Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy

David G. Warr, Paul J. Hesketh, Richard J. Gralla, Hyman B. Muss, Jørn Herrstedt, Peter D. Eisenberg, Harry Raftopoulos, Steven M. Grunberg, Munir Gabriel, Anthony Rodgers, Norman Bohidar, George Klinger, Carolyn M. Hustad, Kevin J. Horgan, Franck Skobieranda

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Abstract

Purpose: This is the first study in which the NK1-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Patients and Methods: Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index-Emesis questionnaire. Results: Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. Conclusion: The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.

Original languageEnglish (US)
Pages (from-to)2822-2830
Number of pages9
JournalJournal of Clinical Oncology
Volume23
Issue number12
DOIs
StatePublished - Apr 20 2005
Externally publishedYes

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aprepitant
Nausea
Vomiting
Ondansetron
Breast Neoplasms
Drug Therapy
Cyclophosphamide
Dexamethasone
Epirubicin
Anthracyclines

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. / Warr, David G.; Hesketh, Paul J.; Gralla, Richard J.; Muss, Hyman B.; Herrstedt, Jørn; Eisenberg, Peter D.; Raftopoulos, Harry; Grunberg, Steven M.; Gabriel, Munir; Rodgers, Anthony; Bohidar, Norman; Klinger, George; Hustad, Carolyn M.; Horgan, Kevin J.; Skobieranda, Franck.

In: Journal of Clinical Oncology, Vol. 23, No. 12, 20.04.2005, p. 2822-2830.

Research output: Contribution to journalArticle

Warr, DG, Hesketh, PJ, Gralla, RJ, Muss, HB, Herrstedt, J, Eisenberg, PD, Raftopoulos, H, Grunberg, SM, Gabriel, M, Rodgers, A, Bohidar, N, Klinger, G, Hustad, CM, Horgan, KJ & Skobieranda, F 2005, 'Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy', Journal of Clinical Oncology, vol. 23, no. 12, pp. 2822-2830. https://doi.org/10.1200/JCO.2005.09.050
Warr, David G. ; Hesketh, Paul J. ; Gralla, Richard J. ; Muss, Hyman B. ; Herrstedt, Jørn ; Eisenberg, Peter D. ; Raftopoulos, Harry ; Grunberg, Steven M. ; Gabriel, Munir ; Rodgers, Anthony ; Bohidar, Norman ; Klinger, George ; Hustad, Carolyn M. ; Horgan, Kevin J. ; Skobieranda, Franck. / Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 12. pp. 2822-2830.
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abstract = "Purpose: This is the first study in which the NK1-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Patients and Methods: Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index-Emesis questionnaire. Results: Of 866 patients randomized, 857 patients (99{\%}) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8{\%} v 42.5{\%}; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5{\%} v 55.6{\%}; P = .019). Both treatments were generally well tolerated. Conclusion: The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.",
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T1 - Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy

AU - Warr, David G.

AU - Hesketh, Paul J.

AU - Gralla, Richard J.

AU - Muss, Hyman B.

AU - Herrstedt, Jørn

AU - Eisenberg, Peter D.

AU - Raftopoulos, Harry

AU - Grunberg, Steven M.

AU - Gabriel, Munir

AU - Rodgers, Anthony

AU - Bohidar, Norman

AU - Klinger, George

AU - Hustad, Carolyn M.

AU - Horgan, Kevin J.

AU - Skobieranda, Franck

PY - 2005/4/20

Y1 - 2005/4/20

N2 - Purpose: This is the first study in which the NK1-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Patients and Methods: Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index-Emesis questionnaire. Results: Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. Conclusion: The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.

AB - Purpose: This is the first study in which the NK1-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Patients and Methods: Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index-Emesis questionnaire. Results: Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. Conclusion: The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.

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