Introduction: Active Surveillance (AS) has been proposed as a conservative approach in Low-grade Non-Muscle-invasive Bladder cancers (NMIBC), in order to avoid or postpone invasive surgical treatments. We present an update of Bladder Cancer Italian Active Surveillance (BIAS) project, to confirm the safety of AS in terms of oncological long-term outcomes. The primary objective of the study is to investigate the rate of failure at a long-term FU. The secondary objective is to report oncological outcomes of patients who failed.
Methods: This prospective observational study, currently on-going, started in January 2013, including patients with pathologically confirmed Ta/T1 low grade NMIBC who experienced recurrence during follow-up (FU) and voluntary accepted AS monitoring. Inclusion criteria were: history of Low-Grade NMIBC (G1-G2) pTa/pT1; number of tumors between 1 and 5; size of larger tumor < 1 cm; absence of hematuria; negative urine cytology (UC). Failure was defined as reaching 1 or more of the exclusion criteria after enrolment. AS monitoring consisted in UC and flexible in-office cystoscopy every 3 months for the first year and then every 6 months.
Results: BIAS protocol included 229 patients (271 AS events). Median (IQR) age at AS entrance was 72 years (65-79). Median time from last TURB to AS enrolment was 11 months (6-21). At last Trans-urethral Resection of Bladder (TURB) before AS, population presented multifocal lesions in 73 cases, in 190 cases lesions were = 5mm. Median time on AS was 16 months (6-28). Overall, we recorded 160 failure due to increase of lesion’s number or dimension in 87 and 101 cases respectively, gross hematuria in 16, positive UC in 16, voluntary exit in 4. We also registered 5 cases of tumor regression during AS period. At failure TURB, in 19 cases there were an upstage to HG\CIS, in 1 case an upstage to T2, while 26 cases were negative. Actually, 86 patients are still on AS. We also evaluated the FU of patients who experienced AS failure and exit from protocol (median FU 38 months [24/52]): 102 of theme did not undergo any other TURB during FU. In those who underwent 1 or more TURB, most frequent histological finding was pTa in 52 patients, while we registered pT1 in only 8 cases and pT2 in 0 cases. Only 15 patients experienced an upstage to HG\CIS.
Conclusions: This update confirms the safety in terms of oncological outcomes of AS in Low-grade NMIBC. Our findings are bolstered by data derived from the FU of patients who failed AS and exit our protocol.