Plenary: Next Frontier, Monday

Plenary: Next Frontier

PNFLBA-16: Late-Breaking Abstract - First results of A-PREDICT: A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer (RCC) Unsuitable for Nephrectomy

Monday, May 15
11:10 AM - 11:15 AM
Location: BCEC: Ballroom East

Presentation Authors: Grant Stewart*, Cambridge, United Kingdom, James Morden, Ekaterini Boleti, London, United Kingdom, Naveen Vasudev, Leeds, United Kingdom, Fiona Thistlethwaite, Manchester, United Kingdom, Agnieszka Michael, Guildford, United Kingdom, Lucy Kilburn, Rebecca Lewis, David Nicol, Linda Pyle, Claire Snowdon, Rachel Todd, Lucy Tregellas, Samra Turajlic, Charlie Swanton, Judith Bliss, James Larkin, London, United Kingdom

Introduction: 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.

Source Of Funding: Pfizer

Grant D. Stewart, MD, PhD, FRCSEd (Urol)

University of Cambridge

Mr Grant D Stewart BSc (Hons), FRCSEd (Urol), MBChB, PhD

Mr Grant D Stewart is University Lecturer in Urological Surgery at the University of Cambridge and Honorary Consultant Urological Surgeon at Addenbrooke’s Hospital, Cambridge. Mr Stewart trained in Edinburgh and Australia during which time he undertook a PhD at the University of Edinburgh in the field of the role of hypoxia in prostate cancer.

Grant is a urological surgeon with clinical expertise in kidney cancer surgery and undertakes translational research into renal cell cancer. Grant co-directs the Scottish Collaboration On Translational Research into Renal Cell Cancer (SCOTRRCC) a Scotland-wide kidney cancer bio-repository with high quality clinical data linkage. Mr Stewart is the Chair of the Surgical Subgroup of the National Cancer Research Institute Renal Cancer Clinical Studies Group, Co-Chair of the Renal Cross Channel Group, CI/PI for a number of renal cancer clinical trials and supervises several PhD students.

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PNFLBA-16: Late-Breaking Abstract - First results of A-PREDICT: A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer (RCC) Unsuitable for Nephrectomy



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