title: High- versus standard-dose megestrol acetate in women with advanced breast cancer: a phase III trial of the Piedmont Oncology Association.
abstract: 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.
authors.affiliation: Piedmont Oncology Association, Cancer Center of Wake Forest University, Bowman Gray School of Medicine, Winston-Salem, NC 27103.
authors.forename: H B
authors.initials: HB
authors.lastname: Muss
authors.forename: L D
authors.initials: LD
authors.lastname: Case
authors.forename: R L
authors.initials: RL
authors.lastname: Capizzi
authors.forename: M R
authors.initials: MR
authors.lastname: Cooper
authors.forename: J
authors.initials: J
authors.lastname: Cruz
authors.forename: D
authors.initials: D
authors.lastname: Jackson
authors.forename: F
authors.initials: F
authors.lastname: Richards
authors.forename: B L
authors.initials: BL
authors.lastname: Powell
authors.forename: C L
authors.initials: CL
authors.lastname: Spurr
authors.forename: D
authors.initials: D
authors.lastname: White
mesh_terms: 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
chemical_list: D008535:Megestrol; D019290:Megestrol Acetate