title: Gemcitabine plus epirubicin in patients with advanced urothelial carcinoma who are not eligible for platinum-based regimens.
abstract: BACKGROUND
  The objective of this study was to evaluate the efficacy and toxicity of gemcitabine plus epirubicin in previously untreated patients with advanced urothelial carcinoma who were not eligible for cisplatin-based regimens.
  
  
  METHODS
  Patients with advanced urothelial carcinoma and at least one of the following characteristics were eligible: impaired renal function (creatinine clearance < 60 mL per minute), an Eastern Cooperative Oncology Group performance status (PS) >or= 2, and age >or= 75 years. The treatment included epirubicin 70 mg/m(2) as an intravenous bolus on Day 1 and gemcitabine 1000 mg/m(2) over 30 minutes on Days 1 and 8 of a 21-day cycle.
  
  
  RESULTS
  Thirty-eight patients entered the study, and a total of 152 cycles were administered, with a median of 4 cycles per patient (range, 1-6 cycles per patient). The following Grade 3-4 hematologic toxicities were reported (percent of cycles): neutropenia, 22.4%; anemia, 11.2%; and thrombocytopenia, 6.5%. No cardiac, renal, or hepatic toxicities were observed. Dose intensities of epirubicin and gemcitabine were 19.6 mg/m(2) per week (84%) and 532.2 mg/m(2) per week (80%), respectively. There were 2 complete responses (5.3%), 13 partial responses (34.2%), 11 patients with stable disease (28.9%), and 12 patients with progressive disease (31.6%), for an overall response rate of 39.5% (95% confidence interval, 25.1-55.1). The median progression free survival (PFS) and overall survival (OS) rates were 4.8 months and 8.0 months, respectively. The 1-year survival rate was 38%, and the median PFS and OS were 6.4 months and 16.4 months, respectively, in patients with PS 0-1. Thirty patients were symptomatic: Seventeen patients (56.7%) achieved a complete response, and 5 patients (16.7%) achieved a partial symptomatic response.
  
  
  CONCLUSIONS
  At the doses given in this study, gemcitabine and epirubicin had a good tolerability profile with interesting activity in patients with advanced urothelial carcinoma who were not fit for cisplatin-based regimens.
authors.affiliation: Division of Medical Oncology, Department of Oncology, S. Chiara University Hospital, Pisa, Italy. s.ricci@med.unipi.it
authors.forename: Sergio
authors.initials: S
authors.lastname: Ricci
authors.forename: Luca
authors.initials: L
authors.lastname: Galli
authors.forename: Aldo
authors.initials: A
authors.lastname: Chioni
authors.forename: Mauro
authors.initials: M
authors.lastname: Iannopollo
authors.forename: Andrea
authors.initials: A
authors.lastname: Antonuzzo
authors.forename: Francesco
authors.initials: F
authors.lastname: Francesca
authors.forename: Vittorio
authors.initials: V
authors.lastname: Vocaturo
authors.forename: Cesare
authors.initials: C
authors.lastname: Selli
authors.forename: Cinzia
authors.initials: C
authors.lastname: Orlandini
authors.forename: PierFranco
authors.initials: P
authors.lastname: Conte
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome; D014516:Ureteral Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000093542:Gemcitabine