title: A 1-year maintenance after early adjuvant intravesical chemotherapy has a limited efficacy in preventing recurrence of intermediate risk non-muscle-invasive bladder cancer.
abstract: OBJECTIVE
  To evaluate the efficacy of 1-year maintenance after a 6-week cycle of early intravesical chemotherapy, as the role of maintenance in intravesical chemotherapy is debated.
  
  
  METHODS
  Between May 2002 and August 2003, 577 patients with non-muscle-invasive bladder cancer (NMI-BC) underwent transurethral resection (TUR) and early intravesical chemotherapy (epirubicin, 80 mg/50 mL). They were randomized between a 6-week induction cycle and the induction cycle plus maintenance with 10 monthly instillations. In all, 95 patients with T1G3, Tis or single and primary Ta-T1 G1-G2 tumours were excluded; 482 patients at intermediate risk of recurrence continued the study. All patients had cytology and cystoscopy at 3-monthly intervals for the first 2-years and 6-monthly thereafter.
  
  
  RESULTS
  The tumours' characteristics were equally distributed between the two arms. Treatment interruption for toxicity was required in 39 patients. One death due to toxicity of early instillation occurred. The median follow-up was 48 months. Ten patients (2.5%) progressed and 117 patients (29.6%) recurred. No statistically significant difference in the recurrence-free rate (RFS) was detected between the two arms (P = 0.43). An advantage in favour of the maintenance arm was evident only at 18 months after TUR (P = 0.03). A trend for a higher benefit from maintenance in primary and multiple tumours was detected.
  
  
  CONCLUSIONS
  In patients with intermediate risk NMI-BC treated by TUR and early adjuvant chemotherapy, adding a maintenance regimen with monthly instillations for 1 year is of limited efficacy in preventing recurrence.
authors.affiliation: Institute of Urology, University of Palermo, Palermo, Italy. vserretta@libero.it
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Serretta
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Morgia
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Altieri
authors.forename: Alessandra
authors.initials: A
authors.lastname: Di Lallo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Ruggiero
authors.forename: Luigi
authors.initials: L
authors.lastname: Salzano
authors.forename: Michele
authors.initials: M
authors.lastname: Battaglia
authors.forename: Mario
authors.initials: M
authors.lastname: Falsaperla
authors.forename: Aniello
authors.initials: A
authors.lastname: Zito
authors.forename: Domenico
authors.initials: D
authors.lastname: Sblendorio
authors.forename: Darvinio
authors.initials: D
authors.lastname: Melloni
authors.forename: Rosalinda
authors.initials: R
authors.lastname: Allegro
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D003558:Cystoscopy / Q000379:methods*; D004812:Epidemiologic Methods; D015251:Epirubicin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy / Q000517:prevention & control* / Q000601:surgery
chemical_list: D000903:Antibiotics, Antineoplastic; D015251:Epirubicin