Eur Urol Suppl 2011;10(2):148 Afterwards they were randomized in a trial comparing three schedules of adjuvant intravesical epirubicin. Standard follow-up was 5 years. Smoking behaviour was investigated with questionnaires. results: 587 of the 730 patients were men and 143 were women. After a follow- up (FU) of 5 years 60.2% of the women and 46.6% of the men were recurrence- free (log rank test, p=0.011). Signiicantly more men (used to) smoke cigarettes (86.7%), compared to 60.1% of the women (chi-square test, p<0.001). 46.6% of current and ex-smokers were recurrence-free after 5 years, compared to 61.7% of the non-smokers (log rank test, p=0.007; Figure 1). In a multivariate analysis with gender and smoking behaviour in the regression model, smoking behaviour remained a statistically signiicant risk factor for recurrence (p=0.031), but gender was not statistically signiicant anymore (p=0.094). The number of cigarettes, or pipe/cigar smoking did not inluence the recurrence-free survival. After FU 93.6% of the women and 94.7% of the men were progression-free (log rank test, p=0.237). Smoking behaviour did not inluence the 5-years progression-free survival (log rank test, p=0.092). Conclusions: This is one of the largest studies in NMIBC that investigated the inluence of smoking behaviour on the development of a recurrence and progression. In our study, a signiicant lower number of patients who never smoked developed a recurrence, compared to current smokers or ex-smokers. 429 neoadjuvant intensive intravesiCal MitoMyCin C regiMen versus standard sChedule for non MusCle invasive bladder CanCer. randoMized Phase ii study Rocchini L., Pellucchi F., Ibrahim B., Maccagnano C., Freschi M., Zanni G., Villa L., Gandaglia G., Capogrosso P., Passoni N.M., Fossati N., Colombo R. Urological Research Institute, Vita-Salute San Raffaele University, Dept. of Urology, Milan, Italy introduction & objectives: It has been suggested that improved oncologic outcome can be expected when using a more intensive schedule for intravesical chemotherapy administration. Materials & Methods: This prospective, randomised phase II study investigated both safety and subjective tolerability of a novel schedule of chemotherapy administration (3 times per week, for 2 weeks) compared to the standard approach (1 time per week, for 6 weeks) as neo-adjuvant treatment of recurrent low-grade non muscle invasive bladder cancer (NMIBC). Secondary end point of the study was the deinition of tumor complete response (CR). Between January 2009 and September 2010, 52 consecutive patients diagnosed with recurrent, single and < 1 cm NMIBC with negative urinary cytology, were recruited. All patients underwent pre-treatment video-cystoscopy with bladder map including location and size of any tumor. Patients were then randomized to receive within 1 week: a neo- adjuvant regimen according to the standard timing with Mitomycin C 40mg/40 ml saline - 1 instillations/week for 6 weeks (Group 1) or the experimental adjuvant regimen with Mitomycin C 40mg/40 ml; 3 instillations/week for 2 weeks (Group 2). Seven to 10 days after treatment completion, a video cystoscopy with bladder map and biopsies of every residual or suspect lesion was performed in all patients. Local and systemic toxicity were investigated in both groups by means of a semistructured questionnaire concerning lower urinary tract symptoms through three items (nicturia, frequency, dysuria and urgency) and SF36 questionnaire score completed at time of pre and post-treatment cystoscopy. results: Mean age was 63.4 years (range: 34-82). All patients were recurrent after TURB for low grade NMIBC and 24 and 28 were assigned to Group 1 and 2, respectively. Overall, 2 patients in group 2 could not complete the scheduled treatment due to severe lower urinary tract symptoms. Logistic regression analysis could not document statistical differences between the two groups, in terms of lower urinary tract symptoms items. One-way Anova evidenced only one signiicant difference between two groups in terms of SF36 physical functioning (PF) after the treatment (P=0.046). The mean PF score was 79.8 (SD 22.3) and 62.5 (SD 34.2) in G1 and G2, respectively. Overall 15/24 (65.5%) patients in G1 and 23/28 (82.1%) in G2 showed a complete tumor response, respectively including the 2 patients who could not complete the treatment. Due to the limited amount of patients included in this study so far, we were not able to identify the prognostic factors associated to optimal oncological outcome in a deinitive multivariate analyses. Conclusions: The intensive schedule for intravesical mytomicin C administration was documented to be well tolerated. When compared to standard approach no difference in terms of local and systemic toxicity could be registered. 