TY - JOUR
T1 - Trabectedin for Patients with Advanced Soft Tissue Sarcoma
T2 - A Non-Interventional, Prospective, Multicenter, Phase IV Trial
AU - Grünwald, Viktor
AU - Pink, Daniel
AU - Egerer, Gerlinde
AU - Schalk, Enrico
AU - Augustin, Marinela
AU - Deinzer, Christoph K W
AU - Kob, Viola
AU - Reichert, Dietmar
AU - Kebenko, Maxim
AU - Brandl, Stephan
AU - Hahn, Dennis
AU - Lindner, Lars H
AU - Hoiczyk, Mathias
AU - Ringsdorf, Uta
AU - Hanker, Lars C
AU - Hempel, Dirk
AU - De Rivas, Beatriz
AU - Wismann, Tobias
AU - Ivanyi, Philipp
PY - 2022
Y1 - 2022
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.
AB - 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.
U2 - 10.3390/cancers14215234
DO - 10.3390/cancers14215234
M3 - Journal articles
C2 - 36358652
VL - 14
JO - Cancers
JF - Cancers
SN - 2072-6694
IS - 21
ER -
