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Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma†

Results of a large phase 2 study

  1. David J. Vaughn MD1,‡,*,
  2. Sandy Srinivas MD2,
  3. Walter M. Stadler MD3,
  4. Roberto Pili MD4,
  5. Daniel Petrylak MD5,
  6. Cora N. Sternberg MD6,
  7. David C. Smith MD7,
  8. Sarah Ringuette MD8,
  9. Edwin de Wit MD8,
  10. Virginie Pautret MD9,
  11. Claude George MD10

Article first published online: 17 JUN 2009

DOI: 10.1002/cncr.24460

Issue

Cancer

Cancer

Volume 115, Issue 18, pages 4110–4117, 15 September 2009

Additional Information

How to Cite

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. and George, C. (2009), Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma. Cancer, 115: 4110–4117. doi: 10.1002/cncr.24460

Author Information

  1. 1

    Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

  2. 2

    Department of Medicine, Stanford University, Stanford, California

  3. 3

    Department of Medicine, University of Chicago, Chicago, Illinois

  4. 4

    Department of Medicine, Johns Hopkins University, Baltimore, Maryland

  5. 5

    Department of Medicine, Columbia University, New York, New York

  6. 6

    Department of Medicine, San Camillo Forlanini Hospital, Rome, Italy

  7. 7

    Department of Medicine, University of Michigan, Ann Arbor, Michigan

  8. 8

    Bristol-Myers Squibb, Wallingford, Connecticut

  9. 9

    Bristol-Myers Squibb, Braine L'Alleud, Belgium

  10. 10

    Bristol-Myers Squibb, Princeton, New Jersey

  1. ‡

    Fax: (215) 662-7804

*Abramson Cancer Center of the University of Pennsylvania, 16 Penn Tower, 300 Spruce Street, Philadelphia, PA 19104

  1. †

    Presented in part at the 14th European Cancer Conference, Barcelona, Spain, September 23-27, 2007; and the American Society of Clinical Oncology Genitourinary Cancers Symposium, San Francisco, California, February 14-16, 2008.

Publication History

  1. Issue published online: 4 SEP 2009
  2. Article first published online: 17 JUN 2009
  3. Manuscript Accepted: 26 JAN 2009
  4. Manuscript Revised: 16 JAN 2009
  5. Manuscript Received: 25 NOV 2008

Funded by

  • Bristol-Myers Squibb

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Keywords:

  • platinum-containing chemotherapy;
  • toxicity;
  • urothelial carcinoma;
  • vinflunine

Vinflunine was evaluated in patients with platinum-pretreated advanced urothelial carcinoma and demonstrated moderate activity. Toxicity was manageable and noncumulative.

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/m2, 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. Cancer 2009. © 2009 American Cancer Society.

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