Abstract 1496P
Background
This non-interventional, prospective phase IV trial (NCT02367924) evaluated trabectedin (Yondelis®) in patients with soft tissue sarcoma (STS) in real-life clinical practice across Germany.
Methods
Eligible were adults (≥18 years old) with advanced STS with either failure of anthracycline-based therapy, or who were unfit to receive these agents. The primary endpoint was progression-free survival (PFS) rates at 3 and 6 months as per investigator assessment.
Results
Overall, 128 patients from 19 German sites were evaluated for efficacy and 130 for safety. Trabectedin was mostly used as second-line treatment (n=66; 51.6%) and patients received a median of 4 cycles per patient (range: 1-44). A total of 40.6% of patients received ≥6 cycles. Median PFS was 5.2 months, with 60.7% (95% CI: 51.5-68.8) and 44.5% (95% CI: 35.5-53.1) of patients free from progression at 3 and 6 months, respectively. Median overall survival (OS) was 15.2 months. One patient had a complete response and 14 patients achieved a partial response for an objective response rate of 11.7%. Additionally, 43 patients had disease stabilization for a disease-control rate of 45.3%. Decreases of white blood cells (27.0% of patients), platelets (16.2%) or 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 lung infection or sepsis were considered trabectedin-related.
Conclusions
Our study supports the use of trabectedin as a standard of care for treatment of patients with divers STS histotypes given as second or further-line treatment, comparable to activity previously reported in clinical trials and other non-interventional studies.
Clinical trial identification
NCT02367924.
Editorial acknowledgement
The authors acknowledge Adnan Tanovic for providing writing and editorial assistance for the abstract (funded by PharmaMar, S.A.).
Legal entity responsible for the study
PharmaMar, S.A.
Funding
PharmaMar, S.A.
Disclosure
D. Pink: Financial Interests, Institutional, Invited Speaker: Blueprint, PharmaMar, BMS, EUSA-Pharma, PharmaMar, Lilly, Roche; Financial Interests, Institutional, Advisory Board: Roche, PharmaMar, Boehringer Ingelheim; Financial Interests, Institutional, Other, scientific lead of a trial with funding from Novartis: Novartis; Non-Financial Interests, , Member: ASCO, Deutsche Krebsgesellschaft - German Cancer Society (DKG), Connective Tissue Oncology Society (CTOS), Deutsche Sarkomstiftung (DSS). C.K. Deinzer: Financial Interests, Personal, Invited Speaker: PharmaMar. D.A. Hahn: Financial Interests, Personal, Advisory Board, advisory board head and neck cancer, publication of case report nivolumab in head and neck cancer patients: BMS, Merck; Financial Interests, Personal, Advisory Board, advisory board head and neck cancer, invited speaker: MSD; Financial Interests, Personal, Advisory Board, advisory board Hodgkin lymphoma, invited speaker: Takeda. M.J. Pontes: Financial Interests, Personal and Institutional, Stocks/Shares: PharmaMar; Financial Interests, Personal and Institutional, Full or part-time Employment: PharmaMar. All other authors have declared no conflicts of interest.