Key result
Trabectedin yields tumor control in ~50% of previously treated patients with advanced soft-tissue sarcoma.
Why the study?
The efficacy and safety profile of trabectedin in patients with advanced soft-tissue sarcoma previously treated with chemotherapy needed evaluation.
Does trabectedin provide tumor control and improve survival in previously treated patients with advanced soft-tissue sarcoma?
Does trabectedin provide tumor control and improve survival in previously treated patients with advanced soft-tissue sarcoma?
Trabectedin offers a promising, well-tolerated treatment option for advanced soft-tissue sarcoma, including in patients resistant to doxorubicin and ifosfamide, without inducing cardiotoxicity.
May support trabectedin in pretreated sarcoma without cardiotoxicity; leaves open prospective cardio-oncology validation.
Trabectedin (ET-743; Yondelis) is a novel DNA-binding agent, originally derived from the marine tunicate, Ecteinascidia turbinata, and now produced synthetically. The efficacy of trabectedin in patients with advanced soft-tissue sarcoma has been demonstrated in three Phase II studies involving 189 previously treated patients. A pooled analysis of data from these studies showed that trabectedin induced tumor control (objective responses plus disease stabilization) in approximately 50% of patients; median overall survival was 10.3 months and progression-free survival at 6 months was 19.8%, with 29.3% of patients alive at 2 years. Responses were achieved in patients who were resistant to both doxorubicin and ifosfamide. Trabectedin is generally well tolerated, with adverse events being non cumulative, reversible and manageable. Unlike other commonly used cytotoxic agents, trabectedin is not associated with cardiotoxicity or neurotoxicity and alopecia is rare. Trabectedin is an interesting new anticancer agent that offers much promise for the treatment of advanced soft-tissue sarcoma.
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Schöffski et al. (2007) conducted a review in advanced soft-tissue sarcoma (n=189). Trabectedin was evaluated on tumor control (objective responses plus disease stabilization). Trabectedin induced tumor control in approximately 50% of previously treated patients with advanced soft-tissue sarcoma, with a median overall survival of 10.3 months.
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