@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}
}