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Randomized Phase II Study Investigating Pazopanib Versus Weekly Paclitaxel in Relapsed or Progressive Urothelial
Robert J Jones1, Syed A Hussain1, Andrew S Protheroe1
1Robert J. Jones, Judith Dixon-Hughes, Laura Alexander, Anna Morris, Caroline Kelly, Jon Stobo, and James Paul, University of Glasgow, Glasgow; Syed A. Hussain, University of Liverpool, Liverpool; Andrew S. Protheroe, Churchill Hospital, Oxford; Alison Birtle, Royal Preston Hospital, Preston; Prabir Chakraborti, Royal Derby Hospital, Derby; Robert A. Huddart, Institute of Cancer Research, Sutton; Satinder Jagdev, St James's University Hospital, Leeds; Amit Bahl, Bristol Haematology and Oncology Centre, Bristol; Andrew Stockdale, University Hospital, Coventry; Santhanam Sundar, Nottingham University Hospitals National Health Service Trust, Nottingham; Simon J. Crabb, University of Southampton, Southampton; and Thomas Powles, Queen Mary University of London, London, United Kingdom.
Abstract:
Purpose Two previous single-arm trials have drawn conflicting conclusions regarding the activity of pazopanib in urothelial cancers after failure of platinum-based chemotherapy. Patients and Methods This randomized (1:1) open-label phase II trial compared the efficacy of pazopanib 800 mg orally with paclitaxel (80 mg/m2 days 1, 8, and 15 every 28 days) in the second-line setting. The primary end point was overall survival (OS). Results Between August 2012 and October 2014, 131 patients, out of 140 planned, were randomly assigned. The study was terminated early on the recommendation of the independent data monitoring committee because of futility. Final analysis after the preplanned number of deaths (n = 110) occurred after a median follow-up of 18 months. One hundred fifteen deaths had occurred at the final data extract presented here. Median OS was 8.0 months for paclitaxel (80% CI, 6.9 to 9.7 months) and 4.7 months for pazopanib (80% CI, 4.2 to 6.4 months). The hazard ratio (HR) adjusted for baseline stratification factors was 1.28 (80% CI, 0.99 to 1.67; one-sided P = .89). Median progression-free survival was 4.1 months for paclitaxel (80% CI, 3.0 to 5.6 months) and 3.1 months for pazopanib (80% CI, 2.7 to 4.6 months; HR, 1.09; 80% CI, 0.85 to 1.40; one-sided P = .67). Discontinuations for toxicity occurred in 7.8% and 23.1% for paclitaxel and pazopanib, respectively. Conclusion Pazopanib did not have greater efficacy than paclitaxel in the second-line treatment of urothelial cancers. There was a trend toward superior OS for paclitaxel.