Olanzapine Versus Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Randomized Phase III Trial

Journal of Supportive Oncology

Volumn 9, Issue 5, 2011, Pages 188-195

  Navari, Rudolph M ^a   Gray, Sarah E ^a   Kerr, Andrew C ^a  

^a INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

APREPITANT; CISPLATIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; OLANZAPINE; PALONOSETRON;

ADULT; AGED; APPETITE DISORDER; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ASSESSMENT; CONTROLLED STUDY; DISTRESS SYNDROME; DROWSINESS; DRUG EFFICACY; DYSPNEA; EMOTIONAL DISORDER; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MOOD DISORDER; NAUSEA AND VOMITING; PAIN; PARESTHESIA; PHASE 3 CLINICAL TRIAL; RATING SCALE; SCORING SYSTEM; SEDATION; SIDE EFFECT; SLEEP DISORDER; TREATMENT DURATION; TREATMENT RESPONSE; XEROSTOMIA;

ADULT; AGED; AGED, 80 AND OVER; ANTIEMETICS; ANTINEOPLASTIC AGENTS; BENZODIAZEPINES; FEMALE; HUMANS; MALE; MIDDLE AGED; MORPHOLINES; NAUSEA; VOMITING;

EID: 82855171513     PISSN: 15446794     EISSN: 1879596X     Source Type: Journal    
DOI: 10.1016/j.suponc.2011.05.002     Document Type: Article

References (39)

