title: Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: a randomised placebo-controlled trial. Australasian Megestrol Acetate Cooperative Study Group.
abstract: OBJECTIVE
  To investigate the effect of two doses of megestrol acetate (MA) compared with placebo on quality of life (QoL) and nutritional status (NS) in patients with advanced endocrine-insensitive cancer.
  
  
  METHODS
  Two hundred forty patients were randomised to double-blind MA 480 mg/day, MA 160 mg/day, or matching placebo for 12 weeks. Nutritional status (including weight, skinfold thickness and midarm circumference) and QoL (using 6 linear analogue self-assessment (LASA) scales) were assessed at randomisation and after four, eight and 12 weeks. A QoL ranking incorporating QoL and death was also used ranging from 1 = dead to 5 = much better QoL.
  
  
  RESULTS
  One hundred seventy-four patients were assessable at week four, 136 at week eight and 103 patients at week 12. Patients receiving MA reported substantially better appetite (P = 0.001), mood (P = 0.001) and overall quality of life (P < 0.001), and possibly less nausea and vomiting (P = 0.08) than patients receiving placebo, based on a test for trend. A larger benefit was seen with the higher dose which (unlike the lower dose) was significantly better in pairwise comparisons with placebo for appetite, mood and overall QoL (each P < or = 0.001). Despite some missing data on QoL scores, QoL ranking was available on 227 (95%) of patients with significantly higher QoL ranking associated with MA (P = 0.002). Improvements in QoL occurred early within four weeks and were sustained. No statistically significant differences were observed in NS measurements, including weight (P = 0.29). Side effects of therapy were minor and did not differ significantly across treatments.
  
  
  CONCLUSIONS
  Megestrol acetate given at 480 mg/day is useful palliation in patients with endocrine-insensitive advanced cancer. It improves appetite, mood and overall quality of life in these patients, although not through a direct effect on nutritional status.
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Australia.
authors.forename: E
authors.initials: E
authors.lastname: Beller
authors.forename: M
authors.initials: M
authors.lastname: Tattersall
authors.forename: T
authors.initials: T
authors.lastname: Lumley
authors.forename: J
authors.initials: J
authors.lastname: Levi
authors.forename: D
authors.initials: D
authors.lastname: Dalley
authors.forename: I
authors.initials: I
authors.lastname: Olver
authors.forename: J
authors.initials: J
authors.lastname: Page
authors.forename: E
authors.initials: E
authors.lastname: Abdi
authors.forename: C
authors.initials: C
authors.lastname: Wynne
authors.forename: M
authors.initials: M
authors.lastname: Friedlander
authors.forename: D
authors.initials: D
authors.lastname: Boadle
authors.forename: H
authors.initials: H
authors.lastname: Wheeler
authors.forename: S
authors.initials: S
authors.lastname: Margrie
authors.forename: R J
authors.initials: RJ
authors.lastname: Simes
mesh_terms: D000368:Aged; D019167:Appetite Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006728:Hormones / Q000627:therapeutic use; D006801:Humans; D008297:Male; D019290:Megestrol Acetate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D009752:Nutritional Status; D010919:Placebos; D011788:Quality of Life; D011795:Surveys and Questionnaires; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D019167:Appetite Stimulants; D006728:Hormones; D010919:Placebos; D019290:Megestrol Acetate