Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin

Cancer Science

Volumn 101, Issue 11, 2010, Pages 2455-2461

  Takahashi, Toshiaki ^a   Hoshi, Eishin ^b   Takagi, Masakazu ^c   Katsumata, Noriyuki ^d   Kawahara, Masaaki ^e   Eguchi, Kenji ^f  

^a SHIZUOKA CANCER CENTER   (Japan)

^b Saitama ^*  (Japan)

^c SHIZUOKA GENERAL HOSPITAL   (Japan)

^d NATIONAL CANCER CENTER HOSPITAL   (Japan)

^e OTEMAE HOSPITAL   (Japan)

^f TEIKYO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

APREPITANT; CISPLATIN; DEXAMETHASONE; GRANISETRON; PLACEBO;

ADULT; ARTICLE; CANCER CHEMOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERANCE; FEMALE; HUMAN; JAPANESE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TREATMENT RESPONSE;

AGED; ANOREXIA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIAN CONTINENTAL ANCESTRY GROUP; CISPLATIN; CONSTIPATION; DEXAMETHASONE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GRANISETRON; HICCUP; HUMANS; JAPAN; MALE; MIDDLE AGED; MORPHOLINES; NAUSEA; NEOPLASMS; PLACEBOS; TREATMENT OUTCOME;

EID: 77958559550     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/j.1349-7006.2010.01689.x     Document Type: Article

References (20)

1. Grunberg SM, Hesketh PJ. Control of chemotherapy-induced emesis. N Engl J Med 1993; 329: 1790-6.
2. Bender CM, McDaniel RW, Murphy-Ende K et al. Chemotherapy-induced nausea and vomiting. Clin J Oncol Nurs 2002; 6: 94-102.
3. Tavorath R, Hesketh PJ. Drug treatment of chemotherapy-induced delayed emesis. Drugs 1996; 52: 639-48.
4. Kris MG, Cubeddu LX, Gralla RJ et al. Are more antiemetic trials with a placebo necessary? Report of patient data from randomized trials of placebo antiemetics with cisplatin Cancer 1996; 78: 2193-8.
5. Gralla RJ, Osoba D, Kris MG et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. J Clin Oncol 1999; 17: 2971-94. Erratum in: J Clin Oncol 1999; 17: 3860. J Clin Oncol 2000; 18: 3064.
6. 3 antagonist prophylaxis is not maintained. J Clin Oncol 1996; 14: 644-51.
7. De Wit R, Van Den Berg H, Burghouts J et al. Initial high anti-emetic efficacy of granisetron with dexamethasone is not maintained over repeated cycles. Br J Cancer 1998; 77: 1487-91.
8. Kris MG, Gralla RJ, Tyson LB, Clark RA, Cirrincione C, Groshen S. Controlling delayed vomiting: double-blind, randomized trial comparing placebo, dexamethasone alone, and metoclopramide plus dexamethasone in patients receiving cisplatin. J Clin Oncol 1989; 7: 108-14.
9. Hesketh PJ, Grunberg SM, Gralla RJ 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(22): 4112-9. Epub 2003 Oct 14.
10. Poli-Bigelli S, Rodrigues-Pereira J, Carides AD et al. Addition of the neurokinin 1 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(12): 3090-8.
11. Chawla SP, Grunberg SM, Gralla RJ et al. Establishing the dose of the oral NK1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting. Cancer 2003; 97(9): 2290-300.
12. Warr DG, Hesketh PJ, Gralla RJ et al. 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: 2822-30.
13. American society of clinical oncology, Kris MG, Hesketh PJ, Somerfield MR et al. American society of clinical oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol 2006; 24: 2932-47.
14. Roila F, Hesketh PJ, Herrstedt J. Antiemetic Subcommittee of the Multinational Association of Supportive Care in Cancer (MASCC). Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol 2006; 17: 20-8.
15. NCCN Clinical Practice Guidelines in OncologyTM. Antiemesis V.1. 2007.
16. 1 antagonist aprepitant for the prevention of acute and delayed chemotherapy-induced nausea and vomiting: pooled data from 2 randomised, double-blind, placebo controlled trials. Eur J Cancer 2005; 41(9): 1278-85.
17. Nygren P, Hande K, Petty KJ et al. Lack of effect of aprepitant on the pharmacokinetics of docetaxel in cancer patients. Cancer Chemother Pharmacol 2005; 55(6): 609-16.
18. Loos WJ, De Wit R, Freedman SJ et al. Aprepitant when added to a standard antiemetic regimen consisting of ondansetron and dexamethasone does not affect vinorelbine pharmacokinetics in cancer patients. Cancer Chemother Pharmacol 2007; 59(3): 407-12.
19. 1 receptor antagonist aprepitant on the pharmacokinetics of dexamethasone and methylprednisolone. Clin Pharmacol Ther 2003; 74(1): 17-24.
20. Nakade S, Ohno T, Kitagawa J et al. Population pharmacokinetics of aprepitant and dexamethasone in the prevention of chemotherapy-induced nausea and vomiting. Cancer Chemother Pharmacol 2008; 63: 75-83. Epub 2008 Mar 4.