Which patients with pre-treated locally advanced or metastatic sarcoma benefit most from trabectedin treatment: First results of a retrospective study of the German Interdisciplinary Sarcoma Group (GISG-14 - ReTraSarc).

Authors

Daniel Pink

Daniel Pink

Helios Klinikum Bad Saarow-Sarcoma Center Berlin-Brandenburg and University Medicine Greifswald, Germany, Bad Saarow, Germany

Daniel Pink , Adrian Richter , Dimosthenis Andreou , Stephan Richter , Anne Flörcken , Christoph Deinzer , Bernd Kasper , Gerlinde Egerer , Philipp Ivanyi , Armin Tuchscherer , Torsten Kessler , Markus Schuler , Christian Schmidt , Jeannette Bahr , Till Ittermann , Peter Reichardt

Organizations

Helios Klinikum Bad Saarow-Sarcoma Center Berlin-Brandenburg and University Medicine Greifswald, Germany, Bad Saarow, Germany, Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany, Helios Hospital Bad Saarow, Sarcoma Center Berlin-Brandenburg, Bad Saarow, Germany, University Hospital Carl Gustav Carus, Dresden, Germany, Department of Hematology, Oncology and Tumor Immunology, Charité University Medicine, Campus Virchow Klinikum, Berlin, Germany, University Hospital Würzburg, Würzburg, Germany, Sarcoma Unit, Interdisciplinary Tumor Center, Mannheim University Medical Center, Mannheim, Germany, Department of Hematology, Oncology, and Rheumatology, Heidelberg University Hospital, Heidelberg, Germany, Dept. Hematology, Hemostaseology, Oncology & Stem Cell Transplantation, Hanover Medical School, Hannover, Germany, Department I of Internal Medicine, University Hospital Cologne, Köln, Germany, Department of Medicine A, University Hospital of Muenster, Muenster, Germany, Helios Klinikum Emil von Behring, Berlin, Germany, Department of Internal Medicine, Greifswald University Hospital, Greifswald, Germany, Sarcoma Center, Helios Klinikum Berlin Buch, Berlin, Germany

Research Funding

Pharmaceutical/Biotech Company
PharmaMar

Background: Despite the growing amount of published data regarding the outcomes of sarcoma patients treated with trabectedin, still some questions remain unanswered. The aim of the ReTraSarc trial (NCT03284320) was to evaluate the efficacy and safety of trabectedin in a large German population. Methods: Patients treated between 2007-2018 were retrospectively analyzed. All patients had histologically confirmed soft tissue (STS; n = 478) or bone (BS; n = 31) sarcoma; either metastatic (n = 468) or locally advanced (n = 41) disease, and had received at least one cycle of trabectedin. Based on follow-up data (until October 2019), progression-free survival (PFS) and overall survival (OS) after initiation of trabectedin treatment were estimated according to the Kaplan-Meier method. Results: A total of 509 patents were analyzed. Patients had a mean age of 54 years for STS and 30 years for BS-patients, and 25.4% of them aged > 65 years. Overall, 71.4% of patients had a good performance status (ECOG 0/1), and 37.7% received two prior lines, 28.3% three and 34% received > 3 prior lines of systemic treatment. Patients received a median of 3 cycles (IQR: 2-6 cycles) of trabectedin. Trabectedin resulted in an objective response rate (ORR) of 10% with a 37.4% of disease control rate (DCR). The median PFS and OS were 2.5 months (IQR: 1.4-6.1 months) and 8.2 months (IQR: 3-21 months), respectively. Significantly more patients with liposarcoma (22.1%; 95% CI: 15.2-32.2) were free from progression at 12 months after treatment as compared with patients with leiomyosarcoma (8.5%; 95% CI: 4.8-14.9). More analyses of effectiveness and safety are in progress (e.g. stratified per sarcoma subtypes or therapeutic line) and will be presented. Conclusions: The results of this real-life study, with a large number of patients and long-term follow-up, allow us to better analyze PFS and OS in sarcoma patients treated with trabectedin, given in different treatment lines and after dose modifications and/or cycle delays. Additionally, the results of this study enable us to evaluate the real-life impact of rechallenge with trabectedin in a further therapy line. Clinical trial information: NCT03284320.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Sarcoma

Track

Sarcoma

Sub Track

Soft Tissue Tumors

Clinical Trial Registration Number

NCT03284320

Citation

J Clin Oncol 38: 2020 (suppl; abstr 11554)

DOI

10.1200/JCO.2020.38.15_suppl.11554

Abstract #

11554

Poster Bd #

442

Abstract Disclosures