A planned, prospective comparison of short-term quality of life outcomes among older patients with breast cancer treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901 Journal Article


Authors: Mandelblatt, J. S.; Makgoeng, S. B.; Luta, G.; Hurria, A.; Kimmick, G.; Isaacs, C.; Tallarico, M.; Barry, W. T.; Pitcher, B.; Winer, E. P.; Hudis, C.; Cohen, H. J.; Muss, H. B.
Article Title: A planned, prospective comparison of short-term quality of life outcomes among older patients with breast cancer treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901
Abstract: Objectives: Patients ≥. 65. years old ("older") are often not included in randomized clinical trials (RCT), but when they are, care in an RCT might improve quality of life (QoL). We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study ("off-trial"). Methods: Older women with invasive, non-metastatic breast cancer (n. =. 150 RCT; 530 off-trial) were included. Linear mixed-effects models tested associations between chemotherapy on- vs. off-trial and changes in EORTC (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) QoL scores over 24. months, controlling for pre-treatment QoL, age, education, tumor factors, comorbidity, and other covariates. Results: Anthracycline regimens were used by 58% of women treated on-trial vs. 54% of those treated off-trial. Women in the RCT reported an adjusted mean increase of 13.7 points (95% CI 10.2, 17.1) in global QoL at 24. months (vs. mid-treatment), while women treated off-trial had only an adjusted improvement of 7.0 points (95% CI 3.5, 10.4; p. =. .007 for difference in mean changes). Women in the RCT had significantly greater improvement in emotional function than those treated off-trial, controlling for baseline; they also had greater reductions in therapy side effects and fatigue at 24. months than women off-trial, controlling for covariates. Conclusion: There may be different QoL trajectories for older women undergoing breast cancer chemotherapy on- vs. off-trial. If confirmed, the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population. © 2013 Elsevier Inc.
Keywords: chemotherapy; quality of life; breast cancer; older patients; randomized clinical trials; observational studies
Journal Title: Journal of Geriatric Oncology
Volume: 4
Issue: 4
ISSN: 1879-4068
Publisher: Elsevier Inc.  
Date Published: 2013-10-01
Start Page: 353
End Page: 361
Language: English
DOI: 10.1016/j.jgo.2013.05.004
PROVIDER: scopus
PMCID: PMC3910230
PUBMED: 24472479
DOI/URL:
Notes: --- - "Export Date: 1 November 2013" - "Source: Scopus"
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  1. Clifford Hudis
    848 Hudis