Plitidepsin and Cardiac Safety in Cancer Patients
Author Information
Author(s): Arturo Soto-Matos, Sergio Szyldergemajn, Sonia Extremera, Bernardo Miguel-Lillo, Vicente Alfaro, Cinthya Coronado, Pilar Lardelli, Elena Roy, Claudia Silvia Corrado, Carmen Kahatt
Primary Institution: Pharma Mar S.A.
Hypothesis
Does plitidepsin have a safe cardiac profile in cancer patients?
Conclusion
Plitidepsin has a safe cardiac risk profile, with the most common cardiac adverse events being non-life-threatening rhythm abnormalities.
Supporting Evidence
- 8% of patients experienced at least one cardiac adverse event.
- Most common cardiac adverse events were rhythm abnormalities, particularly atrial fibrillation/flutter.
- None of the cardiac adverse events had a fatal outcome.
- Significant associations were found with prostate or pancreas cancer primary diagnosis and known baseline cardiac risk factors.
Takeaway
Plitidepsin is a medicine for cancer that doesn't seem to hurt the heart much, and most heart problems it causes are not serious.
Methodology
The study analyzed cardiac adverse events in clinical trials of plitidepsin using univariate and multivariate logistic regression.
Potential Biases
Potential bias due to the lack of a control group and reliance on self-reported adverse events.
Limitations
The study did not include a control arm, which may affect the assessment of cardiac adverse events.
Participant Demographics
578 adult patients with advanced solid tumors or hematological malignancies.
Statistical Information
P-Value
p = 0.0017
Confidence Interval
95% CI, 7.6–13.8
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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