Phase III evaluation of four doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia.
OBJECTIVE
Several placebo-controlled randomized clinical trials have demonstrated that megestrol acetate can result in appetite stimulation and nonfluid weight gain in patients with cancer anorexia/cachexia. The present trial was designed to compare megestrol acetate doses ranging from 160 to 1,280 mg/d.


METHODS
This trial randomized 342 assessable patients with cancer anorexia/cachexia to receive oral megestrol acetate at doses of 160, 480, 800, or 1,280 mg/d. Patients were evaluated monthly by history, examination, patient-completed questionnaires, and serum albumin levels.


RESULTS
The data demonstrate that there is a positive dose-response effect for megestrol acetate on appetite stimulation (P < or = .02). In concert, there was a trend for more nonfluid weight gain with higher drug doses. Megestrol acetate was well tolerated in this group of patients with advanced malignant disease.


CONCLUSIONS
The positive dose-response effect that we observed for megestrol acetate on appetite stimulation supports both our prestudy hypothesis and other available literature. Nonetheless, based primarily on the cost and inconvenience associated with the use of higher doses of this drug, it is reasonable to use 160 mg/d for the initial treatment of cancer anorexia/cachexia in routine clinical practice.
Loprinzi
C L
CL
Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905.
Michalak
J C
JC
Schaid
D J
DJ
Mailliard
J A
JA
Athmann
L M
LM
Goldberg
R M
RM
Tschetter
L K
LK
Hatfield
A K
AK
Morton
R F
RF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000188:drug therapy* / Q000209:etiology; D001066:Appetite / Q000187:drug effects; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008535:Megestrol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019290:Megestrol Acetate; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D011446:Prospective Studies; D015430:Weight Gain / Q000187:drug effects
D008535:Megestrol; D019290:Megestrol Acetate