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

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 1^st, 2^nd, 3^rd, 4^th and 6^th 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