Randomized phase II study investigating Pazopanib versus weekly Paclitaxel in relapsed or progressive urothelial cancer
Randomized phase II study investigating Pazopanib versus weekly Paclitaxel in relapsed or progressive urothelial cancer
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/m(2) 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.
Journal Article
1770-1777
Jones, Robert J.
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Hussain, Syed A.
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Protheroe, Andrew S.
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Birtle, Alison
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Chakraborti, Prabir
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Huddart, Robert A.
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Jagdev, Satinder
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Bahl, Amit
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Stockdale, Andrew
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Sundar, Santhanam
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Crabb, Simon J.
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Dixon-Hughes, Judith
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Alexander, Laura
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Morris, Anna
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Kelly, Caroline
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Stobo, Jon
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Paul, James
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Powles, Thomas
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Jones, Robert J.
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Hussain, Syed A.
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Protheroe, Andrew S.
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Birtle, Alison
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Chakraborti, Prabir
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Huddart, Robert A.
4491c174-99e7-4cfe-a5c2-845be33405dc
Jagdev, Satinder
a5fcb618-852f-4a09-96b0-c7afb5582163
Bahl, Amit
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Stockdale, Andrew
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Sundar, Santhanam
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Crabb, Simon J.
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Dixon-Hughes, Judith
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Alexander, Laura
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Morris, Anna
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Kelly, Caroline
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Stobo, Jon
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Paul, James
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Powles, Thomas
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Jones, Robert J., Hussain, Syed A., Protheroe, Andrew S., Birtle, Alison, Chakraborti, Prabir, Huddart, Robert A., Jagdev, Satinder, Bahl, Amit, Stockdale, Andrew, Sundar, Santhanam, Crabb, Simon J., Dixon-Hughes, Judith, Alexander, Laura, Morris, Anna, Kelly, Caroline, Stobo, Jon, Paul, James and Powles, Thomas
(2017)
Randomized phase II study investigating Pazopanib versus weekly Paclitaxel in relapsed or progressive urothelial cancer.
Journal of Clinical Oncology, 35 (16), .
(doi:10.1200/JCO.2016.70.7828).
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/m(2) 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.
Text
jco.2016.70.7828
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Accepted/In Press date: 16 February 2017
e-pub ahead of print date: 12 April 2017
Keywords:
Journal Article
Organisations:
Cancer Sciences
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Local EPrints ID: 410706
URI: http://eprints.soton.ac.uk/id/eprint/410706
ISSN: 1527-7755
PURE UUID: 8903eb5a-cc68-4dbd-a8f5-8c82a384e3da
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Date deposited: 09 Jun 2017 09:23
Last modified: 16 Mar 2024 05:17
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Contributors
Author:
Robert J. Jones
Author:
Syed A. Hussain
Author:
Andrew S. Protheroe
Author:
Alison Birtle
Author:
Prabir Chakraborti
Author:
Robert A. Huddart
Author:
Satinder Jagdev
Author:
Amit Bahl
Author:
Andrew Stockdale
Author:
Santhanam Sundar
Author:
Judith Dixon-Hughes
Author:
Laura Alexander
Author:
Anna Morris
Author:
Caroline Kelly
Author:
Jon Stobo
Author:
James Paul
Author:
Thomas Powles
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