A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system

References

• Kameda T, Takayama T, Sugihara T, et al. The efficacy of axitinib as a first-line treatment for metastatic renal cell carcinoma. Asia Pac J Clin Oncol. 2020;16(4):241–246.
   PubMed Web of Science ®Google Scholar
• Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011;378(9807):1931–1939.
   PubMed Web of Science ®Google Scholar
• Gross-Goupil M, Massard C, Ravaud A. Targeted therapies in metastatic renal cell carcinoma: overview of the past year. Curr Urol Rep. 2012;13(1):16–23.
   PubMed Web of Science ®Google Scholar
• Sheng X, Bi F, Ren X, et al. First-line axitinib versus sorafenib in Asian patients with metastatic renal cell carcinoma: exploratory subgroup analyses of Phase III data. Future Oncol. 2019;15(1):53–63.
   PubMed Web of Science ®Google Scholar
• Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380(12):1116–1127.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus Axitinib versus Sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380(12):1103–1115.
   PubMed Web of Science ®Google Scholar
• Rini BI, de La Motte Rouge T, Harzstark AL, et al. Five-year survival in patients with cytokine-refractory metastatic renal cell carcinoma treated with axitinib. Clin Genitourin Cancer. 2013;11(2):107–114.
   PubMed Web of Science ®Google Scholar
• Rini BI, Escudier B, Hariharan S, et al. Long-term safety with Axitinib in previously treated patients with metastatic renal cell carcinoma. Clin Genitourin Cancer. 2015;13(6):540–7.e1-7.
   Web of Science ®Google Scholar
• Kirkali Z. Adverse events from targeted therapies in advanced renal cell carcinoma: the impact on long-term use. BJU Int. 2011;107(11):1722–1732.
   PubMed Web of Science ®Google Scholar
• Chen C, Wu B, Zhang C, et al. Immune-related adverse events associated with immune checkpoint inhibitors: an updated comprehensive disproportionality analysis of the FDA adverse event reporting system. Int Immunopharmacol. 2021;95:107498.
   PubMed Web of Science ®Google Scholar
• Meng L, Huang J, Jia Y, et al. Assessing fluoroquinolone-associated aortic aneurysm and dissection: data mining of the public version of the FDA adverse event reporting system. Int J Clin Pract. 2019;73(5):e13331.
   PubMed Web of Science ®Google Scholar
• Harpaz R, DuMochel W, Shah NH. Big data and adverse drug reaction detection. Clin Pharmacol Ther. 2016;99(3):268–270.
   PubMed Web of Science ®Google Scholar
• Chen C, Chen T, Liang J, et al. Cardiotoxicity induced by immune checkpoint inhibitors: a pharmacovigilance study from 2014 to 2019 based on FAERS. Front Pharmacol. 2021;12:616505.
   PubMed Web of Science ®Google Scholar
• Song Y, Xu YL, Lin Y, et al. Fractures due to aromatase inhibitor therapy for breast cancer: a real-world analysis of FAERS data in the past 15 years. Oncol Res Treat. 2020;43(3):96–102.
   PubMed Web of Science ®Google Scholar
• Meng L, Yang B, Qiu F, et al. Lung cancer adverse events reports for angiotensin-converting enzyme inhibitors: data mining of the FDA adverse event reporting system database. Front Med (Lausanne). 2021;8:594043.
   PubMed Web of Science ®Google Scholar
• Peng L, Xiao K, Ottaviani S, et al. A real-world disproportionality analysis of FDA Adverse Event Reporting System (FAERS) events for baricitinib. Expert Opin Drug Saf. 2020;19(11):1505–1511.
   PubMed Web of Science ®Google Scholar
• Capitanio U, Bensalah K, Bex A, et al. Epidemiology of renal cell carcinoma. Eur Urol. 2019;75(1):74–84.
   PubMed Web of Science ®Google Scholar
• Li J, Gu J. Risk of gastrointestinal events with newly approved (after 2011) vascular endothelial growth factor receptor tyrosine kinase inhibitors in cancer patients: a meta-analysis of randomized controlled trials. Eur J Clin Pharmacol. 2017;73(10):1209–1217.
   PubMed Web of Science ®Google Scholar
• Goldman A, Bomze D, Dankner R, et al. Cardiovascular toxicities of antiangiogenic tyrosine kinase inhibitors: a retrospective, pharmacovigilance study. Target Oncol. 2021;16(4):471–483.
   PubMed Web of Science ®Google Scholar
• Totzeck M, Mincu RI, Mrotzek S, et al. Cardiovascular diseases in patients receiving small molecules with anti-vascular endothelial growth factor activity: a meta-analysis of approximately 29,000 cancer patients. Eur J Prev Cardiol. 2018;25(5):482–494.
