title: Maintenance therapy with intravesical bacillus Calmette-Guerin in patients with intermediate- or high-risk non-muscle-invasive bladder cancer.
abstract: OBJECTIVE
  We investigated the efficacy, safety and an optimal schedule of maintenance therapy with intravesical instillation of Bacillus-Calmette Guérin in patients with non-muscle-invasive bladder cancer.
  
  
  METHODS
  We compared the oncological outcome and adverse events of maintenance Bacillus-Calmette Guérin therapy (n = 40) with control subjects (n = 64) of Bacillus-Calmette Guérin induction therapy. Maintenance therapy was scheduled to be administered in 3-week cycles at 6, 12, 18, 24 and 36 months after the induction therapy.
  
  
  RESULTS
  There was a significant difference in the 5-year recurrence-free survival rate between the maintenance and induction groups in all patients (72.4 vs. 62.0%; P = 0.019) and in patients with high recurrence risk (100.0 vs. 17.9%; P = 0.009). There was a significant difference in the 5-year progression-free survival rate between the maintenance and induction groups in patients with high progression risk (100.0 vs. 69.3%; P = 0.047). Maintenance Bacillus-Calmette Guérin instillations for a total of four times or more (recurrence-free survival: hazard ratio: 0.2, P = 0.039) or with a total dosage of >243 mg (recurrence-free survival: hazard ratio: 0.2, P = 0.041) after 6 months of induction therapy significantly improve tumor recurrence-free survival and progression-free survival. There were no significant differences between induction therapy and maintenance therapy in the frequency of all adverse drug reactions.
  
  
  CONCLUSIONS
  Bacillus-Calmette Guérin maintenance therapy was effective in preventing the recurrence and progression of high-risk non-muscle-invasive bladder cancer. Maintenance Bacillus-Calmette Guérin instillations for a total of four times or more or with a total dosage of >243 mg after 6 months of induction therapy are necessary to obtain the optimal effect as maintenance therapy.
authors.affiliation: Department of Urology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Muto
authors.forename: Akiko
authors.initials: A
authors.lastname: Nakajima
authors.forename: Akira
authors.initials: A
authors.lastname: Horiuchi
authors.forename: Masayuki
authors.initials: M
authors.lastname: Inoue
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: China
authors.forename: Keisuke
authors.initials: K
authors.lastname: Saito
authors.forename: Shuji
authors.initials: S
authors.lastname: Isotani
authors.forename: Shin-ichi
authors.initials: S
authors.lastname: Hisasue
authors.forename: Raizo
authors.initials: R
authors.lastname: Yamaguchi
authors.forename: Hisamitsu
authors.initials: H
authors.lastname: Ide
authors.forename: Shigeo
authors.initials: S
authors.lastname: Horie
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine