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Published on: October 30, 2013
Perioperative Immunotherapy in Muscle-Invasive Bladder Cancer: A Systematic Review and Meta-Analysis of Neoadjuvant
C V Suartz1, I M T Huber2, P H de S Brito3
1Department of Urology, Thunder Bay Regional Health Sciences Centre and Northern Ontario School of Medicine University, Thunder Bay, ON, Canada.
Aims:
To evaluate the efficacy and safety of the perioperative immunotherapy-based regimens.
Materials And Methods:
A systematic search of PubMed/MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials was performed from January 2000 to October 2025, with an updated search through June 2026. Eligible studies included randomized trials and prospective clinical studies evaluating neoadjuvant, adjuvant, or combined perioperative immunotherapy-based strategies in patients with MIBC. Outcomes included pathological complete response, overall survival, recurrence-free survival, disease-free survival, and grade 3-4 immune-related adverse events. Random-effects models and sensitivity analyses were used to synthesize outcomes and explore heterogeneity.
Results:
Forty-two studies comprising 6006 patients were included: 32 evaluated neoadjuvant strategies, 4 evaluated adjuvant therapy, and 6 assessed combined neoadjuvant and adjuvant approaches. Neoadjuvant immunotherapy-based regimens achieved a pooled pathological complete response rate of 38.92% (95% CI, 35.00-42.98%). In the neoadjuvant setting, pooled overall survival was 82.33% (95% CI, 78.23-85.80), and pooled recurrence-free survival was 77.78% (95% CI, 74.92-80.39). Grade 3-4 immune-related adverse events were infrequent with neoadjuvant therapy, with a pooled incidence of 8.69% (95% CI, 4.56-15.92). In the adjuvant setting, pooled 3-year overall survival was 63% (95% CI, 58-67), median disease-free survival was 25.22 months (95% CI, 21.02-30.26), and grade 3-4 immune-related adverse events occurred in 11% of patients (95% CI, 5-18). Heterogeneity was mainly driven by differences in trial design, treatment duration, patient selection, endpoint definitions, and use of combination regimens.
Conclusions:
Perioperative immunotherapy has shown meaningful antitumor activity and an acceptable safety profile in MIBC, with particularly encouraging pathological and survival signals in the neoadjuvant setting. Nevertheless, the optimal timing, sequencing, patient selection, biomarker strategy, role in bladder preservation, and long-term survival impact of these approaches remain to be defined.
