Does change in health-related quality of life (HRQoL) score predict survival? Analysis of a lung cancer RCT.

Abstract

7607 Background: Over 60 cancer clinical trials have shown that baseline health-related quality of life (HRQoL) scores are prognostic for patient survival. Few studies have investigated the added value of change in HRQoL scores. Our aim was to investigate if change in HRQoL scores from baseline over time is also associated with survival. Methods: We analyzed data from an EORTC 3-arm randomized clinical trial (RCT) in advanced non-small-cell lung cancer (NSCLC) patients, comparing gemcitabine+cisplatin, versus paclitaxel+gemcitabine, versus standard arm paclitaxel+cisplatin. HRQoL was measured in 394 patients using the EORTC QLQ-C30 at baseline and after each chemotherapy cycle. The prognostic significance of sex, age and WHO performance status (0-1 vs. 2) and the 15 QLQ-C30 subscales were assessed with Cox proportional hazard models stratified for treatment (level of significance 0.05). Changes in HRQoL scores from baseline to each chemotherapy cycle assessment were categorized as “improved”, “stable” and “worsened” using a threshold of 10 points difference. Due to expected attrition, the analysis was limited to changes from baseline up to cycle 3. Results: There were 248 patients in cycle 1, 212 in cycle 2 and 196 in cycle 3. We performed analyses separately using data at cycle 1, cycle 2, and cycle 3. In all analyses, HRQoL in various subscales and socio-demographic and clinical variables (physical functioning (hazard ratio [HR] 0.91, 95% CI 0.85-0.98; p=0.0103), pain (1.11, 1.05-1.17; p= 0.0004), age (0.98, 0.97-1.00, p=0.0413) and WHO performance status (1.77, 1.09-2.89; p=0.0218) at cycle 1; pain (1.11, 1.03-1.20; p=0.0016), age (0.98, 0.96-1.00; p=0.0217) and sex (0.63, 0.42-0.95; p=0.0081) at cycle 2; and role functioning (0.93, 0.88-1.00; p=0.0128) and age (0.98, 0.96-1.00; p=0.0081) at cycle 3) predicted survival; however, change in HRQoL was only an independent predictor for improvement at cycle 1. Conclusions: Our findings suggest that change from baseline over time in HRQoL, as measured on subscales of the EORTC QLQ-C30, contains added prognostic value for survival independent of baseline HRQoL scores. Further work is needed to assess the robustness and sensitivity of these findings.