title: Insignificant role of bacillus Calmette-Guérin maintenance therapy after complete transurethral resection of bladder tumor for intermediate- and high-risk non-muscle-invasive bladder cancer: Results from a randomized trial.
abstract: To investigate the effect of bacillus Calmette-Guérin maintenance therapy on patients with intermediate- and high-risk non-muscle-invasive bladder cancer receiving aggressive complete transurethral resection of bladder tumors standardized by well-trained surgeons.
  
  
  
  A total of 95 patients were prospectively enrolled. Patients were diagnosed with multiple or recurrent non-muscle-invasive bladder cancer (Ta and T1), or with carcinoma in situ after complete transurethral resection of bladder tumors. Patients with Ta or T1 tumors without carcinoma in situ received six bacillus Calmette-Guérin instillations as induction therapy. Those with carcinoma in situ underwent eight bacillus Calmette-Guérin instillations as induction therapy. The patients were randomized into maintenance and non-maintenance groups. The maintenance group received intravesical bacillus Calmette-Guérin instillations once a week for 3 weeks at 3, 6, 12 and 18 months after bacillus Calmette-Guérin instillation. The primary end-point was recurrence-free survival.
  
  
  
  A total of 88 patients were evaluated. The average follow-up period was 48.3 ± 19.0 months. Five-year recurrence-free survival rates for the maintenance and non-maintenance groups were 80.1% and 79.3%, respectively. Five-year progression-free survival rates of the maintenance and non-maintenance groups were 92.4% and 85.3%, respectively. Recurrence- and progression-free survival rates did not significantly increase in the maintenance group compared with that in the non-maintenance group.
  
  
  
  Bacillus Calmette-Guérin maintenance therapy did not improve recurrence- and progression-free survival rates after the initial complete transurethral resection of bladder tumors compared with that after bacillus Calmette-Guérin induction therapy alone.
authors.affiliation: Department of Urology, Nara Medical University, Nara, Japan.|Nara Urological Research and Treatment Group, Nara, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Nakai
authors.affiliation: Department of Urology, Nara Medical University, Nara, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Anai
authors.affiliation: Department of Urology, Nara Medical University, Nara, Japan.
authors.forename: Nobumichi
authors.initials: N
authors.lastname: Tanaka
authors.affiliation: Department of Urology, Nara Medical University, Nara, Japan.
authors.forename: Yoshitomo
authors.initials: Y
authors.lastname: Chihara
authors.affiliation: Nara Urological Research and Treatment Group, Nara, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Haramoto
authors.affiliation: Nara Urological Research and Treatment Group, Nara, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Otani
authors.affiliation: Nara Urological Research and Treatment Group, Nara, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Nakagawa
authors.affiliation: Nara Urological Research and Treatment Group, Nara, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Hirao
authors.affiliation: Department of Pathology, Nara Medical University, Nara, Japan.
authors.forename: Noboru
authors.initials: N
authors.lastname: Konishi
authors.affiliation: Department of Urology, Nara Medical University, Nara, Japan. kiyokun@naramed-u.ac.jp.|Nara Urological Research and Treatment Group, Nara, Japan. kiyokun@naramed-u.ac.jp.
authors.forename: Kiyohide
authors.initials: K
authors.lastname: Fujimoto
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000283:Administration, Intravesical; D001500:BCG Vaccine / Q000627:therapeutic use*; D001407:Bacillus; D006801:Humans; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine
keywords: bacillus Calmette-Guérin; complete transurethral resection of bladder tumors; high-risk non-muscle-invasive bladder cancer; maintenance therapy; random control trial