Study Finds Real-World Data on Cardiac Toxicity of Trabectedin May Be Limited
Researchers observed increased real-world incidence of cardiomyopathy in patients treated with trabectedin compared with that seen in the phase 3 study of the drug.
|The following article features coverage from the Connective Tissue Oncology Society (CTOS) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Increased surveillance of cardiac function in patients with sarcoma who have been treated with trabectedin may be warranted, concluded authors of a poster featured at the Connective Tissue Oncology Society (CTOS) 2018 Annual Meeting, Rome, Italy.1
Based on the high incidence of cardiomyopathy observed across patients who received trabectedin in a retrospective chart review, researchers concluded that an increase in the surveillance of left ventricular ejection fraction (LVEF) could lead to earlier detection of cardiomyopathy, which, in turn, may prevent deterioration of cardiac function.
Investigators from the Abramson Cancer Center at the University of Pennsylvania, Philadelphia, reviewed charts from patients with a histology-proven diagnosis of soft tissue sarcoma who had received trabectedin at a teaching hospital in Center City, Philadelphia, between November 2015 and November 2017. They excluded patients who had a previous history of cardiomyopathy or those with an ejection fraction below 50%.
The researchers found that 5 of the 18 patients included in the study (27.8%) who had received trabectedin in a real-world setting experienced symptoms consistent with grade 3 or grade 4 cardiomyopathy and had a drop in RF from baseline in the range of 10% to 50%. The rate they observed suggests that the frequency of grade 3 or grade 4 cardiotoxicity seen in patients across the phase 3 trial — the study that supported the approval of trabectedin by the US Food and Drug Administration — may not be reflective of the actual rate that could occur in patients outside of a controlled trial environment.
The drug discontinuation rate in the phase 3 trial was lower than that seen in the UPenn investigation (1.1% vs 16.7%, respectively), and the median time it took for patients to develop these serious cardiotoxicities was shorter in real life than it was for patients in the phase 3 cohort (2.35 months vs 5.3 months, respectively).
An increase in the frequency of LVEF assessment could also prevent early termination of a therapy “that has otherwise shown to be effective in reducing the risk of disease progression or death in patients with soft tissue sarcomas that have progressed despite first-line agents.”
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- Bialick SR, Hartner L, Staddon A. Incidence of cardiomyopathy with trabectedin use in soft tissue sarcoma. Presented at: CTOS 2018 Annual Meeting; Rome, Italy: November 14-17. Poster 81.