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Introduction: Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic modalities, such as extensive surgical resection, chemotherapy, and radiotherapy. The most important emerging treatment modalities are immune checkpoint inhibitors. This systematic review and meta-analysis aims to assess the efficacy and safety of pembrolizumab, an immune checkpoint inhibitor, in women with advanced vulvar cancer. Materials and methods: Following a comprehensive search, review, and appraisal, two relevant single-arm studies were included. Meta-analysis was conducted using R4.3.0 software and RStudio 2023.03.0, presenting the overall effect size with a 95% confidence interval. Heterogeneity was assessed using I2 and the Cochrane Q χ2 statistics. Results: Out of 154 studies screened for eligibility, two single-arm studies involving 119 patients receiving pembrolizumab for advanced vulvar cancer were included. The pooled objective response rate (ORR) was overall 10% (95% CI: 0.00-0.84) and 9% (95% CI: 0.00-0.89) in the PD-L1 positive subgroup. In the intention-to-treat (ITT) population, 31% (95% CI: 0.04-0.85) exhibited any clinical benefit (complete response, partial response, or stable disease). In the ITT population at six months, progression-free survival (PFS) was 19% (95% CI: 0.01-0.82), and overall survival (OS) was 48% (95% CI: 0.08-0.90). At 12 months, PFS decreased to 9% (95% CI: 0.00-0.85), and OS was 33% (95% CI: 0.04-0.85). No statistically significant heterogeneity was observed in PFS and OS analyses. Discussion and conclusion: This study suggests that one-third of women with advanced or recurrent vulvar cancer may, without the influence of PD-L1 status, benefit from pembrolizumab treatment despite a decline in both PFS and OS at 12 months. These findings provide support for considering pembrolizumab in the treatment paradigm for this specific subset of cancer patients. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42023391888.
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BACKGROUND: Pelvic organ prolapse constitutes a prevalent condition associated with a considerable impact on the quality of life. The utilization of transvaginal mesh surgery for managing POP has been a subject of extensive debate. Globally, trends in TVM surgery experienced significant shifts subsequent to warnings issued by the FDA. METHODS: This study aims to explore temporal patterns in transvaginal mesh surgery in the German healthcare system. A comprehensive analysis was conducted on in-patient data from the German Federal Statistical Office spanning 2006 to 2021. A total of 1,150,811 operations, each associated with specific codes, were incorporated into the study. Linear regression analysis was employed to delineate discernible trends. RESULTS: The trends in transvaginal mesh surgery within the anterior compartment exhibited relative stability (p = 0.147); however, a significant decline was noted in all other compartments (posterior: p < 0.001, enterocele surgery: p < 0.001). A subtle increasing trend was observed for uterine-preserving transvaginal mesh surgery (p = 0.045). CONCLUSION: Surgical trends over the specified timeframe demonstrate how POP management has evolved globally. Notably, despite observed fluctuations, transvaginal mesh surgery remains a viable option, particularly for specific cases with a high risk of relapse and contraindications to alternative surgical approaches.
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INTRODUCTION: Ultrasound diagnostics is an important examination method in everyday clinical practice, but student education is often inadequate for acquiring sufficient basic skills. Individual universities have therefore started integrating (extra)curricular training concepts into medical education. This study aimed to evaluate sustainable skills development through participation in peer-assisted ultrasound courses. METHODS: From 2017, students in the clinical part of medical school could opt for extracurricular peer-assisted ultrasound courses. Depending on the format (10-week course/2-day compact course) these comprised 20 teaching units focusing on abdominal and emergency ultrasonography. Students attending compulsory workshops at the start of their practical year were enrolled in this study, allowing for a comparison between the study group (attended ultrasound course) and the control group (did not attend ultrasound course). Competency from two out of four practical exams (subjects: "aorta", "gallbladder", "kidney" and "lung") was measured, and a theory test on the same subject areas ("pathology recognition") was administered. Additional questions concerned biographical data, subjective competency assessment (7-point Likert scale), and "attitude to ultrasound training in the curriculum". RESULTS: Analysis included 302 participants in total. Ultrasound courses had been attended on average 2.5 years earlier (10-week course) and 12 months earlier (2-day compact course), respectively. The study group (n = 141) achieved significantly better results than the control group (n = 161) in the long-term follow-up. This applies both to practical exams (p < 0.01) and theory tests (p < 0.01). After course attendance, participants reported a significantly higher subjective assessment of theoretical (p < 0.01) and practical (p < 0.01) ultrasound skills. CONCLUSIONS: Peer-assisted ultrasound courses can sustainably increase both theoretical and practical competency of medical students. This highlights the potential and need for standardised implementation of ultrasound courses in the medical education curriculum.