title: Randomized, placebo-controlled, phase III surgical adjuvant clinical trial of megestrol acetate (Megace) in selected patients with malignant melanoma.
abstract: A randomized, double-blind, placebo-controlled phase III clinical trial was performed to assess megestrol acetate (Megace) as a postsurgical adjuvant therapy for patients with locally advanced malignant melanoma. Patients whose tumors were greater than 1.7 mm thick and had no regional lymph node involvement and patients with regional lymph node involvement were randomized to receive either 160 mg twice per day oral suspension of megestrol acetate or placebo. Treatment was administered for a maximum of 2 years or until disease progression. The study accrued 262 eligible patients. All but two patients were followed until death or a minimum of 4.5 years. Disease progression was documented in 156 patients. Neither progression-free survival (PFS) nor overall survival (OS) was found to differ between the treatments. The median PFS was 2.4 years in the megestrol acetate arm and 2.3 years in the placebo arm. Multivariate analysis revealed a significantly decreased PFS for patients with four or more positive regional lymph nodes and metachronous nodal disease. Median OS was 5.3 years in the megestrol acetate arm and 3.9 years in the placebo arm. Multivariate analysis revealed that OS was significantly decreased for patients 70 years of age or older with four or more positive lymph nodes. Adjuvant therapy with megestrol acetate oral suspension administered at a dose of 160 mg twice a day for 2 years was not found to be effective in prolonging PFS or OS in patients with surgically resected, locally advanced melanoma.
authors.affiliation: Mayo Clinic, 200 First Street, SW, Rochester, MN 55905, USA.
authors.forename: Svetomir
authors.initials: S
authors.lastname: Markovic
authors.forename: Vera J
authors.initials: VJ
authors.lastname: Suman
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Dalton
authors.forename: John E
authors.initials: JE
authors.lastname: Woods
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Fitzgibbons
authors.forename: Lester E
authors.initials: LE
authors.lastname: Wold
authors.forename: Jan C
authors.initials: JC
authors.lastname: Buckner
authors.forename: John W
authors.initials: JW
authors.lastname: Kugler
authors.forename: James A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: Kendrith M
authors.initials: KM
authors.lastname: Rowland
authors.forename: James E
authors.initials: JE
authors.lastname: Krook
authors.forename: David W
authors.initials: DW
authors.lastname: Brown
authors.forename: Maria Tria
authors.initials: MT
authors.lastname: Tirona
authors.forename: Edward T
authors.initials: ET
authors.lastname: Creagan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D019290:Megestrol Acetate / Q000627:therapeutic use*; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D008875:Middle Aged; D015999:Multivariate Analysis; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D019290:Megestrol Acetate