Search

Background: Nowadays, ceftriaxone is being used widely and its use is less compatible with the current guidelines. The aim of this study was to determine the appropriate use of ceftriaxone. The results may help to find a way to prevent its inappropriate use in the emergency department (ED). Methods: In this observational-analytical study, the patients who were referred to EDs of two teaching hospitals from September 23, 2019, to March 19, 2020, and treated with ceftriaxone were analyzed. The appropriate use of ceftriaxone was determined based on the latest evidence-based literature. Results: Ceftriaxone had been prescribed properly in 156 patients (38.4%; 95% CI, 33.5-42.9%) and its use did not meet logical criteria in the remaining 250 patients (69.6%; 95% CI, 57.1-66.5%). The appropriate use of ceftriaxone was independently related to goal-directed use, level I triage, urinalysis (U/A) indicating urinary tract infection (UTI), and chest radiographic evidence of pneumonia. Conclusion: Our study revealed the inappropriate use of ceftriaxone in teaching medical centers; therefore, further education seems to be necessary in this field.

Background: National indicators have been defined for the satisfaction and efficiency of emergency services and for evaluating their functionality. These indicators enlighten strengths and areas where improvements can help improve emergency ward quality. Objectives: This study assessed the knowledge of medical specialists and their experiences, especially concerning the effects of these protocols. Methods: This qualitative study was conducted in 2019 in the emergency departments of hospitals affiliated with the Iran University of Medical Sciences. During semi-structured interviews with 20 professors of emergency medicine in 2019, their experiences regarding the effects of these indicators on providing emergency services were evaluated. The data were collected until saturation. All interviews were recorded with the participant’s permission and then transcribed verbatim and analyzed by content analysis method, and their semantic codes were extracted. Results: By analyzing the interviews, 14 subcategories, and four main categories were obtained. Categories and subcategories consisted of providing services to patients (with three subcategories: Improving the quality of medical services, waiting time reduction, and increasing satisfaction), improving emergency efficiency and performance (with five subcategories: Improving conditions, services, communication improvement, resource management, and facilities and equipment), accreditation (with three subcategories: Performance improvement, management and planning, and service quality improvement), and proposed indicators (with three subcategories: Time, capacity, and resources). Conclusions: The recognition of emergency medicine specialists in hospital emergencies is below average, which can affect the manner of providing health services and upgrading national indicators. With more and more familiarity of emergency medicine specialists with the indicators, a step can be taken to improve the status of hospital emergencies, thus determining patients’ tasks faster, reducing the length of stay in the emergency department, increasing patient satisfaction, and improving the performance of the emergency department.

Correlation of TILs and clinicopathological parameters

Purpose: We elucidated the value of tumor-infiltrating lymphocytes (TIL) as an independent predictor for pathologic complete response (pCR) rate and as a prognostic marker for disease-free survival (DFS) in patients with HER2-positive breast cancer in the neoadjuvant setting.Experimental Design: We evaluated stromal TILs in 498 HER2-positive breast cancer samples of the neoadjuvant GeparQuattro (G4) and GeparQuinto (G5) trials. Levels of TILs were determined as a continuous parameter per 10% increase and as lymphocyte-predominant breast cancer (LPBC; ≥ 60% TILs), and correlated with pCR rate and DFS.Results: In the complete cohort, HER2-positive LPBC cases had a significantly increased pCR rates compared with non-LPBC types. They were significant predictors for pCR in univariate (10% TILs: OR 1.12, P = 0.002; LPBC: OR 2.02, P = 0.002) and multivariate analyses (10% TILs: OR 1.1, P = 0.014; LPBC: OR 1.87, P = 0.009). This effect was also detectable in the trastuzumab-treated (10% TILs: OR 1.12, P = 0.018; LPBC: OR 2.08, P = 0.013) but not in the lapatinib-treated subgroup. We identified a low-risk (pCR/LPBC) and a high-risk group (no pCR/no LPBC) regarding DFS. In triple-positive breast cancer, TILs are of more prognostic relevance than pCR.Conclusions: We could demonstrate the predictive and prognostic impact of TILs in HER2-positive breast cancer in the neoadjuvant setting. In combination with pCR rate, TILs may help to stratify prognostic subgroups, thereby guiding future therapy decisions. Clin Cancer Res; 22(23); 5747–54. ©2016 AACR.

