Does Health-Related Quality of Life Improve for Advanced Pancreatic Cancer Patients Who Respond to Gemcitabine? Analysis of a Randomized Phase III Trial of the Cancer and Leukemia Group B (CALGB 80303)

Abstract

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.

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“…Also in accordance with other studies. [15,[25][26][27][28][29]31,32] Otherwise, of our findings, there are other studies [24,30] who have concluded that Fol significantly reduces QOL impairment in patients with metastatic pancreatic cancer, because of the increased toxicity of Fol.…”

“…Other authors also concluded that Gem did not improve QOL for patients who respond to treatment, so it did affect their emotional and functional status. [31,32] The functional well-being is also better in fol arm compared to Gem arm. Patients in fol arm claimed that it helped them to cope better with depression and anxiety.…”

“…Even though there are differences in the above studies, [19][20][21][22][23][24][25][26][27][28][29][30][31][32] most of them conclude that Fol compared to Gem improves the overall QOL.…”

Cost-effectiveness of FOLFIRINOX for first-line treatment of metastatic pancreatic cancer

“…Our analysis therefore made use of the average utility value for stable disease (that is, 0.80) and the lower value from the range reported for progressive disease (that is, 0.73), given that the 8-week value would be representative of the patients in our model, being carried through progressive disease until death. Similarly, Romanus et al 11 reported the utility value for a partial response as 0.83, and that value was also incorporated into our model ( Table i).…”

“…Similarly, the difference in pfs between the treatment groups was very minimal-2.87 months and 2.89 months for the Weibull and Kaplan-Meier curves respectively. 11 , who reported utilities for both stable and progressed pancreatic cancer patients treated with gemcitabine. In that study, patients with advanced pancreatic cancer participating in the Cancer and Leukemia Group B multicentre double-blind randomized 80303 trial, which compared os in two treatment arms (gemcitabine plus bevacizumab, gemcitabine plus placebo), were evaluated on their health-related qol using the EuroQol instrument (EQ-5D) at baseline and at 8 weeks.…”