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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).

Publication ,  Journal Article
Romanus, D; Kindler, HL; Archer, L; Basch, E; Niedzwiecki, D; Weeks, J; Schrag, D; Cancer and Leukemia Group B
Published in: J Pain Symptom Manage
February 2012

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.

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Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

February 2012

Volume

43

Issue

2

Start / End Page

205 / 217

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Survival Rate
  • Survival Analysis
  • Risk Factors
  • Risk Assessment
  • Quality of Life
  • Prevalence
  • Pancreatic Neoplasms
  • Palliative Care
 

Citation

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Romanus, D., Kindler, H. L., Archer, L., Basch, E., Niedzwiecki, D., Weeks, J., … Cancer and Leukemia Group B. (2012). 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). J Pain Symptom Manage, 43(2), 205–217. https://doi.org/10.1016/j.jpainsymman.2011.09.001
Romanus, Dorothy, Hedy L. Kindler, Laura Archer, Ethan Basch, Donna Niedzwiecki, Jane Weeks, Deborah Schrag, and Cancer and Leukemia Group B. “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).J Pain Symptom Manage 43, no. 2 (February 2012): 205–17. https://doi.org/10.1016/j.jpainsymman.2011.09.001.
Romanus, Dorothy, et al. “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).J Pain Symptom Manage, vol. 43, no. 2, Feb. 2012, pp. 205–17. Pubmed, doi:10.1016/j.jpainsymman.2011.09.001.
Romanus D, Kindler HL, Archer L, Basch E, Niedzwiecki D, Weeks J, Schrag D, Cancer and Leukemia Group B. 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). J Pain Symptom Manage. 2012 Feb;43(2):205–217.
Journal cover image

Published In

J Pain Symptom Manage

DOI

EISSN

1873-6513

Publication Date

February 2012

Volume

43

Issue

2

Start / End Page

205 / 217

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Survival Rate
  • Survival Analysis
  • Risk Factors
  • Risk Assessment
  • Quality of Life
  • Prevalence
  • Pancreatic Neoplasms
  • Palliative Care