title: Gemcitabine and oxaliplatin in advanced transitional cell carcinoma of the urothelium: a pilot study.
abstract: BACKGROUND
  Despite the fact that new drugs have emerged from clinical research in urothelial cancer during the last decade, the prognosis of patients with advanced disease remains poor with a median survival of 12 to 14 months. We designed a feasibility study of gemcitabine and oxaliplatin (GO) in patients with advanced urothelial cancer.
  
  
  METHODS
  Twenty patients received bimonthly cycles of gemcitabine 1500 mg/m2 and oxaliplatin 85 mg/m2. The cycles were given at 2-week intervals without G-CSF support. Thirteen patients were treated with the GO combination as first-line chemotherapy because of a poor performance status or a creatinine clearance < 1 ml/s.
  
  
  RESULTS
  The median number of cycles of GO was 5 (1-7). The median number of days between cycles was 14 throughout the treatment. Seven (8%) out of 87 cycles had to be delayed because of neutropenia or asthenia. A 25% dose reduction in the doses of cytotoxic drugs was necessary in 2 patients. Chemotherapy was stopped before the sixth cycle because of an early death related to a myocardial infarction in 1 patient, a grade 3 neuropathy in 1 patient and a progressive disease in 9 patients.
  
  
  CONCLUSIONS
  Using these doses and schedules, the GO regimen appears a safe therapy for patients with advanced urothelial cancer. Phase II studies are required to assess the possible role of this combination in advanced urothelial cancer.
authors.affiliation: Department of Medical Oncology, C.R.L.C. Val d'Aurelle, Parc Euromédecine, 34598-Montpellier, France. stculine@valdorel.fnclcc.fr
authors.forename: Stéphane
authors.initials: S
authors.lastname: Culine
authors.forename: Xavier
authors.initials: X
authors.lastname: Rebillard
authors.forename: Francois
authors.initials: F
authors.lastname: Iborra
authors.forename: Nicolas
authors.initials: N
authors.lastname: Mottet
authors.forename: Antoine
authors.initials: A
authors.lastname: Faix
authors.forename: Didier
authors.initials: D
authors.lastname: Ayuso
authors.forename: Frédéric
authors.initials: F
authors.lastname: Pinguet
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy; D007682:Kidney Pelvis; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D010865:Pilot Projects; D014516:Ureteral Neoplasms / Q000188:drug therapy; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy; D014571:Urologic Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine