Effect of histological breast cancer subtypes invasive lobular versus non-special type on survival in early intermediate-to-high-risk breast carcinoma: results from the SUCCESS trials.

BACKGROUND: Invasive lobular breast carcinomas (ILC) have different histological features compared to non-special type carcinomas (NST), but the effect of histological subtypes on survival is controversial. In this study, we compared clinicopathological characteristics and outcomes between ILC and NST based on a large pooled data set from three adjuvant breast cancer trials (SUCCESS A, B, and C) and investigated a potential differential effect of recurrence risk related to nodal stage on survival. METHODS: From 2005 to 2017, the large randomized controlled SUCCESS A, B, and C trials enrolled 8190 patients with primary, intermediate-to-high-risk breast carcinoma. All patients received adjuvant chemotherapy, and endocrine and/or HER2-targeted treatment was given where appropriate. Survival outcomes in terms of disease-free survival (DFS), overall survival (OS), breast cancer-specific survival (BCSS), and distant disease-free survival (DDFS) were estimated using the Kaplan-Meier method and analyzed using log-rank tests as well as univariable and adjusted multivariable Cox regression models. RESULTS: In the SUCCESS trials, 6284 patients had NST and 952 had ILC. The median follow-up time was 64 months. ILC patients were older, more likely to receive mastectomy, and more likely to have larger tumor sizes, lymph node infiltration, hormone receptor-positive, HER2neu-negative, and luminal A-like tumors than NST patients. In the overall cohort, no significant differences between ILC and NST were detectable regarding the four survival endpoints, with hazard ratios obtained in adjusted multivariable cox regressions of 0.96 (95% CI 0.77-1.21, p = 0.743) for DFS, 1.13 (95% CI 0.85-1.50, p = 0.414) for OS, 1.21 (95% CI 0.89-1.66, p = 0.229) for BCSS, and 0.95 (95% CI 0.73-1.24, p = 0.689) for DDFS. However, a differential effect of nodal stage on survival was observed, with better survival for ILC patients with pN0/pN1 tumors and worse survival for ILC patients with pN2/pN3 tumors compared to NST patients. CONCLUSIONS: Our results revealed that ILC was associated with worse survival compared to NST for patients at high risk of recurrence due to advanced lymph node infiltration. These findings should be taken into account for treatment decisions and monitoring.

Comparative analysis of EpCAM high-expressing and low-expressing circulating tumour cells with regard to their clonal relationship and clinical value.

BACKGROUND: Circulating tumour cells (CTCs) are mainly enriched based on the epithelial cell adhesion molecule (EpCAM). Although it was shown that an EpCAM low-expressing CTC fraction is not captured by such approaches, knowledge about its prognostic and predictive relevance and its relation to EpCAM-positive CTCs is lacking. METHODS: We developed an immunomagnetic assay to enrich CTCs from metastatic breast cancer patients EpCAM independently using antibodies against Trop-2 and CD-49f and characterised their EpCAM expression. DNA of single EpCAM high expressing and low expressing CTCs was analyzed regarding chromosomal aberrations and predictive mutations. Additionally, we compared CTC-enrichment on the CellSearch system using this antibody mix and the EpCAM based enrichment. RESULTS: Both antibodies acted synergistically in capturing CTCs. Patients with EpCAM high-expressing CTCs had a worse overall and progression-free survival. EpCAM high- and low-expressing CTCs presented similar chromosomal aberrations and mutations indicating a close evolutionary relationship. A sequential enrichment of CTCs from the EpCAM-depleted fraction yielded a population of CTCs not captured EpCAM dependently but harbouring predictive information. CONCLUSIONS: Our data indicate that EpCAM low-expressing CTCs could be used as a valuable tumour surrogate material-although they may be prognostically less relevant than EpCAM high-expressing CTCs-and have particular benefit if no CTCs are detected using EpCAM-dependent technologies.

Implications for surveillance for breast cancer patients based on the internally and externally validated BRENDA-metastatic recurrence score.

PURPOSE: Although the incidence of distant relapse is decreasing, 20-30% of patients with early breast cancer die of metastasis. The aim of this study is to characterize patients with metastasis-free survival(MFS) less than 5 years, to analyze the most probable site of metastases according to the internally and externally validated BRENDA-score. The BRENDA-score is a combination of the biological subtype and clinical staging. METHOD: 3832 patients with primary diagnosis of breast cancer and either distant metastatic recurrence within 5 years or MFS ≥ 5 years were assigned to this study. Patients were classified for metastatic recurrence according to the BRENDA-score. 1765 patients were in a validation set. Statistical methods were Kaplan-Meier curves, Cox regression analysis, Exhausted CHAID, likelihood-ratio tests and the Nearest Neighbor Estimation method. RESULTS: There was a significant(p < 0.001) difference between the Kaplan-Meier MFS-functions of M0-patients stratified by BRENDA-score. The BRENDA score outperforms intrinsic subtypes and the Nottingham prognostic score. It fits the original data and the validation set equally well (p = 0.179).There was a significant(p < 0.001) difference between mean BRENDA-Index for patients with MFS < 5y(21.0 ± 9.0) and patients with MFS ≥ 5y(mean BRENDA-Index 11.7 ± 8.2). 55.6% of the very high risk patients(BRENDA-Index ≥ 27) had metastases within 5 years. The most likely primary metastatic site was bone(30%) followed by liver(19%) and lung(18%). The discriminatory ability(areas under the time dependent ROC curve) of the BRENDA score is good to acceptable for the first 5 years. In the very low/low risk (intermediate, high/very high) risk group 50% of all metastases were diagnosed within 26 months. Guideline adherence had a highly significant influence on outcome independent of the risk group. CONCLUSION: The evaluation showed that the BRENDA-Score is a robust predictive tool for breast cancer recurrence and site of metastases in the first five years after diagnosis. It outperforms intrinsic subtypes and the Nottingham prognostic score. The BRENDA-score could be a tool for a risk orientated and targeted follow up.

Association of social service counseling in breast cancer patients with financial problems, role functioning and employment-results from the prospective multicenter BRENDA II study.

BACKGROUND: This study examined the relationship between social service counseling (SSC) and financial and role functioning problems in primary breast cancer (BC) patients over a 5-year observation period. METHODS: In the multicenter prospective study, patients were approached before surgery (t1), before initiation of adjuvant treatment (t2), after therapy completion (t3), and 5 years after surgery (t4). We examined the proportion of BC survivors who had financial and role functioning problems and the proportion who were employed at t4. We examined how frequently patients were informed about, offered, or used SSC, and we used multivariate logistic regression analyses to examine the relationship between this and financial and role functioning problem prevalence. RESULTS: Of the 456 BC survivors, 33% had financial problems and 22% reported role functioning problems at t4. There was no evidence that women with increased financial problems were informed about SSC more often than those without (OR 1.1, p = 0.84) or that they used SSC more often (OR 1.3, p = 0.25). However, women with role functioning problems were informed about SSC significantly more often (OR 1.7, p = 0.02) and attended counseling significantly more often (OR 1.6, p = 0.03). Among participants aged < 65 years at t4 (n = 255), 70% were employed. Patients who had received SSC were more likely to be employed at t4 than patients who did not (OR 1.9, p = 0.04). CONCLUSION: These findings underline the importance of SSC for BC patients with role functioning issues. They indicate that individuals who use SSC are more likely to be employed later on than individuals who do not.

Evaluating ChatGPT as an adjunct for the multidisciplinary tumor board decision-making in primary breast cancer cases.

BACKGROUND: As the available information about breast cancer is growing every day, the decision-making process for the therapy is getting more complex. ChatGPT as a transformer-based language model possesses the ability to write scientific articles and pass medical exams. But is it able to support the multidisciplinary tumor board (MDT) in the planning of the therapy of patients with breast cancer? MATERIAL AND METHODS: We performed a pilot study on 10 consecutive cases of breast cancer patients discussed in MDT at our department in January 2023. Included were patients with a primary diagnosis of early breast cancer. The recommendation of MDT was compared with the recommendation of the ChatGPT for particular patients and the clinical score of the agreement was calculated. RESULTS: Results showed that ChatGPT provided mostly general answers regarding chemotherapy, breast surgery, radiation therapy, chemotherapy, and antibody therapy. It was able to identify risk factors for hereditary breast cancer and point out the elderly patient indicated for chemotherapy to evaluate the cost/benefit effect. ChatGPT wrongly identified the patient with Her2 1 + and 2 + (FISH negative) as in need of therapy with an antibody and called endocrine therapy "hormonal treatment". CONCLUSIONS: Support of artificial intelligence by finding individualized and personalized therapy for our patients in the time of rapidly expanding amount of information is looking for the ways in the clinical routine. ChatGPT has the potential to find its spot in clinical medicine, but the current version is not able to provide specific recommendations for the therapy of patients with primary breast cancer.

