Amarnath Challapalli
A single arm phase II trial of neoadjuvant cabazitaxel and cisplatin chemotherapy for muscle invasive transitional cell carcinoma of the urinary bladder
Challapalli, Amarnath; Masson, Susan; White, Paul; Dailami, Narges; Pearson, Sylvia; Rowe, Edward; Koupparis, Anthony; Oxley, Jon; Abdelaziz, Ahmed; Ash-Miles, Janice; Bravo, Alicia; Foulstone, Emily; Perks, Claire; Holly, Jeff; Persad, Raj; Bahl, Amit
Authors
Susan Masson
Paul White Paul.White@uwe.ac.uk
Professor in Applied Statistics
Narges Dailami Narges.Dailami@uwe.ac.uk
Senior Lecturer
Sylvia Pearson
Edward Rowe
Anthony Koupparis
Jon Oxley
Ahmed Abdelaziz
Janice Ash-Miles
Alicia Bravo
Emily Foulstone
Claire Perks
Jeff Holly
Raj Persad
Amit Bahl
Abstract
Introduction: Neoadjuvant cisplatin-based combination chemotherapy improves survival in muscle-invasive bladder cancer. However, response rates and survival remain suboptimal. We evaluated the efficacy, safety, and tolerability of cisplatin plus cabazitaxel. Methods: A phase II single-arm trial was designed to recruit at least 26 evaluable patients. This would give 80% power to detect the primary endpoint, an objective response rate defined as a pathologic complete response plus partial response (pathologic downstaging), measured by pathologic staging at cystectomy (p0 = 0.35 and p1 = 0.60, α = 0.05). Results: Objective response was seen in 15 of 26 evaluable patients (57.7%) and more than one- third of patients achieved a pathologic complete response (9/26; 34.6%). Seventy-eight percent of the patients (21/27) completed all cycles of treatment, with only 6.7% of the reported adverse events being graded 3 or 4. There were 6 treatment-related serious adverse event reported, but no suspected unexpected serious adverse reactions. In the patients who achieved an objective response, the median progression-free survival and overall survival were not reached (median follow-up of 41.5 months). In contrast, the median progression-free survival (7.2 months) and overall survival (16.9 months) were significantly worse (P = .001, log-rank) in patients who did not achieve an objective response. Conclusion: Cabazitaxel plus cisplatin for neoadjuvant treatment of muscle-invasive bladder cancer can be considered a well-tolerated and effective regimen before definitive therapy with higher rates (57.7%) of objective response, comparing favorably to that with of cisplatin/gemcitabine (23%–26%). These results warrant further evaluation in a phase III study.
Journal Article Type | Article |
---|---|
Acceptance Date | Feb 13, 2021 |
Online Publication Date | Feb 17, 2021 |
Publication Date | Aug 1, 2021 |
Deposit Date | Feb 14, 2021 |
Publicly Available Date | Feb 18, 2022 |
Journal | Clinical Genitourinary Cancer |
Print ISSN | 1558-7673 |
Electronic ISSN | 1938-0682 |
Publisher | Elsevier |
Peer Reviewed | Peer Reviewed |
Volume | 19 |
Issue | 4 |
Pages | P325-332 |
DOI | https://doi.org/10.1016/j.clgc.2021.02.001 |
Keywords | Neoadjuvant chemotherapy; Pathologic complete response; Bladder cancer; Radical cystectomy; Adverse events |
Public URL | https://uwe-repository.worktribe.com/output/7094593 |
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A single arm phase II trial of neoadjuvant cabazitaxel and cisplatin chemotherapy for muscle invasive transitional cell carcinoma of the urinary bladder.
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This is the author's accepted manuscript. The final published version is available here: https://doi.org/10.1016/j.clgc.2021.02.001
https://doi.org/10.1016/j.clgc.2021.02.001
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Licence
http://creativecommons.org/licenses/by-nc-nd/4.0/
Publisher Licence URL
http://www.rioxx.net/licenses/all-rights-reserved
Copyright Statement
This is the author's accepted manuscript. The final published version is available here: https://doi.org/10.1016/j.clgc.2021.02.001
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