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BACKGROUND: The monarchE and NATALEE trials demonstrated the benefit of CDK4/6 inhibitor (CDK4/6i) therapy in adjuvant breast cancer (BC) treatment. Patient selection, based on clinical characteristics, delineated those at high (monarchE) and high/intermediate recurrence risk (NATALEE). This study employed a historical patient cohort to describe the proportion and prognosis of patients eligible for adjuvant CDK4/6i trials. METHODS: Between 2009 and 2011, 3529 patients were enrolled in the adjuvant PreFace clinical trial (NCT01908556). Eligibility criteria included postmenopausal patients with hormone receptor-positive (HRpos) BC for whom a five-year upfront therapy with letrozole was indicated. Patients were categorized into prognostic groups according to monarchE and NATALEE inclusion criteria, and their invasive disease-free survival (iDFS) and overall survival (OS) were assessed. RESULTS: Among 2891 HRpos patients, 384 (13.3 %) met the primary monarchE inclusion criteria. The majority (n = 261) qualified due to having ≥ 4 positive lymph nodes. For NATALEE, 915 out of 2886 patients (31.7 %) met the eligibility criteria, with 126 patients (13.7 %) being node-negative. Patients from monarchE with ≥ 4 positive lymph nodes and NATALEE with stage III BC exhibited the poorest prognosis (3-year iDFS rate 0.87). Patients ineligible for the trials demonstrated prognoses similar to the most favorable patient groups within the eligibility criteria. CONCLUSION: Patient populations eligible for monarchE and NATALEE trials differed. Nearly a third of the postmenopausal HRpos population, previously under upfront letrozole treatment, met the NATALEE prognostic eligibility criteria. As certain eligible groups had a prognosis similar to non-eligible patients, it might be interesting to explore additional patient groups for CDK4/6i therapy.
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Neoplasias de la Mama , Letrozol , Selección de Paciente , Posmenopausia , Humanos , Letrozol/uso terapéutico , Letrozol/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Neoplasias de la Mama/mortalidad , Femenino , Anciano , Quimioterapia Adyuvante , Persona de Mediana Edad , Pronóstico , Receptor ErbB-2/metabolismo , Supervivencia sin Enfermedad , Receptores de Estrógenos/metabolismo , Anciano de 80 o más Años , Quinasa 4 Dependiente de la Ciclina/antagonistas & inhibidoresRESUMEN
[This corrects the article DOI: 10.1055/a-2238-3153.].
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Introduction: Adjuvant treatment of patients with early-stage breast cancer (BC) should include an aromatase inhibitor (AI). Especially patients with a high recurrence risk might benefit from an upfront therapy with an AI for a minimum of five years. Nevertheless, not much is known about the patient selection for this population in clinical practice. Therefore, this study analyzed the prognosis and patient characteristics of postmenopausal patients selected for a five-year upfront letrozole therapy. Patients and Methods: From 2009 to 2011, 3529 patients were enrolled into the adjuvant phase IV PreFace clinical trial (NCT01908556). Postmenopausal hormone receptor-positive BC patients, for whom an upfront five-year therapy with letrozole (2.5 mg/day) was indicated, were eligible. Disease-free survival (DFS), overall survival (OS) and safety in relation to patient and tumor characteristics were assessed. Results: 3297 patients started letrozole therapy. The majority of patients (n = 1639, 57%) completed the five-year treatment. 34.5% of patients continued with endocrine therapy after the mandated five-year endocrine treatment. Five-year DFS rates were 89% (95% CI: 88-90%) and five-year OS rates were 95% (95% CI: 94-96%). In subgroup analyses, DFS rates were 83%, 84% and 78% for patients with node-positive disease, G3 tumor grading, and pT3 tumors respectively. The main adverse events (any grade) were pain and hot flushes (66.8% and 18.3% of patients). Conclusions: The risk profile of postmenopausal BC patients selected for a five-year upfront letrozole therapy showed a moderate recurrence and death risk. However, in subgroups with unfavorable risk factors, prognosis warrants an improvement, which might be achieved with novel targeted therapies.
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Large databases have played a critical role in pharmacoepidemiological research in the last decade, with this role likely to gain further importance in the future. The aim of the present paper is to describe the characteristics, the recent use, and the limitations of the German longitudinal prescription (LRx) database. The LRx database contains patient-level data on prescriptions collected in retail pharmacies, corresponding to ~ 80% of prescriptions reimbursed by statutory health insurance funds in Germany. The LRx database includes a higher proportion of older adults and women compared to the overall German population with statutory health insurance. Coverage per family of drugs ranges from 71.8% for antiepileptics to 94.7% for urological agents. Multiple pharmacoepidemiological studies based on the data from the German LRx database have been published in the last years on topics such as patterns of prescription and treatment adherence and persistence. A large number of disorders have been investigated in this research (e.g., type 2 diabetes, inflammatory diseases, and psychiatric conditions). The major limitations of the LRx database are the lack of formal diagnoses and the absence of hospital data. In conclusion, the German LRx database could be a key source of data for future pharmacoepidemiological studies.
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Diabetes Mellitus Tipo 2 , Humanos , Femenino , Anciano , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Anticonvulsivantes , Prescripciones de Medicamentos , Alemania/epidemiología , Bases de Datos FactualesRESUMEN
With more novel drugs being approved for the treatment of ovarian carcinoma, the question remains to what extent patients benefit from antiangiogenic treatment with bevacizumab, either in combination with poly-(ADP-ribose) polymerase inhibitors or as single-agent maintenance. As fibroblast growth factor receptors and their ligands (FGFRs/FGFs) are key players in angiogenic signaling and have been linked to resistance to several drugs, we investigated the prognostic or predictive potential of FGFs/FGFRs signaling in the context of bevacizumab treatment within the prospective phase III AGO-OVAR11/ICON-7 study. FGFR1, FGFR2, FGFR3, FGFR4, FGF1, and FGF19 gene expressions were determined in 380 ovarian carcinoma tumor samples collected from German centers in the multicenter phase III AGO-OVAR11 trial/ICON-7 trial. All patients received carboplatin and paclitaxel, administered every 3 weeks for 6 cycles, and were randomized to bevacizumab. Expressions of FGFR1, FGFR2, FGF1, and FGF19 were associated with progression-free survival in both uni- and multivariate (FGFR1: HR, 1.6, P < .001; FGFR2: HR, 1.6, P = .002; FGF1: HR, 2.3, P < .001; and FGF19: HR, 0.7; P = .007) analysis. A signature built by FGFR1, FGFR4, and FGF19 defined a subgroup (n = 62) of patients that derived the greatest bevacizumab-associated improvement of progression-free survival (HR, 0.3; P = .004). In this exploratory analysis of a prospective randomized phase III trial, we provide evidence that the expression of FGFRs/FGFs might have independent prognostic values. An FGFR/FGF-based gene signature identified in our study appears to predict long-term benefit from bevacizumab. This observation is hypothesis-generating and requires validation on independent cohorts.
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Carcinoma , Neoplasias Ováricas , Humanos , Femenino , Bevacizumab/farmacología , Bevacizumab/uso terapéutico , Factor 1 de Crecimiento de Fibroblastos , Estudios Prospectivos , Factores de Crecimiento de Fibroblastos , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/genéticaRESUMEN
PURPOSE: Given the relatively high incidence of both endometriosis and breast cancer, investigating the potential connection between these gynecological diseases is of substantial clinical significance. However, there is no clear consensus in the literature on the extent to which the risk of breast cancer is increased in patients with endometriosis. Therefore, we conducted a large-scale observational study investigating the association between endometriosis and breast cancer risk. METHODS: This study included women aged ≥ 18 years with an initial endometriosis diagnosis from one of 315 office-based gynecologists in Germany between January 2005 and December 2021. Non-endometriosis patients were matched 1:1 to patients with endometriosis based on age, index year, average yearly consultation frequency, and predefined co-diagnoses within 12 months before or on the index date, including obesity and benign breast disorders. The association between endometriosis and the 10-year incidence of breast cancer was studied using Kaplan-Meier curves and log-rank tests. Finally, a univariable Cox regression analysis was conducted to assess the association between endometriosis and breast cancer. RESULTS: Over a follow-up period of up to 10 years, no significant difference was observed between the endometriosis (2.4%) and the matched non-endometriosis group (2.5%) with regard to breast cancer diagnoses. Furthermore, the regression analysis revealed no significant association between endometriosis and subsequent breast cancer. CONCLUSION: In summary, our comprehensive 10-year study involving a substantial sample of women indicates that endometriosis is not significantly associated with an increased risk of subsequent breast cancer.
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Neoplasias de la Mama , Endometriosis , Femenino , Humanos , Endometriosis/complicaciones , Endometriosis/epidemiología , Endometriosis/diagnóstico , Estudios Retrospectivos , Neoplasias de la Mama/complicaciones , Neoplasias de la Mama/epidemiología , Riesgo , Alemania/epidemiologíaRESUMEN
PURPOSE: The aim of this study was to identify the mean age at which breast cancer (BC) was first diagnosed in 2010 or 2022, and to evaluate whether there were any changes in age groups at first BC diagnosis. METHODS: This retrospective cross-sectional study included adult women (18 years or older) who were diagnosed with BC (ICD-10: C50) for the first time in 2010 or 2022 in office-based practices in Germany (in 300 general practices or 95 gynecological practices). We examined the mean age at diagnosis and the percentage of patients in three age groups (18-49, 50-65, and > 65) for both 2010 and 2022. The average age difference between 2010 and 2022 was analyzed using Wilcoxon rank tests, and the proportions of the three age groups were analyzed using chi-squared tests. These analyses were performed separately for patients in general and gynecological practices. RESULTS: The mean age at which BC was initially diagnosed in 2022 was found to be significantly greater than that in 2010 for both general practices (66.9 years vs. 64.0 years p < 0.001) and gynecological practices (62.2 years vs. 60.3 years, p < 0.001). Early-onset BC decreased from 15.6 to 12.0% in general practices and from 23.2 to 18.2% in gynecological practices between 2010 and 2022. The proportion of new BC diagnoses in the age group 50-65 increased from 36.6 to 40.9% in gynecological practices, but did not increase in general practices. CONCLUSION: The study found that BC was diagnosed at an older age in 2022 than in 2010. In addition, the proportion of early-onset BC cases decreased, while the proportion of cases in the age group 50-65 increased in gynecological practices in Germany.
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Neoplasias de la Mama , Adulto , Femenino , Humanos , Anciano , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Estudios Retrospectivos , Incidencia , Estudios Transversales , Alemania/epidemiologíaRESUMEN
PURPOSE: This study investigates the impact of the COVID-19 pandemic on breast cancer (BC) care, analyzing treatment delays and factors associated with them. METHODS: This retrospective cross-sectional study analyzed data from the Oncology Dynamics (OD) database. Surveys of 26,933 women with BC performed between January 2021 and December 2022 in Germany, France, Italy, the United Kingdom, and Spain were examined. The study focused on determining the prevalence of treatment delays due to the COVID-19 pandemic, considering factors such as country, age group, treating facility, hormone receptor status, tumor stage, site of metastases, and Eastern Cooperative Oncology Group (ECOG) status. Baseline and clinical characteristics were compared for patients with and without therapy delay using chi-squared tests, and a multivariable logistic regression analysis was conducted to explore the association between demographic and clinical variables and therapy delay. RESULTS: The present study found that most therapy delays lasted less than 3 months (2.4%). Factors associated with higher risk of delay included being bedridden (OR 3.62; 95% CI 2.51-5.21), receiving neoadjuvant therapy (OR 1.79; 95% CI 1.43-2.24) compared to adjuvant therapy, being treated in Italy (OR 1.58; 95% CI 1.17-2.15) compared to Germany or treatment in general hospitals and non-academic cancer facilities (OR 1.66, 95% CI 1.13-2.44 and OR 1.54; 95% CI 1.14-2.09, respectively) compared to treatment by office-based physicians. CONCLUSION: Addressing factors associated with therapy delays, such as patient performance status, treatment settings, and geographic location, can help guide strategies for improved BC care delivery in the future.
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Neoplasias de la Mama , COVID-19 , Humanos , Femenino , Neoplasias de la Mama/terapia , Neoplasias de la Mama/tratamiento farmacológico , COVID-19/epidemiología , Estudios Retrospectivos , Estudios Transversales , Pandemias , PrevalenciaRESUMEN
PURPOSE: Preliminary data suggest that women with breast cancer are at particularly high risk of adhesive capsulitis of the shoulder. Therefore, this study aimed to investigate the potential association between breast cancer and adhesive capsulitis in adults from Germany. METHODS: This retrospective cohort study included all women aged ≥ 18 years who were diagnosed for the first time with breast cancer in one of 1,274 general practices in Germany between January 2000 and December 2018 (index date). Women without breast cancer were matched (1:1) to those with breast cancer using a propensity score based on age at the index date, index year, and the average number of medical consultations per year during the follow-up. In women without breast cancer, the index date was a randomly selected visit date between 2000 and 2018. The association between breast cancer and the 10-year incidence of adhesive capsulitis was studied using Kaplan-Meier curves and a Cox regression model adjusted for age and several comorbidities. RESULTS: There were 52,524 women included in this study (mean [SD] age 64.2 [12.9] years). The 10-year incidence of adhesive capsulitis was 3.6% in both the group with and the group without breast cancer (log-rank p-value = 0.317). The Cox regression analysis further showed no significant association between breast cancer and adhesive capsulitis (HR = 0.96, 95% CI = 0.86-1.08). CONCLUSION: In this sample of women from Germany, breast cancer was not significantly associated with adhesive capsulitis. Although the present preliminary findings are reassuring, general practitioners should regularly assess shoulder function in breast cancer survivors.
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Neoplasias de la Mama , Bursitis , Adulto , Humanos , Femenino , Hombro , Estudios Retrospectivos , Rango del Movimiento Articular , Bursitis/epidemiología , Bursitis/complicaciones , Bursitis/diagnóstico , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/complicaciones , Alemania/epidemiologíaRESUMEN
PURPOSE: The aim of this retrospective cohort study was to analyze the cumulative incidence of breast cancer following gout and to investigate the association between gout and subsequent breast cancer in 67,598 primary care patients in Germany. METHODS: This study included adult female patients (≥ 18 years) with an initial diagnosis of gout in 1284 general practices in Germany between January 2005 and December 2020. Individuals without gout were matched to gout patients using propensity score matching based on average yearly consultation frequency during the follow-up period, diabetes, obesity, chronic bronchitis/COPD diagnoses, and diuretic therapy. The 10-year cumulative incidence of breast cancer in the cohorts with and without gout was also studied using Kaplan-Meier curves, which were then compared using the log-rank test. Finally, a univariable Cox regression analysis was conducted to assess the association between gout and breast cancer. RESULTS: After up to 10 years of follow-up, 4.5% of gout and 3.7% of non-gout patients were diagnosed with breast cancer. A Cox regression analysis revealed a significant association between gout and subsequent breast cancer in the total population (HR: 1.17; 95% CI: 1.05-1.31). In the age-stratified analyses, gout was only strongly associated with subsequent breast cancer in the age group ≤ 50 (HR: 1.58; 95% CI: 1.10-2.27), but the association was not significant in women over 50 years old. CONCLUSION: Taken together, the findings of our study provide evidence for the association between gout and subsequent breast cancer diagnosis, particularly in the youngest age group.
