title: Active surveillance for low-risk non-muscle-invasive bladder cancer: mid-term results from the Bladder cancer Italian Active Surveillance (BIAS) project.
abstract: OBJECTIVE
  To report the oncological safety and the risk of progression for patients with non-muscle-invasive bladder cancer (NMIBC) included in an active surveillance (AS) programme after the diagnosis of recurrence.
  
  
  METHODS
  This is a prospective study enrolling patients with history of pathologically confirmed low grade pTa-pT1a NMIBC and diagnosed with a tumour recurrence. Inclusion criteria consisted of negative urine cytology, presence of ≤5 lesions with a diameter of ≤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 was performed.
  
  
  RESULTS
  The study population consisted of 55 patients with a previous diagnosis of NMIBC (70 AS events) prospectively recruited since 2008. The mean patient age was 69.8 years. The median follow-up was 53 months. The median time patients remained under AS was 12.5 months. There was disease progression in 28 patients (51%). No patient progressed to muscle-invasive disease. In all, 15 patients (27.3%) had an increase in the number and/or size of the tumour, nine (16.4%) had haematuria, and four (7.3%) had a positive cytology. Only five (9%) patients in the whole series progressed to a high-grade tumour (Grade 3) or presented with associated CIS. The overall adherence to the follow-up schedule was 95%.
  
  
  CONCLUSIONS
  Our data show that an AS protocol for NMIBC could be a reasonable option in a select group of patients with small, recurrent cancers.
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Hurle
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Luisa
authors.initials: L
authors.lastname: Pasini
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Lazzeri
authors.affiliation: Department of Pathology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Piergiuseppe
authors.initials: P
authors.lastname: Colombo
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: NicolòMaria
authors.initials: N
authors.lastname: Buffi
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lughezzani
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Casale
authors.affiliation: Department of Biostatistic Unit, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Morenghi
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Peschechera
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Zandegiacomo
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Alessio
authors.initials: A
authors.lastname: Benetti
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Saita
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Cardone
authors.affiliation: Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milan, Italy.|Department of Urology, Humanitas University, Milan, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Guazzoni
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D009130:Muscle, Smooth; D009361:Neoplasm Invasiveness; D011446:Prospective Studies; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D057832:Watchful Waiting
keywords: 
  NMIBC
  ; 
  TURBT
  ; active surveillance; recurrence