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: 2.49). 08/2008; 17(6):831-43. DOI: 10.1007/s11136-008-9365-y
Source: PubMed


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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Available from: Franck Bonnetain, Apr 09, 2015
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    • "In a population with a hepatitis B virus (HBV) aetiology, Yeo et al. [17] found that QoL scales rated with the EORTC QLQ-C30 were independent prognostic factors for OS in patients with unresectable HCC. "
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    ABSTRACT: Background & aims: Several prognostic classifications (PCs) have been developed for use in palliative care in patients with hepatocellular carcinoma (HCC). We have recently suggested that CLIP combined with WHO PS has the greatest discriminative power. We evaluated the prognostic value of quality of life (QoL) data and whether the latter could improve classification of palliative HCC patients. Methods: This was a reanalysis from the CHOC trial with an evaluation of the discriminative power for overall survival (OS) of the established CLIP/GRETCH/BCLC/BoBar prognostic systems alone and then in association with each of the following groups of parameters: selected clinical factors, QoL as continuous variables, dichotomized QoL, selected clinical factors and continuous QoL, selected clinical factors and dichotomized QoL. Baseline QoL was assessed using the EORTC QLQ-C30. Discriminative power was evaluated with the Harrell's C-index and net reclassification improvement. Results: Quality of life was available in 79% of the patients (n=271). Univariate analysis revealed that better role functioning (HR=0.991 [0.987-0.995]) and better physical functioning (0.991 [0.984-0.997]) scores were associated with longer survival. In contrast, poorer score for fatigue (1.011 [1.006-1.015]) and diarrhoea (1.008 [1.002-1.013]) were associated with shorter survival. After adjustment for clinical and sociodemographic variables, only better role functioning score (0.993 [0.988-0.998]) was associated with longer survival. Adding oedema, hepatomegaly, fatigue and diarrhoea QoL scales to CLIP resulted in the best performance. Conclusions: Our results confirm that QoL scales are independent prognostic factors of OS in palliative HCC patients. Incorporation of QoL data improved all the studied PCs.
    Full-text · Article · Nov 2012 · Journal of Hepatology
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    • "Several different aspects of pretreatment HRQOL have been associated with survival in advanced cancer [13-16], breast cancer [17-19], lung cancer [5-8], oesophageal cancer [20-22], hepatocellular cancer [23], and head and neck cancer [24]. Even though few studies have been carried out in lung cancer patients, our results are in agreement with those in studies of lung cancer patients. "
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    ABSTRACT: Background Patients with non-small cell lung cancer (NSCLC) have a poor prognosis. The objective of this study was to examine the relationship of EORTC QLQ-C30 and QLQ-LC13 and survival in patients with NSCLC undergoing different treatments. Methods Investigators conducted a health-related quality of life (HRQOL) survey of 488 patients with NSCLC: 162 patients undergoing surgery, 312 patients without surgery, and their survival status was prospectively followed up. EORTC QLQ-C30 and QLQ-LC13 scores and clinical variables at baseline were analyzed using Cox’s proportional hazard regression to identify factors that influenced survival. Results Median survival of these 474 patients was 9.82 months. After adjustment, emotional functioning scale, and symptom scales of pain and nausea/vomiting are associated with survival in NSCLC patients with surgery whereas social functioning scale, and symptom scales for fatigue, appetite loss, and financial problems had a significant impact on survival in NSCLC patients without surgery. The results of multivariate analysis showed that none of QLQ-LC13 scales are significant predictors of survival. After simultaneously considering these scales, we found significant independent predictors of survival were nausea/vomiting (HR = 0.11, 95% CI = 0.02-0.63 for score >0 compared with =0) in NSCLC patients with surgery and appetite loss (HR = 1.77, 95% CI = 1.26-2.49 for score >0 compared with =0) in NSCLC patients without surgery. Conclusions HRQOL provides additional predictive information that supplements traditional clinical factors, and is a new prognostic indicator for survival of NSCLC patients under different treatments.
    Full-text · Article · Sep 2012 · BMC Public Health
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    • "F. Bonnetain / Cancer/Radiothérapie xxx (2010) xxx–xxx 3 • apports et pertinence de l'évaluation de la qualité de vie relative à la santé dans la pratique quotidienne au niveau individuel et à l'échelle d'une population [9] [20] [25] ; • analyses longitudinales de la qualité de vie relative à la santé : • recherches et réflexion sur les modalités d'analyses longitudinales et leur standardisation dans les essais cliniques [11] [3] [5] [6], • évaluation et prise en compte de l'occurrence de la Response Shift [5] [24], • prévention et prises en comptes des données manquantes [15] ; • détermination du sens clinique d'une différence ou d'un changement [15] [21]. • valeur pronostique de la qualité de vie relative à la santé et relation avec les critères cliniques : • valeur pronostique de la qualité de vie relative à la santé [4] [14], • relation entre progression, récidive, réponse, toxicité et qualité de vie [3], • évaluation de la qualité de vie relative à la santé en tant que critère substitutif de la survie globale [3] [18]. "
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    ABSTRACT: In order to perform a clinical trial in oncology, the choice of the primary endpoint is a major concern, not only for sample size calculation but also regarding the clinical meaning of the results which represents treatment utility for patients or public health system. Endpoints could be classified in two categories: “clinical endpoints” including overall survival and health related quality of life (QoL); “biological markers” including, for example, progression free survival (PFS). If conceptual and methodological limits of quality of life are well identified with dedicated researches, limits of progression free survival remain less targeted and known by clinicians. Numerous clinical trials having only demonstrated a progression free survival benefit could be discussed according to clinical benefit. In this context, quality of life constitutes an available and a useful alternative endpoint for trials to ensure treatment benefit in a patient or public health point of view. As quality of life, methodological researches should be pursued to improve scientific robustness for assessments and analyses of progression free survival.
    Full-text · Article · Oct 2010 · Cancer/Radiothérapie
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