Axitinib in the treatment of renal cell carcinoma: design, development, and place in therapy

References

• SiegelRLMillerKDJemalACancer statistics, 2016CA Cancer J Clin201666173026742998
   PubMed Web of Science ®Google Scholar
• RiniBIDorffTBElsonPActive surveillance in metastatic renal-cell carcinoma: a prospective, phase 2 trialLancet Oncol20161791317132427498080
   PubMed Web of Science ®Google Scholar
• MotzerRJHutsonTECellaDPazopanib versus sunitinib in metastatic renal-cell carcinomaN Engl J Med2013369872273123964934
   PubMed Web of Science ®Google Scholar
• MotzerRJHutsonTETomczakPOverall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinomaJ Clin Oncol200927223584359019487381
   PubMed Web of Science ®Google Scholar
• Hu-LoweDDZouHYGrazziniMLNonclinical antiangiogenesis and antitumor activities of axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptor tyrosine kinases 1, 2, 3Clin Cancer Res200814227272728319010843
   PubMed Web of Science ®Google Scholar
• EscudierBGoreMAxitinib for the management of metastatic renal cell carcinomaDrugs R D201111211312621679004
   PubMedGoogle Scholar
• InaiTMancusoMHashizumeHInhibition of vascular endothelial growth factor (VEGF) signaling in cancer causes loss of endothelial fenestrations, regression of tumor vessels, and appearance of basement membrane ghostsAm J Pathol20041651355215215160
   PubMed Web of Science ®Google Scholar
• PithavalaYKChenYTohMEvaluation of the effect of food on the pharmacokinetics of axitinib in healthy volunteersCancer Chemother Pharmacol201270110311222644797
   PubMed Web of Science ®Google Scholar
• European Medicines AgencyCommittee for Medicinal Products for Human Use (CHMP)CHMP assessment report; Inlyta (axitinib)2012 Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002406/WC500132190.pdfAccessed August 8, 2017
   Google Scholar
• ChenYTortoriciMAGarrettMHeeBKlamerusKJPithavalaYKClinical pharmacology of axitinibClin Pharmacokinet201352971372523677771
   PubMed Web of Science ®Google Scholar
• RugoHSHerbstRSLiuGPhase I trial of the oral antiangiogenesis agent AG-013736 in patients with advanced solid tumors: pharmacokinetic and clinical resultsJ Clin Oncol200523245474548316027439
   PubMed Web of Science ®Google Scholar
• RiniBISchillerJHFruehaufJPDiastolic blood pressure as a biomarker of axitinib efficacy in solid tumorsClin Cancer Res201117113841384921531811
   PubMed Web of Science ®Google Scholar
• ChenYRiniBIBairAHMugunduGMPithavalaYKPopulation pharmacokinetic-pharmacodynamic modelling of 24-h diastolic ambulatory blood pressure changes mediated by axitinib in patients with metastatic renal cell carcinomaClin Pharmacokinet201554439740725343945
   PubMed Web of Science ®Google Scholar
• RiniBIGarrettMPolandBAxitinib in metastatic renal cell carcinoma: results of a pharmacokinetic and pharmacodynamic analysisJ Clin Pharmacol201353549150423553560
   PubMed Web of Science ®Google Scholar
• RiniBIMelicharBUedaTAxitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trialLancet Oncol201314121233124224140184
   PubMed Web of Science ®Google Scholar
• RiniBIMelicharBFishmanMNAxitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinomaAnn Oncol20152671372137725701454
   PubMed Web of Science ®Google Scholar
• GrünwaldVMerseburgerASAxitinib for the treatment of patients with advanced metastatic renal cell carcinoma (mRCC) after failure of prior systemic treatmentOnco Targets Ther2012511111722787405
   PubMed Web of Science ®Google Scholar
• RiniBIEscudierBTomczakPComparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trialLancet201137898071931193922056247
   PubMed Web of Science ®Google Scholar
• RiniBIEscudierBHariharanSLong-term safety with axitinib in previously treated patients with metastatic renal cell carcinomaClin Genitourin Cancer2015136540547e1726320662
   PubMed Web of Science ®Google Scholar
• LoriotYBoudou-RouquettePBillemontBRopertSGoldwasserFAcute exacerbation of hemorrhagic rectocolitis during antiangiogenic therapy with sunitinib and sorafenibAnn Oncol200819111975
