610 Medizin und Gesundheit
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Rearrangements des MLL Gens sind für 5-10% aller akuten Leukämien, biphenotypischen Leukämien und myelodysplastischen Syndrome im Kindes- und Erwachsenenalter verantwortlich. 5-10% dieser MLL Aberrationen sind wiederum therapiebedingt.
Die 43 heute schon bekannten Partnergene und die mindestens 36 noch nicht identifizierten Partnergene stellen dabei ein großes Problem für die MLL-Diagnostik dar, denn nach der zytogenetischen Analyse werden nur die am häufigsten auftretenden Partnergene MLLT2, MLLT3, MLLT1, MLLT4, ELL, und MLLT10 über RT-PCR untersucht. Dagegen werden die nicht so häufig auftretenden oder unbekannten Partnergene von einer weiteren Untersuchung ausgeschlossen.
Wenn auch alle MLL Translokationen mit einer Hochrisiko-Leukämie in Verbindung gebracht werden, bestimmt jedoch das Partnergen den Verlauf der Leukämie mit günstiger oder schlechter Prognose. Deshalb ist eine schnelle Identifizierung des Partnergens wichtig, um somit einer optimalen Behandlung beginnen zu können.
Aus diesem Grund ist eine universelle Diagnostik-Methode entwickelt worden, die es ermöglicht, alle MLL Rearrangements innerhalb der MLL Bruchpunktsregion zu ermitteln, auch wenn das Partnergen noch nicht bekannt ist. Diese Methode beruht auf der inversen Long Range PCR (LDI-PCR), einer Methode zur Amplifizierung von unbekannten DNA Sequenzen (Partnergen), die von bekannten DNA Sequenzen (MLL Gen) flankiert werden.
Mit dieser universellen Diagnostik-Methode konnten 340 Patienten aus 15 unterschiedlichen europäischen Diagnostikzentren erfolgreich untersucht werden. Die 340 Patienten setzen sich aus 238 Kindern und 102 Erwachsenen zusammen. Bei 157 Patienten (66 Kinder und 91 Erwachsene) konnte über eine Voruntersuchung ein MLL Rearrangement festgestellt werde. 183 Patienten (172 Kinder und 11 Erwachsene) sind vorher nicht auf eine MLL Aberration hin untersucht worden. Insgesamt konnten mit dieser Methode 144 Patienten mit mindestens einem MLL Rearrangement identifiziert werden. Bei diesen Rearrangements handelte es sich in den meisten Fällen um reziproke balancierte Translokationen, aber es konnten mit dieser Methode auch Deletionen, Inversionen, Insertionen und eine Tandem-Duplikation (MLL-PTD) identifiziert werden. Von den 172 vorher nicht untersuchten pädiatrischen Patienten konnten 11 (ca. 6%) mit einer MLL Aberration identifiziert werden. Dies entspricht in etwa der in der Literatur beschriebenen Häufigkeit von 10%. 12 (8%) der schon voruntersuchten Patienten konnten mit dieser Methode nicht verifiziert werden. Diese Fälle sollten weiter untersucht werden, um die Methode dieser Problematik entsprechend zu optimieren.
Während dieser Arbeit konnten auch die 6 neuen Partnergene ACACA, ARHGEF17, SMAP1, SELB und TIRAP (DCPS) identifiziert werden. Damit steigt die Zahl der charakterisierten Partnergene von 43 auf 49.
Diese Ergebnisse zeigen, dass sich diese Methode sehr gut für die Identifizierung von bekannten und unbekannten Partnergenen des MLL Gens eignet. In Verbindung mit der Split-Signal FISH Technik kann diese Methode sehr gut für eine Routinediagnostik und einen hohen Durchsatz an Proben herangezogen werden. Ein langfristiges Ziel wird die Analyse des MLL Rekombinoms sein, denn mindestens 36 Partnergene (40%) warten noch auf ihre Identifizierung.
Darüber hinaus können die patientenspezifischen chromosomalen Fusionssequenzen für das Monitoren von leukämischen Zellen über quantitative PCR Methoden herangezogen werden. Diese genomischen MRD Marker können dann in den einzelnen Zentren genutzt werden und dazu beitragen, dass in Zukunft die Therapieprotokolle und der Therapieerfolg verbessert werden. Erste Studien sind mit Hilfe der von uns generierten molekularen Marker bereits an zwei Zentren durchgeführt worden.
Background: Efficacy of treatment after failure of check point inhibitors (ICI) therapy remains ill-defined in metastatic renal cell carcinoma (mRCC).
Objective: To evaluate the safety and effectiveness of cabozantinib after failure of ICI-based therapies.
Design, setting and participants: Patients with mRCC who concluded cabozantinib treatment directly after an ICI-based therapy were eligible. Data was collected retrospectively from participating sites in Germany.
Interventions: Cabozantinib was administered as a standard of care.
Outcome measurements and statistical analysis
Adverse events (AE) were reported according to CTCAE v5.0. Objective response rate according to RECIST 1.1 and Progression Free Survival (PFS) were collected from medical records. Descriptive statistics and Kaplan-Meyer-plots were utilized.
Results and limitations: About 56 eligible patients (71.4% male) with median age of 66 years and clear cell histology in 66.1% (n = 37) were analyzed. 87.5% (n = 49) had ≥ 2 previous lines. IMDC risk was intermediate or poor in 17 patients (30.4%) and missing in 66.1%. 20 patients (35.7%) started with 60 mg. 55.4% (n = 31) required dose reductions, 26.8% (n = 15) treatment delays and 1.8% (n = 1) treatment discontinuation. Partial response was reported in 10.7% (n = 6), stable and progressive disease were reported in 19.6% (n = 11) and in 12.5% (n = 7). 32 patients were not evaluable (57.1%). Median treatment duration was 6.1 months. Treatment related AE were reported in 76.8% (n = 43) and 19.6% (n = 11) had grade 3-5. Fatigue (26.8%), diarrhea (26.8%) and hand-foot-syndrome (25.0%) were the 3 most frequent AEs of any grade and causality. SAE were reported in 21.4% (n = 12), 2 were fatal. Major limitation was the retrospective data capture in our study.
Conclusions: Cabozantinib followed directly after ICI-based therapy was safe and feasible. No new safety signals were reported. A lower starting dose was frequently utilized in this real-world cohort, which was associated with a favorable tolerability profile. Our data supports the use of cabozantinib after ICI treatment.
The present study examines for the first time the emission patterns and olfactory signatures of 9 complete human corpses of different stages of decomposition. Air sampling was performed inside the body bags with solid sorbents and analysed by coupled gas chromatography-mass spectrometry after thermal desorption (TD-GC-MS). Furthermore, odour-related substances were detected by gas chromatography-olfactometry (GC-O). Sulfurous compounds (mainly dimethyl di- and trisulfide) were identified as most important to the odour perception. Around 350 individual organic substances were detected by TD-GC-MS, notably sulfurous and nitrogenous substances as well as branched alkanes, aldehydes, ketones, alcohols, carboxylic acids, carboxylic acid esters and ethers. A range of terpenes was detected for the first time in a characteristic emission pattern over all decomposition stages. Concentrations of the substances varied greatly, and no correlation between the emission patterns, the stage of decomposition and the cause of death could be found. While previous studies often analysed pig cadavers or only parts of human tissue, the present study shows the importance of analysing complete human corpses over a range of decomposition stages. Moreover, it is shown that using body bags as a kind of “emission test chamber” is a very promising approach, also because it is a realistic application considering the usual transport and store of a body before autopsy.
Background: Transfusion of red blood cell concentrate can be life-saving, but requires accurate dose calculations in children. Aims: We tested the hypothesis that cognitive aids would improve identification of the correct recommended volumes and products, according to the German National Transfusion guidelines, in pediatric transfusion scenarios. Methods: Four online questionnaire-based scenarios, two with hemodynamically stable and two with hemodynamically unstable children, were sent to German and international pediatric anesthetists for completion. In the two stable scenarios, participants were given pre-filled tables that contained all required information. For the two emergency scenarios, existing algorithms were used and required calculation by the user. The results were classified into three categories of deviations from the recommended values (DRV): DRV120 (<80% or >120%), as the acceptable variation; DRV 300 (<33% or >300%), the deviation of concern for potential harm; and DRV 1000 (<10% or >1000%), the excessive deviation with a high probability of harm. Results: A total of 1.458 pediatric anesthetists accessed this simulation questionnaire, and 402 completed questionnaires were available for analysis. A pre-filled tabular aid, avoiding calculations, led to a reduction in deviation rates in the category of DRV120 by 60% for each and of DRV300 by 17% and 20%, respectively. The use of algorithms as aids for unstable emergencies led to a reduction in the deviation rate only for DRV120 (20% and 15% respectively). In contrast, the deviation rates for DRV300 and DRV1000 rose by 37% and 16%, respectively. Participants used higher transfusion thresholds for the emergency case of a 2-year-old compromised child than for the stable case with a patient of the same age (on average, 8.6 g/dL, 95% CI 8.5–8.8 versus 7.1 g/dL, 95% CI 7.0–7.2, p < 0.001) if not supported by our aids. Participants also used a higher transfusion threshold for unstable children aged 3 months than for stable children of the same age (on average, 8.9 g/dL, 95% CI 8.7–9.0 versus 7.9 g/dL, 95% CI 7.7–8.0, p < 0.001). Conclusions: The use of cognitive aids with precalculated transfusion volumes for determining transfusion doses in children may lead to improved adherence to published recommendations, and could potentially reduce dosing deviations outside those recommended by the German national transfusion guidelines.
Distinct immune patterns of hepatocellular carcinoma (HCC) may have prognostic implications in the response to transarterial chemoembolization (TACE). Thus, we aimed to exploratively analyze tumor tissue of HCC patients who do or do not respond to TACE, and to identify novel prognostic biomarkers predictive of response to TACE. We retrospectively included 15 HCC patients who had three consecutive TACE between January 2019 and November 2019. Eight patients had a response while seven patients had no response to TACE. All patients had measurable disease according to mRECIST. Corresponding tumor tissue samples were processed for differential expression profiling using NanoString nCounter® PanCancer immune profiling panel. Immune-related pathways were broadly upregulated in TACE responders. The top differentially regulated genes were the upregulated CXCL1 (log2fc 4.98, Benjamini–Hochberg (BH)-p < 0.001), CXCL6 (log2fc 4.43, BH-p = 0.016) and the downregulated MME (log2fc −4.33, BH-p 0.001). CD8/T-regs was highly increased in responders, whereas the relative number of T-regs to tumor-infiltrating lymphocytes (TIL) was highly decreased. We preliminary identified CXCL1 and CXCL6 as candidate genes that might have the potential to serve as therapeutically relevant biomarkers in HCC patients. This might pave the way to improve patient selection for TACE in HCC patients beyond expert consensus.
For acute and chronic soft tissue infections, radical surgical debridement is required and is considered the gold standard, along with its immediate systemic antibiotic therapy. Treatment with local antibiotics and/or antibiotic-containing materials is commonly used as an additional tool in clinical practice. Spraying with fibrin and antibiotics is a newer technique that has been studied for some antibiotics. However, for gentamicin, data are not yet available on absorption, optimal application, antibiotic fate at the site and transfer of antibiotic into the blood. In an animal study involving 29 Sprague Dawley rats, 116 back wounds were sprayed with gentamicin using either gentamicin alone or one of two possible spray combinations of gentamicin and fibrin. Simultaneous application of gentamicin and fibrin via a spray system to soft tissue wounds resulted in significant antibiotic concentration over a long period of time. The technique is easy and cost-effective. The systemic crossover was significantly minimized in our study, which may have led to fewer side effects in patients. These results could lead to an improvement in local antibiotic therapy.
Background: The Rapid Upper Limb Assessment (RULA) is used for the risk assessment of workplace-related activities. Thus far, the paper and pen method (RULA-PP) has been predominantly used for this purpose. In the present study, this method was compared with an RULA evaluation based on kinematic data using inertial measurement units (RULA-IMU). The aim of this study was, on the one hand, to work out the differences between these two measurement methods and, on the other, to make recommendations for the future use of the respective method on the basis of the available findings. Methods: For this purpose, 130 (dentists + dental assistants, paired as teams) subjects from the dental profession were photographed in an initial situation of dental treatment and simultaneously recorded with the IMU system (Xsens). In order to compare both methods statistically, the median value of the difference of both methods, the weighted Cohen’s Kappa, and the agreement chart (mosaic plot) were applied. Results: In Arm and Wrist Analysis—area A—here were differences in risk scores; here, the median difference was 1, and the agreement in the weighted Cohen’s kappa test also remained between 0.07 and 0.16 (no agreement to poor agreement). In area B—Neck, Trunk, and Leg Analysis—the median difference was 0, with at least one poor agreement in the Cohen’s Kappa test of 0.23–0.39. The final score has a median of 0 and a Cohen’s Kappa value of 0.21–0.28. In the mosaic plot, it can be seen that RULA-IMU had a higher discriminatory power overall and more often reached a value of 7 than RULA-PP. Conclusion: The results indicate a systematic difference between the methods. Thus, in the RULA risk assessment, RULA-IMU is mostly one assessment point above RULA-PP. Therefore, future study results of RULA by RULA-IMU can be compared with literature results obtained by RULA-PP to further improve the risk assessment of musculoskeletal diseases.