Ki67 as Proliferative Marker in Patients with Early Breast Cancer and Its Association with Clinicopathological Factors.

INTRODUCTION: Ki67 as a proliferative marker has prognostic and therapeutic relevance in early breast cancer (EBC). However, standard cutoffs for distinguishing low and high Ki67 do not exist. MATERIAL AND METHODS: Data from all patients treated at the University Hospital Ulm for EBC between January 2013 and December 2015 with documented results for internal Ki67 assessment of the primary (n = 917) tumor were retrospectively analyzed evaluating the associations between Ki67 and other clinicopathological factors. RESULTS: 595 (64.9%) patients had a Ki67 <20% and 322 (35.1%) a Ki67 ≥20%. The median Ki67 was 10% (range 1-90%). Median Ki67 values according to the hormone receptor (HR)/ human epidermal growth factor receptor 2 (HER2) subtypes were 10% for HR-positive/HER2 negative (HR+/HER2-) disease (n = 717), 20% for HR+/HER2+ (n = 76), 30% for HR-/HER2+ (n = 45), and 60% for HR-/HER2- (n = 75). 75.2% or 89.3% of all patients with HER2-positive or triple-negative disease had a Ki67 ≥20%, respectively. Using a multivariable logistic regression with Ki67 (<20% vs. ≥20%) as binary dependent variable, younger age, positive nodal status, higher grading, histological nonspecific type carcinoma, negative HR status, and positive HER2 status were shown to be significantly associated with a higher proliferative index (Ki67 ≥20%). CONCLUSION: This analysis described Ki67 in different subtypes in EBC and its association with clinicopathological factors. According to more aggressive tumor biology, the respective subgroups also showed higher median Ki67 levels. However, definition of low and high proliferation index itself is difficult. It is essential to interpret Ki67 indices carefully with regard to the own institutional values and other clinicopathological factors.

Is extracapsular nodal extension in sentinel nodes a predictor for nonsentinel metastasis and is there an impact on survival parameters?-A retrospective single center cohort study with 324 patients.

The Z0011 trial has fundamentally changed axillary management in breast cancer patients. However, some important questions remain, like the role of extracapsular nodal extension (ENE) in positive sentinel nodes and the need for further axillary treatment. In this retrospective cohort study, we reviewed and analyzed data from 342 clinically node negative (cN0) breast cancer patients with a positive sentinel node and subsequent axillary lymph node dissection (ALND) from the BRENDA data base. The 104 (30.4%) ENE positive patients had a significantly higher proportion of ≥3 positive axillary lymph nodes (65.0%) compared to ENE negative patients with a positive sentinel node (21.4%). Likewise, ENE positive patients had significantly more often lymph node metastasis size >2 mm (96.2%) than ENE negative patients (72.7%). T1 status was observed significantly more often in ENE negative patients (53.2%) than in ENE positive patients (24.0%). While ENE was linked to worse overall survival in univariate analysis, this effect disappeared when adjusting for nodal status, age, and comorbidities in multivariate analysis. ENE of the sentinel node is an important predictor for nonsentinel lymph node involvement. We suggest that ENE influences survival only via a higher number of positive nodes - one of the most predictive parameters for survival outcome in breast cancer.

The use of axillary ultrasound (AUS) to assess the nodal status after neoadjuvant chemotherapy (NACT) in primary breast cancer patients.

INTRODUCTION: Axillary Ultrasound (AUS) is standard for pre-therapeutic axillary staging in early breast cancer patients. 35-75 % of the breast cancer (BC) patients with positive axillary lymph nodes receiving neoadjuvant chemotherapy (NACT) convert to pathological node negative. For those patients, axillary surgery after NACT could be de-escalated, if an accurate prediction of the pathologic nodal status following NACT was possible. This study aims to answer the question, whether AUS can be used as a reliable diagnostic tool for restaging of axillary nodal status after NACT. PATIENTS AND METHODS: We collected data of 96 patients with nodal positive primary breast cancer who received NACT between 2009 and 2015 at the Breast Cancer Center of the University Hospital Ulm. Patients were classified as node negative or positive by AUS after NACT (ycN + or ycN0) and the results were compared to the pathological result obtained after axillary lymph node dissection (ypN + vs ypN0) in all patients. RESULTS: 58.3 % of the patients had pathological complete remission of axillary lymph nodes after NACT (ypN0). The sensitivity and specificity of AUS were 57.5 % and 78.6 %, respectively. The FNR was 42.5 %. The Positive and Negative Predictive Values (PPV and NPV) were 65.7 % and 72.1 %, respectively. The accuracy of AUS was 69.8 % and not associated with any of the investigated clinico-pathological parameters. CONCLUSION: AUS alone is not accurate enough to replace surgical restaging of the axilla after NACT in initially node positive breast cancer patients.

Three-dimensional model for improvement of endometriosis care (3D-E).

OBJECTIVE: Endometriosis affects approximately 10% of women of reproductive age and leads to significant morbidity and financial burden. Consequently, countries such as France and Germany are formulating strategies to combat endometriosis. In this study, we propose the implementation of our three-dimensional model (3D-E) to raise awareness about endometriosis and enhance timely diagnosis, treatment, and long-term care for affected patients. METHODS: Based on the adapted Six Sigma Principle and the modified recommendation of Sales et al. for implementing evidence-based findings into a clinical routine, we first conducted a comprehensive investigation to identify risk factors leading to diagnostic delay of endometriosis. After identifying improvable factors, the applicable options were selected due to defined criteria such as integrability in the clinical routine, cost-effectiveness, and evidence-based-principle. Finally, solutions feasible for health care providers were integrated and the 3D-E model was established. RESULTS: Some of the main risk factors contributing to diagnostic delays are symptoms acceptance and misinterpreted symptoms, especially if presenting to nongynecologists in cases of extragenital endometriosis with atypical presentation. Therefore, we tried to sensitize colleagues (first dimension) with a review paper in Germany's largest medical journal and started an elective for medical students (second dimension) at our university. In order to involve additional health care professionals in endometriosis care (third dimension), we are preparing the concept of the EndoNurse. CONCLUSION: The 3D-E model is a relatively low-cost, comprehensive, and worldwide adaptable approach for facilitating knowledge transfer, sensitizing health care providers, and improving endometriosis diagnostics and therapy for patients with endometriosis who are in the center of the model.

Changes in Endometriosis-Associated Symptoms Following Immunization against SARS-CoV-2: A Cross-Sectional Study.

Background: There are many reports about variations in the menstrual cycle after infection with SARS-CoV-2 or vaccination against it. However, data on SARS-CoV-2 infection or vaccination-related changes in menstruation-associated endometriosis-typical symptoms such as dysmenorrhea, dyspareunia, dyschezia, dysuria, and bloating are rare or missing. Methods: This retrospective study was performed as an online survey among employees and students at the University Hospital Ulm, Germany. Changes regarding the presence of mentioned symptoms and after immunization (vaccination and/or infection) were evaluated with the McNemar Test. Additionally, the risk factors associated with these changes and associations between a subjectively perceived general change in menstruation and changes in the symptoms were evaluated. Results: A total of 1589 respondents were included in the final analysis. Less than 4% of respondents reported the occurrence of new symptoms that they had not experienced before immunization. Overall, there was a significant reduction in the presence of dysmenorrhea, back pain, dyschezia, bloating, and dyspareunia after immunization against coronavirus (p < 0.001). Only 2.3% of all participants reported to have been diagnosed with endometriosis. Factors associated with changes in endometriosis-typical symptoms following immunization were body mass index, age, endometriosis, and thyroid disease. Conclusions: Our results provide unique data about a reduction in the incidence of endometriosis-associated symptoms as dysmenorrhea, dyschezia, and dyspareunia after immunization against COVID-19.

Trial and error - Outcome of breech presentation depending on birth mode and root cause analysis of severe adverse events.

