additional prognostic information independent of clinicopathological features [4]. Data from all patients with ER+ Her2neu− breast cancer undergoing Oncotype DX® testing between 2011 and 2014 at a tertiary referral center in Germany were analyzed. Oncotype DX® was performed in 69 cases, in 2 cases data were missing and in 3 cases Oncotype DX® could not be performed by the company. The results showed a low risk in 39 cases, an intermediate risk in 22 cases and a high risk in 3 cases. Based on Oncotype results, treatment recommendations were changed in 39 of 64 patients (61%). Before Oncotype DX® testing, chemotherapy was recommended in 67 patients, afterwards only in 25 patients. Data from 44 of 67 patients were matched to controls for stage, tumor grade, menopausal and hormone receptor status. Within a mean observation time of 19.7 months, cancer recurrence was observed in two patients. Oncotype DX® testing can be recommended for risk-tailored chemotherapy. Results should be validated in larger prospective studies.

In general surgery, minimally invasive laparoscopic procedures have been steadily increasing over the last decade. The application of advanced bipolar and ultrasonic energy devices for sealing and cutting of blood vessels plays a vital role in routine clinical procedures. The advantages of energy-based instruments are enhanced sealing capability combined with both fast sealing time and minimal thermal injury. The purpose of this study was to compare the safety and efficacy profiles of nine laparoscopic sealing and cutting devices in a porcine model, with a new scoring system. Comparative studies in a porcine model were performed to assess vessel sealing, burst pressure, thermal spread, maximum heat, sealing/cooling time, and compression strength over the full jaw. Nine different devices from five manufacturers were tested in this study. The sealing and cutting devices (SCD) score has been developed to enable standardized comparisons of various devices. For this purpose, the most important parameters were identified through a consensus approach. All sealed vessels with different devices could withstand a median pressure of more than 300 mmHg (range 112–2046 mmHg). The time for the sealing procedure was 7.705 s (range 5.305–18.38 s) for the ultrasonic and 7.860 s (range 5.08–10.17 s) for the bipolar devices. The ultrasonic instruments reached a median temperature of 218.1 °C (range 81.3–349.75 °C) and the bipolar devices a temperature of 125.5 °C (range 94.1–133.35 °C). The tissue reached a median temperature of 61.9 (range 47.1–80.6 °C) after ultrasonic sealing and 76.7 °C (range 63.1–94.2 °C) after bipolar sealing. The median SCD score was 10.47 (range 7.16–13.72). All the instruments used seemed safe for use on the patient. The SCD score allows an indirect comparability of the instruments.

Some women of families at high risk of breast cancer (BC) choose prophylactic mastectomy (PM) in spite of ambiguous evidence for survival benefits. The aim of this study was to investigate counselees’ characteristics, decisions on PM, and frequencies of different procedures to better understand how to tailor interventions. Eight hundred and forty-nine counselees who attended interdisciplinary consultation for genetic risk adjustment at the University Hospital Heidelberg between July 2009 and July 2011 received a tripartite questionnaire addressing sociodemographic characteristics, psychological parameters, behavioural questions, and medical data. Six hundred and twelve of the 849 counselees (72%) returned the questionnaire. Four hundred were classified as high risk of genetic BC (19.5% BRCA mutation carriers; 4% unclassified variant (UV); and 76.5% calculated as high risk by pedigree). Two hundred and thirteen out of 400 (53%) were diagnosed with BC. Fourteen out of 54 (27%) BRCA mutation carriers with BC chose contralateral PM (CPM) compared to 24/126 (14%) without a mutation but with a personal BC history (p = 0.2175). Of those without BC, 12/27 (44%) mutation carriers opted for bilateral PM (BPM) compared to none without a mutation (p

