title: Efficacy and safety of Vinflunine for advanced or metastatic urothelial carcinoma in routine practice based on the French multi-centre CURVE study.
abstract: BACKGROUND
  To retrospectively assess the efficacy and safety of Vinflunine (VFL) under routine conditions and identify overall survival (OS) prognostic factors.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medical Oncology Department, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015, Paris, France. jacquesmedioni@gmail.com.
authors.forename: Jacques
authors.initials: J
authors.lastname: Médioni
authors.affiliation: Department of Medicine, Gustave Roussy Institute, 114 Rue Édouard Vaillant, 94805, Villejuif, France.
authors.forename: Mario
authors.initials: M
authors.lastname: Di Palma
authors.affiliation: Lucien Neuwirth Institute of Cancerology, 108 B Avenue Albert Raimond, 42270, Saint-Priest-en-Jarez, France.
authors.forename: Aline
authors.initials: A
authors.lastname: Guillot
authors.affiliation: Gentilly Oncology Centre, 2 rue Marie Marvingt, 54100, Nancy, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Spaeth
authors.affiliation: Department of Oncology, Hôpital Foch, 92151, Suresnes, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Théodore
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010984:Platinum / Q000627:therapeutic use; D012189:Retrospective Studies; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D019459:Urothelium / Q000187:drug effects / Q000473:pathology*; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D010984:Platinum; C111217:vinflunine; D014747:Vinblastine
keywords: CURVE (urothelial carcinoma patients treated by VinfluninE study-in French); Chemotherapy; Metastatic; Platinum pre-treated; Routine; Urothelial carcinoma; Vinflunine