title: Organ preservation in patients with invasive bladder cancer: initial results of an intensified protocol of transurethral surgery and radiation therapy plus concurrent cisplatin and 5-fluorouracil.
abstract: OBJECTIVE
  To assess safety, tolerance, and disease control of transurethral resection of the bladder tumor (TURB) plus concurrent cisplatin, 5-fluorouracil (5-FU), and radiation therapy (RT) with selective organ preservation in patients with bladder cancer.
  
  
  METHODS
  Forty-five patients with muscle-invading or high-risk T1 (G3, associated carcinoma in situ, multifocality, >5 cm) bladder cancer were entered into a protocol of TURB followed by concurrent cisplatin (20 mg/m(2)/day, 20-min infusion) and 5-FU (600 mg/m(2)/day, 120-hour continuous infusion), administered on Day 1-5 and 29-33 of RT (single dose 1.8 Gy, total dose to the bladder 54-59.4 Gy). Response was evaluated by restaging TURB 6 weeks later. In case of invasive residual or recurrent tumor, salvage cystectomy was recommended. Median follow-up was 35 months (range: 8-80 months).
  
  
  RESULTS
  Thirty-nine patients (87%) had no detectable tumor at restaging TURB; 29 patients (64%) have been continuously free of tumor in their bladders. A superficial relapse occurred in 4 patients, a muscle-invasive relapse in 6 patients. Overall survival and survival with preserved bladder was 67% and 54%, respectively, at 5 years. Hematologic Grade 3/4 toxicity occurred in 10%/4%; Grade 3 diarrhea occurred in 9%. Thirty-four patients (76%) completed the protocol as scheduled or with only minor deviations. One patient required salvage cystectomy because of a shrinking bladder.
  
  
  CONCLUSIONS
  This protocol of concurrent cisplatin/5-FU and RT has been associated with acceptable toxicity. The complete response rate of 87% and the 5-year survival with intact bladder of 54% are encouraging and compare favorably with our historical control series using RT with carboplatin and cisplatin alone.
authors.affiliation: Department of Radiation Therapy, University of Erlangen, Erlangen, Germany. claus.roedel@strahlen.med.uni-erlangen.de
authors.forename: Claus
authors.initials: C
authors.lastname: Rödel
authors.forename: Gerhard G
authors.initials: GG
authors.lastname: Grabenbauer
authors.forename: Reinhard
authors.initials: R
authors.lastname: Kühn
authors.forename: Thomas
authors.initials: T
authors.lastname: Zörcher
authors.forename: Thomas
authors.initials: T
authors.lastname: Papadopoulos
authors.forename: Jürgen
authors.initials: J
authors.lastname: Dunst
authors.forename: Karl M
authors.initials: KM
authors.lastname: Schrott
authors.forename: Rolf
authors.initials: R
authors.lastname: Sauer
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D016879:Salvage Therapy; D001743:Urinary Bladder / Q000601:surgery*; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D002945:Cisplatin; D005472:Fluorouracil