TY  - JOUR
A1  - Merkel, Helena
A1  - Lindner, Dirk
A1  - Gaber, Khaled
A1  - Ziganshyna, Svitlana
A1  - Jentzsch, Jennifer
A1  - Mucha, Simone
A1  - Gerhards, Thilo
A1  - Sari, Sabine
A1  - Stock, Annika
A1  - Vothel, Felicitas
A1  - Falter, Lea
A1  - Quäschling, Ulf
A1  - Hoffmann, Karl-Titus
A1  - Meixensberger, Jürgen
A1  - Halama, Dirk
A1  - Richter, Cindy
T1  - Standardized classification of cerebral vasospasm after subarachnoid hemorrhage by digital subtraction angiography
JF  - Journal of Clinical Medicine
N2  - Background: During the last decade, cerebral vasospasm after aneurysmal subarachnoid hemorrhage (SAH) was a current research focus without a standardized classification in digital subtraction angiography (DSA). This study was performed to investigate a device-independent visual cerebral vasospasm classification for endovascular treatment. Methods: The analyses are DSA based rather than multimodal. Ten defined points of intracranial arteries were measured in 45 patients suffering from cerebral vasospasm after SAH at three time points (hospitalization, before spasmolysis, control after six months). Mathematical clustering of vessel diameters was performed to generate four objective grades for comparison. Six interventional neuroradiologists in two groups scored 237 DSAs after a new visual classification (grade 0–3) developed on a segmental pattern of vessel contraction. For the second group, a threshold-based criterion was amended. Results: The raters had a reproducibility of 68.4% in the first group and 75.2% in the second group. The complementary threshold-based criterion increased the reproducibility by about 6.8%, while the rating deviated more from the mathematical clustering in all grades. Conclusions: The proposed visual classification scheme of cerebral vasospasm is suitable as a standard grading procedure for endovascular treatment. There is no advantage of a threshold-based criterion that compensates for the effort involved. Automated vessel analysis is superior to compare inter-group results in research settings.
KW  - cerebral vasospasm
KW  - subarachnoid hemorrhage
KW  - classification
KW  - vessel diameter
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-270638
SN  - 2077-0383
VL  - 11
IS  - 7
ER  - 
TY  - JOUR
A1  - Grünwald, Viktor
A1  - Pink, Daniel
A1  - Egerer, Gerlinde
A1  - Schalk, Enrico
A1  - Augustin, Marinela
A1  - Deinzer, Christoph K. W.
A1  - Kob, Viola
A1  - Reichert, Dietmar
A1  - Kebenko, Maxim
A1  - Brandl, Stephan
A1  - Hahn, Dennis
A1  - Lindner, Lars H.
A1  - Hoiczyk, Mathias
A1  - Ringsdorf, Uta
A1  - Hanker, Lars C.
A1  - Hempel, Dirk
A1  - De Rivas, Beatriz
A1  - Wismann, Tobias
A1  - Ivanyi, Philipp
T1  - Trabectedin for patients with advanced soft tissue sarcoma: a non-interventional, prospective, multicenter, phase IV trial
JF  - Cancers
N2  - This non-interventional, prospective phase IV trial evaluated trabectedin in patients with soft tissue sarcoma (STS) in real-life clinical practice across Germany. The primary endpoints were progression-free survival (PFS) rates at 3 and 6 months, as defined by investigators. Overall, 128 patients from 19 German sites were evaluated for efficacy and 130 for safety. Median age was 58.5 years (range: 23–84) and leiomyosarcoma was the most frequent histotype (n = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (n = 91; 71.1%). Median PFS was 5.2 months (95% CI: 3.3–6.7), with 60.7% and 44.5% of patients free from progression at 3 and 6 months, respectively. Median overall survival was 15.2 months (95% CI: 9.6–21.4). One patient achieved a complete and 14 patients a partial response, conferring an objective response rate of 11.7%. Decreases in white blood cells (27.0% of patients), platelets (16.2%) and neutrophils (13.1%) and increased alanine aminotransferase (10.8%) were the most common trabectedin-related grade 3/4 adverse drug reactions. Two deaths due to pneumonia and sepsis were considered trabectedin-related. Trabectedin confers clinically meaningful activity in patients with multiple STS histotypes, comparable to that previously observed in clinical trials and other non-interventional studies, and with a manageable safety profile.
KW  - trabectedin
KW  - STS
KW  - sarcoma
KW  - non-interventional
KW  - prospective
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-290898
SN  - 2072-6694
VL  - 14
IS  - 21
ER  -