Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: A randomized, double-blind, placebo-controlled phase III trial

Supportive Care in Cancer

Volumn 22, Issue 4, 2014, Pages 979-987

  Hu, Zhihuang ^a   Cheng, Ying ^b   Zhang, Hongyu ^c   Zhou, Caicun ^d   Han, Baohui ^e   Zhang, Yiping ^f   Huang, Cheng ^g   Chang, Jianhua ^h   Song, Xiangqun ⁱ   Liang, Jun ^j   Liang, Houjie ^k   Bai, Chunxue ^l   Yu, Shiying ^m   Chen, Jia ⁿ   Wang, Jie ^o   Pan, Hongming ^p   Chitkara, Denesh K ^q   Hille, Darcy A ^q   Zhang, Li ^a  

^a SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^b JILIN PROVINCIAL CANCER HOSPITAL   (China)

^c SUN YAT SEN UNIVERSITY   (China)

^d TONGJI UNIVERSITY   (China)

^e SHANGHAI JIAO TONG UNIVERSITY   (China)

^f ZHEJIANG CANCER HOSPITAL   (China)

^g FUJIAN MEDICAL UNIVERSITY   (China)

^h FUDAN UNIVERSITY SHANGHAI CANCER CENTER   (China)

ⁱ China Mobile Group the Guangxi Zhuang Autonomous Region Co Ltd   (China)

^j QINGDAO UNIVERSITY   (China)

^k THIRD MILITARY MEDICAL UNIVERSITY   (China)

^l FUDAN UNIVERSITY   (China)

^m HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY   (China)

ⁿ JIANGSU CANCER HOSPITAL   (China)

^o PEKING UNIVERSITY CANCER HOSPITAL AND INSTITUTE   (China)

^p ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE   (China)

^q MERCK RESEARCH LABORATORIES   (United States)

more..

Author keywords

Aprepitant; Emesis; Emetogenic chemotherapy; Nausea; Standard antiemetic treatment

Indexed keywords

APREPITANT; CISPLATIN; DEXAMETHASONE; GRANISETRON; PLACEBO;

ADULT; ARTICLE; CANCER REGRESSION; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; ELECTROCARDIOGRAPHY; FATIGUE; FEMALE; FOLLOW UP; HUMAN; INSOMNIA; INTENTION TO TREAT ANALYSIS; KARNOFSKY PERFORMANCE STATUS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SAMPLE SIZE; SIDE EFFECT; TREATMENT RESPONSE; VOMITING;

ANTIEMETICS; ANTINEOPLASTIC AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; CISPLATIN; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MORPHOLINES; NAUSEA; VOMITING;

EID: 84895878181     PISSN: 09414355     EISSN: 14337339     Source Type: Journal    
DOI: 10.1007/s00520-013-2043-9     Document Type: Article

References (32)

1. Hesketh PJ (2008) Chemotherapy-induced nausea and vomiting. N Engl J Med 358:2482-2494
2. Cohen L, de Moor CA, Eisenberg P et al (2007) Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer 15:497-503 (Pubitemid 46570778)
3. Laszlo J, Lucas VS Jr (1981) Emesis as a critical problem in chemotherapy. N Engl J Med 305:948-949 (Pubitemid 11014537)
4. Fernandez-Ortega P, Caloto MT, Chirveches E et al (2012) Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients' quality of life. Support Care Cancer 20:3141-3148
5. Warr D (2012) Management of highly emetogenic chemotherapy. Curr Opin Oncol 24:371-375
6. Grunberg SM, Deuson RR, Mavros P et al (2004) Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer 100:2261-2268 (Pubitemid 38580348)
7. Hargreaves R, Ferreira JC, Hughes D et al (2011) Development of aprepitant, the first neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting. Ann N Y Acad Sci 1222:40-48
8. Diemunsch P, Joshi GP, Brichant JF (2009) Neurokinin-1 receptor antagonists in the prevention of postoperative nausea and vomiting. Br J Anaesth 103:7-13
9. Navari RM, Reinhardt RR, Gralla RJ et al (1999) Reduction of cisplatin-induced emesis by a selective neurokinin-1-receptor antagonist. L-754,030 Antiemetic Trials Group. N Engl J Med 340:190-195 (Pubitemid 29063215)
10. Campos D, Pereira JR, Reinhardt RR et al (2001) 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 19:1759-1767 (Pubitemid 32230878)
11. Hesketh PJ, Grunberg SM, Gralla RJ et al (2003) 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 21:4112-4119 (Pubitemid 46606178)
12. Poli-Bigelli S, Rodrigues-Pereira J, Carides AD et al (2003) 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 97:3090-3098 (Pubitemid 36676265)
13. de Wit R, Herrstedt J, Rapoport B et al (2003) Addition of the oral NK1 antagonist aprepitant to standard antiemetics provides protection against nausea and vomiting during multiple cycles of cisplatin-based chemotherapy. J Clin Oncol 21:4105-4111 (Pubitemid 46606177)
14. Herrstedt J, Muss HB, Warr DG et al (2005) Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and emesis overmultiple cycles ofmoderately emetogenic chemotherapy. Cancer 104:1548-1555 (Pubitemid 41356171)
15. Yeo W, Mo FK, Suen JJ et al (2009) A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy. Breast Cancer Res Treat 113:529-535
16. Takahashi T, Hoshi E, Takagi M et al (2010) Multicenter, phase II, placebo-controlled, double-blind, randomized study of aprepitant in Japanese patients receiving high-dose cisplatin. Cancer Sci 101:2455-2461
17. McCrea JB, Majumdar AK, Goldberg MR et al (2003) Effects of the neurokinin1 receptor antagonist aprepitant on the pharmacokinetics of dexamethasone and methylprednisolone. Clin Pharmacol Ther 74:17-24 (Pubitemid 36776172)
18. Boogaerts JG, Vanacker E, Seidel L et al (2000) Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand 44:470-474 (Pubitemid 30159025)
19. Martin AR, Pearson JD, Cai B et al (2003) Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives: a modified version of the Functional Living Index-Emesis (FLIE) with 5-day recall. Support Care Cancer 11:522-527 (Pubitemid 36994435)
20. Decker GM, DeMeyer ES, Kisko DL (2006) Measuring the maintenance of daily life activities using the functional living index-emesis (FLIE) in patients receiving moderately emetogenic chemotherapy. J Support Oncol 4:35-41, 52
21. Martin AR, Carides AD, Pearson JD et al (2003) Functional relevance of antiemetic control: experience using the FLIE questionnaire in a randomised study of the NK-1 antagonist aprepitant. Eur J Cancer 39:1395-1401 (Pubitemid 36773782)
22. Feyer P, Jordan K (2011) Update and new trends in antiemetic therapy: the continuing need for novel therapies. Ann Oncol 22:30-38
23. Aapro M, Molassiotis A, Dicato M et al (2012) The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Ann Oncol 23:1986-1992
24. Roila F, Herrstedt J, Aapro M et al (2010) 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 21(Suppl 5):v232-v243
25. Basch E, Prestrud AA, Hesketh PJ et al (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189-4198
26. Ettinger DS, Armstrong DK, Barbour S et al (2012) Antiemesis. J Natl Compr Cancer Netw 10:456-485
27. Jordan K, Hinke A, Grothey A et al (2007) A meta-analysis comparing the efficacy of four 5-HT3-receptor antagonists for acute chemotherapy-induced emesis. Support Care Cancer 15:1023-1033 (Pubitemid 47340963)
28. Billio A, Morello E, Clarke MJ (2010) Serotonin receptor antagonists for highly emetogenic chemotherapy in adults. Cochrane Database Syst Rev. doi:10.1002/14651858.CD006272.pub2, CD006272
29. del Giglio A, Soares HP, Caparroz C et al (2000) Granisetron is equivalent to ondansetron for prophylaxis of chemotherapy-induced nausea and vomiting: results of a meta-analysis of randomized controlled trials. Cancer 89:2301-2308
30. Botrel TE, Clark OA, Clark L et al (2011) Efficacy of palonosetron (PAL) compared to other serotonin inhibitors (5-HT3R) in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately or highly emetogenic (MoHE) treatment: systematic review and meta- analysis. Support Care Cancer 19:823-832
31. Olver IN (1996) Antiemetic study methodology: recommendations for future studies. Oncology 53(Suppl 1):96-101
32. Longo F, Mansueto G, Lapadula V et al (2012) Combination of aprepitant, palonosetron and dexamethasone as antiemetic prophylaxis in lung cancer patients receiving multiple cycles of cisplatin-based chemotherapy. Int J Clin Pract 66:753-757