title: Alternating chemo-radiotherapy in bladder cancer: a conservative approach.
abstract: OBJECTIVE
  The aim of this Phase II study was to determine a bladder-sparing treatment in patients with invasive bladder cancer, allowing a better quality of life. Objectives were to test toxicity and disease-free and overall survival of patients given an alternated chemo-radiotherapy definitive treatment.
  
  
  METHODS
  Seventy-six patients with bladder cancer Stage T1G3 through T4 N0 M0 were entered in the same chemotherapy regimen (Cisplatin 20 mg/mq and 5-Fluorouracil 200 mg/mq daily for 5 days) alternated with different radiotherapy scheduling, the first 18 patients received two cycles of 20 Gy/10 fractions/12 days each; the second group of 58 patients received two cycles of 25 Gy/10 fractions/12 days each (the last 21 patients received Methotrexate 40 mg/mq instead of 5-Fluorouracil).
  
  
  RESULTS
  A clinical complete response was observed in 57 patients (81%), partial response in 7 patients (10%), and a nonresponse in 6 patients (9%). At a median follow-up of 45 months, 33 patients (47%) were alive and free of tumor. The 6-year overall survival and progression-free survival was 42% and 40%, respectively. Systemic side effects were mild, while a moderate or severe local toxicity was observed in 14 patients and 13 patients (about 20%), respectively.
  
  
  CONCLUSIONS
  Our conservative combination treatment allowed bladder-sparing in a high rate of patients and resulted in a survival comparable to that reported after radical cystectomy.
authors.affiliation: Istituto Nazionale per la Ricerca sul Cancro, Genova.
authors.forename: M
authors.initials: M
authors.lastname: Orsatti
authors.forename: A
authors.initials: A
authors.lastname: Curotto
authors.forename: L
authors.initials: L
authors.lastname: Canobbio
authors.forename: D
authors.initials: D
authors.lastname: Guarneri
authors.forename: D
authors.initials: D
authors.lastname: Scarpati
authors.forename: M
authors.initials: M
authors.lastname: Venturini
authors.forename: P
authors.initials: P
authors.lastname: Franzone
authors.forename: S
authors.initials: S
authors.lastname: Giudici
authors.forename: G
authors.initials: G
authors.lastname: Martorana
authors.forename: F
authors.initials: F
authors.lastname: Boccardo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D015653:Cystectomy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000628:therapy; D018579:Patient Selection; D012074:Remission Induction; D016879:Salvage Therapy; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery
chemical_list: D001500:BCG Vaccine; D002945:Cisplatin; D005472:Fluorouracil