title: Maintenance therapy with bacillus Calmette-Guérin Connaught strain clearly prolongs recurrence-free survival following transurethral resection of bladder tumour for non-muscle-invasive bladder cancer.
abstract: OBJECTIVE
  • To confirm the recurrence-preventing efficacy and safety of 18-month bacillus Calmette-Guérin (BCG) maintenance therapy for non-muscle-invasive bladder cancer.
  
  
  METHODS
  • The enrolled patients had been diagnosed with recurrent or multiple non-muscle-invasive bladder cancer (stage Ta or T1) after complete transurethral resection of bladder tumours (TURBT). • The patients were randomized into three treatment groups: a maintenance group (BCG, 81 mg, intravesically instilled once weekly for 6 weeks as induction therapy, followed by three once-weekly instillations at 3, 6, 12 and 18 months after initiation of the induction therapy), a non-maintenance group (BCG, 81 mg, intravesically instilled once weekly for 6 weeks) and an epirubicin group (epirubicin, 40 mg, intravesically instilled nine times). The primary endpoint was recurrence-free survival (RFS).
  
  
  RESULTS
  • Efficacy analysis was performed for 115 of the full-analysis-set population of 116 eligible patients, including 41 maintenance group patients, 42 non-maintenance group patients and 32 epirubicin group patients. • At the 2-year median point of the overall actual follow-up period, the final cumulative RFS rates in the maintenance, non-maintenance and epirubicin groups were 84.6%, 65.4% and 27.7%, respectively. • The RFS following TURBT was significantly prolonged in the maintenance group compared with the non-maintenance group (generalized Wilcoxon test, P= 0.0190).
  
  
  CONCLUSIONS
  • BCG maintenance therapy significantly prolonged the post-TURBT RFS compared with BCG induction therapy alone or epirubicin intravesical therapy.
authors.affiliation: Kyoto University, Kyoto, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Hinotsu
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Seiji
authors.initials: S
authors.lastname: Naito
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Ozono
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Sumiyoshi
authors.forename: Sumio
authors.initials: S
authors.lastname: Noguchi
authors.forename: Akito
authors.initials: A
authors.lastname: Yamaguchi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nagamori
authors.forename: Akito
authors.initials: A
authors.lastname: Terai
authors.forename: Yasutomo
authors.initials: Y
authors.lastname: Nasu
authors.forename: Haruki
authors.initials: H
authors.lastname: Kume
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Shoji
authors.initials: S
authors.lastname: Samma
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Uemura
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Koga
authors.forename: Tomoyasu
authors.initials: T
authors.lastname: Tsushima
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D015653:Cystectomy; D018572:Disease-Free Survival; D004812:Epidemiologic Methods; D015251:Epirubicin / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009163:Mycobacterium bovis; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000517:prevention & control* / Q000601:surgery; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000517:prevention & control* / Q000601:surgery; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000970:Antineoplastic Agents; D001500:BCG Vaccine; D015251:Epirubicin