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Neoplasias de la Mama , Gota , Adulto , Humanos , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Neoplasias de la Mama/epidemiología , Factores de Riesgo , Gota/complicaciones , Gota/epidemiología , Atención Primaria de Salud , IncidenciaRESUMEN
PURPOSE: The aim of the study was to evaluate the baseline data of women with breast cancer (BC) undergoing treatment in an intercontinental comparison. METHODS: This study included 99,571 women with BC from Europe (70,834), Asia (18,208), and Latin America (10,529) enrolled between 2017 and 2021, based on data from IQVIA's Oncology Dynamics database. This source is supplied with information by means of a cross-sectional partially retrospective survey collecting anonymized data on inpatients and outpatients treated by a representative panel of oncologists. A multivariable logistic regression model was used to investigate the probability of metastases. RESULTS: The data available in Asia (98%) and Latin America (100%) were hospital data, while in Europe, patients were treated both in hospitals and in office-based practices (62%, 38%). The mean age in Asia and Latin America (57 ± 13) was lower than in Europe (61 ± 13; p < 0.001). Lobular BC was diagnosed twice as often in Europe compared to Asia and Latin America (15.2%, 9.8%, 8.0%). The number of patients with metastasized hormone receptor-positive (HR +) BC was significantly higher in Europe and Latin America than in Asia (76%, 68%; p < 0.001). The highest number of women with metastasized BC was reported in Europe (26% compared to 14% and 20%, respectively, in Asia and Latin America). Across the continents, the percentage of women with BC who experienced metastases was 51-61% for bone, 30-39% for lung and 25-32% for liver, followed by 3-6% for skin and 3% for brain. CONCLUSION: Women with BC treated in Europe tend to be significantly older and more likely to develop metastases than women in Asia and Latin America, except for lung metastases.
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Neoplasias de la Mama , Oncólogos , Humanos , Femenino , América Latina/epidemiología , Estudios Retrospectivos , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/terapia , Neoplasias de la Mama/patología , Estudios Transversales , Asia/epidemiología , Europa (Continente)/epidemiologíaRESUMEN
BACKGROUND: The aim of this retrospective cohort study was to measure the proportion of women with an initial prescription of an antiresorptive drug (bisphosphonates or denosumab) during five years of endocrine breast cancer therapy. METHODS: The study included women with an initial prescription of tamoxifen (TAM) or aromatase inhibitors (AIs) between January 2016 and December 2020. Kaplan-Meier analyses were performed to show the cumulative incidence of antiresorptive drug prescription for TAM and AIs separately for four age groups. A univariable Cox proportional hazards regression model was also used to estimate the relationship between initial endocrine drug (AIs vs. TAM) and antiresorptive drug prescription. RESULTS: Within 5 years, 14.1% of patients on AI and 6.1% on TAM received their first prescription for an antiresorptive drug (p < 0.001). The difference between AI and TAM was greatest in women ≤50 years (12.9% of AI and 2.8% of patients on TAM), and smallest in women >80 years (14.5% of AI and 10.3% of patients on TAM). The proportion of denosumab was 46.2% among AI patients vs. 29.1% among patients on TAM (p < 0.001) as alendronate was prescribed to 36.9% of AI vs. 50.0% of patients on TAM. CONCLUSIONS: Across all age groups, the cumulative incidence of antiresorptive drug prescriptions was higher in patients with BC treated with AI than those receiving TAM. Denosumab was most frequently used as an antiresorptive drug in patients treated with AI, while alendronate was administered more often in patients treated with TAM.
