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Table 11 Randomized Controlled Trials of Glucocorticoids and Meta-analysis in Patients with a Variety of Cancers

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)
Della Cuna et al [30], 1989 preterminal carcinoma; male (196): 38.8% lung, 12.8% stomach, 11.2% buccal cavity and pharynx, 7.1% prostate, 5.1% rectum/rectosigmoid junction female (207): 34.8% breast, 10.1% stomach, 11.1% large intestine, 7.7% cervix uteri, 5.3% lung, 5.3% rectum/rectosigmoid junction methylprednisolone 125 mg IV daily for 8 weeks (207/NR) vs. placebo (196/NR) 5 mortality at 8 weeks: males 40.2% vs. 35.5%, females 40.0% vs. 27.7% (p < 0.01)
Popiela et al [39], 1989 terminal cancer, female, 85% with gastrointestinal or breast or genitourinary cancers, only solid tumors methylprednisolone 125 mg IV daily for 56 days (85/NR) vs. placebo (88/NR) 5 mortality at 56 days of 38% vs. 30% (p > 0.05)
Lundholm et al [14], 1994 liver/pancreas 44, colorectal 30, gastric 18, esophagus 15, melanoma 7, breast 3, head and neck 3, miscellaneous 15 indomethacin 50 mg po twice daily (45/NR) vs. prednisolone 10 mg po twice daily (45/NR) vs placebo (45/NR); all treatments until death 2 when all 3 groups compared simultaneously, survival of indomethacin > prednisone > placebo (p < 0.07)
Loprinzi et al [49], 1999 40% lung cancer, 36% GI cancer, no breast or prostate or ovarian or endometrial cancer; megestrol acetate 800 mg po every day (NR/158) vs. dexamethasone 0.75 mg po four times daily (NR/158) vs. fluoxymesterone 10 mg po twice daily (NR/159) 2 median survival of 126 days with no statistically significant difference between the 3 arms
Mercadante et al [61], 2007 advanced cancer patients on strong opioids opioids vs. opioids + dexamethasone 8 mg po daily; 76 randomized/66 evaluable 2 Mean survival (range) of 33 (26-40) vs. 37 (28-45) days
Feuer et al [62], 1999, Metaanalysis patients with bowel obstruction due to malignancy; vast majority either gynecological or GI cancer glucocorticoids (65/54) vs. no glucocorticoids (32/29)   Kaplan-Meier survival curves and 1 month survival: no differences of statistical significance
Horton et al [27], 1966 19 colorectal cancers, 13 adenocarcinomas of other primary sites, 10 miscellaneous cancers 5-FU IV 15 mg/kg on 1st, 2nd, 3rd, 4th and 6th days and 7.5 mg/kg every other day thereafter until diarrhea, stomatitis or leukopenia (21/NR) vs. same + methyprednisolone 24 mg po daily (21/NR) 4 response rates of 24% vs. 19%
Bernhardt et al [52], 2006 cancers of lung (9), prostate (7), pancreas (3), ovary (2), breast (1), other (4) docetaxel 75 mg/m2 day 8 of each 21 day cycle + perifosine 50 mg po 1 or 2 or 3 times a day in successive cohorts on days 1-14 vs. same + prednisone 5 mg twice daily 1 2 SD (2 prostate) in 7 evaluable patients vs. 3 PR (1 lung and 2 prostate) and 1 SD (prostate) in 9 evaluable patients
Sorensen et al [29], 1994 patients with compression of spinal cord or cauda equina due to cancer: 34 breast cancers, 6 GI cancer, 5 prostate cancer, 3 lung cancer, 4 sarcoma, 2 melanoma, 1 each of kidney, mesothelioma and thyroid radiation (30/30) vs. radiation + initial dose of dexamethasone 96 mg IV followed by dexamethasone 96 mg po daily for 3 days followed by 10 day taper (29/27) 2 median survival of 6 months in both arms
Graham et al, [57], 2006 patients with spinal cord compression not due to lymphoma or myeloma: 11 breast or prostate cancer, 9 lung or GI or renal or other radiation + 16 mg of dexamethasone intravenously for 3 days followed by 13 day taper (9/9) vs. same except 96 mg of dexamethasone for first 3 days (11/11) 1 median survivals of 2.4 vs. 2.1 months