BMC Cancer 2008, 8:84 http://www.biomedcentral.com/1471-2407/8/84 Table 7: Randomized Controlled Trials of Chemotherapy +/- Glucocorticoids of Breast Cancer in the Adjuvant Setting Author [reference], Year Patient Characteristics Tormey et al [12], 1990 Ludwig Breast Cancer Study Group [53, 85], 1985 Premenopausal, ER+ve 51%, ER- ve 49%, pre and peri-menopausal, ER +ve 28%, ER -ve 24% ER unknown 48% Treatment Arms Patient Number (Randomized/Evaluable) Quality Score Outcome(s) CMF (222/188) vs. CMFP (220/183) vs. CMFP + tamoxifen 10 mg po twice daily(220/182), all treatments for one year CMF (250/241) vs. CMF + prednisone 7.5 mg daily (255/250), all treatments for one year 2 3 median time to relapse: CMF 6.2 months vs. CMFP 6.6 months (p = 0.64), survival: CMF vs. CMFP (p = 0.91) 13 year disease-free survival of 52% vs. 49% (p = 0.39), 13 year overall survival of 65% vs. 59% (p = 0.30) has been published in abstract form only; it is difficult to draw conclusions based on the information presented. See Table 8 for a description of these trials. Cancer found [26]. There are two ongoing randomized controlled trials of chemotherapy +/- glucocorticoids in hormone refractory prostate cancer; results are not available [71,73]. Randomized Controlled Trials of Glucocorticoids in GI There is one trial comparing glucocorticoid monotherapy to placebo in GI cancer; no difference in survival was There are two trials of chemotherapy +/- glucocorticoids in GI cancer [11,20]. One of the two trials used response criteria that are not readily comparable to those presently used. In that trial, fluorometholone monotherapy had a response rate of 9%. The addition of fluorometholone to 5-FU did not change the response rate of 13% [20]. In the other trial of chemotherapy +/- glucocorticoids (FUDR +/ - dexamethasone), the addition of glucocorticoids resulted in an increased response rate and a borderline improvement in survival (p = 0.06). However, FUDR dose, as the mean percentage of planned FUDR dose, was 61% and 52% in the FUDR/dexamethasone arm and FUDR arm respectively (p = 0.13). At least in part, the increased dose of FUDR in the FUDR/dexamethasone arm was due to the decreased biliary toxicity associated with concurrent dexamethasone administration resulting in less FUDR dose reductions. The chemoprotective property of dexamethasone, allowing a greater FUDR dose, may have contributed to the improved results in the combined arm [11]. Other postulated reasons are a potentiation of FUDR cytotoxicity by dexamethasone and a potential antiangiogenic property of dexamethasone [86,87]. Table 8: Randomized Controlled Trials of Glucocorticoids in Prostate Cancer Author [reference], Year Patient Characteristics Quality Score Outcome(s) Sander et al [43], 1982 Williams et al [59], 1990 Fossa et al [33], 1985 Patel et al [8], 1990 Datta et al [35], 1997 Tyrrell [36, 54, 60], 1996 Fossa et al [32], 2001 Tombal et al [50], 2003 Advanced untreated prostate cancer Advanced untreated prostate cancer Hormone refractory prostate cancer Hormone refractory metastatic prostate cancer Hormone refractory metastatic prostate cancer Hormone refractory metastatic prostate cancer Hormone refractory metastatic prostate cancer Treatment Arms Patient Number (Randomized/Evaluable) orchiectomy (7/7) vs. ochiectomy + prednisone 2.5 mg po four times daily for 6 weeks (14/14) vs. ochiectomy + cyproterone acetate 50 mg po four times daily for 6 weeks (13/13) orchiectomy (24/24) vs. orchiectomy + dexamethasone 0.5 mg in morning and 0.3 mg at night (16/16) vs. orchiectomy + cyproterone acetate 100 mg 3 times daily (20/20) MPA 500 mg po twice daily (24/21) vs. prednisolone 5 mg po four times daily (24/24) Megestrol acetate 40 mg po four times daily (29/25) vs. dexamethasone 0.75 mg po twice daily (29/26), Treatment until PD Flutamide 250 mg three times daily (20/20) vs. prednisolone 5 mg twice daily (20/20) prednisone 5 mg po four times a day (101/95) vs. flutamide 250 mg po three times a day (100/ 96); treatment until PD irofulven (24 mg/m2 for first 18 patients then 0.55 mg/kg for next 43 patients) IV days 1 and 15 q4 weeks (29/28) vs. same + prednisone 10 mg daily (32/28) 1 3 2 2 2 1 2 1 Hormone refractory advanced prostate cancer prednisone 10 mg po twice daily (103/NR) vs. liarozole 300 mg po twice daily (117/NR) response rates of 86% vs. 93% vs. 62% response rates of 33% vs. 62.5% vs. 45% at 1 year response rates of 38% vs. 13% (p < 0.05), no survival difference response rates of 10% vs. 7%, median survival of 268 vs. 246 days (p = 0.2) PSA response rates of 50% vs. 55%, median survival of 30 vs. 36 weeks (p > 0.05) PSA response rates of 25% vs. 18% (p = 0.31); time to PSA progression of 4.7 vs. 3.5 months; median survivals of 15.8 months vs. 11.7 months (p = 0.01) PSA responses of 21% vs. 23%, median time to progression of 3.4 months vs. 2.3 months (p = 0.0885); overall survival of 10.6 months vs. 11.2 months (p = 0.8370) PSA responses of 3/28 vs. 5/28 Page 10 of 19 (page number not for citation purposes)