Background During the last decade, neoadjuvant chemotherapy (NACT) of early breast cancer (EBC) evolved from a therapy intended to enable operability to a standard treatment option aiming for increasing cure rates equivalent to adjuvant chemotherapy (ACT). In parallel, improvements in the quality control of breast cancer care have been established in specialized breast care units. Patients and methods This study analyzed chemotherapy usage in patients with EBC treated at the Heidelberg University Breast Unit between January 2003 and December 2014. Results Overall, 5703 patients were included in the analysis of whom 2222 (39 %) received chemotherapy, 817 (37 %) as NACT, and 1405 (63 %) as ACT. The chemotherapy usage declined from 48 % in 2003 to 34 % in 2014 of the cohort. Further, the proportion of NACT raised from 42 to 65 % irrespective of tumor subtype. In addition, frequency of pathologic complete response (pCR) defined as no tumor residues in breast and axilla (ypT0 ypN0) at surgery following NACT increased from 12 % in 2003 to 35 % in 2014. The greatest effect was observed in HER2+ breast cancer with an increase in patients achieving pCR from 24 to 68 %. Conclusions The results mirror the refined indication for chemotherapy in EBC and its preferred usage as NACT in Germany. The increase in pCR rate over time suggests improvement in outcome accomplished by a multidisciplinary decision-making process and stringent measures for quality control. Electronic supplementary material The online version of this article (doi:10.1007/s10549-016-4016-4) contains supplementary material, which is available to authorized users.

Advances in genetics and increased public awareness increased the demand for interdisciplinary genetic outpatient consultation (IOGC). Communicating cancer risk is complex, and ideally information transfer should be individualized. Although psychological experiences with genetic testing have been studied in detail, studies on long-term experiences with IOGC and information transfer are lacking. We assessed patients' understanding and satisfaction with IOGC in families at risk of hereditary breast and ovarian cancer (HBOC) with the aim of informing best clinical practice, improving compliance and informed decision-making.Female counselees referred for IOGC between July 1, 2009 and July 1, 2011 were eligible. Data were collected using a 47-item postal questionnaire to assess sociodemographic, psychological, behavioral parameters. Overall satisfaction and personal usefulness of IOGC were assessed with a five-point, and risk perception with a visual analog scale. Data were analyzed using Spearman rank, Wilcoxon U or Chi-squared test.612 (72 %) of 849 women participated reported being highly satisfied (75 %, n = 430) and declared personal usefulness (73 %, n = 421) on average 3.5 years after IOGC. Women deemed "high risk" assessed their risk of developing BC as significantly higher than non-high-risk counselees (3.2 versus 3.0, p = 0.00484). Risk perception was lower in BRCA1/2 mutation carriers than in women with unclassified variants or no mutation (2.8 versus 3.5 and 3.1, respectively).Women with an HBOC background have additional needs to achieve long-term satisfaction after IOGC. Prospective studies are required to optimize care for the increasing number of people who seek genetic consultation, particularly as the complexity of genetics knowledge increases.

This study aims at developing and evaluating a prototype of a lesion candidate detection algorithm for a 3D-US computer-aided diagnosis (CAD) system. Additionally, to routine imaging, automated breast volume scans (ABVS) were performed on 63 patients. All ABVS exams were analyzed and annotated before the evaluation with different algorithm blob detectors characterized by different blob-radiuses, voxel-sizes and the quantiles of blob filter responses to find lesion candidates. Lesions found in candidates were compared to the prior annotations. All histologically proven lesions were detected with at least one algorithm. The algorithm with optimal sensitivity detected all cancers (sensitivity = 100 %) with a very low positive predictive value due to a high false-positive rate. ABVS is a new technology which can be analyzed by a CAD software. Using different algorithms, lesions can be detected with a very high and accurate sensitivity. Further research for feature extraction and lesion classification is needed aiming at reducing the false-positive hits.

To explore whether patients after a reexcision due to involved or close margins have the same risk of local recurrence (LR) than those after a one-step breast-conserving surgery (BCS); to learn whether the presence of residual cancer in the reexcision specimen influences the probability of LR. We reviewed demographic, clinical, radiologic, and pathologic records of a cohort of women diagnosed with invasive cancer or carcinoma-in situ who underwent BCS surgery as final surgical treatment between January 1, 2003, and December 31, 2011. Univariable and multivariable Cox regression analyses were used to evaluate influencing factors of LR. A total of 2657 patients were eligible for inclusion onto this study. LR was observed in 67 patients (2.5 %) after a median follow-up of 52 months. Reexcision surgery was performed in 486 patients (18.3 %). The 5-year LR-free survival rate was 94.5 % in the reexcision group and 98.0 % in the group with one-step BCS surgery (p

The aim of this study was to identify differences between breast cancer patients with and without migrant background in Germany, especially differences concerning patient characteristics, tumor biology, diagnostics, therapy, and oncological outcome. In 99 breast cancer patients (composed of 50 native, randomly selected Germans and 49 consecutively selected immigrants of Anatolian origin) who were operated due to breast cancer at the Heidelberg University Hospital between the years 2009–2012, relevant information was retrospectively reviewed. Patients with migrant background were significantly younger at the time of receiving the diagnosis of breast cancer than native German patients with an average age difference of nine years (p

This study evaluated breast imaging procedures for predicting pathologic complete response (pCR = ypT0) after neoadjuvant chemotherapy (NACT) for breast cancer to challenge surgery as a diagnostic procedure after NACT. This retrospective, exploratory, monocenter study included 150 invasive breast cancers treated by NACT. The patients received magnetic resonance imaging (MRI), mammography (MGR), and ultrasound (US). The results were classified in three response subgroups according to response evaluation criteria in solid tumors. To incorporate specific features of MRI and MGR, an additional category [clinical near complete response (near-cCR)] was defined. Residual cancer in imaging and pathology was defined as a positive result. Negative predictive values (NPVs), false-negative rates (FNRs), and false-positive rates (FPRs) of all imaging procedures were analyzed for the whole cohort and for triple-negative (TN), HER2-positive (HER2+), and HER2-negative/hormone-receptor-positive (HER2−/HR+) cancers, respectively. In 46 cases (31 %), pCR (ypT0) was achieved. Clinical complete response (cCR) and near-cCR showed nearly the same NPVs and FNRs. The NPV was highest with 61 % for near-cCR in MRI and lowest with 44 % for near-cCR in MGR for the whole cohort. The FNRs ranged from 4 to 25 % according to different imaging methods. The MRI performance seemed to be superior, especially in TN cancers (NPV 94 %; FNR 5 %). The lowest FPR was 10 % in MRI, and the highest FPR was 44 % in US. Neither MRI nor MGR or US can diagnose a pCR (ypT0) with sufficient accuracy to replace pathologic diagnosis of the surgical excision specimen.

Disseminated tumor cells (DTC) in the bone marrow (BM) of primary breast cancer (BC) patients are a promising surrogate marker of micrometastatic spread and an independent predictor of poor prognosis for disease-free survival (DFS) and overall survival (OS). The present study aims to analyze DTCs as an independent prognostic factor for DFS/OS in tumor biology and bisphosphonate treatment. A total of 504 patients with operable primary BC and a median observation time of 72.3 months [lower quartile (LQ) 58.1; upper quartile (UQ) 82.8] have been included. DTCs were detected via immunohistochemistry as MUC-1 positive cells in the BM of 59.13 % (298 of 504) of the patients. The immunophenotyping of cancer cells was achieved immunohistochemically as well. For luminal A/B carcinoma patients, we observed a significant benefit of BM DTC negativity with respect to DFS (luminal A, P = 0.0498; luminal B, P = 0.0224). In triple-negative patients, DTC-negative BM was associated with a longer OS (P = 0.0326). In a multivariate Cox survival analysis relating to DFS and OS, the DTC status was identified as an independent prognostic factor for DFS in luminal A/B BC (P = 0.0071). A multivariate Cox survival analysis among DTC-positive patients with luminal immunophenotype showed bisphosphonate application (P = 0.0326) to be an independent prognostic factor for DFS. The findings of our multivariate analyses reveal BM DTC positivity as an independent risk factor for DFS particularly in luminal A/B BC patients. This might be a novel criterion for the identification of candidates most likely to benefit from additional adjuvant therapy possibly including bisphosphonates.

The aim of the study was to evaluate cryoablation (CA) under ultrasound guidance in the office setting with liquid nitrogen system for patients with fibroadenoma (FA).For this prospective multicenter trial, an office-based cryosurgical system was used to treat histological confirmed benign FA with a maximum dimension of 3 cm. Sixty CA procedures were performed under ultrasound guidance. A freeze-thaw-freeze treatment cycle was performed according to the size of the FA. During the CA procedure continuous ultrasound monitoring was performed, verifying engulfment of the FA. Patients attended four follow-up visits at 1 week, 3, 6 months and 1 year and underwent ultrasound, physical examination and photography.Data were collected and analyzed in 60 cases. 59 of 60 FA (98 %) were fully engulfed by the ice ball. No serious adverse events occurred related to the IceSense3 system. At the 1-year follow-up, the FAs were gone in 93% of the cases. Prior to CA procedure, 76% of the FAs were palpable. Afterwards in some cases (22%), a scar/cryo lesion was palpable. 28% of the patients reported pain, described as mild or moderate, compared to 2% after 1 year. Cosmetic results at 12 months follow-up were reported as good or excellent in 100% by physician and in 97% by patients.The cryodestruction of the FA using liquid nitrogen system proved functional and safe, while showing meaningful reduction in volume, palpability, pain and cosmetic satisfying outcomes.

The PIP/Rofil Medical breast implant recall affected around 40,000 women worldwide. An impact on quality of life (QoL) has been suspected but not yet reported.To quantify QoL and anxiety in affected women with respect to implant indication and their removal.Women who attended consultation and opted for implant removal between December 2011 and 2012 were eligible for study. Quality of life and anxiety were measured using validated questionnaires pre- and postoperatively.Fifty-five patients completed at least one questionnaire, of which 32 had received implants for breast cancer, 15 for aesthetic augmentation, and 8 for primary breast malformations. Removal of the implants improved QoL in every group, especially those who had malformations. The QoL of breast cancer patients was generally better compared to the patients with implant for other reasons.The recall of PIP/Rofil Medical breast implants had a measurable impact on QoL in affected women and no pathological worry was measurable among those women.

Analysis of mastectomy rates in breast cancer patients diagnosed between 2006 and 2010 in Germany with focus on impact of breast magnetic resonance imaging (MRI), immediate breast reconstruction (IBR) rates, and hospital volume as possible influencing factors of mastectomy rates. Data of a voluntary monitored benchmarking project were used to evaluate mastectomy trends across time in an unselected cohort of breast cancer patients. We used univariate and multivariate logistic regression analysis to identify predictive factors of mastectomy. A total of 142.863 cases were included into the analysis. There was an overall decrease of 5.9 % (95 % confidence interval 5.1–6.7) in mastectomy trend from 36.5 % in 2006 to 30.6 % in 2010 (P

In this study, we analyzed a "variant of uncertain significance" (VUS) located in exon 23 of the BRCA2 gene exhibited by six members of five distinct families with hereditary breast cancer (BC). The variant was identified by DNA sequencing, and cDNA analysis revealed its co-expression with wild-type mRNA. We analyzed co-occurrence with other pathological mutations in BRCA1/2, performed a case-control study, looked for evolutionary data and used in-silico analyses to predict its potential clinical significance. Sequencing revealed an in frame deletion of 126 nucleotides in exon 23, leading to a deletion of 42 amino acids (c.9203_9328del126, p.Pro2992_Thr3033del). All of the VUS-carriers suffered from either BC or ovarian/pancreatic cancer. No other definite pathologic mutation of BRCA genes was found in the five families. The identified deletion could not be observed in a control cohort of 2,652 healthy individuals, but in 5 out of 916 (0.5%) tested BC families without a bona fide pathogenic BRCA1/2 mutation (P = 0.0011). According to these results, the in frame deletion c.9203_9328del126 is a rare mutation strongly associated with familial BC. In summary, our investigations indicate that this BRCA2 deletion is pathogenic.

