title: A carboplatin-based regimen for the treatment of patients with advanced transitional cell carcinoma of the urothelium.
abstract: BACKGROUND
  Many patients with advanced transitional cell carcinoma are unable to receive cisplatin-based therapy. The efficacy and toxicity of a carboplatin-based regimen in the treatment of patients with advanced transitional cell carcinoma was therefore evaluated.
  
  
  METHODS
  Twenty-three patients with advanced transitional cell carcinoma were treated. Metastatic disease was present in 19 of 23 patients (83%) whereas 4 patients with T4, and/or N1, disease were treated. Patients were treated every 28 days with methotrexate, 30 mg/m2 intravenously (i.v.) on Days 1 and 15, along with leucovorin, 15 mg/m2 orally every 6 hours, 3 times daily beginning 24 hours after each methotrexate dose; vinblastine, 3 mg/m2 i.v. on Days 1 and 15; mitoxantrone, 15 mg/m2 i.v. on Day 1; and carboplatin, 300 mg/m2 i.v. on Day 1, adjusted for creatinine clearance (MVNCa). Dosage in subsequent cycles was adjusted according to hematologic toxicity.
  
  
  RESULTS
  Median age was 70 years (range, 52-83 years) and median pretreatment creatinine clearance was 50 mL/min (range, 30-106 mL/min). Of 23 patients, 8 (34.8%) obtained a complete response, and 5 (21.7%) obtained a partial response. The overall response proportion was 56.5% (95% confidence interval, 34.5-76.8%). Median survival was 10 months (range, 1-44+ months). Toxicity was moderate. Grade 4 neutropenia occurred in 10 of 107 (9.3%) administered treatment cycles; Grade 4 thrombocytopenia occurred in 11 of 107, (10.3%). There were 4 episodes of febrile neutropenia (3.7% of cycles). Renal, neurologic, or otic toxicity were not observed. Age older than 70 did not appear to impact on response proportion, survival, and toxicity.
  
  
  CONCLUSIONS
  The carboplatin-based MVNCa regimen is active in the treatment of patients with advanced transitional cell carcinoma and is well tolerated. Therapy with this regimen may be a less toxic alternative for patients for whom treatment with cisplatin is not an option.
authors.affiliation: Department of Medicine, University of California, San Francisco, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Small
authors.forename: L J
authors.initials: LJ
authors.lastname: Fippin
authors.forename: M L
authors.initials: ML
authors.lastname: Ernest
authors.forename: P R
authors.initials: PR
authors.lastname: Carroll
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009362:Neoplasm Metastasis; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D014747:Vinblastine; D016190:Carboplatin; D008942:Mitoxantrone; D002955:Leucovorin; D008727:Methotrexate