Overall, >900 patients have been treated at Osaka Medical College (Takatsuki, Osaka, Japan) using the novel approach of balloon-occluded arterial infusion (BOAI) to deliver an extremely high concentration of the anticancer agents cisplatin (CDDP)/gemcitabine to the pelvis (referred to as the OMC-regimen), together with pelvic irradiation. In a previous study, overall survival (OS) rate was significantly higher in this treatment group compared with that in a control group receiving total cystectomy (79.6 vs. 49.6%, respectively, at 10 years). It was speculated that intensive treatment of the pelvic area may aid in preventing metastasis, and thus the present study focused on the effect of this therapy in patients with lymph node metastasis (LN + ). A total of 102 patients with advanced LN + bladder cancer received tetramodal therapy (termed the Azuma regimen), comprising radical transurethral resection of the bladder tumor, systemic chemotherapy, BOAI and pelvic irradiation. Patients who failed to achieve a complete response (CR) underwent secondary BOAI with an increased amount of CDDP and/or gemcitabine with/without hemodialysis. A CR was achieved in 57.8% (59/102) of patients in total, and in 78.8% (41/52) of patients with N1 and Tis-3 disease. Among the complete responders, 81.4% (48/59) of patients retained their bladders with no evidence of recurrence or metastasis within a mean follow-up period of 121 weeks. Stages N2-3 and T4 were determined as significant risk factors for treatment failure in addition to survival. Notably, the 10-year overall survival rates in N1, Tis-3, and N1 and Tis-3 were 67.6% (vs. 33.6% in N2-3; P=0.0003), 61.5% (vs. 37.9% in T4; P=0.0485) and 75.1% (vs. 35.5% in N2-3 or T4; P=0.0002), respectively. No patients suffered from grade IV toxicities. In conclusion, the Azuma regimen may be a feasible option for patients with LN + disease. The use of intensive treatment in the pelvic area may serve an important role in outcome improvement, and the prevention of metastasis may be its mechanism.
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