Clinical and pharmacokinetic evaluation of trabectedin for the treatment of soft-tissue sarcoma

Introduction: Forty percent of patients with soft-tissue sarcoma (STS) will develop metastatic disease. Furthermore, up until 2007, doxorubicin and ifosfamide were the only drugs approved for the treatment of patients with advanced STS. In addition to the lack of available drugs on the market, there was a distinct lack of alternative options for patients who had first-line doxorubicin-based chemotherapy failure even though more than 40 different drugs have been investigated in this setting over the past three decades. In 2007, trabectedin received European approval for patients with advanced or metastatic STS who had either failed with or were unsuitable for first-line therapy with anthracyclines and ifosfamide, either sequentially or in combination. Areas covered: The article was based on a literature search performed through PubMed for papers published between January, 2000, and June, 2011, using the search terms 'trabectedin,' 'ET-743' and 'ecteinascidin'. Expert opinion: Despite an objective response rate lower than 10%, trabectedin met the European Organisation for the Research and Treatment of Cancer criteria, in terms of non-progression rate, to be considered as an active drug in advanced STS after failure of standard first-line chemotherapy. The authors believe that further biological and clinical studies are needed in order for clinicians to be able to identify patients who are more likely to benefit from the administration of this drug.