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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.

Introduction Conservative management is not applicable to all T1G3 tumors. The appropriate treatment should minimize mortality while assuring reduced morbidity and good quality of life. Several attempts have been done to identify categories of T1G3 patients at higher risk. The role of biologic markers is unclear and the prognostic risk factors are mainly clinical. The proper time to abandon the conservative approach in favor of cystectomy is still object of debate.Objectives The aim of the present study is to assess the clinical tumor features showing a detrimental effect on survival, identify the clinical risk factors impacting survival in patients undergoing conservative management of T1G3 bladder tumor, and to analyze the prognostic role of recurrence.Methods The present analysis is extended to 236 patients with T1G3 bladder tumors treated by TUR plus intravesical therapy between 1976 and 2005. Patients with previous T1G3, Tis, more than 3 tumors or greater than 3cm were excluded. Urinary cytology was obtained within 30 days after TUR. Since 2000 re-TUR has been performed. A sequential combination of mitomycin-C (30mg/30ml) and epirubicin (50mg/50ml) was adopted in 106 patients (44.9%). BCG or other agents were given intravesically in 85 (36.0%) and 38 (16.1%) patients, respectively. Seven (3%) patients refused intravescical therapy. In the case of Ta-T1 recurrence, TUR and one year of adjuvant intravesical therapy were repeated. Patients went off study if Tis, T1G3 or T-category tumor over T1 were detected. Age, previous history, number of tumors, re-TUR, adjuvant therapy, recurrence and progression were considered for survival analysis.Results Tumors were primary in 177 (75.3%) and single in 144 (61.5%) cases. At a mean follow-up of 52 months (range: 3–246 months), 116 patients (49.2%) relapsed. The recurring tumor was T1 in 47 (40.5%) cases and T1G3 in 33 (28.4%). In 11 additional patients (9.5%) a Tis was detected. Twenty-five patients (10.6%) progressed and 15 patients (6.4%) underwent cystectomy. Median overall survival was 167 months. The 5-year progression-free survival rate was 87.8%. Thirty-two patients (13.6%) died, 22 (9.3%) for bladder cancer. A higher mortality was detected in recurrent (p= 0.002) and multiple (p=0.009) tumors undergoing conservative management. Survival was decreased by NMI recurrence (p<0.0001) and by progression (p=0.009). No statistical significant difference in survival was evident in relation to the grade and stage of the recurrent tumor.Conclusions Previous positive history and multiplicity are relevant risk factors for survival in patients affected by T1G3 NMI TCCB conservatively treated. Survival is decreased if conservative management is not given up at the time of NMI recurrence, independently from its grade and stage.

AimsTo find a predictor of extraprostatic extension in clinically localized prostate cancer (PCa), pre-operative ultrasound-guided prostate needle biopsies and clinico-pathological data were reviewed.MethodsOne hundred and eighty-three consecutive patients who underwent radical retropubic prostatectomy for clinical T1-T2 PCa and serum PSA <10ng/ml were reviewed. Pre-operative biopsy was performed according to an extended protocol and whole-mount prostatectomy specimens were processed. The following biopsy variables were categorized to this analysis: Gleason score (@?6, >6), TPC (@?20%; >20%), GPC (@?50%; >50%), cancer-positive cores (@?2; >2), cancer-positive cores in both lateral portions (yes; no), PCa (monolateral; bilateral).ResultsOnly 60/183 specimens showed an organ-confined PCa; the remaining ones showed pT3a in 57 cases, pT3b in 11 and pT3 with positive surgical margins in 55. A locally advanced PCa was found in 60.2 and 76.8% of T1c and T2 clinical stage, respectively. The positive predictive value and negative predictive value of biopsy findings to predict a locally advanced PCa was 89.9 and 75%, respectively. All biopsy variables associations were statistically significant; however, among these variables (non-categorized), in multivariate logistic regression analysis, only GPC was significantly associated with pathologic stage (odds ratio estimate was 1.075, 95% CI: 1.053-1.098).ConclusionsQuantitative histology, especially GPC, seems to be helpful for pre-operative staging of PCa in patients with T1c-T2 clinical stage and PSA <10ng/ml.

