Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma
Vaughn DJ et al. - In a study to evaluate the activity and safety of vinflunine in pts with locally advanced or metastatic urothelial carcinoma (UC) who developed disease progression within 12 mos of platinum-containing chemotherapy, it was shown that vinflunine demonstrates moderate activity in pts with platinum-pretreated UC. Toxicity is manageable and noncumulative. Methods- Pts 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 mos.
- Vinflunine was administered intravenously every 3 wks.
- Pts with Karnofsky performance status of 80 or 90, impaired renal function, prior pelvic irradiation, or age 75 yrs received an initial dose of 280 mg/m2, which was escalated to 320 mg/m2 in cycle 2 if well tolerated.
- All other pts received an initial dose of 320 mg/m2.
- Primary endpoint was response rate.
Results- 22 pts achieved a partial response, with a response rate of 15% with a median duration of response of 6.0 mos.
- 64 (42%) pts had stable disease.
- Median progression-free survival was 2.8 mos, and median overall survival was 8.2 mos.
- Myelosuppression was the most frequent adverse event, with grade 3 of 4 neutropenia reported in 58% of pts.
- Grade 3 of 4 febrile neutropenia occurred in 10 (7%) pts.
- Nonhematologic treatment-related events (grade 3 of 4) were generally manageable and included constipation (17%), asthenia/fatigue (13%), ileus (5%), and abdominal pain (5%).
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