title: Risk of subsequent tumour recurrence and stage progression in bacille Calmette-Guérin relapsing non-muscle-invasive bladder cancer.
abstract: What's known on the subject? and What does the study add? So far, few previous reports have analysed the risk factors for tumour recurrence and stage progression with a special focus on BCG-relapsing disease, defined as the recurrence after achieving a disease-free status by initial BCG instillations for 6 months. There are no guidelines outlining a specific treatment strategy for BCG-relapsing disease, although many BCG failure cases are attributable to BCG-relapsing disease. In this study, additional BCG instillation was shown to decrease the subsequent tumour recurrence rate against BCG-relapsing tumours with intermediate pathological risk features; however, a BCG-relapsing tumour with a pathologically high risk was a significant risk factor for both subsequent tumour recurrence and stage progression. This information might identify a therapeutic strategy for BCG-relapsing tumours.
  
  
  OBJECTIVE
  • To investigate the risk of subsequent tumour recurrence and stage progression in bacillus Calmette-Guérin (BCG)-relapsing non-muscle-invasive bladder cancer, defined as recurrence after achieving a disease-free status for 6 months.
  
  
  METHODS
  • A total of 183 patients with BCG-relapsing tumours were treated with conservative therapy between 1985 and 2008 at our three institutions. • We analysed the association between their clinicopathological parameters and subsequent tumour recurrence or stage progression.
  
  
  RESULTS
  • Additional induction courses of BCG or anticancer drug (mitomycin C or epirubicin) instillations were performed in 119 patients and 24 patients, respectively. The remaining 40 patients did not undergo any adjuvant therapy. • Multivariate analysis showed that a relapsing tumour with a pathologically high risk (defined as tumours with G3 and/or pT1 and/or concomitant carcinoma in situ) was a significant risk factor for subsequent tumour recurrence (P= 0.002; hazard ratio [HR] 2.15). Additional BCG instillation significantly decreased the subsequent tumour recurrence rate (P<0.001; HR 0.41). • Multivariate analysis also showed that a relapsing tumour with a pathologically high risk was also significantly associated with stage progression (P < 0.001; HR 8.05).
  
  
  CONCLUSIONS
  • An additional course of BCG instillation might be effective in patients with BCG-relapsing tumours with pathologically intermediate risk. • Nevertheless, some patients with high-risk pathological features developed subsequent stage progression. Such patients should be followed up closely and counselled on the need for aggressive therapeutic options, such as radical cystectomy.
authors.affiliation: Department of Urology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Matsumoto
authors.forename: Eiji
authors.initials: E
authors.lastname: Kikuchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Shirakawa
authors.forename: Nozomi
authors.initials: N
authors.lastname: Hayakawa
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Tanaka
authors.forename: Akiharu
authors.initials: A
authors.lastname: Ninomiya
authors.forename: Akira
authors.initials: A
authors.lastname: Miyajima
authors.forename: So
authors.initials: S
authors.lastname: Nakamura
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Oya
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015994:Incidence; D007322:Instillation, Drug; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology* / Q000473:pathology; D009367:Neoplasm Staging; D012307:Risk Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine