Table 9 Randomized Controlled Trials of Glucocorticoids in GI Cancer

Moertel et al [26], 1974

GI cancer with expected survival of less than 2 months (61 colorectal, 22 gastric, 15 pancreatic, 9 hepatoma, 10 other)

placebo (47/NR) vs. dexamethasone 0.75 mg four times daily (33/NR) vs. dexamethasone 1.5 mg four times daily (36/NR); treatment until death or patient unable to take pills

3

Median survival (weeks) of 6.6 vs. 6.2 vs. 5.2

Reitemeier et al [20], 1967

advanced GI cancer (37 gastric, 23 pancreatic, 52 unknown but presumed GI in origin)

fluorometholone 25 mg po every 12 hour for at least 2 months (34/32) vs. 5-FU IV 15 mg/kg/day for 5 consecutive days then 7.5 mg/kg/day every other day for a maximum of 4 additional doses (40/40) vs. 5-FU plus fluorometholone as just described (38/32)

3

response rates of 9% vs. 13% vs. 13%; average duration of response of 4 vs. 6.5 vs. 4 months

Kemeny et al [11], 1992

untreated colorectal cancer with only metastases being in liver

hepatic arterial FUDR 0.3 mg/kg/day for 14 of every 28 day cycle (25/25) vs. same plus hepatic arterial dexamethasone 20 mg over 14 days with the FUDR (25/24)

3

response rates of 40% vs. 71% (p = 0.03), median time to progression of 12 vs. 19 months (p = 0.58), median survival of 15 vs. 23 months (p = 0.06)

Sato et al [51], 2002

patients with esophageal squamous cell carcinoma scheduled to undergo esophageal resection

surgery (33/33) vs. surgery + 10 mg/kg methyprednisolone IV within 30 minutes of start of surgery (33/33)

5

p = 0.4465 for difference in overall survival rates 1 and 3 yr survival rates of 85% and 65% vs. 82% and 62% respectively

Yano et al [58], 2005

patients with thoracic esophageal cancer scheduled for esophagectomy

surgery (20/20) vs. surgery + methylprednisolone 500 mg IV 2 hours before surgery (20/20)

3

p = 0.3304 for difference in survival rates