The diagnosis of prostate carcinoma has been monitored in Sicily and Calabria for one year.Material e Methods Twenty-seven urological centres of Sicily and Calabria joined the study. Detailed informations about age, familiarity, PSA, Gleason score and TNM stage at diagnosis were centralized between november 2001 and november 2002.Results 721 patients have been recruited. The median age was 73 years. More than 80% of the patients were older than 65 years. Median PSA was 14 ng/ml. The clinical stage at diagnosis was T1c in 33% of patients and 67% had an organ confined prostate cancer (T1-T2). Familiarity was detected in 8% of cases. Age and PSA at diagnosis in these patients were similar to those of the remaining population. However, only 18% of them had a T1 tumor, emphasizing the delay in diagnosis in these patients. Although only 10% of the patients shows at diagnosis a metastatic tumor, 29% only are fit for radical prostatectomy in according to age, PSA and stage.

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.

Introduction The European guidelines classify primary bladder tumors of Ta category and G1–2 grade as low risk tumors when single or less than 7 in number and 3 cm in diameter. The aim of the present paper was to evaluate the usefulness of EORTC Risk Tables when applied to non-selected patients in daily clinical practice.Material and Methods In the present retrospective study 129 consecutive patients affected by primary bladder tumors category Ta and Grade G1–2 have been considered. The median follow-up was 48 months. Bladder tumors were TaG1 in 69 (53.5%) patients, TaG2 in 60 (46.5%), single in 82 (63.6%) and multiple in 47 (36.4%) cases. Fifty-one patients (39.5%) received adjuvant intravesical chemotherapy.Results At a median follow-up of 48 months, 70 (41.8%) patients recurred. Recurrence occurred in 43.5% of TaG1 versus 66.7% of TaG2 tumors (p=0.003), in 50% of single tumors versus 61.7% of multiple (p=0.096), in 41.2% of patients receiving adjuvant chemotherapy versus 62.8% of untreated patients (p=0.007). Progression to G3 grade, T1 category and muscle invasive tumor occurred in 3%, 10% and 2% of cases, respectively.Conclusions The EORTC Risk Tables can be applied in common clinical practice to unselected low-risk patients.

Subclinical infections of the prostate can increase the prostate-specific antigen (PSA) values in patients with normal digital rectal examination. This study aimed to evaluate the role of short-term antimicrobial therapy in reducing the PSA value in patients as candidates for transrectal biopsy. Fifty-eight patients with negative digital rectal examination and PSA values between 4 and 20 ng/mL were included in the study. Antibiotics were administered to all patients for 3 weeks, and the PSA was reassessed 10 days after the end of the treatment. Patients were subsequently submitted to prostate biopsy.A reduction in PSA was detected in 34 patients (59%). Mean percentage reduction was 32%. In only six patients (10%) did the PSA return to normal levels. Prostate biopsy revealed prostate cancer in 26 patients (45%). Prostate cancer was not detected in patients with PSA levels above 4 ng/mL. Prostate biopsy can be avoided only in a small number of patients showing the normalization of PSA levels after short-term antimicrobial therapy. These patients should be strictly monitored with frequent PSA determinations.

The prognostic value of p53 in predicting recurrence and progression of superficial transitional cell carcinoma of the bladder (TCCB) is still uncertain.Materials and methods P53 expression was retrospectively assessed in 160 patients. At a median follow-up of 45 months, (up to years) 84 patients (53%) recurred and 13 (8%) progressed. Adjuvant intravesical chemotherapy after TUR was adopted in 51 patients (32%). The correlations between p53 and G-grade, T-category, risk of recurrence and progression, and intravesical chemotherapy were investigated. Similarly, the correlations between variations in grade and stage at recurrence and modifications in p53 expression were also studied.Results Seventy-nine patients (49%) were negative for p53. P53 was expressed in 84% of G3 tumors and in 65% of T1 lesions. A significant correlation between p53 expression and G-grade (p<0.0001) and T-category (p<0.0001) of the tumor was found. Eight-four patients (53%) recurred and 13 (8%) progressed. No correlation was found with recurrence and response to intravesical chemotherapy. P53 expression resulted correlated to progression in T1 tumors (although was not independent from G-grade).Conclusion According to our experience, p53 expression is not independent from grade and stage of superficial TCCB. A significant correlation between p53 expression and progression, not independent from G-grade, was detected only in T1 tumors.