OBJECTIVES: The debate about the safest birth mode for breech presentation at term remains unresolved. The comparison of a vaginal breech birth (VBB) with an elective caesarean section (CS) regarding fetal outcomes favors the CS. However, the question of whether attempting a VBB is associated with poorer fetal outcomes is examined in this study. Additionally, the study evaluates factors contributing to a successful VBB and illustrates possible errors in VBB management. STUDY DESIGN: We performed a retrospective analysis of term breech births over 15 years in a Perinatal Center Level I regarding fetal, maternal, and obstetric outcomes by comparing successful with unsuccessful VBB attempt and all attempted VBB vs. CS including a multivariate analysis of predictors for a successful VBB. A root cause analysis of severe adverse events (SAE) was conducted to evaluate factors leading to poorer fetal outcomes in VBB. RESULTS: Of 863 breech cases, in 78 % a CS was performed and in 22 % a VBB was attempted, with 57 % succeeding. Comparing successful with unsuccessful VBB attempts, successful VBB showed significantly lower maternal blood loss (p < 0.001) but poorer umbilical arterial pH (UApH) (p < 0.001), while other fetal outcome parameters showed no significant differences. Predictive factors for a successful VBB attempt were a body mass index (BMI) below 30.0 kg/m2 (p = 0.010) and multiparity (p = 0.003). Comparing all attempted VBB to CS, maternal blood loss was significantly higher in CS (p < 0.001), while fetal outcomes were significantly worse in VBB attempts, included poorer Apgar scores (p < 0.001), poorer UApH values (p < 0.001), higher transfer rate to the Neonatal Intensive Care Unit (NICU) (p < 0.001) and higher rate of respiratory support in the first 24 h (p = 0.003). CONCLUSION: The failed attempt of VBB indicates significantly worse UApH without lower Apgar scores or higher transfer rate to the NICU. The likelihood of a successful VBB is 9% lower with obesity and 2.5 times higher in multiparous women. Attempting a VBB should include detailed pre-labor counseling, regarding predictive success factors, an experienced team, and consistent management during birth.

The Transobturator Tape Versus Retropubic Tension-Free Vaginal Tape in the Treatment of Comorbid and Elderly Women With Stress Urinary Incontinence: A Retrospective Analysis of Over 800 Women.

Background and objective The first-line surgical treatment for female stress urinary incontinence (SUI) involves midurethral slings (MUS), including the transobturator tape (TOT) and the retropubic tension-free vaginal tape (TVT). However, whether offering these procedures to older and comorbid women could lead to increased complications is a question that needs to be seriously addressed. In this retrospective cohort study, we aimed to compare the two procedures and evaluate the impact of age, BMI, and comorbidities on complications. Materials and methods A total of 873 procedures (306 TVTs/567 TOTs) performed between 2007 and 2017 were compared and correlated with regard to age, BMI, and comorbidities. Intraoperative complications included bleeding >50 ml, bladder injury, and anesthesia-associated complications. Postoperative complications included post-void residual volume, pain, hematoma, lower urinary tract infection, revision for loosening tape, and bladder infections. The comorbidities were evaluated based on the American Society of Anesthesiologists (ASA) and Charlson scores. Results A total of 873 MUS were conducted during the study period: 306 TVTs and 567 TOTs. Groupwise comparison between these procedures showed that women in the TOT group were older (p<0.001) with a higher BMI (p<0.001) and a higher ASA score (p<0.001) compared to the TVT group. Nevertheless, significantly more intraoperative complications, especially bladder injuries, were recorded in the TVT group. Postoperative complications occurred in 19.4% of the entire cohort, especially increased post-void residual volume. Postoperative hematoma and tape loosening were significantly more frequent in the TOT group. Age, BMI, and comorbidities showed no significant impact on intraoperative complications; however, the TOT procedure was associated with significantly fewer intraoperative complications [p=0.001, odds ratio (OR): 0.281]. Conclusions Overall, both procedures were associated with a low number of perioperative complications. The TOT technique had a lower incidence of intraoperative complications. It must be highlighted that age and comorbidities had no influence on either the intra- or postoperative complication rates. Hence, we recommend that TOT is employed to treat SUI in older, more obese, and comorbid women.

Disturbances of menstrual cycle after immunization against SARS-CoV-2 and their risk factors: Cross-sectional clinical study.

