Pius Hospital Oldenburg

RET fusions appear in 1%-2% of non-small cell lung cancers (NSCLCs). The results from the ARROW study (ClinicalTrials.gov identifier: NCT03037385) supported US Food and Drug Administration approval of pralsetinib, an oral selective RET inhibitor, for metastatic RET-altered NSCLC and RET fusion-positive thyroid cancers. ARROW was a phase I/II open-label study of pralsetinib 400 mg once daily in RET fusion-positive NSCLCs. Coprimary end points were overall response rate (ORR) and safety. Key secondary end points included duration of response, progression-free survival, and overall survival (OS). At data lock (May 20, 2024), 281 patients initiated pralsetinib (median treatment duration, 15.0 months). ORR (measurable disease patients; n = 259) was 78% (95% CI, 69 to 86) for treatment-naïve patients and 63% (95% CI, 54 to 71) for prior platinum-based chemotherapy patients. Median OS was 44.3 months (95% CI, 30.9 to 53.1), 50.1 months (95% CI, 28.3 to not reached) in treatment-naïve patients, and 39.7 months (95% CI, 27.8 to 53.2) in prior platinum patients. Common grade ≥3 treatment-related adverse events were anemia (21%), hypertension (15%), and decreased neutrophils (13%). Three treatment-related deaths occurred (pneumonia, n = 2; interstitial lung disease and rhabdomyolysis, n = 1 each). Safety was consistent with previous ARROW reports; no hypersensitivity was reported in patients receiving prior immunotherapies. Pralsetinib produced robust, durable responses with manageable safety in treatment-naïve and previously treated patients with RET fusion-positive NSCLCs, confirming previous findings with longer follow-up.

This study aimed to learn from the experiences of patients who have undergone medical rehabilitation following hip or knee arthroplasty in the Netherlands and Germany. A qualitative focus group study was conducted among Dutch revision total hip and knee arthroplasty patients who had experience with initial rehabilitation in the Netherlands plus inpatient rehabilitation in Germany as part of the ‘Common Care’ pilot project. The focus group was recorded, transcribed verbatim and pseudonymised. A thematic analysis using an inductive approach was performed. Five patients and two family members joined the focus group. Analysis revealed five themes: language, location, therapy content, outcomes and structure. Content-wise, therapy, outcomes and structure of rehabilitation in Germany were perceived as more beneficial. In terms of location and language, patients favoured the Dutch approach. Participants generally expressed higher levels of satisfaction with the German rehabilitation trajectory versus the Dutch. The German approach’s main advantages were the more extensive therapy content and supervision plus a feeling of faster recovery, the Dutch were the home-sweet-home feeling, language and travel distance. Future research should further evaluate effects of rehabilitation policies especially on return to work.

Background/Objectives: Endoscopic submucosal dissection (ESD) is a state-of-the-art en bloc resection for early gastro-intestinal cancers and precursors developed and validated in Japan. Western expertise with this complex technique remains limited. Tutored training might be optimal for patients and ESD learning. We established ESD tutoring courses led by experienced Japanese experts to provide (i) optimal long-term curative outcomes and low complication rates for patients and (ii) hands-on training on difficult lesions for European endoscopists under direct expert supervision. Methods: Prospective data from 2011 to 2015 (follow-up to 12/2024) were analyzed. A total of 118 neoplasms (50% HGIEN and cancer) in 101 patients (median age 68 [37-91] years; 38% with significant comorbidities) were treated with expert or tutored ESD. Japanese experts performed 28 ESDs, while 22 trained beginners conducted 90 supervised procedures on difficult lesions during 5 live and 20 tutoring events (1-4 days each). Results: Analysis of the complete data showed curative and en bloc resection rates of 88% and 95%, respectively, with no recurrence after R0 resections during a median follow-up of 9.8 [1.5-14.9] years. Long-term survival remained recurrence-free after endoscopic resection of 3 recurrent adenomas (at R1/Rx) and curative surgery/2nd ESD for 5 non-curative ESDs. Adverse events occurred in 9.3% without emergency surgery or 30-day mortality. Comparing expert-only vs. tutored ESD procedures, beginners correctly applied curative ESD indications in 94% of 118 neoplasms. Experts resected larger lesions (22 cm2) at a rate of 9.3 cm2/h in 121 min. Tutored beginners achieved a 75% [25-100] self-completion rate on 33% smaller lesions in 112 min. Conclusions: ESD tutoring courses led by Japanese experts ensure excellent patient outcomes and standardized procedural training. This model may foster professional ESD performance across European referral centers.