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Several studies have demonstrated the de novo formation of lymphatic vessels or the reorganization of lymphatic sinus in tumor-draining lymph nodes, partly preceding the detection of lymphatic metastases. This "lymphovascular niche"is supposed to facilitate the survival of metastatic tumor cells. Few studies on nodal lymphangiogenesis in invasive breast cancer (BC) have been published, not considering tumor-free sentinel lymph nodes (SLN) and tumor types. Specimens of SLN and/ or non-SLN (NSLN) of 95 patients with BC were examined immunohistochemically for expression of the lymphatic endothelial marker D2-40 (podoplanin) on lymphatic vessels and the subcapsular sinus. The number of D2-40-positive lymph vessels in metastases was evaluated with two morphometric methods (Chalkley count and number per HPF). Data was explored with respect to TNM parameters, grading, tumor type, size of metastasis, lymph vessel number and hormone receptor/HER2 status with appropriate statistical tests. Lymphangiogenesis was detected exclusively in and around BC metastases with both methods for lymph vessel quantification being equivalent. Lymph vessel number correlated with the size of metastases, being significantly higher in larger metastases (p < 0.001). There was no significant statistical difference with respect to tumor types. Intranodal lymphangiogenesis could not be verified by D2-40 staining in any of the tumor-free lymph nodes examined. However, D2-40 was frequently detected in sinus endothelial/virgultar cells of the subcapsular sinus, partly with strong uniform positivity. Staining intensity and stained proportion of the subcapsular sinus were markedly heterogeneous, significantly correlating with each other both in SLN and NSLN (p < 0.001). A higher proportion of D2-40 stained subcapsular sinus in SLN was significantly associated with worse overall survival (p = 0.0036) and an independent prognostic parameter in multivariate analysis (p = 0.033, HR 2.87). Further studies are necessary to elucidate the biological and clinical significance of the observed immunophenotypic variations of nodal sinus endothelium.
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Neoplasias de la Mama , Ganglio Linfático Centinela , Humanos , Femenino , Biopsia del Ganglio Linfático Centinela/métodos , Ganglio Linfático Centinela/patología , Ganglios Linfáticos/patología , Neoplasias de la Mama/patología , Endotelio/metabolismoRESUMEN
OBJECTIVE: Gynecological sarcomas account for 3% of all gynecological malignancies and are associated with a poor prognosis. Due to the rarity and heterogeneity of gynecological sarcomas there is still no consensus on optimal therapeutic strategies. This study's objective was to describe the treatment strategies used in patients with gynecological sarcomas in the primary course of disease. METHODS: The German prospective registry for gynecological sarcoma (REGSA) is the largest registry for gynecological sarcomas in Germany, Austria and Switzerland. Primary inclusion criteria for REGSA are histological diagnosis of sarcoma of the female genital tract, sarcoma of the breast or uterine smooth muscle tumors of uncertain malignant potential (STUMP). We evaluated data of the REGSA registry on therapeutic strategies used for primary treatment from August 2015 to February 2021. RESULTS: A total of 723 patients from 120 centers were included. Data on therapeutic strategies for primary treatment were available in 605 cases. Overall, 580 (95.9%) patients underwent primary surgery, 472 (81.4%) of whom underwent only hysterectomy. Morcellation was reported in 11.4% (n=54) of all hysterectomies. A total of 42.8% (n=202) had no further surgical interventions, whereas an additional salpingo-ophorectomy was performed in 54% (n=255) of patients. An additional lymphadenectomy was performed in 12.7% (n=60), an omentectomy in 9.5% (n=45) and intestinal resection in 6.1% (n=29) of all patients. Among 448 patients with available information, 21.4% (n=96) received chemo- or targeted therapies, more commonly as single-agent treatment than as drug combinations. Information about anti-hormonal treatment was available for 423 patients, among which 42 (9.9%) received anti-hormonal treatment, 23 (54.8%) of whom with low-grade endometrial stroma sarcomas. For radiotherapy, data of 437 patients were available, among which 29 (6.6%) patients underwent radiotherapy. CONCLUSION: Our study showed that treatment of patients with gynecologic sarcomas is heterogeneous. Further trials are needed along with more information on treatment modalities, therapy response and patient-reported outcomes to implement new treatment strategies.
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Neoplasias Endometriales , Ginecología , Sarcoma , Neoplasias Uterinas , Humanos , Femenino , Sarcoma/epidemiología , Sarcoma/terapia , Sarcoma/patología , Histerectomía , Alemania/epidemiología , Neoplasias Endometriales/patología , Neoplasias Uterinas/patología , Estudios RetrospectivosRESUMEN
Immunohistological examinations are useful for the histopathological diagnosis of breast carcinoma in various clinical situations. This review article aims to summarize the different immunohistological options. A distinction is made between diagnostic, prognostic, and predictive markers. Especially when a therapeutic decision results from the immunohistological expression pattern, a quantitative, quality-controlled, and validated diagnostic approach is essential.This is relevant, for example, for the classical markers ER, PR, and HER2, but also for Ki-67 and additional markers such as PD-L1. This article provides a practice-oriented summary of the most important immunohistochemical markers in routine breast cancer diagnosis and for the distinction of malignant findings from benign alterations or precursor lesions.
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Biomarcadores de Tumor , Neoplasias de la Mama , Humanos , Femenino , Biomarcadores de Tumor/metabolismo , Inmunohistoquímica , Mama/metabolismo , Neoplasias de la Mama/diagnóstico , PronósticoRESUMEN
PURPOSE: The aim of this retrospective study was to investigate the impact of a broad spectrum of antihypertensive (AH) medications on urinary tract infections (UTI) of outpatients diagnosed in general practices in Germany. METHODS: This study included a total of 367,960 patients aged ≥ 18 years newly a diagnosed with UTI in 1274 general practices in Germany between January 2010 and December 2019. The analysis was conducted for five groups representing five AH therapy classes (diuretics (DIU); beta blockers (BB); calcium channel blockers (CCB); ACE inhibitors (ACEi); angiotensin II receptor blockers (ARB)), each containing 73,592 patients. A Cox regression model was used to analyze the association between each antihypertensive drug class and UTI incidence as compared to all other antihypertensive drug classes (as a group). RESULTS: The incidence of UTI diagnosis was slightly higher in patients treated with DIU (8.6%), followed by ACEi (8.1%), ARB (7.9%), and CCB (6.5%). Antibiotic therapy for UTI was given in 5.6% of DIU and 4.3% of CCB patients. The incidence of UTI and antibiotic therapy was much higher in women than in men across all therapy classes. No significant increase or decrease in UTI incidence or antibiotic therapy was observed in any of the AH therapy classes investigated. CONCLUSION: The present study did not identify a significant increase or decrease of UTI incidence or antibiotic therapy in patients treated with ACEi, ACB, CCB, beta blockers or diuretics. Across all AH classes studied, the incidence of UTI and antibiotic therapy was higher in women than in men, although not significantly.
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Antihipertensivos , Hipertensión , Masculino , Humanos , Femenino , Antihipertensivos/uso terapéutico , Estudios Retrospectivos , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Antagonistas de Receptores de Angiotensina/uso terapéutico , Pacientes Ambulatorios , Antagonistas Adrenérgicos beta/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Diuréticos/uso terapéuticoRESUMEN
PURPOSE: The aim of this study was to analyze the persistence of women on tamoxifen (TAM) and aromatase inhibitors (AIs) in Germany, and to investigate possible determinants of non-persistence. METHODS: The present retrospective cohort study was based on the IQVIA longitudinal prescription database (LRx). The study included women with an initial prescription of TAM or AIs (anastrozole, letrozole, and exemestane) between January 2016 and December 2020 (index date). Kaplan-Meier analyses were performed to show the persistence for TAM and AI, using a therapy gap of 90 or 180 days, respectively. A multivariable Cox proportional hazards regression model was further used to estimate the relationship between non-persistence and drug prescription (AI versus TAM), age, and the specialty of the physician initiating therapy (gynecologist, oncologist, or general practitioner). RESULTS: Up to 5 years after the index date, only 35.1% of AI and 32.5% of TAM patients were continuing therapy when therapy discontinuation was defined as at least 90 days without therapy. Using a 180-day therapy gap, 51.9% of AI and 50.4% of TAM patients remained on therapy after 5 years. Cox regression models reveal that initial therapy with TAM (HR 1.06, 95% CI 1.04-1.07), therapy initiation by oncologists (HR 1.09, 95% CI 1.07-1.11), or general practitioners (HR 1.24, 95% CI 1.21-1.27) and age ≤ 50 (HR 1.08, 95% CI 1.06-1.10) were significantly associated with an increased risk of therapy discontinuation. CONCLUSION: Overall, the present study indicates that persistence rates are low in all age groups for both TAM and AI treatment. We found several factors (e.g., physician specialty, younger age, and type of endocrine therapy) to be associated with an increased risk for non-persistence.
