Skip to main content

Research Repository

Advanced Search

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

A single arm phase II trial of neoadjuvant cabazitaxel and cisplatin chemotherapy for muscle invasive transitional cell carcinoma of the urinary bladder Thumbnail


Authors

Amarnath Challapalli

Susan Masson

Paul White Paul.White@uwe.ac.uk
Professor in Applied Statistics

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

Files








You might also like



Downloadable Citations