Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer Therapies

The adverse effects of protein kinase inhibitors (PKIs) and other anticancer therapies were compared using FDA Adverse Events Reporting System (FAERS) data. The dataset included 159 FDA-approved anticancer drugs (71 PKIs, 88 nonPKIs) and analyzed 8216 unique adverse event (AE) terms. PKIs showed few...

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Main Authors: Ioana Lavinia Radulian, Georgiana Nitulescu, Anca Zanfirescu, George Mihai Nitulescu
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Scientia Pharmaceutica
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Online Access:https://www.mdpi.com/2218-0532/93/2/20
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author Ioana Lavinia Radulian
Georgiana Nitulescu
Anca Zanfirescu
George Mihai Nitulescu
author_facet Ioana Lavinia Radulian
Georgiana Nitulescu
Anca Zanfirescu
George Mihai Nitulescu
author_sort Ioana Lavinia Radulian
collection DOAJ
description The adverse effects of protein kinase inhibitors (PKIs) and other anticancer therapies were compared using FDA Adverse Events Reporting System (FAERS) data. The dataset included 159 FDA-approved anticancer drugs (71 PKIs, 88 nonPKIs) and analyzed 8216 unique adverse event (AE) terms. PKIs showed fewer systemic toxicities, with an average of 230.1 distinct AEs per drug, compared to 537.7 in nonPKIs. Hematologic AEs were significantly lower in PKIs (e.g., febrile neutropenia: 1.93% vs. 5.25%; thrombocytopenia: 2.18% vs. 3.87%), coupled with a lower incidence of infections (6.87% vs. 14.2%) and immunosuppressive effects. However, gastrointestinal and skin-related AEs were more common in PKIs (e.g., diarrhea: 13.95% vs. 8.36%). A higher proportion AEs in the PKI group (14.57%) were classified under “Investigations”, compared to the nonPKI group (9.87%). The frequency of “Skin and subcutaneous tissue disorders” AEs was twice as high in the PKI group. Clustering analysis grouped drugs by AE profiles, showing that PKIs formed more homogeneous clusters, while nonPKIs had broader variability. Multi-kinase inhibitors with VEGFR activity were linked to dermatologic AEs, likely due to EGFR inhibition in basal keratinocytes. Despite PKIs’ targeted mechanisms, resistance remains a challenge, requiring biomarker-driven strategies. This study highlights PKIs’ improved tolerability but emphasizes using personalized treatment approaches to optimize efficacy and safety.
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spelling doaj-art-8af0a0e044d64ddc875477a0614631522025-08-20T03:29:48ZengMDPI AGScientia Pharmaceutica0036-87092218-05322025-04-019322010.3390/scipharm93020020Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer TherapiesIoana Lavinia Radulian0Georgiana Nitulescu1Anca Zanfirescu2George Mihai Nitulescu3Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 020956 Bucharest, RomaniaFaculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 020956 Bucharest, RomaniaFaculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 020956 Bucharest, RomaniaFaculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 020956 Bucharest, RomaniaThe adverse effects of protein kinase inhibitors (PKIs) and other anticancer therapies were compared using FDA Adverse Events Reporting System (FAERS) data. The dataset included 159 FDA-approved anticancer drugs (71 PKIs, 88 nonPKIs) and analyzed 8216 unique adverse event (AE) terms. PKIs showed fewer systemic toxicities, with an average of 230.1 distinct AEs per drug, compared to 537.7 in nonPKIs. Hematologic AEs were significantly lower in PKIs (e.g., febrile neutropenia: 1.93% vs. 5.25%; thrombocytopenia: 2.18% vs. 3.87%), coupled with a lower incidence of infections (6.87% vs. 14.2%) and immunosuppressive effects. However, gastrointestinal and skin-related AEs were more common in PKIs (e.g., diarrhea: 13.95% vs. 8.36%). A higher proportion AEs in the PKI group (14.57%) were classified under “Investigations”, compared to the nonPKI group (9.87%). The frequency of “Skin and subcutaneous tissue disorders” AEs was twice as high in the PKI group. Clustering analysis grouped drugs by AE profiles, showing that PKIs formed more homogeneous clusters, while nonPKIs had broader variability. Multi-kinase inhibitors with VEGFR activity were linked to dermatologic AEs, likely due to EGFR inhibition in basal keratinocytes. Despite PKIs’ targeted mechanisms, resistance remains a challenge, requiring biomarker-driven strategies. This study highlights PKIs’ improved tolerability but emphasizes using personalized treatment approaches to optimize efficacy and safety.https://www.mdpi.com/2218-0532/93/2/20pharmacovigilancedrug-related side effectstarget-specific safety profileoncology pharmacotherapyadverse effectsadverse events
spellingShingle Ioana Lavinia Radulian
Georgiana Nitulescu
Anca Zanfirescu
George Mihai Nitulescu
Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer Therapies
Scientia Pharmaceutica
pharmacovigilance
drug-related side effects
target-specific safety profile
oncology pharmacotherapy
adverse effects
adverse events
title Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer Therapies
title_full Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer Therapies
title_fullStr Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer Therapies
title_full_unstemmed Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer Therapies
title_short Comparative Analysis of Adverse Effects: Protein Kinase Inhibitors Versus Traditional Anticancer Therapies
title_sort comparative analysis of adverse effects protein kinase inhibitors versus traditional anticancer therapies
topic pharmacovigilance
drug-related side effects
target-specific safety profile
oncology pharmacotherapy
adverse effects
adverse events
url https://www.mdpi.com/2218-0532/93/2/20
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AT georgiananitulescu comparativeanalysisofadverseeffectsproteinkinaseinhibitorsversustraditionalanticancertherapies
AT ancazanfirescu comparativeanalysisofadverseeffectsproteinkinaseinhibitorsversustraditionalanticancertherapies
AT georgemihainitulescu comparativeanalysisofadverseeffectsproteinkinaseinhibitorsversustraditionalanticancertherapies