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Inhibidores de la Aromatasa , Cumplimiento de la Medicación , Tamoxifeno , Tamoxifeno/uso terapéutico , Estudios Retrospectivos , Alemania , Humanos , Inhibidores de la Aromatasa/uso terapéutico , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Persona de Mediana Edad , AncianoRESUMEN
PURPOSE: The goal of this study is to examine the chronological development of hospitalized oncology and COVID-19 patients, and compare effects on oncology sub-disciplines for pre-pandemic (2017-19) and pandemic (2020-21) years in the setting of a German university maximum care provider. METHODS: Data were retrospectively retrieved from the hospital performance controlling system for patient collectives with oncological main (nOnco) and COVID-19 secondary diagnosis (nCOVID-19). Data analysis is based on descriptive statistical assessment. RESULTS: The oncology patient collective (nOnco = 27,919) shows a decrease of hospitalized patients for the whole pandemic (- 4% for 2020 and - 2,5% for 2021 to 2019). The number of hospitalized COVID-19 patients increases from first to second pandemic year by + 106.71% (nCOVID-19 = 868). Maximum decline in monthly hospitalized oncology patients amounts to - 19% (May 2020) during the first and - 21% (December 2020) during the second lockdown. Relative monthly hospitalization levels of oncology patients reverted to pre-pandemic levels from February 2021 onwards. CONCLUSION: The results confirm a decline in hospitalized oncology patients for the entire pandemic in the setting of a maximum care provider. Imposed lockdown and contact restrictions, rising COVID-19 case numbers, as well as discovery of new virus variants have a negative impact on hospitalized treated oncological patients.
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COVID-19 , Neoplasias , Humanos , Estudios Retrospectivos , COVID-19/epidemiología , Control de Enfermedades Transmisibles , Neoplasias/epidemiología , Neoplasias/terapia , HospitalesRESUMEN
The study pursues the objective of drawing a comparison between the data of gyne-oncology, gynecology, and obstetrics patient collectives of a German university hospital regarding the progression of patient number and corresponding treatment data during the five-year period of 2017-2021 to assess the impact of the COVID-19 pandemic on gyne-oncological treatment. Descriptive assessment is based on data extracted from the database of the hospital controlling system QlikView® for patients hospitalized at the Department of Gynecology and Obstetrics of Marburg University Hospital. Gynecology and gyne-oncology experience a maintained decline in patient number (nGynecology: -6% 2019 to 2020, -5% 2019 to 2021; nGyne-Oncology: -6% 2019 to 2020, -2% 2019 to 2021) with varying effects on the specific gyne-oncological main diagnoses. Treatment parameters remain unchanged in relative assessment, but as gyne-oncology constitutes the dominating revenue contributor in gynecology (35.1% of patients, 52.9% of revenue, 2021), the extent of the decrease in total revenue (-18%, 2019 to 2020, -14%, 2019 to 2021) surpasses the decline in patient number. The study displays a negative impact on the gynecology care situation of a German university hospital for the entire pandemic, with an even greater extent on gyne-oncology. This development not only endangers the quality of medical service provision but collaterally pressurizes gynecology service providers.