Trabectedin Effective in Heavily Pretreated Metastatic Soft Tissue Sarcomas .
Silas Inman @silasinman /// Wednesday, September 16, 2015 .
In the final analysis of progression-free survival (PFS), there was a 45% reduction in the risk of disease progression or death with trabectedin compared with dacarbazine.
The median PFS with trabectedin was 4.2 months compared with 1.5 months with dacarbazine (HR, 0.55; 95% CI, 0.44-0.70; P 0.001). At this interim analysis, 64% of events were available for the primary endpoint of overall survival (OS). In this group, there was a trend toward a 13% reduction in the risk of death for patients treated with trabectedin, although it was not statistically significant (HR, 0.87; P = .37). The median OS with trabectedin was 12.4 versus 12.9 months with dacarbazine.
**.- A final analysis of OS will be presented at the 2015 European Cancer Congress, later this month.
“The interim analysis of OS, the primary endpoint of this study, demonstrated a statistically nonsignificant 13% reduction in risk of death that favored the trabectedin group,” wrote the authors of the study, which was led by George D. Demetri, MD. “Of note, the median OS in the dacarbazine arm was statistically equivalent to the trabectedin group and exceeded the predefined statistical assumption of 10 months; this may reflect the use of subsequent therapies, including pazopanib, which was approved by regulatory agencies for STS during the conduct of this trial.”
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During the FDA’s review period, patients with soft tissue sarcoma who are unlikely to benefit from available therapies and who cannot participate in a clinical trial can apply to receive trabectedin through an FDA expanded access program (NCT00210665).
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