Randomized phase II study investigating pazopanib versus weekly paclitaxel in relapsed or progressive urothelial cancer

Jones, R. J. et al. (2017) Randomized phase II study investigating pazopanib versus weekly paclitaxel in relapsed or progressive urothelial cancer. Journal of Clinical Oncology, 35(16), pp. 1770-1777. (doi:10.1200/JCO.2016.70.7828) (PMID:28402747)

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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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Paul, Mr James and Alexander, Mrs Laura and Jones, Professor Robert and Kelly, Mrs Caroline and Stobo, Mr Jon and Dixon, Miss Judith and Morris, Miss Anna
Authors: Jones, R. J., Hussain, S. A., Protheroe, A. S., Birtle, A., Chakraborti, P., Huddart, R. A., Jagdev, S., Bahl, A., Stockdale, A., Sundar, S., Crabb, S. J., Dixon-Hughes, J., Alexander, L., Morris, A., Kelly, C., Stobo, J., Paul, J., and Powles, T.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Journal of Clinical Oncology
Publisher:American Society of Clinical Oncology
ISSN:0732-183X
ISSN (Online):1527-7755
Published Online:12 April 2017
Copyright Holders:Copyright © 2017 American Society of Clinical Oncology
First Published:First published in Journal of Clinical Oncology 35(16): 1770-1777
Publisher Policy:Reproduced in accordance with the publisher copyright policy

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