title: Can gemcitabine instillation ablate solitary low-risk non-muscle-invasive bladder cancer? Results of a phase II marker lesion study.
abstract: OBJECTIVE
  The purpose of this phase II study was to evaluate whether low-risk non-muscle-invasive bladder cancer can be ablated with intravesical gemcitabine in a marker lesion study.
  
  
  METHODS
  The study had a Simon II-stage design. Thirteen patients were to be recruited for stage I. In the event of ≥4 responses, another 30 patients were to be recruited. Patients were given gemcitabine 2,000 mg intravesically once per week for 6 weeks and the response was assessed with endoscopic, histological, and urine cytological findings.
  
  
  RESULTS
  Fourteen patients evaluated for efficacy completed the study; complete responses were achieved by 2 patients (14.3%), both of these patients had lesions of <1 cm. Eleven patients (78.6%) were non-responders and 1 patient (7.1%) had progressive disease. Since the response rate in stage I was below the minimal pre-defined limit, the study was stopped.
  
  
  CONCLUSIONS
  This study shows that intravesical gemcitabine does not merit further study in this patient population. A tumor size of >1 cm may be a critical factor in accounting for the low response rate.
authors.affiliation: Department of Urology, Local Health Unit, Modena, Italy.
authors.forename: Maurizio A
authors.initials: MA
authors.lastname: Brausi
authors.forename: Paolo
authors.initials: P
authors.lastname: Gontero
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Altieri
authors.forename: Renzo
authors.initials: R
authors.lastname: Colombo
authors.forename: Ilaria
authors.initials: I
authors.lastname: Conti
authors.forename: Aldo Vittorio
authors.initials: AV
authors.lastname: Bono
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004724:Endoscopy; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D013997:Time Factors; D016896:Treatment Outcome; D047368:Tumor Burden; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D014556:Urine / Q000166:cytology; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine