Combined treatment with local thermo-chemotherapy for non muscle invasive bladder cancer. The present role in the light of acquired data and preliminary cumulative clinical experiences.

OBJECTIVES During the last 15 years the endovesical administration of microwave-induced hyperthermia and chemotherapy as a combined regimen has been widely tested in many clinical trials for the treatment of patients suffering from non muscle invasive bladder cancer. In this manuscript clinical results were assessed drawn from clinical prospective randomized or single arm studies already published. In addition we collected and critically examined the most recent multicentric cumulative experiences still waiting for publication in the effort to update and define the clinical role of this procedure in both neo- and adjuvant settings. METHODS The rationale and some basic physical and biologic aspects concerning the clinical application of the combined treatment using local hyperthermia and chemotherapy are reported. Recent "in vitro" studies which support this rationale and open novel strategies are also included. When used as ablative procedure (mono-therapy or complementary treatment to transurethral resection) the thermo-chemotherapy regimen has proved to be an effective treatment showing about 80% tumor complete response in many clinical studies. Prospective, randomized as well as single arm studies also showed that thermo-chemotherapy procedure is consistently more effective than chemotherapy alone when treating both intermediate and high risk non muscle invasive bladder cancer. Of particular interest, recent multicentric experiences showed that thermo-chemotherapy treatment is also effective in patients highly recurrent and failure after BCG. In addition, patients with carcinoma in situ were tested with encouraging preliminary results. CONCLUSION Many clinical trials confirmed that endovesical thermo-chemotherapy is a safe and effective treatment when used for both ablative and prophylaxis approaches to non muscle invasive bladder cancer. To date, patients suffering from multifocal and highly recurrent disease after chemotherapy and/or BCG seem to represent the most adequate indication. Further multicentric studies are certainly needed in order to define clinical outcomes and to assess the cost/effectiveness analysis at long term follow-up.