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 published in European Urology Oncology.

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

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 group that did not receive neoadjuvant treatment.

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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. 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 noted that patients with downstaging after neoadjuvant immunotherapy displayed an overall survival benefit compared to 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,” the investigators wrote. “Phase 3 trials should be conducted to test the noninferiority of neoadjuvant immunotherapy to neoadjuvant chemotherapy.”

The investigators noted that, as this 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

This article originally appeared on Renal and Urology News