Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy at relapse in patients with muscle-invasive bladder cancer submitted to radical cystectomy: An italian, multicenter, randomized phase iii trial

  • F. C
  • E.M. R
  • A. F
 et al. 
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Background: The purpose of the study was to evaluate the benefit of adjuvant chemotherapy (AC) versus surgery alone in patients with muscle-invasive bladder cancer (MIBC). Patients and methods: One hundred and ninety-four patients with pT2G3, pT3-4, N0-2 transitional cell bladder carcinoma were randomly allocated to control (92 patients) or to four courses of AC (102 patients). These latter patients were further randomly assigned to receive gemcitabine 1000 mg/m2 days 1, 8 and 15 and cisplatin 70 mg/m2 day 2 or gemcitabine as above plus cisplatin 70 mg/m2 day 15, every 28 days. Results: At a median follow-up of 35 months, the 5-year overall survival (OS) was 48.5%, with no difference between the two arms [P = 0.24, hazard ratio (HR) 1.29, 95% confidence interval (CI) 0.84-1.99]. Mortality hazard was significantly correlated with Nodes (N) and Tumor (T) stage. The control and AC arms had comparable disease-free survival (42.3% and 37.2%, respectively; P = 0.70, HR 1.08, 95% CI 0.73-1.59). Only 62% of patients received the planned cycles. A significant higher incidence of thrombocytopenia was observed in patients receiving cisplatin on day 2 (P = 0.006). A similar global quality of life was observed in the two arms. Conclusion: The study was underpowered to demonstrate that AC with cisplatin and gemcitabine improves OS and disease-free survival in patients with MIBC. The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Author-supplied keywords

  • *bladder carcinoma/dt [Drug Therapy]
  • *bladder carcinoma/su [Surgery]
  • *cancer adjuvant therapy
  • *cisplatin/ae [Adverse Drug Reaction]
  • *cisplatin/ct [Clinical Trial]
  • *cisplatin/dt [Drug Therapy]
  • *cisplatin/iv [Intravenous Drug Administration]
  • *cystectomy
  • *gemcitabine/ae [Adverse Drug Reaction]
  • *gemcitabine/ct [Clinical Trial]
  • *gemcitabine/dt [Drug Therapy]
  • *gemcitabine/iv [Intravenous Drug Administration]
  • *muscle invasive bladder cancer/dt [Drug Therapy]
  • *muscle invasive bladder cancer/su [Surgery]
  • *transitional cell carcinoma/dt [Drug Therapy]
  • Italy
  • alopecia/si [Side Effect]
  • anemia/si [Side Effect]
  • article
  • asthenia/si [Side Effect]
  • cancer mortality
  • cancer staging
  • controlled study
  • creatinine clearance
  • diarrhea/si [Side Effect]
  • disease free survival
  • drug efficacy
  • drug fever/si [Side Effect]
  • drug induced headache/si [Side Effect]
  • follow up
  • human
  • hypercreatinemia/si [Side Effect]
  • hypertransaminasemia/si [Side Effect]
  • infection/si [Side Effect]
  • leukopenia/si [Side Effect]
  • major clinical study
  • mucosa inflammation/si [Side Effect]
  • multicenter study
  • multiple cycle treatment
  • nausea and vomiting/si [Side Effect]
  • neutropenia/si [Side Effect]
  • overall survival
  • phase 3 clinical trial
  • priority journal
  • proteinuria/si [Side Effect]
  • quality of life
  • randomized controlled trial
  • side effect/si [Side Effect]
  • stomatitis/si [Side Effect]
  • thrombocytopenia/si [Side Effect]

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  • Cognetti F.

  • Ruggeri E.M.

  • Felici A.

  • Gallucci M.

  • Muto G.

  • Pollera C.F.

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