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Aim: To evaluate the potential contribution of a fluorescent in situ hybridization (FISH) as prognostic indicator of the risk of recurrence or progression in patients undergoing follow-up for non-muscle-invasive bladder cancer (NMIBC)., Patients and Methods: A total of 126 consecutive patients with a history of NMIBC being followed-up with urinary cytology and cystoscopy at a referral centre were studied. Patients with carcinoma in situ, or tumour stage higher than pT1 were excluded. A UroVysion FISH kit was used to detect four chromosomal abnormalities, specifically, locus 9p21, Ch 3, 7, and 17. Three FISH patterns were defined: negative; low-risk positive, i.e. positive staining for 9p21 and/or Ch3 abnormalities; and high-risk positive, i.e. positive staining for Ch7 and/or 17., Results: Overall 73 out of 126 patients (57.9%) had a positive urinary FISH test. After a median time of 14 months, 46 FISH-positive patients underwent recurrence (36.5%) and in 15 patients there was progression of disease (11.9%). Among positive patients, the low-risk category was found in 34, and the high-risk in 39. Low-risk FISH-positive patients had a higher rate of recurrence as compared to FISH-negative patients, with a hazard ratio (HR) of 1.6. The recurrence rate was even greater in patients with a high-risk positive test, with an HR of 1.9. The limitation of the study was that the impact of intravesical treatment was not assessed., Conclusion: The urinary FISH test can be used as an aid in predicting the risk of recurrence during follow-up of patients with history of NMIBC.

Primary Objective: to assess ablative efficacy and tolerability of short-schedule intravesical gemcitabine for intact, low- and intermediate-risk, recurrent superficial bladder tumours., Secondary Objective: to assess effect on prophylaxis., Methods: Patients with a diagnosis of recurrence and a history of previous superficial, low- or intermediate-risk bladder tumours were selected for the study. They received 2000 mg gemcitabine in 50 ml, that is 40 mg/ml, intravesically, weekly for 4 wk, followed by resection of any residual lesions. Complete responses consisted of absence of any macroscopic, histologically confirmed, residual lesion, and no response in the presence of residual lesions. The effect on prophylaxis was measured in months as disease-free interval to first recurrence, and as percentage of patients recurring within the first 12 mo. Toxicity was assessed as local and systemic., Results: Of 34 recruited patients, 28 consecutive patients were evaluable, with complete responses observed in 13 of 28 (46.4%) and no response in 15 (53.6%). Median time to first recurrence was 9.1 mo (range: 2.9-26.5) for 19 of 28 (67.8%) patients experiencing recurrence during the first year. Local or systemic toxicity was observed in 9 of 34 (26.4%) patients, resulting in protocol interruption in 6 patients., Conclusions: Intravesical gemcitabine alone showed ablative efficacy in nearly one half of the patients under study. Drug tolerability was good, both locally and systemically.

Background: The ablative potential and toxicity of gemcitabine, administered intravesically in low stage and grade superficial transitional cell carcinoma (TCC), were evaluated., Patients and Methods: Patients with a history of recurrent Ta-T1, GI-G2 bladder TCC were considered eligible for the study. Gemcitabine was administered intravesically at 40 mg/mL concentration (2000 mg in 50 ml saline) in one weekly instillation for 4 consecutive weeks. Fifteen days after the last instillation, patients were submitted to transurethral resection (TUR)., Results: Twenty-six patients were evaluable for toxicity, and 20 were evaluable for response, 6 patients being excluded due to toxicity. A complete response was achieved by 10 out of 20 patients (50%), whereas no response was documented in the remainder. Toxicity leading to treatment interruption was grade 3 in 1 patient and grade 2 in 5 patients., Conclusion: Intravesical gemcitabine administered at 40 mg/mL showed the capability of ablating small volume, superficial TCC in 50% of the population under study, with acceptable tolerability.