Entwicklung eines Standards zur Kombination relevanter Medikamente bei Studienprotokollen von soliden Tumoren

Hintergrund: Die Verabreichung von Zytostatika ist in der Therapie gegen Krebs essenziell. In Studienprotokollen (Therapieoptimierungsstudien) werden Zytostatika kombiniert, um den Krebs mit verschiedene Wirkmechanismen anzugreifen [1]. Einige Zytostatika brauchen eine Vor- oder Begleitmedikation, andere spezielle Überwachung. Bei der Applikation über das Infusionssystem ist man bei verschiedenen Studienprotokollen gezwungen, multiple Zytostatika und deren Begleitmedikamente sowie Elektrolyte miteinander zu kombinieren. Hierbei muss man auf die Kompatibilität der verschiedenen Medikamente achten, um die Wirkweise nicht zu beeinträchtigen. Die Zytostatika Apotheke des Universitätsklinikums Heidelberg hat eine Kompatibilitätsliste für die onkologischen Stationen des Universitätsklinikums Heidelberg zusammengestellt. Hier werden alle Zytostatika, dazugehörige Medikamente und Elektrolyte, tabellarisch dargestellt. Kompatibilitäten werden in „N“ für „nicht kompatibel“, „K“ für „kompatibel“ und „Y“ für „Y-Stück kompatibel“ eingeteilt. Die Liste erfasst nicht zu jeder relevanten Kombination Kompatibilitätsdaten. Einige Studienprotokolle geben Kombinationen von Medikamenten vor, zu denen noch keine Kompatibilitätsdaten auf der Kompatibilitätsliste vorhanden sind. Ziel dieses Projektes ist es, einen Standard zur Kombination von Medikamenten aus den Studienprotokollen der häufigsten soliden Tumore zu entwickeln (Neuroblastom, Ewingsarkom, Osteosarkom und Rhabdomyosarkom). Methoden: Zur Planung und Durchführung des Projektes wird der PDCA-Zyklus verwendet. Dieser gliedert sich in die Phasen: „Plan“, „Do“, „Check“ und „Act“. Ergebnisse: In Kooperation mit der Zytostatika Apotheke und der Kinderonkologie, wird dieses Projekt gestartet. Es werden alle relevanten Zytostatika Blöcke mit fehlenden Kompatibilitätsdaten der soliden Tumore eingeschlossen. Anschließend wird in drei pharmazeutischen Datenbanken (Stabilis, Medicines complete und Upt to date) eine Literaturrecherche zu fehlenden Kompatibilitätsdaten durchgeführt. Ergebnisse werden von pharmazeutischer und ärztlicher Profession begutachtet. Im Standard ist eine graphische Darstellung des Zytostatika Blockes, die neu erstellte Kompatibilitätsliste und eine Handlungsempfehlung für die Praxis enthalten. Diskussion: Trotz der Verbreitung und Nutzen der Studienprotokolle zur Applikation der Chemotherapie, gibt es nicht für alle Medikamente Kompatibilitätsdaten. Bei der Verabreichung von Medikamenten ohne Kompatibilitätsauskunft können Wechselwirkungen sowie Interaktionen der Wirkstoffe entstehen. Diese können die Wirkung der Medikamente einschränken [2]. Die Problematik der Durchführung der Studienprotokolle mit unvollständigen Kompatibilitätsangaben wurde bisher dem medizinischen Personal der Kliniken überlassen. Dieses Projekt ist daher übergreifend für Kliniken relevant. Quellen: [1] Deutsche Krebsgesellschaft. Klinische Studien in der Krebstherapie – Informationen für Patienten; 2017. [Internet] [zuletzt aufgerufen am 21.01.2020]. Verfügbar unter: URL: https://www.krebsgesellschaft.de/onko-internetportal/basis-informationen-krebs/basis-informationen-krebs-allgemeine-informationen/klinische-studien.html [2] Heiner Berthold: Klinikleitfaden Arzneimitteltherapie. 2. Auflage. Urban und Fischer, München/Jena 2003, S 106 f

Intracardiac Extension of Wilms Tumor: A Case of a 2.5-Year-Old Girl Presenting with Upper Venous Congestion Caused by Tumor Growth into the Right Cardiac Ventricle

