INTRODUCTION AND OBJECTIVES. The role of maintenance regimen following early intravesical chemotherapy after TUR of intermediate risk non-muscle invasive bladder cancer (NMI-BC) is still debated. Only few studies have been published on this topic, rarely dealing with patients receiving an early treatment. The aim of the present study is to evaluate the efficacy of one-year maintenance after a 6-week cycle of early intravesical chemotherapy.METHODS. Between May 2002 and August 2003, 482 patients with intermediate risk NMI-BC after TUR and early intravesical chemotherapy (epirubicin, 80mg/50mL) were randomized between 6-week induction cycle and induction plus maintenance with 10 monthly instillations. A written informed consent was obtained. All patients underwent cytology and cystoscopy 3-monthly for 2 years and 6-monthly thereafter.RESULTS. Treatment interruption for toxicity was required in 39 patients. Median follow-up was 48 months. Ten patients (2.5%) progressed and 117 patients (29.6%) recurred. The tumor characteristics were equally distributed between the two arms. No statistically significant difference in recurrence free survival (RFS) was detected between the two arms (p=0.43). An advantage in terms of recurrence free rate (RFR) in favor of the maintenance arm was evident only until 18 months after TUR (p=0.03). A trend for a higher benefit from maintenance in primary and multiple tumors was detected.CONCLUSIONS. The risk of tumor recurrence is significantly reduced by one-year maintenance only for 18 months after TUR in comparison with patients receiving a 6-week cycle of early intravesical chemotherapy. The disadvantages of prolonged intravesical chemotherapy should be taken into account.

20632 Background: Docetaxel-based regimens represent the treatment of choice of HRPC. However, in some patients toxicity may be a concern and the quality of life may be compromised. The aim of this phase II randomized study is to investigate the efficacy and safety of low-dose chemotherapy regimen adopting a combination of EMP and VP16 in patients affected by HRPC. Methods: 54 HRPC patients were randomized between: arm A, daily oral standard dose EMP (10mg/kg) and arm B, low-dose EMP (3mg/kg) plus VP16 (25mg/mq) for 2 weeks followed by 2-weeks’rest. Systemic toxicity and hematologic exams were monitored every 2 weeks. Performance status, pain and analgesic use were evaluated according to WHO scales. Quality of Life (QoL) was evaluated through a self-administered visual analog scale (VAS). Results: Median age was 75 years (range 65–83).The most common adverse event was mild to moderate gastrointestinal toxicity. No grade 4 toxicity was registered. Treatment interruption due to grade 3 toxicity was necessary in 6 patients (30%) of arm A and 5 (18.5%) of arm B. A statistical significant difference in favor of the combination arm (B) emerged in terms of tolerability (p=0.02). Improvement in PS, pain and QoL was observed in 14 (70%) and 21 (77%) patients of arm A and B respectively. Ten patients (50%) of arm A and 13 of arm B progressed (48%). Median time to progression was 6 and 14 months (p= 0.02) in arm A and arm B, respectively. Thirty-one (66%) patients are alive with a median survival of 17 months. No difference emerged in overall survival between the 2 treatment arms. Conclusions: Patients affected by HRPC may benefit from oral low-dose combination of EMP and VP16 as palliative treatment. No significant financial relationships to disclose.

V Serretta, G Morgia, V Altieri, A Siragusa, M Motta, F Orestano, M Napoli, G De Grande, A Galuffo, D Melloni, C Pavone, M Pavone Macaluso, R Allegro, all members of G.S.T.U. University Of Palermo, Urology, Palermo, Italy, University Of Sassari, Urology, Sassari, Italy, University Of Napoli, Urology, Napoli, Italy, Civic Hospital, Urology, Caltagirone (CT), Italy, University Of Catania, Urology, Catania, Italy, Private Clinic, Urology, Palermo, Italy, Civic Hospital, Urology, Trapani, Italy, Civic Hospital, Urology, Siracusa, Italy, G S T U, Foundation, Sicilia, Calabria, Campania, Molise, Puglia, Basilicata, Italy

As a preliminary approach to define the object of larger case-control studies, the distribution of potential risk factors coming from environmental pollution among patients affected by superficial bladder cancer (TCCB) has been analyzed. Material e Methods. The analysis included only patients affected by medium risk superficial TCCB. Forty Italian urological centres joined the study. Detailed information about age, sex, residency, employment, active and passive cigarette smoking, water resource, hair-dye use were centralized. All patients underwent TUR and early intravesical chemotherapy. The distribution of the above mentioned environmental factors was related to tumor characteristics such as multiplicity and previous natural history. Results. Until today 474 patients have been recruited, 182 (38.4%) with primary tumors and 293 (61.8%) with multiple lesions. Over 80% of the patients lived in urban areas, 20% were employed in industry at risk for bladder cancer and 8% used hair dye. Forty percent of the patients were smokers, with a median smoking period of 30 years. Bottled water was the only water resource in 42% of cases. At multivariate statistical analysis a significant correlation between tumor multiplicity and employment in industry (p<0.01) and between past natural history and period of cigarette smoking (p<0.05) was found. Preliminar/y, an interesting trend was detected for a correlation between water resource and bladder cancer in non-smoking patients. The municipal water system was the main water resource more frequently in non-smokers (75% vs 53%). This might imply a pathogenic role of water pollution and chlorination.