title: Phase II trial of neoadjuvant gemcitabine and cisplatin in patients with resectable bladder carcinoma.
abstract: OBJECTIVE
  Gemcitabine and cisplatin (GC) is an active combination in the treatment of metastatic bladder cancer. We have prospectively analyzed the efficacy and tolerability of GC as neoadjuvant treatment of invasive bladder cancer.
  
  
  METHODS
  In this single-institution phase II trial, patients with muscle-invasive transitional cell carcinoma received three cycles of gemcitabine 1200 mg/m2 on days 1 and 8 with cisplatin 75 mg/m2 on day 1 prior to surgery. Radiologic response was evaluated by computed tomography and magnetic resonance imaging. All patients were referred to surgery after chemotherapy completion.
  
  
  RESULTS
  Between June 2002 and March 2005, 22 patients (19 males) were enrolled. Median age was 63 years. Initial stage was II (T2) in 11 and III (T3-4) in 11 patients. Median follow-up is 26 months (4-43). Partial or complete radiologic response rate was documented in 13 out of 20 assessable patients (70%). One patient was excluded due to sarcomatoid carcinoma at definitive pathologic examination. Cystectomy was performed in 15 patients and pelvic radiotherapy in four patients. Nine out of 21 patients (43%) relapsed and four (19%) died due to disease progression. Complete pathologic response was observed in four patients (26.7% of 15). Median progression-free survival was 27 months (CI 95% not reached) with median overall survival of 36 months (CI 95%: 28.7 - 43.3). Grade III/IV toxicity was infrequent, with no deaths due to chemotherapy.
  
  
  CONCLUSIONS
  The combination of GC is effective and well-tolerated when used as neoadjuvant therapy in muscle-invasive bladder cancer. Longer follow-up is necessary to evaluate its impact on the overall survival of these patients.
authors.affiliation: Department of Clinical Oncology, National Cancer Institute, Rio de Janeiro, RJ, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Herchenhorn
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Dienstmann
authors.forename: Fabio A
authors.initials: FA
authors.lastname: Peixoto
authors.forename: Franz S
authors.initials: FS
authors.lastname: de Campos
authors.forename: Valdelice O
authors.initials: VO
authors.lastname: Santos
authors.forename: Denise M
authors.initials: DM
authors.lastname: Moreira
authors.forename: Hedilene
authors.initials: H
authors.lastname: Cardoso
authors.forename: Isabele A
authors.initials: IA
authors.lastname: Small
authors.forename: Carlos G
authors.initials: CG
authors.lastname: Ferreira
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000601:surgery; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine