Table 5 Randomized Controlled Trials of Glucocorticoids in the Endocrine Therapy of Breast Cancer in the Adjuvant Setting

DiMartino et al [9], 1991

Postmenopausal

Tamoxifen 40 mg per day vs. same + prednisolone 7.5 mg per day; 67/57 vs. 49/47; treatment until recurrence

1

p values of 0.6743 and 0.2367 for differences in disease free survival and overall survival respectively

Fentiman et al [6], 1994

Postmenopausal

Tamoxifen 20 mg daily vs. same + prednisolone 7.5 mg daily; 186/173 vs. 184/168

2

p values of 0.26 and 0.32 for differences in relapse free survival and overall survival respectively

Meakin et al, [44], 1996

no further treatment (NT) vs. ovarian irradiation (R) vs. (if ≥ 45) ovarian irradiation + prednisolone 7.5 mg daily up to 5 years (R +P); Premenopausal (≥ 45 years old) 64 vs. 71 vs. 73/Postmenopausal 136 vs. 111 vs. 111; 779 randomized, 703 analyzed as above

1

Premenopausal(≥ 45 years old)/Postmenopausal; median recurrence free survival (yrs): 9.4 vs. 18 vs. > 25/6.2 vs. 8.2 vs. 6.8; median survival (yrs): 12.8 vs. 14.9 vs. >25/9.3 vs. 9.9 vs. 7.7

Scottish Cancer Trials Breast Group [13], 1993

Premenopausal ER+ve 54%, ER status unknown 19%

Second randomization to prednisolone 7.5 mg po daily for 5 years vs. no prednisolone after first randomization to ovarian ablation vs. CMF (IV); 165/NR vs. 167/NR in second randomization

3

prednisolone effect did not depend on whether CMF or ovarian ablation (p = 0.46); hazard ratio and 95% CI for deaths for +/-prednisolone was 1.26 (0.86–1.84)