Effect of megestrol acetate on quality of life in a dose-response trial in women with advanced breast cancer Journal Article


Authors: Kornblith, A. B.; Hollis, D. R.; Zuckerman, E.; Lyss, A. P.; Canellos, G. P.; Cooper, M. R.; Herndon, J. E. 2nd; Phillips, C. A.; Abrams, J.; Aisner, J.; Norton, L.; Henderson, C.; Holland, J. C.; for the Cancer and Leukemia Group B
Article Title: Effect of megestrol acetate on quality of life in a dose-response trial in women with advanced breast cancer
Abstract: Purpose: The impact of the side effects of megestrol acetate on the quality of life of noncachectic women with advanced breast cancer was studied in a dose-response clinical trial of the Cancer and Leukemia Group B (CALGB 8741). Side effects of appetite increase and weight gain at higher doses were predicted to have a negative effect on quality of life. Patients and Methods: Stage IV breast cancer patients were randomized to receive either 160, 800, or 1,600 mg/d of megestrol acetate. Quality of life was assessed in 131 patients at trial entry and at 1 and 3 months while on treatment, by telephone interview, using the following measures: the Functional Living Index-Cancer (FLIC), Rand Functional Limitations Scale, Rand Mental Health Inventory (MHI), the Body Image Subscale, and linear analog scales of drug side effects. Results: At 3 months, women treated with 160 mg/d reported less severe side effects (P < .0005), better physical functioning (FLS, P < .0005), less psychologic distress (MHI, P = .008), and an improvement in overall quality of life (FLIC, P = .003) from the time of study entry as compared with those treated with 1,600 mg/d. Patients who received the 800- mg/d dose fell between the low- and high-dose arms in reported intensity of drug side effects, but responded similarly to those in the 160-mg/d group in terms of physical functioning, psychologic distress, and overall quality of life. Conclusion: Unless additional follow-up data demonstrate a survival advantage at higher doses, the 160-mg/d dose is optimal, achieving maximal treatment effect with the fewest side effects and better quality of life.
Keywords: adult; cancer survival; controlled study; aged; major clinical study; clinical trial; fatigue; advanced cancer; quality of life; breast cancer; randomized controlled trial; obesity; cancer hormone therapy; megestrol acetate; psychologic assessment; dose time effect relation; human; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 11
Issue: 11
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1993-11-01
Start Page: 2081
End Page: 2089
Language: English
DOI: 10.1200/jco.1993.11.11.2081
PUBMED: 8229122
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 1 March 2019 -- Source: Scopus
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  1. Larry Norton
    758 Norton
  2. Jimmie C B Holland
    379 Holland