VALIDATION STUDY OF THE BASELINE QUALITY OF LIFE AS A PROGNOSTIC INDICATOR OF SURVIVAL- A POOLED ANALYSIS OF INDIVIDUAL PATIENT DATA FROM NCIC CLINICAL TRIALS
Author(s)
Ediebah DE1, Quinten C2, Coens C3, Zikos E1, Ringash J4, Gotay C5, Flechtner HH6, Osoba D7, King M8, Cleeland C9, Greimel E10, Reeve BB11, Taphoorn M12, Schmucker-Von Koch J13, Weis J14, Bottomley A31European Organisation for Research and Treatment of Can
OBJECTIVES: Our aims were to investigate the association between baseline health-related quality of life (HRQOL) scores of the EORTC QLQ-C30 and survival. METHODS: We analyzed data from pooled, randomized, controlled trials from National Cancer Institute Canada Clinical Trials Group started between 1991 and 2004, which included survival data from 3635 patients with 8 different cancer sites. Sociodemographic variables were sex (men vs. women) and age ( 60 vs. > 60), and clinical variables were WHO performance status (0-1 vs. 2-3) and distant metastases (no vs. yes). The prognostic significance of sociodemographic and clinical variables and the 15 QLQ-C30 scales were assessed with Cox proportional hazard models stratified for cancer site. RESULTS: In the stratified multivariate model including sociodemographic, clinical, and HRQOL data, the HRQOL parameters of global QOL/health status (hazard ratio [HR] 1.097, 95% CI 1.05- 1.14; p<.0001), physical function (0.94, 0.897-0.98; p=0.0010), dyspnoea (1.04, 1.00-1.07; p=0.0120), and appetite loss (1.06, 1.03-1.09; p<.0001) provided significant prognostic information in addition to the sociodemographic and clinical variables. The gain in predictive accuracy of prognosis of overall survival of the four HRQOL parameters over the sociodemographic and clinical characteristics was 3% (Harrell’s C-index for sociodemographic and clinical variables = 0.69, and for sociodemographic, clinical, and HRQOL variables = 0.71). The model developed by Quinten et al. 2009 included pain but this was not found to be statistically significant in our model. CONCLUSIONS: Our findings suggest that HRQOL scales of the EORTC QLQ-C30 provide prognostic information in addition to that of sociodemographic and clinical measures. This replicates previous findings (Quinten et al., 2009) showing that HRQOL data can help to predict survival in patients with cancer, although the specific HRQOL domains that are predictive may vary. The impact of these findings for clinical management (e.g., in stratification for clinical trials entry or treatment decision making) need additional study.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
CN3
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology