Over 20-Year Outcomes of a Bladder-Preserving Multimodal Strategy Using Balloon-Occluded Intraarterial Infusion (AZUMA Regimen) in 1,701 Patients With High-Risk and Locally Advanced Bladder Cancer

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ABSTRACT Purpose: We evaluated long-term oncologic outcomes, including cancer-specific survival, of a bladder-preserving multimodal strategy (AZUMA regimen) combining balloon-occluded arterial infusion, radiotherapy, and hemodialysis in patients with high-risk and locally advanced bladder cancer. Materials and Methods: Between 1988 and 2025, 1701 patients with bacillus Calmette–Guérin-refractory carcinoma in situ, T1 disease, or muscle-invasive bladder cancer (T2–T4) without distant metastasis were treated with the AZUMA regimen. Treatment response, recurrence, overall survival (OS), cancer-specific survival (CSS), and progression-free survival (PFS) were analyzed. Prognostic factors were evaluated using logistic regression and Cox proportional hazards models. Results: Complete response was achieved in 1432 patients (84.2%). The median follow-up was 366 weeks. Among complete responders, 78.1% preserved a functional bladder without recurrence. The 5-, 10-, and 15-year OS rates were 80.5%, 73.9%, and 63.3%, and the corresponding 5-, 10-, and 15-year PFS rates were 70.8%, 65.5%, and 56.2%, respectively. After excluding non–cancer-related deaths, the 5-, 10-, 15-, and 20-year CSS rates were 84.4%, 81.9%, 80.3%, and 80.3%, respectively. Lymph node involvement, T4 disease, and nonurothelial carcinoma histology were independently associated with inferior outcomes. Among node-positive patients, 70.2% achieved complete response, and the 15-year CSS rate was 57.9%. Outcomes were particularly favorable in N1 disease, with a 15-year CSS of 72.9%. Grade IV toxicity was not observed. Conclusions: The AZUMA regimen was associated with durable cancer control and high rates of bladder preservation with acceptable toxicity, supporting its consideration as a bladder-preserving option in selected patients with advanced bladder cancer.

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