5-Aminolevulinic acid in intraoperative photodynamic therapy of bladder cancer (results of multicenter trial).

The results of multicenter prospective trial for efficacy of combined modality treatment: transurethral resection (TUR)+photodynamic therapy (PDT) with alasens for bladder cancer are represented in the article. Trials were organized by Research Institute of Organic Intermediates and Dyes and conducted according to clinical protocol approved by Ministry of Health of Russia, at the sites of leading Russian cancer clinical centers. The trial included 45 subjects with verified diagnosis of non-muscle-invasive bladder cancer. Patients underwent TUR of bladder with simultaneous PDT as anti-relapse treatment. Alasens was administered to patients as intravesicular instillation of 3% solution in volume of 50ml with 1.5-2h exposure (prior to TUR). TUR was performed after instillation. PDT session was conducted immediately after the completion of TUR on a single occasion by means of combined local irradiation on tumor bed with diffuse irradiation on whole urinary bladder mucosa (light dose of local irradiation - 100J/cm2, diffuse irradiation - 20J/cm2). Good tolerance of the treatment was noticed, there were no complications. Among 45 patients included in the trial, 35 (78%) completed 12 month protocol follow-up without relapse. In our study PDT with alasens after TUR reported a recurrence rate of non-muscle-invasive bladder cancer for 1st year after treatment of 22%. TUR with intraoperative PDT with 5-aminolevulinic acid may offer an alternative in the treatment of non-muscle-invasive intermediate and high-risk bladder cancer.