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lüll Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma: results of a large phase 2 study Vaughn DJ; Srinivas S; Stadler WM; Pili R; Petrylak D; Sternberg CN; Smith DC; Ringuette S; de Wit E; Pautret V; George CCancer 2009[Sep]; 115 (18): 4110-7BACKGROUND: 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>or=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.|Adult[MESH]|Aged[MESH]|Aged, 80 and over[MESH]|Antineoplastic Agents/*therapeutic use[MESH]|Carcinoma, Transitional Cell/*drug therapy[MESH]|Disease Progression[MESH]|Disease-Free Survival[MESH]|Drug Administration Schedule[MESH]|Female[MESH]|Humans[MESH]|Male[MESH]|Middle Aged[MESH]|Neoplasm Metastasis[MESH]|Platinum Compounds/therapeutic use[MESH]|Retreatment[MESH]|Urinary Bladder Neoplasms/*drug therapy/pathology[MESH]|Vinblastine/adverse effects/*analogs & derivatives/therapeutic use[MESH] |