title: 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.
abstract: 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.
authors.affiliation: Memorial Sloan-Kettering Cancer Center/Cornell University Medical College, New York, NY 10021.
authors.forename: A B
authors.initials: AB
authors.lastname: Kornblith
authors.forename: D R
authors.initials: DR
authors.lastname: Hollis
authors.forename: E
authors.initials: E
authors.lastname: Zuckerman
authors.forename: A P
authors.initials: AP
authors.lastname: Lyss
authors.forename: G P
authors.initials: GP
authors.lastname: Canellos
authors.forename: M R
authors.initials: MR
authors.lastname: Cooper
authors.forename: J E
authors.initials: JE
authors.lastname: Herndon
authors.forename: C A
authors.initials: CA
authors.lastname: Phillips
authors.forename: J
authors.initials: J
authors.lastname: Abrams
authors.forename: J
authors.initials: J
authors.lastname: Aisner
mesh_terms: 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
chemical_list: D008535:Megestrol; D019290:Megestrol Acetate