Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: A randomised, active-controlled, double-blind, phase 3 trial

The Lancet Oncology

Volumn 16, Issue 9, 2015, Pages 1071-1078

  Schwartzberg, Lee S ^a   Modiano, Manuel R ^b   Rapoport, Bernardo L ^c   Chasen, Martin R ^d   Gridelli, Cesare ^e   Urban, Laszlo ^f   Poma, Allen ^g   Arora, Sujata ^g   Navari, Rudolph M ^h   Schnadig, Ian D ⁱ  

^a WEST CLINIC   (United States)

^b Arizona Clinical Research Center and Arizona Oncology   (United States)

^c Medical Oncology Centre of Rosebank   (South Africa)

^d OTTAWA REGIONAL CANCER CENTRE   (Canada)

^e S G MOSCATI HOSPITAL   (Italy)

^f Matrahaza Healthcare Center and University Teaching Hospital   (Hungary)

^g TESARO   (United States)

^h INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ Medical Oncology Hematology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; CARBOPLATIN; CYCLOPHOSPHAMIDE; CYTARABINE; DAUNORUBICIN; DEXAMETHASONE; DOXORUBICIN; EPIRUBICIN; GRANISETRON; IDARUBICIN; IFOSFAMIDE; IRINOTECAN; PLACEBO; ROLAPITANT; 8-((1-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)ETHOXY)METHYL)-8-PHENYL-1,7-DIAZASPIRO(4,5)DECAN-2-ONE; SPIRO COMPOUND;

ADULT; ADVERSE OUTCOME; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CONSTIPATION; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEADACHE; HUMAN; INCIDENCE; KARNOFSKY PERFORMANCE STATUS; LIFE EXPECTANCY; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEOPLASM; NEUTROPENIA; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; ADVERSE DRUG REACTION; CHEMICALLY INDUCED; CLINICAL TRIAL; MIDDLE AGED; NAUSEA; NEOPLASMS; PATHOLOGY; VERY ELDERLY; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTHRACYCLINES; CYCLOPHOSPHAMIDE; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NAUSEA; NEOPLASMS; SPIRO COMPOUNDS; VOMITING;

EID: 84940587425     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)00034-0     Document Type: Article

References (20)

1. Aapro M, Molassiotis A, Dicato M, et al. The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Ann Oncol 2012, 23:1986-1992.
2. Jordan K, Gralla R, Jahn F, Molassiotis A International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol 2014, 722:197-202.
3. Hesketh PJ Chemotherapy-induced nausea and vomiting. N Engl J Med 2008, 358:2482-2494.
4. Clinical practice guidelines in oncology: antiemesis, version 2 National Comprehensive Cancer Network, (accessed Dec 9, 2014). http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf.
5. Roila F, Herrstedt J, Aapro M, et al. 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):v232-v243.
6. Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 2011, 29:4189-4198.
7. Salsman JM, Grunberg SM, Beaumont JL, et al. Communicating about chemotherapy-induced nausea and vomiting: a comparison of patient and provider perspectives. J Natl Compr Canc Netw 2012, 10:149-157.
8. Emend (package insert) 2009, Merck & Co, Merck & Co, Whitehouse Station.
9. Akynzeo (package insert) 2014, Helsinn Healthcare, Helsinn Healthcare, Lugano.
10. McCrea JB, Majumdar AK, Goldberg MR, et al. Effects of the neurokinin-1 receptor antagonist aprepitant on the pharmacokinetics of dexamethasone and methylprednisolone. Clin Pharmacol Ther 2003, 74:17-24.
11. 1 receptor antagonist, on the pharmacokinetics of midazolam, erythromycin, and dexamethasone. Support Care Cancer 2013, 21:2783-2791.
12. Poma A, Christensen J, Pertikis H, et al. Rolapitant and its major metabolite do not affect the pharmacokinetics of midazolam, a sensitive cytochrome P450 3A4 substrate. Presented at the Multinational Association of Supportive Care in Cancer 2013 annual meeting; Berlin, Germany; June 27-29, 2013. Abstr 441.
13. Duffy RA, Morgan C, Naylor R, et al. Rolapitant (SCH 619734): a potent, selective and orally active neurokinin NK-1 receptor antagonist with centrally-mediated antiemetic effects in ferrets. Pharmacol Biochem Behav 2012, 102:95-100.
14. Poma A, Christensen J, Davis J, Kansra V, Martell RE, Hedley ML Phase 1 positron emission tomography (PET) study of the receptor occupancy of rolapitant, a novel NK-1 receptor antagonist. Proc Am Soc Clin Oncol 2014, 32(suppl). abstr e20690.
15. Rapoport BL, Chasen MR, Gridelli C, et al. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials. Lancet Oncol 2015, published online Aug 11. http://dx.doi.org/10.1016/S1470-2045(15)00035-2.
16. Lindley CM, Hirsch JD, O'Neill CV, Transau MC, Gilbert CS, Osterhaus JT Quality of life consequences of chemotherapy induced emesis. Qual Life Res 1992, 1:331-340.
17. 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, 12:2822-2830.
18. Rapoport BL, Jordan K, Boice JA, et al. 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.
19. Rojas C, Raje M, Tsukamoto T, Slusher BS Molecular mechanisms of 5-HT(3) and NK(1) receptor antagonists in prevention of emesis. Eur J Pharmacol 2014, 722:26-37.
20. Rapoport B, Chua D, Poma A, Arora S, Yan Wang Y, Fein LE Study of rolapitant, a novel, long-acting, NK-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC). Support Care Cancer 2015, published online May 5. 10.1007/s00520-015-2738-1.