Reexcision is a clinically relevant aspect of oncological breast conservation surgery. The influence of reexcision on aesthetic outcome is described differently in the literature. Our aim was to analyze this question in a well-defined cohort with standardized study instruments. A total of 439 patients from a prospectively followed cohort were included in this analysis. Aesthetic results were assessed by the Breast Cancer Treatment Outcome Scale (BCTOS) aesthetic status. Dates of assessments were shortly after surgical interventions and before surgery. Group comparison was performed between patients with reexcisions (80 cases; 18%) and patients without reexcision (359 cases; 82%). We considered variables of differing distribution between the two groups that could hypothetically influence BCTOS aesthetic status in a nonparametric analysis of covariance (ANCOVA). The aesthetic status of patients with reexcisions was found to be significantly worse than for patients with a single breast conservation surgery (P

To analyze the relationship of objective and subjective evaluation tools of breast aesthetics, we compare the results of the BCCT.core (breast cancer conservative treatment.cosmetic results) software, a semiautomated objective symmetry evaluation tool, with those of the Aesthetic Status of the BCTOS (Breast Cancer Treatment Outcome Scale) patient questionnaire.We included 128 patients with one-sided, primary breast cancer, treated conservatively in a prospective, exploratory study in order to assess the inter-rater reliability of the BCCT.core and the agreement between the BCCT.core and the BCTOS preoperatively, shortly and 1 year after surgery. Therefore, we use agreement rates, multiple (mk), and weighted (wk) kappa coefficients as statistical methods. Furthermore, we analyzed patient-, tumor-, and therapy-related variables as possible covariates to explain agreement.The inter-rater reliability for the semiautomated BCCT.core is very good with agreement rates up to 84% (mk = 0.80). The agreement rates of the BCCT.core and the BCTOS Aesthetic Status range between 35 and 44% subject to the different times of assessment (wk = 0.34 at best). Moreover, the patients judge their aesthetic outcome more positively than the software. None of the considered patient-, tumor-, and therapy-related covariates turned out to explain agreement.The BCCT.core is a reliable instrument that shows fair agreement with patient's perspective.

The conventional first trimester screening (FTS) method integrates maternal age into risk calculation. It was suggested that this concept increases the false-positive rate in older, and the false-negative rate in younger mothers.Six thousand five hundred and eight combined FTS with known fetal outcome underwent regular risk calculation with the software programs Pia fetal database (PIA) (GE-ViewPoint, GE Medical Systems), prenatal risk calculation (PRC) (Version 1.0.61, gmt/nexus), and JOY (Version 2.1, PET software). The results were mathematically modified as if generated with age-independent software (PIA(mod), PRC(mod), and JOY(mod)).17 of 40 trisomy 21 cases were present in women younger than 35. A right shift in the mean maternal age of false-negative cases occurred in all programs (PIA: 30.00, PIA(mod): 32.00, PRC: 30.00, PRC(mod): 32.25, JOY: 30.00, JOY(mod): 34.50). The overall false-positive rate declined by -40.03% (PIA(mod)), -38.64% (PRC(mod)), and -37.50% (JOY(mod)) and in women over 35 (40) years by -72.37, -73.45, and -73.20% (-89.04, -90.33, and -90.56%), being then as high as in the other age groups.First trimester screening would become reasonable in women over 40 years. However, women over 35 would also be more often affected by false-negative results. The implications of a concept adaptation should be analyzed in a large prospective study.

First trimester screening (FTS) became standard in non-invasive testing for chromosomal abnormalities in early pregnancy. The individual risk is calculated on the basis of a general background risk, which refers to the maternal age. A new method, Advanced Firsttrimester Screening (AFS) excludes the background risk in its algorithm. This study had the aim to analyze how the detection of aneuploidies is influenced by the in- or exclusion of the maternal age in the risk calculation. The data of 15,228 first trimester screenings were recalculated with FTS and AFS. The study cohort was divided by age into nine groups and the numbers of detected cases were recorded according to the groups of age. Of 129 detected aneuploidies 90% got the same test results, disregarding whether risk assessment is performed including maternal age or not. FTS detected five aneuploidies at age 35 or older that were not recorded by AFS. AFS detected six aneuploidies that were not detected by FTS. Out of these, the oldest mother was 32 years old. When excluding the maternal age from risk calculation, the detection of aneuploidies showed a shift from older to younger women. Overall, the detection rate did not change significantly. However, the false positive rate was 25% lower with the exclusion of maternal age.