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Randomized trials for upper abdomen irradiation

Randomized trials for upper abdomen irradiation
Reference Number of patients Radiotherapy Antiemetic Complete response (percent) Results
Priestman1 82 8-10 Gy single fraction OND (8 mg x 3/day PO for 5 days) 97 OND better than MCP
MCP (10 mg x 3/day PO for 5 days) 46
Priestman2 135 1.8 Gy/day for at least 5 fractions OND (8 mg x 3/day PO) 61 OND better than MCP for vomiting
MCP (10 mg x 3/day PO) 35
Bey3 50 At least 6 Gy single fraction DOL (0.3 mg/kg IV) 100* DOL better than placebo
DOL (0.6 mg/kg IV) 93*
DOL (1.2 mg/kg IV) 83*
Placebo 54*
Franzen4 111 At least 1.7 Gy/day for ≥10 fractions OND (8 mg x 2/day PO) 67 OND better than placebo
Placebo 45
Aass5 23 2 Gy/day to 30 Gy in 15 fractions TRO (5 mg/day PO) 91 TRO better than MCP
MCP (10 mg x 3/day PO) 50
Lanciano6 260 10-30 fractions GRAN (2 mg/day) 57.5 GRAN better than placebo
(1.8-3 Gy/fraction) Placebo 42
Kirkbride7 154 At least 5 fractions to minimum total dose of 20 Gy DEX (2 mg x 3/day PO for 5-7 days) 70 DEX better than placebo
Placebo 49
Wong8 211 ≥15 fractions to the upper abdomen to a dose of 20 or more Gy OND (8 mg BID for 5 days) + placebo for 5 days

71

12Δ		 OND + DEX better than OND alone
OND (8 mg BID) + DEX (4 mg for 5 days)

78

23Δ
Mystakidou9 288 Fractionated radiotherapy of moderate or high emetogenic potential TRO 5 mg daily starting 1 day before radiotherapy until 7 days after end of radiotherapy Incidence of vomiting was 2.19 times higher in rescue arm Prophylactic TRO better than rescue TRO
TRO 5 mg on an as needed basis
OND: ondansetron; PO: orally; MCP: metoclopramide; DOL: dolasetron; IV: intravenously; TRO: tropisetron; DEX: dexamethasone; BID: twice a day.
* Complete plus major response.
¶ Primary endpoint: CR day 1-5.
Δ Secondary endpoint: CR day 1-15.
Reference:
  1. Priestman TJ, Roberts JT, Lucraft H, et al. Results of a randomized, double-blind comparative study of ondansetron and metoclopramide in the prevention of nausea and vomiting following high-dose upper abdominal irradiation. Clin Oncol (R Coll Radiol) 1990; 2:71.
  2. Priestman TJ, Roberts JT, Upadhyaya BK. A prospective randomized double-blind trial comparing ondansetron versus prochlorperazine for the prevention of nausea and vomiting in patients undergoing fractionated radiotherapy. Clin Oncol (R Coll Radiol) 1993; 5:358.
  3. Bey P, Wilkinson PM, Resbeut M, et al. A double-blind, placebo-controlled trial of i.v. dolasetron mesilate in the prevention of radiotherapy-induced nausea and vomiting in cancer patients. Support Care Cancer 1996; 4:378.
  4. Franzen L, Nyman J, Hagberg H, et al. A randomised placebo controlled study with ondansetron in patients undergoing fractionated radiotherapy. Ann Oncol 1996; 7:587.
  5. Aass N, Håtun DE, Thoresen M, Fosså SD. Prophylactic use of tropisetron or metoclopramide during adjuvant abdominal radiotherapy of seminoma stage I: a randomised, open trial in 23 patients. Radiother Oncol 1997; 45:125.
  6. Lanciano R, Sherman DM, Michalski J, et al. The efficacy and safety of once-daily Kytril (granisetron hydrochloride) tablets in the prophylaxis of nausea and emesis following fractionated upper abdominal radiotherapy. Cancer Invest 2001; 19:763.
  7. Kirkbride P, Bezjak A, Pater J, et al. Dexamethasone for the prophylaxis of radiation-induced emesis: a National Cancer Institute of Canada Clinical Trials Group phase III study. J Clin Oncol 2000; 18:1960.
  8. Wong RK, Paul N, Ding K, et al. 5-hydroxytryptamine-3 receptor antagonist with or without short-course dexamethasone in the prophylaxis of radiation induced emesis: a placebo-controlled randomized trial of the National Cancer Institute of Canada Clinical Trials Group (SC19). J Clin Oncol 2006; 24:3458.
  9. Mystakidou K, Katsouda E, Linou A, et al. Prophylactic tropisetron versus rescue tropisetron in fractionated radiotherapy to moderate or high emetogenic areas: a prospective randomized open label study in cancer patients. Med Oncol 2006; 23:251.
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