title: Long-term risk of progression of carcinoma in situ of the bladder and impact of bacille Calmette-Guérin immunotherapy on the outcome.
abstract: OBJECTIVE
  This study aimed to determine the long-term risk of cancer progression of carcinoma in situ (CIS) of the urinary bladder, and whether intravesical bacille Calmette-Guérin (BCG) immunotherapy can reduce the risk of progression of CIS.
  
  
  METHODS
  From a prospectively enrolled cohort of bladder cancer patients treated at Århus University Hospital Skejby, Denmark, between 1994 and 2008, all 163 cases with CIS in the bladder, and a history free of invasive bladder cancer (stage T1-4) at least 1 year prior to inclusion were included in the study.
  
  
  RESULTS
  Median follow-up was 51 (0-253) months for progression. Initial treatment consisted of transurethral resection (TUR) alone (109 patients) or TUR plus BCG (54 patients). Twenty-eight patients underwent delayed treatment with BCG. Twenty-one patients in the TUR-alone group (19%) and 42 BCG-treated patients (51%) were free of disease at the end of follow-up (p < 0.001). Progression occurred in 18 BCG-treated patients (22%) versus 31 patients (41%) treated by TUR alone. The 10-year progression-free survival was 62% overall, 50% without BCG and 71% after BCG treatment (p = 0.04). BCG reduced the risk of progression by 46% (hazard ratio 0.54, 95% confidence interval 0.3-0.97). Thirteen patients (9%) experienced progression in the prostate and nine (6%) showed extravesical progression (upper urinary tract or metastases). This was independent of BCG treatment.
  
  
  CONCLUSIONS
  CIS in the absence of invasive (T1) disease carried a 10-year risk of progression of 29?48%. Although BCG was effective against CIS, this effect was limited to the bladder. BCG provided a marginal, but significant reduction in the overall long-term risk of progression.
authors.affiliation: Department of Urology, Århus University Hospital Skejby, Denmark. karsten.zieger@ki.au.dk
authors.forename: Karsten
authors.initials: K
authors.lastname: Zieger
authors.forename: Klaus Møller-Ernst
authors.initials: KM
authors.lastname: Jensen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D015653:Cystectomy; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009362:Neoplasm Metastasis; D011468:Prostatectomy; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine