The efficacy of Trabectedin (Yondelis®- see prescription information) monotherapy in patients with STS has been demonstrated in the results of a randomised study involving 270 patients and is supported by the results of three previously conducted single-armphase II studies. The results of these studies indicate that:
Yondelis® is effective when administered at a dose of 1.5 mg/m2 24-hr q3wk (i.e. the recommended regime). This regime is superior to a weekly regime of 0.58 mg/m2 administered as a 3-hour infusion. With Yondelis® at the recommended regime, the median TTP was 3.7 months, with a significant 27% reduction in the risk of progression relative to the 3-hr qwk schedule (p=0.0302).
With Yondelis® at the recommended regime the median PFS was 3.3 months in the randomised study and PFS rates at 3 months and 6 months were 51.5% and 35.5%. Similar PFS rates were also obtained in the EORTC study (3 months, 52%; 6 months, 29%). The 6-month PFS rates reported for Yondelis® in both studies seem to be favourable versus the 14% 6-month PFS rates reported by Van Glabbeke et al for active regimes in pre-treated patients with STS.
A clinical benefit rate (CR+PR+SD ?24 weeks) of 38.9% was achieved with the recommended regime in the randomised study. Yondelis®, at the recommended regime, was associated with a median OS of 13.8 months and a 1-year OS of 60.6%. These data seem to be favourable versus those reported in patients with STS having progressed after second-line ifosfamide and for second-line treatment with dacarbazine or etoposide, and versus survival data for first-line anthracycline-based chemotherapy in patients with advanced/metastatic STS.
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
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