title: Phase II trial of intravesical gemcitabine in bacille Calmette-Guérin-refractory transitional cell carcinoma of the bladder.
abstract: OBJECTIVE
  The aim of this phase II study was to determine the efficacy of gemcitabine administered as an intravesical agent in patients with bacille Calmette-Guérin (BCG) -refractory transitional cell carcinoma of the bladder.
  
  
  METHODS
  Patients with superficial bladder cancer refractory or intolerant to intravesical BCG therapy and refusing a cystectomy were considered eligible for the trial. Eligible patients received two courses of intravesical gemcitabine twice weekly at a dose of 2,000 mg/100 mL for 3 consecutive weeks, with each course separated by 1 week of rest. Patients were evaluated for response at 8 weeks, then every 3 months to 1 year.
  
  
  RESULTS
  Thirty eligible patients were included on study. The median follow-up for all the patients was 19 months (range, 0 to 35 months). Of the 30 patients, 15 (50%; 95% CI, 32% to 68%) achieved a complete response (CR). Twelve patients had tumor recurrence with a median recurrence-free survival time of 3.6 months (95% CI, 2.9 to 11.0 months). Two patients maintained a CR at 23 and 29 months, respectively. The 1-year recurrence-free survival rate for patients with a CR was 21% (95% CI, 0% to 43%). Two patients progressed to a higher stage while receiving gemcitabine treatment. The median follow-up for patients who did not have a progression or a cystectomy was 19 months (range, 2 to 35 months). Eleven patients (37%) underwent a cystectomy subsequent to gemcitabine therapy.
  
  
  CONCLUSIONS
  Gemcitabine has activity in a high-risk patient population and remains a viable option for some patients who refuse cystectomy.
authors.affiliation: Department of Urology, Division of Epidemiology and Biostatistics, the Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. dalbagng@mskcc.org
authors.forename: Guido
authors.initials: G
authors.lastname: Dalbagni
authors.forename: Paul
authors.initials: P
authors.lastname: Russo
authors.forename: Bernard
authors.initials: B
authors.lastname: Bochner
authors.forename: Leah
authors.initials: L
authors.lastname: Ben-Porat
authors.forename: Joel
authors.initials: J
authors.lastname: Sheinfeld
authors.forename: Pramod
authors.initials: P
authors.lastname: Sogani
authors.forename: Machelle S
authors.initials: MS
authors.lastname: Donat
authors.forename: Harry W
authors.initials: HW
authors.lastname: Herr
authors.forename: Dean
authors.initials: D
authors.lastname: Bajorin
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001500:BCG Vaccine / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D001500:BCG Vaccine; D003841:Deoxycytidine; D000093542:Gemcitabine