title: International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial.
abstract: OBJECTIVE
  This article presents the long-term results of the international multicenter randomized trial that investigated the use of neoadjuvant cisplatin, methotrexate, and vinblastine (CMV) chemotherapy in patients with muscle-invasive urothelial cancer of the bladder treated by cystectomy and/or radiotherapy. Nine hundred seventy-six patients were recruited between 1989 and 1995, and median follow-up is now 8.0 years.
  
  
  METHODS
  This was a randomized phase III trial of either no neoadjuvant chemotherapy or three cycles of CMV.
  
  
  RESULTS
  The previously reported possible survival advantage of CMV is now statistically significant at the 5% level. Results show a statistically significant 16% reduction in the risk of death (hazard ratio, 0.84; 95% CI, 0.72 to 0.99; P = .037, corresponding to an increase in 10-year survival from 30% to 36%) after CMV.
  
  
  CONCLUSIONS
  We conclude that CMV chemotherapy improves outcome as first-line adjunctive treatment for invasive bladder cancer. Two large randomized trials (by the Medical Research Council/European Organisation for Research and Treatment of Cancer and Southwest Oncology Group) have confirmed a statistically significant and clinically relevant survival benefit, and neoadjuvant chemotherapy followed by definitive local therapy should be viewed as state of the art, as compared with cystectomy or radiotherapy alone, for deeply invasive bladder cancer.
authors.affiliation: Medical Research Council Clinical Trials Unit, London, United Kingdom. griffithsg@cf.ac.uk
authors.forename: Gareth
authors.initials: G
authors.lastname: Griffiths
authors.forename: Reginald
authors.initials: R
authors.lastname: Hall
authors.forename: Richard
authors.initials: R
authors.lastname: Sylvester
authors.forename: Derek
authors.initials: D
authors.lastname: Raghavan
authors.forename: Mahesh K B
authors.initials: MK
authors.lastname: Parmar
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D019042:Muscle Neoplasms / Q000188:drug therapy* / Q000556:secondary; D020360:Neoadjuvant Therapy / Q000379:methods*; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D008727:Methotrexate