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Small-Molecule Targeted Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
The FDA approval was based on a pivotal Phase III study (i.e., the AXIS 1032 trial) in patients with previously treated advanced renal cell carcinoma (RCC) in which those in the axitinib arm experienced a significant improvement in PFS (i.e., median of 6.7 months versus 4.7 months) compared to patients being treated with sorafenib. Furthermore, the company noted that axitinib lengthened median PFS to more than a year in a subset of patients who had been previously treated with cytokines. Clinical studies have also been carried out in other tumor types, including hepatocellular carcinoma, gastric, thyroid and colorectal cancers, NSCLC, and soft-tissue sarcoma.
Renal Cell Cancer
Published in Pat Price, Karol Sikora, Treatment of Cancer, 2020
Axitinib (Inlyta) is a potent oral selective inhibitor of VEGFR1-3 with phase III data supporting its use as a second-line treatment option.61 The AXIS study compared axitinib to sorafenib in a randomized open label phase III trial in 723 patients with advanced clear-cell RCC. First-line treatments included sunitinib (54%), cytokines alone (35%), bevacizumab/IFNa (8%), and temsirolimus (3%).
Renal cell cancer
Published in Pat Price, Karol Sikora, Treatment of Cancer, 2014
Axitinib (Inlyta) is a potent oral selective inhibitor of VEGFR1-3 with phase III data supporting its use as a second-line treatment option.113,114 The AXIS study compared Axitinib to Sorafenib in a randomized open label phase III trial in 723 patients with advanced clear cell RCC. First-line treatments included Sunitinib (54%), cytokines alone (35%), Bevacizumab/IFNa (8%) and Temsirolimus (3%).
Bilateral Central Retinal Vein Occlusion Associated with Axitinib Therapy: A Case Report
Published in Ocular Immunology and Inflammation, 2023
Richa Pyare, Amol Ganvir, Shina Goyal, Chetan Rao, Parthopratim Dutta Majumder
Axitinib, a tyrosine kinase inhibitor and a potent inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3, along with immune checkpoint inhibitors like pembrolizumab/ avelumab, is used as first-line and as a single agent in second-line treatment for advanced RCC.1 The commonly reported adverse effects of axitinib include diarrhea, nausea, fatigue, palmar-plantar erythrodysaesthesia syndrome, and hypertension. However, due to the short half-life of axitinib, these adverse effects are short-lived after drug withdrawal.2 Though the initial clinical trial data of axitinib reported the risk of retinal vein occlusions, there is no such event reported in the literature to the best of our knowledge.1 Jenkins et al.2 described cotton wool spots and retinal hemorrhages in 62-year-old woman on axitinib, that improved with cessation of the drug. In another report, a 57-year-old male treated with axitinib for metastatic renal cell carcinoma for two years developed a sudden onset defective field vision in his right eye. His fundus examination exhibited multiple soft exudates and significant fluorescein filling delay of the retinal vessels in the right eye on fluorescein angiography. Further follow-up details of this patient was not available, as his general condition worsened due to the progression of brain metastasis.3
A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system
Published in Expert Opinion on Drug Safety, 2022
Yamin Shu, Yufeng Ding, Bing Dai, Qilin Zhang
In the clinical phase II and phase III studies of axitinib, the most common adverse drug reactions (ADRs) included diarrhea, fatigue, hypertension, dysphonia, hand-foot syndrome, and decreased appetite, which were manageable in the clinical trial setting [2,7,8]. Due to the relatively recent introduction of targeted agents for the treatment of RCC, long-term efficacy, and safety data of these therapies have only been reported in clinical trials or case reports, and ADRs are mostly focused on a single or several systems due to strict diagnosis standards, selection criteria, relatively small sample sizes, and limited duration of follow-ups. In addition, prolonged treatment with targeted agents may result in the occurrences of previously unidentified or serious safety issues [9]. Currently, data on the large sample and real-world comprehensive safety of axitinib are lacking. Axitinib is the most representative tyrosine kinase inhibitor in the treatment of advanced RCC and has been widely used in clinic. Therefore, it is very necessary to use data mining algorithm to search for the potential ADRs signals of axitinib by post-marketing monitoring.
Adjuncts to pulsed dye laser for treatment of port wine stains: a literature review
Published in Journal of Cosmetic and Laser Therapy, 2021
Bing Wang, Xianglin Mei, Yanlong Wang, Xin Hu, Fuqiu Li
Axitinib, an anti-angiogenic agent approved by the U.S. Food and Drug Administration for the second-line treatment of patients with advanced renal cell carcinoma, is an effective, multi-target, highly selective tyrosine kinase inhibitor. It can also act on VEGF-receptors tyrosine kinases 1 to 3, platelet-derived growth factor receptor (PDGFRβ), and stem cell growth factor receptor (c-Kit). Axitinib was shown to exert anti-tumor effect through regulation of kinases leading to blockade of VEGF-mediated endothelial cell survival, angiogenesis, downstream signal transduction via endothelial nitric oxide synthase, phosphorylated protein kinase b, and extracellular signals (45). Axitinib has been used for advanced renal cell carcinoma, thyroid cancer, and other tumors. Gao et al. observed the inhibitory effect of axitinib on PDL-induced angiogenesis in animal models. They found that axitinib could restrain PDL-induced angiogenesis by inhibiting the AKT/mTOR/p70s6k pathway and Src homology 2 domain containing transforming protein-1(SHC1)/mitogen-activated protein kinase (MEK)/extracellular signal regulated kinases (ERK) pathway cascades (46).