TY - JOUR
T1 - Effect of megestrol acetate on quality of life in a dose-response trial in women with advanced breast cancer
AU - Kornblith, Alice B.
AU - Hollis, Donna R.
AU - Zuckerman, Enid
AU - Lyss, Alan P.
AU - Canellos, George P.
AU - Robert Cooper, M.
AU - Herndon, James E.
AU - Phillips, Carol Ann
AU - Abrams, Jeffrey
AU - Aisner, Joseph
AU - Norton, Larry
AU - Henderson, Craig
AU - Holland, Jimmie C.
PY - 1993
Y1 - 1993
N2 - 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 160mg/d dose is optimal, achieving maximal treatment effect with the fewest side effects and better quality of life.
AB - 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 160mg/d dose is optimal, achieving maximal treatment effect with the fewest side effects and better quality of life.
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M3 - Article
C2 - 8229122
AN - SCOPUS:0027442957
SN - 0732-183X
VL - 11
SP - 2081
EP - 2089
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 11
ER -