Context
Gemcitabine for advanced pancreas cancer (APC) is palliative and prognosis is poor, making health-related quality of life (HRQOL) particularly important.
Objectives
We evaluated HRQOL with the EuroQol EQ-5D™, in patients with APC participating in Cancer and Leukemia Group B (CALGB) 80303, a multicenter, double-blind, randomized trial comparing overall survival (OS) between two treatment arms, gemcitabine with bevacizumab, or gemcitabine with placebo.
Methods
A consecutive subsample of patients was invited to complete the EQ-5D surveys. Because neither clinical nor HRQOL outcomes differed based on study arm, analyses were pooled. Changes in mean scores from baseline to eight weeks and the prognostic value of the EQ-5D were evaluated.
Results
Mean index scores remained stable (0.78 at baseline [n=267], 0.79 at eight weeks [n=186], P-value=0.34, Wilcoxon signed rank test), attributable to a modest deterioration of physical function domain scores coincident with small improvements in pain and anxiety/depression scores. A small decline in visual analogue scale (VAS) scores was observed (70.7 vs. 68.2, P-value=0.026). HRQOL changes within chemotherapy response strata revealed stable index scores, but a trend of worsened physical function among patients with disease progression compared with those with stable or improved disease. VAS scores trended downward over time irrespective of chemotherapy response status, with a statistically meaningful deterioration in patients who progressed (68.9 vs. 64.4, P-value=0.029). Baseline scores from both EQ-5D scales were significant predictors of OS in Cox proportional hazard models.
Conclusion
Response to gemcitabine treatment in APC is not associated with appreciable improvement of global HRQOL. Small improvements in pain and mood are observed despite progressive functional decline. Those who respond to gemcitabine may experience a slight slowing of functional deterioration.