Por lo Qué Hasta la Obtención de los Resultados Completos ... Más la Elaboración del Dossier ... Más la Evaluación de las Agencias ... Nos Podemos Ir al 2027 .
16 octubre 2015
Yondelis is a Very Promising Treatment for Advanced SFTs.
Efficacy of Trabectedin in malignant solitary fibrous tumors: a retrospective analysis from the French Sarcoma Group .
J. Khalifa1*, M. Ouali2†, L. Chaltiel2†, S. Le Guellec3, A. Le Cesne4, J-Y Blay5, P. Cousin5, L. Chaigneau6, E. Bompas7, S. Piperno-Neumann8, B. Bui-Nguyen9, M. Rios10, J-P Delord1, N. Penel11 and C. Chevreau1 .
Abstract.
Background :
Advanced malignant solitary fibrous tumors (SFTs) are rare soft-tissue sarcomas with a poor prognosis. Several treatment options have been reported, but with uncertain rates of efficacy. Our aim is to describe the activity of trabectedin in a retrospective, multi-center French series of patients with SFTs.
Methods :
Patients were mainly identified through the French RetrospectYon database and were treated between January 2008 and May 2013. Trabectedin was administered at an initial dose of 1.5 mg/m 2 , q3 weeks. The best tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors 1.1. The Kaplan–Meier method was used to estimate median progression-free survival (PFS) and overall survival (OS). The growth-modulation index (GMI) was defined as the ratio between the time to progression with trabectedin (TTP n ) and the TTP with the immediately prior line of treatment (TTP n-1 ).
Results :
Eleven patients treated with trabectedin for advanced SFT were identified. Trabectedin had been used as second-line treatment in 8 patients (72.7 %) and as at least third-line therapy in a further 3 (27.3 %). The best RECIST response was a partial response (PR) in one patient (9.1 %) and stable disease (SD) in eight patients (72.7 %). Disease-control rate (DCR = PR + SD) was 81.8 %. After a median follow-up of 29.2 months, the median PFS was 11.6 months (95 % CI = 2.0; 15.2 months) and the median OS was 22.3 months (95 % CI = 9.1 months; not reached). The median GMI was 1.49 (range: 0.11–4.12).
Conclusion :
Trabectedin is a very promising treatment for advanced SFTs. Further investigations are needed.
...