Combined endocrine treatment of elderly postmenopausal patients with metastatic breast cancer - A randomized trial of tamoxifen vs. tamoxifen plus aminoglutethimide and hydrocortisone and tamoxifen plus fluoxymesterone in women above 65 years of age

The efficacy of combined endocrine therapy with tamoxifen (TAM), aminoglute thimide (AG), and hydrocortisone (H) or tamoxifen and fluoxymesterone (FLU) was evaluated against treatment with tamoxifen alone in 311 patients above 65 years of age with a first recurrence of a metastatic breast cancer. A t otal of 279 patients were eligible. The response rates were assessed for 25 8 fully evaluable patients and were the following for the TAM (N=94), the T AM+AG+H (N=83), and the TAM+FLU (N=81) groups, respectively, PR: 14, 18, an d 21%, and CR: 20, 11, and 23%. The overall response rates are not statisti cally different (p=0.30). The 95% CL of difference in response rates for TA M vs. TAM+AG+H are -9-19% and for TAM vs. TAM+FLU -4-25%. Time to treatment failure was comparable with median values of 9.2, 7.7, and 9.2 months in t he TAM, TAM+AG+H, and TAM+FLU group, respectively (p=0.17). The correspondi ng figures for survival are median times of 22.0, 24.1, and 21.1 months wit h a p-value of 0.62. Toxicity was more pronounced in both the combined trea tment groups, and could in most instances be attributed to treatment with e ither AG+H or FLU. Currently, new specific aromatase inhibitors with lesser toxicity than AG are being evaluated in combination with TAM for treatment of primary and metastatic breast cancer. In conclusion, the simultaneous u se of TAM and AG+H or FLU does not seem to improve the therapeutic efficacy in elderly postmenopausal patients with metastatic disease. So far, combin ed endocrine therapy in this group of patients should only be used in the c ontext of clinical trials.