title: Vemurafenib in BRAFV600 mutated metastatic melanoma: a subanalysis of the Italian population of a global safety study.
abstract: OBJECTIVE
  We describe the ad interim analysis of the Italian cohort of the global safety study on vemurafenib in patients with metastatic melanoma.
  
  
  METHODS
  A total of 385 patients received vemurafenib 960 mg twice daily.
  
  
  RESULTS
  In total, 330 patients (86%) reported adverse events; 16 serious adverse events were observed (three related to vemurafenib). The response rate was 30.4%. Median progression-free survival (PFS) and overall survival (OS) were 5.9 months and 16.3 months, respectively. In patients with brain metastasis (BM; n = 83), median PFS was 4.3 months and OS was 7.6 months. In patients without BM, PFS was 6.5 months and OS was not reached. Median PFS was 12.6 months in patients with M1a stage of disease, 9.6 months in those with M1b stage and 5.4 months in subjects with M1c stage.
  
  
  CONCLUSIONS
  Vemurafenib appears safe and active in clinical practice, and seems particularly active in patients without BM and low tumor burden.
authors.affiliation: Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Del Vecchio
authors.forename: Paolo Antonio
authors.initials: PA
authors.lastname: Ascierto
authors.forename: Mario
authors.initials: M
authors.lastname: Mandalà
authors.forename: Vanna Chiarion
authors.initials: VC
authors.lastname: Sileni
authors.forename: Michele
authors.initials: M
authors.lastname: Maio
authors.forename: Lorenza
authors.initials: L
authors.lastname: Di Guardo
authors.forename: Ester
authors.initials: E
authors.lastname: Simeone
authors.forename: Paola
authors.initials: P
authors.lastname: Queirolo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D009154:Mutation; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D048493:Proto-Oncogene Proteins B-raf / Q000235:genetics*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000077484:Vemurafenib
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D047428:Protein Kinase Inhibitors; D013449:Sulfonamides; D000077484:Vemurafenib; D048493:Proto-Oncogene Proteins B-raf
keywords: metastatic melanoma; safety; vemurafenib