@article{MerkelLindnerGaberetal.2022, author = {Merkel, Helena and Lindner, Dirk and Gaber, Khaled and Ziganshyna, Svitlana and Jentzsch, Jennifer and Mucha, Simone and Gerhards, Thilo and Sari, Sabine and Stock, Annika and Vothel, Felicitas and Falter, Lea and Qu{\"a}schling, Ulf and Hoffmann, Karl-Titus and Meixensberger, J{\"u}rgen and Halama, Dirk and Richter, Cindy}, title = {Standardized classification of cerebral vasospasm after subarachnoid hemorrhage by digital subtraction angiography}, series = {Journal of Clinical Medicine}, volume = {11}, journal = {Journal of Clinical Medicine}, number = {7}, issn = {2077-0383}, doi = {10.3390/jcm11072011}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-270638}, year = {2022}, abstract = {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.}, language = {en} } @article{GruenwaldPinkEgereretal.2022, author = {Gr{\"u}nwald, Viktor and Pink, Daniel and Egerer, Gerlinde and Schalk, Enrico and Augustin, Marinela and Deinzer, Christoph K. W. and Kob, Viola and Reichert, Dietmar and Kebenko, Maxim and Brandl, Stephan and Hahn, Dennis and Lindner, Lars H. and Hoiczyk, Mathias and Ringsdorf, Uta and Hanker, Lars C. and Hempel, Dirk and De Rivas, Beatriz and Wismann, Tobias and Ivanyi, Philipp}, title = {Trabectedin for patients with advanced soft tissue sarcoma: a non-interventional, prospective, multicenter, phase IV trial}, series = {Cancers}, volume = {14}, journal = {Cancers}, number = {21}, issn = {2072-6694}, doi = {10.3390/cancers14215234}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-290898}, year = {2022}, abstract = {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.}, language = {en} }