Introduction

Active surveillance (AS) is an accepted policy for some urological low risk malignancies, such as prostate cancer and small renal tumors in elderly patients. Low-risk non-muscle invasive bladder cancer (NMIBC) has a low probability of progression (0.8 % at five years for pTa G1 and pTa G2 tumors) and preliminary data showed that, in selected cases, AS could be a safe and valid alternative to standard transurethral resection of bladder tumor (TURBT). We report our single centre experience of a prospective cohort study in patients with low-risk NMIBC selected for a monitoring program (Bladder Cancer Italian Active Surveillance - BIAS project).

Methods

This is an observational prospective longitudinal study (EC approval: ICH/1390/C780) enrolling patients, aged ≥ 18 yrs, with a history of low-grade pTa-pT1a tumours with recurrence. Inclusion criteria were: negative cytology (three consecutive negative samples), ≤ 5 endoscopic lesions, diameter ≤ 10 mm and no carcinoma in situ (CIS) or persistent gross haematuria. Cases were followed-up by urine cytology and in-office flexible cystoscopy at intervals of four months in the first year, and then every six months annually. The primary outcome was to test the adherence to monitoring (AS) defining a failure as any progression in number/dimension/positive cytology/signs (gross haematuria persistent) or any further intervention (resection or electro-fulguration). Secondary end-point consisted in the assessment of pathological progression defined as up-grading and up-staging at failure. A descriptive statistical analysis with qualitative variables presented by frequency distribution and the quantitative variables by the mean or median with ± SD/IQR was applied.

Results

Overall, 99 patients (mean age 72.1 ± 14.7 years) underwent 120 AS events from June 2008 to September 2016. The median follow-up was 44 months (IQR:51). The median time between first TURBT and recruitment to AS was 22.5 mo (IQR:12.5). The median number of TURBT before AS entry was 2 (r. 1-4). The pathological characteristics at entry showed pTa and pT1a in 80 and 19 patients respectively; 69 had G1 (69.7%) and 30 G2 (30.3%). Patients remained under AS for a median time of 21.3 months (IQR:21.5); 5 patients were lost to FU due to deaths, which were not related to bladder cancer. A failure was observed in 40 (40.4%) patients, corresponding to 45 events (37.5%). Within failure events, 17 (37.8%) were due to dimensions, 10 (22.2%) to number and 3 to contemporary dimension and number increase. Gross haematuria was the cause of failure in 10 events and positive cytology in 5. No patient experienced stage and grade progression. Eleven failures presented as pT1a and 31 as pTa; 6 failures were classified as G3, 9 G2 and 27 G1. In three patients the TURBT did not reveal neoplasia in pathological samples. One (1%) patient showed CIS. The overall adherence to controls was 95%.

Conclusions

Current findings seem to support AS for NMIBC as a reasonable option in patients with small, low stage, low-grade recurrent papillary bladder cancer after TURBT. Although the current population is one of the largest with a long-term follow-up, further multicentre studies under randomisation criteria are mandatory in order to include AS in our daily practice.

Funding

None