Baseline characteristics

As a respiratory viral infection caused by a novel coronavirus, COVID-19 became rapidly pandemic within a few months. Despite the wide range of manifestations and organ involvement in COVID-19 patients, the exact pathogenesis of severe and fatal types of COVID-19 and causes involved with the individual base of the disease is not yet understood. Several studies have reported clinical, laboratory and histopathological data in favor of vascular injury in multiple organs of critically ill patients with COVID-19 as a result of hyperactive immune response, inflammation and cytokine storm. Also, both clinical and histopathological evidence points to such vascular involvements in the skin. Given the ease of clinical examinations and skin biopsy and the lower risks of transmission of COVID-19 to healthcare workers, the present review article was conducted to investigate the vascular skin manifestations of COVID-19 patients clinically and/or histopathologically as helpful clues for better understanding the pathogenesis and predicting the prognosis of the disease, especially in severe cases. This article is protected by copyright. All rights reserved.

AIM To evaluate HER2-negative breast cancer (BC) with a low hormone receptor (HR) expression, with regard to pathological complete response (pCR) and survival, in comparison to triple-negative BC (TNBC) and strong HR-positive BC. METHODS We compared negative oestrogen (ER) and progesterone receptor (PR) {\textless}1{\%}, low-positive (ER and/or PR 1-9{\%})~and strong-positive (ER or PR 10-100{\%}) HR-expression in neoadjuvant clinical trial cohorts (n~=~2765) of BC patients. End-points were disease-free survival (DFS), distant-disease free survival (DDFS)~and overall survival (OS). We performed RNA sequencing on available tumour tissue samples from patients with low-HR expression (n~=~38). RESULTS Ninety-four (3.4{\%}) patients had low HR-positive tumours, 1769 (64.0{\%}) had strong HR-positive tumours, and 902 (32.6{\%}) had TNBC. There were no significant differences in pCR rates between women with low HR-positive tumours (27.7{\%}) and women with TNBC (35.5{\%}). DFS and DDFS were also not different for DFS, hazard ratio 1.26, 95{\%}-CI (confidence interval) : 0.87-1.83, log-rank test p~=~0.951; for DDFS, hazard ratio 1.17, 95{\%}-CI: 0.78-1.76, log-rank test p~=~0.774. Patients with strong HR-positive tumours had a significantly lower pCR rate (pCR 9.4{\%}; odds ratio 0.38, 95{\%}-CI: 0.23-0.63), but better DFS (hazard ratio 0.48, 95{\%}-CI: 0.33-0.70) and DDFS (hazard ratio 0.49, 95{\%}-CI: 0.33-0.74) than patients with low HR-positive tumours. Molecular subtyping (RNA sequencing) of low HR-positive tumours classified these predominantly into a basal subtype (86.8{\%}). CONCLUSION Low HR-positive, HER2-negative tumours have a similar clinical behaviour to TNBC showing high pCR rates and poor survival and also a basal-like gene expression signature. Patients with low HR-positive tumours should be regarded as candidates for therapy strategies targeting TNBC.

Background: Breast conserving surgery is the standard in T1-T3 primary breast cancer. The cosmetic result is very much depending on the surgeon´s experience, the tumor-size/breast ratio and the technique applied. To improve cosmetic outcome and reduce repeated surgery, we have proposed a nomogram earlier (1) which has been cited by the American Society of Breast Surgeons Consensus Conference (2). In this nomogram, we proposed 5 simple oncoplastic techniques to handle the vast majority of breast cancer cases with a good cosmetic result. However, these techniques used direct access to the mammary gland, leaving scars in the visible skin of the breast. To avoid this, we chose a more natural access to the mammary gland at the natural transitions. Methods: We conducted a prospective open-arm study including all primary invasive and non-invasive breast cancer cases of tumor stages AJCC 0-III A (Version 8.0). Access to the tumor was chosen according to the proximity of the tumor to one of the following natural transitions (Areola, Lateral Insertion of the breast, inframmary fold): Non-palpable tumors and those undergoing neoadjuvant chemotherapy had to be marked by a wireand clippes before. Intraoperative ultrasound was applied before skin incision and after removal of the tumour (ultrasound of the specimen to confirm clear margins). Resection was performed as a segmentectomy and SLN biopsy and axillary clearance was done according to current guidelines.Results: 84 patients with breast conserving NTT-surgery have been enrolled so far. 76 patients had primary surgery with stage distribution as follows: Tis (1), T1a (3), T1b (8), T1c (30), T2 (30), T3 (4) and T4b(1). 8 patients had neoadjuvant chemotherapy with stage distribution as follows: ypT0 (3), ypT1a(2), ypT1c(1) and ypT2 (2). Histopathology was predominantly invasive-ductal breast cancer (70), followed by invasive-lobular (6), ductulo-lobular (5), invasive-ductal and DCIS (1),invasive-ductal and mucinous (1) and mucinous only (1). After first surgery 77 patients had a tumor resection according to the nomogramm of NTT-surgery with free margins and 7 with involved margins, thus 91,6 % tumors were resected with free margins at first surgery. The remaining 8,4 % were margin-free after second surgery. Conclusion: Scars were not visible on the surface of the breast outside of natural transitions and rate of free margins was high at 91,6 % without impairment due to the remote access to the mammary gland. We report a high patient satisfaction. Patient-reported outcome in detail has been evaluated by validated questionnaires and will be presented onsite. References:1. Rezai M., Knispel S., Kellersmann S., Lax H., Kimmig R., Kern P: Systematization of Oncoplastic Surgery: Selection of Surgical Techniques and Patient-Reported Outcome in a Cohort of 1,035 Patients, Ann Surg Oncol (2015) 22:3730-37372. Landercasper J. et al.: Toolbox to Reduce Lumpectomy Reoperations and Improve Cosmetic Outcome in Breast Cancer Patients: The America Society of Breast Surgeons Consensus Conference, Ann Surg Oncol 22, 3174-3183 (2015) Citation Format: Peter Kern, Oliver Hoffmann, Ann-Kathrin Bittner, Rainer Kimmig, Mahdi Rezai, Ines Bücker, Alina Kessel. Natural transition targeted surgery [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS1-11.

Simple Summary CA27.29 (MUC1) is a well described biomarker for prediction of prognosis and treatment efficacy. CA27.29 is mainly evaluated in the preoperative setting. However, testing of postoperative levels and additional assessment after chemotherapy might be more informative for analyzing the usefulness of CA27.29 in relation to the efficacy of chemotherapy. Thus, both pre- and post-chemotherapy values were assessed from patients enrolled in the breast cancer SUCCESS-A trial. Pre-chemotherapy assessment was associated with disease-free survival. It had no prognostic value in node-negative patients, but there was a clear association in node-positive patients. Furthermore, it was shown that post-chemotherapy CA27.29 assessment did not add any prognostic value, either on its own or in addition to pre-chemotherapy assessment. In conclusion, this indicates that pre- and post-chemotherapy values do not provide additional information. However, pre-chemotherapy CA27.29 could be a suitable tool to identify a group with unfavorable prognosis among node-positive patients. Abstract Soluble MUC1 has been discussed as a biomarker for predicting prognosis, treatment efficacy, and monitoring disease activity in breast cancer (BC) patients. Most studies in adjuvant settings have used preoperative assessment. This study, part of the SUCCESS-A trial (NCT02181101), assessed the prognostic value of soluble MUC1 before and after standard adjuvant chemotherapy. Patients with high-risk BC were treated within the SUCCESS-A trial with either three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide followed by three cycles of docetaxel or three cycles of FEC followed by three cycles of docetaxel and gemcitabine. Cox regression analyses were performed to investigate the prognostic value of CA27.29 before and after chemotherapy relative to disease-free survival (DFS), along with established BC prognostic factors such as age, body mass index, tumor size, nodal status, estrogen receptor, progesterone receptor, HER2 status, and grading. Pre-chemotherapy and post-chemotherapy CA27.29 assessments were available for 2687 patients of 3754 randomized patients. Pre-chemotherapy CA27.29 assessment was associated with DFS in addition to established prognostic factors. It had no prognostic value in node-negative patients, but there was a clear association in node-positive patients. Post-chemotherapy CA27.29 assessment did not add any prognostic value, either on its own or in addition to pre-chemotherapy CA27.29 assessment.

Introduction: Although various factors have been recognized influencing the short-term and long-term survival of patients suffering from a heart attack, there are some other factors that have not been determined as prognostic factors affecting the survival of patients. One of these factors is the history of opioid use among patients. This study was conducted to investigate the relationship between the survival of patients suffering from acute myocardial infarction (AMI) and the use of opioids. Methods: This prospective cohort study was carried out on 222 patients suffering from AMI admitted to two teaching hospitals. The patients who passed away in the emergency department were excluded from this study. All patients were divided into two consumers or non-consumers groups according to the past and present use of opioids. The patientschr('39') status was investigated within 3 months of hospitalization while their clinical symptoms were recorded. The collected data were analyzed in SPSS software (Version 18) using the Mann–Whitney U test and independent t-test. A p-value of < 0.05 was considered significant. Results: The mean age scores of subjects in the case and control groups were 61.3±13.2 and 61.5±12.6, respectively. Both groups had the same history of diabetes, hyperlipidemia, hypertension, and ischemic heart disease. Based on the results, although the mean score of survival of patients in the opioid user group was slightly higher than that in the control group within 1, 2, and 3 months after the hospitalization, this difference was not significant (P>0.05). Conclusions: Opioid use has not any significant effect on the pain severity or mortality (survival) of patients after heart attack during 1, 2, or 3 months.

Reza Mosaddegh,1 Samane Nabi,2 Sogand Daei,3 Fatemeh Mohammadi,1 Gholamreza Masoumi,2 Samira Vaziri,1 Mahdi Rezai11Emergency Medicine Management Research Center, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran; 2Trauma and Injury Research Centre, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran; 3Student Research Committee, Faculty of Medicine, Iran University of Medical Sciences, Tehran, IranCorrespondence: Mahdi RezaiEmergency Medicine Management Research Center, Hazrat Rasool Hospital, Niayesh Street, Sattarkhan Street, Tehran, IranTel +98 912 138 1048Email rezaei.m@iums.ac.irIntroduction: Abdominal trauma accounts for 15–20% of all-cause mortality of trauma. Abdominopelvic CT scan with intravenous contrast is considered the most accurate non-invasive diagnostic tool in detecting intra-abdominal injuries. In previous studies, rise in liver enzymes and amylase was associated with intra-abdominal injuries but the studies were not sufficient. Our aim was to assess the diagnostic values of liver enzymes and amylase for intra-abdominal injuries in blunt trauma patients.Methods: We included blunt abdominal trauma patients who referred to three teaching hospitals in 2018. The patients who had 14 years old or more and Glasgow Coma Scale above 8 were enrolled the study if the treating physician had high index of suspicion for intra-abdominal injuries and sent the patients for abdominopelvic CT scan with intravenous contrast. Sensitivity, specificity, positive and negative predictive values are calculated for results of liver enzymes, amylase and abdominal ultrasound.Results: Eventually, 300 patients with blunt abdominal trauma entered the study. Sensitivity, specificity, positive and negative predictive values of concurrent positive results of abdominal ultrasound, amylase and liver enzymes were 81.73 (95% CI, 73.2–88.1), 63.78 (95% CI, 65.36–70.61), 58.38 (95% CI, 56.36–70.61) and 84.89 (95% CI, 77.6–90.19), respectively.Conclusion: Considering findings of the present study, the combination of liver enzymes, amylase and abdominal ultrasound results can be an alternative method for detecting intra-abdominal injuries in patients in whom treating physicians have limitations such as overweight, instability of hemodynamic and lack of CT scan facility.Keywords: blunt abdominal trauma, liver enzymes, amylase, intra-abdominal injury

Combining immune-checkpoint inhibitors with chemotherapy yielded an increased response rates in patients with metastatic triple-negative breast cancer (TNBC). Therefore, we evaluated the addition of durvalumab to standard neoadjuvant chemotherapy (NACT) in primary TNBC.GeparNuevo is a randomised phase II double-blind placebo-controlled study randomising patients with TNBC to durvalumab or placebo given every 4 weeks in addition to nab-paclitaxel followed by standard EC. In the window-phase durvalumab/placebo alone was given 2 weeks before start of nab-paclitaxel. Randomisation was stratified by stromal tumour-infiltrating lymphocyte (sTILs). Patients with primary cT1b-cT4a-d disease, centrally confirmed TNBC and sTILs were included. Primary objective was pathological complete response (pCR) (ypT0 ypN0).A total of 174 patients were randomised, 117 participated in the window-phase. Median age was 49.5 years (range 23-76); 47 patients (27%) were younger than 40 years; 113 (65%) had stage ≥IIA disease, 25 (14%) high sTILs, 138 of 158 (87%) were PD-L1-positive. pCR rate with durvalumab was 53.4% (95% CI 42.5% to 61.4%) versus placebo 44.2% (95% CI 33.5% to 55.3%; unadjusted continuity corrected χ2P = 0.287), corresponding to OR = 1.45 (95% CI 0.80-2.63, unadjusted Wald P = 0.224). Durvalumab effect was seen only in the window cohort (pCR 61.0% versus 41.4%, OR = 2.22, 95% CI 1.06-4.64, P = 0.035; interaction P = 0.048). In both arms, significantly increased pCR (P 0.01) were observed with higher sTILs. There was a trend for increased pCR rates in PD-L1-positive tumours, which was significant for PD-L1-tumour cell in durvalumab (P = 0.045) and for PD-L1-immune cell in placebo arm (P = 0.040). The most common immune-related adverse events were thyroid dysfunction any grade in 47%.Our results suggest that the addition of durvalumab to anthracycline-/taxane-based NACT increases pCR rate particularly in patients treated with durvalumab alone before start of chemotherapy.ClinicalTrials.gov number: NCT02685059.

PURPOSE The aim of the current work was to clarify whether a preoperative lymphoscintigraphy (LSG) enhances staging accuracy of sentinel lymph node biopsy (SLNB). PATIENTS AND METHODS In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. As the false-negative rate of SLNB correlates with the number of resected sentinel lymph nodes (SLNs), our primary end point was the mean number of histologically detected SLNs per patient. One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG. Stratified one-sided 95% CI for the difference (without LSG − with LSG) in the mean number of histologically detected SLNs had to be greater than −0.27 (10% noninferiority margin). Stratification was performed according to tumor focality and trial site. Additional predefined secondary end points (rates of node-positive patients and of completion axillary lymph node dissection) were analyzed to rule out differences in the reliable detection of nodal metastases. RESULTS Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers. Modified intention-to-treat analysis (n = 1,163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI, −0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences. CONCLUSION We show that SLNB is equally effective irrespective of the surgeon’s knowledge of preoperative LSG results. SLNB without LSG will speed up the preoperative workflow and reduce cost.

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

Die brusterhaltende Therapie des Mammakarzinoms hat sich zum Standard in der Behandlung des Mammakarzinoms entwickelt. Mit zunehmendem Resektionsvolumen nimmt jedoch das Risiko fur sichtbare Deformitaten und inakzeptable kosmetische Ergebnisse zu. Der Konflikt zwischen onkologischer Sicherheit und asthetischem Resultat wird besonders bei kleiner Brust-Tumor-Ratio klinisch evident. Mit zunehmendem Einsatz der brusterhaltenden Therapie nimmt deshalb die Bedeutung fur onkoplastische Operationsverfahren zur Vermeidung ungunstiger kosmetischer Operationsergebnisse zu. Das teilweise unubersichtliche Spektrum publizierter onkoplastischer Operationsverfahren macht eine systematische Strukturierung dieser Techniken im Sinne einer zielgerichteten Onkoplastik notwendig.

