title: Twelve-year follow up of a randomized prospective trial comparing bacillus Calmette-Guerin and epirubicin as adjuvant therapy in superficial bladder cancer.
abstract: OBJECTIVE
  To compare bacillus Calmette-Guerin (BCG) with epirubicin in adjuvant therapy of superficial bladder transitional cell carcinoma, with respect to recurrence, progression and survival. Prognostic factors are also evaluated.
  
  
  METHODS
  Between October 1991 and September 1999, all patients harboring superficial bladder cancers (Ta or T1) with any of the relevant criteria (stage>a, grade>1, size>1 cm, multiple or recurrent tumors), after complete transurethral resection were randomized to receive either 81 mg Connaught strain BCG or 50 mg epirubicin. Patients with recurrences were eligible to crossover, even repeatedly, until progression. Recurrence, progression and survival were analyzed in relation to initial treatment, patient characteristics and tumor characteristics.
  
  
  RESULTS
  There were 209 patients included in the study, 149 men and 60 women. The mean age was 69.9 years (range, 24-92). The BCG group consisted of 102 patients and the epirubicin group contained 107 patients. Final analysis was made at a median follow up of 23, 47 and 61 months for recurrence, progression and survival, respectively. The 10-year Kaplan-Meier estimates for recurrence-free, progression-free and disease-specific survival were 61%, 78% and 80%, respectively, for the BCG group. The corresponding figures were 32%, 74% and 92%, respectively, for the epirubicin group. Time to recurrence differed significantly between two treatment groups (P=0.0004). Multiplicity increased the risk of recurrence, while grading influenced recurrence, progression and disease specific survival.
  
  
  CONCLUSIONS
  Bacillus Calmette-Guerin prolonged time to recurrence when compared with epirubicin. Grading was shown to be a universal prognostic factor for recurrence, progression and disease specific survival.
authors.affiliation: Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China. drmcheng@hotmail.com
authors.forename: Chi Wai
authors.initials: CW
authors.lastname: Cheng
authors.forename: Siu Foon Peter
authors.initials: SF
authors.lastname: Chan
authors.forename: Lung Wai
authors.initials: LW
authors.lastname: Chan
authors.forename: Chi Kwok
authors.initials: CK
authors.lastname: Chan
authors.forename: Chi Fai
authors.initials: CF
authors.lastname: Ng
authors.forename: Ho Yuen
authors.initials: HY
authors.lastname: Cheung
authors.forename: Shu Yin Eddie
authors.initials: SY
authors.lastname: Chan
authors.forename: Wai Sang
authors.initials: WS
authors.lastname: Wong
authors.forename: Fernand Mac-Moune
authors.initials: FM
authors.lastname: Lai
authors.forename: Ka Fai
authors.initials: KF
authors.lastname: To
authors.forename: Miu Ling
authors.initials: ML
authors.lastname: Li
mesh_terms: D058891:5-alpha Reductase Inhibitors; D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018592:Cross-Over Studies; D015653:Cystectomy / Q000379:methods*; D003558:Cystoscopy; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery
chemical_list: D058891:5-alpha Reductase Inhibitors; D000276:Adjuvants, Immunologic; D000730:Androstadienes; D001500:BCG Vaccine; C072547:epristeride