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Cisplatin-Based Combinations-Associated Vasculopathy - A Disproportionality Analysis of Real-World Pharmacovigilance
Krutarth K Pandya1, Chitsimran Mann2, Wei Fang3
1Department of Cardiology, Cleveland, Ohio, 44195, USA.
Cisplatin chemotherapy combinations are linked to increased vascular events, particularly with gemcitabine. Healthcare providers should monitor patients for thrombotic events during treatment.
Area of Science:
- Oncology
- Pharmacovigilance
- Cardiovascular Medicine
Background:
- Cisplatin is a widely used chemotherapy agent for solid tumors and hematologic malignancies.
- While effective, cisplatin is associated with toxicities like nephro-, gastrointestinal-, and hepatotoxicity.
- Limited data exists on cisplatin's association with adverse vascular events.
Purpose of the Study:
- To investigate the risk of drug-related adverse vascular events associated with four cisplatin-based combination therapies.
- Utilized the FDA Adverse Events Reporting System (FAERS) for analysis.
Main Methods:
- Case/non-case disproportionality analysis using Reporting Odds Ratio (ROR) on 2016-2020 FAERS data.
- Included peripheral, cerebrovascular, coronary, venothromboembolic, and arterial events.
- Analyzed four cisplatin combination groups: cisplatin/etoposide, cisplatin/gemcitabine, cisplatin/paclitaxel, and cisplatin/docetaxel.
Main Results:
- All four cisplatin-based combination groups showed statistically significant vasculopathies.
- Cisplatin and gemcitabine combination exhibited the highest signal for associated vasculopathy (ROR and IC).
- Cisplatin and paclitaxel/docetaxel showed a trend but did not reach statistical significance for vasculopathy.
Conclusions:
- Increased vasculopathies linked to cisplatin combinations may stem from a pro-thrombotic state.
- Highlights the need for caution and monitoring for thrombotic events in patients receiving cisplatin-based chemotherapy.
- Emphasizes considering patient-specific factors for treatment decisions and managing vascular risks.
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