High- versus standard-dose megestrol acetate in women with advanced breast cancer: a phase III trial of the Piedmont Oncology Association.
One hundred seventy-two patients with advanced breast cancer were randomized to receive oral standard-dose megestrol acetate (MA), 160 mg/d or high-dose MA, 800 mg/d. All but two patients had one prior trial of tamoxifen therapy for either metastatic disease (74%) or as adjuvant treatment (26%). Pretreatment characteristics were similar for both arms. High-dose MA resulted in a superior complete plus partial response rate (27% v 10%, P = .005), time to treatment failure (median, 8.0 v 3.2 months, P = .019), and survival (median, 22.4 v 16.5 months, P = .04) when compared with standard-dose therapy. These differences remained significant after adjustment for other covariates. Thirty-four patients were given high-dose MA after failure of standard-dose MA treatment, and none responded. Weight gain was the most distressing side effect, with 13% of standard-dose and 43% of high-dose patients gaining more than 20 lbs. Four major cardiovascular events occurred in patients receiving high-dose treatment and one in patients given standard doses. Other toxicity was modest. High-dose MA may represent a significant improvement in secondary endocrine therapy for advanced breast cancer patients refractory to initial endocrine treatment, but its use on a regular basis should be reserved until these results are confirmed by other clinical trials.
Muss
H B
HB
Piedmont Oncology Association, Cancer Center of Wake Forest University, Bowman Gray School of Medicine, Winston-Salem, NC 27103.
Case
L D
LD
Capizzi
R L
RL
Cooper
M R
MR
Cruz
J
J
Jackson
D
D
Richards
F
F
Powell
B L
BL
Spurr
C L
CL
White
D
D
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002318:Cardiovascular Diseases / Q000209:etiology; D005260:Female; D006801:Humans; D008535:Megestrol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019290:Megestrol Acetate; D008875:Middle Aged; D015996:Survival Rate; D015430:Weight Gain
D008535:Megestrol; D019290:Megestrol Acetate