1. Bloechl-Daum B., Deuson R.R., Mavros P., Hansen M., Herrstedt J. Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 2006, 24:4472-4478.
2. Navari R.M. Pharmacological management of chemotherapy-induced nausea and vomiting: focus on recent developments. Drugs 2009, 69:515-533.
3. Navari R.M. Palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients with cancer. Future Oncol 2010, 6:1073-1084.
4. Curran M.P., Robinson D.M. Aprepitant: a review of its use in the prevention of nausea and vomiting. Drugs 2009, 69:1853-1858.
5. Sankhala K.K., Pandya D.M., Sarantopoulos J., Soefje S.A., Giles F.J., Chawla S.P. Prevention of chemotherapy induced nausea and vomiting: a focus on aprepitant. Expert Opin Drug Metab Toxicol 2009, 12:1607-1614.
6. Navari R.M., Einhorn L.H., Passik S.D., Loehrer P.J., Johnson C., Mayer M.L., McClean J., Vinson J., Pletcher W. A phase II trial of olanzapine for the prevention of chemotherapy-induced nausea and vomiting. Support Care Cancer 2005, 13:529-534.
7. Navari R.M., Einhorn L.H., Loehrer P.J., Passik S.D., Vinson J., McClean J., Chowhan N., Hanna N.H., Johnson C.S. A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting. Support Care Cancer 2007, 15:1285-1291.
8. Tan L., Liu J., Liu X., Chen J., Yan Z., Yang H., Zhang D. Clinical research of olanzapine for the prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res 2009, 28:1-7.
9. Eisenberg P., MacKintosh F.R., Ritch P., Cornett P.A., Macciocchi A. Efficacy, safety, and pharmacokinetics of palonosetron in patients receiving highly emetogenic, cisplatin-based chemotherapy: a dose-ranging, clinical study. Ann Oncol 2004, 15:330-337.
10. 3 receptor internalization and causes prolonged inhibition of receptor function. J Pharmacol 2010, 626:193-199.
11. Aapro M.S., Grunberg S.M., Manikhas G.M., Olivares G., Suarez T., Tjulandin S.A., Bertoli L.F., Yunus F., Morrica B., Lordick F., Macciocchi A. A phase III, double blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol 2006, 17:1441-1449.
12. Eisenberg P., Figueroa-Vadillo J., Zamora R., Charu V., Hajdenberg J., Cartmell A., Macciocchi A., Grunberg S. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5HT3 receptor antagonist: results of a phase III, single dose trial versus dolasetron. Cancer 2003, 98:2473-2482. 99-04 Palonosetron Study Group.
13. Gralla R., Lichinitser M., Van Der Vegt S., Sleeboom H., Mezger J., Peschel C., Tonini G., Labianca R., Macciocchi A., Aapro M. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase II trial comparing single dose of palonosetron with ondansetron. Ann Oncol 2003, 14:1570-1577.
14. Saito M., Aogi K., Sekine I. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for the prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomized, comparative phase III trial. Lancet Oncol 2009, 10:115-124.
15. Kris M.G., Hesketh P.J., Somerfield M.R., Feyer P., Clark-Snow R., Koeller J.M., Morrow G.R., Chinnery L.W., Chesney M.J., Gralla R.J., Grunberg S.M. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. Clin Oncol 2006, 24:2932-2947.
16. Antiemesis: Clinical Practice Guidelines in Oncology, v 1 NCCN National Comprehensive Cancer Network. http://www.nccn.org.
17. Roila F., Herrstedt J., Aapro M., Gralla R.J., Einhorn L.H., Ballatori E., Bria E., Clark-Snow R.A., Espersen B.T., Feyer P., Grunberg S.M., Hesketh P.J., Jordan K., Kris M.G., Maranzano E., Molassiotis A., Morrow G., Olver I., Rapoport B.L., Rittenberg C., Saito M., Tonato M., Warr D. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol 2010, 21(suppl 5):232-243. ESMO/MASCC Guidelines Working Group.
18. Navari R.M. Pathogenesis-based treatment of chemotherapy-induced nausea and vomiting: two new agents. J Support Oncol 2003, 1:89-103.
19. Grote T., Hajdenberg J., Cartmell A., Ferguson S., Ginkel A., Charu V. Combination therapy for chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy: palonosetron, dexamethasone, and aprepitant. J Support Oncol 2006, 4:408.
20. Bymaster F.P., Calligaro D.O., Falcone J.F., Marsh R.D., Moore N.A., Tye N.C., Seeman P., Wong D.T. Radioreceptor binding profile of the atypical antipsychotic olanzapine. Neuropsychopharmacology 1996, 14:87-96.
21. 6 receptors by olanzapine. Eur J Pharmacol 2001, 430:341-349.
22. Allison D.B., Casey D.E. Antipsychotic-associated weight gain: a review of the literature. J Clin Psychiatry 2001, 62:22-31.
23. Hale A.S. Olanzapine. Br J Hosp Med 1997, 58:443-445.
24. Goldstein L.E., Sporn J., Brown S., Kim H., Finkelstein J., Gaffey G.K., Sachs G., Stern T.A. New-onset diabetes mellitus and diabetic ketoacidosis associated with olanzapine treatment. Psychosomatics 1999, 40:438-443.
25. Vardy J., Chiew K.S., Galica J., Pond G.R., Tannock I.F. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer 1999, 94:1011-1015.
26. Cleeland C.S., Mendoza T.R., Wang X.S., Chou C., Harle M.T., Morrissey M., Engstrom M.C. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer 2000, 89:1634-1646.
27. Hesketh P.J., Grunberg S.M., Gralla R.J., Warr D.G., Roila F., de Wit R., Chawla S.P., Carides A.D., Ianus J., Elmer M.E., Evans J.K., Beck K., Reines S., Horgan K.J. 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, 21:4112-4119. Aprepitant Protocol 052 Study Group.
28. Navari R.M., Reinhardt R.R., Gralla R.J., Kris M.G., Hesketh P.J., Khojasteh A., Kindler H., Grote T.H., Pendergrass K., Grunberg S.M., Carides A.D., Gertz B.J. Reduction of cisplatin-induced emesis by a selective neurokin-1 receptor antagonist. N Engl J Med 1999, 340:190-195.
29. Poli-Bigelli S., Rodrigues-Pereira J., Carides A.D., Julie Ma G., Eldridge K., Hipple A., Evans J.K., Horgan K.J., Lawson F. Addition of the neurokinin-1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Cancer 2003, 97:3090-3098. Aprepitant Protocol 054 Study Group.
30. Schmoll H.J., Aapro M.S., Poli-Bigelli S., Kim H.K., Park K., Jordan K., von Pawel J., Giezek H., Ahmed T., Chan C.Y. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol 2006, 17:1000-1006.
31. Warr D.G., Hesketh P.J., Gralla R.J., Muss H.B., Herrstedt J., Eisenberg P.D., Raftopoulos H., Grunberg S.M., Gabriel M., Rodgers A., Bohidar N., Klinger G., Hustad C.M., Horgan K.J., Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol 2005, 23:2822-2830.
32. Passik S.D., Kirsh K.L., Theobald D.E., Dickerson P., Trowbridge R., Gray D., Beaver M., Comparet J., Brown J. A retrospective chart review of the use of olanzapine for the prevention of delayed emesis in cancer patients. J Pain Symptom Manage 2003, 25:485-489.
33. Pirl W.F., Roth A.J. Remission of chemotherapy-induced emesis with concurrent olanzapine treatment: a case report. Psychooncology 2000, 9:84-87.
34. 3 antagonist and a corticosteroid for prevention of chemotherapy-induced nausea and vomiting: effect of gender on treatment response. Support Care Cancer 2006, 14:354-360.
35. Rapoport B.L., Jordan K., Boice J.A., Taylor A., Brown C., Hardwick J.S., Carides A., Webb T., Schmoll H.J. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer 2010, 18:423-431.
36. Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med 2000, 342:1554-1559. Italian Group for Antiemetic Research.
37. Rudd J.A., Ngan M.P., Wai M.K., King A.G., Witherington J., Andrews P.L., Sanger G.J. Antiemetic activity of ghrelin in ferrets exposed to the cytotoxic anti-cancer agent cisplatin. Neurosci Lett 2006, 393:79-83.
38. Yakabi K., Sadakane C., Noguchi M., Ohno S., Ro S., Chinen K., Aoyama T., Sakurada T., Takabayashi H., Hattori T. Reduced ghrelin secretion in the hypothalamus of rats due to cisplatin-induced anorexia. Endocrinology 2010, 151:3773-3782.
39. Red Book Annual Drug Topic 2010, 239-243. Medical Economics, Montvale, NJ.