Purpose: To evaluate the efficacy and safety of microwave ablation (MWA) as a treatment for recurrent hepatocellular carcinoma (HCC) after initial successful surgical resection. Methods: This retrospective study included 40 patients (11 women and 29 men; mean age: 62.3 ± 11.7 years) with 48 recurrent lesions of HCC after initial surgical resection that were treated by percutaneous MWA. Several parameters including complications, technical success, local tumor progression (LTP), intrahepatic distant recurrence (IDR), overall survival (OS), and progression-free survival (PFS) were evaluated in order to investigate the safety and efficacy of MWA for these recurrent HCC lesions after surgical treatment. Results: All MWA treatments were performed without complications or procedure-related deaths. Technical success was achieved in all cases. Two cases developed LTP at a rate of 5%, and IDR occurred in 23 cases at a rate of 57.5% (23/40). The 1-, 2-, 3-, 4-, and 6-year OS rates were 97%, 89.2%, 80.3%, 70.2%, and 60.2%, respectively. The 1- and 3-year PFS rates were 50.2% and 34.6%, respectively. Conclusion: MWA is effective and safe as a local treatment for recurrent HCC after initial surgical resection.
CEND-1 (iRGD) is a bifunctional cyclic peptide that can modulate the solid tumour microenvironment, enhancing the delivery and therapeutic index of co-administered anti-cancer agents. This study explored CEND-1’s pharmacokinetic (PK) properties pre-clinically and clinically, and assessed CEND-1 distribution, tumour selectivity and duration of action in pre-clinical tumour models. Its PK properties were assessed after intravenous infusion of CEND-1 at various doses in animals (mice, rats, dogs and monkeys) and patients with metastatic pancreatic cancer. To assess tissue disposition, [3H]-CEND-1 radioligand was administered intravenously to mice bearing orthotopic 4T1 mammary carcinoma, followed by tissue measurement using quantitative whole-body autoradiography or quantitative radioactivity analysis. The duration of the tumour-penetrating effect of CEND-1 was evaluated by assessing tumour accumulation of Evans blue and gadolinium-based contrast agents in hepatocellular carcinoma (HCC) mouse models. The plasma half-life was approximately 25 min in mice and 2 h in patients following intravenous administration of CEND-1. [3H]-CEND-1 localised to the tumour and several healthy tissues shortly after administration but was cleared from most healthy tissues by 3 h. Despite the rapid systemic clearance, tumours retained significant [3H]-CEND-1 several hours post-administration. In mice with HCC, the tumour penetration activity remained elevated for at least 24 h after the injection of a single dose of CEND-1. These results indicate a favourable in vivo PK profile of CEND-1 and a specific and sustained tumour homing and tumour penetrability. Taken together, these data suggest that even single injections of CEND-1 may elicit long-lasting tumour PK improvements for co-administered anti-cancer agents.
Background:
There is growing evidence that Internet-based cognitive behavioral therapy (ICBT) is as effective as a stand-alone treatment and helps facilitating access to treatment. Given the complexity of the treatment, we argue that the effect of ICBT could be even greater if guided by a therapist, as this could increase treatment adherence. We modified an established and well-evaluated treatment approach and developed a mobile application for treating social anxiety disorder (SAD). In the present study, we compare the efficacy of app use alone (APP) with video-based, therapist-guided app use (TG-APP) and with a wait-list control group (WLC) in terms of symptom reduction, and various secondary outcomes such as increase in quality of life or decrease of general psychological distress.
Methods/design:
A within-between interaction design with randomization to one of three conditions will be used. In the APP condition, patients receive only the app without any additional contact with therapists, while in the TG-APP condition, therapists provide 8 sessions of video-based treatment in addition to using the app. The study will be conducted in two university outpatient treatment centers with reliably diagnosed SAD patients. The primary outcome will be defined as change in SAD symptoms, as measured by the Liebowitz Social Anxiety Scale (expert rating). Furthermore, a wide range of self-reports and clinician ratings for other symptoms (depression, general psychopathology) or quality of life will be used. A simulation-based power analysis for a 3 × 2 interaction effect (group × time) on the primary outcome in a linear mixed model resulted in a total sample size of N = 165.
Discussion:
The present study will be one of the first to examine the additional benefit of therapist-guided video sessions regarding the use of an app treating SAD. Study results are pivotal to future treatment application in SAD.