Soft Tissue Sarcoma Knowledge Centre
Management
Novel Therapy - Trabectedin
Introduction
Trabectedin (Yondelis®- see prescription information) has been demonstrated to provide clinical benefit in many patients in whom STS progresses despite previous anthracycline and ifosfamide therapy. Following demonstration of promising activity in preclinical and phase I studies in solid tumours, the clinical activity of Yondelis® was investigated in single-arm phase II studies in patients with STS1,2,3 , and clinical benefit has subsequently been demonstrated in a large, randomised phase II clinical trial in patients with liposarcoma and leiomyosarcoma4.
The results of these studies have shown that Yondelis® arrests tumour growth in approximately 50% of patients and produces statistically significant prolongation of the time to tumour progression (TTP), as well as PFS, in patients with STS after failure of at least both anthracyclines and ifosfamide1-4. In addition, the safety profile of Yondelis has been well characterised and Yondelis® side effects have been found to be generally manageable5.
Read more about trabectedin:
- Mode of Action
- Efficacy
- Safety and Tolerability
- Clinical Studies
- Research & Advances
- Clinical Updates
- Summary of Product Characteristics (SmPC)
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Pharma Mar (contact details below).
Adverse Events Reporting
Pharmacovigilance Department
- Fax: +34 91 846 6004
- Tel: +34 91 846 6055
- e-mail: phv@pharmamar.com
References:
1. Garcia-Carbonero R, Supko JG et al. (2004) “Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive
2. Le Cesne A, Blay JY et al. (2005) “Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial.” J Clin Oncol 23(3): 576–84.
3. Yovine A, Riofrio M et al. (2004) “Phase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patients.” J Clin Oncol 22(5): 890–99.
4. Morgan JA, Le Cesne A et al. (2007) “Randomized phase II study of trabectedin in patients with liposarcoma and leiomyosarcoma after failure of prior anthracycline and ifosfamide.” J Clin Oncol 25(18S): Abstract 10060.
5. Yondelis®. (2007) Summary of product characteristics. PharmaMar: Madrid, Spain.