Table 1_Neoadjuvant disitamab vedotin (RC-48) plus a PD-1 inhibitor in muscle-invasive bladder cancer: a multicenter real-world study with stratification by HER2 expression and tertiary lymphoid structures.docx

After a median follow-up of 18.0 months (range, 9–29 months), the 12-month DFS rate was 89.4% (95% CI: 74.2%–95.9%), and the 12-month OS rate was 100% (95% CI: 100%–100%). HER2 overexpression was significantly associated with a higher objective response rate (ORR) (OR = 22.50, 95% CI: 1.51 - 335.33, p = 0.024). In stratified analyses based on TLS, both TLS-2 (primary lymphoid follicles) and TLS-3 (secondary lymphoid follicles with germinal centers) demonstrated significant associations with higher ORR, with ORs of 20.00 (95% CI: 2.75 - 145.48, p = 0.003) and 36.00 (95% CI: 2.72 - 476.21, p = 0.007), respectively, suggesting that greater TLS with enhanced therapeutic benefit.

Furthermore, N1 stage (OR = 0.06, 95% CI: 0.01 - 0.59, p = 0.016), N2 stage (OR = 0.04, 95% CI: 0.00 - 0.62, p = 0.021), and T3 stage (OR = 0.08, 95% CI: 0.01 - 0.46, p = 0.004) were each significantly associated with poorer treatment response. Treatment-related adverse events (TRAEs) were generally manageable.</p>Conclusions<p>The combination of RC-48 and a PD-1 inhibitor exhibits promising efficacy as a neoadjuvant therapy for MIBC.

Both HER2 expression and TLS maturity serve as effective stratification indicators for treatment response and prognosis. These findings support further evaluation of this combined regimen in biomarker-driven prospective trials.</p>