title: A prospective, randomized controlled trial of megestrol acetate among high-risk patients with resected malignant melanoma.
abstract: In light of some evidence that hormonal factors may impact on malignant melanoma, we performed a randomized trial of megestrol acetate versus observation among 67 patients with high-risk resected stage I or stage II (nodal) malignant melanoma. Following stratification by relevant prognostic factors, we observed a statistical significance in survival advantage for megestrol acetate that approached 7.6 versus 2.6 years, median survival; two-sided log rank p = 0.06. Disease-free survival was also greater for patients who received this hormonal therapy (3.4 versus 1.1 years, median disease-free survival), but the difference was not statistically significant (two-sided log rank p = 0.20). The most noteworthy side effects were weight gain (median 6-month gain of 8.2 kg) and impotence. Fully recognizing the hazards of limited sample analyses and the need for confirmatory trials, our findings suggest a possible role for megestrol acetate as adjuvant therapy for selected patients with malignant melanoma.
authors.affiliation: Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905.
authors.forename: E T
authors.initials: ET
authors.lastname: Creagan
authors.forename: J N
authors.initials: JN
authors.lastname: Ingle
authors.forename: A J
authors.initials: AJ
authors.lastname: Schutt
authors.forename: D J
authors.initials: DJ
authors.lastname: Schaid
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008535:Megestrol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019290:Megestrol Acetate; D008545:Melanoma / Q000188:drug therapy / Q000601:surgery*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011379:Prognosis; D011446:Prospective Studies; D011897:Random Allocation; D012307:Risk Factors; D013997:Time Factors; D015430:Weight Gain
chemical_list: D008535:Megestrol; D019290:Megestrol Acetate