Related Experiment Video
Updated: May 12, 2025
Assessment of Resistance to Tyrosine Kinase Inhibitors by an Interrogation of Signal Transduction Pathways by Antibody Arrays
Published on: September 19, 2018
Adverse reactions of four multi-targeted tyrosine kinase inhibitors: a descriptive analysis of the WHO-VigiAccess
Lijun Li1,2,3, Jiayu Bai4, Xuelong Wen5
1Department of Pharmacy, The Second Affiliated Hospital, University of South China, Hengyang, Hunan, China.
Background:
The introduction of multi-targeted tyrosine kinase inhibitors (MTKIs) such as axitinib, lenvatinib, sorafenib, and sunitinib has greatly broadened the available treatment options for Renal Cell Carcinoma (RCC). The study aims to compare the nature of the adverse reactions associated with these four MTKIs to identify which medication poses the least risk for personalized patient management, thus enabling more accurate clinical drug oversight.
Methods:
Employing a retrospective descriptive analysis methodology, this research concentrated on four commercially available MTKIs. Reports pertaining to these medications were sourced from the WHO-VigiAccess database. The data gathering process involved collecting comprehensive information on various parameters, such as age demographics, gender, and the geographical distribution of patients associated with the ADR reports. Furthermore, the study explored disease systems and symptoms that were documented alongside the adverse reactions, as outlined in the annual ADR reports produced by the WHO. To assess the relationship between these four MTKIs and the linked AEs, both the Proportional Reporting Ratio (PRR) and the Reported Odds Ratio (ROR) were utilized.
Results:
At the time of the search, a total of 123,818 AEs associated with the four MTKIs had been documented in the VigiAccess database. The common ADRs for these four MTKIs include diarrhoea, fatigue, death, hypertension, nausea, asthenia, weight decreased, and vomiting. Gastrointestinal disorders and general disorders and administration site conditions emerged as the SOCs with the highest number of adverse signals, both ranking first in terms of frequency. The elevated ROR (1.08) and PRR (1.06) values associated with gastrointestinal disorders in patients treated with sorafenib suggest a higher incidence of such adverse events compared to those observed with axitinib, lenvatinib, and sunitinib.
Conclusion:
Recent comparative observational research suggests that the ADR reports submitted to the WHO and the FDA for these medications highlight both common and specific ADRs. It is essential for clinical practitioners to develop personalized treatment strategies that consider the adverse effects linked to different medications, alongside the unique circumstances of their patients, thus encouraging the responsible use of these MTKIs.
Insights
This study compared adverse reactions of four multi-targeted tyrosine kinase inhibitors (MTKIs) for renal cell carcinoma (RCC). Sorafenib showed a higher risk of gastrointestinal issues compared to axitinib, lenvatinib, and sunitinib.
Area of Science:
- Oncology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Multi-targeted tyrosine kinase inhibitors (MTKIs) like axitinib, lenvatinib, sorafenib, and sunitinib are key treatments for renal cell carcinoma (RCC).
- Understanding the comparative safety profiles of these MTKIs is crucial for effective patient management and clinical drug oversight.
Purpose of the Study:
- To compare the nature and frequency of adverse reactions associated with four specific MTKIs used in RCC treatment.
- To identify which MTKI may pose a lower risk of adverse events for personalized patient care.
Main Methods:
- Retrospective descriptive analysis of adverse drug reaction (ADR) reports from the WHO-VigiAccess database.
- Data included patient demographics, geographical distribution, disease systems, and symptoms.
- Proportional Reporting Ratio (PRR) and Reported Odds Ratio (ROR) were used to assess the association between MTKIs and adverse events (AEs).
Main Results:
- A total of 123,818 AEs were documented for the four MTKIs.
- Common ADRs included diarrhea, fatigue, hypertension, nausea, and vomiting.
- Sorafenib demonstrated elevated ROR (1.08) and PRR (1.06) for gastrointestinal disorders, suggesting a higher incidence compared to other MTKIs.
Conclusions:
- ADR reports highlight common and specific adverse effects for these MTKIs.
- Personalized treatment strategies considering individual patient circumstances and drug-specific adverse effects are essential for responsible MTKI use.
Related Concept Videos
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
02:50Combination Therapies and Personalized Medicine
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
01:27Transducer Mechanism: Enzyme-Linked Receptors
Major types that are helpful drug targets include:
01:26Treatment for Pulmonary Arterial Hypertension: Receptor Tyrosine Kinase Inhibitors and Calcium Channel Blockers
TKIs, such as imatinib (Gleevec), are particularly effective in tackling the growth and mitogenic factors that become upregulated in PAH patients. These factors contribute to the...
01:26Receptor Tyrosine Kinases