   PubMed Web of Science ®Google Scholar
• CoriatRRopertSMirOPneumatosis intestinalis associated with treatment of cancer patients with the vascular growth factor receptor tyrosine kinase inhibitors sorafenib and sunitinibInvest New Drugs20112951090109320524036
   PubMed Web of Science ®Google Scholar
• HescotSVignauxOGoldwasserFPancreatic atrophy – a new late toxic effect of sorafenibN Engl J Med2013369151475147624106956
   PubMed Web of Science ®Google Scholar
• AlivonMGirouxJBrietMGoldwasserFLaurentSBoutouyriePLarge artery stiffness and hypertension after antiangiogenic drugs: influence on cancer progressionJ Hypertens20153361310131725715093
   PubMed Web of Science ®Google Scholar
• RopertSVignauxOMirOGoldwasserFVEGF pathway inhibition by anticancer agent sunitinib and susceptibility to atherosclerosis plaque disruptionInvest New Drugs20112961497149920676744
   PubMed Web of Science ®Google Scholar
• RiniBIQuinnDIBaumMHypertension among patients with renal cell carcinoma receiving axitinib or sorafenib: analysis from the randomized phase III AXIS trialTarget Oncol2015101455324595903
   PubMed Web of Science ®Google Scholar
• MaitlandMLBakrisGLBlackHRCardiovascular Toxicities Panel, Convened by the Angiogenesis Task Force of the National Cancer Institute Investigational Drug Steering CommitteeInitial assessment, surveillance, and management of blood pressure in patients receiving vascular endothelial growth factor signaling pathway inhibitorsJ Natl Cancer Inst2010102959660420351338
   PubMedGoogle Scholar
• ChenYSuzukiATortoriciMAAxitinib plasma pharmacokinetics and ethnic differencesInvest New Drugs201533252153225663295
   PubMed Web of Science ®Google Scholar
• ChenYRiniBIMotzerRJEffect of renal impairment on the pharmacokinetics and safety of axitinibTarget Oncol201611222923426400730
   PubMed Web of Science ®Google Scholar
• BrennanMWilliamsJAChenYTortoriciMPithavalaYLiuYCMeta-analysis of contribution of genetic polymorphisms in drug-metabolizing enzymes or transporters to axitinib pharmacokineticsEur J Clin Pharmacol201268564565522170007
   PubMed Web of Science ®Google Scholar
• HuillardOMirOPeyromaureMSarcopenia and body mass index predict sunitinib-induced early dose-limiting toxicities in renal cancer patientsBr J Cancer201310851034104123462722
   PubMed Web of Science ®Google Scholar
• AntounSBaracosVEBirdsellLEscudierBSawyerMBLow body mass index and sarcopenia associated with dose-limiting toxicity of sorafenib in patients with renal cell carcinomaAnn Oncol20102181594159820089558
   PubMed Web of Science ®Google Scholar
• TortoriciMATohMRahavendranSVInfluence of mild and moderate hepatic impairment on axitinib pharmacokineticsInvest New Drugs20112961370138020596748
   PubMed Web of Science ®Google Scholar
• NishidaHFukuharaHYamagishiASequential molecularly targeted drug therapy including axitinib for a patient with end-stage renal failure and metastatic renal cell carcinomaHemodial Int2016202E1E4
   Web of Science ®Google Scholar
• Thiery-VuilleminAOrillardEMouilletGHemodialysis does not impact axitinib exposure: clinical case of a patient with metastatic renal cell carcinomaCancer Chemother Pharmacol20177961273127628451830
   PubMed Web of Science ®Google Scholar
• JonkersIJAMvan BurenMNephrotic-range proteinuria in a patient with a renal allograft treated with sorafenib for metastatic renal-cell carcinomaClin Exp Nephrol200913439740119381758
   PubMed Web of Science ®Google Scholar
• FortinMCRaymondMAMadoreFIncreased risk of thrombotic microangiopathy in patients receiving a cyclosporinsirolimus combinationAm J Transplant20044694695215147429
   PubMed Web of Science ®Google Scholar
• Thomas-SchoemannABlanchetBBardinCDrug interactions with solid tumour-targeted therapiesCrit Rev Oncol Hematol201489117919624041628
   PubMed Web of Science ®Google Scholar
• PithavalaYKTongWMountJEffect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteersInvest New Drugs201230127328120740300
   PubMed Web of Science ®Google Scholar
