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Randomized, Placebo-Controlled, Phase III Surgical Adjuvant Clinical Trial of Megestrol Acetate (Megace) in Selected Patients With Malignant Melanoma

Markovic, Svetomir M.D., Ph.D.; Suman, Vera J. Ph.D.; Dalton, Robert J. M.D.; Woods, John E. M.D.; Fitzgibbons, Robert J. Jr. M.D.; Wold, Lester E. M.D.; Buckner, Jan C. M.D.; Kugler, John W. M.D.; Mailliard, James A. M.D.; Rowland, Kendrith M. M.D.; Krook, James E. M.D.; Brown, David W. M.D.; Tirona, Maria Tria M.D.; Creagan, Edward T. M.D.

American Journal of Clinical Oncology: December 2002 - Volume 25 - Issue 6 - p 552-556

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.

From the Mayo Clinic and Mayo Foundation (V.J.S., J.E.W., L.E.W., J.C.B., E.T.C), Rochester, Minnesota; Duluth CCOP (R.J.D., J.E.K.), Duluth, Minnesota; Missouri Valley Cancer Consortium (R.J.F., J.A.M), Omaha, Nebraska; Illinois Oncology Research Association CCOP (J.W.K.), Peoria, Illinois; Carle Cancer Center Community Clinical Oncology Program (K.M.R.), Urbana, Illinois; Toledo Community Hospital Oncology Program CCOP (D.W.B.), Toledo, Ohio; Saskatoon Cancer Centre, Saskatoon, Saskatchewan (M.T.T.), Canada; and Allan Blair Cancer Centre, Regina, Saskatchewan, Canada.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-15083, CA-35269, CA-63849, CA-35113, CA-35195, CA-35415, CA-35101, CA-35272, CA-35103, CA-35448, CA-37417, CA-52352, CA-63826, and CA-60276 from the National Cancer Institute, Department of Health and Human Services.

Address correspondence and reprint requests to Dr. Svetomir Markovic, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905, U.S.A.

Additional participating institutions include: Iowa Oncology Research Association CCOP, Des Moines, Iowa (Roscoe F. Morton, M.D.); Grand Forks Clinic, Ltd., Grand Forks, North Dakota (Daniel J. Walsh, M.D.); Ochsner Community Clinical Oncology Program, New Orleans, Louisiana (Carl G. Kardinal, M.D.); Siouxland Hematology–Oncology Associates, Sioux City, Iowa (John C. Michalak, M.D.); Geisinger Clinic and Medical Center CCOP, Danville, Pennsylvania (Suresh Nair, M.D.); Meritcare Hospital CCOP, Fargo, North Dakota (Ralph Levitt, M.D.); Cedar Rapids Oncology Project CCOP, Cedar Rapids, Iowa (Martin Wiesenfeld, M.D.); Quain and Ramstad Clinic, Bismarck, North Dakota (Delano M. Pfeifle, M.D.); Mayo Clinic Scottsdale CCOP, Scottsdale, Arizona (Richard Wheeler, M.D.); Rapid City Regional Oncology Group, Rapid City, South Dakota (Larry P. Ebbert, M.D.); Sioux Community Cancer Consortium, Sioux Falls, South Dakota (Loren K. Tschetter, M.D.); and University of Nebraska and Affiliates, Omaha, Nebraska.

© 2002 Lippincott Williams & Wilkins, Inc.