Villejuif, monday 4 june 2018
Validation of the efficacy of trabectedin in metastatic soft tissue sarcomas
On Monday 4 June, in an oral session of the Congress of the American Society of Clinical Oncology (Asco) in Chicago, Professor Axel Le Cesne, Medical Oncologist at Gustave Roussy, is presenting the results of the T – SAR study. This is a multicentre study comparing trabectedin with best supportive care in patients with metastatic soft tissue sarcomas.
"There has been considerable experience for eighteen years now of using this drug to treat patients, initially in therapeutic trials, and then with marketing authorisation since 2007, but trabectedin had, in the final analysis, never been compared with best supportive care" explained Professor Le Cesne.
This phase III randomised study was carried out at the request of the DGOS (General Directorate for Provision of Care), and was coordinated by the French Sarcoma Group and sponsored by Gustave Roussy.
The objective was to test the efficacy of trabectedin against best supportive care (anti-inflammatories, analgesics, etc.) in patients with pre-treated metastatic soft tissue sarcomas.
The study recruited 103 patients in 2015. It showed that trabectedin-treated patients had significantly improved progression-free survival when compared with patients who only received symptomatic treatment.
This difference was especially significant in certain sarcoma sub-types, in particular the L-sarcomas (liposarcomas and leiomyosarcomas) in which progression-free survival was 4 times longer.
In addition, trabectedin is one of the rare chemotherapeutic agents manifesting very little cumulative toxicity. In long-responders (about 30% of patients received at least 6 cycles), this drug can thus be administered for months or even years.
"It is not uncommon to see patients who have received 30, 40 or 50 successive courses of chemotherapy with completely acceptable tolerance, and in soft tissue sarcomas we had not previously had any other agent displaying such long-term efficacy." stated Professor Le Cesne.
This drug is a component of the therapeutic arsenal for metastatic soft tissue sarcomas, which, by contrast to that in other malignant diseases, is relatively limited. It is an active agent whose effect on progression-free survival has now been established.
Sarcomas are “rare” tumours accounting for some 4,000 new cases per year in metropolitan France (1 to 2% of cancers). These ubiquitous tumors affect adults of all ages (96%) as well as children (4%). More than 70 histological sub-types have been described. The prognosis of such tumours (5-year survival currently 60%) depends to a large extent on the quality of the initial management which should be discussed routinely in Multidisciplinary Meetings devoted exclusively to these conditions.
Results of a prospective randomized phase III T-SAR trial comparing trabectedin (T) vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS): A French Sarcoma Group (FSG) trial.
Oral presentation by Pr AXEL LE CESNE, Gustave Roussy
Oral session: Monday 4 June at 10.24 am (local time) Place: S100a
> Read the abstract n° 11508