While Wilms tumors (WT) typically present solely with an abdominally palpable mass, rare cases exhibiting vascular tumor growth can also present with circulatory problems. Here, we report the case of a 2.5-year-old girl presenting with upper venous congestion and arterial hypertension as the primary symptoms of intraventricular tumor growth exhibiting remarkable tubular and perfused morphology. Clinical situation stabilized after initiation of neoadjuvant chemotherapy (NAC) with actinomycin D and vincristine, followed by surgical resection via laparotomy and sternotomy supported by cardiopulmonary bypass and deep hypothermia. Our results highlight the previously reported feasibility of this approach, even in primarily unstable patients

Intensity Modulated Radiotherapy (IMRT) and Fractionated Stereotactic Radiotherapy (FSRT) for children with head-and-neck-rhabdomyosarcoma

<p>Abstract</p> <p>Background</p> <p>The present study evaluates the outcome of 19 children with rhabdomyosarcoma of the head-and-neck region treated with Intensity Modulated Radiotherapy (IMRT) or Fractionated Stereotactic Radiotherapy (FSRT) between August 1995 and November 2005.</p> <p>Methods</p> <p>We treated 19 children with head-and-neck rhabdomyosarcoma with FSRT (n = 14) or IMRT (n = 5) as a part of multimodal therapy. Median age at the time of radiation therapy was 5 years (range 2–15 years). All children received systemic chemotherapy according to the German Soft Tissue Sarcoma Study protocols.</p> <p>Median size of treatment volume for RT was 93,4 ml. We applied a median total dose of 45 Gy (range 32 Gy – 54 Gy) using a median fractionation of 5 × 1,8 Gy/week (range 1,6 Gy – 1,8 Gy).</p> <p>The median time interval between primary diagnosis and radiation therapy was 5 months (range 3–9 months).</p> <p>Results</p> <p>After RT, the 3- and 5-year survival rate was 94%. The 3- and 5-year actuarial local control rate after RT was 89%.</p> <p>The actuarial freedom of distant metastases rate at 3- and 5-years was 89% for all patients.</p> <p>Radiotherapy was well tolerated in all children and could be completed without interruptions > 4 days. No toxicities >CTC grade 2 were observed. The median follow-up time after RT was 17 months.</p> <p>Conclusion</p> <p>IMRT and FSRT lead to excellent outcome in children with head-and-neck RMS with a low incidence of treatment-related side effects.</p

Variability of sleep bruxism—findings from consecutive nights of monitoring

Objectives!#!To determine sleep bruxism (SB) behavior during five consecutive nights and to identify correlations between SB episodes per hour (SB index) and sleep-time masseter-muscle activity (sMMA).!##!Material and methods!#!Thirty-one participants were included in the study. Of these, 10 were classified as sleep bruxers (group SB-1) and nine as non-sleep bruxers (group non-SB). The bruxism status of these 19 patients was identified by means of questionnaires, an assessment of clinical symptoms, and electromyographic/electrocardiographic data (Bruxoff® device). The remaining 12 participants were also identified as bruxers, but based exclusively on data from the Bruxoff device (group SB-2). Data analysis included descriptive statistics and Spearman's correlation to assess the relationship between the SB index and sMMA.!##!Results!#!Participants in group SB-1 showed an overall mean SB index of 3.1 ± 1.6 and a mean total sMMA per night of 62.9 ± 38.3. Participants in group SB-2 had an overall mean SB index of 2.7 ± 1.5 and a mean total sMMA of 56.0 ± 29.3. In the non-SB group, participants showed an overall mean SB index of 0.8 ± 0.5 and a mean total sMMA of 56.8 ± 30.3. Spearman's correlation yielded values of - 0.27 to 0.71 for the correlation between sMMA and SB index.!##!Conclusions!#!The data revealed variable SB activity and the absence of a reliable correlation between sMMA and the SB index.!##!Clinical relevance!#!The high variation in SB activity and lack of correlation between sMMA and the SB index should be considered when diagnosing SB.!##!Trial registration!#!Clinical Trials [NIH], clinical trial no. NCT03039985

