Active surveillance for low-risk Non-Muscle Invasive Bladder Cancer (NMIBC): mid-term results from a Bladder cancer Italian Active Surveillance (BIAS) project.

AbstractOBJECTIVE:To report the oncologic safety and the risk of progression for patients with NMIBC included in an active surveillance (AS) program after the diagnosis of recurrence.SUBJECTS AND METHODS:This is a prospective study enrolling patients with history of pathologically confirmed LG pTa-pT1a Non-Muscle Invasive Bladder Cancer (NMIBC) and diagnosed with a tumour recurrence. Inclusion criteria consisted of negative urine cytology, presence of ≤ 5 NMIBCs with a diameter ≤ 10 mm, absence of carcinoma in situ (CIS) or persistent gross haematuria. The primary outcome of interest was adherence to AS. Need to proceed with treatment was defined as progression in number/dimension/positive cytology/symptoms (gross haematuria persistent) or any further intervention (resection or electro-fulguration). Finally, we assessed the up-grading and up-staging when transurethral resection of bladder tumour (TURBT) was performed.RESULTS:The study population consisted of 55 patients with a previous diagnosis of NMIBC (70 active surveillance events) prospectively recruited since 2008. The mean patient age was 69.8 years. Median follow-up was 53 months. The median time patients remained under AS was 12.5 months. A disease progression was observed in 28 patients (51%). No patient experienced progression to muscle-invasive disease. Fifteen patients (27.3%) showed an increase in the number and/or size of the tumour, 9 (16,4%) suffered from hematuria and 4 (7.3%) had a positive cytology. Only 5 (9%) patients in the whole series experienced progression to a high- grade tumour (G3) or presented with associated CIS. The overall adherence to the follow-up schedule was 95%.CONCLUSION:Our data showed that an AS protocol for NMIBC could be a reasonable option in a selected group of patients with small, recurrent cancers. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.