OBJECTIVE: Abnormalities of the menstrual cycle were reported after infection with SARS-CoV-2 and vaccination against it, but the available data are very heterogeneous, do not reflect intermenstrual variations or regional differences, and their risk factors are missing. METHODS: We performed a survey-based study among 6383 employees and students of Ulm University Hospital in Germany between March 1 and 31, 2021. Attributes of menstrual cycles such as cycle length (CL), menses duration (MD), and bleeding volume (BV) were reported as categorical variables before and after immunization against SARS-CoV-2 (first, second, third vaccination or infection). Additionally, the potential risk factors for cycle changes were evaluated and all participants reported the subjective perception of changes, their duration, and time of occurrence. RESULTS: The final analysis included 1726 participants. CL and BV significantly changed after vaccination, but not MD. The subjective perception showed only slight levels of agreement with the objective changes, with the highest Cohen's kappa for CL. The risk factors for the variations in CL were previous cycle irregularities, and risk factors for the changes in BV were age and body mass index. The combination of vaccines (homogenous or heterogeneous) and different types of immunization (infection and vaccination) had no significant effect on cycle irregularities. CONCLUSION: In summary, immunization against SARS-CoV-2 causes changes in the characteristics of the menstrual cycle, which are mostly temporary. The individual risk factors, but not the type of immunization, can affect the mentioned changes.

Predictors of Decreased Quality of Life in Breast Cancer Survivors Five Years After Diagnosis.

PURPOSE: Due to improved therapy, early diagnosis, and growing incidence rates, the number of long-term breast cancer survivors is increasing. Survivors can still be affected by aftercare, resulting in reduced quality of life (QoL). Thus, in this study, we investigated possible predictors of decreased physical and social functioning in breast cancer survivors. METHODS: In a German multicenter prospective study, we enrolled 759 female patients with breast cancer before surgery (t1), and contacted them again 5 years after surgery (t4). Data on QoL were assessed at t4 using the European Organization for Research and Treatment of Cancer QoL Core Questionnaire (EORTC QLQ-C30) and its breast cancer module EORTC QLQ-BR23. Predictors of decreased physical and social functioning were analyzed using logistic regression with odds ratios as effect estimates and 95% confidence intervals. Thresholds for the clinical importance of detrimental effects on QoL were defined according to Giesinger. RESULTS: Questionnaires from 759 patients were retrieved at t1. Of these, 456 participated in the study at t4. Poor QoL 5 years after diagnosis was reported by 20%-50% of the participants. Age, mastectomy, chemotherapy, education, employment, cohabitation, psychiatric comorbidities at t1, anxiety, depression, and intensity of physical activity emerged as predictors of decreased physical and social functioning 5 years after diagnosis. CONCLUSION: Relief of symptoms and improvement in the QoL should be priorities in aftercare. Detecting patients with a decreased QoL is a rising challenge. Healthcare providers should take special care of patients aged 50-59 years, patients with psychiatric comorbidities and depression, and patients who have undergone mastectomy.

Extragenital Endometriosis in the Differential Diagnosis of Non- Gynecological Diseases.

BACKGROUND: Endometriosis is a chronic, benign disease that affects approximately 10% of women of childbearing age. Its characteristic clinical features are dysmenorrhea, dyschezia, dysuria, dyspareunia, and infertility. The manifestations of extragenital endometriosis (EE) are a diagnostic challenge, as this disease can mimic other diseases due to its unusual location with infiltration of various organs and corresponding symptoms. METHODS: This review is based on publications retrieved by a selective search of the literature on the commonest extragenital sites of endometriosis, including the relevant current guideline. RESULTS: Current evidence on the treatment of extragenital endometriosis consists largely of cohort studies and cross-sectional studies. The treatment is either surgical and/or conservative (e.g., hormonal therapy). Gastrointestinal endometriosis is the most common form of EE, affecting the rectum and sigmoid colon in nearly 90% of cases and typically presenting with dyschezia. Urogenital endometriosis is the second most common form of EE. It affects the bladder in more than 85% of cases and may present with dysuria, hematuria, or irritable bladder syndrome. The diaphragm is the most common site of thoracic endometri - osis, potentially presenting with period-associated shoulder pain or catamenial pneumothorax. Endometriosis affecting a nerve often presents with sciatica. In abdominal wall endometriosis, painful nodules arise in scars from prior abdominal surgery. CONCLUSION: There is, as yet, no causally directed treatment for chronic endometriosis. The treatment is decided upon individually in discussion with the patient, in consideration of risk factors and after assessment of the benefits and risks. Timely diagnosis is essential.

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review.

