Quality of life as a prognostic factor of overall survival in patients with advanced hepatocellular carcinoma: results from two French clinical trials.

Methodological and Biostatistical unit, Fédération Francophone de Cancérologie Digestive, INSERM U866, Dijon, France.
Quality of Life Research (Impact Factor: 2.86). 08/2008; 17(6):831-43. DOI: 10.1007/s11136-008-9365-y
Source: PubMed

ABSTRACT 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).
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.
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).
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.

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    ABSTRACT: Hepatocellular carcinoma (HCC) is a common and rapidly fatal cancer ranking third among the leading causes of cancer-related deaths. Potentially curative therapies like surgery, transplant and ablation are not an option for most patients as they are often diagnosed when the disease is advanced. Liver directed therapy and oral targeted therapies are used in these patients to prolong life and palliate symptoms of the cancer and associated liver failure. Overall survival remains poor and hence health-related quality of life (HRQoL) is of paramount importance in these patients. As novel therapies are developed to improve outcomes, a comprehensive knowledge of available tools to assess impact on QoL is needed. Hence we reviewed all the studies in HCC patients published within the last 13 years from 2001-2013 which assessed HRQoL as a primary or secondary endpoint. A total of 45 studies and 4 meta-analysis were identified. Commonly used tools were European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (15 studies) and the Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep) (14 studies). Of the 45 publications which incorporated HRQoL as end-point only 24 were clinical trials, 17/24 (71%) assessed systemic therapies while 7/24 (29%) assessed liver-directed therapies. Majority of the publications (trials + retrospective reviews) that had HRQoL as an endpoint in HCC patients were studies evaluating liver-directed therapies (23/45 or >50%). We discuss the measures included in the tools, their interpretation, and summarize existing QoL data that will help design future HCC trials.
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