Doxorubicin continues to be the standard treatment in eligible patients with advanced or metastatic soft tissue sarcoma while trabectedin 1.5mg/m2/24-hour infusion is the overall proven approach to delivering this agent in the second-line setting, a recent study published in the European Journal of Cancer has concluded.

For the multicenter, prospective dose-selection phase IIb superiority trial, researchers enrolled 133 patients with advanced or metastatic soft tissue sarcoma. Patients were randomly assigned to receive doxorubicin, trabectedin 3-hour infusion, or trabectedin 24-hour infusion.

Results showed median progression-free survival was 2.8 months in the 3-hour infusion arm, 3.1 months in the 24-hour infusion arm, and 5.5 months in the doxorubicin arm.

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Researchers found that there were no significant improvements in progression-free survival in the trabectedin arms as compared to the doxorubicin arm.

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In regard to safety, one toxic death occurred in the 3-hour infusion arm and treatment was discontinued due to toxicity in 15.2%, 19.5%, and 2.5% of 3-hour infusion, 24-hour infusion, and doxorubicin patients, respectively.

The study was terminated early due to lack of superiority in both trabectedin arms versus the doxorubicin control arm.

The findings suggest that doxorubicin should remain the first-line treatment in eligible patients with advanced or metastatic soft tissue sarcoma.


  1. Bui-Nguyen B, Butrynski JE, Penel N, et al. A phase IIb multicentre study comparing the efficacy of trabectedin to doxorubicin in patients with advanced or metastatic untreated soft tissue sarcoma: the TRUSTS trial. Eur J Cancer. 2015. [Epub ahead of print]. doi: 10.1016/j.ejca.2015.03.023.