Related Experiment Video
Updated: Jul 18, 2026
Culture of Bladder Cancer Organoids as Precision Medicine Tools
Published on: December 28, 2021
Postoperative Management After Pathological Complete Response to Neoadjuvant Therapy for Muscle-Invasive Bladder
Shugo Yajima1, Soichiro Yoshida2, Naoki Imasato3
1Department of Urology, National Cancer Center Hospital East, Chiba, Japan; Department of Urology, Institute of Science Tokyo, Tokyo, Japan.
Introduction:
The optimal postoperative management strategy for patients with muscle-invasive bladder cancer (MIBC) who achieve pathological complete response (pCR) after neoadjuvant therapy remains undefined. We aimed to compare disease-free survival (DFS) outcomes among 3 strategies: observation alone, adjuvant immune checkpoint inhibitor (ICI) continuation, and adjuvant enfortumab vedotin plus pembrolizumab (EV+P) continuation.
Patients And Methods:
We conducted a comprehensive literature search of PubMed, Cochrane Library, Web of Science, Google Scholar, and ClinicalTrials.gov to identify prospective phase II or higher trials evaluating ICI-based or EV-containing neoadjuvant therapy for MIBC. Individual patient data were reconstructed from published Kaplan-Meier curves stratified by pCR status using the Guyot algorithm. DFS was compared using Kaplan-Meier analysis, Cox proportional hazards models, and restricted mean survival time (RMST) analysis.
Results:
Five trials reported survival data for pCR subgroups, yielding 534 patients: 226 observation, 211 ICI continuation, and 97 EV+P continuation. An estimated 74 DFS events were reconstructed (37 observation, 22 ICI, 15 EV+P). No significant differences in DFS were observed among groups (log-rank P = .12). Two-year DFS rates were 86.6%, 90.8%, and 86.6% for observation, ICI continuation, and EV+P continuation, respectively. Hazard ratios (HRs) for ICI continuation vs. observation (HR 0.64; 95% confidence intervals [CI], 0.38-1.08; P = .097) and EV+P vs. observation (HR 1.24; 95% CI, 0.67-2.27; P = .49) were not statistically significant. RMST analysis confirmed no significant differences at 12, 24, 36, and 48 months across all pairwise comparisons.
Conclusion:
This exploratory analysis found no evidence that adjuvant therapy provides an additional survival benefit in MIBC patients achieving pCR; however, the limited number of events constrains power, and this absence of evidence should not be interpreted as evidence of no benefit. Given substantial heterogeneity in baseline patient characteristics and cisplatin eligibility across included trials, these findings require prospective validation before informing clinical practice.