We analyzed the predictive potential of pretreatment soluble carbonic anhydrase IX levels (sCAIX) for the efficacy of bevacizumab in the phase III neoadjuvant GeparQuinto trial. sCAIX was determined by enzyme-linked immunosorbent assay (ELISA). Correlations between sCAIX and pathological complete response (pCR), disease-free and overall survival (DFS, OS) were assessed with logistic and Cox proportional hazard regression models using bootstrapping for robust estimates and internal validation. 1,160 HER2-negative patient sera were analyzed, of whom 577 received bevacizumab. Patients with low pretreatment sCAIX had decreased pCR rates (12.1 vs. 20.1%, p = 0.012) and poorer DFS (adjusted 5-year DFS 71.4 vs. 80.5 months, p = 0.010) compared to patients with high sCAIX when treated with neoadjuvant chemotherapy (NCT). For patients with low sCAIX, pCR rates significantly improved upon addition of bevacizumab to NCT (12.1 vs. 20.4%; p = 0.017), which was not the case in patients with high sCAIX (20.1% for NCT vs. 17.0% for NCT-B, p = 0.913). When analyzing DFS we found that bevacizumab improved 5-year DFS for patients with low sCAIX numerically but not significantly (71.4 vs. 78.5 months; log rank 0.234). In contrast, addition of bevacizumab worsened 5-year DFS for patients with high sCAIX (81 vs. 73.6 months, log-rank 0.025). By assessing sCAIX levels we identified a patient cohort in breast cancer that is potentially undertreated with NCT alone. Bevacizumab improved pCR rates in this group, suggesting sCAIX is a predictive biomarker for bevacizumab with regards to treatment response. Our data also show that bevacizumab is not beneficial in patients with high sCAIX.

Background: Currently, patients with breast cancer (BC) with hormone receptor (HR) immunohistochemical expression between 1-9% are eligible to receive endocrine therapy. However, recent data suggest that these tumors express a basal-like molecular phenotype associated with triple negative BC (TNBC) rather than luminal phenotype associated with HR positive BC. Here, we aimed to determine the differences between strong HR positive, low HR positive and negative HR BC, in regard to responsiveness to neoadjuvant chemotherapy (NACT) and disease free survival (DFS) in large cohorts from GBG clinical trials. Methods: In this retrospective analysis of data from women with BC treated in the neoadjuvant GeparQuinto (n=2572), GeparSixto (n=588) and GeparSepto (n=1206) clinical trials, we compared patients with three HR phenotypes: low positive (ER and/or PR= 1-9%), strong positive (ER or PR= 10-100%), and negative (ER and PR= Results: Patients median age was 49 years, the majority had clinical tumor stage 2 (54.1%), negative nodal status (54.7%), and Her2 negative tumors (72.4%). 85.1% of women had BC classified as no special histological type. The pCR rate across the studies was 26.2%. 145 (3.4%) patients had low HR positive, 2417 (57.3%) strong HR positive and 1658 (39.3%) HR negative tumors. After NACT, 16.3% of patients with strong HR positive BC achieved a pCR, while among those with HR negative and low HR positive tumors, pCR rates were 40.2% and 37.9%, respectively (p Conclusions: Similarly to patients with negative HR tumors, patients with low HR positive tumors have a better responsiveness to NACT and worse survival rates, compared to patients with strongly HR positive BC. We suggest that studies on treatment options for basal-like/TNBC, should also consider including patients with low HR positive tumors. Citation Format: Villegas SL, Lederer B, Untch M, Holms F, Ulmer H-U, Diebold K, Fasching PA, Weber K, Schmitt WD, Tesch H, Rezai M, Marmé F, Sinn B, Hackmann J, Schneeweiss A, Tannapfel A, Nekljudova V, Denkert C, Loibl S. Similarities between low hormone receptor positive and hormone receptor negative breast cancer: An analysis of 4366 patients from multicenter clinical trials [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-08-10.

