title: Intravesical gemcitabine for high risk, nonmuscle invasive bladder cancer after bacillus Calmette-Guérin treatment failure.
abstract: OBJECTIVE
  We report our experience with intravesical gemcitabine for bladder cancer after failed bacillus Calmette-Guérin treatment.
  
  
  METHODS
  We retrospectively reviewed the records of patients at our cancer center treated with intravesical gemcitabine after bacillus Calmette-Guérin failure. We estimated progression-free, recurrence-free and cancer specific survival using the cumulative incidence function, considering death from another cause as a competing risk. Comparisons were made using the Gray test. Overall survival was estimated using the Kaplan-Meier method and differences were compared with the log rank test.
  
  
  RESULTS
  Of 69 patients treated with intravesical gemcitabine 37 had bacillus Calmette-Guérin refractory disease. Median followup in progression-free patients was 3.3 years. Progression-free and cancer specific survival were similar in patients with refractory disease and those with other types of bacillus Calmette-Guérin failure. Overall survival was lower in patients with refractory disease (58% vs 71%) but this was not statistically significant (p=0.096). Of the patients 27 patients experienced a complete response. Progression-free, cancer specific and overall survival did not differ significantly between patients with and without a complete response. Cystectomy was subsequently performed in 20 patients. Those with a complete response had a delayed time to cystectomy and no muscle invasive bladder cancer at cystectomy. There were no serious adverse events and only a minority of patients discontinued treatment due to adverse events.
  
  
  CONCLUSIONS
  In our experience intravesical gemcitabine should be considered after bacillus Calmette-Guérin failure in patients with bladder cancer who refuse radical cystectomy or who are not candidates for major surgery.
authors.affiliation: Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors.forename: Itay A
authors.initials: IA
authors.lastname: Sternberg
authors.forename: Guido
authors.initials: G
authors.lastname: Dalbagni
authors.forename: Ling Y
authors.initials: LY
authors.lastname: Chen
authors.forename: Sherri M
authors.initials: SM
authors.lastname: Donat
authors.forename: Bernard H
authors.initials: BH
authors.lastname: Bochner
authors.forename: Harry W
authors.initials: HW
authors.lastname: Herr
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000283:Administration, Intravesical; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001500:BCG Vaccine / Q000627:therapeutic use; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D012189:Retrospective Studies; D018570:Risk Assessment; D017211:Treatment Failure; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D000276:Adjuvants, Immunologic; D000964:Antimetabolites, Antineoplastic; D001500:BCG Vaccine; D003841:Deoxycytidine; D000093542:Gemcitabine
keywords: BCG; BCG vaccine; CIS; CR; CSS; MIBC; NMIBC; NR; OS; PFS; PR; RFS; bacillus Calmette-Guérin; cancer specific survival; carcinoma in situ; complete response; gemcitabine; muscle invasive bladder cancer; no response; nonMIBC; overall survival; partial response; progression-free survival; recurrence-free survival; treatment failure; urinary bladder; urinary bladder neoplasms