Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma: Results of a large phase 2 study

David J. Vaughn, Sandy Srinivas, Walter M. Stadler, Roberto Pili, Daniel Petrylak, Cora N. Sternberg, David C. Smith, Sarah Ringuette, Edwin De Wit, Virginie Pautret, Claude George

Research output: Contribution to journalArticle

103 Scopus citations

Abstract

BACKGROUND: The activity and safety of vinflunine was evaluated in patients with locally advanced or metastatic urothelial carcinoma (UC) who developed disease progression within 12 months of platinum-containing chemotherapy. METHODS: Patients with UC were eligible if they received a prior platinum-based regimen in the neoadjuvant/adjuvant setting or as first-line treatment for advanced/metastatic disease and had developed disease progression within 12 months. Vinflunine was administered intravenously every 3 weeks. Patients with Karnofsky performance status of 80 or 90, impaired renal function, prior pelvic irradiation, or age ≥75 years received an initial dose of 280 mg/m 2, which was escalated to 320 mg/m2 in Cycle 2 if well tolerated. All other patients received an initial dose of 320 mg/m2. The primary endpoint was response rate defined by an independent response review committee (IRRC). RESULTS: Per the IRRC, 22 patients achieved a partial response, with a response rate of 15% (95% confidence interval, 9%-21%) with a median duration of response of 6.0 months. Sixty-four (42%) patients had stable disease. The median progression-free survival was 2.8 months, and the median overall survival was 8.2 months. Myelosuppression was the most frequent adverse event, with grade 3 of 4 (adverse events were evaluated according to the National Cancer Institute Common Toxicity Criteria [version 2.0] guidelines) neutropenia reported in 58% of the patients. Grade 3 of 4 febrile neutropenia occurred in 10 (7%) patients. Nonhematologic treatment-related events (grade 3 of 4) were generally manageable and included constipation (17%), asthenia/fatigue (13%), ileus (5%), and abdominal pain (5%). No cumulative toxicity was observed. CONCLUSIONS: Vinflunine demonstrates moderate activity in patients with platinum-pretreated UC. Toxicity is manageable and noncumulative.

Original languageEnglish (US)
Pages (from-to)4110-4117
Number of pages8
JournalCancer
Volume115
Issue number18
DOIs
StatePublished - Sep 15 2009

Keywords

  • Platinum-containing chemotherapy
  • Toxicity
  • Urothelial carcinoma
  • Vinflunine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Vaughn, D. J., Srinivas, S., Stadler, W. M., Pili, R., Petrylak, D., Sternberg, C. N., Smith, D. C., Ringuette, S., De Wit, E., Pautret, V., & George, C. (2009). Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma: Results of a large phase 2 study. Cancer, 115(18), 4110-4117. https://doi.org/10.1002/cncr.24460