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RESEARCH PRODUCT

Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results

Salvatore PiscontiVittorio GebbiaMichele AietaErica PalesandroEmanuele NaglieriDonatello GasparroNicolò BorsellinoAntonio MaestriAnna CrispoA. FarnesiFrancesco GrilloneLucia BonomiGaetano FacchiniGiovanni Lo ReGiacomo CartenìRocco De VivoSarah ScagliariniGiuseppe Di LorenzoUmberto BassoFerdinando De VitaEnrico RicevutoGelsomina IovaneClaudio SiniMaria Giuseppa VitaleLuca GalliCarla CavaliereSabrina RossettiCarmine D'anielloMichele De TursiCarlo BuonerbaChiara CiccareseRoberto IacovelliClaudio ScavelliUgo De GiorgiPaolo MarchettiVincenza ConteducaLeonardo La TorreMassimiliano Berretta

subject

AdultMale0301 basic medicineOncologymedicine.medical_specialtyMultivariate analysisAxitinibAxitinib; Metastatic; Renal cancer; Sunitinib; Treatmentmedicine.medical_treatmentPopulationlcsh:MedicineKaplan-Meier EstimateDisease-Free SurvivalGeneral Biochemistry Genetics and Molecular Biology03 medical and health sciences0302 clinical medicineInternal medicineSunitinibHumansMedicineNeoplasm MetastasiseducationAdverse effectMetastatic renal cell cancerCarcinoma Renal CellAgedAged 80 and overSecond-line therapyeducation.field_of_studybusiness.industrySunitinibResearchlcsh:RGeneral MedicineMiddle AgedKidney NeoplasmsNephrectomyAxitinibTreatment030104 developmental biologyRenal cancer030220 oncology & carcinogenesisMultivariate AnalysisMetastaticFemalebusinessmedicine.drug

description

Abstract Background This multi-institutional retrospective real life study was conducted in 22 Italian Oncology Centers and evaluated the role of Axitinib in second line treatment in not selected mRCC patients. Methods 148 mRCC patients were evaluated. According to Heng score 15.5%, 60.1% and 24.4% of patients were at poor risk, intermediate and favorable risk, respectively. Results PFS, OS, DCR and ORR were 7.14 months, 15.5 months, 70.6% and 16.6%, respectively. The duration of prior sunitinib treatment correlated with a longer significant mPFS, 8.8 vs 6.3 months, respectively. Axitinib therapy was safe, without grade 4 adverse events. The most frequent toxicities of all grades were: fatigue (50%), hypertension (26%), and hypothyroidism (18%). G3 blood pressure elevation significantly correlated with longer mPFS and mOS compared to G1-G2 or no toxicity. Dose titration (DT) to 7 mg and 10 mg bid was feasible in 24% with no statistically significant differences in mPFS and mOS. The sunitinib-axitinib sequence was safe and effective, the mOS was 41.15 months. At multivariate analysis, gender, DCR to axitinib and to previous sunitinib correlated significantly with PFS; whereas DCR to axitinib, nephrectomy and Heng score independently affected overall survival. Conclusions Axitinib was effective and safe in a not selected real life mRCC population. Trial registration INT – Napoli – 11/16 oss. Registered 20 April 2016. http://www.istitutotumori.na.it

yearjournalcountryeditionlanguage
2019-01-01Journal of Translational Medicine
10.1186/s12967-019-2047-4http://link.springer.com/article/10.1186/s12967-019-2047-4