Gemcitabine plus Cisplatin versus Gemcitabine plus Carboplatin as First-Line Chemotherapy in Advanced Transitional Cell Carcinoma of the Urothelium: Results of a Randomized Phase 2 Trial

Luigi Dogliotti, Giacomo Cartenì, Salvatore Siena, Oscar Bertetto, Andrea Martoni, Aldo Bono, Dino Amadori, Haluk Onat, Luca Marini

Research output: Contribution to journalArticle

Abstract

Objectives: This phase 2 randomized study compared the toxicity and assessed the efficacy of gemcitabine-cisplatin (GP) and gemcitabine-carboplatin (GC) in patients with advanced transitional cell carcinoma of the urothelium (TCC), with the main objective to demonstrate a reduction in toxicity of at least 25% in the GC arm. Methods: A total of 110 chemonaive patients (55 per arm) with locally advanced or metastatic TCC received gemcitabine 1250 mg/m2 on days 1 and 8 plus cisplatin 70 mg/m2 on day 2 (GP) every 3 wk or gemcitabine 1250 mg/m2 on days 1 and 8 plus carboplatin AUC 5 on day 2 (GC) every 3 wk for a maximum of six cycles. Results: No differences between arms were noted in the overall toxicity profiles and any parameter of toxicity. The most frequent grade 3-4 hematologic toxicity was neutropenia in 34.6% of patients for GP and 45.4% for GC. The most frequent grade 3-4 nonhematologic toxicity was nausea and vomiting (GP: 9.1%; GC: 3.6%). Grade 1-2 nephrotoxicity occurred in 14 GP-treated patients (26.0%) and 9 GC-treated patients (16.3%). Per an intent-to-treat analysis, overall response, evaluated on 80 patients, was 49.1% for GP (CR: 14.5%; PR: 34.5%) and 40.0% for GC (CR: 1.8%; PR: 38.2%). Median time to progression was 8.3 mo for GP and 7.7 mo for GC. Median survival was 12.8 mo and 9.8 mo for GP and GC, respectively. Conclusions: GC has a comparably acceptable toxicity profile compared with that of GP and seems active in patients with TCC.

Original languageEnglish
Pages (from-to)134-141
Number of pages8
JournalEuropean Urology
Volume52
Issue number1
DOIs
Publication statusPublished - Jul 2007

Keywords

  • Bladder cancer
  • Carboplatin
  • Chemotherapy
  • Cisplatin
  • Gemcitabine

ASJC Scopus subject areas

  • Urology

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