Multivariate quality of life (QoL) prognostic factor analysis in hepatocellular carcinoma (HCC)

Abstract

4162 Background: The aim of this study was to explore whether pre-treatment quality of life (QoL) predicts survival in patients with non-operable HCC. Methods: Between 1995 and 2002, 123 eligible cirrhotic patients of Child-Pugh class A or B with unresectable HCC of Okuda stage I or II were included in a randomized multicentric phase III trial (FFCD 9402). At baseline, the clinician measured QoL ranging from 0 to 10 with Spitzer index. The overall survival (OS) was calculated until death or last follow-up using the Kaplan-Meier method. A univariate assessment of the prognostic effect of each baseline factor using Cox model was performed to calculated hazard ratio (HR) with 95% CI. Multivariate analysis was performed using backward stepwise Cox proportional hazards regression modeling (p = 0.05 to add and 0.10 to sort). Results: According to Spitzer QoL Index (N= 94) the median of OS ranged from 2.4 (Spitzer = 6) to 21.8 (Spitzer =10) months. It was respectively 3.9 and 18.6 months among patients with QoL < 9 (N=36) and ≥ 9 (N=58). Relevant or univariate significant factors included for multivariate analyses were: Spitzer (ordinal score, p< 0.0001), WHO performance status > 0 (p =0.015), sex (women vs men, NS), Okuda stage (II vs I, p< 0.0001), included patients by center < 6 (NS), treatment (Chemoembolization vs Tamoxifen, NS), alcohol cirrhosis (NS), Child-Pugh class (B vs A, p< 0.0001), hepatomegaly (p =0.03), hepatalgia (p< 0.0001), age ≥ 65 years, (NS), AFP ≥ 400 ng/ml (p< 0.0001), icterus (p=0.01), Diameter of the main nodule ≥ 5cm (p=0.14), tumor stage multinodular (p =0.014), and portal vein thrombosis (NS). Seven independent prognostic factors were retained by multivariate analysis: Spitzer QoL Index (HR = 0.79 [0.6 - 0.97]), Hepatalgia (HR = 2.31 [1.3 - 4.3], sex (HR = 0.49 [0.2 - 0.97], Child-Pugh (HR = 2.01 [1.2 - 3.44], AFP (HR = 2.47 [1.5 - 4.11], Center (HR = 2.46 [1.3 - 4.60]) and hepatomegaly (HR = 1.92 [1.2 - 3.12]). Conclusions: QoL could help individual HCC patient risk stratification and to plan future phase III trials. No significant financial relationships to disclose.