Gemcitabine plus vinorelbine chemotherapy in patients with advanced bladder carcinoma who are medically unsuitable for or who have failed cisplatin-based chemotherapy

Eur Urol. 2003 Dec;44(6):682-6. doi: 10.1016/s0302-2838(03)00385-3.

Abstract

Objective: To evaluate the efficacy and toxicity of gemcitabine plus vinorelbine chemotherapy in patients with advanced bladder carcinoma who are unsuitable for or who have failed cisplatin-containing chemotherapy.

Patients and methods: Thirty-one patients with advanced transitional cell carcinoma (TCC) of the bladder were scheduled to receive gemcitabine and vinorelbine chemotherapy. Twenty-one patients had received no prior chemotherapy and their creatinine clearance was below 50 ml/min (group 1), and the remaining 10 patients did not respond to previous cisplatin-containing chemotherapy (group 2).

Results: In group 1, objective response rate was 47.6%, including 2 (9.5%) complete and 8 (38.9%) partial responses. In group 2, partial response was observed in 2 (20%) patients. The median survival time for patients in group 1 and 2 were 15 months (range 3-23) and 7 months (range 3-21), respectively. Grades 3 or 4 leukopenia developed in 16.1% of patients. Overall, 12.9% of the patients suffered from grade 3 nonhematologic toxicity.

Conclusion: Our preliminary data indicate that the combination of gemcitabine and vinorelbine is active and well tolerated especially in patients with advanced TCC who are unsuitable for cisplatin-based chemotherapy.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carcinoma, Transitional Cell / drug therapy*
  • Carcinoma, Transitional Cell / mortality
  • Carcinoma, Transitional Cell / pathology
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Deoxycytidine / administration & dosage*
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Gemcitabine
  • Humans
  • Infusions, Intravenous
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Prospective Studies
  • Risk Assessment
  • Survival Analysis
  • Terminally Ill
  • Treatment Failure
  • Urinary Bladder Neoplasms / drug therapy*
  • Urinary Bladder Neoplasms / mortality
  • Urinary Bladder Neoplasms / pathology
  • Vinblastine / administration & dosage*
  • Vinblastine / adverse effects
  • Vinblastine / analogs & derivatives*
  • Vinorelbine

Substances

  • Deoxycytidine
  • Vinblastine
  • Cisplatin
  • Vinorelbine
  • Gemcitabine