Background Even though patients with a pCR following neoadjuvant chemotherapy have an excellent prognosis still some of these patients will eventually relapse. A better identification of pts with an increased risk of relapse despite a pCR would be helpful to select these patients for additional post-neoadjuvant treatment strategies. Thus, the rationale of this retrospective analysis was to identify factors predicting relapse despite a pCR. Methods This pooled retrospective analysis based on the GBG meta-database includes the neoadjuvant trials GeparTrio, GeparQuattro, GeparQuinto, GeparSixto and GeparSepto. In these trials 2188 (27%) of 7933 pts had a pCR according to ypT0/ypTis ypN0 Definition and were included. The primary endpoint was disease-free survival (DFS), secondary endpoints were distant DFS (DDFS) and overall survival (OS). A multivariate Cox proportional hazards model was used to report hazard ratios with 95% confidence interval (CI). The two-sided significance level was set to α=0.05. Endpoints were analysed for all pts and in subgroups defined by intrinsic subtypes. The potential risk factors intrinsic subtype (HER2 negative/hormone receptor (HR) positive, triple negative, HER2 positive/HR positive, HER2 positive/HR negative), histological tumor type (lobular vs other), grade (G1/G2 vs G3), KI67 (≤20% vs higher), initial cT and cN stadium (cT1 vs cT2 vs cT3/4; cN0 vs cN+), age (≤40 vs 41-59 vs ≥60), BMI (< 25 vs 25-29 vs ≥ 30), planned number of cycles of chemotherapy (≤6 vs > 6), menopausal status (pre- vs postmenopausal) and clinical response after 2-4 cycles (SD vs PR vs CR vs PD) were included as covariates in multivariate Cox regression models as well as study identification. Results From 2188 evaluable patients DFS, DDFS and OS events were observed in 290/197/130 pts respectively; the median follow-up over all studies was 59 months. In multivariate analysis including study and all potential risk factors DFS was significantly different with regard to the initial cN status (cN+ vs cN0, hazard ratio (HR) 1.70; 95% CI [1.2, 2.4], p=0.002). Of borderline significance was histological type (non-lobular vs lobular, HR 0.52 95% CI [0.3, 1.1]; p=0.076) and initial tumor stage (cT3/4 vs cT1, HR 1.61 95% CI [1.0, 2.7]; p=0.064). In terms of DDFS significant differences were seen for the initial cN status (cN+ vs cN0, HR 2.34; 95% CI [1.5, 3.6], p Conclusions Initial tumor load before start of neoadjuvant chemotherapy (tumor stage and nodal status) and lobular subtype were predictors of long term outcome after a pCR following neoadjuvant chemotherapy. Intrinsic subtype, KI67, grade and planned number of cycles were not predictive for a relapse. Citation Format: Huober J, Schneeweiss A, Blohmer J-U, Denkert C, Tesch H, Hanusch CA, Salat C, Rhiem K, Rezai M, Solbach C, Fasching PA, Jackisch C, Mehta K, Nekljudova V, Seither F, von Minckwitz G, Loibl S, Untch M. Factors predicting relapse in early breast cancer patients with a pathological complete response after neoadjuvant therapy – Results of a pooled analysis based on the GBG meta-database [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-08-01.

Iran is among the countries which change official time, every year according to their constitutions. Studies have shown an increase of incidence ratio (IR) of acute myocardial infarction by these time transitions. Despite annual time changes in Iran, there is no published data to prove this among the Iranian. This retrospective study examined the IR of patients with AMI, who were admitted to the Emergency Department (ED) of 5 teaching hospitals during the week just after the time transitions (observed period), with two weeks before and after the time transitions (expected period), both in spring and fall. In total, 11051 patients were admitted during the ten weeks (observed and expected), in both spring and fall time transitions. The IR of AMI during both observed and expected period did not show any significant difference (p > 0.05); however, the incidence of AMI was increased during the first week after the transition in spring (p > 0.05). Although the results of the present study did not prove the relation between time transitions and incidence of AMI, a slight increase existed for IR of AMI during three days after spring shift. This increase in IR of AMI can be due to Nowrooz, the national holidays which lasts four days after turning clocks forward in Iran.

