Real-world comparison of neoadjuvant chemoimmunotherapy with chemotherapy in muscle-invasive bladder cancer.

e16549 Background: Muscle-invasive bladder cancer (MIBC) continues to pose a significant health challenge, as conventional neoadjuvant chemotherapy (NAC) has shown limited improvements in efficacy outcomes. Recent clinical trials suggest that combining NAC with immune checkpoint blockade (NAC.NICB) may enhance therapeutic efficacy. This study aims to explore the short-term therapeutic efficacy and outcomes of NAC.NICB compared to NAC in real-world settings for the treatment of MIBC. Methods: A total of 100 patients with MIBC who received either NAC or NAC.NICB were included in the study. The treatment efficacy of the NAC and NAC.NICB groups was evaluated based on pathological complete response (pCR) and the rate of pathological downstaging through post treatment pathological assessment. In the NAC.NICB group, clinical characteristics were compared between patients who achieved pCR and those who did not, using the independent samples t -test or the Mann-Whitney U test. Results: Overall, 71 patients received NAC and 29 patients received NAC.NICB. At baseline, the NAC.NICB group exhibited higher T and N stages compared to the NAC group. However, 48.3% (14/29) of the patients in the NAC.NICB group achieved pCR, which was significantly higher than that observed in the NAC group (18/71, 24.7%; p = 0.034). In addition, the pathological downstaging rate in the NAC.NICB group was higher than that of the NAC group (75.9% vs. 47.9%; p = 0.014). The disease control rate (DCR) in the NAC.NICB group was higher than that observed in the NAC group (96.6% vs. 77.5%; p = 0.020). Higher pretreatment hemoglobin levels ( p = 0.018) or lower platelet levels ( p = 0.026) in patients undergoing NAC.NICB therapy may serve as a potential predictor for achieving a higher pCR rate. Conclusions: Neoadjuvant chemotherapy combined with immune checkpoint blockade improves pCR and pathological downstaging rates in MIBC, highlighting the benefits of neoadjuvant chemoimmunotherapy for MIBC. NAC (N=71) NAC.NICB (N=29) P value Treatment cycles 0.415 2 12(16.9%) 4(13.8%) 3 15(21.1%) 3(10.3%) 4 44(62.0%) 22(75.9%) Pathological response 0.030* Complete response 18(25.4%) 14(48.3%) Partial response 16(22.5%) 8(27.6%) Stable disease 21(29.6%) 6(20.7%) Progression disease 16(22.5%) 1(3.4%) pCR 0.034* Yes 18(25.4%) 14(48.3%) No 53(74.6%) 15(51.7%) Pathological downstage 0.014* Yes (CR+PR) 34(47.9%) 22(75.9%) No (SD+PD) 37(52.1%) 7(24.1%) DCR 55(77.5%) 28(96.6%) 0.020* pCR: Pathological complete response; DCR: disease control rate; NAC.NICB: neoadjuvant chemotherapy combined with immune checkpoint blockade; NAC: neoadjuvant chemotherapy. *P < 0.05 was recognized as statistically different.