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Signals of adverse reactions to anti-angiogenic drugs in cancer: a scoping review of the literature from studies of spontaneous reporting systems
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  • Ciccone V,
  • Marina Ziche,
  • Spini A,
  • Sandra Donnini
Ciccone V
Universita degli Studi di Siena Dipartimento di Scienze della Vita
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Marina Ziche
Azienda Ospedaliera Universitaria Senese
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Spini A
Azienda Ospedaliera Universitaria Senese
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Sandra Donnini
Universita degli Studi di Siena Dipartimento di Scienze della Vita

Corresponding Author:[email protected]

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Abstract

With the increasing use of anti-angiogenic drugs (AADs) in clinical practice, a wide spectrum of adverse events (AEs) has been recognized, compromising the quality of life of oncologic patients. Global repositories of post-marketing safety reports enhance the understanding of drug toxicities in real-life setting, often not observable in clinical trials. The aim of this scoping review was to map the evidence arose from spontaneous reporting systems studies (SRSs) about AADs in cancer patients and to highlight if the found AEs with disproportionality signals were validated and thus mentioned in the respective Summary of product Characteristics documents (SmPC). Twenty-four studies were retrieved (most part of them focused on cardiovascular AEs): among them twelve studies performed a disproportionality analysis. Arterial aneurysm/aortic dissection was the most studied AE in SRSs. With this analysis, we observed a knowledge gap about the safety of AADs: first, several cardiovascular AEs were not mentioned in the SmPCs and no pharmacovigilance studies were conducted despite the well-recognized safety concern for these drugs about the cardiovascular system. Secondly, a disproportionality signal of pericardial disease (not validated through causality assessment by the authors) was found in literature for axitinib with no mention in SmPC of the drug. Further active pharmacovigilance studies need to be performed with regards to the knowledge gap identified to better characterize the safety profile of AADs.