Correlations between sleep bruxism and temporomandibular disorders

The aim of this study was to identify correlations between sleep bruxism (SB) and temporomandibular disorders (TMD) as diagnosed by means of the research diagnostic criteria for temporomandibular disorders (RDC/TMD). Sleep bruxism was diagnosed on the basis of I) validated questionnaires, II) clinical symptoms, and III) electromyographic/electrocardiographic data. A total of 110 subjects were included in the study. Fifty-eight patients were identified as bruxers and 52 as nonbruxers. A psychosocial assessment was also performed. An RDC/TMD group-I diagnosis (myofascial pain) was made for 10 out of 58 bruxers, whereas none of the nonbruxers received a diagnosis of this type. No significant differences were found between bruxers and nonbruxers with regard to RDC/TMD group-II (disc displacement) and group-III (arthralgia, arthritis, arthrosis) diagnoses. Somatization was significantly more common among bruxers than nonbruxers. Multivariate logistic regression analysis revealed that somatization was the only factor significantly correlated with the diagnosis of myofascial pain. The results of this study indicate a correlation between myofascial pain, as diagnosed using the RDC/TMD, and somatization. It seems that somatization is a stronger predictor of an RDC/TMD diagnosis of myofascial pain than sleep bruxism is

Ceramic Crowns and Sleep Bruxism: First Results from a Randomized Trial

Background: This randomized clinical trial was conducted to assess whether sleep bruxism (SB) is associated with an increased rate of technical complications (ceramic defects) in lithium disilicate (LiDi) or zirconia (Z) molar single crowns (SCs). Methods: Adult patients were classified as affected or unaffected by SB based on structured questionnaires, clinical signs, and overnight portable electromyography (BruxOff) and block randomized into four groups according to SB status and crown material (LiDi or Z): LiDi-SB (n = 29), LiDi-no SB (n = 24), Z-SB (n = 23), and Z-no SB (n = 27). Differences in technical complications (main outcome) and survival and success rates (secondary outcomes) one year after crown cementation were assessed using Fisher’s exact test with significance level α = 0.05. Results: No technical complications occurred. Restoration survival rates were 100% in the LiDi-SB and LiDi-no SB groups, 95.7% in the Z-SB group, and 96.3% in the Z-no SB group (p > 0.999). Success rates were 96.6% in the LiDi-SB group, 95.8% in the LiDi-no SB group (p > 0.999), 91.3% in the Z-SB group, and 96.3% in the Z-no SB group (p ≥ 0.588). Conclusions: With a limited observation time and sample size, no effect of SB on technical complication, survival, and success rates of molar LiDi and Z SCs was detected

Osteosarcoma in patients with Rothmund–Thomson syndrome

Background: Rothmund-Thomson syndrome (RTS) is associated with an increased risk of osteosarcoma, but information about affected patients is limited. Procedure: Seven patients with osteosarcoma, treated in the Cooperative Osteosarcoma Study Group-trials, had a diagnosis of RTS. Their patient-, tumor-and treatment-related variables and outcome were reviewed retrospectively. Results: Median age at diagnosis of osteosarcoma was 13 years (range 7-16), five were female, two male. Tumor involved proximal tibia (n = 4), distal tibia (n = 1), distal fibula (n = 1) and proximal ulna (n = 1). Three patients had metastatic disease at diagnosis. All patients received surgery and chemotherapy. Four of seven patients required dose modifications and three of them terminated treatment prematurely. Complete resection of the primary tumor was achieved in all individuals. Two of three affected patients failed to achieve surgical clearance of their primary metastases and died. The third patient relapsed with multiple metastases and died. Two of four patients with localized disease were alive in first complete remission, a third patient in second complete remission after recurrence and a fourth patient died of acute leukemia, while still in first complete remission of osteosarcoma. Conclusions: Patients with RTS and osteosarcoma may be cured of their cancer with appropriate multimodal therapy. They should be treated like other osteosarcoma patients but preexisting disorders, needs for special support and development of toxicities have to be considered

Overall survival in 19 children with head-and-neck RMS treated with FSRT or IMRT

<p><b>Copyright information:</b></p><p>Taken from "Intensity Modulated Radiotherapy (IMRT) and Fractionated Stereotactic Radiotherapy (FSRT) for children with head-and-neck-rhabdomyosarcoma"</p><p>http://www.biomedcentral.com/1471-2407/7/177</p><p>BMC Cancer 2007;7():177-177.</p><p>Published online 13 Sep 2007</p><p>PMCID:PMC2077337.</p><p></p