08 junio 2010

Yondelis en Pacientes con Sarcoma Sinovial . ASCO 2010 .

Trabectedin (T) in advanced, pretreated synovial sarcomas (SS): A retrospective analysis of 39 patients (pts) from three European institutions.

Sub-category: Soft Tissue

Category: Sarcoma

Meeting: 2010 ASCO Annual Meeting

Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 10030)

Abstract No: 10030

Author(s): P. Dileo, R. Sanfilippo, F. Grosso, E. Fumagalli, J. Blay, J. Domont, A. Le Cesne, J. C. Tercero, P. G. Casali; Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy; ASO Alessandria, Alessandria, Italy; Université Claude Bernard Lyon I, Lyon, France; Institut Gustave Roussy, Villejuif, France; PharmaMar, Colmenar Viejo, Madrid, Spain; Istituto Nazionale dei Tumori, Milano, Italy

Abstract:

Background: T is effective in advanced soft tissue sarcomas, with special regard to liposarcoma and leiomyosarcoma. Mechanisms of action may be multifold: induction of DNA damage, involving specific and peculiar DNA repair pathways, and transcriptional interference. The latter mechanism may be more significant in myxoid liposarcomas. Other translocation-related sarcomas may be sensitive to T. SS is a translocation-related sarcoma. We report on a series of 39 pts with advanced SS who were treated with T in three European sarcoma centres within compassionate-use programs. Methods: The datasets of Istituto Nazionale Tumori, Milano, Italy; Centre Leon Berard, Lyon, and Institut Gustave Roussy, Villejuif, France, were retrospectively reviewed from 2000 to 2009. Overall, 21/39 pts were female, and age ranged from 18 to 67 years. Sites of primary lesions were extremities = 23, mediastinum = 6, trunk = 5, pelvis = 4, head and neck = 1. At the time of treatment, all pts presented with metastatic disease, and were pre-treated with a median of 3 chemotherapy lines (range: 2-7). Results: 186 courses were delivered (median: 3). All pts were evaluable for response. Seven pts had a PR, for an overall response rate (RR) of 18%. In addition, 2 MR, and 11 SD were observed. Progression-free survival at 6 months (PFR-6) was 23%. Median PFS was 29, 21, and 18 weeks, respectively, in pts who experienced PR, MR and SD. Conclusions: In this series of adult pts with advanced pre-treated SS, T induced a RR of 18% and a PFR-6 of 23%. This suggests that SS constitute a sarcoma subgroup with distinct sensitivity to T.