Tamoxifen and fluoxymesterone versus tamoxifen and danazol in metastatic breast cancer — A randomized study

Summary A prospective randomized trial of tamoxifen and fluoxymesterone versus tamoxifen and danazol in metastatic breast cancer was conducted from December 1980 to September 1985. Patients were eligible regardless of site of disease, estrogen receptor status, or age. Sixty-two of sixty-three randomized patients were evaluable for response. Overall response for tamoxifen and fluoxymesterone was 11% with 61% stabilization of disease, versus 12% response rate for tamoxifen and danazol with 59% stabilization. Toxicities with tamoxifen and fluoxymesterone were greater with an increase in masculinization. We conclude that the response rates to the combinations of tamoxifen and fluoxymesterone or tamoxifen and danazol reported are equivalent in this study but that the increased toxicity with tamoxifen and fluoxymesterone would make tamoxifen and danazol the treatment of choice if a combination were to be used. References Mouridsen HT, Palshof R, Patterson J, Battersby L: Tamoxifen in advanced breast cancer. Cancer Treat Rev 5: 131–141, 1978 Patterson JS, Battersby LA, Edwards DG: Review of the clinical pharmacology and international experience in advanced breast cancer. Reviews on Endocrine-Related Cancer 9: 563–582, 1981 Westerberg H: Tamoxifen and fluoxymesterone in advanced cancer: a controlled clinical trial. Cancer Treat Rep 64: 117–121, 1980 Cooperative study. Testosterone propionate therapy in breast cancer. JAMA 188: 1069–1072, 1964 Allegra JC, Lippman ME, Thompson Bet al.: Distribution, frequency, and quantitative analysis of estrogen, progesterone, androgen, and glucocorticoid receptors in human breast cancer. Cancer Res 39: 1447–1454, 1979 Potts GO: Pharmacology of danazol. J Int Med Res 5 (Supp 3): 1–14, 1977 Madanes AE, Farber M: Danazol. Ann Intern Med 96: 625–630, 1982 Coombes RC, Perez D, Gazet JCet al.: Danazol treatment for advanced breast cancer. Cancer Chemother Pharmacol 10: 194–195, 1983 Tormey DC, Lippman ME, Edwards BK, Cassidy JG: Evaluation of tamoxifen doses with and without fluoxymesterone in advanced breast cancer. Ann Int Med 98: 139–144, 1983 McGuire WL, DeLaGarza M: Improved sensitivity in the measurement of estrogen receptor in human breast cancer. J Clin Endocrinol Metab 36: 548–552, 1973 U.S. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health: Breast Cancer: Suggested protocol guidelines for combination chemotherapy trials and for combined modality trials. Publication No.(NIH) 78-1192, 1978 Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: 457–481, 1958 Mantel N: Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemo Rep 50: 163–170, 1966 Gockerman JP, Spremulli EN, Raney M, Logan T: Randomized comparison of tamoxifen versus diethylstilbestrol in estrogen receptor positive or unknown metastatic breast cancer: a Southwestern Cancer Study Group Trial. Cancer Treat Rep 70: 1199–1203, 1986 Henderson IC: Endocrine therapy in metastatic breast cancer.In: Harris JR, Hellman S, Henderson IC, Kinne DW (eds) Breast Diseases. J.B. Lippincott, London, 1987, pp. 398–428 Powles TJ, Gordon C, Coombes RC: Clinical trial of multiple endocrine therapy for metastatic and locally advanced breast cancer with tamoxifen-aminoglutethimide-danazol compared to tamoxifen used alone. Cancer Res (Suppl) 42: 3458–3460, 1982 Ingle JN, Green SJ, Ahmann DLet al: Randomized trial of tamoxifen alone or combined with aminoglutethimide and hydrocortisone in women with metastatic breast cancer. J Clin Oncol 4: 958–964, 1986 Author information Authors and Affiliations Rights and permissions About this article Cite this article Swain, S.M., Steinberg, S.M., Bagley, C. et al. Tamoxifen and fluoxymesterone versus tamoxifen and danazol in metastatic breast cancer — A randomized study. Breast Cancer Res Tr 12, 51–57 (1988). https://doi.org/10.1007/BF01805740 Issue date: DOI: https://doi.org/10.1007/BF01805740