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Randomized trials for total body or hemibody irradiation

Randomized trials for total body or hemibody irradiation
Reference Number of patients Radiotherapy Antiemetic Complete response (percent) Results
Tiley1 20 10.5 Gy (TBI, single fraction) OND (8 mg IV) 90* OND better than placebo
Placebo 50*
Spitzer2 20 TBI: 13.2 Gy in 11 fractions over 4 days OND (8 mg x 3/day PO) 50 OND better than placebo
Placebo 0
Prentice3 30 7.5 Gy (TBI, single fraction) GRAN (3 mg IV) 53 GRAN better than MTC + DEX + LOR
MCP (20 mg IV) + DEX (6 mg/m2 IV) + LOR (2 mg IV) 13
Huang4 116 7 to 7.7 Gy (TBI, single fraction) OND (8 mg) + DEX (10 mg) 84 OND + DEX better than MCP + DEX
MCP (10 mg) + DEX (10 mg) 20
Sykes5 66 8 to 12.5 Gy (HBI, single fraction) OND (8 mg x 2 PO) 94 OND better than CLP + DEX
CLP (25 mg x 3 PO) + DEX (6 mg x 3 PO) 34
Spitzer6 34 TBI: 13.2 Gy in 11 fractions over 4 days OND (8 mg x 3/day PO) 47 No difference
GRAN (2 mg x 1/day PO) 61
TBI: total body irradiation; IV: intravenously; OND: ondansetron; PO: orally; GRAN: granisetron; MCP: metoclopramide; DEX: dexamethasone; LOR: lorazepam; HBI: hemibody irradiation; CLP: chlorpromazine.
* All patients received intravenous dexamethasone (8 mg) and phenobarbitone (60 mg/m2).
References:
  1. Tiley C, Powles R, Catalano J, et al. Results of a double blind placebo controlled study of ondansetron as an antiemetic during total body irradiation in patients undergoing bone marrow transplantation. Leuk Lymphoma 1992; 7:317.
  2. Spitzer TR, Bryson JC, Cirenza E, et al. Randomized double-blind, placebo-controlled evaluation of oral ondansetron in the prevention of nausea and vomiting associated with fractionated total-body irradiation. J Clin Oncol 1994; 12:2432.
  3. Prentice HG, Cunningham S, Gandhi L, et al. Granisetron in the prevention of irradiation-induced emesis. Bone Marrow Transplant 1995; 15:445.
  4. Huang X, Guo N, Fan Y. [Ondansetron in the prophylaxis of acute emesis induced by supra-high single dose total body irradiation (TBI)]. Zhonghua Zhong Liu Za Zhi 1995; 17:64.
  5. Sykes AJ, Kiltie AE, Stewart AL. Ondansetron versus a chlorpromazine and dexamethasone combination for the prevention of nausea and vomiting: a prospective, randomised study to assess efficacy, cost effectiveness and quality of life following single-fraction radiotherapy. Support Care Cancer 1997; 5:500.
  6. Spitzer TR, Friedman CJ, Bushnell W, et al. Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation. Bone Marrow Transplant 2000; 26:203.
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