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Clinical Trial
. 2022 Jun;40(6):272.e1-272.e9.
doi: 10.1016/j.urolonc.2021.12.015. Epub 2022 Jan 17.

Radical cystectomy versus trimodality therapy for muscle-invasive urothelial carcinoma of the bladder

Kenneth Softness  1 , Sumedh Kaul  2 , Aaron Fleishman  2 , Jason Efstathiou  3 , Joaquim Bellmunt  4 , Simon P Kim  5 , Ruslan Korets  1 , Peter Chang  1 , Andrew Wagner  1 , Aria F Olumi  1 , Boris Gershman  6
Affiliations
Clinical Trial

Radical cystectomy versus trimodality therapy for muscle-invasive urothelial carcinoma of the bladder

Kenneth Softness et al. Urol Oncol. 2022 Jun.

Abstract

Background: The comparative effectiveness of radical cystectomy (RC) and trimodality therapy (TMT) for muscle-invasive bladder cancer remains uncertain, as no randomized data exist. A phase 3 trial (SPARE) was attempted in the UK, however, was deemed infeasible and closed.

Objective: To emulate the SPARE trial using observational data.

Design, setting, and participants: We identified patients aged 40 to 79 with cT2-3cN0cM0 urothelial carcinoma of the bladder diagnosed from 2006 to 2015 who were treated with multiagent neoadjuvant chemotherapy + RC with lymphadenectomy (RC arm) or multiagent chemotherapy + 3D conformal radiotherapy to the bladder (TMT arm) in the National Cancer Database.

Outcome measurements and statistical analysis: The primary outcome was overall survival (OS). We fit a flexible logistic regression model for treatment to estimate the propensity score, and then used inverse probability of treatment weights to evaluate the associations of treatment group with OS.

Results and limitations: A total of 2,048 patients were included, of whom 1,812 underwent RC and 236 underwent TMT. Median follow-up was 29.0 months. After propensity score adjustment, compared to TMT, RC was not associated with a statistically significant difference in OS (HR 0.87; 95% CI 0.64-1.19; P = 0.40). When examining heterogeneity of treatment effects, RC appeared to be associated with improved OS only for patients with cT3 disease. Similar results were observed in sensitivity analyses. Our study is limited by the retrospective design and the lack of cancer-specific survival data.

Conclusions: In observational analyses designed to emulate the SPARE trial, there was no statistically significant difference in OS between RC and TMT. Heterogeneity of treatment effects suggested improved survival with RC only for cT3 disease.

Keywords: Bladder cancer; Clinical trial; Radiation therapy; Radical cystectomy; SPARE; Survival.

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Conflict of interest statement

Conflict of interest The authors have no conflicts of interest to disclose. The National Cancer Data Base (NCDB) is a joint project of the Commission on Cancer (CoC) of the American College of Surgeons and the American Cancer Society. The CoC's NCDB and the hospitals participating in the CoC NCDB are the source of the de-identified data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.

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