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Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous
Valerio Ciccone1, Marina Ziche2, Andrea Spini2,3
1Department of Life Sciences, University of Siena, Via Aldo Moro 2, 53100 Siena, Italy.
Abstract:
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of antiangiogenic drugs (AADs) in cancer patients and highlight if the found disproportionality signals of adverse events (AEs) were validated and thus mentioned in the respective Summary of product Characteristics (SmPC). This scoping review was conducted according to PRISMA guidelines for scoping reviews. A knowledge gap on the safety of AADs was found: firstly, several cardiovascular AEs were not mentioned in the SmPCs and no pharmacovigilance studies were conducted despite the well-known safety concerns about these drugs on the cardiovascular system. Second, a disproportionality signal (not validated through causality assessment) of pericardial disease was found in the literature for axitinib with no mention in SmPC of the drug. Despite the exclusion of pharmacoepidemiological studies, we believe that this scoping review, which focuses on an entire class of drugs, could be considered as a novel approach to highlight possible safety concerns of drugs and as a guide for the conduction of a target postmarketing surveillance on AADs.
Insights
This review highlights safety gaps in antiangiogenic drugs (AADs) for cancer. Cardiovascular adverse events (AEs) and pericardial disease signals were often unmentioned in drug labels, indicating a need for better postmarketing surveillance.
Area of Science:
- Pharmacovigilance and Drug Safety
- Oncology
- Cardiovascular Medicine
Background:
- Postmarketing safety reports reveal real-world drug toxicities beyond clinical trials.
- Antiangiogenic drugs (AADs) are used in cancer treatment, but their real-world safety profiles require continuous monitoring.
Purpose of the Study:
- To map evidence from spontaneous reporting systems studies (SRSs) on AADs in cancer patients.
- To identify if reported adverse events (AEs) disproportionality signals were validated and included in Summaries of Product Characteristics (SmPCs).
Main Methods:
- Scoping review conducted following PRISMA guidelines.
- Focused on spontaneous reporting systems studies (SRSs) of antiangiogenic drugs (AADs).
- Analyzed findings for validation and mention in drug SmPCs.
Main Results:
- Identified a knowledge gap regarding AAD safety.
- Several cardiovascular AEs were not listed in SmPCs, despite known cardiovascular risks.
- A disproportionality signal for pericardial disease with axitinib was noted but not validated or mentioned in its SmPC.
Conclusions:
- AADs present unaddressed cardiovascular safety concerns.
- Unvalidated safety signals, like pericardial disease for axitinib, require further investigation.
- This review offers a novel approach to identify drug safety concerns and guide postmarketing surveillance for AADs.
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