Chemotherapy-induced nausea and vomiting: Antiemetic trials that impacted clinical practice

Journal of Oncology Pharmacy Practice

Volumn 16, Issue 4, 2010, Pages 233-244

  Trigg, Michael E ^a,b   Higa, Gerald M ^c  

^a MERCK RESEARCH LABORATORIES   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

^c WEST VIRGINIA UNIVERSITY   (United States)

Author keywords

5 HT3; anti emetics; cancer chemotherapy; NK1; serotonin; substance P

Indexed keywords

ANTIEMETIC AGENT; APREPITANT; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOLASETRON MESILATE; DROPERIDOL; EZLOPITANT; GRANISETRON; HALOPERIDOL; L 754 030; METOCLOPRAMIDE; NEUROKININ 1 RECEPTOR ANTAGONIST; NEUROTRANSMITTER; OLANZAPINE; ONDANSETRON; PALONOSETRON; PHENOTHIAZINE DERIVATIVE; PLACEBO; PROCHLORPERAZINE; SEROTONIN; SEROTONIN 3 ANTAGONIST; SUBSTANCE P; TACHYKININ; THIOTEPA; UNCLASSIFIED DRUG; VOFOPITANT;

ABDOMINAL PAIN; ADVERSE DRUG REACTION; ANTIEMETIC ACTIVITY; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER PATIENT; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL PRACTICE; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; CROSSOVER PROCEDURE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG COST; DRUG EFFICACY; DRUG MECHANISM; DRUG MEGADOSE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXTRAPYRAMIDAL SYMPTOM; FATIGUE; GASTROINTESTINAL TOXICITY; HEADACHE; HEART ATRIUM FIBRILLATION; HEART MUSCLE ISCHEMIA; HEART VENTRICLE TACHYCARDIA; HICCUP; HUMAN; HYPERGLYCEMIA; INSOMNIA; LOW DRUG DOSE; MEDLINE; MIGRAINE; MONOTHERAPY; MOOD DISORDER; MULTICENTER STUDY (TOPIC); NAUSEA; NAUSEA AND VOMITING; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SINGLE DRUG DOSE; TREATMENT DURATION; TREATMENT RESPONSE;

ANIMALS; ANTIEMETICS; ANTINEOPLASTIC AGENTS; DRUG THERAPY, COMBINATION; GLUCOCORTICOIDS; HUMANS; NAUSEA; PRACTICE GUIDELINES AS TOPIC; RECEPTORS, NEUROKININ-1; SEROTONIN; SEROTONIN 5-HT3 RECEPTOR ANTAGONISTS; SEROTONIN ANTAGONISTS; SUBSTANCE P; VOMITING;

EID: 78650446121     PISSN: 10781552     EISSN: None     Source Type: Journal    
DOI: 10.1177/1078155209354655     Document Type: Review

References (75)

1. Surveillance Epidemiology and End Results. Available at http://www.seer.cancer.gov/ (accessed date January 3, 2009 ).
2. Fisher B., Anderson S., Redmond CK, Womark N., Wickerham DL, Cronin WM Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med 1995 ; 333: 1456-61.
3. Fisher B., Ravdin RG, Ausman RK, Slack NH, Moore GE, Noer RJ Surgical adjuvant chemotherapy in cancer of the breast; results of a decade of cooperative investigation. Ann Surg 1968 ; 168: 337-56.
4. Piccart-Gebhart MJ, Procter M., Leyland-Jones B., Goldhirsch A., Untch M., Smith I. et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005 ; 353: 1659-72.
5. Sargent D., Sobrero A., O'Connell MJ, Buyse M., Andre T., Zheng Y. et al. Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient data from 20,898 patients on 18 randomized trials J Clin Oncol 2009 ; 27: 872-77.
6. Harousseau JL, Attal M., Leleu X., Troncy J., Pegourie B., Stoppa AM et al. Bortezomib plus dexamethasone as induction treatment prior to autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: results of an IFM phase II study. Haematologica 2006 ; 91: 1498-1505.
7. Coates A., Abraham S., Kaye SB, Sowerbutts T., Frewin C., Fox RM et al. On the receiving end - patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol 1983 ; 19: 203-8.
8. de Boer-Dennert M., de Wit R., Schmitz PI, Djontono JV, Beurden V., Stoter G. et al. Patient perceptions of the side-effects of chemotherapy: the influence of 5HT3 antagonists. Br J Cancer 1997 ; 76: 1055-61.
9. Grunberg SM, Boutin N., Ireland A., Miner S., Silveira J., Ashikaga T. Impact of nausea/vomiting on quality of life as a visual analogue scale-derived utility score. Support Care Cancer 1996 ; 4: 435-9.
10. Stewart DJ, Dahrouge S., Coyle D., Evans WK Costs of treating and preventing nausea and vomiting in patients receiving chemotherapy. J Clin Oncol 1999 ; 17: 344-51.
11. Passik SD, Kirsh KL, Rosenfeld B., McDonald DV, Theobald DE The changeable nature of patients' fears regarding chemotherapy: implications for palliative care. J Pain Symp Management 2001 ; 21: 113-20.
12. More than half of oncology nurses stop or delay chemotherapy due to nausea and vomiting. Cancer Consultants.com. Available at http://professional. cancerconsultants.com/oncology-main-news.aspx?id=42215 (accessed date January 3, 2009 ).
13. Kris MG, Hesketh PJ, Somerfield MR, Feyer P., Clark-Snow R., Koeller JM et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol 2006 ; 24: 2932-47.
14. Veyrat-Follet C., Farinotti R., Palmer JL Physiology of chemotherapy-induced emesis and antiemetic therapy. Drug 1997 ; 53: 206-34.
15. Cubeddu LX Serotonin mechanisms in chemotherapy-induced emesis in cancer patients. Oncology 1996 ; 53 (Suppl 1). 18-25.
16. Dubois A. Gastroparesis, nausea, and vomiting. In: Lewis JH. ed. A pharmacologic approach to gastrointestinal disorders. Baltimore, MD: Williams & Wilkins, 1994: 131-62.
17. Fukui H., Yamamoto M., Sato S. Vagal afferent fibers and peripheral 5-HT3 receptors mediate cisplatin-induced emesis in dogs. Jpn J Pharmacol 1992 ; 59: 221-6.
18. Cubeddu LX, Hoffmann IS, Fuenmayor NT, Finn AL Efficacy of ondansetron (GR38032F) and the role of serotonin in cisplatin-induced nausea and vomiting. N Engl J Med 1990 ; 322: 810-6.
19. De Mulder PH, Seynaeve C., Vermorken JB, van Liessum PA, Mols-Jevdevic S., Allman EL 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 1990 ; 113: 834-40.
20. Grunberg SM, Akerley WL, Krailo MD, Johnson KB, Baker CR, Cariffe PA Comparison of metoclopramide and metoclopramide plus dexamethasone for complete protection from cisplatinum-induced emesis. Cancer Invest 1986 ; 4: 379-85.
21. Cubeddu LX, Hoffman IS Participation of serotonin on early and delayed emesis induced by initial and subsequent cycles of cisplatinum-based chemotherapy: effects of antiemetics. J Clin Pharmacol 1993 ; 33: 691-7.
22. Wilder-Smith OHG, Borgeat A., Chappuis P., Fathi M., Forni M. Urinary serotonin metabolite excretion during cisplatin chemotherapy. Cancer 1993 ; 72: 2239-41.
23. Janes RJ, Muhonen T., Karjalainen UP, Wiklund T. Urinary 5-hydroxyindolacetic acid (5-HIAA) excretion during multiple day high-dose chemotherapy. Eur J Cancer 1998 ; 34: 196-8.
24. Higa GM, Auber ML, Altaha R., Piktel D., Jurian S., Hobbs G. et al. 5-hydroxyindoleacetic acid and substance P profiles in patients receiving emetogenic chemotherapy. J Oncol Pharm Practice 2006 ; 12: 201-10.
25. Martin M. The severity and pattern of emesis following different cytotoxic agents. Oncology 1996 ; 53 (Suppl 1). 26-31.
26. Gardner CJ, Bountra C., Bunce KT et al. Anti-emetic activity of neurokinin NK1 receptor antagonists is mediated centrally in the ferret. Br J Pharmacol 1996 ; 112: 516 P.
27. Tattersall FD, Rycroft W., Cumberbatch M., Mason G., Tye S., Williamson DJ, Hale JJ et al. The novel NK1 receptor antagonist MK-0869 (L-754,030) and its water soluble phosphoryl prodrug, L-758,298, inhibit acute and delayed cisplatin-induced emesis in ferrets. Neuropharmacol 2000 ; 39: 652-63.
28. Cocquyt V., Van Belle S., Reinhardt RR, Decramer ML, O'Brien M., Schellens JH et al. Comparison of L-758,298, a prodrug for the selective neurokinin-1 antagonist, L-754,030, with ondansetron for the prevention of cisplatin-induced emesis. Eur J Cancer 2001 ; 37: 835-42.
29. Hesketh PJ, Gralla RJ, Webb RT, Ueno W., DelPrete S., Bachinsky ME, Dirlam NL et al. Randomized phase II study of the neurokinin 1 receptor antagonist CJ-11,974 in the control of cisplatin-induced emesis. J Clin Oncol 1999 ; 17: 338-43.
30. Navari RM, Reinhardt RR, Gralla RJ, Kris MG, Hesketh PJ, Khojasteh A. et al. Reduction of cisplatin-induced emesis by a selective neurokinin1-receptor antagonist. NEJM 1999 ; 340: 190-5.
31. Kris MG, Radford JE, Pizzo BA, Inabinet R., Hesketh A., Hesketh PJ Use of an NK1 receptor antagonist to prevent delayed emesis after cisplatin. J Natl Cancer Institute 1997 ; 89: 817-8.
32. Campos D., Pereira JR, Reinhardt RR, Campos D., Pereira JR, Reinhardt RR, Carracedo C., Poli S., Vogel C. et al. Prevention of cisplatin-induced emesis by the oral neurokinin-1 antagonist, MK-869, in combination with granisetron and dexamethasone or with dexamethasone alone. J Clin Oncol 2001 ; 19: 1759-67.
33. Van Belle S., Lichinitser MR, Navari RM, Garin AM, Decramer ML, Riviere A. et al. Prevention of cisplatin-induced acute and delayed emesis by the selective neurokinin-1 antagonists, L-758298 and MK-0869. Cancer 2002 ; 94: 3032-41.
34. Hesketh PJ, Van Belle S., Aapro M., Tattersall FD, Naylor RJ, Hargreaves R. et al. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer 2003 ; 39: 1074-80.
35. Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F., de Wit R. et al. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin - the Aprepitant Protocol 052 Study Group. J Clin Oncol 2003 ; 21: 4112-9.
36. Poli-Bigelli S., Rodrigues-Pereira J., Carides AD, Jule Ma G., Eldridge K., Hipple A. et al. Addition of the NK1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy induced nausea and vomiting: Results from a randomized, double-blind, placebo controlled trial in Latin America. Cancer 2003 ; 97: 3090-8.
37. Higa G., Auber M., Altaha R., Kurian S., Hobbs G. Concordance between substance P and antiemetic guidelines. J Supp Oncol 2009 ; 7: 138-142.
38. Heitz P., Polak JM, Timson DM, Pearse AGEe. Enterochromaffin cells as the endocrine source of gastrointestinal substance P. Histochemistry 1976 ; 49: 343-7.
39. Andrews PLR, Bhandari P. Resinferatoxin, an ultrapotent capsaicin analogue, has anti-emetic properties in the ferret. Neuropharmacology 1993 ; 32: 799-806.
40. Sasek CA, Wessendorf MW, Helke CJ Evidence for co-existence of thyrotropin-releasing hormone, substance P and serotonin in ventral medullary neurons that project to the intermediolateral cell column of the rat. Neuroscience 1990 ; 35: 105-19.
41. Tattersall FD, Rycroft W., Francis B., Pearce D., Merchant K., MacLeod AM et al. Tachykinin NK1 receptor antagonists act centrally to inhibit emesis induced by the chemotherapeutic agent cisplatin in ferrets. Neuropharmacol 1996 ; 35: 1121-9.
42. Sanger GJ The involvement of 5-HT3 receptors in visceral function. In: Hamon M. ed. Central and peripheral 5-HT3 receptors. London: Academic Press, 1992: 207-55.
43. Gralla RJ, Itri LM, Pisko SE, Squillante AE, Kelsen DP, Braun DW Jr et al. Antiemetic efficacy of high-dose metoclopramide: randomized trials with placebo and prochlorperazine in patients with chemotherapy-induced nausea and vomiting. N Engl J Med 1981 ; 305: 905-9.
44. Moertel CG, Reitemeier RJ Controlled clinical studies of orally administered antiemetic drugs. Gastroenterology 1969 ; 57: 262-8.
45. Fozard JR, Mobarok Ali AT Blockade of neuronal tryptamine receptors by metoclopramide. Eur J Pharmacol 1978 ; 49: 109-12.
46. Marlelletti P., Stirparo G., Rinaldi C., Giacovazzo M. Upregulated expression of peripheral serotonergic receptors in migraine and cluster headache by sumatriptan. Int J Clin Pharmacol Res 1994 ; 14: 165-75.
47. Miyata K., Honda K. Serotonin (5-HT)3 receptors antagonists and their pharmacological profiles. Nippon Yakurgaku Zasshi 1994 ; 104: 143-52.
48. Charbit B., Alvarez JC, Dasue E., Abe E., Demolis JL, Junck-Brentano C. Droperidol and ondansetron-induced QT interval prolongation: a clinical drug interaction study. Anesthesiology 2008 ; 109: 206-12.
49. Leslie JB, Gan TJ Meta-analysis of the safety of 5-HT3 antagonists with dexamethasone or droperidol for prevention of PONV. Ann Pharmacother 2006 ; 40: 856-72.
50. de Jonge ME, Huitema AD, Holtkamp JM, van Dam SM, Beijnen JH, Rodenhuis S. Aprepitant inhibits cylcophosphamide bioactivation and thiotepa metabolism. Cancer Chemother Pharmacol 2005 ; 56: 370-8.
51. Bubalo JS, Leis JF, Curin PT, Kovascovics TJ, Meyers G., Hayes-Lattin B. et al. A double blinded pilot study of aprepitant vs placebo combined with standard antiemetics for the control of nausea and vomiting during hematopoietic cell transplantation. Biol Blood Marrow Transplant 2007 ; 13 (Suppl 2). 152.
52. Bubalo JS, Leis JF, Curtin PT, Maziarz RT, Kovascovics TJ, Meyers G. et al. A randomized, double-blinded, pilot trial of aprepitant added to standard antiemetics during conditioning therapy for hematopoietic stem cell transplant (HSCT). J Clin Onc 2007 ; 25 (18S). 9112.
53. Walko CM, Yu YA, Bhushan S., Spasojevic I., Carey L., Collichio F. et al. Effect of aprepitant (AP) on cyclophosphamide (CPA) pharmacokinetics (PK) in early breast cancer patients. J Clin Onc 2009 ; 27: 15 s(supple; abstr 588 ).
54. McCrea JB, Majumdar A., Goldberg MR, Iwamoto M., Gargano C., Panebianco DL et al. Effects of the neurokinin 1 receptor antagonist aprepitant on the pharmacokinetics of dexamethasone and methylprednisolone. Clin Pharmacol 2003 ; 74: 17-24.
55. Depre M., Van Hecken A., Oeyen M., De Lepeleire I., Laethem T., Rothenberg P. et al. Effect of aprepitant on the pharmacokinetics and pharmacodynamics of warfarin. Eur J Clin Pharmacol 2005 ; 61: 341-6.
56. Osinski MA, Uchic ME, Seifert T., Shaughnessy TK, Miller LN, Nakane M. et al. Dopamine D2, but not D4, receptor agonists are emetogenic in ferrets. Pharmacol Biochem Behav 2005 ; 81: 211-9.
57. D'Olimpio JT, Camacho F., Chandra P., Lesser M., Maldonado M., Wollner D. et al. Antiemetic efficacy of high-dose dexamethasone versus placebo in patients receiving cisplatin-based chemotherapy: a randomized double-blind controlled clinical trial. J Clin Oncol 1985 ; 3: 1133-5.
58. Aapro MS, Alberts DS High-dose dexamethasone for prevention of cisplatin-induced vomiting. Cancer Chemother Pharmacol 1981 ; 7: 11-14.
59. Markman M., Sheidler V., Ettinger DS, Quaskey SA, Mellits ED Antiemetic efficacy of dexamethasone. Randomized, double-blind, crossover study with prochlorperazine in patients receiving cancer chemotherapy. N Engl J Med 1984 ; 311: 549-52.
60. Bruera ED, Roca E., Cedaro L., Chacon R., Estevez R. Improved control of chemotherapy-induced emesis by the addition of dexamethasone to metoclopramide in patients resistant to metoclopramide. Cancer Treat Rep 1983 ; 67: 381-3.
61. Ibrahim EM, Al-Idrissi HY, Ibrahim A. et al. Antiemetic efficacy of high-dose dexamethasone: randomized, double-blind, crossover study with high-dose metoclopramide in patients receiving cancer chemotherapy. Eur J Cancer Clin Oncol 1986 ; 22: 283-8.
62. Hesketh PJ, Harvey WH, Harker WG, Beck TM, Ryan T., Bricker LK et al. A randomized, double-blind comparison of intravenous ondansetron alone and in combination with intravenous dexamethasone in the prevention of high-dose cisplatin-induced emesis. J Clin Oncol 1994 ; 12: 596-600.
63. NCCN Clinical Practice Guidelines in Oncology-Antiemesis V.1.2009. Available at http://www.nccn.org/professionals/physician-gls/PDF/antiemesis.pdf (accessed date March 1, 2009 ).
64. Multinational Association of Supportive Care in Cancer Antiemetic Guideliens-latest update: Available at http://www.mascc.org/media/Resource- centers/MASCC-Guidelines-Update.pdf (accessed date March 1, 2009 ).
65. American Society of Health-System Pharmacists ASHP Therapeutic guidelines on the pharmacologic management of nausea and vomiting in adult and pediatric patients receiving chemotherapy or radiation therapy or undergoing surgery. Am J Health-Syst Pharm 1999 ; 56: 729-64.
66. ONS Nausea and Vomiting. Available at http://www.ons.org/outcomes/ volume1/nausea.shtml (accessed date March, 2009 ).
67. Agura ED, Cleveland Brown M., Schaffer R., Donaldson G., Shen DD Antiemetic efficacy and pharmacokinetics of intravenous ondansetron infusion during chemotherapy conditioning for bone marrow transplant. Bone Marrow Transplant 1995 ; 16: 213-22.
68. Frakes LA, Brehm TL, Kosty MP, Miller WE, McMillan RL, Mason J. et al. An all oral antiemetic regimen for patients undergoing high-dose chemotherapy with peripheral blood stem cell transplant. Bone Marrow Transplant 1997 ; 20: 473-8.
69. Mendoza F., Mangan K., Maziarz R., Hurd D., DeGroot T., Schuster M. Multiple-day dosing of palonosetron may enhance emesis and nausea prevention in patients receiving high-dose melphalan chemotherapy prior to stem cell transplant. Support Care Cancer 2008 ; 16: 637.
70. Dranitsaris G., Joy A., Young S., Clemons M., Callaghan W., Petrella T. Identifying patients at high risk for nausea and vomiting after chemotherapy: the development of a practical prediction tool. I. Acute nausea and vomiting. J Support Oncol 2009 ; 7: W1-8.
71. Petrella T., Clemons M., Joy A., Young S., Callaghan W., Dranitsaris G. Identifying patients at high risk for nausea and vomiting after chemotherapy: the development of a practical validated prediction tool. II. Delayed nausea and vomiting. J Support Oncol 2009 ; 7: W9-16.
72. Vanscoy GJ, Fortner B., Smith R., Weber R., Rihn TL Preventing chemotherapy-induced nausea and vomiting: the economic implications of choosing antiemetics. Community Oncol 2005 ; 2: 127-32.
73. Lordick F., Ehlken B., Ihbe-Heffinger A., Berger K., Krobot K., Pellissier J. et al. Health outcomes and cost-effectiveness of aprepitant in outpatients receiving antiemetic prophylaxis for highly emetogenic chemotherapy in Germany. Eur J Cancer 2007 ; 43: 299-307.
74. Johnson J., Rittenberg C. An opportunity to reduce telephone follow-up time by nurses assessing the status of patients' nausea and vomiting postchemotherapy. Oncol Nurs Forum 2004 ; 31: 417, abstract 132.
75. Burke TA, Wisniewski T., Ernst FR Resource utilization and costs of chemotherapy-induced nausea and vomiting (CINV) following highly or moderately emetogenic chemotherapy administered in the US outpatient hospital setting. In: Multi-National Association for the Supportive Care in Cancer annual meeting, June 2009, Italy, Abstract #157.