A phase II study of gemcitabine and oxaliplatin in advanced transitional cell carcinoma of the bladder

Cancer Chemother Pharmacol. 2013 Jul;72(1):263-7. doi: 10.1007/s00280-013-2178-x. Epub 2013 May 1.

Abstract

Cisplatin-based chemotherapy is recommended for use as first-line treatment for patients with advanced transitional cell carcinoma of the bladder. Unfortunately, 30-50 % of patients are ineligible for cisplatin due to renal insufficiency. Oxaliplatin is a less nephrotoxic platin which can be used for patients with impaired renal function. We carried out a phase II study of gemcitabine (1,200 mg/m²) in combination with oxaliplatin (100 mg/m²) given on days 1 and 14 every 28 days (GEMOX) in predominantly cisplatin-'unfit' stage IV transitional cell bladder cancer patients to determine whether this combination exhibited a clinical activity profile similar to cisplatin plus gemcitabine. Eighteen patients with a median GFR of 49 ml/min were enrolled. GEMOX treatment led to a 36 % response rate in assessable patients. Median progression-free survival was 4.9 months, with a median overall survival (OS) of 10.4 months and a one-year survival rate of 44.4 %. GEMOX in bladder cancer patients exhibited a tolerable side effects profile, with thrombocytopenia as the most frequent grade 3/4 toxicity. These findings suggest that GEMOX is an active combination in advanced bladder cancer patients with reduced renal function.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carcinoma, Transitional Cell / complications
  • Carcinoma, Transitional Cell / drug therapy*
  • Carcinoma, Transitional Cell / pathology
  • Carcinoma, Transitional Cell / physiopathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / therapeutic use
  • Drug Monitoring
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Kidney / drug effects
  • Kidney / physiopathology
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Organoplatinum Compounds / administration & dosage
  • Organoplatinum Compounds / adverse effects
  • Organoplatinum Compounds / therapeutic use
  • Renal Insufficiency / complications
  • Renal Insufficiency / physiopathology
  • Severity of Illness Index
  • Survival Analysis
  • Thrombocytopenia / chemically induced
  • Thrombocytopenia / physiopathology
  • Urinary Bladder Neoplasms / complications
  • Urinary Bladder Neoplasms / drug therapy*
  • Urinary Bladder Neoplasms / pathology
  • Urinary Bladder Neoplasms / physiopathology

Substances

  • Organoplatinum Compounds
  • Deoxycytidine

Supplementary concepts

  • gemcitabine-oxaliplatin regimen