Active surveillance for low-risk Non-Muscle Invasive Bladder Cancer (NMIBC): a confirmatory and resource consumption study from Bladder cancer Italian Active Surveillance (BIAS) project

To investigate the predictive factors of failure and to provide a resource consumption analysis in patients who underwent active surveillance (AS) for Non-Muscle Invasive Bladder Cancer (NMIBC).

This is a prospective observational study, which monitored patients with a history of pathologically confirmed stage pTa (G1-G2) or pT1a (G2) NMIBC and recurrent small size and number tumors without haematuria and positive urine cytology. The primary end-point was the failure rate of AS. The assessment of failure-predictive variables and per-year "direct-hospital" resource consumption analysis were secondary outcomes. Descriptive statistical analysis and Cox regression test with univariable and multivariable analysis complemented data.

Out of 625 patients with NMIBC, 122 patients (overall 146 AS events) were included in the protocol. Fifty-nine (40.4%) events were deemed to require treatment after entering in AS. The median time on AS was 11 months (IQI 5-26). Currently, 76 patients (62.3%) are still under observation. In univariable analysis only time from first TUR to active surveillance start seems to be inversely associated with recurrence free survival (HR 0.99, 95% CI 0.98-1.00, p=0.027), while multivariable analysis showed association also with age at AS start (HR 0.97, 95% CI 0.94 - 1.00, p=0.031) and the size of the lesion at first TUR (HR 1.55, 95% CI 1.06 - 2.27, p=0.025). Specific annual resource consumption savings for each avoided TURBT was on average 1.378€ for each intervention avoided.

AS might be a reasonable clinical and cost-effective strategy in patients presenting with small low-grade pTa/pT1a recurrent papillary bladder tumors.

The Journal of urology. 2017 Aug 25 [Epub ahead of print]

Rodolfo Hurle, Massimo Lazzeri, Elena Vanni, Giovanni Lughezzani, NicolòMaria Buffi, Paolo Casale, Alberto Saita, Emanuela Morenghi, Giovanni Forni, Pasquale Cardone, Giuliana Lista, Piergiuseppe Colombo, Roberto Peschechera, Luisa Pasini, Silvia Zandegiacomo, Alessio Benetti, Davide Maffei, Ivano Vavassori, Giorgio Guazzoni

Department of Urology, Istituto Clinico Humanitas IRCCS - Clinical and Research Hospital, Rozzano (Milan)- Italy., Department of Urology, Istituto Clinico Humanitas IRCCS - Clinical and Research Hospital, Rozzano (Milan)- Italy. Electronic address: ., Humanitas Clinical and Research Center, Business Operations Officer, Rozzano (Milan), Italy; Humanitas University, Department of Biomedical Science, Rozzano (Milan), Italy., Humanitas University, Department of Biomedical Science, Rozzano (Milan), Italy; Department of Biostatistic, Istituto Clinico Humanitas IRCCS - Clinical and Research Hospital, Rozzano (Milan)- Italy., Department of Pathology, Istituto Clinico Humanitas IRCCS - Clinical and Research Hospital, Rozzano (Milan)- Italy., Department of Urology Ospedale di Treviglio (Bergamo)- Italy., Department of Urology, Istituto Clinico Humanitas IRCCS - Clinical and Research Hospital, Rozzano (Milan)- Italy; Humanitas Clinical and Research Center, Business Operations Officer, Rozzano (Milan), Italy; Humanitas University, Department of Biomedical Science, Rozzano (Milan), Italy.

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