Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma
Vaughn, David J.; Srinivas, Sandy; Stadler, Walter M.; Pili, Roberto; Petrylak, Daniel; Sternberg, Cora N.; Smith, David C.; Ringuette, Sarah; de Wit, Edwin; Pautret, Virginie; George, Claude
2009-09-15
Citation
Vaughn, David J.; Srinivas, Sandy; Stadler, Walter M.; Pili, Roberto; Petrylak, Daniel; Sternberg, Cora N.; Smith, David C.; Ringuette, Sarah; de Wit, Edwin; Pautret, Virginie; George, Claude (2009). "Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma 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. ." Cancer 115(18): 4110-4117. <http://hdl.handle.net/2027.42/64118>
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/m 2 in Cycle 2 if well tolerated. All other patients received an initial dose of 320 mg/m 2 . 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.Publisher
Wiley Subscription Services, Inc., A Wiley Company
ISSN
0008-543X 1097-0142
Other DOIs
PMID
19536904
Types
Article
Metadata
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