   PubMed Web of Science ®Google Scholar
• Nakai K, Fujii H, Kono K, et al. Hypertension induced by tyrosine-kinase inhibitors for the treatment of renal cell carcinoma in hemodialysis patients: a single-center experience and review of the literature. Ther Apheresis Dialysis. 2017;21(4):320–325.
   PubMed Web of Science ®Google Scholar
• Robinson ES, Khankin EV, Karumanchi SA, et al. Hypertension induced by vascular endothelial growth factor signaling pathway inhibition: mechanisms and potential use as a biomarker. Semin Nephrol. 2010;30(6):591–601.
   PubMed Web of Science ®Google Scholar
• Bæk Møller N, Budolfsen C, Grimm D, et al. Drug-induced hypertension caused by Multikinase inhibitors (Sorafenib, Sunitinib, Lenvatinib and Axitinib) in renal cell carcinoma treatment. Int J Mol Sci. 2019;20(19):4712.
   PubMed Web of Science ®Google Scholar
• Niwa N, Nishiyama T, Ozu C, et al. Acute aortic dissection in a patient with metastatic renal cell carcinoma treated with axitinib. Acta Oncol. 2015;54(4):561–562.
   PubMed Web of Science ®Google Scholar
• Gürel E, Günaydın ZY, Karaoğlanoğlu M, et al. Acute myocardial infarction induced by axitinib. Anadolu kardiyoloji dergisi. Anadolu Kardiyoloji Dergisi/The Anatolian Journal of Cardiology. 2014;14(7):661.
   Google Scholar
• Edeline J, Laguerre B, Rolland Y, et al. Aortic dissection in a patient treated by sunitinib for metastatic renal cell carcinoma. Ann Oncol. 2010;21(1):186–187.
   PubMed Web of Science ®Google Scholar
• Hutson TE, Lesovoy V, Al-Shukri S, et al. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol. 2013;14(13):1287–1294.
   PubMed Web of Science ®Google Scholar
• Atkins MB, Plimack ER, Puzanov I, et al. Axitinib plus pembrolizumab in patients with advanced renal-cell carcinoma: long-term efficacy and safety from a phase Ib trial. Eur J Cancer. 2021;145:1–10.
   PubMed Web of Science ®Google Scholar
• Hartl DM, Ferté C, Loriot Y, et al. Dysphonia induced by vascular endothelium growth factor/vascular endothelium growth factor receptor inhibitors. Invest New Drugs. 2010;28(6):884–886.
   PubMed Web of Science ®Google Scholar
• Saavedra E, Hollebecque A, Soria JC, et al. Dysphonia induced by anti-angiogenic compounds. Invest New Drugs. 2014;32(4):774–782.
   PubMed Web of Science ®Google Scholar
• Stefaniak AA, Wójcik E, Matusiak Ł, et al. Axitinib-induced scrotal ulcers: a novel cutaneous adverse event. J Eur Acad Dermatol Venereol JEADV. 2021;35(1):e77–e78.
   PubMed Web of Science ®Google Scholar
• Kameda T, Nakano K, Yamazaki M, et al. Axitinib-induced pneumatosis intestinalis and acute acalculous cholecystitis in a patient with renal cell carcinoma. Urology. 2017;101:e7–e8.
   PubMed Web of Science ®Google Scholar
• Figueroa-Perez N, Kashyap R, Bal D, et al. Autoimmune myasthenia, primary adrenal insufficiency, and progressive hypothyroidism due to pembrolizumab and Axitinib combination regimen. Cureus. 2021;13(8):e16933.
   PubMed Web of Science ®Google Scholar
• Kimura M, Kusuhara S, Tagami M, et al. Impaired retinal circulation during Axitinib treatment for metastatic renal cell carcinoma. Case Rep Ophthalmol. 2019;10(1):5–10.
   PubMed Web of Science ®Google Scholar
• Patel V, Sproat C, Kwok J, et al. Axitinib-related osteonecrosis of the jaw. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017;124(5):e257–e260.
   PubMed Web of Science ®Google Scholar
• Peng L, Mao QQ, Jiang B, et al. Bilateral posterior uveitis and retinal detachment during immunotherapy: a case report and literature review. Front Oncol. 2020;10:549168.
   PubMed Web of Science ®Google Scholar
• Locati LD, Licitra L, Agate L, et al. Treatment of advanced thyroid cancer with axitinib: phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014;120(17):2694–2703.
   PubMed Web of Science ®Google Scholar
• Oshima Y, Tanimoto T, Yuji K, et al. EGFR-TKI-associated interstitial pneumonitis in nivolumab-treated patients with non-small cell lung cancer. JAMA Oncol. 2018;4(8):1112–1115.
   PubMed Web of Science ®Google Scholar