Abstract 2011P
Background
Neoadjuvant immunotherapy-driven bladder preservation (Neoimmu-CMT), despite its prominence, is constrained in application due to the absence of robust clinical evidence. Currently, there is a lack of comparative studies on the efficacy of Neoimmu-CMT versus the traditional trimodal therapy (TMT) or neoadjuvant chemotherapy- driven bladder preservation (NAC-CMT). To address this gap, our study (ChiCTR2300069303) aims to assess Neoimmu-CMT's viability and identify suitable candidates through a multicenter, propensity score-matched analysis.
Methods
The study included 163 patients from 14 hospitals, categorized into Neoimmu-CMT (n=97), TMT (n=30), and NAC-CMT (n=36) subgroups. PSM was utilized to mitigate baseline variability. Primary outcomes were disease-free survival (DFS), bladder-intact DFS (BI-DFS), and overall survival (OS). Univariate and multivariate Cox analyses were used to identify potential prognostic factors. Biomarker assessment comprised immunohistochemistry and single-cell RNA sequencing.
Results
Post-PSM, Neoimmu-CMT significantly outperformed NAC-CMT in DFS (HR: 2.112, 95% CI: 1.247-3.576, P=0.005) and BI-DFS (HR: 2.329, 95% CI: 1.138-4.770, P=0.021), with a 2-year BI-DFS rate of 90.28% compared to NAC-CMT's 71.59%. However, Neoimmu-CMT and TMT showed no significant difference in DFS and BI-DFS, with Neoimmu-CMT marginally surpassing TMT in 2-year BI-DFS rates (86.42% vs. 80.89%). Clinical complete response to neoadjuvant treatment and lower clinical T stage were positive prognostic factors for Neoimmu-CMT. Biomarker analysis showed the tumor microenvironment immune phenotype closely relates to bladder preservation outcomes. The limitations included inherent bias from its retrospective design, the brief follow-up duration and the sample size limited.
Conclusions
Neoimmu-CMT is a promising bladder preservation strategy, comparable to TMT and superior to NAC-CMT. Its advancement could significantly broaden bladder preservation treatment options.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Xiangya Hospital, Central South University.
Funding
The National Natural Science Foundation of China, the China Postdoctoral Innovation Talents Support Program, the China Postdoctoral Science Foundation, Hunan Natural Science Foundation, Hunan Province Young Talents Program, Changsha Natural Science Foundation, the Youth Science Foundation of Xiangya Hospital.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1987P - TROP-2 as a promising ADC target in penile squamous cell carcinoma that promotes cell proliferation by activating AKT through PKCα pathway
Presenter: Yi Tang
Session: Poster session 13
1988P - Enfortumab vedotin (EV) + pembrolizumab (P) outcomes outside clinical trials and biomarkers of benefit in patients (pts) with advanced urothelial carcinoma: Analysis of the UNITE study
Presenter: Tanya Jindal
Session: Poster session 13
1989P - Efficacy of enfortumab vedotin (EV) in patients (pts) with (w) advanced urothelial carcinoma (aUC) who have baseline neuropathy (N) and/or diabetes mellitus (DM): A UNITE study analysis
Presenter: Albert Jang
Session: Poster session 13
1990P - MRG002-HER2 ADC combined with pucotenlimab (a PD-1 inhibitor), in patients with locally advanced or metastatic urothelial carcinoma (UC): Preliminary results of a phase I/II study
Presenter: Chuanliang Cui
Session: Poster session 13
1992P - Real-world (RW) characteristics and outcomes in patients (pts) with muscle-invasive urothelial carcinoma (MIUC) treated with adjuvant nivolumab (NIVO) with or without neoadjuvant chemotherapy (NAC)
Presenter: Hedyeh Ebrahimi
Session: Poster session 13
1993P - A randomized, phase II trial to evaluate the safety and efficacy of eribulin mesylate in combination with atezolizumab compared to atezolizumab alone in subjects with locally advanced or metastatic transitional cell urothelial cancer where cisplatin-based treatment is not an option
Presenter: Anishka D'Souza
Session: Poster session 13
1994P - Updated efficacy profile of the double antibody drug conjugate (DAD) phase I trial: Sacituzumab govitecan (SG) plus enfortumab vedotin (EV) in ≥ second line in metastatic urothelial carcinoma (mUC)
Presenter: Bradley McGregor
Session: Poster session 13
1995P - Insights into second-line (2L) systemic treatment (tx) receipt in patients (pts) with metastatic urothelial carcinoma (mUC): Results of a retrospective observational study in Germany
Presenter: Günter Niegisch
Session: Poster session 13
1996P - Primary analysis of post-marketing surveillance (PMS) data for avelumab maintenance therapy in patients (pts) with curatively unresectable urothelial carcinoma (UC) in Japan
Presenter: Eiji Kikuchi
Session: Poster session 13