Randomized Phase II Study Investigating Pazopanib Versus Weekly Paclitaxel in Relapsed or Progressive Urothelial Cancer.
View/ Open
Date
2017-06-01ICR Author
Author
Jones, RJ
Hussain, SA
Protheroe, AS
Birtle, A
Chakraborti, P
Huddart, RA
Jagdev, S
Bahl, A
Stockdale, A
Sundar, S
Crabb, SJ
Dixon-Hughes, J
Alexander, L
Morris, A
Kelly, C
Stobo, J
Paul, J
Powles, T
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
Humans
Urologic Neoplasms
Sulfonamides
Paclitaxel
Pyrimidines
Antineoplastic Agents, Phytogenic
Administration, Oral
Drug Administration Schedule
Survival Rate
Aged
Middle Aged
Female
Male
Kaplan-Meier Estimate
Research team
Clinical Academic Radiotherapy (Huddart)
Language
eng
Date accepted
2017-04-12
License start date
2017-06
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017, 35 (16), pp. 1770 - 1777
Publisher
AMER SOC CLINICAL ONCOLOGY