Purpose Systematic evaluation of health apps designed to support and aid remote monitoring of patients during breast cancer treatment and aftercare. Method A systematic search and assessment of apps was conducted using search terms: breast cancer; breast cancer therapy; and breast cancer aftercare. Evaluation criteria were user assessments, scientifically published benefits, user-friendliness, data protection, app individualization, motivation, and financial aspects. Up to two points (P) could be awarded per criterion. The lowest possible score was 0P and the maximum was 28P. Three examiners from different institutions independently assessed the apps according to the specified criteria. Reference value was defined as the average value given by the examiners. Apps with > 18P were classified as "recommended"; ≥ 11-≤ 18P as "partially recommended" and ≤ 10P as "not recommended". Results A total of 776 apps (n = 24 from the Apple App Store, n = 752 from the Google Play Store) were identified via search query. After applying exclusion criteria, 36 apps (n = 1 from the Apple App Store; n = 35 from the Google Play Store) were evaluated. Using the mean point values of the examiners, 20 apps were classified as not recommended and 12 as partially recommended (≥ 11-≤ 18P). Four apps were rated partially recommended by two examiners and recommended by one examiner. Three apps were rated as recommended by all examiners. Conclusion Only a small minority of available apps meet recommendation criteria. Use of these apps may benefit breast cancer patients.

Outcome analysis of primary breast cancer patients who declined adjuvant chemotherapy-results from the prospective multi-center BRENDA II study.

BACKGROUND: This study examined 5-year overall, recurrence and distant metastasis-free survival (OS, RFS, MFS) of high- and intermediate-risk breast cancer (BC) patients who declined guideline-recommended adjuvant chemotherapy (CHT). METHODS: In the prospective multicenter cohort study BRENDA II, patients with primary BC were sampled over a period of four years (2009-2012). A multi-professional team (tumorboard) discussed recommendation for adjuvant CHT according to the German guideline. Potential differences in 5 year survival were analyzed using Kaplan-Meier curves and Cox regression. The hazard ratios (HR) were adjusted for age, Charlson Comorbidity Score, American Society of Anesthesiologist (ASA) physical status classification, and endocrine therapy. RESULTS: A total of 759 patients were enrolled of which 688 could receive CHT according to the guidelines (n = 219 had a clear indication, in n = 304 it was possible). For 360 patients, the tumorboard advised to perform CHT, for 304 it advised against and in 24 cases, no decision was documented. Of those with a positive suggestion, 83% received CHT. Until 5 years after diagnosis, 57 patients were deceased, 41 had at least one distant metastasis and 29 a recurrence. There was no evidence for differences in OS and MFS in patients who declined CHT despite tumorboard recommendation (HR 3.5, 95% CI 0.8-15.1 for OS, HR 1.9, 95% 0.6-6.6 for MFS). Patients who received CHT had significantly better 5-year RFS compared to those who declined (HR 0.3, 95% CI 0.1-0.9, p = 0.03). There was no evidence for different survival in those who had no CHT because of comorbidity and those who declined actively, neither for OS, MFS nor RFS. CONCLUSION: The prospective BRENDA II study demonstrates benefit in RFS by guideline adherence in adjuvant breast cancer treatment, indicating prospectively the value of internationally validated guidelines in breast cancer care.

Resemblance of the Recurrence Patterns in Primary Systemic, Primary Surgery and Secondary Oncoplastic Surgery.

PURPOSE: Surgical interventions tend to have an effect on the generation of recurrences in tumor patients due to the anesthesia involved as well as tissue damage and subsequent inflammation. This can also be found in patients with breast cancer. METHODS: In this multicenter study, we investigated data of 632 patients with breast cancer and the subsequent diagnosis of a recurrence. The patient data were acquired from 1 January 2006 to 31 December 2019 in eight different centers in Germany. The data sets were separated into those with primary surgery, primary systemic therapy with subsequent surgery, and reconstructive surgery. Three different starting points for observation were defined: the date of diagnosis, the date of first surgery, and the date of reconstructive surgery, if applicable. The observational period was divided into steps of six months and maxima of recurrences were compared. Furthermore, the variance was calculated using the difference of the distribution in percent. RESULTS: The descriptive analysis showed no resemblance between the groups. The variance of the difference of the recurrence rates analysis using the surgical date as the starting point showed similarities in the age subgroup. CONCLUSION: Our clinical analysis shows different metastatic behavior in different analysis and treatment regimes. These findings justify further investigations on a larger database. These results may possibly identify an improved follow-up setting depending on tumor stage, biology, treatment, and patient factors (i.e., age, …).