430 should follow-uP CystosCoPy in baCillus CalMette-guérin (bCg) treated Patients be terMinated after 5 tuMour-free years? Ströck V., Holmäng S. Sahlgrenska University Hospital, Dept. of Urology, Gothenburg, Sweden introduction & objectives: Few authors have reported long-term data on BCG treated patients. We report the outcome after a minimum tumour-free period of 5 years after BCG treatment. Materials & Methods: We updated our database on all 580 patients treated with BCG from 1986 to 2003. Patients who had a tumour-free period of at least 60 months at any time after BCG treatment were included. Group 1 had TaG1-G2 tumours before treatment and group 2 had TaG3 /cis/ T1 tumours. results: A total of 190 patients (32%) out of 580 were tumour-free for at least 5 years. The median tumour-free period was 105 months (range 62-225). A total number of 18 out of 190 (9.5%) had a recurrence after 5 years. The Kaplan-Meier estimated risk for recurrence was 11% at 10 years and 18% at 15 years. In group 1, only 5/73 patients (6.8%) had recurrences, all small G1 tumours, after 74-145 months. No patient progressed in stage. In group 2, 13/117 patients (11%) had recurrences after a tumour-free period of 63-133 months. Three of these were deeply invasive in the urethra or ureter. In the bladder, one was a T2 tumour, six were Tis and 3 were TaG1-2. Conclusions: A tumour-free period of 5 years after BCG treatment is a very good prognostic sign but recurrences after more than 10 years are not unusual. We recommend life-long follow-up cystoscopy for patients with BCG-treated bladder cancer, regardless of the initial grade and stage. 431 initial bCg instillation is under-used in t1 bladder CanCer Jahnson S. 1 , Holmäng S. 2 , Liedberg F. 3 , Ljungberg B. 4 , Malmström P.U. 5 , Månsson W. 6 , Wijkstöm H. 7 1 University Hospital, Dept. of Urology, Linköping, Sweden, 2 Sahlgren University Hospital, Dept. of Urology, Gothenburg, Sweden, 3 Växjö Central Hospital, Dept. of Urology, Växjö, Sweden, 4 Northern University Hospital, Dept. of Urology, Umeå, Sweden, 5 Academic University Hospital, Dept. of Urology, Uppsala, Sweden, 6 University Hospital, Dept. of Urology, Lund, Sweden, 7 Karolinska University Hospital, Dept. of Urology, Stockholm, Sweden introduction & objectives: Evidence based guidelines for the management of bladder cancer have been issued more than ten years ago but the implementation in general practice is not well known. In T1 tumours intravesical BCG is a cornerstone in recommended treatment. The purpose of the present investigation was to analyse adherence to guidelines of T1 bladder cancer in a national population-based register. Materials & Methods: All patients registered in the Swedish Bladder Cancer Register 1997-2006 with T1 bladder cancer were included in the study. A high- volume hospital was deined as one that registered 10 ore more T1 tumours per year and a low-volume hospital was one that registered less than 10 patients with T1 tumours per year. results: There were 3149 (74%) men and 942 (26%) women with a mean age 72 years. Intravesical BCG was given to 932 (24%) patients for all ten years. The percentage increased from 18% during1997-2000, to 27% during 2001-2003 and to 41% during 2004-2006. A logistic regression analysis found intravesical BCG to be more common in G3 tumours, in patients younger than 76 years, in high- volume hospitals and in later part of the study period but no difference was found for gender and healthcare region. Cox analysis limited to patients younger than 76 years showed that tumour speciic death was associated with tumour grade and no BCG treatment but not with gender and hospital volume, however, selection of patients to have or not to have BCG might inluence results. Conclusions: Intravesical BCG is despite clear recommendations under-used in T1 tumours of the urinary bladder and this is particularly the case for patients older than 76 years and for those treated in low-volume hospitals. Reasons for this might be the risk of higher morbidity of intravesical BCG and the lack of routine for BCG instillations, respectively. Concentration of bladder cancer treatment to high- volume hospitals might improve adherence to guidelines and treatment results. 432 re-treatMent by intravesiCal theraPy in reCurring Patients affeCted by interMediate risk non-MusCle invasive bladder CanCer (nMi-bC) Serretta V. 1 , Sommatino F. 1 , Billone V. 2 , Daricello M. 1 , Allegro R. 2 , Melloni D. 1 1 Section of Urology, University of Palermo, Dept. of Internal Medicine, Cardiovascular and Nephro-Urological Diseases, Palermo, Italy, 2 GSTU Foundation, Dept. of Statistics, Palermo, Italy