CDK4/6 Inhibitors in Advanced HR+/HER2 - Breast Cancer: A Multicenter Real-World Data Analysis

CDK4/6 inhibitors (CDK4/6i) combined with endocrine therapy are considered standard-of-care for first-line therapy of patients with hormone receptor positive, HER2 negative, advanced breast cancer (HR+/HER2- ABC). Superiority of combination therapy over endocrine monotherapy has been demonstrated in a multitude of randomized controlled trials (RCTs) in phase III and IV. However, RCTs reflect clinical reality only to a limited extent, as narrow inclusion criteria lead to a selected patient collective. Here, we present real-world data (RWD) on CDK4/6i treatment in patients with HR+/HER2- ABC at four certified German university breast cancer centers.This study was supported by Novartis Pharma GmbH as part of the “ERIC” (“Excellent Researchers in Breast Cancer”) project

Evaluation of an OSCE’s implementation and a two-step approach for a theoretical and practical training program in Obstetrics and Gynecology

Objective structured clinical examination (OSCE) is a well-known assessment method to evaluate clinical skills and competence in healthcare. Following the recently reformed National Competence-Based Catalog of Learning Objectives in Medicine, the implementation of this assessment method in the training program for medical students is now obligatory in Germany. This major change requires a reorganization not only of the training programs but also of the students themselves and the way they learn. We performed a poll evaluating the students’ opinions regarding these major changes and the implementation of the OSCE with a new training program. To implement this assessment method and to evaluate the OSCE, Kern’s six-step approach comprising (1) problem identification and general needs assessment, (2) needs assessment of the targeted learners, (3) goals and objectives, (4) educational strategies, (5) implementation, and (6) evaluation and feedback was applied. To evaluate and gather feedback, a poll was used to analyze the student’s opinions regarding OSCE in gynecology and obstetrics and OSCE in general, in addition to the regular analysis of the students’ results. To reform the educational strategy, a two-step approach was developed: First, the students completed the regular training program and a written examination, and second, they participated in a 1-week clerkship, in small group teaching, and in the OSCE. The OSCE stations were developed primarily based on the National Competence-Based Catalog and the German Catalog of Learning Objectives in Medicine, as well as on the feedback of experts reflecting their expectations for physicians beginning their careers. The students performed well in the OSCE and gave positive feedback regarding this examination method. Furthermore, they welcomed the upcoming changes by considering OSCE a valuable assessment tool, and they showed appreciation for the two-step approach by supporting the combination of an OSCE and a written examination. Thus, this article presents the implementation of an OSCE and a strategy for the adaptation of the curriculum to fulfill the new OSCE requirements and—to our knowledge—reveals students’ primary opinions regarding the changes in their medical training program for the first time

Significance of intraperitoneal Chemotherapy in advanced Ovarian Cancer

Patientinnen mit Ovarialkarzinom werden in etwa 70% der Falle im fortgeschrittenen Tumorstadium FIGO III oder IV diagnostiziert. Die 5-Jahres-uberlebensraten fur diese Patientinnen sind hierbei mit etwa 32% (FIGO IIIC) und 19% (FIGO IV) begrenzt 1. Die Standardtherapie besteht aus der primaren Operation mit Entfernung beider Adnexe, Hysterektomie, infragastrischer Omentektomie und systematischer Lymphonodektomie im Bereich der gro ss en Bauchgefa ss e bis zum Nierenstiel, der pelvinen Lymphonodektomie, Peritonektomie und Entfernung des sichtbaren Tumors. Ziel ist die makroskopische Tumorfreiheit am Ende der Operation, die in spezialisierten Zentren in etwa 65-74% erreicht wird 2. In der Regel erfolgt hiernach eine Chemotherapie mit 6 Zyklen Carboplatin und Paclitaxel oder, seltener, Docetaxel. Die Hinzunahme von Bevazicumab wird von der Organkommission Ovar der Arbeitsgemeinschaft Gynakologische Onkologie (AGO) seit Januar 2012 empfohlen, sie gehort in anderen Landern, wie den USA, noch nicht zur Empfehlung der Fachgesellschaften. In Untergruppen kann die Sequenz zugunsten einer neoadjuvanten Chemotherapie von 2-3 Zyklen vor der Operation verandert werden 3,4

Impact of Open Laparoscopy in Patients Under Suspicion of Ovarian Cancer

Background/Aim: Feasibility and value of diagnostic open laparoscopy (DOL) was assessed in patients presenting under suspicion of advanced ovarian cancer (AOC) mostly with large-volume ascites. Patients and Methods: This retrospective study analyzed 143 consecutive patients who underwent DOL for histopathological verification of AOC performed from 2002 to 2012. Results: Out of the 143 patients presenting at our Center with an ovarian mass and mostly with ascites under suspicion of ovarian cancer, we diagnosed 125 AOCs, three AOCs with three concomitant tumors of other origin, and 15 other diseases causing an ovarian mass and ascites mimicking AOC (e.g. gastrointestinal malignancies, tuberculosis, mesothelioma, endometrial cancer and benign conditions). Conclusion: DOL can be considered a valid and safe diagnostic tool for histopathologically verifying epithetlial ovarian cancer and preventing patients with other diagnoses undergoing the wrong course of therapy

c-myc copy number gain is a powerful prognosticator of disease outcome in cervical dysplasia

Cervical carcinoma develops from preneoplasia by a multistep process. Although most low-grade dysplastic lesions will regress without intervention and even highgrade changes exhibit a substantial rate of regression, a small percentage of dysplasia will progress over time. Thus, indicators are needed to estimate the biological risk and to help avoid overtreatment in women who desire to preserve fertility. In addition to the classical biomarkers, PCR-ELISA-determined HPV genotype and immunohistochemically assessed p16(INK4a) and Ki-67 expression, cells with integrated HPV and copy number gain of TERC and c-myc were quantified in a panel of 104 benign, intraepithelial neoplastic (CIN I, II, III) and cancerous lesions using fluorescence in situ hybridization. Optimal cut-off values were calculated; Kaplan-Meier curves and a Cox proportional hazard regression model were used to evaluate prognostic signatures. The assay reliably identified HPV integration, TERC and c-myc copy number gain as determined by comparisons with established biomarkers. All biomarker levels increased with the progression of the disease. However, only c-myc copy number gain independently prognosticated a low probability of dysplastic regression. Our results suggest that c-myc plays a key role in the process of dysplastic transformation and might thus be exploited for treatment and follow-up decision-making of cervical dysplasia

Barrier films for the prevention of acute radiation dermatitis in breast cancer: A systematic review and meta-analysis of randomised controlled trials

Purpose: Radiation dermatitis (RD) is the most common side effect of adjuvant whole-breast or chest wall irradiation, majorly impacting quality of life in numerous patients. The use of barrier films (polyurethane dressings such as Hydrofilm® and Mepitel® film remaining on the skin for the duration of the radiation treatment) has been investigated as a prophylactic measure in several prospective trials. Here, we critically appraise the available evidence behind preventive barrier film application in the context of breast cancer treatment. Methods: International literature was reviewed and high-quality randomised controlled trials (RCTs) were included in this meta-analysis. Results: The results of 5 RCTs (663 patients; >90% Caucasian) were analysed. Overall, barrier films lead to improved clinician- and patient-reported outcomes: fewer grade ≥2 RD (11% vs. 42%; OR = 0.16; p < 0.001) and moist desquamation (2% vs. 16%; OR = 0.12; p = 0.006), as well as less patient-reported pain (standardised mean difference [SMD] −0.51; p < 0.001), itching (SMD −0.52; p = 0.001), burning (SMD −0.41; p = 0.011), and limitations in daily activities (SMD −0.20; p = 0.007). Furthermore, barrier films have a high acceptance rate among patients, as well as a favourable cost-benefit ratio. Possible side effects due to its application are mild and mostly self-limiting. Overall, there was a lack of information on the radiation treatment techniques used. Conclusion: The evidence presented in this meta-analysis suggests that barrier films are an excellent tool in the prevention of RD among Caucasian patients receiving whole-breast or chest wall irradiation. Its use should therefore be considered routinely in these patients

Do Barrier Films Impact Long-Term Skin Toxicity following Whole-Breast Irradiation? Objective Follow-Up of Two Randomised Trials

Purpose: Hydrofilm, a polyurethane-based barrier film, can be used to prevent acute radiation dermatitis (RD) in adjuvant whole-breast irradiation (WBI) for breast cancer. This cost-effective prophylactic measure is currently being recommended to a growing number of patients, yet long-term safety data and its impact on late radiation-induced skin toxicity such as pigmentation changes and fibrosis have not been investigated. Methods: We objectively evaluated patients who were previously enrolled in either of two intrapatient-randomised (lateral versus medial breast halve) controlled trials on the use of Hydrofilm for RD prevention (DRKS00029665; registered on 19 July 2022). Results: Sixty-two patients (47.7% of the initial combined sample size) provided consent for this post-hoc examination, with a median follow-up time (range) of 58 (37–73) months. Following WBI, there was a significant increase in yellow skin tones of the entire breast when compared to baseline measurements before WBI (p p p p = 0.004, respectively). At follow-up, there were no significant differences in either pigmentation changes or skin fibrosis between the Hydrofilm and standard of care breast halves. Conclusion: These data suggest that Hydrofilm can be safely used in the context of acute RD prevention, without affecting late side effects, supporting its widespread use