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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.

AbstractPURPOSE:
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.
PATIENTS AND 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.
CONCLUSION:
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.
AuthorsE Beller, M Tattersall, T Lumley, J Levi, D Dalley, I Olver, J Page, E Abdi, C Wynne, M Friedlander, D Boadle, H Wheeler, S Margrie, R J Simes
JournalAnnals of oncology : official journal of the European Society for Medical Oncology / ESMO (Ann Oncol) Vol. 8 Issue 3 Pg. 277-83 (Mar 1997) ISSN: 0923-7534 [Print] NETHERLANDS
PMID9137798 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
Chemical References
  • Appetite Stimulants
  • Hormones
  • Placebos
  • Megestrol Acetate
Topics
  • Aged
  • Appetite Stimulants (adverse effects, therapeutic use)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Hormones (therapeutic use)
  • Humans
  • Male
  • Megestrol Acetate (adverse effects, therapeutic use)
  • Middle Aged
  • Neoplasms (therapy)
  • Nutritional Status
  • Placebos
  • Quality of Life
  • Surveys and Questionnaires
  • Survival Rate
  • Treatment Outcome

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