Comparative review of 5-HT3 receptor antagonists in the treatment of acute chemotherapy-induced nausea and vomiting

Cancer Investigation

Volumn 18, Issue 2, 2000, Pages 163-173

  Hesketh, Paul J ^a  

^a ST ELIZABETH'S MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOTOXIC AGENT; DOLASETRON MESILATE; GRANISETRON; METOCLOPRAMIDE; ONDANSETRON; SEROTONIN 3 ANTAGONIST; TROPISETRON;

CANCER CHEMOTHERAPY; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG EXCRETION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG PROTEIN BINDING; HEADACHE; HUMAN; NAUSEA; PRIORITY JOURNAL; REVIEW; SEDATION; SIDE EFFECT; VERTIGO; VOMITING;

EID: 0033998179     PISSN: 07357907     EISSN: None     Source Type: Journal    
DOI: 10.3109/07357900009038248     Document Type: Review

References (84)

1. Coates A, Abraham S, Kaye SB, et al: On the receiving end-patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol 19:203-208, 1983.
2. Cooper S, Georgiou V: The impact of cytotoxic chemotherapy -perspectives from patients, specialists and nurses. Eur J Cancer 28A(Suppl 1):S36-38, 1992.
3. Tortorice PV, O'Connell MB: Management of chemotherapy-induced nausea and vomiting. Pharmacotherapy 10:129-145, 1990.
4. Graves T: Emesis as a complication of cancer chemotherapy: pathophysiology, importance, and treatment. Pharmacotherapy 12:337-345, 1992.
5. Aapro MS, Kirchner V, Terrey JP: The incidence of anticipatory nausea and vomiting after repeat cycle chemotherapy: the effect of granisetron. Br J Cancer 69:957-960, 1994.
6. Andrews PLR, Rapeport WG, Sanger GJ: Neuropharmacology of emesis induced by anti-cancer therapy. Trends Pharmacol Sci 9: 334-341, 1988.
7. 3 receptor antagonists. An overview of their present status and future potential in cancer therapy-induced emesis. Drugs 42:551-568, 1995.
8. Gralla RJ: Current issues in the management of nausea and vomiting. Ann Oncol 4(Suppl 3):S3-7, 1993.
9. Grunberg SM, Hesketh PJ: Control of chemotherapy-induced emesis. N Engl J Med 329:1790-1796, 1993.
10. 3 receptor antagonists act as anti-emetics? In: Serotonin and the Scientific Basis of Anti-Emetic Therapy, edited by DJM Reynolds, PLR Andrews, CJ Davis, Oxford. Oxford Clinical Communications, 1995, pp. 111-126.
11. 3 antagonists MDL 73147EF (dolasetron mesilate) and MDL 74156 in NG108-15 neuroblastoma × glioma cells. Eur J Pharmacol 219:9-13, 1992.
12. 3 receptor antagonist. Drug Dev Res 34:289-296, 1995.
13. Galvan M, Gittos MW, Fatmi M: Dolasetron mesylate. Drugs Future 18:506-509, 1993.
14. 3 receptors. Br J Pharmacol 94:397-412, 1988.
15. Tyers MB, Bunce KT, Humphrey PP: Pharmacological and anti-emetic properties of ondansetron. Eur J Cancer Clin Oncol 25(Suppl 1):S15-19, 1989.
16. Fake CS, King FD, Sanger GJ: BRL 43694: a potent and novel 5-HT, receptor antagonist. Br J Pharmacol 91:335P, 1987 (abstract).
17. Sanger GJ, Nelson DR: Selective and functional 5-hydroxytryptamine receptor antagonism by BRL 43694 (granisetron). Eur J Pharmacol 159:113-124, 1989.
18. Richardson BP, Engel G, Donatsch P, et al: Identification of serotonin M-receptor subtypes and their specific blockade by a new class of drugs. Nature 316:126-131, 1985.
19. 4 receptor in zacopride-and copper sulphate-induced vomiting in the ferret. Eur J Pharmacol 204: 273-280, 1991.
20. 3 receptor antagonism in the control of cytostatic drug-induced emesis. Eur J Cancer 26(Suppl 1):S8-11, 1990.
21. 3 receptor antagonists the same? Eur J Cancer 28A(Suppl 1):S2-6, 1992.
22. Zofran® (ondansetron hydrochloride) Injection and Tablets Product Information. Glaxo Wellcome Oncology/HIV. In: Physicians' Desk Reference, 52nd ed., Montvale, NJ, Medical Economics Company, 1998, pp. 1177-1183.
23. Kytril® (granisetron hydrochloride) Injection and Tablets Product Information. SmithKline Beecham Pharmaceuticals. In: Physicians' Desk Reference, 52nd ed., Montvale, NJ, Medical Economics Company, 1998, pp. 2836-2840.
24. ® (dolasetron mesylate) Injection and Tablets Product Information. In: Physicians' Desk Reference, 53rd ed., Montvale, NJ, Medical Economics Company, 1999, pp. 1299-1304.
25. de Bruijn KM: Tropisetron: a review of the clinical experience. Drugs 43(Suppl 3): 11-22, 1992.
26. Fischer V, Baldeck J-P, Tse FL: Pharmacokinetics and metabolism of the 5-hydroxytryptamine antagonist tropisetron after single oral doses in humans. Drug Metab Dispos 20:603-607, 1992.
27. Boxenbaum H, Gillespie T, Heck K, et al: Human dolasetron pharmacokinetics. I. Disposition following single-dose intravenous administration to normal male subjects. Biopharm Drug Dispos 13:693-701, 1992.
28. Boxenbaum H, Gillespie T, Heck K, et al: Human dolasetron pharmacokinetics. II. Absorption and disposition following single-dose oral administration to normal male subjects. Biopharm Drug Dispos 14:131-141, 1993.
29. 3 receptor antagonist. Drug Metab Dispos 23:806-812, 1995.
30. Allen A, Crome P, Davie CC, et al: The pharmacokinetics of granisetron, a 5-HT3 antagonist in healthy young and elderly volunteers. Eur J Clin Pharmacol 48:519-520, 1995.
31. Pritchard JF, Bryson JC, Kemodle AE, et al: Age and gender effects on ondansetron pharmacokinetics: evaluation of healthy aged volunteers. Clin Pharmacol Ther 51:51-55, 1992.
32. Fauser AA, Bleiberg H, Chevallier B, et al: A double-blind, randomized, parallel study of IV dolasetron mesilate versus IV metoclopramide in patients receiving moderately emetogenic chemotherapy. Cancer J 9:196-202, 1996.
33. De Mulder PHM, Seynaeve C, Vermorken JB, et al: Ondansetron compared with high-dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced nausea and vomiting: a multicenter, randomized, double-blind, crossover study. Ann Intern Med 113: 834-840, 1990.
34. Chevallier B on behalf of the Granisetron Study Group: Efficacy and safety of granisetron compared with high-dose metoclopramide plus dexamethasone in patients receiving high-dose cisplatin in a single-blind study. Eur J Cancer 26(Suppl 1):S33-36, 1990.
35. 3 (serotonin) antagonist ondansetron (GR 38032F) with high-dose metoclopramide in the control of cisplatin-induced emesis. N Engl J Med 322:816-821, 1990.
36. Hesketh PJ, Kris MG, Grunberg SM, et al: Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol 15:103-109, 1997.
37. Tonato M, Roila F, Del Favero A: Methodology of antiemetic trials: a review. Ann Oncol 2:107-114, 1991.
38. Grote TH, Pineda LF, Figlin RA, et al: Oral dolasetron mesylate in patients receiving moderately emetogenic platinum-containing chemotherapy. Cancer J Sci Am 3:45-51, 1997.
39. Pendergrass K, Audhuy B, Hesketh P, et al: Analysis of optimal dose from eight pooled clinical trials assessing the acute anti-emetic efficacy of IV dolasetron mesylate (DM) after emetogenic chemotherapy (ECT). Proc Am Soc Clin Oncol 15:547, 1996 (abstract 1782).
40. Rubenstein E, Fauser A, Grote T, et al: Determination of optimal dolasetron mesylate (DM) dose in prevention of acute nausea and vomiting (ANV) after moderately emetogenic chemotherapy (MECT) using pooled data from three pivotal trials. Proc Am Soc Clin Oncol 15:532, 1996 (abstract 1722).
41. Rubenstein EB, Gralla RJ, Hainsworth JD, et al: Randomized, double blind, dose-response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy. Cancer 79:1216-1224, 1997.
42. Beck TM, Ciociola AA, Jones SE, et al: Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. Ann Intern Med 118:407-413, 1993.
43. Braken JB, Raemaekers JM, Koopmans PP, et al: Control of nausea and vomiting with ondansetron in patients treated with intensive non-cisplatin chemotherapy for acute myeloid leukaemia. Eur J Cancer 29A:515-518, 1993.
44. Fraschini G, Ciociola A, Esparza L, et al: Evaluation of three oral dosages of ondansetron in the prevention of nausea and emesis associated with cyclophosphamide-doxorubicin chemotherapy. J Clin Oncol 9:1268-1274, 1991.
45. Rosso R, Campora E, Cette G, et al: Oral ondansetron (GR38032F) for the control of acute and delayed cyclophosphamide induced emesis. Anticancer Res 11:937-940, 1991.
46. Bremer K on behalf of the Granisetron Study Group: A single-blind study of the efficacy and safety of intravenous granisetron compared with alizapride plus dexamethasone in the prophylaxis and control of emesis in patients receiving 5-day cytostatic therapy. Eur J Cancer 28A:1018-1022, 1992.
47. Ettinger DS, Eisenberg PD, Fitts D, et al: A double-blind comparison of the efficacy of two dose regimens of oral granisetron in preventing acute emesis in patients receiving moderately emetogenic chemotherapy. Cancer 78:144-151, 1996.
48. Italian Group for Antiemetic Research: Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer. N Engl J Med 332:1-5, 1995.
49. 3 antagonist, versus a standard anti-emetic regimen of chlorpromazine plus dexamethasone in the treatment of cytostatic-induced emesis. Eur J Cancer 26(Suppl 1):S28-32, 1990.
50. Smith IE on behalf of the Granisetron Study Group: A comparison of two dose levels of granisetron in patients receiving moderately emetogenic cytostatic chemotherapy. Eur J Cancer 26(Suppl 1): S19-23, 1990.
51. Warr D, Willan A, Fine S, et al: Superiority of granisetron to dexamethasone plus prochlorperazine in the prevention of chemotherapy-induced emesis. J Natl Cancer Inst 83:1169-1173, 1991.
52. Adams M, Soukop M, Barley V, et al: Tropisetron alone or in combination with dexamethasone for the prevention and treatment of emesis induced by non-cisplatin chemotherapy: a randomized trial. Anti-Cancer Drugs 6:514-521, 1995.
53. Perez EA, Lembersky B, Kaywin P, et al: Intravenous (IV) granisetron vs ondansetron in the prevention of cyclophosphamide-doxorubicin-induced emesis in breast cancer patients: a double-blind crossover study. Proc Am Soc Clin Oncol 15:543, 1996 (abstract 1764).
54. Perez EA, Hesketh P, Sandbach J, et al: Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy: a multicenter, double-blind, randomized parallel study. J Clin Oncol 16:754-760, 1998.
55. Pion JM, Fournier C, Darloy F, et al: Oral granisetron vs oral ondansetron, a comparative double-blind cross-over multicenter study of preventive anti-emetic in moderately emetogenic chemotherapy, by the French Northern Oncology Group (FNOG). Proc Am Soc Clin Oncol 15:530, 1996 (abstract 1715).
56. Lofters WS, Pater JL, Zee B, et al: Phase III double-blind comparison of dolasetron mesylate and ondansetron and an evaluation of the additive role of dexamethasone in the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy. J Clin Oncol 15:2966-2973, 1997.
57. Fauser AA, Duclos B, Chemaissani A, et al: Therapeutic equivalence of single oral doses of dolasetron mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy. Eur J Cancer 32A:1523-1529, 1996.
58. Stewart A, McQuade B, Cronje JDE, et al: Ondansetron compared with granisetron in the prophylaxis of cyclophosphamide-induced emesis in out-patients: a multicentre, double-blind, double-dummy, randomised, parallel-group study. Oncology 52:202-210, 1995.
59. Chevallier B, Cappelaere P, Splinter T, et al: A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy. Support Care Cancer 5:22-30, 1997.
60. Harman GS, Omura GA, Ryan K, et al: A randomized, double-blind comparison of single-dose and divided multiple-dose dolasetron for cisplatin-induced emesis. Cancer Chemother Pharmacol 38:323-328, 1996.
61. Thant M, Pendergrass K, Harman G, et al: Double-blind randomized study of the dose-response relationship across five single doses of IV dolasetron mesylate (DM) for prevention of acute nausea and vomiting (ANC) after cisplatin chemotherapy (CCT). Proc Am Soc Clin Oncol 15:533, 1996 (abstract 1727).
62. Yeilding A, Bertoli L, Eisenberg P, et al: Antiemetic efficacy of two different single intravenous doses of dolasetron in patients receiving high-dose cisplatin-containing chemotherapy. Am J Clin Oncol 19:619-623, 1996.
63. Brown GW, Paes D, Bryson J, et al: The effectiveness of a single intravenous dose of ondansetron. Oncology 49:273-278, 1992.
64. Grunberg SM, Lane M, Lester EP, et al: Randomized double-blind comparison of three dose levels of intravenous ondansetron in the prevention of cisplatin-induced emesis. Cancer Chemother Pharmacol 32:268-272, 1993.
65. Navari RM, Kaplan HG, Gralla RJ, et al: Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin. J Clin Oncol 12:2204-2210, 1994.
66. Riviere A on behalf of The Granisetron Study Group: Dose finding study of granisetron in patients receiving high-dose cisplatin chemotherapy. Br J Cancer 69:967-971, 1994.
67. Venner P for the Clinical Trials Group of the National Cancer Institute of Canada: Granisetron for high-dose cisplatin (HDCP)-induced emesis: a randomized double-blind study. Proc Am Soc Clin Oncol 9:320, 1990 (abstract 1238).
68. de Wit R, de Boer-Dennen M, Stoter G, et al: Sustainment of efficacy of tropisetron during 6 courses of cisplatin-containing chemotherapy. Ann Oncol 3(Suppl 5):185, 1992 (abstract).
69. Schmidt M, Sorbe B, Hogberg T, et al: Efficacy and tolerability of tropisetron and dexamethasone in the control of nausea and vomiting induced by cisplatin. Ann Oncol 4(Suppl 3):S31-34, 1993.
70. Navari R, Gandara D, Hesketh P, et al: Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis. J Clin Oncol 13:1242-1248, 1995.
71. Gralla RJ, Navari RM, Hesketh PJ, et al: Single-dose oral granisetron has equivalent antiemetic efficacy to intravenous ondansetron for highly emetogenic cisplatin-based chemotherapy. J Clin Oncol 16:1568-1573, 1998.
72. Ruff P, Paska W, Goedhals L, et al: Ondansetron compared with granisetron in the prophylaxis of cisplatin-induced acute emesis: a multicentre double-blind, randomised, parallel-group study. Oncology 51:113-118, 1994.
73. Italian Group for Antiemetic Research: Ondansetron versus granisetron, both combined with dexamethasone, in the prevention of cisplatin-induced emesis. Ann Oncol 6:805-810, 1995.
74. Audhuy B, Cappelaere P, Martin M, et al: A double-blind, randomised comparison of the anti-emetic efficacy of two intravenous doses of dolasetron mesilate and granisetron in patients receiving high dose cisplatin chemotherapy. Eur J Cancer 32A:807-813, 1996.
75. Hesketh P, Navari R, Grote T, et al: Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer. J Clin Oncol 14: 2242-2249, 1996.
76. ® (ondansetron) in cisplatin-induced emesis? Anti-Cancer Drugs 6(Suppl 1):15-21, 1995.
77. Lee CR, Plosker GL, McTavish D: Tropisetron: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential as an antiemetic. Drugs 46:925-943, 1993.
78. Milne RJ, Heel RC: Ondansetron: therapeutic use as an anti-emetic. Drugs 41:574-595, 1991.
79. Plosker GL, Goa KL: Granisetron: a review of its pharmacological properties and therapeutic use as an antiemetic. Drugs 42:805-824, 1991.
80. Benedict CR, Arbogast R, Martin L, et al: Single-blind study of the effects of intravenous dolasetron mesylate versus ondansetron on electrocardiographic parameters in normal volunteers. J Cardiovasc Pharmacol 28:53-59, 1996.
81. Boike SC, Ilson B, Zariffa N, et al: Cardiovascular effects of i.v. granisetron at two administration rates and of ondansetron in healthy adults. Am J Health Syst Pharm 54:1172-1176, 1997.
82. Jantunen IT, Kataja VV, Muhonen TT, et al: Effects of granisetron with doxorubicin or epirubicin on ECG intervals. Cancer Chemother Pharmacol 37:502-504, 1996.
83. Lifsey DS, Gralla RJ, Clark RA, et al: Electrocardiographic changes with serotonin antagonist antiemetics: Rate of occurrence and clinical relevance. Proc Am Soc Clin Oncol 12:463, 1993 (abstract 1611).
84. Watanabe H, Hasegawa A, Shinozaki T, et al: Possible cardiac side effects of granisetron, an antiemetic agent, in patients with bone and soft-tissue sarcomas receiving cytotoxic chemotherapy. Cancer Chemother Pharmacol 35:278-282, 1995.