Effect of megestrol acetate on quality of life in a dose-response trial in women with advanced breast cancer. The Cancer and Leukemia Group B.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Kornblith
A B
AB
Memorial Sloan-Kettering Cancer Center/Cornell University Medical College, New York, NY 10021.
Hollis
D R
DR
Zuckerman
E
E
Lyss
A P
AP
Canellos
G P
GP
Cooper
M R
MR
Herndon
J E
JE
Phillips
C A
CA
Abrams
J
J
Aisner
J
J
D001066:Appetite / Q000187:drug effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D016014:Linear Models; D008535:Megestrol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019290:Megestrol Acetate; D008875:Middle Aged; D015999:Multivariate Analysis; D011788:Quality of Life; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
D008535:Megestrol; D019290:Megestrol Acetate