PNFLBA-16 FIRST RESULTS OF A-PREDICT: A PHASE II STUDY OF AXITINIB IN PATIENTS WITH METASTATIC RENAL CELL CANCER (RCC) UNSUITABLE FOR NEPHRECTOMY

Abstract

You have accessJournal of UrologyPlenary: Next Frontier (PNFLBA)1 Apr 2017PNFLBA-16 FIRST RESULTS OF A-PREDICT: A PHASE II STUDY OF AXITINIB IN PATIENTS WITH METASTATIC RENAL CELL CANCER (RCC) UNSUITABLE FOR NEPHRECTOMY Grant Stewart, James Morden, Ekaterini Boleti, Naveen Vasudev, Fiona Thistlethwaite, Agnieszka Michael, Lucy Kilburn, Rebecca Lewis, David Nicol, Linda Pyle, Claire Snowdon, Rachel Todd, Lucy Tregellas, Samra Turajlic, Charlie Swanton, Judith Bliss, and James Larkin Grant StewartGrant Stewart More articles by this author , James MordenJames Morden More articles by this author , Ekaterini BoletiEkaterini Boleti More articles by this author , Naveen VasudevNaveen Vasudev More articles by this author , Fiona ThistlethwaiteFiona Thistlethwaite More articles by this author , Agnieszka MichaelAgnieszka Michael More articles by this author , Lucy KilburnLucy Kilburn More articles by this author , Rebecca LewisRebecca Lewis More articles by this author , David NicolDavid Nicol More articles by this author , Linda PyleLinda Pyle More articles by this author , Claire SnowdonClaire Snowdon More articles by this author , Rachel ToddRachel Todd More articles by this author , Lucy TregellasLucy Tregellas More articles by this author , Samra TurajlicSamra Turajlic More articles by this author , Charlie SwantonCharlie Swanton More articles by this author , Judith BlissJudith Bliss More articles by this author , and James LarkinJames Larkin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.03.042AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Axitinib is a potent oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) not previously tested in the UK in metastatic RCC patients with their primary tumour in situ. A-PREDICT aims to determine whether axitinib has activity in this population and explore biomarkers of activity and resistance METHODS A-PREDICT is a phase II single group study (maximum n=99) of axitinib (starting dose 5mg BID) in patients with metastatic clear cell RCC unable to have immediate cytoreductive nephrectomy. Participants consented to provide biosamples (tumour, blood, urine) at baseline, on treatment and at progression. The primary endpoint is proportion of patients alive and free from disease progression (RECIST v1.1) at 6 months. Secondary endpoints include toxicity (CTCAE v4), progression free, overall survival and correlation of biomarkers with clinical endpoints. RESULTS 65 participants were recruited between 10/10/2012 and 23/12/2016. In December 2016 the Independent Data Monitoring and Steering Committee recommended that the trial close to recruitment as the pre-defined threshold level of activity had been reached. As of 19/12/2016 tumour samples were available for 92% participants at baseline, 87% on treatment and 13% at progression with equivalent return rates for blood and for urine samples. Final data on response and toxicity will be available Q2 2017. CONCLUSIONS Recruitment to translational studies is challenging. Due to close cooperation of oncologists, urologists, radiologists and pathologists, A-PREDICT represents the largest UK translational therapeutic study of first line treatment using axitinib in metastatic RCC, presenting a unique opportunity to study mechanisms of sensitivity and resistance to axitinib. Importantly, axitinib met predefined activity thresholds. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e917 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Grant Stewart More articles by this author James Morden More articles by this author Ekaterini Boleti More articles by this author Naveen Vasudev More articles by this author Fiona Thistlethwaite More articles by this author Agnieszka Michael More articles by this author Lucy Kilburn More articles by this author Rebecca Lewis More articles by this author David Nicol More articles by this author Linda Pyle More articles by this author Claire Snowdon More articles by this author Rachel Todd More articles by this author Lucy Tregellas More articles by this author Samra Turajlic More articles by this author Charlie Swanton More articles by this author Judith Bliss More articles by this author James Larkin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...