Abstract Aim Data on physical activity (PA) and sports participation in individuals with total knee arthroplasty (TKA) are limited. This study aimed to assess PA and sports participation before and one year after TKA and to identify associated factors. Subject and methods In this cohort study, patients undergoing primary or revision TKA at a German university hospital (Dec 2019–May 2021) were surveyed one day before and 12 months after surgery. Questionnaires assessed PA, sports participation, sociodemographics, and lifestyle factors; data were linked to medical records. Multivariable logistic regression identified factors associated with sports participation one year postoperatively. Results Of 283 eligible patients, 241 (85%) participated, and 95% provided follow-up data. The 229 patients analysed had a mean age of 69.3 years, with 59% being female. PA was reported by 55% pre- and 53% postoperatively, with a shift of people who were active or not. Sports participation remained stable (65% vs. 67%), with cycling, hiking, swimming, and aquatic exercise most common. Higher education (OR middle vs. low: 2.50; high vs. low: 7.68) and non-smoking status (OR: 4.10) were significantly associated with post-TKA sports participation. Conclusion PA and sports participation remained largely stable across the TKA trajectory, though with a shift in individuals who were and were not physically active. Furthermore, the prevailing hypothesis that predominantly knee-related disease burden is the main driver of activity levels does not appear to be sufficient to explain this finding. Rather, it appears that affected individuals’ educational level and current smoking status have a substantial influence.

Vascular inflammation is involved in the pathophysiology of post-stroke cognitive impairment. We aimed to assess whether blood-based biomarkers of inflammation and endothelial dysfunction, such as interleukin 6 (IL-6), vascular cell adhesion molecule (VCAM-1), and tumor necrosis factor-alpha (TNF-α), are associated with cognitive function over time in a prospective cohort of first-ever ischemic stroke patients. Data were obtained from the Prospective Cohort with Incident Stroke Berlin (NCT01363856). Cognitive function was assessed with the Telephone Interview for Cognitive Status-modified (TICS-m) at 1 to 3 years of follow-up. Associations of baseline levels of IL-6, VCAM-1, and TNF-α with cognitive function over time were estimated using a linear mixed model adjusted for demographics, education, vascular risk factors, stroke severity, ischemic stroke subtype, and severity of white matter hyperintensity. We included 570 patients with mild-to-moderate ischemic stroke and baseline data on biomarker levels. The mean age was 67 (± 12 SD), 38.6% were female, and the median National Institutes of Health Stroke Scale (NIHSS) was 2 (IQR 1-4). Frequency of cognitive impairment defined as TICS-m score ≤ 31 was 21.9% at year one, 15.4% at year two, and 11.6% at year three. Higher log-transformed levels of IL-6 and VCAM-1 were associated with lower TICS-m scores over time in the adjusted linear mixed model including white matter hyperintensity burden (IL-6: β = -2.0, 95% CI -3.3 to -0.7, p = 0.003; VCAM-1: β = -4.1, 95% CI -7.3 to -1.0, p = 0.01). In patients with mild-to-moderate first-ever ischemic stroke, higher baseline levels of IL-6 and VCAM-1 were associated with lower Telephone Interview for Cognitive Status-modified during 3 years of follow-up.ClinicalTrials.gov Identifier: NCT01363856.

Endometriosis is a multifactorial disease that affects mainly women of reproductive age. It is unclear whether each form of pelvic endometriosis is an independent entity and whether a spatial relationship between all three endometriosis forms exists. We aimed with this research to examine the distribution of deep endometriosis in patients with ovarian endometriomas. We also aimed to assess the influence of unilateral and bilateral ovarian endometriomas on the distribution of deep endometriotic nodules. This is a retrospective single-center cohort study that included all patients with histologically-proven ovarian endometriomas. The #Enzian classification was used to classify endometriosis. The distribution of deep endometriosis in patients with endometriomas was assessed. A total of 106 out of 121 patients with ovarian endometriomas had coexisting deep endometriosis (87.6%). Bilateral endometriomas were more common than unilateral ones. There was a statistically significant correlation between ipsilateral ovarian endometriomas and same-sided deep endometriosis of the pelvic compartment B according to the #Enzian classification. Patients with bilateral ovarian endometriomas had deep endometriosis of the left #Enzian B pelvic compartment and rectovaginal septum at a higher frequency than patients with unilateral endometriomas. Deep Endometriosis coexists with unilateral or bilateral ovarian endometriomas in the great majority of patients. Bilateral endometriomas are associated with higher frequencies of deep endometriosis in the left #Enzian B compartment and rectovaginal septum (#Enzian A). In order to avoid incomplete surgeries and complications, patients with endometriomas should be carefully screened for deep endometriosis of the pelvis using transvaginal ultrasound or MR imaging.