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  -