title: Quality of life as a prognostic factor of overall survival in patients with advanced hepatocellular carcinoma: results from two French clinical trials.
abstract: OBJECTIVE
  The aims of our study were to assess quality of life (QoL) as a prognostic factor of overall survival (OS) and to determine whether QoL data improved three prognostic classifications among French patients with advanced hepatocellular carcinoma (HCC).
  
  
  METHODS
  We pooled two randomized clinical trials conducted by the Fédération Francophone de Cancérologie Digestive in a palliative setting. In each trial QoL was assessed at baseline using the Spitzer QoL Index (0-10). Three prognostic classifications were calculated: Okuda, Cancer of the Liver Italian Program (CLIP), and Barcelona Clinic Liver Cancer group (BCLC) scores. To explore whether the scores could be improved by including QoL, univariate Cox analyses of all potential baseline predictors were performed. A final multivariate Cox model was constructed including only significant multivariate baseline variables likely to result in improvement of each scoring system. In order to retain the best prognostic variable to add for each score, we compared Akaike information criterion, likelihood ratio, and Harrell's C-index. Cox analyses were stratified for each trial.
  
  
  RESULTS
  Among 538 included patients, QoL at baseline was available for 489 patients (90%). Longer median OS was significantly associated with higher Spitzer scores at baseline, ranging from 2.17 months (Spitzer=3) to 8.93 months (Spitzer=10). Variables retained in the multivariate Cox model were: jaundice, hepatomegaly, hepatalgia, portal thrombosis, alphafetoprotein, bilirubin, albumin, small HCC, and Spitzer QoL Index (hazard ratio=0.84 95% CI [0.79-0.90]). According to Harrell's C-index, QoL was the best prognostic variable to add. CLIP plus the Spitzer QoL Index had the most discriminating value (C=0.71).
  
  
  CONCLUSIONS
  Our results suggest that QoL is an independent prognostic factor for survival in HCC patients with mainly alcoholic cirrhosis. The prognostic value of CLIP score could be improved by adding Spitzer QOL Index scores.
authors.affiliation: Methodological and Biostatistical unit, Fédération Francophone de Cancérologie Digestive, INSERM U866, Dijon, France. fbonnetain@dijon.fnclcc.fr
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Xavier
authors.initials: X
authors.lastname: Paoletti
authors.forename: Sandra
authors.initials: S
authors.lastname: Collette
authors.forename: Michel
authors.initials: M
authors.lastname: Doffoel
authors.forename: Olivia
authors.initials: O
authors.lastname: Bouché
authors.forename: Jean Luc
authors.initials: JL
authors.lastname: Raoul
authors.forename: Philippe
authors.initials: P
authors.lastname: Rougier
authors.forename: Fadil
authors.initials: F
authors.lastname: Masskouri
authors.forename: Jean Claude
authors.initials: JC
authors.lastname: Barbare
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
mesh_terms: D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000523:psychology*; D002986:Clinical Trials as Topic; D005260:Female; D005602:France; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D011581:Psychological Tests; D011594:Psychometrics; D011788:Quality of Life; D011795:Surveys and Questionnaires