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

From: Systematic review of the clinical effect of glucocorticoids on nonhematologic malignancy

Author [reference], Year Patient Characteristics Treatment Arms; Patient Number (Randomized/Evaluable) Quality Score Outcome(s)
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)