Title |
Efficacy and safety of Vinflunine for advanced or metastatic urothelial carcinoma in routine practice based on the French multi-centre CURVE study
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Published in |
BMC Cancer, March 2016
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DOI | 10.1186/s12885-016-2262-9 |
Pubmed ID | |
Authors |
Jacques Médioni, Mario Di Palma, Aline Guillot, Dominique Spaeth, Christine Théodore |
Abstract |
To retrospectively assess the efficacy and safety of Vinflunine (VFL) under routine conditions and identify overall survival (OS) prognostic factors. Twenty centres participated in the retrospective study (minimum 4 patients undergoing VFL treatment for advanced/metastatic UC after platinum-based regimen progression. Primary endpoint was OS. Secondary endpoints: progression-free survival (PFS), radiological response rate (RR) RECIST criteria and toxicity (CTC NCI v3). These centres enrolled 134 patients. Prior chemotherapy (CT) lines (≥1 palliative): 1 and ≥2 in 69 % and 26 % of patients, respectively. Performance status (PS): 0, 1, 2 in 25 %, 46 % and 23 % of patients. Median OS = 8.2 months [6.5-9.4], PFS = 4.2 months and RR 22 %, median number of 5 cycles. In risk groups based on 0-3 presence of adverse prognostic factors (PS ≥1, haemoglobin ≤10 g/dl and liver metastasis), median OS: 13.2, 9.9, 3.6, and 2.4 months (P < .0001), respectively; 3.3 months (1.9-5.6) in PS ≥ 2 subgroup. This study reflects routine UC management and confirmed VFL patient efficacy. The drug is safe with gastro-intestinal and haematological prophylaxis. Analysis of prognostic factors for OS is consistent with pivotal trials. |
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Country | Count | As % |
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Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 3 | 19% |
Unspecified | 1 | 6% |
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Other | 1 | 6% |
Other | 2 | 13% |
Unknown | 2 | 13% |
Readers by discipline | Count | As % |
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Psychology | 1 | 6% |
Other | 3 | 19% |
Unknown | 2 | 13% |