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).

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

CONTEXT: Gemcitabine for advanced pancreatic cancer (APC) is palliative and the 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 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 the 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=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 scores was observed (70.7 vs. 68.2, P=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. Visual analogue scale 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=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.

Full Text

Duke Authors

Cited Authors

  • Romanus, D; Kindler, HL; Archer, L; Basch, E; Niedzwiecki, D; Weeks, J; Schrag, D; Cancer and Leukemia Group B,

Published Date

  • February 2012

Published In

Volume / Issue

  • 43 / 2

Start / End Page

  • 205 - 217

PubMed ID

  • 22104618

Pubmed Central ID

  • PMC3658140

Electronic International Standard Serial Number (EISSN)

  • 1873-6513

Digital Object Identifier (DOI)

  • 10.1016/j.jpainsymman.2011.09.001


  • eng

Conference Location

  • United States