Background GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet®) with additional carboplatin (PM(Cb)) in triple-negative BC (TNBC). Patients and methods Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER)2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN+. Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC) to receive 18 weeks of E (150 mg/m2) followed by P (225 mg/m2) followed by C (2000 mg/m2), each q2w for 3 cycles or weekly P (80 mg/m2) plus M (20 mg/m2) plus, in TNBC, Cb (area under curve (AUC) 1.5). HER2-positive BC patients additionally received trastuzumab (6 [loading dose 8]mg/kg q3w) and pertuzumab (420 [840]mg q3w) with all P and C cycles. Primary end-point was pathological complete response (pCR, ypT0/is ypN0), secondary end-points included other pCR definitions, pCR in stratified subpopulations, tolerability and compliance. This trial is registered with ClinicalTrials.gov number NCT02125344 . Results 945/961 randomised patients started treatment. The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%, with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence interval 0.77–1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P Conclusions In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective dose-dense regimens feasible in daily practice.

Background In the neoadjuvant GeparSixto study, adding carboplatin to taxane- and anthracycline-based chemotherapy improved pathological complete response (pCR) rates in patients with triple-negative breast cancer (TNBC). Here, we present survival data and the potential prognostic and predictive role of homologous recombination deficiency (HRD). Patients and methods Patients were randomized to paclitaxel plus nonpegylated liposomal doxorubicin (Myocet®) (PM) or PM plus carboplatin (PMCb). The secondary study end points disease-free survival (DFS) and overall survival (OS) were analyzed. Median follow-up was 47.3 months. HRD was among the exploratory analyses in GeparSixto and was successfully measured in formalin-fixed, paraffin-embedded tumor samples of 193/315 (61.3%) participants with TNBC. Homologous recombination (HR) deficiency was defined as HRD score ≥42 and/or presence of tumor BRCA mutations (tmBRCA). Results A significantly better DFS (hazard ratio 0.56, 95% CI 0.34–0.93; P = 0.022) was observed in patients with TNBC when treated with PMCb. The improvement of OS with PMCb was not statistically significant. Additional carboplatin did not improve DFS or OS in patients with HER2-positive tumors. HR deficiency was detected in 136 (70.5%) of 193 triple-negative tumors, of which 82 (60.3%) showed high HRD score without tmBRCA. HR deficiency independently predicted pCR (ypT0 ypN0) [odds ratio (OR) 2.60, 95% CI 1.26–5.37, P = 0.008]. Adding carboplatin to PM significantly increased the pCR rate from 33.9% to 63.5% in HR deficient tumors (P = 0.001), but only marginally in HR nondeficient tumors (from 20.0% to 29.6%, P = 0.540; test for interaction P = 0.327). pCR rates with carboplatin were also higher (63.2%) than without carboplatin (31.7%; OR 3.69, 1.46–9.37, P = 0.005) in patients with high HRD score but no tmBRCA. DFS rates were improved with addition of carboplatin, both in HR nondeficient (hazard ratio 0.44, 0.17–1.17, P = 0.086) and HR deficient tumors (hazard ratio 0.49, 0.23–1.04, P = 0.059). Conclusions The addition of carboplatin to neoadjuvant PM improved DFS significantly in TNBC. Long-term survival analyses support the neoadjuvant use of carboplatin in TNBC. HR deficiency in TNBC and HRD score in non-tmBRCA TNBC are predictors of response. HRD does not predict for carboplatin benefit.

Primary breast cancer is addressed with multimodal treatment which constitutes surgery, systemic therapy, and radiotherapy.

Introduction: Meckel’s Diverticulum (MD) affects approximately 2% of the population. Phytobezoar is defined as a vegetable and fiber-based ball in the gastrointestinal tract. We report a rare case of phytobezoar within MD presenting with partial intestinal obstruction. Case Reports: We hereby present a 20-year-old man who referred to the Emergency Department of a hospital with a two-day history of nausea, vomiting, abdominal pain, and constipation. He underwent a midline laparotomy with surgical exploration, which revealed an MD 60 cm proximal to ileocecal valve containing phytobezoar. Histopathology reported the extracted specimen as an MD without ectopic tissue. Conclusion: Meckel’s diverticulum can be affected by bezoars as well as other parts of the gastrointestinal tract. We recommend that phytobezoar within MD be considered among differential diagnosis of bowel obstruction.