Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and mortality. While neoadjuvant chemotherapy (NAC) has been shown to improve survival outcomes, the rate of complete pathological response remains limited. Recently, the addition of immune checkpoint inhibitors (ICIs) to NAC—forming neoadjuvant chemoimmunotherapy—has emerged as a promising strategy. However, real-world data on pathological response and clinical outcomes are still limited. Therefore, we aimed to evaluate the pathological and clinical responses of MIBC patients treated with neoadjuvant chemoimmunotherapy prior to radical cystectomy.

We conducted a retrospective study of 9 patients with localized MIBC who received platinum-based chemotherapy in combination with immunotherapy followed by radical cystectomy between March 2013 and March 2023. Data on chemoimmunotherapy regimens and histological features were collected. The primary endpoints were pathologic complete response (pCR), defined as ypT0N0, and pathologic downstaging, defined as < ypT2N0. Secondary endpoints included disease-free survival (DFS) and safety.

Among the 9 patients, 5 (55.6%) were male and 4 (44.4%) were female, with a mean age of 64.3 years (range 35–86). Histologically, 5 patients (55.6%) had papillary urothelial carcinoma, while 4 (44.4%) had non-papillary urothelial carcinoma. Regarding treatment regimens, 5 patients (55.6%) received Nivolumab, 3 (33.3%) received Pembrolizumab, and 1 (11.1%) received Durvalumab, all in combination with gemcitabine plus cisplatin-based chemotherapy. Pathologic complete response was achieved in 5 patients (55.6%), and pathologic downstaging in 7 patients (77.8%). The most common adverse events (any grade) were thrombocytopenia, anemia, and neutropenia. Median DFS was not reached at the time of analysis.

Neoadjuvant chemoimmunotherapy demonstrated a promising pathological response in patients with MIBC. Although the sample size was limited, our real-world data support further investigation of this approach in larger prospective trials to validate long-term survival benefits and safety outcomes.