title: Single monthly bacillus Calmette-Guérin intravesical instillation is effective maintenance therapy to prevent recurrence in Japanese patients with non-muscle-invasive bladder cancer.
abstract: BACKGROUND
  A series of bacillus Calmette-Guérin (BCG) bladder instillations is the gold standard therapy to prevent recurrence after transurethral resection of bladder tumor (TUR-Bt) of non-muscle-invasive bladder cancer (NMIBC). However, in some cases the outcome is not optimal with the standard 6- to 8-week protocol and therefore interest has focused on additional maintenance therapy. The present study was conducted to assess the utility of single monthly intravesical instillation treatments for up to 1 year in Japanese patients.
  
  
  METHODS
  A total of 75 stage Ta and T1 patients who had undergone TUR-Bt were retrospectively evaluated, all first receiving 80 mg BCG (Tokyo 172 strain) given once a week, 6-8 times, for primary prophylaxis. Comparison was then made of groups with (group A, 48 patients) and without (group B, 27 patients) additional maintenance BCG therapy given once a month 6-8 times.
  
  
  RESULTS
  Recurrence-free survival rates at 5 years in groups A and B were 83.0 and 51.9% (P = 0.006), despite the greater proportion of T1 patients and the longer follow-up period in the group A patients. Significant protection against recurrence persisted on multivariate analysis with adjustment for age, stage, grade, and tumor number.
  
  
  CONCLUSIONS
  These findings indicate maintenance BCG therapy of single intravesical instillations given once a month with our protocol to be definitely effective for prophylactic use, especially in stage Ta patients. Further evaluation of parameters such as the continuance period and dose protocol is warranted.
authors.affiliation: Department of Urology, J A Aichi Anjo Kosei Hospital, 28 Higashihirokute, Anjo-cho, Anjo 446-8602, Japan. hiko2546@sf.commufa.jp
authors.forename: Takehiko
authors.initials: T
authors.lastname: Okamura
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Akita
authors.forename: Ryosuke
authors.initials: R
authors.lastname: Ando
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Ikegami
authors.forename: Taku
authors.initials: T
authors.lastname: Naiki
authors.forename: Noriyasu
authors.initials: N
authors.lastname: Kawai
authors.forename: Keiichi
authors.initials: K
authors.lastname: Tozawa
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Kohri
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000627:therapeutic use; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery
chemical_list: D001500:BCG Vaccine; D019496:Cancer Vaccines