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Grünwald, Viktor; Pink, Daniel; Egerer, Gerlinde; Schalk, Enrico; Augustin, Marinela; Deinzer, Christoph K. W.; Kob, Viola; Reichert, Dietmar; Kebenko, Maxim; Brandl, Stephan; Hahn, Dennis; Lindner, Lars H.; Hoiczyk, Mathias; Ringsdorf, Uta; Hanker, Lars C.; Hempel, Dirk; De Rivas, Beatriz; Wismann, Tobias; Ivanyi, Philipp

Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial

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  • Media type: E-Article
  • Title: Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial
  • Contributor: Grünwald, Viktor; Pink, Daniel; Egerer, Gerlinde; Schalk, Enrico; Augustin, Marinela; Deinzer, Christoph K. W.; Kob, Viola; Reichert, Dietmar; Kebenko, Maxim; Brandl, Stephan; Hahn, Dennis; Lindner, Lars H.; Hoiczyk, Mathias; Ringsdorf, Uta; Hanker, Lars C.; Hempel, Dirk; De Rivas, Beatriz; Wismann, Tobias; Ivanyi, Philipp
  • Published: MDPI AG, 2022
  • Published in: Cancers, 14 (2022) 21, Seite 5234
  • Language: English
  • DOI: 10.3390/cancers14215234
  • ISSN: 2072-6694
  • Keywords: Cancer Research ; Oncology
  • Origination:
  • Footnote:
  • Description: 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.
  • Access State: Open Access