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Vinflunine in platinum‐pretreated patients with locally advanced or metastatic urothelial carcinoma
Author(s) -
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
Publication year - 2009
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24460
Subject(s) - medicine , neutropenia , metastatic urothelial carcinoma , adverse effect , regimen , febrile neutropenia , clinical endpoint , oncology , progression free survival , chemotherapy , surgery , gastroenterology , cancer , bladder cancer , urothelial carcinoma , clinical trial
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.