title: The Impact of Early Dermatologic Events in the Survival of Patients with Hepatocellular Carcinoma Treated with Sorafenib.
abstract: The presence of dermatologic reaction as an adverse event to sorafenib treatment in patients with unresectable hepatocellular carcinoma has been indicated as a prognostic factor for survival in a recent prospective analysis. To date, this is the only clinical predictor of treatment response, which can be evaluated earlier in the treatment and, therefore, contribute to a better and more individualized patient management.
  
  
  
  This retrospective study included 127 patients treated with sorafenib under real-life practice conditions in two hepatology reference centers in Brazil. Demographic data, disease/medical history and time of sorafenib administration as well as adverse events related to the medication were recorded in a database.
  
  
  
  Cirrhosis was present in 94% of patients, 85.6% were Child-Pugh A, 80.3%BCLC-C, 81% had vascular invasion and/or extrahepatic spread and 95% had a performance status 0 to 1.The median duration of treatment was 10.1 months (range: 0.1-47 months).The most common adverse event within the first 60 days of treatment were diarrhea (62.2%) and dermatological reaction (42%).The median overall survival for the cohort was 20 months, and it was higher for patients who developed dermatological reactions within the first 60 days compared to those who did not present this adverse event.
  
  
  
  This retrospective analysis showed the use of sorafenib in patients selected according to BCLC staging, and it is the first external validation of early dermatologic adverse events as a predictor of overall survival in patients with advanced hepatocellular carcinoma.
authors.affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre Hospital, Department of Hepatology, Federal University of Health Sciences of Porto Alegre, Brazil.
authors.forename: Fernanda
authors.initials: F
authors.lastname: Branco
authors.affiliation: São Paulo Clínicas Liver Cancer Group, São Paulo, Cancer Institute of São Paulo and Clínicas Hospital School of Medicine University of São Paulo, Brazil.
authors.forename: Regiane S M
authors.initials: RS
authors.lastname: Alencar
authors.affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre Hospital, Department of Hepatology, Federal University of Health Sciences of Porto Alegre, Brazil.
authors.forename: Fernanda
authors.initials: F
authors.lastname: Volt
authors.affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre Hospital, Department of Hepatology, Federal University of Health Sciences of Porto Alegre, Brazil.
authors.forename: Giovana
authors.initials: G
authors.lastname: Sartori
authors.affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre Hospital, Department of Hepatology, Federal University of Health Sciences of Porto Alegre, Brazil.
authors.forename: Andressa
authors.initials: A
authors.lastname: Dode
authors.affiliation: São Paulo Clínicas Liver Cancer Group, São Paulo, Cancer Institute of São Paulo and Clínicas Hospital School of Medicine University of São Paulo, Brazil.
authors.forename: Luciana
authors.initials: L
authors.lastname: Kikuchi
authors.affiliation: São Paulo Clínicas Liver Cancer Group, São Paulo, Cancer Institute of São Paulo and Clínicas Hospital School of Medicine University of São Paulo, Brazil.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Tani
authors.affiliation: São Paulo Clínicas Liver Cancer Group, São Paulo, Cancer Institute of São Paulo and Clínicas Hospital School of Medicine University of São Paulo, Brazil.
authors.forename: Aline L
authors.initials: AL
authors.lastname: Chagas
authors.affiliation: Oncology, University of São Paulo School of Medicine, São Paulo, Brazil.
authors.forename: Tulio
authors.initials: T
authors.lastname: Pfiffer
authors.affiliation: Oncology, University of São Paulo School of Medicine, São Paulo, Brazil.
authors.forename: Paulo
authors.initials: P
authors.lastname: Hoff
authors.affiliation: São Paulo Clínicas Liver Cancer Group, São Paulo, Cancer Institute of São Paulo and Clínicas Hospital School of Medicine University of São Paulo, Brazil.
authors.forename: Flair J
authors.initials: FJ
authors.lastname: Carrilho
authors.affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre Hospital, Department of Hepatology, Federal University of Health Sciences of Porto Alegre, Brazil.
authors.forename: Angelo A
authors.initials: AA
authors.lastname: Mattos
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001938:Brazil; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003875:Drug Eruptions / Q000175:diagnosis / Q000209:etiology* / Q000401:mortality; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000009:adverse effects*; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D012307:Risk Factors; D000077157:Sorafenib; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
keywords: Dermatologic adverse events; hepatocellular carcinoma; overall survival