Neoadjuvant immunotherapy appears to provide better survival outcomes than upfront radical cystectomy in patients with muscle-invasive bladder cancer (MIBC), according to real-world data.

Noting the positive results of clinical trials such as PURE-1, investigators studied data from 18,483 real-world patients who underwent radical cystectomy for localized MIBC (without variant histology) in the 2014-2019 National Cancer Data Base.

Using nearest-neighbor propensity-score caliper matching, the investigators defined 3 groups (280 patients in each) with similar baseline characteristics: a neoadjuvant immunotherapy group, a neoadjuvant chemotherapy group, and a no neoadjuvant treatment group.

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The pathologic downstaging rate to pT0N0 was significantly higher for the neoadjuvant immunotherapy and chemotherapy groups compared with the upfront surgery group: 22.5% and 26.4% vs 6.7%, respectively, Jackson Schmidt, MD, of Oregon Health & Science University in Portland, Oregon, and colleagues reported in European Urology Oncology. Neoadjuvant immunotherapy and chemotherapy were significantly associated with 4- and 5-fold increased odds of pathologic downstaging, respectively, compared with upfront surgery.

The overall survival rate also favored neoadjuvant therapy. All-cause mortality was a significant 32% and 38% lower with neoadjuvant immunotherapy and chemotherapy, respectively, compared with upfront surgery, the investigators reported. The investigators noted that patients with downstaging after neoadjuvant immunotherapy displayed an overall survival benefit compared with patients without downstaging.

“Neoadjuvant immunotherapy is a promising alternative to neoadjuvant chemotherapy for patients with clinically localized MIBC, as evidenced by similar pathologic downstaging and overall survival benefits in comparison to no neoadjuvant therapy,” Dr Schmidt’s team wrote. “Phase 3 trials should be conducted to test the noninferiority of neoadjuvant immunotherapy to neoadjuvant chemotherapy.”

As the study was observational, they could not rule out the possibility of confounding by indication.


Grassauer J, Schmidt J, Cowan A, Gilbert SM, Chakiryan NH. Downstaging and survival associated with neoadjuvant immunotherapy before radical cystectomy for muscle-invasive bladder cancer. Eur Urol Oncol. Published online July 14, 2023. doi:10.1016/j.euo.2023.06.005