• GomoCCoriatRFaivreLPharmacokinetic interaction involving sorafenib and the calcium-channel blocker felodipine in a patient with hepatocellular carcinomaInvest New Drugs20112961511151420706860
   PubMed Web of Science ®Google Scholar
• Da SilvaFThomas-SchoemannAHuillardOGoldwasserFBlanchetBBenefit of therapeutic drug monitoring to disclose pharmacokinetic interaction between sunitinib and calcium channel blockerAnn Oncol20162781651165227117534
   PubMed Web of Science ®Google Scholar
• PithavalaYKTortoriciMTohMEffect of rifampin on the pharmacokinetics of axitinib (AG-013736) in Japanese and Caucasian healthy volunteersCancer Chemother Pharmacol201065356357019603168
   PubMed Web of Science ®Google Scholar
• TherassePArbuckSGEisenhauerEANew guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of CanadaJ Natl Cancer Inst200092320521610655437
   PubMed Web of Science ®Google Scholar
• MukoharaTNakajimaHMukaiHEffect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patientsCancer Sci2010101496396820180805
   PubMed Web of Science ®Google Scholar
• RixeOBukowskiRMMichaelsonMDAxitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II studyLancet Oncol200781197598417959415
   PubMed Web of Science ®Google Scholar
• RiniBIde La Motte RougeTHarzstarkALFive-year survival in patients with cytokine-refractory metastatic renal cell carcinoma treated with axitinibClin Genitourin Cancer201311210711423391371
   PubMed Web of Science ®Google Scholar
• RiniBIWildingGHudesGPhase II study of axitinib in sorafenib-refractory metastatic renal cell carcinomaJ Clin Oncol200927274462446819652060
   PubMed Web of Science ®Google Scholar
• EtoMUemuraHTomitaYJapan Axitinib Phase II Study GroupOverall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinomaCancer Sci2014105121576158325283266
   PubMed Web of Science ®Google Scholar
• TzoganiKSkibeliVWestgaardIThe European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human useOncologist201520219620125616431
   PubMed Web of Science ®Google Scholar
• MotzerRJEscudierBTomczakPAxitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trialLancet Oncol201314655256223598172
   PubMed Web of Science ®Google Scholar
• HuillardOBoissierEBlanchetBDrug safety evaluation of sorafenib for treatment of solid tumors: consequences for the risk assessment and management of cancer patientsExpert Opin Drug Saf201413566367324693873
   PubMed Web of Science ®Google Scholar
• BlanchetBBillemontBCramardJValidation of an HPLC-UV method for sorafenib determination in human plasma and application to cancer patients in routine clinical practiceJ Pharm Biomed Anal20094941109111419278805
   PubMed Web of Science ®Google Scholar
• ArrondeauJMirOBoudou-RouquettePSorafenib exposure decreases over time in patients with hepatocellular carcinomaInvest New Drugs20123052046204922038662
   PubMed Web of Science ®Google Scholar
• Boudou-RouquettePRopertSMirOVariability of sorafenib toxicity and exposure over time: a pharmacokinetic/pharmacodynamic analysisOncologist20121791204121222752067
   PubMed Web of Science ®Google Scholar
• BellesoeurACartonEMirOCritical role of sorafenib exposure over time for its antitumor activity in thyroid cancerInvest New Drugs201432356957224399106
   PubMed Web of Science ®Google Scholar
• Boudou-RouquettePThomas-SchoemannABellesoeurAGoldwasserFSorafenib for patients with differentiated thyroid cancerLancet20153859964227228
   PubMed Web of Science ®Google Scholar
• HuillardOAlexandreJGoldwasserFTreatment of advanced renal-cell carcinomaN Engl J Med2016374888
   PubMed Web of Science ®Google Scholar
• PowlesTStaehlerMLjungbergBUpdated EAU guidelines for clear cell renal cancer patients who fail VEGF targeted therapyEur Urol20166914626508312
   PubMed Web of Science ®Google Scholar
• DranitsarisGSchmitzSBroomRJSmall molecule targeted therapies for the second-line treatment for metastatic renal cell carcinoma: a systematic review and indirect comparison of safety and efficacyJ Cancer Res Clin Oncol2013139111917192624037486
   PubMed Web of Science ®Google Scholar
• MiyakeHHaradaK-IOzonoSFujisawaMEfficacy and safety of axitinib in elderly patients with metastatic renal cell carcinomaMed Oncol20163389527444960
   PubMed Web of Science ®Google Scholar
• D’AnielloCVitaleMGFarnesiAAxitinib after sunitinib in metastatic renal cancer: preliminary results from Italian ‘real-world’ SAX studyFront Pharmacol2016733127733829
   PubMed Web of Science ®Google Scholar
• MacLeanECisarLMehleKEreminaDQuigleyJMReal-world axitinib use in the United States: a retrospective study using linked datasetsJ Manag Care Spec Pharm2016226723u732u27231799
   PubMed Web of Science ®Google Scholar
• MotzerRJEscudierBMcDermottDFCheckMate 025 InvestigatorsNivolumab versus everolimus in advanced renal-cell carcinomaN Engl J Med20153731803181326406148
   PubMed Web of Science ®Google Scholar
• ChoueiriTKEscudierBPowlesTMETEOR InvestigatorsCabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trialLancet Oncol201617791792727279544
   PubMed Web of Science ®Google Scholar
• ChoueiriTKEscudierBPowlesTMETEOR InvestigatorsCabozantinib versus everolimus in advanced renal-cell carcinomaN Engl J Med20153731814182326406150
   PubMed Web of Science ®Google Scholar
• ChoueiriTKHalabiSSanfordBLCabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the alliance A031203 CABOSUN trialJ Clin Oncol201735659159728199818
   PubMed Web of Science ®Google Scholar
• EscudierBPortaCSchmidingerMRenal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-upAnn Oncol201627suppl 5v58v6827664262
   PubMed Web of Science ®Google Scholar
• WiecekWKarcherHNivolumab versus cabozantinib: comparing overall survival in metastatic renal cell carcinomaPLoS One2016116e015538927271250
   PubMed Web of Science ®Google Scholar
• WellsJCStukalinINortonCThird-line targeted therapy in metastatic renal cell carcinoma: results from the international metastatic renal cell carcinoma database consortiumEur Urol201771220420927318422
   PubMed Web of Science ®Google Scholar
• HutsonTELesovoyVAl-ShukriSAxitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trialLancet Oncol201314131287129424206640
   PubMed Web of Science ®Google Scholar
• HutsonTEAl-ShukriSStusVPAxitinib versus sorafenib in first-line metastatic renal cell carcinoma: overall survival from a randomized phase III trialClin Genitourin Cancer2017151727627498023
   PubMed Web of Science ®Google Scholar
• KaramJADevineCEUrbauerDLPhase 2 trial of neoadjuvant axitinib in patients with locally advanced nonmetastatic clear cell renal cell carcinomaEur Urol201466587488024560330
   PubMed Web of Science ®Google Scholar
• KawakamiFRaoPTamboliPWoodCGKaramJAStudy of the kidney tumor-parenchymal interface after neoadjuvant treatment with axitinib for locally advanced clear cell renal cell carcinoma: matched analysis from a phase II trialJ Urol20171973 pt 155956527678298
   PubMed Web of Science ®Google Scholar
• HaasNBManolaJUzzoRGAdjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trialLancet2016387100322008201626969090
   PubMed Web of Science ®Google Scholar
• RavaudAMotzerRJPandhaHSS-TRAC InvestigatorsAdjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomyN Engl J Med20163752246225427718781
   PubMed Web of Science ®Google Scholar
• RoskoskiRSunitinib: a VEGF and PDGF receptor protein kinase and angiogenesis inhibitorBiochem Biophys Res Commun2007356232332817367763
   PubMed Web of Science ®Google Scholar
• WilhelmSMCarterCTangLBAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesisCancer Res200464197099710915466206
   PubMed Web of Science ®Google Scholar
• KumarRKnickVBRudolphSKPharmacokinetic- pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activityMol Cancer Ther2007672012202117620431
   PubMed Web of Science ®Google Scholar
• LacySHsuBMilesDAftabDWangRNguyenLMetabolism and disposition of cabozantinib in healthy male volunteers and pharmacologic characterization of its major metabolitesDrug Metab Dispos20154381190120726015560
   PubMed Web of Science ®Google Scholar