Journal article
A phase IIb multicentre study comparing the efficacy of trabectedin to doxorubicin in patients with advanced or metastatic untreated soft tissue sarcoma: The TRUSTS trial
European journal of cancer (1990), Vol.51(10), pp.1312-1320
07/2015
DOI: 10.1016/j.ejca.2015.03.023
PMID: 25912752
Abstract
To evaluate whether trabectedin as first-line chemotherapy for advanced/metastatic soft tissue sarcoma prolongs progression-free survival (PFS), compared to doxorubicin and, in the phase IIb part here, to select the most appropriate trabectedin treatment schedule (3-hour or 24-hour infusion) in terms of safety, convenience and efficacy.
In this randomised multicentre prospective dose-selection phase IIb superiority trial, 133 patients were randomised between doxorubicin (n=43), trabectedin (3-hour infusion, T3h) (n=47) and trabectedin (24-hour infusion, T24h) (n=43). PFS was defined as time from random assignment until objective progression by response evaluation criteria in solid tumours (RECIST 1.1), a global deterioration of the health status requiring discontinuation of the treatment, or death from any cause.
The study was terminated due to lack of superiority in both trabectedin treatment arms as compared to the doxorubicin control arm. Median PFS was 2.8months in the T3h arm, 3.1months in the T24h arm and 5.5months in the doxorubicin arm. No significant improvements in PFS were observed in the trabectedin arms as compared to the doxorubicin arm (T24h versus doxorubicin: hazard ratio (HR) 1.13, 95% confidence interval (CI) 0.67–1.90, P=.675; T3h versus doxorubicin: HR 1.50, 95% CI 0.91–2.48, P=.944). Only one toxic death occurred in the T3h arm, but treatment had to be stopped due to toxicity in 7 (15.2%) (T3h), 8 (19.5%) (T24h) and 1 (2.5%) doxorubicin patients.
Doxorubicin continues to be the standard treatment in eligible patients with advanced/metastatic soft-tissue sarcoma (STS). Trabectedin 1.5mg/m2/24-hour infusion is the overall proven approach to delivering this agent in the second-line setting for patients with advanced or metastatic STS.
Details
- Title: Subtitle
- A phase IIb multicentre study comparing the efficacy of trabectedin to doxorubicin in patients with advanced or metastatic untreated soft tissue sarcoma: The TRUSTS trial
- Creators
- B. Bui-Nguyen - Institut BergoniéJ.E. Butrynski - Dana-Farber Cancer InstituteN. Penel - Centre Oscar LambretJ.Y. Blay - Centre Léon BérardN. Isambert - Centre Georges François LeclercM. Milhem - University of Iowa Hospitals and ClinicsJ.M. Kerst - The Netherlands Cancer InstituteA.K.L Reyners - University Medical Center GroningenS. Litière - European Organisation for Research and Treatment of CancerS. Marréaud - European Organisation for Research and Treatment of CancerF. Collin - Centre Georges François LeclercW.T.A van der Graaf - Radboud University NijmegenEuropean Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group (EORTC/STBSG) and the Sarcoma Alliance for Research through Collaboration (SARC)
- Resource Type
- Journal article
- Publication Details
- European journal of cancer (1990), Vol.51(10), pp.1312-1320
- Publisher
- Elsevier Ltd
- DOI
- 10.1016/j.ejca.2015.03.023
- PMID
- 25912752
- ISSN
- 0959-8049
- eISSN
- 1879-0852
- Grant note
- DOI: 10.13039/501100004099, name: La Ligue Nationale Contre le Cancer; DOI: 10.13039/501100004898, name: EORTC Charitable Trust
- Language
- English
- Date published
- 07/2015
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359793602771
Metrics
19 Record Views