title: Maintenance intravesical bacillus Calmette-Guérin instillation for Ta, T1 cancer and carcinoma in situ of the bladder: randomized controlled trial by the BCG Tokyo Strain Study Group.
abstract: OBJECTIVE
  We carried out a prospective, randomized, controlled trial to investigate the efficacy and safety of both induction and maintenance therapy with intravesical instillation of bacillus Calmette-Guérin (BCG) for high-risk non-muscle invasive bladder cancer (NMIBC).
  
  
  METHODS
  Intravesical instillation of 80 mg Tokyo strain was given to patients with high-risk NMIBC, including carcinoma in situ (CIS), once weekly for eight consecutive weeks as induction therapy. Patients who achieved complete response (CR) were randomly assigned to either the maintenance group or the observation group.
  
  
  RESULTS
  A total of 90 patients were enrolled. After induction therapy, 75% of the patients achieved CR and 53 of them were enrolled in the randomized comparative phase. A total of four maintenance instillations were given. Median follow-up was 26.5 and 28.7 months after randomization in the maintenance and the observation group, respectively. Although it was not statistically significant, the 2-year recurrence-free survival rate in the maintenance group (95.8%) was higher than that in the observation group (74.1%, P = 0.078). Univariate analysis identified maintenance therapy as a significant factor influencing recurrence. During induction therapy, 82.2% of patients experienced urination-related adverse drug reactions, but most events were not serious. There were fewer adverse drug reactions with maintenance therapy than with induction therapy. Neither induction therapy nor maintenance therapy reduced patients' quality of life (QOL).
  
  
  CONCLUSIONS
  These findings show high levels of efficacy and safety of BCG induction treatment for high-risk NMIBC, and suggest that the number of maintenance instillations could probably be reduced without reducing treatment efficacy or influencing QOL.
authors.affiliation: Department of Urology, Graduate School of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Koga
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Ozono
authors.forename: Tomoyasu
authors.initials: T
authors.lastname: Tsushima
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Tomita
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Horiguchi
authors.forename: Michiyuki
authors.initials: M
authors.lastname: Usami
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Hirao
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Seiji
authors.initials: S
authors.lastname: Naito
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000283:Administration, Intravesical; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage*; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine