Does health-related quality of life (HRQL) improve for patients who respond to chemotherapy? Analysis of patients with advanced pancreas cancer (APC) receiving gemcitabine on Cancer and Leukemia Group B (CALGB) study #80303

Abstract

9008 Background: Gemcitabine chemotherapy for APC is palliative and confers only modest survival advantage. Therefore HRQL concerns are of paramount importance. Methods: We compared HRQL scores based on response to chemotherapy at the first interval restaging (8 weeks). We evaluated HRQL at baseline on paper, and then q8 weeks by phone using the EQ5D instrument in patients with APC participating in a double-blind, randomized trial comparing overall survival for gemcitabine with bevacizumab (GB) or placebo (GP). The EQ5D is a HRQL measure whose composite (C) and visual analog scale (VAS) scores respectively reflect societal and patient valuations. Results: Among 552 patients starting protocol treatment, characteristics did not differ between 359 who did and 193 who didn’t complete baseline assessments. Patients who didn’t complete 8 week assessments were more likely to have died, progressed or discontinued protocol therapy. Changes in EQ5D scores from baseline to 8 weeks did not differ by treatment arm (p-values=0.84, 0.79 for C and VAS scales, Wilcoxon rank sum test). At 8 weeks, all patients and those with progressive disease had a modest decline in VAS scores (p-values≤0.02, Wilcoxon signed rank test). Comparisons of changes from baseline in C scores at 8 week follow-up revealed no differences within other response group strata (all p-values > 0.05). Conclusions: Based on this preliminary analysis, gemcitabine therapy was not associated with higher HRQL scores, nor was there any strong association between tumor response and HRQL. To increase data representativeness, future APC trials should assess HRQL more often than every 8 weeks. HRQL Scores Based on Gemcitabine Response Strata. Values are Mean (SD) [Table: see text] [Table: see text]