Phase I study of gemcitabine-cisplatin versus pemetrexed cisplatin for patients with advanced or metastatic bladder cancer

J BUON. 2018 Mar-Apr;23(2):475-481.

Abstract

Purpose: The present study aimed to compare the chemotherapeutic regimens of gemcitabine plus cisplatin (GC) vs pemetrexed plus cisplatin (PC) in bladder cancer (BC) with vascular invasion and/or distant metastasis.

Methods: From January 2010 to January 2017, 53 patients with advanced or metastatic BC were included and randomly divided into two groups. Patients in the GC group were administered 1,000 mg/m2 gemcitabine on day 1 and 15 and 70 mg/m2 cisplatin on day 1 as an IV infusion. Patients in the PC group were administered 500 mg/m2 pemetrexed on day 1 and 15 and 70 mg/m2 cisplatin on day 1 as an IV infusion. The two regimens were repeated every 28 days. Patients were treated for about 4-6 cycles until the occurrence of severe toxicity or patient refusal.

Results: The median overall survival (OS) and the median progression-free survival (PFS) in the GC group were significantly higher than that in the PC group (OS: p=0.033 and PFS: p=0.039, respectively). Besides, the response rates and disease control were obviously higher in the GC group (68% and 86%, respectively) compared to the PC group (44% and 56%, respectively), although without statistical significance. Regarding toxicity, higher rates of neutropenia and nausea in the PC group were noted, while thrombocytopenia was more frequent in the GC group.

Conclusions: The gemcitabine plus cisplatin combination was more effective and well tolerated in patients with advanced or metastatic BC compared to the pemetrexed plus cisplatin regimen.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Cisplatin / administration & dosage*
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives*
  • Drug-Related Side Effects and Adverse Reactions / classification
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Female
  • Gemcitabine
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Pemetrexed / administration & dosage
  • Progression-Free Survival
  • Treatment Outcome
  • Urinary Bladder Neoplasms / drug therapy*
  • Urinary Bladder Neoplasms / pathology

Substances

  • Pemetrexed
  • Deoxycytidine
  • Cisplatin
  • Gemcitabine